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1 FDA TECHNOLOGY TRANSFER – Startup Maryland Pitch Bus Stop TechFire Incubator Tuesday, October 17, 2017 Prepared for TechFire Incubator by FDA Technology Transfer Program www.fda.gov

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FDA TECHNOLOGY TRANSFER –Startup Maryland Pitch Bus StopTechFire Incubator

Tuesday, October 17, 2017

Prepared for TechFire Incubator by FDA Technology Transfer Program

www.fda.gov

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What the FDA Does

Protect public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.

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What is Regulatory Science?

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“Regulatory Science is the science of developing new [knowledge], tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA-regulated products”

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FDA Centers (6+2)

• Center for Food Safety and Applied Nutrition (CFSAN)

• Center for Biologics Evaluation and Research (CBER)

• Center for Devices and Radiologic Health (CDRH)

• Center for Drug Evaluation and Research (CDER)

• Center for Veterinary Medicine (CVM)

• Center for Tobacco Products (CTP)

• National Center for Toxicological Research (NCTR)

• Office of Regulatory Affairs (ORA)

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FDA Office of Regulatory Affairs (ORA)

The Office of Regulatory Affairs (ORA) is the lead office for all agency field activities. ORA inspects regulated products and manufacturers, conducts sample analyses of regulated products and reviews imported products offered for entry into the United States. In pursuit of its mission, ORA also works with state, local, tribal, territorial and foreign counterparts.

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13 ORA Lab Locations

ORA Regulatory Lab

ORA Regulatory/Specialty Lab

MANY

OH

MI

GA

PA

AR

KSCOCA

WA

PR

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FDA Technology Transfer Program Activities

T2 legal and policy frameworks for developing new public health advancesSpecific laws permit patenting and licensing of federal inventions, permit collaborations under CRADAs, and require ethical conduct to avoid conflict of interest situations

Execute agreements to exchange research materials, conduct scientific collaborations, protect government intellectual property

Train FDA scientists on using T2 mechanisms to promote research effots

Meet client T2 needs, serving researchers in all FDA Centers and ORA, along with researchers and staff within the OC

Determine/update T2 policies and carry out FDA T2 policy initiatives (e.g., IP in testing standards) in collaboration T2 offices at PHS level and across federal government

Manage FDA invention portfolio, including intake of inventions, decision making on patent protection, and transitioning inventions into products through partnering

Provide guidance for grants and contracts IP

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FY16 FDATT

In FY16, FDATT and Center Tech Transfer staff supported science and innovation at FDA by completing over 860 technology transfer actions for programs across the Agency. 614 of these actions were performed by FDATT staff.

www.fda.gov

FY16 Tech Transfer Activities

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FDA CRADAs in FY16 Overview

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• 8 new CRADAs established in FY16

• 41 active CRADA collaborations in FY16

Num

ber

of

CR

AD

As

FY16 NEW CRADAsCenters and Collaboration Areas

Protect Food Supply

Enhance Regulatory Capability

Develop Regulatory Tools

0

1

2

3

4

CBER ORA CDER

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FY16 FDATT

www.fda.gov

FY16 Activities

12 new technologies

43 issued patents

13 new technology licenses

95 new collaborations

>600 intellectual property and collaboration concerns resolved (FDATT not including Center Reps)

>140 transfer agreements to shareout or bring in research materials

Consolidation and Expansion of FDATT

• Fully integrated patenting and licensing activities into FDATT

– Tech transfer knowledge management system installed and in use as of Q1 FY16

– Patent law firm contract awarded in December 2016

• Investment in tech transfer professionals resulted in 2 new FTEs in FY15 and 1 new FTE in FY16.

• Increases in program efficiency through comprehensive program all contained at FDA—results in better partnership with Center T2 reps and scientists

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Examples

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1. Development of imaging standards (phantoms that mimic human tissue)

for calibrating imaging for ultrasound, MRIs, and new photo acoustic

imaging devices (CDRH)

2. Confocal laser method for assessing the properties of intraocular lenses

(IOLs) including toric IOLs (CDRH)

3. Improve ways to assess and follow drug performance post-licensure- take

advantage of new sources of data and expand types of information

collected post-licensure (CDER and CBER)

http://www.fda.gov/ScienceResearch/CollaborativeOpportunities/Inventi

ons/ucm464037.htm

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Examples

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4. Reducing the failure rate of therapeutic proteins- identify antigenic sites

on bioengineered therapeutic proteins that result in antidrug antibodies

(ADAs) and reducing the immunogenicity of these sites

5. Development of recombinant viruses and antibodies to improve vaccine

development and assess the potency of vaccines- develop mismatched flu

viruses for evaluating the contribution of neuraminidase to vaccine

potency and the development of epitope-specific antibodies.

6. Portable gamma-ray analytical apparatus for determining gamma

radiations and gamma-emitting isotopes present in food and other

samples (ORA)

7. Antimicrobial peptides (CBER and CSFAN)

http://www.fda.gov/ScienceResearch/CollaborativeOpportunities/Inventi

ons/ucm464037.htm

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Leverage novel ideas, advanced technologies, collaborations with industry:

• Develop & build analytical systems addressing expertise shortage

• Increase nation’s radio-analytical capacity

Design & build features:

• Enabling field applications portability

• Free of knowledge and experience requirement of end-user

• Light-weight, modular, scalable, mobile

• Robust

• User-friendly

• Laboratory analytical data quality

• Real time in-situ high throughput sample data collections

Preparedness and Solutions (ORA)

Counterfeit Device (CD) Evolutions (ORA)

Forensic Chemistry Center(UV-Vis-IR imaging)

Note: visible and invisible to human eye wavelength ranges

Counterfeit

CD3 Real Time Scan

(captured images of actual counterfeit versus authentic finished dosages)

15July 20, 2012 USFDA (Forensic Chemistry Center)

Note: large sample was analyzed quickly

Cialis 20mg

Actual Cases

Authentic

Counterfeit Authentic

Counterfeit Authentic

Counterfeit Authentic

Authentic Counterfeit

Reveal Evidence of Diversion and Fingerprinting(Use of UV-Vis range imaging)

16July 20, 2012 USFDA (Forensic Chemistry Center)

Diverted Product

Actual Case

Note: indistinguishable differences under white lighting but noticeable under UV-Vis

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MenAfriVac, Meningitis A VaccineCBER, Robert Lee, Carl Frasch

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Neisseria meningitides A vaccine- conjugation of polysaccharide

and tetanus toxoid protein

Conjugation methodology invented at the FDA

Since vaccine campaign began in Africa in 2010 220 million

people in 20 African countries have been vaccinated1

Only a handful of meningitis cases were reported in 2013/2014

(between 1996 and 1997 the disease infected 250,000 and

killed 25,0001

Costs 50 cents per dose to manufacture

Recently approved for young children and infants by WHO- intend

to routinely immunize infants and young children in Africa

1 Ewen Callaway. New meningitis strains could thrive following vaccine success. Nature. Nov 10, 2012. (viewed

online at http://www.nature.com/news/new-meningitis-strains-could-thrive-following-vaccine-success-1.18757 on Dec

7 2015)

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MenAfriVac, Meningitis A VaccineCBER, Robert Lee, Carl Frasch

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MenAfriVac is a product of the Meningitis Vaccine Project (MVP) a

collaboration between PATH and the WHO, in partnership with the

Serum Institute of India

Technology from the FDA Center for Biologics Evaluation and Research

(CBER) (conjugation method), SynCo Bio Partners B.V., Netherlands

(Meningococcal A polysaccharide), and Aerial, France (tetanus toxoid)

The FDA collaborated with PATH (under a CRADA) to scale-up the

conjugation process and the technology was licensed nonexclusive to

PATH and sublicensed to the Serum Institute of India

Developing Innovative Test Method for Preclinical Evaluation of

Fundamental Optical Properties of IOLs (CDRH)

Example #1

6 mm

13 mm

Three-piece Monofocal IOL

F1

P1

ffl

=546 nm IOLrefractive-index

IOLcentral

thickness

IOL Fundamental Optical Properties

dioptric power: DIOL = 1/ffl refractive-index of the IOL material

IOL central thickness

reflected glare

light scattering characteristics

imaging quality

spectral transmittance

An estimated 20.5 million Americans over age 40 have

cataracts in at least one eye

>3 million surgeries/year in US, >3 billion USD/year cost

Critical importance of precise preclinical IOL optical

testing for evaluating the safety and effectiveness

Conventional test methods have specific limitations:

high accuracy both +/- IOL testing, spatial alignment and

subjective imaging

Motivation

Developing Innovative Method for Precise IOL Power Testing

Confocal Laser Method (CLM) for IOL Dioptric Power Testing

(proof-of-concept innovation)

E1

E2

E3

E4

h CONFOCAL MICROSCOPY FIBER-OPTIC SENSORS AUTOCOLLIMATION METHOD

high-magnification imaging

out-of-focus signal rejection

non-contact optical sectioning

submicron resolution

high sensing resolution

micrometer size core diameter

compact, flexible

scanning potential

double increased accuracy

simple and compact design

Ilev, EYE 21, p. 818, 2007, Nature Publishing Group

Ilev, Pending Patent, March, 2006PM

Single-Mode Fiber Coupler

(21, 50/50)

IOLtestOc

Mtotal

ft

Input Gaussian

Laser Beam

ISO Oin

LASER

Operating Principle

stakeholder f-b

patent

proof-of-concept

motivation

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GenomeTrakr Network and Database (CSFAN)

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GenomeTrakr Fast Facts at:

http://www.fda.gov/Food/FoodScienceResearch/WholeGenomeSequencingProgramWGS/ucm403550.

htm

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FDA Technology Transfer Contacts

Office/Center T2 Representative or Program Contact

CBER Nisha Narayan

CDER Yolanda Hawkins, Chekesha Clingman

CDRH Annie Saha, James Kolonay, Rochelle Fink

CFSAN LaQuia Geathers, Tashea Brown, Kevin Robinson

CVM John Graham, Dana Gaffney, Michelle Fuller

CTP Matthew Holman, Julia McGinn-Rodriguez

NCTR Ashley Groves, Thomas Flammang

ORA Marilyn Khanna

OC Alice Welch, Bill Ronnenberg, Whitney Hastings, Charlene Maddox, Ken Millburne

More details at: http://www.fda.gov/techtransfer

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Web Resources

FDA Technology Transfer Program

http://www.fda.gov/techtransfer

FDA Technologies Search Page

http://www.fda.gov/ScienceResearch/CollaborativeOpportunities/In

ventions/ucm464037.htm

FDA Technology Transfer Program Contact Page

http://www.fda.gov/ScienceResearch/CollaborativeOpportunities/u

cm149671.htm