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CPRIT 4

FUTURE DIRECTIONS MEETING 5

JUNE 26, 2012 6

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BE IT REMEMBERED that the above-entitled meeting 10

came on the 26th day of June, 2012, from 10:04 a.m. until 11

2:58 p.m. at the Renaissance Hotel, 9721 Arboretum Blvd., 12

Sabine Room, Austin, Texas and the following proceedings 13

were reported by me, Denise Ganz Byers, Certified 14

Shorthand Reporter in and for the State of Texas. 15

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BILL GIMSON: First of all, thanks to 1

everyone here for coming today and taking important 2

time out of your schedule to be with us. 3

I think I know most folks in the room or 4

probably all of the folks in the room, I'm Bill 5

Gimson, the Executive Director of the Cancer Prevention & 6

Research Institute of Texas. Around you are more than 7

30 members of our Advisory Committees for CPRIT, so, 8

actually, this is the very first time that all of the 9

Advisory Committees have met in one place at one time, 10

so we're pretty excited. 11

Also, we have our Chairs. 12

Dr. Phil Sharp is going to join us from the Scientific 13

Review Council. Dr. Bob Ulrich -- 14

Bob, are you on the phone? 15

BOB ULRICH: Yes, I am, Bill. 16

BILL GIMSON: Great. Thanks, Bob. 17

Bob is the Chair of our 18

Commercialization Review Council. 19

I believe Dr. Steve Wyatt is here. 20

Steve is the Director of our Prevention Review Council. 21

John Nemunaitis, I know John is here. 22

Hi, John. 23

John is the Chair of our Scientific & 24

Prevention Advisory Committee.25

3

Dr. Gail Tomlinson -- 1

Everyone is a doctor, so maybe we'll just drop that; 2

right? 3

(Laughter.) 4

Gail, you're here. Gail Tomlinson is 5

the Chair of our Advisory Committee on Childhood 6

Cancer. 7

Joe Cunningham -- Joe, are you on the 8

phone? I think Joe is going to join us. Joe is the 9

Chair of our Commercialization Strategy 10

Committee. 11

And last, but certainly not least, Jim 12

Willson. Jim is the Chair of our University Advisory 13

Committee. 14

Jim, thanks for being here today. 15

We've been planning this workshop 16

since our last board meeting, about three 17

months ago, and we felt that it was time for us 18

to take stock of where we are at CPRIT, 19

consider fresh ideas and look at big ideas for moving 20

forward. 21

I'm very pleased that Mr. Jim Down -- 22

Jim is a former Vice Chair of Mercer Management 23

Consulting -- will be facilitating the 24

event today. Jim is a senior strategic advisor, has25

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worked for AT&T, Merck and other large 1

Fortune 500 firms. Jim volunteered to come down and 2

help us today, so we're very, very excited. 3

Jim is going to be joined by Jennifer 4

Redmond. Jennifer has a wealth of experience working 5

with the Kentucky Cancer Consortium. 6

Jennifer, welcome. 7

We plan to follow this meeting 8

with a group of regional meetings, and I know Dr. Becky 9

Garcia, our Chief Prevention Officer, has selected a 10

couple of cities with our input. 11

Can I say them? Can I mention the 12

cities, Becky? 13

Let's see, what's the first one, Paris? 14

No. They are Dallas, Houston, Lubbock and San Antonio. So 15

we plan to host regional events around the 16

state in a very rapid fashion to move this 17

process forward quickly. 18

Also, in addition, for anyone 19

who is unable to attend a session in person, we will 20

have an online survey where anybody in the 21

state can join online and offer recommendations. 22

The recommendations -- or at least23

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preliminary recommendations -- are going to be presented 1

at CPRIT's Third Annual Conference to be held 2

right here in this hotel in October, October 24th 3

through the 26th. We're excited about the prospect 4

of having the recommendations presented at that time. 5

So, I'm very aware of the fact 6

that the clock is ticking. We've spent about 7

30 percent of our time, so we're very quickly eating up 8

the precious time left that CPRIT has. It really feels like 9

it's passed in the blink of an eye. 10

We've had some impressive successes, and, as 11

you know, we've had a few challenges, and I'm going to 12

talk about the challenge in a few minutes. But we know 13

that we only have seven years to finish our work. 14

So what we want to do is lay out a road 15

map for the next two to three years. We've asked you 16

here because we need your help now that we know where we are. 17

I jokingly say that sometimes, but until you can figure out where 18

you're going, you have to figure out where you are. 19

It took us a couple of years to establish 20

the portfolios and really understand how we had set up the 21

foundation of the institute.22

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But right now, before I go on, I wanted 1

to ask Jim to come up for a few minutes and walk us through 2

the process today and answer any questions you might have. 3

Thank you, Jim. 4

JIM DOWN: Thank you, Bill. 5

I am delighted to be here today. I live 6

in Massachusetts so I don't get to Austin very often, 7

and I have to say I'm extremely impressed with your 8

weather here. I thought I had to go to Kuwait to get 9

temperatures of 106, and now I find I can just come 10

here. Luckily, today we'll be sequestered in this very 11

cool room, which I hope will be conducive to a lot of 12

discussion. 13

The whole day has been structured for 14

input. As Bill said, I think given that CPRIT has been 15

in existence about three years, it's an excellent time 16

to pull up and start to ask some questions. Are they 17

working on the right things? What does the future look 18

like? We'll really spend the whole day in discussion 19

mode. 20

You're going to see one presentation 21

today. We asked Bill to give a brief presentation 22

upfront just to do some level setting. I think 23

everybody here certainly knows the organization, but24

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everybody would have different levels of knowledge, and 1

we thought it would be helpful to just go through some 2

facts and figures on what the organization has been 3

doing. 4

So I'd ask you to hold your questions on 5

that until Bill gets done; and then if you do have any 6

questions on what he's presented, we'll have some time 7

to go through that. 8

Then we'll switch into the discussion 9

mode. We're going to talk about what success looks 10

like looking down the road, and I'll come back and talk 11

a little bit more about that later on. We'll talk 12

about impact, how CPRIT can have the most impact. 13

We'll talk about what the organization can do perhaps 14

that other organizations can't do. We'll talk about 15

differentiation. 16

We'll talk about resource allocation. 17

We did ask most of you to do a little survey in advance 18

of the meeting, and I would say the results of that I 19

find quite fascinating. But particularly on resource 20

allocation, it's fair to say that we have some very 21

different views on that in the room, so we'll talk 22

about that. 23

Then we'll also talk about process 24

improvements and how potentially processes could be25

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improved going forward. 1

So that's pretty much the day. We will 2

take a break for lunch between 12 and 1. We know that 3

all of you probably have e-mails or phone calls to 4

return or just use the chance to network while you're 5

here. 6

A couple of things in terms of roles. 7

My role is very simple today. I'm here to move the 8

discussion along, make sure that people participate, 9

make sure that we cover the subjects not in too rigidly 10

a fashion, but at least in some reasonable order, so I 11

view that as relatively easy overall. 12

Now, your role is potentially easy, but 13

we'll see. Your role is really to participate. What 14

I'd ask you to do -- and I know that you all come from 15

different constituencies, so obviously you're going to 16

have that hat on at times -- but, also, as we talk 17

about the organization I'd ask you all to try to take a 18

broader view, because we'll get a lot more out of the 19

meeting if people can really step back and think about 20

this organization that's been in existence three years. 21

So I would ask you to wear two hats over the course of 22

the meeting. 23

The logistics of this meeting are a bit 24

complex, but, as I understand it, we do have a phone25

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line for anybody that wants to listen in, but those 1

people will not be able to make comments, but there are 2

a number of people that are probably listening in. 3

We do have three people -- Bill, you 4

mentioned two of them, and the third is -- 5

BILL GIMSON: Dr. Phil Sharp. 6

JIM DOWN: -- and Lawrence Green. 7

RAMONA MAGID: And one more. Dr. Juan 8

Carlos Bernini. He's dialing in now. 9

JIM DOWN: Okay. So we will have four 10

people that actually will be participating on the 11

phone, not for the whole meeting, but some at various 12

times of the day. So that always gets a little tricky 13

and I will do my best to certainly include those people 14

and ask them for input. But your role is to 15

participate today. 16

The person who I think has the most 17

difficult role is Denise, who is trying to record this 18

session and, therefore, it would be helpful for her if 19

when you make a statement you could identify yourself. 20

I know that could be a little bit disruptive, but I 21

think that's the only way to really have her match up 22

the comments with the people, so we're going to ask you 23

to do that. 24

Jennifer is going to compensate for one25

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of my great weaknesses. I am left-handed, and I will 1

attribute that to the fact that my penmanship has never 2

been a great strength of mine. 3

JENNIFER REDMOND: Oh, I'm also 4

left-handed, so we'll see how that works. 5

JIM DOWN: Okay. But, Jennifer, whether 6

she's capturing it up there or capturing it through 7

other means, will be trying to just capture the essence 8

of the meeting, so that's also a difficult role. 9

So that is pretty much the day, I would 10

say. I think it's going to be a very good day. I 11

certainly look forward to learning from all of you, and 12

I hope that you look forward to learning from each 13

other, and I hope that we can have some very candid and 14

productive discussions. 15

So unless anybody has any questions on 16

the logistics or how the day is going to work, I will 17

ask Bill to take us through his overview. 18

BILL GIMSON: Speak up? You know, I 19

usually speak pretty loud, but I'll speak a little bit 20

louder. 21

As Jim said, what we really want to do 22

today is ask ourselves some very important questions 23

about accomplishments, about CPRIT's impact, about 24

success and what is the right allocation of funds for25

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our portfolios. 1

So one of the questions that we really 2

want to ask is how can we improve our processes? CPRIT 3

has received a lot of attention lately for an award 4

that we made. Our peer reviewers -- Prevention, 5

Research and Commercialization -- have diligently 6

reviewed 3,000 applications and recommended almost 400 7

for funding. And while CPRIT's very first Incubator 8

Award was peer reviewed and recommended by the 9

Commercialization Review Council, some of our own steps 10

for the review were not followed. 11

We pride ourselves on being nimble and 12

not overly bureaucratic, but not at the expense of 13

doing a thorough job. 14

It's been a point of pride that CPRIT 15

has earned a reputation for a gold standard review 16

process, free from conflicts of interest and unfair 17

influence, exactly what Al Gilman insisted on from Day One. 18

The departure from the standard process 19

unfairly casts doubt on a program that promises to 20

deliver innovative approaches to finding cancer cures. 21

Exactly why we were created.22

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The project will be resubmitted, the 1

project will comply with all of our requirements -- 2

and, again, it was CPRIT that didn't ensure the 3

compliance -- and the project will undergo a scientific 4

and commercial review. 5

What we're interested in today is 6

hearing from you any recommendations on how we can 7

improve that process. Our Oversight Committee is 8

extremely interested in what happens today. They 9

absolutely want a very fast report because they want 10

these recommendations very quickly codified. 11

Obviously, not all of the recommendations will be 12

accepted by the Oversight Committee. 13

As I think folks know, we have an 14

eleven-member board; nine members are private citizens, 15

one member is the Comptroller of the State of Texas, 16

one member is the Attorney General of the State of 17

Texas. All volunteer their time, all are passionate 18

about the work that we're doing at CPRIT, all are 19

very public service oriented and all are looking for 20

performance. 21

So from our perspective, these board 22

members are extremely interested in your advice and, 23

again, you represent the total sum of our Advisory 24

Committees and the responsibility of our Advisory25

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Committees is to advise the Oversight Committee. What 1

they want is the best for Texas and the best for cancer 2

patients, survivors and their families in the State of 3

Texas. 4

CPRIT's future direction is really 5

very much in your hands. You're the members of our 6

committees. We turn to you for advice and input. And 7

I'm pleased that all of the Chairs of the 8

committees are participating today. 9

In addition, we have some very important 10

stakeholders: The Lance Armstrong Foundation, the 11

American Cancer Society, Susan G. Komen for the Cure, 12

THBI and the Cancer Alliance of Texas and others. 13

What I want to do is provide you a 14

little bit of an update on CPRIT, where we've been, our 15

goals, our progress to date and how we plan to measure our 16

success. 17

I think you can see in this slide our 18

Legislative mandate. This is the mandate 19

to the Executive Director to give priorities to these 20

areas: Investing in innovative and game-changing 21

projects; expanding research capabilities around the 22

state; strengthening science; focusing on comprehensive 23

and coordinated approaches to cancer activities;24

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demonstrating economic benefit; expediting innovation 1

and commercialization; expanding the private sector; 2

increasing high-quality jobs; and collaboration between 3

organizations. 4

So when we look at proposals that come 5

forward, these are the areas that we're extremely 6

interested in as directed by the Legislature. 7

At CPRIT, we try and keep our internal 8

costs low. Our in-house costs at CPRIT, for every grant 9

dollar invested, is a little more than 1-1/2 10

cents. This really is our overhead. This is the 11

day-to-day operations. These are the 18 or 20 FTEs 12

that we have working full-time at the agency. 13

In terms of processing grants -- the 3,000 14

proposals and all of the associated work that goes 15

along with the cost of doing business -- we spend a 16

little more than 2 cents for every grant dollar 17

invested. So we are very conscious about spending 18

taxpayer dollars and making sure we get the best value 19

for the buck, so to speak. 20

I think we all know that the annual cost 21

of cancer is $28 billion in 2011. To date, we've invested 22

$647 million to combat cancer in Texas. 23

An economic assessment of the cost of24

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cancer and the benefits that CPRIT brings to the state 1

that was compiled by the Perryman Group shows that 2

every CPRIT dollar generates $4.78 in economic output 3

and every CPRIT dollar generates $1.99 in state and 4

local revenue with thousands of jobs created. 5

To date, we've awarded about $650 million. 6

We invest those funds across our portfolios as you can 7

see the numbers, prevention, research and commercialization. 8

The funding distribution by portfolio is 9

interesting. We don't have any set-asides for cancer 10

type. We have no set-asides for regions. 11

Our overall funding principles are: 12

invest in the best; look for innovation, importance and 13

impact; encourage risks, but risks for greater success; 14

put discoveries into practice; recruit talent; and 15

always be stewards of the public trust. 16

Again, research that primarily occurs in 17

academic institutions right now takes the bulk of our 18

portfolio. Of course, evidence-based prevention 19

activities are limited by statute to no more than 10 20

percent. But having said that, our instructions not 21

only from the Legislature but also from the Oversight 22

Committee is to take a look at all of the portfolios 23

and give us your best judgment.24

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This slide shows funding distribution by 1

institution. We can get into more detail about that in 2

the future. 3

We've always had the question about 4

translational research, and I remember that Dr. Osborne 5

brought that up at an SPAC meeting probably two and a half 6

years ago. 7

What we've done is ask principal 8

investigators to self-identify what type of research 9

they are proposing. 10

So this gives you a little bit of a 11

flavor of what we've invested in. Of course, no 12

definition is perfect. There must be an overlap, 13

because if we didn't overlap there'd be a gap. And I 14

think we know that in the research continuum, there's 15

really not a gap. But, again, I will just leave this 16

slide and let you give me your 17

opinions of how accurate you think that may be. 18

One of our most successful programs has 19

been the CPRIT Scholars in Cancer Research. It's a 20

program that not only people throughout Texas talk about, 21

but people certainly throughout the country talk about. 22

We're bringing the best talent to the 23

state of Texas. We're building our research 24

superiority for the next 20 years. To date, we've 25

approved and accepted 43 CPRIT scholars in cancer 26

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research. 1

Again, it's very exciting. You can see 2

the different categories. We have first-time tenured 3

track scholars, we have rising stars, we have 4

established investigators, we have missing links, someone 5

who can be plugged into a team. We also have clinical 6

investigators and translational investigators. I don't 7

believe we've had many proposals in those categories. 8

Again, folks are aware of the state-wide 9

Clinical Trials Network. It's being led by Dr. Chuck 10

Geyer. I'm sure everyone in this room has met 11

Dr. Geyer. It's a statewide network that is intended 12

to provide cutting-edge therapies to citizens around 13

the state. 14

Texas, we hope, will lead the nation in 15

the best clinical trials. There's a board that's been 16

established for CTNeT. The leadership team has been 17

recruited, the infrastructure is in development with a18

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centralized IRB. Trial candidates have been selected 1

and I believe that six trials will start very soon. 2

Chuck's goal is that by the end of the calendar year 3

we will have them operational. 4

Mr. Jerry Cobbs is here today. Jerry is 5

our Chief Commercialization Officer. If you have any 6

specific questions about the commercialization portfolio, 7

please don't hesitate to ask Jerry during the breaks. 8

We have a number of different types of 9

requests for applications under commercialization. 10

Obviously, company commercialization, company 11

relocation -- where we would move a company to the 12

state of Texas, and I believe we just awarded our first 13

company relocation which is exciting. It's a company 14

coming in from the UK with an affiliation with Baylor 15

College of Medicine. We also have a company formation 16

RFA where we actually look at forming a new company. 17

We have an accelerator program that allows industry to 18

have access to our research portfolio and utilize a sort 19

of one-stop shopping mechanism with CPRIT. 20

The Texas Life Science Incubator 21

Infrastructure Program RFA is now being retweaked.22

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Last, but not least, we have the 1

Entrepreneur-in-Residence Program, which in many ways 2

is similar to the CPRIT Scholar in Cancer Research, but 3

brings in entrepreneurs and plugs them into industries 4

here in the state of Texas. We've recently brought in our 5

first entrepreneur. 6

Jerry can talk a little bit about this. 7

We have invested in 13 companies, and for the first seven 8

companies, if you look at the total CPRIT investment 9

of roughly $61 million, the outside capital that was 10

attracted totaled $200 million. 11

One of the goals of CPRIT is to 12

attract follow-on capital after investments in these 13

companies, and so we're very pleased with this metric, 14

and it's increasing with the additional companies that 15

we've awarded. And, just as a footnote, we've also 16

received royalties from companies. 17

I think everyone knows that our grant 18

contracts require a return on investment clause in 19

either a royalty benefit or an equity benefit. One 20

company has already sent us four or five royalty checks.21

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The prevention program, evidence-based 1

prevention, is led by Dr. Becky Garcia, who is here. 2

Again, you can see the portfolio on this slide. Clinical 3

services is obviously the biggest area of the prevention 4

program, and the biggest component of that would be 5

the screening program, looking at screening for breast 6

cancer, screening for cervical cancer and screening for 7

colorectal cancer. All three of these are critically 8

important to the people of the state of Texas. 9

We know we can have a dramatic impact on 10

cervical cancer through virtual elimination, we know we 11

can have a dramatic impact on colorectal cancer through 12

screening and we know that we can have a very good 13

impact on breast cancer in terms of detecting at an 14

earlier stage of diagnosis. 15

So Becky's program is very exciting. 16

You can see by this map that it's state-wide. We have 17

75 projects covering the entire state. Again, if you 18

have any questions, please grab Becky at the break. 19

As you know, we serve Texans. You can 20

see the numbers of education and training contacts on 21

this slide. Again, I mentioned the clinical services.22

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One area that I'd like to highlight is 1

our tobacco-free policy. Now, the tobacco-free policy, 2

apart from being extremely important for an institute 3

like CPRIT, was one of the recommendations 4

from our Scientific and Prevention Advisory Council. 5

So I think folks in this room should 6

realize that these recommendations do go through the 7

system and do go to the Oversight Committee. We've 8

been able to implement the tobacco policy. Any 9

institution in the state of Texas -- company, private, 10

public, academic, nonacademic -- receiving CPRIT funds 11

must have a tobacco-free policy. 12

Thanks to the SPAC, now 13

UT-Austin is completely tobacco-free and the University 14

of Houston is going to be -- I don't know if UT-Austin 15

has completely implemented it and I'm not sure whether 16

University of Houston has completely implemented it, 17

but we're going to take credit for the fact that these 18

institutions have looked to CPRIT and have used us as 19

a sort of guidepost to move forward and implement a 20

tobacco-free policy. So we're very excited at that. 21

Becky's group put in much time with many 22

folks in this room developing the 2012 Texas Cancer 23

Plan. The last plan was actually issued in 2005. 24

Many of our partners, as I said, participated in that. 25

I'm very pleased, because there are 26

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actual measurable objectives in that plan, which really 1

is something that we all ought to hold ourselves to in 2

terms of trying to show the people of Texas that we're 3

serious about what we're doing. 4

So at CPRIT, we really do 5

pride ourselves on being a learning organization. 6

That's why we're here today. We're going to 7

reinvent ourselves on a regular basis. We're going to 8

reinvent ourselves to make a difference. And that's 9

why we really need your help. We need folks in this 10

room to advise us. 11

Looking at funding distributions 12

right away indicates how serious we are. I mean, this 13

is a meeting where we are going to take those 14

recommendations, distill them and turn around and give 15

them to the Oversight Committee. And the Oversight 16

Committee, I can assure you, will implement the best of the 17

recommendations. 18

Let me mention that there's an entire 19

group of CPRIT employees here, I won't go through all 20

of them -- just look for the name tags and please make 21

sure you meet them.22

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So we're going to have a smaller working 1

group, probably 10 people, maybe 15 people. I mentioned 2

the online survey, the regional meetings. We're going to 3

ask the smaller working group to help us in terms of going 4

around to the regional meetings. We're providing transcripts 5

of all of the meetings on the website. I think that's important. 6

As Jim said, we have a listen-only phone 7

line that literally anybody in the state of Texas can 8

call in. We sent out the invitation to our LISTSERV, 9

which is approximately 1,000 people, primarily folks we 10

all know. At the end of the meeting, I will ask our 11

folks if we can give an estimate of how many people are 12

on the phone. 13

At the Annual Conference -- I 14

believe it's the third day -- we plan to use the entire 15

half of the third day to walk through the recommendations 16

that have percolated to the top. We're very excited 17

and we want to move this along extremely quickly. 18

I won't go through this slide because it 19

really is somewhat of a repetition of what I just said. 20

Again, our Third Annual Conference is October 24th, 21

25th and 26th right here at the Renaissance. You can22

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go online now and register, so please do. 1

Again, today really is up to you. The 2

framework of questions that we thought we would ask 3

is: What are our accomplishments so far? How can 4

Texas have the greatest impact? How can we be 5

different than what's been done in the past in cancer 6

research, cancer prevention and cancer 7

commercialization programs? What does success look 8

like? 9

In a very thoughtful process, if 10

we were standing here in 2020, what do you want to see? 11

That's exactly what we need to figure out. What would 12

CPRIT look like? What would cancer research, 13

prevention and commercialization look like? What's the 14

allocation of grant funds? Is 75 percent to academic 15

research about right? Is 15 percent to commercial 16

research about right? Is evidence-based prevention at 17

10 percent something that we're comfortable with? 18

And last but not least, how can our 19

process improve? We've had a challenge. We 20

want to hear from you. We want to make sure that our 21

processes are above reproach. I defer to you and, please, 22

let's just have a fun day. 23

Thank you. 24

JIM DOWN: Thank you, Bill.25

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Are there any questions for Bill on any 1

of the information that he presented? Any points of 2

clarification? 3

I think everybody, Bill, has access to 4

your presentation? I think you've provided it. 5

BILL GIMSON: I think they provided it. 6

JIM DOWN: Great. No questions? 7

Okay. You must have been quite clear. 8

So we are going to shift over to the 9

discussion mode. Just a couple of things again in 10

terms of the logistics. All of these mics are on all 11

of the time and I'm told they're quite sensitive, so 12

you might just want to keep that in mind as you have 13

any side discussions. 14

I also need to keep in mind, because I 15

tend to roam around the room, so I have this portable 16

mic. But my track record of actually turning this off 17

before I leave the room is quite poor, which has led to 18

some very embarrassing situations, so hopefully you can 19

keep me honest with that. 20

What we want to start with is the issue 21

that's mentioned in the middle here. I think we can 22

kill this projector at any time that anybody would like 23

to do that since I don't think we're going to need this 24

for a while.25

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But we would like to start with talking 1

about what success looks like and would like you to 2

think about 2020, seven years down the road. 3

The reason for starting with this is it 4

is very difficult to talk about things like resource 5

allocation and process improvement if we don't have 6

agreement on where it is we want to go. We all know 7

the saying, "If you don't know where you want to go, 8

every road will lead you there." 9

So I've always found that it's helpful, 10

whether it's on the corporate side or the nonprofit 11

side, to spend a fair amount of time upfront just 12

talking about what is it we're trying to do so that 13

when we get to 2020, the typical question is going to 14

be: Were we successful? 15

You'd be amazed at the number of 16

organizations that never really had agreement on what 17

success looks like. So we're going to spend a little 18

bit of time on that right upfront. 19

We'd like to ask you that question. I'm 20

sure that there are many, many factors. Based on the 21

surveys, there are a lot of factors that people had 22

mentioned. But if there is just one thing that you 23

could pick, what do you think would be the most 24

important factor in 2020 in determining whether CPRIT25

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has been successful? 1

Yes. 2

Steve WYATT: I'm not sure I could give 3

one factor. It's complex. 4

JIM DOWN: Could you -- 5

STEVE WYATT: Steve Wyatt from UK and 6

Prevention Review Council. 7

So I think it's hard because what we 8

might -- I'll put this on the table -- what we might 9

count as success, the people that will be making 10

funding decisions might have a different perspective. 11

So I think it's hard as an outcome measure when you 12

don't know what, for example, the Legislators would 13

count as a success. So I think you have to recognize 14

that because I dealt with Congress, as Bill did, for 15

many, many years. That was always -- that tension 16

between the two is important to recognize. Just a 17

comment. 18

JIM DOWN: Good point. 19

MATT WINKLER: Matt Winkler, Asuragen. 20

I know a number of members here, but 21

just so that everybody knows me, I'm a former UT 22

professor who was funded with NIH grants and I'm also a 23

businessman. I have one very successful biotech 24

company and the jury is still out on the next two25

28

biotech companies, which CPRIT has made awards to both 1

of them. 2

I would hope in 2020 we could explain to 3

a Legislator or to an ordinary citizen how the CPRIT 4

money made a difference, and we should be able to do 5

that in plain English. 6

JIM DOWN: Now, when you say "made a 7

difference," can you just push that a little bit 8

further in terms of what factors it might have made a 9

difference in? 10

MATT WINKLER: Sure. 11

So I was on the SPAC Committee, and John 12

Nemunaitis, who is the head of that, he can perhaps 13

give more detail than me, but my memory is that he said 14

we should not be a clone of the NIH, we should do 15

things differently. 16

When I look at the 75 percent or so 17

going into basic research, I have trouble with that, 18

because it's going to be difficult to see how the CPRIT 19

money, which is small compared to what the NIH spends, 20

and where you might be able to, in scientific terms, 21

explain to somebody how it made a difference, I am 22

pretty convinced that you'd be unable to do that to an 23

ordinary citizen. 24

Does that answer your question or did I25

29

kind of get off? 1

JIM DOWN: No. It's a good start. 2

So any other thoughts in terms of when 3

you say whether it would have made a difference or not? 4

What are the factors that come to mind? 5

MATT WINKLER: Well, I come immediately 6

to resource allocation. I don't want to be seen just 7

as touting my own self-interests regarding cancer, but 8

I would like to see much more investment in help 9

catalyzing companies getting started and building their 10

clinics faster. 11

I like the fact that we're recruiting 12

great talent from out of state. But after we give them 13

their startup package, I would say that any follow-on 14

money should come from where they're collaborating, the 15

companies, hopefully, in Texas doing very translational 16

research, clinical trials, and that we really get out 17

of the business of copying what the NIH does. Great 18

scientists will be able to get their own funding from 19

the NIH. 20

JIM DOWN: We will come back to that 21

issue later on. 22

Yes, Jacqueline? 23

JACQUELINE NORTHCUTT: This is 24

Jacqueline Northcutt with Texas BioAlliance.25

30

I just want to -- maybe to answer a 1

question, when I look at how CPRIT money can make a 2

difference, one of the things that I think about that 3

if you want to talk clearly and plainly to the 4

Legislature and people of Texas is how it's benefited 5

patients. I think that's something that's -- there are 6

probably going to be a lot of things that are going to 7

be hard for this group to agree on. That may be 8

something easy for us to agree on, is how it benefits 9

patients. 10

The other thing is that to measure that, 11

I mean, there is always -- in this industry, when it 12

starts, almost all of the time it starts in academic 13

institutions, but there's almost always a hand-off to 14

industry, to for-profit businesses to be able to get 15

all the way to patients. 16

So I'm just echoing what Matt is saying, 17

is that there's got to be that balance in the funding 18

to be able to do that. 19

JIM DOWN: But you are tying the impact 20

to patients -- 21

JACQUELINE NORTHCUTT: To patients. 22

JIM DOWN: -- which I think is a very 23

important point. (Indiscernible), which is impressive. 24

KAREN TORGES: This is Karen Torges25

31

representing Cancer Alliance of Texas, which is our 1

comprehensive cancer coalition that we've got in all of 2

the rest of the states in the nation. 3

We have a wonderful opportunity in that it's 4

a success and a challenge in the same breath, and I'm 5

agreeing with the comments made before me. 6

But we've raised the bar for the 7

awareness of cancer in the state of Texas, and as all 8

of the stakeholders have, from patients to Legislators 9

to all of us who collaborate together, but I don't know 10

that we are able to articulate anything more than the 11

awareness of cancer and the giant challenge that it is 12

in the state. 13

JIM DOWN: So far. 14

KAREN TORGES: So far. So if we were to 15

have -- I think we need to sell our successes in a way 16

that is tangible, in a way that is understandable to 17

all of the stakeholders. It may not be the same 18

message that you give to a patient or you give to a 19

Legislator, but our ability to tell the story has not 20

yet come to fruition. 21

So with each one of our progress steps, 22

I think we will have to make clear, this is what it was 23

and this is what it resulted in. Some of those can be 24

early wins and some will take longer, of course, to25

32

come to fruition. 1

But in the meantime we have such a short 2

attention span of all of the stakeholders that we will 3

need to have something that we can keep their attention 4

on a positive that says, we're done -- making progress 5

here, and we're making progress and we want to keep on 6

going, and that part has not yet gelled. 7

And I think the research part of that 8

story is mine, because I'm on the prevention end of 9

things -- but the research end of that story is going 10

to be harder to tell because the progress takes longer 11

to show. So if the balance were made a little 12

(indiscernible) (interfering noise) with a little bit 13

of knowledge of the human element of the investment in 14

research or of the prevention side, then it may be 15

easier to tell the average Texan what we're doing with 16

the funds. 17

JIM DOWN: You did raise the point of 18

time frame, which is a very important one and we do 19

want to come back to. 20

MATT WINKLER: I don't want to hog the 21

microphone, but a simple metric could be whether in 22

2020 the citizens of Texas were willing to vote another 23

$3 billion to us. 24

JIM DOWN: Well, you could say that25

33

could be the ultimate test. That is true. 1

Okay. Other thoughts over here? Yes? 2

VINCE FONSECA: I'm Vince Fonseca 3

representing American College of Preventive Medicine. 4

I think you've asked the question a 5

couple of times: What factors would lead to making a 6

difference? We haven't even talked about what 7

difference is it that we're trying to make, so I think 8

there is that upstream question. 9

I think to make it as general, for at 10

least us in the room would be -- and this isn't 11

something you would convey to Legislators, but an 12

overarching thing would be to increase the overall 13

population, so not just in patients, but in Texans, we 14

have 25 million of us, that the money and the efforts 15

that we spent under these 10 years and that dollar 16

amount, what impact qualities that we changed over all 17

our people. 18

Now, there's many, many ways to do that. 19

And I think if we're saying that, that goes back to the 20

question of research and all of that, we can spend a 21

whole lot of money, we can spend all of the money in 22

research and spend it all this year. 23

But if you went and said, "What 24

difference did you make? Who feels better because of25

34

that, other than the guys that got those jobs?" Not 1

many. 2

So that's one extreme versus "We did a 3

lot of things that actually improved people -- making 4

people feel better about them, their families, their 5

friends." So there's human economic costs, too, 6

related to that and decreased productivity at work. 7

So you can put all of those things into 8

a weigh, then you can build a logic model going 9

upstream and then figuring out what should success look 10

like knowing what we want to maximize. But we have to 11

figure out first theoretically what is it we're trying 12

to maximize, and then we can talk about what factors 13

along the logic mode. 14

JIM DOWN: Good point. 15

Before I forget, why don't I ask if 16

there is anybody on the phone that would like to weigh 17

in on that? 18

JUAN CARLOS BERNINI (telephonic): I 19

have a comment. This is Juan Bernini for Baylor 20

College of Medicine of McAllen. 21

You know, I agree with everyone, but I'd 22

also like to see if it's a successful company in -- 23

along with the lines stated earlier (indiscernible), 24

but as far as being able to be a successful company and25

35

continue to provide funding. And funding is going to 1

have to be there in thinking about the remedies and the 2

companies and the (indiscernible) the money 3

that we can recover. 4

And I want to see if there is any way we 5

can roll and have a (indiscernible) tax tobacco, that 6

they will tax to get money back quick and be able to 7

get more funding to continue to help all of these 8

people and research. Because, you know, what we're 9

doing is great, but this money that we got 10

from (indiscernible) did not end and eventually we're 11

going to run out of money. We're doing our best to 12

invest and recover some of this money, but we don't 13

know what is going to happen. So one of my missions or 14

visions is to be able to continue to do this forever. 15

JIM DOWN: Good point. John? 16

JOHN NEMUNAITIS: John Nemunaitis from 17

Mary Crowley. 18

To me, it would be integration and 19

achievement of a universally accepted gold standard. 20

An example of a universally accepted gold standard 21

would be an FDA approval for a product and a new drug 22

application. 23

The integration would be the discovery 24

that would originate from an academic center within25

36

Texas that would be utilized through some of the 1

biopharmaceutical opportunities of manufacturing and 2

whatnot within Texas that would be applied during 3

clinical testing in a clinical trial setting, 4

integrating both community practice as well as 5

noncommunity practice sites to achievement of that NDA. 6

So that integration is what the 7

staff needs you to outline, but it would involve the 8

assets of Texans. But the universal gold standard 9

would be that product approval. That's it. And that 10

would generate revenue back into Texas. 11

JIM DOWN: Other people may know it, but 12

it would help me if you could mark out the time frame 13

involved with getting the approval. 14

JOHN NEMUNAITIS: The gold standard of a 15

product from discovery to actual approval by FDA, when 16

it starts with the original discovery, one in 10,000 17

basic science discoveries will actually achieve product 18

administered to a patient as commercialized. But as 19

you take that path, from that discovery to product 20

approval, it takes generally about 15 years. 21

However, in certain areas where the 22

mechanisms are understood and the molecular biologies 23

are understood, the achievement has been done within 24

five to seven years.25

37

So the focus would be integration of 1

technology that would involve first-line therapeutic 2

molecular targeting as your best opportunity, and 3

that's achievable within a seven-year time frame with 4

the assets that are in Texas. 5

JIM DOWN: Okay. 6

SPEAKER ON PHONE: Yes, but what about 7

the possibility of taxes for fighting tobacco, 8

something like that (indiscernible) -- 9

JIM DOWN: I'm sorry. The connection 10

isn't the best. Could you repeat that? 11

BILL GIMSON: He said tobacco taxes. 12

JIM DOWN: Tobacco taxes. And the point 13

there would be? 14

BILL GIMSON: To raise revenues. 15

STEVE WYATT: (Indiscernible) very 16

effective prevention intervention. 17

(Laughter.) 18

STEVE WYATT: Effective prevention 19

intervention, I think this is not on point. 20

JIM DOWN: Certainly most cost 21

effective. 22

JOHN MINNA: This is John Minna. 23

I don't think this is on point to what 24

your topic is, but as important -- I'm all for25

38

antismoking tobacco tax. 1

In terms of -- let me take a more 2

practical view as a citizen and a doctor from Texas. 3

In 2020, for every new cancer patient that appears in 4

Texas, I'd like them to be able to have their tumor 5

sampled. And I'm using that as an example. There 6

could be other studies done. Molecular tests and other 7

studies could be done on that or on the patient. 8

From that information, you would know 9

what's the best possible treatment for that patient, 10

rationally based treatment, also to provide a mechanism 11

for following, evaluating, responding and following 12

that patient up to return that patient to as normal a 13

life with the least toxicity as possible. 14

It would amount to a huge cost savings. 15

We are on the cusp of doing that, I feel, with lung 16

cancer and that's happening with lung cancer now. 17

Texas is in a unique position to do that. Exactly 18

between other prevention (noise interference) you have 19

risk assessment and prevention, which is rationally 20

based. And we're probably one of the few places in the 21

world with the CPRIT funding that can indeed do that. 22

I think it echoes a lot of the integration 23

and things that we're talking about. It involves 24

research, it involves translation to the clinic, it25

39

involves commercialization of companies, a whole 1

variety of things, but it's clearly within our reach. 2

I mean, I think -- I wouldn't have thought 3

that 10 years ago, but at least it's clearly within our 4

reach and we have the opportunity to do it. It's a 5

very practical demonstration. 6

So anybody in the Legislature would know if 7

they or their family member had cancer and went into a 8

doctor they would have access to that, and so I think 9

that's a very practical outcome. 10

JIM DOWN: You said that Texas -- I 11

think you said was uniquely positioned -- 12

JOHN MINNA: Yeah. CPRIT 13

and CTNeT. I think Bill's initial comments before 14

that, we haven't talked about the tumor repository and 15

all the other stuff. But this involves everything and, 16

quite frankly, this is what pharma/biotech wants to 17

have access to and we're in a unique position to have 18

commitments. 19

JIM DOWN: It sounds like it would 20

require integrating. 21

JOHN MINNA: Oh, absolutely. By the 22

way, Becky and I were talking beforehand. And I think 23

exactly the same thing with regard to prevention 24

efforts. Different types of tests, but this could cut25

40

across many different tumor types. 1

JIM DOWN: Gail? 2

GAIL TOMLINSON: Gail Tomlinson, UT 3

Health Science Center, San Antonio. 4

Along those same lines, Texas is a huge 5

state and, although I don't have data, I think it's 6

fair to say that in the past most of the clinical trial 7

enrollment in the state of Texas has been in a few 8

select locations in the tertiary care centers. 9

It would be nice in 10 years to 10

demonstrate and show the Legislature that cancer 11

patients from every county and every area in Texas can 12

have access to the clinical trials, the clinical 13

investigations, and the personalized medicine. 14

Part of that is simply clinical trials, 15

and I think if we can demonstrate that patients with 16

cancer have access, I think that would be favorable to 17

the Legislature and might propel them to think about 18

continuing CPRIT funding. 19

JOHN MINNA: This is John Minna again. 20

I prefaced what I was saying, that every 21

patient in Texas, every Texas citizen, and I think this 22

really cuts across any private practice underserved 23

population. 24

GAIL TOMLINSON: And it would take more25

41

effort to get patients from smaller towns, smaller 1

locales to be enrolled in these studies, but I think 2

it's something that should be kept track of and 3

documented. And prevention does that, in prevention, 4

but I think we need to do it in clinical trials, too. 5

PAT REYNOLDS: Pat Reynolds, Texas Tech. 6

I agree with these metrics that John 7

Minna just stated and also with John Nemunaitis. 8

I think we have a unique opportunity 9

here to bring these metrics together by implementing 10

the clinical trials process whereby we increase the 11

percentage of patients going on trial. (Indiscernible) 12

we're used to 75 percent of our patients going on 13

clinical trials. We're talking about 3 percent 14

happening in the adult community. 15

If we could go to 5 or 6 or 7 percent of 16

the adult patients going on clinical trials, this would 17

show we have granted that access -- we have to get that 18

access geographically distributed, that could be a huge 19

metric -- you could actually increase the 20

number of patients that have access to clinical trials 21

and actually enrolling in them. 22

In doing so, you will speed the process 23

which John brought up, which is a very important 24

metric. If we can deliver standard care therapy that25

42

was tested out in Texas and export it outside of 1

Texas -- Texans are proud people -- they're not just 2

going to ask, "What did you do for me?" They're going 3

to say, "Hey, what did we do for everyone else?" 4

And if we can register a drug -- and 5

these drugs should not be limited to drugs that are 6

commercially superstars. They should be commercially 7

viable and small niche populations should be 8

considered, something that's not being considered right 9

now. 10

But if we can register these drugs and 11

show that they get out to everyone beyond Texas and 12

carry out these clinical trials within this network and 13

make it accessible, what could be a better metric? 14

But let's face it, folks. We're not 15

going to convince the people of Texas that CPRIT is 16

doing a good job with the number and nature of medical 17

and science papers published. They're going to want to 18

see us do something actually in the clinic. 19

JIM DOWN: Yes? 20

JAMES GRAY: James Gray with the 21

American Cancer Society. 22

I just want to say a couple things to 23

maybe give you a different time line to think about, 24

and that is, Bill, if I remember correctly, your25

43

funding -- the funding began on September 1 of 2009, 1

which means funding ends August 31st of 2019, which 2

means if you bind in another 3 billion you have to have 3

voter approval which has to be sent to the voters in 4

the 2017 session. So your timeline is probably more 5

accelerated than what we actually have the luxury 6

talking about with a 10-year 2019 date certain. 7

But a couple things that I would ask you 8

to think about, having worked in the Texas Legislative 9

process a couple of sessions on CPRIT and having been 10

around for the 2007 debate and then the Prop 15 11

campaign, I have a strong sense of what works in the 12

Capitol. 13

And not one thing works for everybody, 14

so it's really important as we think about how we 15

message this to understand that there are certain 16

representatives that really don't care about bench 17

research and that's not going to motivate them, but 18

they are very passionate about what you're doing for 19

prevention, and those same members that care about 20

bench research might not care about prevention. 21

So the message that we bring into the 22

Capitol has to be tailored, and I think we're at a 23

position right now at CPRIT with what we've done to 24

really provide something to everybody.25

44

What I'd ask us to think about -- and I 1

think we're saying it, but maybe just saying it 2

differently -- is what goes away when CPRIT goes away, 3

when CPRIT starts to go away by the time we get to this 4

point in 2017 session, which is not that far away. 5

JIM DOWN: Sure. 6

TOM KOWALSKI: This is Tom Kowalski with 7

THBI. 8

Along those same lines -- very well said 9

by the way -- in the messaging I think we need to 10

include the press. Legislators will read the press and 11

it will affect them different ways in different 12

districts. 13

Along that path, you've got four 14

Legislative sessions of which '17 will be critical. 15

'13, the one coming up, we're going to have a huge 16

budget deficit already projected. '15 is already on 17

the horizon and you're beginning to hear the Medicaid 18

shortfalls that we will face in '15. 19

So we've got two sessions with budget 20

challenges. Legislators will look at that. 21

Legislators will want transparency and they're going to 22

want results: Where is the money going? How is it 23

being invested? 24

So I think we need to include the press25

45

in the equation of messaging to Legislators and I think 1

we need to look very hard at the next three Legislative 2

sessions, because '19, you know, 2019, that's a given. 3

JIM DOWN: So what I'm taking away from 4

this is the time frame is even shorter and you may need 5

to show results earlier to work this process, and you 6

want to have a good communications effort to do that. 7

Am I correct? 8

JAMES GRAY: Yes. 9

JIM DOWN: I know there are other people 10

trying to weigh in here, but I want to be sensitive to 11

the people on phone. 12

Is there anybody else on the phone that 13

wants to weigh in? 14

(No response.) 15

Okay. 16

VINCE FONSECA: I would say it's really 17

important to get the press, but, more importantly, it's 18

the average Texan. Right now, I've not seen a very 19

concerted effort of letting the average Texan know what 20

CPRIT is doing. 21

So the Legislators, whether they're 22

voting '13, '15 or '17, what really matters is what 23

their constituents say. And so that we have to be able 24

to show what difference we make, no matter what time25

46

frame it is, again, to that average person so when they 1

come up to say, "Yes, Elected Official, I think it's 2

important because this is the difference it made to 3

me." 4

And I think that, therefore, again, what 5

do we really do? So one of the common threads that 6

Bill has heard me say plenty -- I'm in the SPAC -- is 7

that I don't think we're doing enough to disseminate 8

those things that are already proven to be effective. 9

So we know that a lot of the 10

stakeholders here and in the community do research and 11

want to bring new products and NDAs and all that, but 12

we have a tremendous arsenal already proven to be 13

effective that is not optimally being delivered today, 14

especially when you have a shorter time frame to focus 15

on those things. 16

So the rural disparities, for example, 17

it doesn't matter what the cancer is, as far as we 18

understand it right now, certain common things enhance 19

survivorship. And it doesn't matter what drug you use, 20

that physical activity and healthy 21

eating we know and now understand very well for the 22

common cancers that people survive -- breast, 23

colorectal, prostate -- and we're not promoting 24

research in those kind of things.25

47

So, I think, you know, Bill has been 1

consistent and CPRIT has been consistent and we don't 2

have any set-asides. Set-asides are different than 3

saying, "This is the kind of mix we would want to see." 4

When we have hardly any dissemination 5

research, no comparative effectiveness research, no 6

surveillance research, things that are well-defined in 7

types of research, so even on that pie graph, there's 8

chunks that are entirely not even a slice on that pie. 9

So I think all of those things also make normal people 10

feel positively impacted. 11

JIM DOWN: Yes? 12

KENT OSBORNE: I think I've heard 13

everybody talking about their favorite way of 14

making patient care a mission, making diagnosis, 15

prevention, treatment of cancer better, which I think 16

has got to be the Number 1 goal of this agency, but I 17

haven't heard division mentioned all that often. 18

I think what's really right in 19

all of this is a mixture of the things that we're 20

doing. I don't think there's just one way to do it. 21

And I would disagree with Patrick a 22

little bit. With many of our cancers, we don't have a 23

clue what to take into the clinic. If you gave me a 24

zillion dollars, I wouldn't know how to treat a25

48

triple-negative breast cancer with a new approach to 1

the treatment unless I published a paper in "Cell," 2

which we did a couple of months ago, and gave us new 3

ideas about what targets to even aim after. 4

So I think we need a whole menu of 5

different things, from very basic research to discover 6

the things that we need to do, all the way up to the 7

clinical testing of things we've discovered. 8

Now, the thing that the Legislature is 9

thinking is that "If I pour 3 billion in, after two 10

years we'll have a discovery, we'll have it in the 11

clinic and we'll cure cancer." That's nonsense. 12

We've got to educate the Legislature, 13

especially about how this really works. It doesn't 14

work that way. It works this way by putting money into 15

pyramid building blocks at the bottom and getting some 16

basic discovery information; putting some money in at 17

the mid level to begin testing those new strategies and 18

discoveries; and then maybe at the upper level to 19

confirm that. 20

That's not going to happen in 10 years. 21

I think we have to be realistic about this. If I made 22

a discovery today that's going to cure triple-negative 23

breast cancer, we wouldn't know it for 10 years until 24

it goes through all of that process.25

49

So I think we're all worried about 1

getting funding after this 10-year period. I think we 2

have to educate the people that are giving us the money 3

and the public about what this process really is and 4

how difficult it is, but that we've made had a lot of 5

progress, we can dissect a cancer cell down to the gene 6

level now, which we couldn't do before, and that's 7

given us an edge now in the fight against 8

cancer. 9

But I think we need a mixture of all of 10

these things, much like CPRIT is doing, to get at this 11

question. 12

JIM DOWN: It sounds like setting the 13

right expectation now might be a good idea. 14

KENT OSORNE: Exactly. 15

JOHN NEMUNAITIS: But I think, Kent, you 16

and many of your colleagues made discoveries four years 17

ago and five years ago, so we don't have to start the 18

phase with a three-year plan with CPRIT. Or it could 19

come out next week and go over how to get the SRT-3s 20

into the clinic. That discovery was made before CPRIT. 21

Why not have a bigger share of those 22

discoveries that were made before CPRIT engage the 23

clinical -- 24

KENT OSORNE: So that was a discovery,25

50

but there's no drug. We've got to find a drug. 1

JOHN NEMUNAITIS: There is. 2

KENT OSBORNE: Not really, not really. 3

So, yes, sure, there are things that 4

were discovered a few years ago that you can take 5

advantage of at the mid level of the pyramid building, 6

that's true, but there's a lot of cancers where we're 7

not there yet. We're not there. Pancreas cancer, 8

triple-negative breast cancer, kidney, on and on. 9

We need to have some basic discovery 10

work in order to even know what to do at the next 11

level. 12

CHANDINI PORTTEUS: I think that you're 13

certainly not going to have any shortage of -- 14

JIM DOWN: Identify yourself, please. 15

CHANDINI PORTTEUS: Chandini Portteus 16

from Susan G. Komen. 17

I think you're certainly not going to 18

have any shortage of great ideas in terms of where 19

people feel there could be impacts within the 10 years 20

that CPRIT has a window, but I think that what I hear 21

is that from a 30,000-foot level the patient really 22

wants to know what's important to them, and it sounds 23

like that tailored approach, looking at constituencies, 24

maybe it's five buckets, six buckets, whatever it is,25

51

it sounds like there needs to be maybe a proactive, 1

strategic plan to be able to say here's what we could 2

accomplish in these first three years, and then are we 3

collecting baseline data now to know what is the space 4

before we even feed them funds and how can we really 5

look at what CPRIT's attribution has been and are we 6

okay with shared attribution? Do we want it to be sole 7

attribution? 8

And asking those questions now and 9

collecting that data now I think would be important in 10

terms of identifying the questions and the data that 11

could then support messages that are both digestible 12

for the patient but then also impactable in very a 13

small amount of space. 14

JIM DOWN: Okay. Let me -- I want to 15

continue with this, but maybe we could just shift gears 16

a little bit, talk about what CPRIT can do that other 17

organizations can't do. 18

What's different about CPRIT? I like to 19

think about it as what differentiates CPRIT. If it's 20

just doing things that other organizations set out to 21

do, that, I think, would be less impactable. So what 22

is different about CPRIT? 23

MATT WINKLER: One simple thing, it's 24

sort of a follow-on to John Minna's comment, is that a25

52

cancer diagnostics company, a major bottleneck for us 1

is getting access to high-quality tumor samples that 2

have been well taken care of. 3

CPRIT could provide a follow-up 4

mechanism. We talked about making sure that all 5

counties in Texas had access to clinical trials. By 6

the same token, CPRIT could collect hyperbolic tumor 7

samples and make them available to companies in Texas. 8

JIM DOWN: Nobody is doing that now, I 9

assume? 10

KENT OSORNE: We have such a mechanism 11

already funded. 12

PAT REYNOLDS: Yes. The Texas Cancer 13

Research Biobank has been advised by CPRIT and is 14

actively collecting tumor samples. 15

MATT WINKLER: When will it be available 16

to companies trying to develop market diagnostics? 17

PAT REYNOLDS: It's available -- 18

KENT OSORNE: Right now. 19

PAT REYNOLDS: -- right now. We just 20

haven't put out a public announcement, but we've been 21

starting to get requests among the Tissue Access 22

Committee. John is involved as well. We've go to stop 23

meeting like this. 24

JIM DOWN: Sounds like it was a good25

53

idea. 1

(Laughter and multiple people 2

speaking at once.) 3

JIM DOWN: That is good. That is good. 4

So when you think about CPRIT, what does 5

it do that's different? 6

JOHN MINNA: John Minna. Whether it's 7

prevention or clinical trials, many publications deal 8

with very select patient populations. 9

One of the hits against M.D. Anderson -- 10

Ray, I'm using this as an example -- is that they get 11

great results because they've highly selected their 12

patient population. (Indiscernible) is probably harder 13

to treat the cases. 14

But when you have a state as a whole -- 15

you have population-based, whether it's delivery, 16

contamination, the biorepository, all of these things -- 17

and that is hugely powerful and it's really not 18

available, very few places in the world today, and 19

would have a huge impact on future FDA approvals. 20

For example, the Food & Drug 21

Administration is very interested in longer term 22

follow-up and treatment. Obviously, there's 23

population-based efforts here. So I think there's 24

that, that is one thing that differentiates it.25

54

The other thing that's really unique in 1

my mind is the potential for collaboration between the 2

academic and the private sectors, which really doesn't 3

go on anywhere else in the United States that I know of 4

particularly on a large basis, and I think that's a 5

unique opportunity. 6

JIM DOWN: So is that a convener role? 7

What would that role look like? Or private practice? 8

JOHN MINNA: I mean, both of those 9

things go together to implement and discover tests. 10

Pat talked about the small percentage of patients. He 11

said 3 to 5 percent. I think it should be 3 to 20 12

percent of the adult population or more. The only way 13

that is going to happen is if the private and academic 14

cooperate together in those clinical trials. 15

The same roles could apply for the 16

biorepository as well. That's a very powerful 17

resource. It's very powerful for commercialization and 18

pharma/biotech as well. 19

JIM DOWN: What else in terms of how 20

CPRIT could be different? 21

VINCE FONSECA: I think if you think 22

about CPRIT, because it's in Texas, how Texas is 23

different. So we are very different than the rest of 24

the country based on our size, our growth, our ethnic25

55

makeup. So what we talk about, people who do 1

population medicine know that the rest of the country 2

20 years from now is going to look more like Texas is 3

today. 4

So we have an opportunity in Texas to 5

deal with the challenges that we face with our ethnic 6

makeup and our obesity problem particularly growing 7

related to that. And so we do have a unique 8

opportunity because we're based in Texas to lead, if we 9

can figure out to how to address these challenges cost 10

effectively, a way for the rest of the country to learn 11

as it deals with growing disparities, growing obesity 12

and the same financial impact in the healthcare 13

services. 14

So that, I think, is where we are 15

clearly unique because there's no state like us, even 16

though every state is going to become more like us. 17

KAREN TORGES: I will concur with what 18

Dr. Fonseca and Dr. Minna both have said earlier. 19

THE REPORTER: She needs a microphone. 20

KAREN TORGES: We are not a SEER state; 21

however, we have a clear opportunity -- in just 22

taking a look at our entire demographic, and if we can 23

figure out a way (outside noise interference )by any 24

initiative childhood cancer of evidence-based25

56

prevention. If we could figure out the demographic 1

population (indiscernible) -- everybody 2

take your guard down and do the right thing about what 3

the population intervention is and be able to do an 4

experiment to do a trial sort that would say here's 5

the -- Bill, I'll take your cervical cancer, for 6

example, a really clear one. How many women in Texas 7

suffer disproportionately from the cervical cancer 8

problem? It's not huge. It's targeted to a handful of 9

counties in Texas. There is an evidence-based 10

intervention that's going against the problem and if we 11

could figure out a way to collaborate, a way to reach 12

the women at greater risk, we can save lives and share 13

that in a public way and that would be accomplishable 14

in a short amount of time frame using what we've got 15

now. We would not to have a new clinical trial drug 16

available for that. Just have some of that be part of 17

the portfolio balance of CPRIT. Because if we don't 18

have a few of those minor success stories, I think the 19

rest of the picture will be harder to elaborate on. 20

JIM DOWN: Gail? 21

GAIL TOMLINSON: Just to switch back to 22

some things that were brought up earlier and going back 23

to the finances and the basic discovery and the high 24

impact. Academically looking at the number of high25

57

impact papers that may influence cancer care maybe 1

20 years from now are important in several ways, and 2

one way that hasn't been demonstrated (inaudible and 3

indiscernible). Again, we're relying on educating our 4

Legislature because they won't see it (inaudible and 5

indiscernible). In the last three years our standing 6

has been elevated impact-wise, and CPRIT -- 7

THE REPORTER: I can't hear her. 8

GAIL TOMLINSON: -- brought in by 9

(indiscernible) a lot of superstars. 10

But I think, in addition, just the fact 11

that that will affect people who (indiscernible) will 12

want to move here, you know, careers and that will 13

provide expansion of the impact CPRIT will take some 14

time and I don't think that is obvious to the 15

Legislature and the immediate population. 16

JIM DOWN: Pat? 17

PAT REYNOLDS: You were asking how CPRIT 18

is different. It strikes that me that since we 19

compared it to the NCI some, that what Bill presented 20

earlier was CPRIT is not afraid to reinvent itself. 21

NCI is quite afraid to reinvent itself. And I think 22

the nimbleness of CPRIT and the ability to actually get 23

constituents together, ask them what's going on, and 24

then change and redirect what things are going on is25

58

something that makes it vastly different. 1

Let's not forget, since there's nothing 2

like CPRIT anywhere else in the United States, those 3

two things make this drastically different. 4

JIM DOWN: That's an interesting point. 5

So this process would tie into that, redirecting some 6

efforts. Good point. 7

Yes? 8

SUZY LOCKWOOD: I'm Suzy Lockwood and 9

I'm here to represent the Texas Nursing 10

Association and NOEP, which is the Nurse Oncology 11

Education Program. You said earlier about putting on 12

your other hat and being sure that you're representing 13

not just who you're here for but others. I'm also a 14

professor of nursing at Texas Christian University, so 15

I feel like I'm also representing the nurses here 16

being the only nurse, I think, that's here as well. 17

I think when we talk about what does 18

CPRIT do differently and what are some of the 19

opportunities for how can we make a difference, we talk 20

about how can we do prevention, how can we reach out. 21

I was looking at our Cancer Prevention Plan. 22

When we talk about prevention and we 23

talk about education and how can we make a difference 24

to the state and to the patients and communicate what25

59

we're doing, I think it's important that for the State 1

of Texas we don't forget that the nurses are often 2

the ones that are going to be the ones communicating to 3

the patient and have an opportunity to really get close 4

to those patients and to reach out to some of those 5

rural areas. 6

And as Texas we have NOEP, which we are 7

the only state in the United States that has any type 8

of program like NOEP, and we are recognized nationally 9

for our program. So I think there's an opportunity for 10

us to take advantage of that program. 11

I think CPRIT has awarded some grants to 12

NOEP, and I think there is some possibility to even 13

take greater advantage of that, and that's a way to 14

also recognize and have some other successes. 15

JIM DOWN: Excellent. 16

JACQUELINE NORTHCUTT: Excuse me. Jim? 17

JIM DOWN: Yes. 18

JACQUELINE NORTHCUTT: To answer your 19

question, the obvious answer how the difference, just 20

by the size, the sheer size, there's no other state 21

that has a program of this size, except for the 22

(indiscernible) initiative in California, and that enables 23

us to be able to do things that other states aren't 24

able to do.25

60

Then I had another comment earlier or 1

question for Kent Osborne. I heard someone 2

say earlier how important it would be for CPRIT for 3

tumors and patient information. 4

And for purposes of your tissue bank, 5

would it be helpful to have more volume going into the 6

tissue bank and could CPRIT, working with the state, 7

somehow mandate all tissue for cancers -- 8

KENT OSBORNE: No. 9

JACQUELINE NORTHCUTT: I'm just trying 10

to brainstorm ideas. 11

KENT OSBORNE: Right. I think we're 12

going to have enough tissue to go around to biotech 13

companies and things like that and the bank is growing. 14

If we had more funding and we had -- 15

first of all, tumor banking is much more complex than 16

it seems. It's actually very, very difficult to get 17

good quality samples, even from academic institutions, 18

and then to get the follow-up of the patients. It's 19

extremely expensive and it requires considerable 20

expertise. 21

We're now doing it in, 22

what, three or four institutions, something like that, 23

and even there there's problems in manpower needs 24

that's just incredibly problematic.25

61

So to require every patient to have 1

their tumor sent would take up all of CPRIT's budget. 2

I mean, every hospital would have to have an expert 3

that knew how to do it and process the tissue and blah, 4

blah, blah. It would just be impossible. But 5

certainly we can do better, I think, with more money. 6

PAT REYNOLDS: Let me address that. The 7

Texas Cancer Research Biobank has spent a lot of time 8

on developing the process for selecting high-quality 9

tissue, so the kind of genomics that John Minna was 10

talking about could be done. 11

That process is very well in place and 12

we're now exporting it across West Texas, so I think 13

that we're getting the penetration into the smaller 14

intuitions. We're just getting El Paso and Amarillo on 15

board, Lubbock has been on board, Houston has certainly 16

been on board, San Antonio and Dallas. 17

But as that process is vetted, then 18

expanding it will be easy. But as Ken mentioned, 19

that's going to require more resources than are 20

currently available to us and a decision that CPRIT is 21

going to have to make on do you want to spend those 22

resources on collecting (indiscernible). 23

JOHN NEMUNAITIS: I mean, right now the 24

DNA, RNA, and protein analyses are demonstrating25

62

quantitative information that is going to allow the 1

basic discovery to move forward and allow the 2

diagnostics to be clear to FDA and usable for patients, 3

so that's why it's being done at small sites 4

(indiscernible) through the principal SRTs and then the 5

intention to span both community practice and 6

academics. 7

PAT REYNOLDS: And be aware this is 8

linked in with CTNeT, so it's all going to be one 9

seamless organization if we do it right, which will be 10

huge. 11

JIM DOWN: Other thoughts on how CPRIT 12

is different or could be different? 13

JOE CUNNINGHAM: So I'll go. 14

JIM DOWN: Okay. 15

JOE CUNNINGHAM: Joe Cunningham. Sorry 16

that I'm late, and there's nothing worse than being 17

late and then giving a bunch of unpopular ideas, but 18

why not go for it, right? 19

I'm Chair of the Commercialization 20

Strategy Committee for CPRIT. I'm a physician and I'm 21

a venture capitalist, and nobody loves venture 22

capitalists, so there's going to be two strikes against 23

me. 24

And I'm not sure that CPRIT was really25

63

even a good idea in the first place, so there's three 1

and I guess we're out. 2

So I've always struggled with what we 3

spend the money on in CPRIT, and a lot of very esteemed 4

academicians here will really dislike this, but 5

$3 billion is a lot of money, $300 million is a lot of 6

money, but not compared to 35 billion that the NIH and 7

NCI have. 8

So then you have to ask yourself the 9

question: Are we wanting to fund things that couldn't 10

get NIH funding? It doesn't seem to me like a great 11

idea. Are we going to fund things that otherwise would 12

have been funded by the NIH? Well, that doesn't seem 13

like a good idea. So I've struggled with where exactly 14

the research award should go. 15

Then you talk about commercialization, 16

and everybody likes that idea because of economic 17

development. But I do that for a living. Maybe I'm 18

just not very good at it, but I tell you, it's hard, 19

it's really hard. You've got to come in on the 20

weekends, you know, and it takes 10 years, 12 years to 21

develop these companies. 22

So during the attention span time frame 23

of the Legislature, if you're a successful biotech 24

company, you're now three guys in the garage instead of25

64

one. I mean, that's what the growth rates look like. 1

So it's hard to get economic development 2

stuff. Well, maybe you can do that by bringing in 3

resources from outside the state, companies that are a 4

little further along that otherwise wouldn't be in 5

Texas, and use the money to recruit them in. That 6

seems like a good idea. And that works as long as 7

you're not diluting money, as long as you're not taking 8

equity. But if you start taking equity and everybody 9

wants a return on investment, so they want some equity 10

value for that, if you start taking equity, then you've 11

got lemons problems because the great companies can get 12

smart money behind them. And it's not a reflection on 13

the smartness of people involved, but because of the 14

lack of alignment in spendings and stuff, CPRIT money 15

isn't considered smart money. And so then you're going 16

to get the people that otherwise couldn't get that 17

funding elsewhere and you just have a lemons problem. 18

So then you say, well, let's go to 19

prevention. How can anybody not be for prevention? 20

And that's absolutely true, but you really have to home 21

in on where prevention is doing 22

good. 23

You picked a perfect one. I loved your 24

idea. It was a great idea. With cervical cancer,25

65

we've got something we can do, we know it works, so do 1

that. 2

But so much of it's a slippery, 3

hard and difficult slope, because so much of it is, 4

okay, "For solid tumors we haven't made that much 5

progress, this is when you die. With early detection, 6

you get to enjoy knowing you had cancer longer but you 7

still die here unless there's an effective treatment." 8

So you've got to really be careful and, 9

unless you spend your life doing this, those kind of 10

things get lost -- nobody's intentionally 11

deceiving about it, but if you're an advocacy group, 12

you want to be showing progress and so your messaging 13

is all about progress when the progress is not as easy 14

to show. 15

I'm picking on everybody then. Take 16

CTNeT -- we spent some time 17

investigating why the 2 to 3 percent of people that 18

have tumors that don't have great treatments for them, 19

why don't more of those people get referred for 20

clinical trials. 21

Well, if you get down to the 22

oncologists' levels, with apologies to all of my 23

friends in the room that are oncologists, that 24

oncologist in Muleshoe, if he's seeing the patient in25

66

his office, he's given a hard choice. 1

He's given the choice of "I can give 2

this patient treatment, it's the community standard of 3

treatment, it's the national standard of treatment. 4

You know, it doesn't work very well, but I can do that 5

and, by the way, I get paid well for doing that and 6

that's pretty good." 7

(Voices on phone.) 8

JIM DOWN: Maybe people on phone could 9

mute their phones if they're not speaking into the 10

meeting. Thank you. 11

JOE CUNNINGHAM: Or he can refer the 12

patient for a clinical trial. You know, if he refers 13

them, he loses the income, he gets the reputation in 14

town of "all he ever does is send somebody to M.D. 15

Anderson anyway." 16

You say, well, let's find a way for him 17

to participate in the clinical trials. There are ways 18

for him to do that now if he wants to. There's 19

economic disincentives -- what they'll do is, their idea 20

of economic incentives is to make him lose less money 21

per patient as opposed to making money. The economic 22

disincentives are way more profound than you can solve 23

like that. So all of these things are more difficult24

67

to approach. 1

So targeted therapies I like. The 2

education aspect of it is good. And so much of the 3

evidence-based real preventive education stuff comes 4

from community programs and they don't sound like 5

cancer, because it is obesity reduction, it's diet, 6

it's smoking cessation, it's stuff like that. 7

We could easily spend the money for that 8

and do a lot more public health good, but, let's face 9

it, that's not as sexy to go back to the Legislature 10

and raise money. Especially in a red state, that's a 11

difficult thing to go. 12

So now that I've said all of my 13

unpopular things. Thank you. 14

JIM DOWN: Well, I'm glad you showed up. 15

JOE CUNNINGHAM: People really are. 16

JIM DOWN: I don't know if you're right, 17

but those certainly were thought-provoking 18

observations. 19

We certainly don't want anybody from 20

CPRIT to respond, but I would be interested if 21

any of the other participants here have any reaction to 22

Joe's comments. 23

MALE SPEAKER: I'm (indiscernible) with 24

the Lance Armstrong Foundation -- all of this is hard. 25

The slippery slope is acknowledged, but I'm going to 26

68

harken back to the attentiveness, which was the 1

simplification of saving lives in the state, and 2

this was born out of thinking of creative and innovative 3

ways with Texans being creative and thinking about fresh 4

investments to save lives. 5

And really thinking about -- coming back 6

to your first question, Jim -- what are the denotations 7

for success, if there's some way to think about a metric 8

that can connect to your point, so how do you translate 9

this to, I would argue, two audiences -- one is the 10

public and then the Legislators, who also have to 11

respond to the public. Looking at an equation that 12

really lays out how many lives are going to be saved 13

by 2020 or even earlier, as Jim's point, it's really 14

2017, how does it really lace into the earlier set 15

of politics that are going to be in play here. 16

And let me get to prevention, which I 17

think has been mentioned several times is really 18

central to that, connected to whether it's ten new 19

therapies are going to be applied in that time frame, 20

and then I think what has already been proven, at least,21

69

the agreement will be in drawing the brain powers to 1

the state, which I think one could argue already has 2

happened, is a fairly simple equation to the two 3

audiences that I'm referring to, it's easy for us to 4

get to the details. 5

To simplify this is looking at lives 6

saved, therapies created and the number of folks who 7

are coming here and moving here and providing 8

innovation and resource development to the state in a 9

very significant way. So I'm sort of wrapping it -- 10

JOE CUNNINGHAM: I agree, I agree with 11

that. I think that has been a great use of these 12

proceeds. 13

MALE SPEAKER: Right. And how we 14

translate that back to, again, the Legislators and to 15

the state public, added to what the original intent was 16

to Bill's challenge earlier, and then what can this 17

become. And I think you have to put some very clear 18

metrics around that over the next five years. 19

JIM DOWN: Good. Vince? 20

VINCE FONSECA: I think there are two 21

additional components feeding off of the last two 22

speakers that we haven't mentioned yet, and those are 23

additional cost savings from the side effects. So he24

70

was just saying it doesn't sound like cancer when you 1

talk about healthy eating and physical activity. Even 2

though on a population basis 80 percent of people don't 3

smoke, those are the biggest causes of cancer, 4

preventable cancer, but it doesn't sound like cancer, 5

it doesn't sound like it's sexy. 6

But if we weigh into it the different 7

cost offsets to Medicaid, for example, to other general 8

revenue related to that cardiovascular disease 9

prevention, for example, then it does become sexy to 10

our Legislature. 11

So there are things that aren't just for 12

cancer, even though they are the biggest cause of 13

cancer, healthy eating and physical activity, for 14

80 percent of the Americans it has tremendous 15

beneficial side effects Legislators do get interested 16

in. So there's that component. 17

The other one is we've heard a bunch 18

from the commercialization types about return on 19

investment. Well, in every state we have a wonderful 20

return on investment through Medicaid. You will never 21

ever -- no businessman will ever get a guarantee like 22

states get through the federal match of Medicaid. 23

So if we can think again of using 24

moneys that are there, tying in to draw down more25

71

federal funds, which is also very sexy to our 1

Legislature, it makes sense to Texans. Most people 2

have no idea, I mean an ROI of 180 percent every single 3

year guaranteed? So those are the kind of themes that 4

we can bring in to consider even going through the 5

application process. 6

What are the other ways that this 7

improves lives in Texas, creates jobs in Texas? So, 8

again, with a Medicaid match and hiring promoters and 9

going out to deliver what's already proven to have been 10

effective, we just created 20,000 jobs and 180 percent 11

ROI. So those are the kinds of themes to think about 12

that we ought to put on our map. 13

PAT REYNOLDS: Joe, I'll answer your 14

Muleshoe question. I agree with you that 15

the problems of economics of getting patients in 16

clinical trials, especially in our small communities, 17

is very difficult. 18

But I think we've got to start dreaming 19

big. Right now that patient with non-small cell 20

lung cancer and that Muleshoe oncologist you're talking 21

about gets on an ALK inhibitor, and when the 22

patient progresses he's going to follow exactly what 23

they said at ASCA, "Okay. Well, the best thing we can 24

do is leave him on the ALK inhibitor because it will25

72

slow it down a little bit." 1

But what I'm dreaming of is that that 2

patient got a biopsy sent in to the right lab, which 3

happens to be at Baylor for the TCRB, and got a 4

sequencing done so that it's plugged into the 5

system and so that oncologist is notified, "You know 6

what? There's a clinical trial going on now at M.D. 7

Anderson with the next generation of ALK inhibitor. 8

And if you refer your patient, they're likely going to 9

get a response." 10

You're going to be more likely to 11

respond and he's looked at as a hero and not as 12

somebody who only sends their patients to M.D. 13

Anderson, if we molecularly inform this clinical 14

oncologist that we've got a new drug that is developed 15

and can actually affect his patients. That's where we 16

should go and that's where we have the capability of 17

going. That's where we really have to dream big and 18

not dream small. 19

JOE CUNNINGHAM: So, Pat, I agree with 20

you on that, and so I should end on a little optimism. 21

Just because it's hard doesn't mean it's not 22

worthwhile. In fact, my mom would say if it's not 23

hard, it isn't worthwhile. So I want us to find 24

answers to do that. I just don't want us to be25

73

Pollyannaish, that that stuff is easy. 1

The fact is, that oncologist in 2

Muleshoe -- I actually don't know if there is an 3

oncologist in Muleshoe -- but that oncologist in 4

Muleshoe, if he's interested in doing that, he could do 5

it now. 6

So if we're really going to have an 7

effect, it's by making the guy that's only borderline 8

interested, making it easier for him to do that. 9

PAT REYNOLDS: Let me just say I've got 10

to disagree with you on that, because -- 11

JOE CUNNINGHAM: You've never disagreed 12

with me before. Well, maybe once. 13

PAT REYNOLDS: In talking to a surgeon 14

who wanted to participate in our (indiscernible) 15

program, back when we were starting (indiscernible) 16

and I said, "All you've got to do it put this through 17

your IRB?" And he said, "Our what?" 18

And I used to argue with Al Gilman on 19

the central IRB concept until I ran across that. I 20

said, "No. This is a great idea now." 21

If we have a central IRB and all of the 22

small institutions can participate, then this issue 23

gets in and gets research quality molecular diagnostics 24

done and then we can inform the process.25

74

So he can participate now for several 1

barriers. Okay. But most of the patients out in the 2

rural community are not going to see an oncologist 3

first; they're going to see a surgeon. So if we 4

concentrate on getting those people plugged in and use 5

the Central IRB process, which has not taken off at 6

all, and it should, I think we can do a lot of good 7

with very little dollars invested. 8

JOE CUNNINGHAM: So let me ask you about 9

that. So we did clinical trials all over the world, 10

and our risk in doing those clinical trials, the costs 11

and the risks of doing those in places where you're 12

uncertain is such that you just won't take that risk. 13

So I'm going to go to the PIs that I 14

know at the centers that do them all the time where 15

they've got boots on ground and I'm not going to take 16

the risk of doing that because if somebody just 17

accidently, human nature, screws that up, costs me 18

millions of dollars -- I'm not going to take the risk. 19

How do you respond to that? 20

PAT REYNOLDS: Well, my response is, 21

sure, it depends on the nature of the trial and nature 22

of the drug. They're not going to do a Phase 1 study 23

in Muleshoe. 24

But what risk is there to collecting a25

75

high-quality molecular diagnostic material on a 1

majority of patients in Texas so that we can understand 2

what's happening with their cancers and direct them to 3

the right targeted therapy? 4

And, most importantly, figuring out how 5

to collect that tissue when they relapse, because we're 6

already seeing the papers coming out in NATURE and 7

GENERAL MEDICINE on tumor heterogeneity in essence -- 8

and we're already seeing the failure of response in 9

targeted therapy because they come back with something 10

that is mutated six months later. 11

So I think that the opportunities there 12

for us to contribute a mechanism for doing this are 13

huge, and there's no reason why we can't do it in the 14

small communities because what is the risk to 15

collecting a consented piece of tissue? 16

JOE CUNNINGHAM: It depends if they 17

accidentally leave it 45 minutes out in the air or 18

they -- 19

PAT REYNOLDS: There are procedures put 20

in place to address that. And, by the way, we have 21

mechanisms for quality controlling those even after the 22

fact. Just look at the RAN on the RNA and you will 23

know whether it was appropriately taken out and stored. 24

JIM DOWN: Tim?25

76

TIM HUANG: Tim Huang from San Antonio. 1

One thing is we want to be different 2

from other states. We want to be unique and 3

demonstrate forefront of the coming age of technology. 4

For example, we talk about a tissue bank, but a lot of 5

times, the tumor heterogeneity, it's going to be a big 6

issue. 7

One way to do it perhaps we can model the 8

profile of a solid tumor -- how about this -- to model 9

profiling of separate tumor cells. This concept is 10

very innovative if we can have it statewide. 11

For example, a patient undergoing a 12

Phase 1 clinical trial can have this kind of procedure 13

implemented, perhaps we can be very unique because the 14

technology now is right at the door. Then, 15

with the CPRIT funding, this kind of support can be 16

state-wide support based on clinical trial patients and 17

they can perform here in the state of Texas. 18

JIM DOWN: Thank you. 19

Is there anyone on the phone that wants 20

to weigh in on this? 21

(No response.) 22

RAY DuBOIS: I'm Ray DuBois from M.D. 23

Anderson. 24

You know, one of the things that we're25

77

obviously all talking about is things that CPRIT was 1

charted to do from the beginning. I think it's a 2

matter of prioritization at this point and what's in 3

that portfolio in terms of pieces of the pie that are 4

being supported and what might be optimal in the 5

portfolio to be supported to make CPRIT maximally 6

effective. 7

So all of the things that 8

everyone has mentioned are clearly important issues 9

that need to be addressed for cancer, for Texans and 10

for the future of CPRIT, and I think it's becoming 11

clear that it's just a matter of prioritization of 12

the funds that we're going to have now and in the 13

future, should we refocus that on areas that we think 14

we're going to get the maximum output in or should we 15

continue to do more of the same. 16

I think it's become clear that 17

there's a lot of emphasis on basic science and maybe 18

that was more than some of the other areas. 19

Clearly, some of that research is paying off, so it's 20

been beneficial. But at this point, do we need to 21

tweak things a bit to focus on clinical and 22

translational to look at the commercialization effort 23

to optimize some of those investments. 24

JIM DOWN: That's a very good point.25

78

After lunch, we are going to talk about resource 1

allocation, which I think will touch on that. 2

But related to that, let me just raise a 3

question and that is: How much focus should CPRIT 4

have? 5

Because if you think about what we 6

talked about this morning, we've already covered a lot 7

of ground. And while the amount of funding that CPRIT 8

has sounds very impressive, when you start taking that 9

over a 10-year time period (indiscernible), that can go 10

very quickly. 11

So the choice that organizations have to 12

make is to make some big bets and go in deep and just 13

focus on a relatively few number of things and say 14

that's what I'm going to do, or do you try to plant a 15

lot of seeds and hope that some of those are going to 16

grow? 17

Those are sort of two ends of the 18

spectrum. I'd be interested in your thoughts on CPRIT, 19

where in that spectrum do you think CPRIT should fall? 20

TOM KOWALSKI: Tom Kowalksi. 21

Legislatively, you're mandated on the 22

90/10. Correct? Is that the only parameter? That's a 23

rule. 24

JIM DOWN: 10 percent prevention?25

79

TOM KOWALSKI: 10 percent prevention, 1

90 percent the other factors. 2

JIM DOWN: I assume we could eventually 3

ask for that to be changed. 4

TOM KOWALSKI: Absolutely. 5

JIM DOWN: But you're right, that is the 6

starting point right now. 7

And I don't want to get into how much 8

money should be spent in which area. We will do that 9

after lunch. 10

But just in terms of focus, do you think 11

CPRIT should be a highly focused organization or, as 12

difficult as it is, let's make a couple of bets and 13

really go after those in a big way, or do you see CPRIT 14

as we have to do a lot of different things? 15

Thoughts on that? 16

KENT OSBORNE: The National Cancer 17

Institute has tried that experiment on multiple 18

occasions in the past and it wasn't very successful. 19

Years ago, 30 years ago, 35 years ago, 20

they had the Breast Cancer Task Force where they were 21

really focusing their efforts on breast cancer. And 22

what they found was that the discoveries that would 23

influence a breast cancer patient came from somewhere 24

else just as likely as it came from that group.25

80

So I think when you're talking about 1

things like this, it's really difficult. There may be 2

some examples that would be okay, but I think a more 3

general approach in my mind would be a better way to do 4

it, than carving out some specific areas. 5

There's two ways to improve the 6

diagnosis and prognosis of cancer. One is to implement 7

what we know today to everybody, and that is sort of 8

what the prevention and service part is doing. The 9

other is research and better diagnosis and treatment, 10

and I think CPRIT has got it right in those categories. 11

But to focus now on certain diseases or 12

certain subsets of questions to ask I think would 13

probably be a mistake, because you never know where the 14

answers are going to come from. 15

EUGENIE KLEINERMAN: Eugenie Kleinerman 16

from M.D. Anderson. 17

Well, I'm going to disagree with you a 18

little bit, Kent. I think if we decide that the 19

success of CPRIT is measured by lives saved or new 20

therapies provided that really we should focus -- and I 21

don't mean on a specific disease -- but maybe areas like 22

you say, examine our portfolio, where have we made some 23

real progress, where can we identify things. 24

One thing that I've heard that's come up25

81

over and over again is obesity. And so picking 1

something like that where we know it influences cancer, 2

where we know it influences heart disease, perhaps we 3

should reexamine whether CPRIT should not have special 4

pots of money for certain things, and if we really want 5

to make an impact on lives saved and therapies provided 6

that we should choose specific areas. 7

That doesn't mean that we say it 8

doesn't matter how good the science is or how good the 9

program is, but we say this is what we really want 10

people to propose, this is what we want to use with 11

what we know and disseminate. 12

So I think we should reexamine. Perhaps 13

CPRIT should focus on certain areas. 14

JIM DOWN: Other thoughts? 15

JOHN NEMUNAITIS: The original CTNeT 16

grant that was funded actually had a section in it, a 17

significant section, where discovery in Texas was 18

evaluated with commercialization weigh-in, so the 19

opportunity for that discovery has moved to a clinical 20

process and become a potential product with CTNeT, the 21

(indiscernible) started to take steps within Texas to 22

accomplish those goals along the appropriate path for 23

NDA application. 24

So the bottom line is that by25

82

engineering aids from basic science, involving 1

clinicians in Texas to a acquire total commercialization, 2

you would have an opportunity to create significant 3

revenue and, again, things at the pace that you want to 4

perform, like the treatment of cancer, that activity. 5

However, in a sense there's some level 6

of competitive grant submissions -- and I don't mean to 7

be critical -- outside of Texas review making decisions 8

for what inside of Texas should do. I don't want to 9

make that an issue. You want to keep it objective. 10

But at some point you have to have an 11

organized focus, and so when you get into the focus, 12

that CTNeT was intended to have some level of focus in 13

that sort of direction, and it's not tabulated yet, but 14

I don't know how it's going to turn out and become, but 15

it seems to be lesser of a picture as it's taking 16

longer and longer to become activated in the search for 17

studies, and that's not necessarily focused on products 18

that have been developed in Texas from (indiscernible 19

and noise interference). You could share a key insight 20

into it, but it's not some of the discovery. So that's 21

something that might need to be discussed as we 22

approach the new session. 23

JOE CUNNINGHAM: Well, I've got to put a 24

bit of the commercialization plug in there. There is a25

83

big constraint -- there are a lot of technologies that 1

deserve to be available for patients that aren't 2

available for patients because of the commercialization 3

gap, that bridge, and so I actually think there is a 4

benefit, I think there will be treatments and 5

technologies that will become available for patients 6

because of CPRIT funding of commercialization 7

activities that otherwise wouldn't come available. 8

JIM DOWN: Uh-huh. That's good. 9

Other thoughts on focus? 10

MATT WINKLER: I think I articulated 11

earlier that I think there needs to be less focus on 12

early basic research that won't move the needle in 10 13

years. 14

I think John articulated very clearly 15

that there's lots of results from basic research funded 16

by the NCI and NIH that can be moved forward more 17

rapidly and directly affect patient lives. 18

JIM DOWN: Pat? 19

PAT REYNOLDS: Since you mentioned 20

focus, the NCI tried an experiment called the RAID 21

Program, Rapid Access to Intervention Discovery, which 22

is gone now, basically the (indiscernible) has no 23

money.24

84

CPRIT has an early translational 1

program, but they don't have a late translational 2

program. I doubt there's an oncologist in the room 3

that would tell me that if you had a drug that had 4

multiple complete response in the Phase 1 trial you 5

wouldn't want to see that move forward. 6

I would suggest that a focus should be 7

any Texas product that has multiple indications of 8

activity in the early phase trials should get some sort 9

of a priority. There should be at least an RFA 10

mechanism whereby those drugs could move forward. 11

Currently, there is not. There are drugs that are 12

active against patients that are languishing but 13

they can't be developed because the NCI is broke right 14

now and CPRIT does not have anything in that space. 15

JIM DOWN: Okay. Well, why don't we do 16

this? We're almost at noon. 17

So we are going to break for lunch for 18

about an hour to give you time to catch up on things 19

and network. We'll come back at 1:00. 20

What we'll spend the afternoon on is 21

we'll talk about resource allocations. Are we spending 22

the money in the right areas? Do we need to think 23

about reallocating that? I would assume that would be24

85

a fairly lively discussion. Then we do want to talk 1

about processes. 2

So those will be the two main subjects 3

this afternoon, and then we'll wrap up and talk about 4

the regional meetings that are going to held and put 5

together. So that's the agenda. 6

But from my standpoint, you've been very 7

active in the morning. I think there are a number of 8

key takeaways. One is how complex this subject is. A 9

lot of differing opinions. 10

But also, in my experience, choices are 11

very important and are also very difficult. 12

Organizations do need to make choices. That's one of 13

the things we'll have to struggle with in terms of 14

where the money is being spent, because you need to 15

decide where you're going to place the bets. 16

I'm not saying it needs to be highly 17

focused. That's one option. But usually organizations 18

are much better off taking choices rather than just 19

saying we're going to try to be everything to everyone. 20

I think there were some very important 21

points that were made about what I felt were 22

constituencies and the Legislature and the people in 23

the state of Texas. And if that is in the end who you 24

are going to answer to, then we need to think about25

86

what's going to add value to them. 1

I thought there was a lot of good 2

discussion about time frames and in terms of the 3

successes, how quickly do they need to come. And so we 4

need to think about that when we talk about how the 5

money is going to be spent. And I think a lot of good 6

discussion in terms of ideas on where 7

could we have more impact. 8

Can you do everything that was discussed 9

this morning? My guess is no. So that's where the 10

choices will be made and we need to have a process for 11

choices. 12

But we're not trying to make decisions 13

this afternoon. We're trying to get ideas. We're 14

going to talk about the potential reallocation of 15

funding. 16

Bill? 17

BILL GIMSON: Could I ask, is Dr. Phil 18

Sharp on? Phil, are you on? I guess the logistics for 19

the folks on the phone in terms of return. 20

JIM DOWN: Come back at 1:00, which is 21

when we’ll reconvene. 22

RAMONA MAGID: If they can just stay on 23

the line, if possible. 24

JIM DOWN: Sure, if they want. Whatever25

87

works in terms of tying them back in. 1

Okay. Thank you very much. 2

(Luncheon recess from 11:50 until 1:06.) 3

JIM DOWN: Luckily, I think we have one 4

of the more interesting subjects to talk about. 5

Before we jump into that, a couple of 6

things. One is I've been asked to let you know that we 7

are tweeting from the meeting. I don't see the person 8

here who has been tweeting, but I'm told we do have 400 9

followers. So if you're interested in signing into 10

that, when she comes back I'm sure -- 11

UNIDENTIFIED WOMAN: She's interviewing. 12

JIM DOWN: Well, she can tell how people 13

can tie into that. 14

The second is I've also been told that 15

for the most part you're doing a great job of speaking 16

into the microphone, but if you'll just make sure that 17

if you do speak try to grab one of the microphones. 18

That will be helpful. 19

So for this afternoon we're going to 20

concentrate on resource allocation and where we're 21

spending money, we're going to talk about process 22

improvements, and then at the very end we'll do a 23

little built of a wrap-up and we'll also talk about 24

this working group and get your input.25

88

While we're scheduled to go to 3:00, not 1

that we want to rush anything, but there is some 2

possibility that we could get done a little bit earlier 3

than that. If so, I'm sure that we won't have a lot of 4

complaints about that. 5

So before we start talking about the 6

numbers, let me just ask you, as you reflect upon the 7

discussions that we had this morning, would you say 8

that as we look forward to CPRIT that it's let's just 9

keep doing what we've been doing, or would you say that 10

based on this morning we need to think about maybe 11

redirecting some things? What are your thoughts on 12

that? 13

EUGENIE KLEINERMAN: Redirect. 14

JIM DOWN: Redirect. Can you tell us a 15

little bit more on why you would conclude that? 16

EUGENIE KLEINERMAN: This is Eugenie 17

Kleinerman from M.D. Anderson. 18

Since CPRIT does have a life expectancy, 19

I think it is important that we make sure that there 20

are deliverables at the end of that. 21

It's run for three years. I think that 22

we've gained some knowledge about things that are 23

successful and things that have potential. So I think 24

our job as the Advisory Committee is to make tough25

89

choices and decide what things we can push through in 1

the next three years -- I mean, six years -- so that we 2

can have some significant deliverables by then. 3

JIM DOWN: Okay. Time to sharpen the 4

deliverables and maybe the expectations. 5

Okay. Other thoughts? 6

MATT WINKLER: Jim? 7

JIM DOWN: Yes. 8

MATT WINKLER: I've already made my 9

views known that we should be putting more effort into 10

commercialization. 11

One thing that might be done is the 12

position on basic research, those basic researchers 13

that are collaborating or doing translational work of 14

industry to use the CPRIT dollars to catalyze things 15

that have better short-term yields. 16

JIM DOWN: That's an interesting 17

thought -- I heard a 18

number of people this morning talk about how 19

we need to integrate more areas, so that might help. 20

MATT WINKLER: We bring in all these 21

great new basic researchers. Let's give them the 22

incentive to go and translate. 23

JIM DOWN: Any thoughts?24

90

KAREN TORGES: Karen Torges, Cancer 1

Alliance of Texas. 2

You can't forecast the future, but I 3

think it's clear that since CPRIT has been in existence 4

the focus has not been on marketing. So when there are 5

some, we need to be able to tell the constituents that 6

we've been talking about exactly how the product will 7

be made. 8

So I don't think that's one size fits 9

all, but I think there may be the need for some 10

infrastructure into marketing communication of those 11

successes (indiscernible). That's just a different 12

perspective than where we've been. We haven't been 13

needing it till now. 14

JIM DOWN: I think that's an excellent 15

point, because we did hear a number of people this 16

morning talk about how we need more communication and 17

we need to understand who the audiences are and we need 18

to talk about what we're doing. 19

Other thoughts? Does anybody think it's 20

just let's keep doing what we're doing? 21

RAY DuBOIS: Ray DuBois from M.D. 22

Anderson. 23

One thing that I want to make clear from 24

my perspective is that these recruitment efforts have25

91

been phenomenal. I think that we really have brought 1

people to the State of Texas that we may not have ever 2

attracted without this mechanism. 3

So I think CPRIT deserves some 4

significant credit for that, because it will have a 5

long-lasting impact on the state, long after the CPRIT 6

support is gone. So I think kudos should go for that 7

vision. 8

There are now opportunities 9

for so-called missing link and clinical and 10

translational, so that could also continue to increase 11

the talent pool in the state. 12

JIM DOWN: Absolutely. 13

Is there anybody on the phone that would 14

like to weigh on this? Is there anybody on the phone? 15

UNIDENTIFIED VOICE: Yes, we're on the 16

phone. 17

JIM DOWN: No pressure. But if you do 18

want to weigh in on any of these, just let us know. 19

Okay. So let's talk a little bit about 20

resource allocation, and what we'd like to do is start 21

with what I would call the three things -- the present 22

expenditure of dollars would fall 75 percent into23

92

research so far, 15 percent into commercialization and 1

10 percent into prevention. 2

So what I'd ask you to do is think about 3

going forward. The dollars that are being spent are 4

being spent, but from now on looking out what you think 5

those percentages should be, and I'd also ask you to 6

not be limited by the 10 percent that I know is 7

statutory right now. 8

But just what do you think the 9

expenditures should be? And I'll ask you to write that 10

down in front of you, so just take a minute. Write 11

that down. 12

UNIDENTIFIED SPEAKER: Question. Is it 13

possible to subdivide the research? 14

JIM DOWN: Well, we're going to do that 15

next. I'm glad you mentioned that, because I should 16

have mentioned that. 17

What we'll do is start with the three 18

big buckets and then see what you think about the 19

overall allocation, and then we're going to work 20

through each bucket and talk about how further to 21

segregate that. 22

VINCE FONSECA: I have a question. 23

Right now survivorship doesn't have a bucket. I think 24

that if we focus in that way, we're leaving out25

93

survivorship. 1

I know how we fund it now. 2

(Multiple people speaking.) 3

VINCE FONSECA: I know. We take part of 4

the 10 percent of prevention services for survivorship. 5

(Indiscernible words from 6

unidentified speaker.) 7

(Multiple people speaking.) 8

VINCE FONSECA: Yes. Just like 9

prevention research is supposed to be prevention, but 10

we don't spend money on prevention research anyway. 11

But survivorship most people would not 12

think of as cancer prevention services. And since most 13

people survive cancer, then we have a 14

whole bunch of cancer survivors who are getting 15

sub-optimum care. 16

JIM DOWN: So could we say that would go 17

in prevention for this group? 18

VINCE FONSECA: I don't see any reason 19

to do that. 20

JIM DOWN: Well, you then would create a 21

fourth bucket? 22

VINCE FONSECA: I would have a fourth 23

bucket.24

94

JIM DOWN: Changing the rules of the 1

game. 2

VINCE FONSECA: Flexibility is about 3

going in a forward position. 4

JIM DOWN: Well, we'll give you that 5

flexibility. If you want to add a fourth bucket to put 6

something in it, feel free. 7

KENT OSBORNE: I have a question. I'm a 8

bit confused on what is meant by "commercialization." 9

JIM DOWN: Okay. 10

KENT OSBORNE: Perhaps someone that 11

knows about that could explain it. 12

JIM DOWN: I will ask somebody from 13

CPRIT. Jerry is not here. 14

But for our purposes, when you slotted 15

the dollars into these buckets, what was the definition 16

of "commercialization"? 17

BILL GIMSON: I guess the research and 18

primarily companies. 19

KRISTEN DOYLE: Yes, I'm going to say 20

15 percent is definitely for companies. There may be 21

some commercialization that comes after that. 22

KENT OSBORNE: I know it's for 23

companies. That's evident. What is it allocated the 24

companies to do?25

95

JIM DOWN: Can you give us an example 1

maybe? 2

KRISTEN DOYLE: Typically, it's early 3

stage, they're doing a Phase 2 4

(indiscernible). 5

You have companies that are doing some 6

drug (indiscernible). 7

THE REPORTER: I can't hear. 8

KRISTEN DOYLE: So it's funding for some 9

of their trials (indiscernible) -- 10

PAT REYNOLDS: That's helpful. 11

Kristen, could you tell us how many of 12

the commercialization efforts actually have an open 13

IND? 14

KRISTEN DOYLE: I don't know that 15

answer. I can get that for you. I think they're 16

trying to find Jerry and he'll fill it in for you, too. 17

JIM DOWN: So for our exercise here, is 18

everybody ready to roll? 19

Why don't we start with 20

prevention and let me ask how many people have 21

prevention at 10 percent or less? 22

(Show of hands.)23

96

Okay. Let me just get the data and then 1

we can talk a little bit about why people came up with 2

what they came up with. 3

How many people had prevention at 11 to 4

20 percent? 5

(Show of hands.) 6

JIM DOWN: And how many above, 7

prevention above 20 percent? 8

(Show of hands.) 9

JIM DOWN: Interesting. And then 10

commercialization? How many people had 11

commercialization at 15 percent or more? 12

(Show of hands.) 13

JIM DOWN: A fair number. Okay. 14

And 16 to 25 percent? 15

(Show of hands.) 16

JIM DOWN: Okay. And above 25 percent? 17

(Show of hands.) 18

JIM DOWN: A couple. Okay. 19

And then research? How many people had 20

research at 75 or above? 21

(Show of hands.) 22

JIM DOWN: A couple. How many people 23

had research at 15 to 74? 24

(Show of hands.)25

97

JIM DOWN: Did anybody have research at 1

less than 15? 2

(Show of hands.) 3

JIM DOWN: So you can see we're in total 4

agreement here. 5

(Laughter.) 6

JENNIFER REDMOND: What about 7

survivorship? Do we add a new bucket or not? 8

JIM DOWN: That I don't know. Vince, 9

did you write survivorship? How much did you put in 10

that? 11

VINCE FONSECA: 30. 12

JIM DOWN: Wow, wow. Okay. 13

So what would you take away? 14

UNIDENTIFIED VOICE ON PHONE: For those 15

of us on the phone -- 16

JIM DOWN: Yes. I'm sorry. 17

So for those of you on the phone, could 18

you maybe just give us a sense of what you had? 19

UNIDENTIFIED VOICE ON THE PHONE: I'm 20

asking for the results of the audience. 21

JIM DOWN: Ahh. That's true. You would 22

be at a bit of a loss if you couldn't see the hands 23

going up. 24

THE REPORTER: Do we know who is on the25

98

phone? 1

JIM DOWN: I wouldn't say it was a 2

third, a third, a third, but it wasn't too far off. 3

There certainly seems to be a camp that 4

would like to spend more money on prevention and then a 5

lot more money on prevention. 6

And then I'd say the same with 7

commercialization, there's a camp that would like to 8

spend more and then a camp that would like to spend a 9

lot more on commercialization. 10

I would say most people in research 11

would spend less, but there was a contingent of people 12

that seemed to feel that we should spend most of the 13

money on research and just a couple of people that felt 14

that research should go below 50 percent, but there 15

were a couple. 16

UNIDENTIFIED VOICE ON PHONE: Thank you. 17

JOHN MINNA: This is John Minna. 18

I think that a lot of these votes would 19

be dependent on the makeup of people in the room here. 20

Believe me, I'm speaking as a researcher.21

99

As Becky and I were talking before, I'm 1

wholly in support of prevention and survivorship as 2

well and early detection, and I think I've already 3

expressed my views about ways that we really need 4

commercialization for ways going forward here. 5

But I still agree with Kent Osborne who 6

said earlier, I think, that this has got to be an 7

integrated plan. I think research has got to be a key, 8

a major position, because, quite frankly, we don't know 9

what to do for a lot of situations right now. 10

So I think some of these percentages and 11

votes are really being determined by the composition of 12

various constituencies, which should be expressed, 13

within this room. 14

JIM DOWN: Yeah. 15

JOHN MINNA: And I think it's important 16

to think about that. 17

I'm very pleased to 18

hear about the survivorship and prevention things as 19

well. 20

JIM DOWN: Yes. 21

STEVE WYATT: I 22

mean, I came up with arbitrary percentages, but until 23

you know what the outcome metrics are, it's really hard 24

to make that goal and make it make sense.25

100

Whatever the outcome measures are of the 1

constituency groups that matter the most would drive 2

what the percentage allocations would be, from my 3

perspective. That's just me. 4

JIM DOWN: That is what 5

would be the classic way to do it, that you would reach 6

agreement on the outcomes of the success and then you 7

would say, "Okay. What then would drive that and where 8

would the dollars be best spent to drive that?" 9

Whether we can get there after all of 10

these different meetings or not, we'll have to see, but 11

that's what you'd like to think we are heading towards. 12

TOM KOWALSKI: This is Tom Kowalski. 13

I'm a political realist. So when you 14

begin to tinker with Legislative mandates on a 90/10 15

rule you could get what you don't want, because then 16

that opens it up to full discussion, not only committee 17

hearings but on the floor of both houses. 18

And if we're thinking 19

outside of the box, I would rather we think in a box 20

where you don't have to tinker with what has already 21

been put forth and approved. You run the risk. 22

JIM DOWN: Yeah. I think that's a very 23

good point, and I'm sure that would be evaluated before24

101

we'd actually go down that path. 1

I think it's interesting for this group 2

to say if you didn't have constraints, how would we 3

spend the money? 4

KATHRYN PEEK: I just want to add to 5

what Tom was saying. Just one way to skin the cat 6

possibly is to -- I don't know if you do 7

this with percent target allocations or what -- 8

carve money out of research and add in 9

commercialization that's targeted for prevention. That 10

is one possible way to get more money for prevention 11

without going to the Legislators, I 12

guess. I don't know. 13

JIM DOWN: We don't have to get into 14

that now, but I don't know what the firm definition is 15

on that 10 percent of prevention and what needs to be 16

called prevention. Maybe we can sort that out. 17

But maybe we can hear from some of the 18

people that voted at what I'd call the extremes, 19

because there were some people that said we should 20

continue to spend something like 75 percent of the 21

money on research and then there were some people that 22

said we should roughly double what we're spending now on 23

commercialization and prevention. So those are two24

102

different views of the world. Maybe hearing from some 1

of those people on why they voted that way would be 2

helpful. 3

Kent? 4

KENT OSBORNE: This is Kent Osborne 5

from Baylor. 6

Do you know how much, quote, 7

"prevention-type" research is being done in the 8

research area? Because no research is done in the 9

prevention component. It's all service. So things 10

that would to fit into the large rubric of prevention 11

-- do you know how many research 12

dollars are going into that right now? 13

JIM DOWN: Becky? 14

BECKY GARCIA: I don't have the dollar 15

amount, but (indiscernible). I would say it's probably 16

about five, if we're comparing that to a research 17

grant for a couple of behavioral research projects, 18

if you're not looking at clinical prevention, but more 19

of the behavioral type prevention. 20

KENT OSBORNE: What about basic science 21

that's leading to prevention? 22

BECKY GARCIA: Now, we've got a whole 23

lot of that, depending on how you define "prevention24

103

research." 1

JIM DOWN: So could we hear from people 2

that are at the other ends of that spectrum, just to 3

get the rationale? 4

LAUREN HUTTON: Lauren Hutton, Lance 5

Armstrong Foundation. 6

We would like to see up to even 7

30 percent prevention-focused dollars, and that is 8

derived from a metric that we would 9

like to see of 10,000 lives saved. So that is just one 10

of the areas. 11

Our other breakdown is 50 percent 12

translational research and 20 percent commercialization. 13

JIM DOWN: Okay. 14

MATT WINKLER: Increasing prevention, I 15

think we simply get so much bang for our buck there. 16

I'd like an increase in commercialization. 17

I would also like to see CPRIT 18

catalyzing research grants by having a component of the 19

review process be what kind of involvement is the 20

scientist doing in terms of actually commercializing 21

their research and pushing into the clinic. 22

JIM DOWN: Yes? 23

JIM WILSON: Jim Wilson, UT 24

Southwestern.25

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From the standpoint of continuing 1

investing in research, I point out that prevention, 2

while laudable, there's still a considerable 3

amount of what we do not know and the application of 4

current practices still has a limited impact. 5

The second point is that we've already 6

discussed the importance of recruiting good talent and 7

passing expertise to the state that has an impact on our 8

future as well as our potential for commercialization, 9

and I think that is a big component of research. 10

Finally, there are investments in 11

bringing people who have not been in cancer research 12

into cancer research who have tremendous 13

opportunities to cross institutions. They're 14

going to be up for renewal of their projects, and I 15

think we want to enable that opportunity to go forward, 16

at least embedded by peer reviews and meritorious 17

(noise interference), so I think you still have a lot 18

to do to invest in research that's going to have an 19

impact across all of the constituencies that are 20

represented here. 21

JIM DOWN: Gail? 22

GAIL TOMLINSON: What about increasing 23

the amount for prevention, but also within the increase, 24

having some of that go to prevention research so that 25

we will have more evidence-based preventive efforts 26

105

that apply. I agree (indiscernible) sometimes you just 1

want to keep applying the same thing, but (indiscernible) -- 2

JIM DOWN: More prevention, but 3

prevention research? 4

GAIL TOMLINSON: Both, both. 5

JIM DOWN: Okay. Could I ask a question 6

on the research? Because the survey has a meaning 7

which is very helpful. Just to get where people are 8

coming from. 9

There were a number of comments that 10

people wrote in that basically said we shouldn't try to 11

duplicate what NIH is doing, they're already spending a 12

tremendous amount of money on research and what can we 13

do that they can't do. 14

And we seem to have lost Joe, but I 15

think that was part of his message. So I'm just 16

wondering what the response to that is. 17

PAT REYNOLDS: I'm sorry. I'm not aware 18

that the NIH has cured cancer. What can we do that19

106

they can't do? We can do the same thing that everybody 1

can do -- we can contribute to solving the problem. 2

But "Let's not duplicate 3

NIH" -- I hear this over and over again, but I don't 4

understand the concept. Because what are we going to 5

do other than investigate the cancer problem? So how 6

can we not be doing what the NCI does? 7

JIM DOWN: Again, 8

I'm just the reporter here. I'm reporting what some 9

people put down. 10

But the question would be: Are we using 11

a different approach? Is it that we have a couple 12

billion dollars so we're going to put more money at it 13

and pretty much do what they're doing, or is it that 14

we're taking a different approach in research than they 15

would be taking, or we're focusing on different areas 16

than they might be focusing on? That would be the 17

question or the questions that would come to mind. 18

PAT REYNOLDS: From that perspective, I 19

would say focusing on translational research, which has 20

traditionally not been well funded at the NCI would be 21

something we should think about. 22

JIM DOWN: That could be a possibility. 23

PAT REYNOLDS: Another thing I'll 24

mention, I'm not only here as a member of25

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(indiscernible) community but also representing West 1

Texas. I think that people have to realize 2

that -- those of you that are not in West Texas -- that 3

CPRIT is not just something that's nice for us; it's 4

essential. 5

75 percent of all of the cancer research 6

dollars in West Texas is coming from CPRIT. And if we 7

don't solve the problem we're facing right now with the 8

media and this goes away at the end of this biennium, 9

that's going to be devastating to us in about half of 10

the state. This is one-half of the state, 11 percent 11

of the population and 82 percent of the State's 12

revenue. 13

JIM DOWN: Wow. 14

PAT REYNOLDS: So I think one thing that 15

CPRIT can do that NCI is not doing, since only 16

1 percent of the NCI dollars to this state go to West 17

Texas, is to consider the half of the state that's 18

ignored by the federal government. 19

JIM DOWN: Okay. Vince? 20

VINCE FONSECA: Vince Fonseca. 21

I think I was one of the people that was 22

on the extremes of lower research, and that would be 23

very focused. It would only be effectiveness research 24

and dissemination research, survivorship research. So25

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we do know what works. 1

We know that with tobacco cessation, there's 2

no question. We also know that fewer than half of the 3

smokers get advised (indiscernible) and counseling and 4

(indiscernible) for smokers, even though 75 percent of 5

smokers want to quit. 6

So we have a dissemination problem. We 7

know what works. We have trouble disseminating it. 8

Similarly for other preventive services. So there's 9

plenty of research to be done. 10

NCI does not fund very much 11

dissemination research. A little bit to survivorship 12

research. So we can do things differently. So I would 13

stay greatly focused in the research portfolio. 14

Similarly for prevention, we also know 15

the number of women over 50 who have not had a 16

mammogram in the past five years. We could literally 17

spend all of the money that we have just 18

caring for people with one disease for people that are 19

way overdue. 20

And then finally on survivorship, most 21

people survive cancer, and they have problems dealing 22

with it every day. And right now we're taking the 23

money out of prevention, even though that's a grave24

109

reallocation. 1

In terms of selling it, everybody knows 2

a cancer survivor. Everybody. Most people have a 3

cancer survivor in their family. So not only are we 4

getting great benefit delivering optimal care -- other 5

than the medicines that we're giving them, 6

the surgery and the chemotherapy and the radiation we 7

give them -- we're dealing with the aftermath of those 8

therapies. And that will go a long way to improving 9

health in Texas and selling it, because everybody knows 10

a cancer survivor. 11

JIM DOWN: Thank you. 12

JIM WILSON: I want to come back to the 13

comments about not duplicating the NCI's position, and 14

I think that presents a more slippery reviewing 15

process. 16

I don't think there's evidence at 17

this point that, in fact, that's occurred. To point to 18

the major expenditures again in terms of recruitment, 19

in terms of infrastructure investment and in terms of 20

attracting noncancer investigators into the cancer 21

research environment. 22

And I think if we look closely at the 23

portfolio you would see that that's been the major 24

impact of the research dollars as opposed to25

110

duplicating the NCI's portfolio. In fact, that's one 1

of the legacies that Texas will be able to build on in 2

terms of going forward and being innovative at 3

successful commercializations because of that 4

intervention. 5

JIM DOWN: So what should we take away 6

from this discussion that we've been having since we 7

came back from lunch? What do you think we should take 8

away from this? 9

PAT REYNOLDS: Everything is important. 10

JIM DOWN: Well, that is part of it. 11

People have been very eloquent in explaining their 12

positions, and it would be difficult to say that any of 13

this is not important or a waste of money or a waste of 14

time, so that should be one take-away. 15

What else should we take away from this? 16

RAY DuBOIS: So you raised the question 17

about recalibrating the amount in each pot, and I think 18

it really depends on what's in that pot. We didn't get 19

into that discussion. But clearly I think there's a 20

significant number of individuals that would 21

recalibrate how much is flowing into those different 22

buckets. I think that's the clear consensus from this 23

group. 24

The other thing, I'd like to reiterate25

111

what Jim mentioned. These recruits that we pull into 1

the state, they drag a bunch of federal funding with 2

them because they're top scientists and they bring 3

their ideas, they bring their discoveries, and those 4

are also things that could be recalibrated into the 5

commercialization scheme of things. 6

KAREN TORGES: Karen Torges, Cancer 7

Alliance of Texas. 8

I agree totally with what was just said. 9

The recalibration, it would just be a good idea to 10

revisit what those buckets are. And then the other 11

piece of it would be to consider how to matrix that, 12

how to define what our goals will be. So when we talk 13

about how would we describe this in terms of 14

short-term successes, medium, long-term, we'll have to 15

tell the story that way. 16

Some people only care about change in the 17

media. There will be another way of doing it, and some 18

people will only care about survivorship issues, so we 19

might need to frame it up that way. 20

But no matter how we do it, we're going 21

to have to tell the story several different ways. And I 22

suggest at this point it would be helpful to reconsider, 23

that it's time to do that, and I think we should be 24

revisiting the issue (indiscernible) --25

112

JIM DOWN: Yes. 1

JAMES GRAY: James Gray, American Cancer 2

Society. 3

I put 10 percent down for prevention. 4

We fought hard to get 10 percent in the original bill 5

because there was nothing in the original bill that 6

came forward and we finally got it up to 10 percent. 7

So we, as an organization, would love to 8

have more funds, but I just can't bring myself to want 9

to find the will to open that Legislation up again. So 10

there's that reality that I deal with. 11

JIM DOWN: Yes. 12

JAMES GRAY: But I think what's 13

important -- and I don't know if the path is slippery or 14

not, but I can see it being a role -- is when we 15

think about trying to increase it from 10 to 20 16

percent. In many ways we've already done that at the 17

state because there's significant money, relatively 18

speaking, in Texas that goes to cancer prevention 19

through other programs, but there's also significant 20

opportunities at the federal level to draw more money 21

in. 22

So as we think about increasing that 23

percentage, there are other ways to do it than opening 24

up that Legislation. Maybe some thought needs to be25

113

put into if we want to increase the percentage, let's 1

leverage the money that actually goes into various 2

agencies to fight cancer and support prevention. There 3

may be opportunities at the federal level, too. 4

EUGENIE KLEINERMAN: Eugenie Kleinerman, 5

M.D. Anderson. 6

I have a question. So where does 7

education fit in? Does that fit into prevention? 8

Because you talk about smoking cessation. It would be 9

great if we could stop kids from smoking, get kids 10

eating right, teach people to stay out of the sun and 11

use sunblock so that we don't have to have 12

screening for melanoma or basal cell, we don't have to 13

have smoking cessation, we don't have to start at the 14

university making them smoke-free. 15

So I increased my prevention pool 16

because I felt we're not doing enough in the education 17

realm to unify how we teach the children across Texas 18

to keep themselves healthy. 19

BECKY GARCIA: Just to answer your 20

question, public and professional education is about at 21

10 percent prevention. (Noise interference.) 22

EUGENIE KLEINERMAN: We talk 23

about making an impact. We can make an impact 24

relatively inexpensively if we increase the pool and25

114

standardize the way we put into the pool smoking 1

prevention, sun education and nutritional types of 2

programs. 3

RAY DuBOIS: So, Becky, even the 4

training grants come out of the prevention side? 5

BECKY GARCIA: No. 6

RAY DuBOIS: Because those are really 7

also very effective for training younger individuals. 8

KENT OSBORNE: Could I ask a question 9

about that, too? Because I think it gets to Jim's 10

point. 11

I think we're thinking about research as 12

being 75 percent of this money goes to some guy 13

working in his laboratory, as Pat said 14

earlier, to publish a NATURE paper. 15

It's nowhere near that. I think you 16

really need to break down that research component into 17

new recruiting awards -- prevention research, 18

training grants -- and then see what you're left with 19

for the guy working in the lab with the test tubes 20

trying to make a new discovery that will actually have 21

a major impact in 10 years in fighting cancer. 22

I think you're going to find that your 23

percentages are not -- those of you who said 30 percent 24

for research -- far off, considering what you were25

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really thinking is research. 1

And I don't think we have enough 2

information yet to -- for me, at least -- to actually 3

change my recommendations, because I don't know where 4

all these things are right now. I think that would be 5

very helpful to know. I think we're talking without a 6

lot of accurate information. 7

VINCE FONSECA: Texas is also unique in 8

that we have more medical students than we have 9

residency slots. We're talking about building yet 10

another medical school with tax dollars, which is 11

really crazy. It's far more effective to expand the 12

primary care where we can train folks, for example. 13

Almost all counties in 14

Texas have a health professional shortage in preventive 15

care and in mental health and in benefits. 16

So if there were another way to 17

bring in people that are going to make a difference, 18

because what happens is we spend a whole lot of tax 19

dollars training people in medical schools and then 20

they go off to other states to do their residencies 21

(noise interference and indiscernible), so we have this 22

net loss of tax dollars, where we could be expanding 23

residency programs 24

so that we keep physicians here in this shortage area,25

116

which is not the urban core. We 1

grow at about 600,000 people a year in Texas. We 2

grow a Wyoming every year. 3

All of those things are going against 4

even the state that we are now. Things will get worse 5

if we continue to do things the same based on 6

demographics, based on population growth and based on 7

the outflow of publicly funded money. 8

And we brought this up one time, and 9

I'm not saying it's CPRIT's responsibility, but we 10

had an opportunity, and we still do, to say, "Hey, 11

how do we expand one, two, three positions in residency 12

programs and, again, where are these tax dollars going?" 13

JIM DOWN: So in terms of takeaways 14

from what I call the big buckets, because we are now 15

going to drill down into each of them and talk about 16

what's in our budget. 17

A couple of thoughts. One is that 18

everything is important, and I think that's clear. 19

The second is people tend to see the 20

issues depending on the lens that they 21

look through or their own backgrounds. That's just 22

natural. We referred to some of that here. 23

But a couple of things that strike me,24

117

-- and it's dangerous to say consensus, because 1

the best idea might come from somebody who's an 2

outlier, so we always need to be open to that. 3

But if you think about the consensus, to 4

me it clearly was that this is going to continue to be 5

what I would call primarily a research institution. 6

There were a few people that said let's 7

not spend too much money on research, but the 8

overwhelming majority I think said 50 percent or more 9

of the expenditures should go on to research, however 10

we define that. So that was clear. 11

Then the second in terms of consensus 12

is that we should be 13

reallocating some of the dollars. People seem to be 14

clear that we should spend more on commercialization 15

and potentially on prevention, whether you change the 16

Legislation on that or you do it by spending that money 17

more on research or whatever, but there seemed to be a 18

consensus on that. 19

Why don't we now shift and go through 20

each of the buckets? And we'll start with research, 21

which I think is the largest bucket. 22

JENNIFER REDMOND: I brought this up. 23

JIM DOWN: Perfect. In Bill's 24

presentation, you do have this data that breaks down25

118

how the research is being spent now, and I will just 1

walk through this and make sure that I understand it. 2

And if I don't, somebody can correct me. 3

But I would take away that 38 percent 4

of the 75 percent of total expenditures is spent on 5

what I call pure basic research. Okay? 6

Another 27 percent could either be 7

called basic research or translational research, and 8

somebody can tell us why. 9

19 percent, again, of the 75 is spent on 10

pure translational research. 11

Then a very small amount of money, 12

4 percent, is being spent on clinical research. Okay? 13

Can somebody just speak to this big 14

overlap here? Just to define it for us. 15

UNIDENTIFIED SPEAKER: When people don't 16

like our category, what is the definition of 17

translational research? 18

BILL GIMSON: Basically their own 19

definition. 20

JIM DOWN: So this is self-selective? 21

VINCE FONSECA: Without even a common 22

standard in tech, the translational can be a tremendous 23

span -- 24

KENT OSBORNE: It's actually pretty well25

119

defined. It's defined by the NCI. It's basic research 1

that has immediate clinical application. 2

And when you're doing your basic 3

research, you're thinking about that clinical 4

application while you're doing it and you're thinking 5

immediately about how to hand it off to the 6

next guy. Or if you're a translational researcher, 7

like I've been for 35 years, you sort of just know it, 8

because that's what you do. So you study in the lab a 9

clinical problem and you take it to the clinic right 10

away. That's translational research. 11

VINCE FONSECA: Is the research from the 12

tech side to the trenches, which is actual tactics 13

where actual humans live and get the majority of their 14

care and -- 15

KENT OSBORNE: That's clinical research. 16

VINCE FONSECA: And you believe that 17

that's what that is, Jim? That that bucket is 18

merely -- We know it's not. We can look at the graph. 19

TIM HUANG: Well, sometimes when you 20

structure a grant you can have a clinical trial or a 21

human component there. You study a population of 22

patients. But then you want to study the method, and 23

then you need many more models. You need to do in vitro 24

observation. So in a grant you may have these 25

120

three components. 1

VINCE FONSECA: I'm not talking about 2

that. I'm saying the real life, after it's already 3

gone through its FDA approval, it's already been proven 4

to work, you've already done that definition of 5

translational research already. 6

And I know that there is not that slice 7

of the pie in research that's delivering, going from the 8

trenches to actual care. It's not met. It's a very, 9

very small amount. 10

KENT OSBORNE: By that time, it's no 11

longer research. I'm not quite sure I understand what 12

you're talking about. 13

By the time you have something that's 14

proven to be effective and then to get it through 15

research and then to get it to the people, I don't 16

quite understand what you're talking about. 17

VINCE FONSECA: Well, there are a lot of 18

definitions of translational research that talk about 19

how do I disseminate this into actual practice that are 20

also called translational research under a different 21

definition. 22

So there are quite a few people that 23

write about why don't we study and do research on how 24

we deliver those things that have already been proven25

121

to be efficacious with effectiveness research, 1

comparative effectiveness research, dissemination 2

research, whatever other words you want to call it 3

related to that. So we know what does work and we also 4

know that virtually most people in most populations are 5

getting suboptimal screening and care. So that is also 6

research. We just don't have application and that's 7

the question that I've asked before and the answer is 8

we don't have any set-asides. Having no set-asides can 9

be okay, but you should have an idea of the 10

different kinds of research being done. 11

The NCI also defines surveillance as 12

research. We don't have surveillance money to do that. 13

There are many things that will fall under research 14

that are woefully not on any sliver of those circles 15

there right now. 16

So if you go back to the very beginning 17

of NCI when they laid out all of the different kinds of 18

research, they're there. They're still there today, 19

we're just not funding that many of them here in Texas. 20

STEVE WYATT: To me, a great example 21

would be the HPV vaccine uptake in populations. We 22

don't know a lot about effective 23

interventions for increasing uptake. We just simply 24

don't. We know the vaccine is effective, but we don't25

122

know how to target families, moms, dads, grandparents 1

to increase uptake in kids. 2

That's a stream of research that 3

might struggle in the current 4

dynamic of funding. It just might struggle competing 5

against more in bench and clinical research. It's an 6

important stream of funding, but I think it would 7

struggle. 8

So using that as an example, I 9

suspect that's kind of what you're pointing out. 10

VINCE FONSECA: That's one of them. 11

People do great bench research, do great clinical 12

research, they do great translational research to get 13

that IND, get the NDA, get it out. It's been on the 14

market six years. Still fewer than 50 percent of young 15

woman have had three doses of HPV vaccine. We know it 16

works really well once you get it into 17

somebody's arm. 18

KENT OSBORNE: Is that research or is 19

that education and is it research in order to know how 20

to educate? Whether that's 21

really research or not, I think is -- maybe it is, 22

but -- 23

STEVE WYATT: I would call it 24

intervention research. Clearly, NCI -- if you25

123

look at NCI -- they fund some. We actually had quite 1

a bit of funding in this area in my school, beyond a grant. 2

We're in the early stages. We're really 3

increasing uptake in a small rural population in 4

Appalachia, but it's incredibly expensive and 5

time-intensive to figure this out. 6

I mean, that's just one example. There 7

are many, many. I call it research, but I would define 8

it as intervention research. 9

JIM DOWN: Can I just ask on that? I 10

know you have funded some research looking at Hispanic 11

young women, because if you look at the data, Spanish 12

women are much lower than other categories. I believe 13

the pundits relied upon logical research on that, but 14

does that fall into research the way we're doing it 15

here or does that fall someplace else right now, the 16

way you categorize the numbers? 17

BECKY GARCIA: A proposal like that 18

right now would go into the research function. 19

JIM DOWN: Okay. So when you look at 20

this, given the discussion we've had so far today, what 21

conclusions would you draw? 22

Does that look about right? Would you 23

say it should look different going forward? What's24

124

your initial reaction? 1

GAIL TOMLINSON: Well, if we really are 2

doing the translation and looking at what's been 3

successful by the end of CPRIT in 2020 -- 4

(indiscernible) -- 5

UNIDENTIFIED VOICE ON PHONE: We're not 6

hearing her at all. 7

THE REPORTER: I can't either. 8

JIM DOWN: Could you repeat that? I 9

think they were saying on the phone they couldn't hear 10

you. 11

GAIL TOMLINSON: I was saying in an 12

ideal situation as CPRIT moves forward we should see 13

some of the topics covered being translated into applied or 14

clinical research. 15

That would be a mark of success. If 16

some of the products, if some of the ideas were carried 17

to the clinic, then that would translate into more 18

clinical research over the course of CPRIT. 19

JIM DOWN: So that wouldn't require, 20

if I understand you correctly, a reallocation? That 21

would just be the normal evolution? If we saw some 22

success, we would have things we would normally then 23

move into a clinical phase at some point?24

125

GAIL TOMLINSON: I mean, 10 years is a 1

short timeline in terms of development of new agents in 2

applied cancer research. It goes by really quickly. 3

In theory, that's the movement we should 4

see. Maybe over 15 to 20 years is more likely, but I 5

think we should start to see it by the end of CPRIT. 6

By 2020, we should see it. 7

JIM DOWN: Okay. Pat? 8

PAT REYNOLDS: Since we were talking 9

about what it would be in terms of reallocation, 10

something that Eugenie pointed out earlier was a focus. 11

And I think everyone knows that when you're diffuse, 12

you accomplish less sometimes than when you're focused. 13

I don't see that the issue is 14

really a reallocation of any numbers you have 15

there. But the question I pose is the granularity 16

of what's in research. The RFAs are broad, in fact 17

totally broad, and the question is: Should there be 18

RFAs issued that enable areas that are not so broad? 19

The one I brought up earlier was there 20

is no means to translate into Phase 2 trials active 21

drugs currently with CPRIT. There's no funding 22

mechanism. We have a CTNeT, but CTNeT is going to 23

study a lot of drugs from places other than Texas 24

because there's no way to get the drugs beyond -- the 25

early translational grant opportunity is great. 26

126

But once you get to that point, then 1

where do you go? The only opportunity is the 2

commercialization sector, which may not be interested 3

in certain drugs because there are not large 4

populations. 5

The sort of things that I 6

think we ought to really be getting into is the 7

granularity as to what should the RFAs be that will 8

guide the process that the reviewers will then take on 9

when they review grants. 10

KATHRYN PEEK: Kathryn Peek, University 11

of Houston. 12

I'd like to add a question along those 13

same lines and using your term of "granularity." 14

Is there any way, Bill, to define what 15

proportion of the research identified by the 16

investigator that falls under the category of 17

preventive research? What proportion of the research 18

is preventive research? 19

BILL GIMSON: I think Becky answered the 20

question. Right now, you said, Becky, roughly 5 grants 21

out of about 280 grants, or 10. 22

BECKY GARCIA: Again, what is our23

127

definition of "prevention research," what is our 1

definition of "translational research"? 2

Kathryn’s and my definition of prevention 3

research might mean something different. We might be 4

talking about dissemination research or behavioral 5

research or comparative effectiveness research. 6

So we can definitely look at the 7

portfolio that way once we've settled on what the 8

definition is. 9

KATHRYN PEEK: And would there be an 10

opportunity for an RFA that was focused on 11

prevention research? 12

We seem to be talking about those 13

categories, those topics, that are at the interface of 14

the three big buckets. 15

BILL GIMSON: I think that's why we're 16

here, to get recommendations for a different 17

approach or more specificity in a particular area. 18

CHANDINI PORTTEUS: Chandini Portteus. 19

I think this comes back to the very 20

first question, which is: What is that? It's really 21

hard to reallocate the pie until you determine where 22

you want success. Is it answering those challenging 23

questions in prevention research or is it really 24

translated to patients? Is it really the same thing?25

128

So it's hard to look at that and say it should be here 1

or there. 2

KENT OSBORNE: It's hard to reallocate 3

it if you don't know what the current allocation is, 4

and we don't. 5

JIM DOWN: Would that be one of the 6

takeaways here, that we do need to dissect this a lot 7

more and know more about the allocation? 8

(Indiscernible multiple people 9

speaking.) 10

CHANDINI PORTTEUS: Becky, do you think 11

CSO codes help, such to classify things? 12

BECKY GARCIA: Not CSO codes, but we do 13

have coding. It's all self-selection. 14

JIM DOWN: So other thoughts on that? 15

Where did it go? 16

JENNIFER REDMOND: Research allocation? 17

JIM DOWN: I'm talking about -- oh, it's 18

up there. 19

JENNIFER REDMOND: Oh, I'm sorry. I 20

moved it further back. 21

JIM DOWN: That's okay. 22

Any other thoughts on that allocation? 23

VINCE FONSECA: I think everybody has to 24

do the one-page summary. And rather than25

129

self-selection, I could see it being worthwhile to look 1

at how much time we spend on the peer, to actually pay for 2

a group of different perspective people to read those 3

one-pagers and categorize them, and then we'd be able to 4

answer this question and have this discussion that we 5

have had here. With that number, what I call a hybrid, 6

you can do it pretty quickly. 7

JIM WILSON: I think the other point 8

that hasn't been made but I think we should be careful 9

about is that it's not just the approved grants and the 10

awarded grants but it's also what has been received, 11

and it would be interesting to know whether or not we 12

just don't have the credible proof of investigators to 13

compete for these important areas. And if that's the 14

case, that would be information that could influence 15

going forward in terms of the approach; i.e., 16

recruitment opportunities or special infrastructure 17

investments that would enable innovative connections. 18

JIM DOWN: Could I just ask, when a 19

grant request comes in now, what criteria are used to 20

screen and prioritize? 21

BILL GIMSON: Basically, there are 22

phases that are wide open in terms of looking at 23

research. And so when it comes down to it, it's funding 24

very vast projects. The committees take a look at that, 25

but there are no quotas, no targets for prevention 26

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research or translational research or basic research, 1

so -- 2

JIM DOWN: There are a lot of ways that 3

you -- 4

BILL GIMSON: One thing I could say is 5

that out of roughly $500 million, probably 20 to 25 6

percent are recruits, so that's an easy group to take 7

out. Those are recruitment grants. And I would guess 8

that 10 to 15 percent are the training grants, so again 9

those are easy to pull out. So the other would be -- 10

between 60 and 70 percent probably -- basic 11

translational, clinical, some prevention research. 12

And we could certainly slice and dice it even more. 13

PAT REYNOLDS: Bill, isn't it fair to 14

say, given the fact that you had such a difficult 15

time getting clinical investigator recruits, that 16

there's very little clinical investigation in the 17

recruit process, so there is a bias towards basic 18

science in the recruit process? 19

BILL GIMSON: Well, if I was 20

going to say anything about the Venn Diagram, I would 21

say -- again, as an operations person -- that 22

basic is first, translational is second and clinical is23

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third or last. 1

JIM DOWN: That, I think, is clear. 2

BILL GIMSON: Staying away from the 3

numbers, right. 4

JIM DOWN: But the question I 5

would ask is, is there a need to have more of what I 6

would call a screening or prioritization process that 7

still would result in fairly good projects as 8

opposed to saying "we want the best"? That's a pretty 9

broad field. So would it make sense to have more of 10

a screening or more of a prioritization, or is the 11

way we're doing it today the right way? 12

VINCE FONSECA: I would say if we first 13

analyzed what's been funded and then say, "This is what 14

we're doing. This is what we believe the balance 15

should be." 16

So if we came up with six 17

categories of research, and had people categorize them 18

and say, "This is what we want," rather than screening, 19

I think it would be a targeted RFA. 20

If you believe surveillance is important 21

or intervention research is important or basic science 22

research is important and we didn't have enough of that, 23

then we say let's have some targeted RFAs for that 24

kind of research rather than having them broad and 25

trying to put layers of screening. 26

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JIM DOWN: That's a good point. What's 1

the reaction to that? 2

EUGENIE KLEINERMAN: I'd like to go back 3

and react to what Jim said. I agree. I think we have 4

to get a feeling for the grants that came in at one 5

time. 6

Because when you say, Bill, we fund the 7

very best, I don't know what that means. The very best 8

as judged by the study sections that we put together, 9

what they feel is the very best? And having read a lot 10

of review sheets, sometimes it's felt that the impact 11

won't be high, that the science impact won't be high, 12

sometimes it's felt that it's rare, sometimes it's felt 13

that it's really well laid out, but 14

it's not really exciting, by their definition. 15

So I think it would be important to know 16

what else came in that wasn't funded, and then I think 17

we have to give a more narrow charge to the study 18

section based on what we feel is important to moving 19

forward. 20

So, yes, I think RFAs would help. But 21

there may be people out there who have tried to get the 22

money and they were told it's not good enough. But 23

based on whose criteria?24

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JIM DOWN: Other thoughts on this? 1

STEVE WYATT: One of the topics, and I 2

don't know when to bring this up, but is jumping the 3

curb here and sort of putting the idea of not reprising 4

what the NIH is doing. I worry that if we have 5

set-asides we end up not necessarily distinguishing the 6

opportunities. 7

So in the area of prevention research, I 8

think it would be very informative to know what are the 9

opportunities to do something special and innovative 10

that isn't going on elsewhere and is not going on 11

currently in our environment. 12

So in fact, one of the discussions we 13

had earlier today was how enabling a population 14

registry might be as an infrastructure investment for 15

the state and people of Texas. Those kinds of 16

questions I'd like to see along with the discussion 17

about what has been and what hasn't been funded in the 18

past. 19

JIM DOWN: That's a very intriguing 20

approach. Who would do that? Who would look for those 21

gaps and say, "Nobody is doing this." 22

STEVE WYATT: Well, we have at this 23

table content expertise in prevention research that 24

could be a starting point in looking at those25

134

individuals to help. 1

I think the same thing could be true of 2

clinical research. What is the opportunity to really 3

jump ahead rather than leave it to the standard 4

approaches to clinical research? 5

We had some examples. CTNeT is supposed 6

to do that, so it seems that we have already 7

invested in those opportunities, and thinking about 8

ways to enhance them rather than just suggesting a 9

general RFA would be appealing from my point of view. 10

JIM DOWN: I think that is an 11

interesting idea. I think there were a number of 12

suggestions here morning where people were saying 13

nobody is doing this and saying we could do it, and 14

that kind of thinking could be very beneficial. 15

JOHN MINNA: Believe me, I have had several CPRIT 16

applications come back that I thought were fabulous 17

that had many of the comments 18

that you talked about. 19

However, at some point you're either 20

going to have a review process or you're not. If 21

you're not going to have a review process, then, in my 22

opinion, the thing becomes chaotic. I don't think23

135

anybody is advocating not having a review process here. 1

But if you are, you have to trust your 2

reviewers obviously. You have to get the best possible 3

reviewers and trust them. 4

One of the comments, I think having RFAs 5

that are clear and concise is one way to do that. But 6

at some point somebody is going to be happy and 7

somebody is going to be sad. 8

I think we do need to look at the 9

totality of grants. Will that review process make some 10

mistakes? Probably in some cases they might. But at 11

some point you're going to have to trust those people, 12

and right now I think the percentage funding for all 13

CPRIT, of all of the grants you fund, is it about 14

10 percent of all the grants? 15

And that alone -- we can argue about the 16

categories and everything they're in, but that alone 17

tells me that there must be pretty strict review 18

criteria. The ones that got funded must have been 19

pretty good in general. 20

So I think we are going to have to 21

balance that out. At some point, you're going to have 22

to trust your review panel. By the way, if you don't 23

trust the review panel, the review panel is just going 24

to quit.25

136

EUGENIE KLEINERMAN: I disagree. I 1

didn't mean to say that I don't trust the review panel. 2

But I served on four or five different study sections 3

for NIH. In each one of the study sections, the goal 4

and the focus of the grants was different and there was 5

some clarity. 6

For example, I sit on the clinical 7

oncology study section right now and the focus of 8

those, the clarity of what our criteria should be for 9

judging a grant is much more specific than the basic 10

science section. 11

So I'm not saying don't trust the 12

reviewers. What I'm saying is, say we want to fund the 13

best science, what does that mean? 14

Your judgment of what the best science 15

is and the goal for what CPRIT is may not be the same 16

as somebody else's. I think we have to be more 17

stringent on how we educate the people that we put on 18

the panel on what we want, what are the deliverables 19

we're looking at. 20

If it's the best science and it doesn't 21

make any difference how many patients are served or 22

whether we get new drugs, that's fine, but I think 23

that's what we're trying to address here today: What 24

are the deliverables that we think are important. And25

137

once we decide that, then I think we better put some 1

thought into how we can structure study sections and 2

the instructions. 3

JOHN MINNA: Well, I don't disagree with 4

you, but I think it's important to keep the playing 5

field level that when the RFA goes out, the criteria 6

that the grants are going to be judged and should be 7

specified there. 8

And I think that's helpful for the 9

review process, too. And, believe me, having been on 10

NIH study sections, I know what you mean. Obviously, 11

there can be politics within those study sections. 12

But if the goal from the RFA is to be 13

translational, things have to move into the clinic, 14

those need to be specified. 15

And if it doesn't matter if a disease is 16

rare, if it's an exciting new idea that can make an 17

impact even on a rare disease, then that should be 18

considered. It should not be thrown out just because 19

it's rare. Also, if it could make a big impact, even 20

if it's not novel or exciting, that could be important, 21

too. 22

So I guess it's clarity for the reviews, 23

and that's helpful to the reviewers as well.24

138

JIM DOWN: We're going to have to move 1

on because I do want to get you out of here by 3:00. 2

I think there are some very important 3

takeaways from this discussion in terms of analyzing 4

the data on the grants that have already been 5

processed, maybe looking at the ones that didn't make 6

it through, and this clarity, you say the best science, 7

that would be pretty broad, so having some clarity on 8

exactly what we are looking for would seem to be 9

important. 10

So I think those are important 11

takeaways and we'll certainly have to have a few more 12

of these meetings to get input on focusing on asking 13

everybody what are the next steps coming out of that. 14

We do want to talk about the other two 15

big buckets, prevention and commercialization, and talk 16

about how the money is being spent there, whether 17

within that bucket we need to allocate it differently. 18

In terms of prevention, my understanding 19

is that about half of the money is spent on primary 20

prevention and about half on secondary and a third on 21

tertiary. Is that right? 22

BECKY GARCIA: Yes. 23

JIM DOWN: So thoughts on that? Does 24

that seem about right to people?25

139

Does everybody understand what were 1

going to primary, what were going to secondary, what 2

were going tertiary? 3

GAIL TOMLINSON: There's been a lot of 4

discussion about increasing survivorship and where it 5

would be, in the tertiary -- 6

JIM DOWN: Yes. 7

GAIL TOMLINSON: -- prevention -- 8

JIM DOWN: Yes. 9

KAREN TORGES: Karen Torges, Cancer 10

Alliance of Texas, and I do represent the 11

community-based folks when I say that is not 12

understood, prevention is not understood 13

(indiscernible) there are some issues for the most 14

part -- (indiscernible) -- 15

The registry is very clear, you have to 16

address the patient, be about as simple as it can be, 17

but the average community-based person applying for a 18

grant (indiscernible) process even one 19

(indiscernible) -- help them by providing workshops and 20

let them know. But the average person in Texas, when 21

you say "prevention," they think you prevent the cancer 22

by not smoking. They do not think of in terms of tests23

140

or survivorship issues. 1

Actually at the very, very first there 2

was a pretty good concern from the survivorship 3

community on the radar screen, and that's just an 4

understanding the language that you could use mostly 5

from a layperson, the language of almost any entity. 6

Prevention is not well understood by the average 7

person. That is part of the issue. 8

Also, the 450,000 Texas survivors take 9

offense at thinking that they're not included in that 10

bucket of prevention, and there are special needs of 11

several of the survivorship groups here represented 12

today that could speak to the special needs of someone 13

who has had cancer and is trying to live a good quality 14

of life the rest of their life. So that part of it, 15

I'm happy to hear we will be exploring the possibility 16

of expanding that perspective, because there are 17

certain needs for preventing the cancer from recurring 18

in someone who is living with it. 19

VINCE FONSECA: I think that just like 20

having focused on our phase in the research world, I 21

think if we do the evaluation and we said this is what 22

we think the distribution should be, based on whether 23

maximizing qualities or cost effectiveness or whatever 24

you want to do, then you do that.25

141

So I don't think there's one on alcohol 1

yet that's been funded. Right? 2

BECKY GARCIA: As the component of 3

education? 4

VINCE FONSECA: Services. Not in 5

services -- 6

BECKY GARCIA: Not in -- 7

VINCE FONSECA: -- to decrease risks 8

from drinking. 9

So we have some related to tobacco, 10

which most of them are. A few related to healthy 11

eating and physical activity and obesity, which is, 12

again, the biggest component, so you would hope to see 13

that, but that's not what we have. Virtually none in 14

sun or alcohol and a few on vaccines. 15

So that if we looked at that, my 16

guess -- if I were to do it, I would say that's about 17

what I would want the mix to be, based on either 18

quality maximization or cost effectiveness so that then 19

the focus is on them. 20

So when we have these very broad ones, I 21

think it is very hard for a reviewer to say, "What 22

are they thinking? If they don't tell me, I'm going to 23

use what I care about." So if I care about something 24

other than vaccines or healthy eating, I'm going to25

142

weigh those less rather than saying, "Here's one on 1

vaccine delivery and you guys pick the best one," and 2

this all the opinions (indiscernible) -- they're 3

competing against other vaccine delivery ones against 4

other alcohol ones, so that we know what the burden of 5

those things related to cancer are and the positive 6

secondary effects. 7

So remember, looking to sell, if you 8

have Mothers Against Drunk Driving and people like that 9

on their end and all of our prisons which are full of 10

substance abuse patients as we lock them up here in 11

Texas is what we do with them, that those are all the 12

other things that can help us even though they are 13

scientifically sound cancer prevention activities. 14

JIM DOWN: Any other thoughts on 15

prevention? 16

If not, we'll shift to 17

commercialization. I believe the money, most of the 18

money, 85, 90 percent is being be spent on company 19

commercialization. 20

Kent? 21

KENT OSBORNE: I think maybe what the 22

Legislature had in mind when they put the 23

commercialization part in there was to make us the next 24

Silicon Valley or northern New Jersey or Boston with25

143

regard to these issues. 1

So you have to ask: Why aren't we now? 2

The reason is because we don't have the players in that 3

area. We don't have the Stanford for computer 4

technology. We don't have the Boston megalopolis for 5

biotechnology. 6

And so to get what they want, I think 7

the recruiting thing is extremely important. As Jim 8

was saying before, we've got to recruit these people 9

that can do that and that will make the discoveries 10

that will generate new companies, not just to fund 11

companies that already exist and have them do their 12

next Phase 1 drug, but to have new companies that start 13

up as a result of discoveries that come from 14

CPRIT-funded grants and from CPRIT recruiting awards, 15

to bring those people in. 16

So, again, I would wonder -- those would 17

come under research right now. Again, when you divide 18

that research bucket up into people that have come in 19

that will actually in five or 10 years increase the 20

commercialization component, you know, it's more than 21

15 percent is what I'm saying. 22

JIM DOWN: Yeah. 23

KENT OSBORNE: And I think that that's 24

got to be one of the focuses for commercialization, is25

144

to bring in the talent that does that sort of thing or 1

will lead to that sort of thing. 2

JIM DOWN: Yes, that's a very 3

interesting point. 4

MATT WINKLER: Jim? 5

JIM DOWN: Yes. 6

MATT WINKLER: Let me give a different 7

view. 8

JIM DOWN: Okay. 9

MATT WINKLER: I serve on an ETF Review 10

Committee and we're frequently reviewing out-of-state 11

companies that hear about ETF and think "Perhaps we 12

should relocate to Texas to get access to these funds." 13

I think that similar things could occur 14

around CPRIT if it became known that if you have 15

researchers ready to commercialize, that Texas is the 16

place where you can move your company. 17

JIM DOWN: So that could be more of a 18

communications challenge, to let people know that that 19

could be available? 20

MATT WINKLER: Another issue -- and I 21

think I have a little bit of ignorance -- Jerry 22

probably can fill me in here -- is my present company 23

and a previous company were always Number 1 and Number 24

2 in the number of NIH and CIR grants received. I'm 25

using that as a metric of high scientific quality. 26

145

It took us three tries to get a CPRIT 1

grant for the diagnostics company. I'm guessing that 2

it's the scientific review where we've gotten hung up. 3

If there was a specific RFA where 4

specifically channeling more money to the 5

commercialization that we would have gotten funded more 6

quickly and, again, word gets around that this is more 7

of an opportunity for venture capitalists here, "Hey, 8

this is a friendly state. We should invest our dollars 9

here because they're going to go further." 10

JIM DOWN: Okay. Other thoughts on 11

commercialization and how we're spending the money 12

there? 13

Eugenie? 14

EUGENIE KLEINERMAN: Eugenie Kleinerman 15

again. 16

Okay. So I think, Kent, you brought up 17

a very good point. The biotech companies that have 18

sprung up in California and Boston spring up around 19

great graduate schools, and I think some people feel 20

that's a very important component of having a 21

successful biotech company, North Carolina, you know, 22

in the Raleigh/Durham, the Research Triangle Park. 23

So is this a component that we think24

146

CPRIT should participate in, trying to strengthen some 1

of our -- I mean, we have great graduate schools, but 2

we have some graduate schools that are not really 3

terrific in some of our bigger cities. 4

Is this something that would benefit -- 5

and I have turn to my biotech colleagues and say, is 6

that something that's important for you? Do you look 7

at where the graduate school is so you can pull those 8

minds in to your company? 9

MATT WINKLER: Something that's 10

interested me is UT-Austin is exempt. The technologies 11

developed there that are generally outside of the 12

cancer field go to one coast or the other and venture 13

capitalists don't like to get on airplanes and fly to 14

the middle part of the United States as part of the 15

flyover area. 16

Clearly, if there was more dollars 17

available across the whole scientific realm, there 18

would be more opportunity to do home growing. 19

There's also a phenomenon that people 20

like to have companies in their backyard and so, again, 21

I think if there was more commercialization money 22

available, more would occur here. 23

EUGENIE KLEINERMAN: Does the graduate 24

school influence a choice -- when you are setting up a25

147

biotech company, does the graduate school, quality of 1

the graduate school influence you? 2

MATT WINKLER: A lot of this is 3

serendipitous. Clearly, if you have entrepreneurial 4

people in great universities, there will be spinoffs. 5

JIM DOWN: Jacqueline? 6

JACQUELINE NORTHCUTT: Jacqueline 7

Northcutt, Texas BioAlliance. 8

We do have an abundance of, I think, 9

graduate students who really want to go to work for the 10

companies, and it's very important, but there's a 11

dearth of the companies. We don't have enough good 12

companies for them to go to work. 13

You know, I think if you take a high 14

level look at creating an industry -- you know, if you 15

go back to your original slide, Bill, or one of your 16

original slides about what was mandated out of the 17

Legislature and you want to do something for patients, 18

you want to have the economic development, you want 19

to build something that's sustainable. 20

And what we don't want to do is what 21

happened in Singapore, which was 10 years of money went 22

in; and when the Singapore money dried up, then 23

everything around it just vanished.24

148

And so I think what we want to do is 1

something that's sustainable and at the same time that 2

we're doing something that's good for patients and for 3

the economy in Texas. So, you know, I think to do 4

that, we do have to relocate companies here. 5

I spend a lot of time talking to 6

investors, and it's a good excuse to say that they 7

want to invest in their backyard; but when you really 8

boil it all down, they're looking for a home run 9

company and they'll go anywhere in the world. 10

Especially with a partner like -- you have good 11

technology -- a good financial partner like CPRIT, the 12

sophisticated investors, they get it and they will be 13

here. 14

They want to make sure. They're sitting 15

on the sidelines right now, I'll tell you, and looking 16

at the process. Not so much about how it works, but 17

the predictability of the process. 18

If they have a high-quality company they 19

want to have comfort that a high-quality company will 20

make it through and there won't be some snag that's 21

political in nature. 22

I think the other thing that 23

we have to think about when we're relocating 24

companies -- to build an industry we're going to have25

149

to relocate companies, and CPRIT just funded their 1

first one. You have to think about when is it a 2

company will move. And right now the way companies are 3

structured early on is they're very virtual in nature, 4

so there will be sponsored research agreements back in 5

academia, there will be CROs that will do a lot, but 6

very virtual in nature. 7

One of the things that I think CPRIT is 8

going to have to think about is that when companies 9

look at when is a good time for them to move, it's got 10

to be in some transition period. What we're seeing now 11

is that some of the transition period is "We're wanting 12

to get approved or we've already been approved, and now 13

we're going to build ourselves a marketing capability 14

and does that make sense?" 15

So does it make sense for 16

CPRIT to move past preclinical Phase 1, Phase 2, 17

Phase 3 -- or actually Phase 1 and Phase 2, does it 18

make sense for CPRIT to look at companies that have 19

approval and can build a sustainable amount of people 20

and build a real business in Texas and recruit those 21

companies in? 22

Somebody said it earlier -- I think, 23

Ray, it might have been you -- this is very complex, 24

just as the science is very complex, and what CPRIT is25

150

doing is very complex, building a business is very 1

complex. It's not one silver bullet. There are a lot 2

of things that we're going to have to do. 3

The Entrepreneurs in Residence program 4

is going to create probably the highest quality 5

companies that you could possibly create in the state, 6

but you're going to have to relocate and you're going 7

to have to fund company formations. I mean, it takes 8

all of that, but I think we have to look at the 9

spectrum and not limit ourselves. 10

JIM DOWN: That sounds like there 11

potentially is the opportunity to reallocate the money 12

that's being spent within commercialization to some 13

other areas as opposed to almost all of it now just 14

going to one bucket. I don't think much money is being 15

spent on relocation of companies. 16

JACQUELINE NORTHCUTT: So I think that 17

is a chicken-and-egg situation because, let's just face 18

it, the commercialization leg, if you will, of CPRIT 19

was the last piece to be put into place and so it was a 20

year kind of into everything else being launched. 21

So I think there is some of it that is 22

just -- it's a lag. I know that there are several in 23

the process right now that are relocation24

151

candidates. I don't think its for a lack of a desire 1

on the part of CPRIT staff. 2

I think it's just the word getting out 3

there. And you want the word to get out from a quality 4

perspective, because what you don't want is what Joe 5

Cunningham mentioned this morning. What you don't want 6

to do is, you know, advertise this, as I call it, put 7

the for-sale sign in the front yard, because then every 8

company that can't get funded anywhere else, they're 9

going to be the first ones that are going to be there. 10

So it's really a strategic approach of 11

finding high-quality companies that already have 12

quality investors. Then we can move those companies, we 13

can pair up, we can co-invest with quality companies 14

that we bring in. Because if you don't 15

fund the quality companies, then you won't do anything 16

that's sustainable back to the example with Singapore. 17

It's got to be quality, because then you have the 18

chance of something being truly sustainable once the 19

CPRIT money is gone. 20

So I think back to your point, it's 21

definitely something that I think is on the radar 22

screen of the CPRIT staff. It's slow, but it's 23

starting to happen. 24

JIM DOWN: Okay. Anything else on25

152

commercialization? If not, we will switch into our last 1

subject, which is processes, and the question will be: 2

How can CPRIT improve its processes? 3

I think we talked about a number of 4

processes over the course of the day. We talked about 5

communication. We talked a lot about how we spend 6

money and how we do grants. 7

So unless there is something new on 8

those, I wouldn't come back to those now, but we will 9

capture those under process improvements. 10

But what haven't we talked about in 11

terms of processes that you'd like to bring up that you 12

think there potentially could be improvements? 13

Every organization can improve, so I 14

don't think this is going to be critical. I'm sure 15

every one of your organizations could improve. So what 16

processes would come to mind? 17

GAIL TOMLINSON: I have a question. It 18

relates to the processes about commercialization. 19

Commercialization, as I understand, the 20

end of result of commercialization would benefit Texas 21

by creating jobs and companies and income, or how much 22

will the success be addressed as tying it back to input 23

from a broad, global perspective? How much of it is 24

really going to be tied to the more pure goals? 25

I'm all about creating jobs and seeing 26

153

Texans succeed commercially, but I just want to know 1

what are the benefits to obtaining commercialization 2

(indiscernible) -- 3

JACQUELINE NORTHCUTT: I think we've got 4

to -- the starting point of all of this is that I don't 5

know of a product out there that has ever been fully 6

developed all the way through, approved by the FDA and 7

launched that there's not a hand-off into a company. 8

So if you're talking about patients, at 9

some point it has to go into a company. So I think 10

that's where it starts. This is all talking about 11

patients, cancer, diagnostics, cancer treatments, 12

whether it's a drug or biologic, it's a device, it's 13

a surgical device, implantable device. This is all 14

about patients. So, I think that's where you start. 15

And then the way I look at it is the 16

byproduct is a strong and diversified economy for the 17

State of Texas. 18

JIM DOWN: But you do raise a very 19

interesting question in my mind, and that's how 20

integrated are these different pieces of the puzzle?21

154

Because there's no right or wrong, but 1

you could say for example, on commercialization, we do 2

want to stimulate the economy, but that's different 3

than what we're doing in research and potentially 4

different that what we're doing in prevention. Where 5

you could say this all has to come together to -- going 6

back to what we talked about at the beginning of the 7

meeting -- to really move the needle on whatever we 8

decide success is. 9

JACQUELINE NORTHCUTT: I guess the way I 10

look at it is there is a continuum, which is basic 11

research and preclinical research and whatnot. 12

But I think what CPRIT -- instead of 13

thinking that they're going to fund something that's 14

going to start on the left of a continuum and fund it 15

all the way through, I think they're going to have to 16

fund each piece of it at the same time. 17

And back to the relocation part, 18

I think it may make sense for CPRIT to have a target 19

allocation for relocation or target 20

allocation for something that's later staged, because 21

it is the only way that you're going to make a real 22

significant leapfrog in putting ourselves on the map 23

as far as the industry is concerned.24

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We're going to have to do something. 1

Just funding the discoveries that are made here, it's 2

going to take too long and we will have missed the 3

dance. 4

MATT WINKLER: I have something. You 5

know, in the late '70s, early '80s, the United States 6

feared it was falling behind the Japanese in terms of 7

semiconductors. So there were two national consortiums 8

MCC and Sematech here in Austin, and the end result of 9

that was to create an incredibly vibrant, high-tech 10

industry here in Austin. 11

So a reasonable legacy of this 10-year 12

CPRIT endeavor could be to create a vibrant cancer 13

technology, if you will, in the state of Texas, and 14

that's where we should perhaps look at integrating all 15

of these pieces. 16

JACQUELINE NORTHCUTT: In fact, let's 17

say Austin, what do you want to see happen by 2020? I 18

want the NEW YORK TIMES to say, "If you want to develop 19

a cancer product, the only place in the world you 20

should be is in Texas." 21

JIM DOWN: Great. 22

KAREN TORGES: Karen Torges. 23

On a similar but not directly related 24

note, when we looked at some of the information this25

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morning on the pie chart, on the visuals, one of the 1

things that I observed was that we're not making much 2

investment in systems (indiscernible), and I do think 3

that that would really be a way that we could expand 4

our present impact. 5

And let me do a prevention example of 6

that. If we chose some of our prevention investment to 7

be delivered through systems that already exist in 8

Texas, through federally qualified health center 9

partners, (indiscernible), approved cancer hospitals 10

where a lot of cancer care is delivered, through other 11

entities that already exist that have the structure, 12

the standards, the certifications, the ability to 13

support what the CPRIT dollars are being able to invest 14

in, we would be able to just get farther with what they 15

have and we have. 16

And the other thing that would be nice 17

about that is that a lot of these entities, federally 18

qualified health centers, the Commission on Cancer, as 19

examples, have their own incentive to cooperate with 20

others. So it would make us look good, it would look 21

good outside of Texas, it would help us get further 22

down the road and we would be able to network with 23

other entities that are trying to do the same thing we 24

are.25

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JIM DOWN: In terms of processes, other 1

processes that we maybe haven't of covered? 2

KATHRYN PEEK: What's the breakdown of 3

these processes, a peer review process, an RFA process? 4

Define the territory when we're talking about a 5

"process." 6

JIM DOWN: Well, processes can cover a 7

lot of ground, but certainly communications would be a 8

process. Hiring, recruitment is a process. Human 9

resources. You could go through the various functions. 10

There's lots of different processes. 11

I think what this question was designed 12

to get at is, is there anything that CPRIT should be 13

looking to improve in terms of the way they've run 14

the entity? That would be my interpretation. 15

Pat? 16

PAT REYNOLDS: I'd say with processes, 17

with respect to funding research or similar entities by 18

peer review, that there are two operative words that we 19

really need to pay very close attention to. The first 20

is "transparency" and the second is "conflict of 21

interest." 22

JIM DOWN: Yeah. 23

PAT REYNOLDS: Now, the pachyderm in the 24

room is that we're dealing with a conflict of interest25

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public relations nightmare. 1

JIM DOWN: Yes. 2

PAT REYNOLDS: And I would suggest that 3

the very first thing that should be done in the process 4

is to ensure that everyone involved in the process is 5

free of real or apparent conflicts of interest. 6

And if that cannot be achieved, I think 7

that this discussion is a moot point, because I don't 8

think we'll be sitting here having a discussion in 18 9

months. We'll be doing other things. 10

So that's where I really think we ought 11

to spend our time, is on dealing with this public 12

relations, how we can get rid of conflicts of interest, 13

both real and apparent. 14

The second thing is transparency. One 15

of the things I like about the NIH -- and we can spend 16

all of the rest of the day talking about what we don't 17

like about peer reviews in the NIH, those of us that 18

have to do the reviews as well as those who have to 19

read the reviews that they write. But one of the 20

things that they have that CPRIT doesn't have is 21

transparency. I can pull out the roster of the study 22

section that reviews my grant. That's really 23

important, because one of the concepts about peer 24

review is peers.25

159

As a pediatric oncologist, one of the 1

things I can do is make sure that the present system's 2

study section that is going to read my grant actually 3

has pediatric oncologists on it. 4

And if they don't, I can call up CPRIT 5

and say, "Hey, guys" -- not CPRIT, but NCI -- and say, 6

"Hey, guys, what are you doing? You have no peers 7

here. There's no pediatric oncologist in the study 8

section and you've got to fix this." 9

They actually fix it. That's why they 10

publish the rosters. 11

Is there any person in here besides Bill 12

or a couple of others who knows who the rosters are 13

that review our grants? It's a carefully guarded 14

secret. I haven't been able to find a roster of the 15

individual study sections. It's just a global thing. 16

Are the people that actually -- are the 17

rosters broken down by the groups that review our 18

grants available to us? 19

In other words, my grant at the NCI is 20

assigned to a study section, and I can read everyone on 21

that study section and their qualifications. 22

But that's a minor point. The real 23

important point is COI and I hope we can discuss it. 24

JIM DOWN: This would be the time to do25

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it. 1

JENNIFER REDMOND: And? 2

PAT REYNOLDS: By state law, correct me 3

if I'm wrong, no one involved in the Oversight 4

Committee or in the leadership can have any conflict of 5

interest. Is that not true? 6

BILL GIMSON: Or any interest, I guess; 7

right, Kristen? 8

KRISTEN DOYLE: The law defines what 9

"conflict of interest" is. 10

PAT REYNOLDS: Can we extend that to 11

both real and apparent conflict of interest? 12

KRISTEN DOYLE: Again, the statute 13

specifically defines that. The Legislature 14

cares about this issue and took the time to define prohibited conflicts. 15

BILL GIMSON: We've actually had 16

Oversight Committee members where they're affiliated 17

with an institution and when that institution received 18

a grant, they had to step off the board. 19

But, you know, I'd like to hear, again, 20

how we improve that process and make it airtight. 21

JIM DOWN: Pat, could you maybe say a 22

little bit more about what you'd like to see? 23

PAT REYNOLDS: Well, I mean, I think 24

what I'd like to see is that the way that the Oversight25

161

Committee -- and I know you've got a problem here, 1

because the Oversight Committee is not appointed by 2

you. All right. But there's got to be some way of 3

dealing with this. 4

When ODAC is appointed, or any FDA 5

advisory committee, there's a clear-cut vetting process 6

that if there's any even close to apparent conflict of 7

interest then you're out. Okay. Or you can be a 8

special government employee, and then you have to sit 9

out -- you're completely out of that meeting. 10

Having read way too many HOUSTON 11

CHRONICLE articles lately -- I don't usually read the 12

HOUSTON CHRONICLE, but I get them e-mailed to me all of 13

the time now on a regular basis, there are obviously 14

some issues here that have not been dealt with 15

optimally, and I'm just wondering if we couldn't figure 16

out a way for the process to deal with those. 17

JIM DOWN: Well, why don't we see what 18

other thoughts there are? This meeting is supposed to be about 19

listening, so I'm just a little hesitant to launch into 20

what the response would be, but I think it's an 21

excellent point. 22

I don't know what the processes are, but 23

there are a lot of processes. All organizations deal24

162

with these issues and there are different ways of doing 1

it in a lot of organizations. 2

I don't know if you do it here, if you 3

do it on an oversight committee or other form, but I 4

understand what the policy is, and you either disclose 5

certain things or you say, "I don't have anything to 6

disclose." 7

PAT REYNOLDS: So just to extend this a 8

little bit longer, and I don't want to dominate this, 9

but since Kristen is here it could be very useful. 10

Does the Legislation deal with only 11

actual, solid, traceable conflicts of interest or does 12

it deal with apparent and indirect conflicts of 13

interest? 14

KRISTEN DOYLE: Again, the statute 15

defines conflicts of interest. One thing that is 16

really important to remember is that in terms 17

of our Oversight Committee, we are set up differently 18

than I think almost any other board. 19

Funding recommendations are made by the Review 20

Council. Those then go to the ED. In our statute, it says 21

that the executive director must present a list that is 22

substantially based on those Review Council 23

recommendations. 24

And then when the recommendations go in front of the25

163

Oversight Committee -- and I know you have been at some 1

of the Oversight Committee meetings -- it's a very 2

different process, because the only thing the board can do is 3

reject the slate, and that has to be by a two-thirds vote. 4

The slates are announced and the board doesn’t 5

vote to approve the slates. The only action that they can take 6

is to reject the slates if they believe it is necessary. 7

So in terms of people who actually have 8

involvement in the review process, the ones with 9

the power are the reviewers, and we 10

are very specific about this, that's where the real 11

and apparent conflicts of interest come into play, 12

because it's those award recommendations that 13

become the executive director’s recommended slates. 14

PAT REYNOLDS: You're presenting a good 15

point. So my question then -- I'm relatively 16

comfortable, and I could easily be corrected as being 17

wrong, but that every single person that reviews a 18

scientific grant that has been put in is not in the 19

state of Texas? 20

BILL GIMSON: Correct. 21

PAT REYNOLDS: And that would include 22

the prevention side as well. 23

But it is apparent to me from reading a 24

lot of news articles that that is not true for the25

164

commercialization side. 1

KRISTEN DOYLE: That is standard in our system. 2

Our commercialization folks are also out of state. 3

PAT REYNOLDS: But they do have 4

connections in the state. 5

KRISTEN DOYLE: Well, just saying that they 6

have connections to the state doesn’t violate our policy. 7

Keep in mind that just because something appeared 8

in the HOUSTON CHRONICLE does not mean it is necessarily 9

an accurate picture of our process. 10

(Scattered applause.) 11

KRISTEN DOYLE: So I'm happy to talk 12

with you about that, and it's very important for CPRIT 13

to have the trust in terms of not just people around 14

the table, but all sectors. And we do to try protect 15

that review process very closely. 16

So we can talk about things that were in 17

the HOUSTON CHRONICLE, but you're either 18

going to need to air them or you and I are going to 19

have to talk offline about them. You know, I 20

don't know how else to -- 21

PAT REYNOLDS: Well, I mean, to state 22

things without being completely direct, okay, first of 23

all, the review process in terms of who does it remains 24

nontransparent to me.25

165

BILL GIMSON: And that applies across 1

the board? 2

PAT REYNOLDS: Right. 3

BILL GIMSON: That's something -- 4

PAT REYNOLDS: That's across the board. 5

(Multiple people speaking at same time.) 6

PAT REYNOLDS: And a clarification that 7

the reviewers are really out of the state of Texas, or 8

everyone that makes the decision is, and the 9

transparency on that would be, I think, very useful to 10

what we've all been dealing with. 11

The second aspect is that there does 12

appear to be some appearance of conflicts of interest within 13

the Oversight Committee, and that's just – there is an 14

apparence. Okay. And apparent conflicts of interest 15

need to be put to rest, and some haven't, and 16

they're damaging the reputation of an organization we 17

all hold very dear. 18

KRISTEN DOYLE: You and I have talked 19

about this offline and, again, for our staff and committees 20

the conflict sheet sets forth what is the conflict of interest, 21

what members are voting, and none of the statements or 22

requirements that would move a board member to have to23

166

either recuse themselves from voting on something or 1

being a member of our board has been initiated. 2

EUGENIE KLEINERMAN: I think what Pat is 3

trying to say is that perhaps that needs to be 4

re-reviewed. Because you can say those things, but 5

appearance of conflict and impression go a long way and 6

truth has nothing to do with it. 7

So this is the perception that's out 8

there. So don't get defensive, listen to what is said 9

and try to put steps into place that will either 10

educate or correct what the perceived conflict is. 11

And if people believe that that is an 12

important conflict, even though it's not set down in 13

the law that it is, maybe they can re-examine that for 14

the good of the whole program. 15

BILL GIMSON: Can I ask one question? 16

Just out of curiosity. So, our statute, in my 17

opinion is extremely unusual, as Kristen says, in that 18

the Oversight Committee can only reject a slate. They 19

have to reject it by a two-thirds vote, which would 20

mean that eight members out of eleven have to reject, 21

which is quite a heavy lift. 22

I'm sort of curious, because you're 23

members of our Advisory Committees, how many people 24

actually knew that? Could you raise your hands?25

167

(Showing of hands.) 1

GAIL TOMLINSON: Could you say that 2

again? 3

BILL GIMSON: How many people actually 4

knew that the Oversight Committee does not approve, but 5

actually can only reject, recommendations? 6

Dr. Kleinerman, I'd like to ask you, is 7

that part of the information we should be getting out? 8

EUGENIE KLEINERMAN: Yes. 9

BILL GIMSON: I mean, I think we're so 10

close to this that we assume everybody knows that. 11

VINCE FONSECA: I would like to say that 12

always perceptions are going to be critical. And even 13

before CPRIT came up with its process, Bill -- I don't 14

think Becky was even there yet -- came down to San 15

Antonio, and one of the things, too, in a big military 16

town, we said, "Think of it like the BRAC. When they 17

close bases, every Congress person wants to keep them 18

there. Make it as much like the BRAC as possible where 19

all they can do is reject." 20

That way it is clear that they can't get 21

their pet projects in. Nobody has that power. Nobody 22

can keep their base alive in the BRAC. That committee 23

has to vote to close all of the bases on the slate or 24

reject it.25

168

I think that maybe the problem is 1

communication. I think that obviously is a problem if 2

the people in the room didn't know it. So one thing, I 3

think the transparency is critical to anything 4

governmental. 5

One of the concerns that I remember -- 6

and I'm trying to think back how all of the this played 7

out -- was even when the Oversight Committee got 8

selected, so even though there's not a conflict of 9

interest, but everybody has their own perspective. We 10

all do, we can't help it. 11

I remember just mapping where the people 12

are from and I said, "Oops, I see a problem right 13

away." Not knowing -- well, I knew the Rice -- the 14

president introduced -- (indiscernible) -- at Rice. 15

But other than that, I said, "This isn't 16

how I would have picked it for the state of Texas. 17

They are centered into too many key cities. So the 18

geographic distribution wasn't one that I would have 19

picked. Just to make sure that I represented West 20

Texas, for example, South Texas. 21

We drew a line where people were 22

centered and we said, "Wow, look at all of west and 23

south Texas." One person at that time. 24

PAT REYNOLDS: Well, let me just25

169

interject. I'm glad you brought that up, because one 1

of the things in the Legislation -- and correct me if I 2

am wrong, Kristen -- is that the Oversight Committee 3

will be representative of the cultural and geographic 4

diversity of the state of Texas, which it is not. 5

VINCE FONSECA: And the cultural 6

diversity was the other point. So we said, "Oops, I 7

see two blips." 8

Again, I'm not saying there's conflict 9

of interest, but not being representative. So the 10

perception of fairness, other than conflicts of 11

interest, is also important was that there were not 12

enough minorities. 13

So when we are sitting here looking at 14

that traditional minorities on there, saying 15

that's going to be an issue throughout. And it's a 16

problem that every science-based organization struggles 17

with because there's no question, there's fewer 18

traditional minorities to pick from. 19

Still, those are the kinds of things of 20

just looking like you're trying to do it anyway. So as 21

people move off and you're not replacing them to get 22

this representation feel to it. If there was one thing 23

to approve, even though you don't want to say there's 24

quotas, if you're saying we're being representative,25

170

then that's what you're trying to do. 1

And I think we could do a better job at 2

the Oversight Committee of being able to say, "Yes, I 3

do care about South Texas or West Texas or East Texas 4

even." Houston is represented, but I can draw a 5

whole big line of a whole bunch of counties in East 6

Texas which have the worst cancer problem in the whole 7

state, but they're not represented on the Oversight 8

Committee by geographic and certainly not by ethnicity 9

either. 10

We can make recommendations. I bet Bill 11

and everybody else didn't think that we would have 12

gotten where we got with the tobacco part. I remember 13

when that first came up, what a struggle that was. 14

So we certainly won't unless we try. I 15

can guarantee that. I don't know how successful we'll 16

be by stating it, but I think it's worthwhile. 17

JIM DOWN: Okay. Anything else on this? 18

Because we're trying to get you out by 3 and it's about 19

five to 3. 20

Pat? 21

PAT REYNOLDS: One last thing. And 22

actually I'm going to mention Dave Poplack, even though 23

he's not here. He couldn't be here because of family 24

issues.25

171

Dave and I have had some conversations, 1

and I really like his suggestion and I'd like to put it 2

on the table, and that is that this has become too 3

dangerous to a very valuable organization to not get it 4

under control in a way that is publicly transparent. 5

And David suggested we bring in some outside group to 6

come in and look at the process; for example, the 7

Institute of Medicine or somebody that's really 8

recognized as being above reproach to come in and vet 9

the process, make recommendations, that might even 10

extend to recommendations that turn into Legislation. 11

But we all have a dog in this fight. 12

Let's get somebody who doesn't to come in here and 13

straighten this out. 14

JIM DOWN: I'll just spend a couple of 15

minutes trying to wrap up where we are on the day and 16

then I'll turn it over to Bill to close and hopefully 17

we will get you out at 3 on the nose. 18

But if I go back to what we said at the 19

beginning of the day that we wanted to accomplish, it 20

was all about input, and I think you've done a great 21

job of offering input on a variety of important 22

subjects. 23

So the process is this isn't the only 24

meeting that's being held. There are going to be25

172

regional meetings held around the state of Texas 1

covering the same kind of material, and the plan is to 2

look for what are the themes that have come up across 3

the meetings. 4

One of the things I will say, just my 5

own opinion having gone through processes like this 6

many times, I thought the discussion we had this 7

morning on impact and what a success looks like is very 8

good, but we didn't exactly wrestle that to the ground. 9

And as people had said over the course 10

of the day, a number of times people have said, "Well, 11

you know, it really goes back to what does success look 12

like and what needle are we trying to move, and then we 13

can figure out how we should be spending money in the 14

programs. So I think there is some more work that 15

needs to be done on that issue. 16

I thought it was a very good start this 17

morning. We had a good sense of where people are 18

coming from, but it is difficult in a group like this 19

to finalize an issue like that. It's a tough issue. 20

People have many different thoughts on it. So you can 21

get those out on the table, but you can't expect that 22

this group would necessarily reach a conclusion on 23

that. But I do think that is a very important issue. 24

And I think the Texas Cancer Plan, it25

173

was mentioned by a couple of people that perhaps this 1

could be a starting point for impact and whether you 2

want to embrace this. I know a number of you have had 3

involvement with the Texas Cancer Plan, so that 4

certainly is a thought and I think everybody has a copy 5

of that. 6

So I thought it was a very good day. I 7

think you did a great job of bringing up issues, some 8

of them very difficult issues, getting those on the 9

table, getting your thoughts. And I certainly hope 10

that at the end of the process that this will leave us 11

going back to some of the issues that we talked about 12

at the beginning of the day, and that is the 13

organization is three years into its life and it's a 14

good time to kind of pull up and say, "Do we need to do 15

anything differently?" And I think we have some great 16

suggestions. 17

I do want to mention, because you are 18

putting together this steering group, that I think 19

we're looking for 10 to 15 members, looking for 20

diversity across different constituencies. So the 21

process for people, because you can nominate people to 22

be on that, you can self-nominate if you have an 23

interest in being on that -- 24

But who do they contact on that?25

174

BILL GIMSON: Actually nominate by just 1

sending an e-mail by July 6th. Right, Becky? It's an 2

online nomination? 3

BECKY GARCIA: We'll send it to the 4

Advisory Group. It's an online nomination form. Look 5

for that in your mail soon, in your e-mail, and that 6

way you can just respond online. 7

We'd like it to be people from the 8

Advisory Committees, so we'll start with that group and 9

then we might have a few other invited participants. 10

BILL GIMSON: And diversity in terms of 11

disciplines -- 12

BECKY GARCIA: And geography. 13

BILL GIMSON: -- and geography. 14

And I think other thing, Jim, is that 15

tomorrow we'll have a one-page summary that we want to 16

share with everyone before we post on the Web site, not 17

really for comments, but just so when folks come up to 18

you, you have that available. And then in about ten 19

days we will share the transcript with you prior to 20

posting that. 21

Pat, in terms of transparency, we're 22

going to post this to make sure -- 23

PAT REYNOLDS: And I congratulate you on 24

that.25

175

BILL GIMSON: Well, I think it's 1

important. You know, this is really our money. It's 2

not CPRIT's money. We're Texans. It's important for 3

us to listen and make sure that we are good stewards of 4

taxpayer dollars. Perception or fact, you know, we 5

need to correct. 6

What I'd like to do is thank the CPRIT 7

folks, Becky and Kristen and the CPRIT team really put 8

in a lot of work on this and they're still working with 9

the regional effort. Jay Jell (phonetic) helped us 10

with the logistics. The CPRIT Foundation actually 11

provided the food because, as you know, with a state 12

government, you know, food is verboten, at least on our 13

side. 14

Certainly thanks to Jim and Jennifer. 15

In terms of facilitation, it couldn't have been better. 16

And, again, I think this is the first step in something 17

that I know will really be very positive for the state 18

of Texas and I'm excited about the report that will be 19

issued sometime in October. 20

So thanks, everybody. Have a nice 21

Fourth of July. 22

(Applause.) 23

(Proceedings concluded at 2:58 p.m.) 24

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I, Denise Ganz Byers, Certified Shorthand Reporter 1

in and for the State of Texas, certify that I have 2

transcribed this meeting to the best of my ability. 3

I further certify that I am neither counsel for, 4

related to, nor employed by any of the parties to the 5

action in which this proceeding was taken, and further 6

than I am not financially or otherwise interested in 7

the outcome of the action. 8

9

Certified to by me on this the 3rd day of July, 10

2012. 11

12

____________________________________ 13

DENISE GANZ BYERS, CSR, RMR, CRR 14

TEXAS CSR 2037

Expiration: 12/31/12 15

Firm Registration No. 241

1601 Rio Grande, Suite 443 16

Austin, Texas 78701

512-499-0277 17

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