requisite biomedical i-corps@nih 121014
TRANSCRIPT
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Intravascular medical device drug coatings
that promote vascular healing
2 2
Intravascular medical device drug coatings
that promote vascular healing
Plavix
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Total Interviews = 108
Average = 10 per week
Investor Readiness = 4
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Margaret E (Meg) Groh, PhD/MBA -- CEO
• Biotechnology business development experience
• NSF I-Corps graduate (U Akron)
•
Tammy “The Tamminator” Dugas, PhD -- PI
• Professor, LSU School of Veterinary Medicine
• Cardiovascular pharmacologist/toxicologist
• Co-Founder
John D. Foley, PhD -- IE
• Medical device industry executive
• Co-Founder
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“Yeah, I got out of
the building and
look what it got
me…. wish I were
there.”
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Business Model Canvas – Earliest Version
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SO HERE’S WHAT WE DID…
First 20 Interviews
KOL
REGULATORY
REIMBURSEMENT
CLINICIAN
• Stent versus balloon decision needs more input
• Clinical trial design/cost and market size will guide
preclinical decisions (stent v balloon, coronary v
peripheral)
• Regulatory hurdle is significant, yet Drug Master
Files already exist
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Business Model Canvas – Next Version
EXPANDED
AND
QUANTIFIED
ADDED
REAL
PEOPLE
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SO HERE’S WHAT WE DID…
SO HERE’S WHAT WE FOUND…
Next set of
interviews
DECISION
MAKERS
HOSPITAL
SALES REPS CLINICIANS
• Hospital product technology assessment
committees have a key role in new product
adoption
• HOWEVER, with strong data clinicians can
advocate for a new product and prevail
$$!!
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CUSTOMER RELATIONSHIPS Hypothesis Interviews Learnings
Actions
Clinicians will drive
uptake.
Vascular surgeon (2 this
week, 4 total)
Interven’l Cardiologist (1 this
week, 3 total)
“Show me the study.”
Docs are very data-driven.
Will need to publish in
high impact journals,
present at major
meetings, utilize other
media.
FDA is a key
customer.
FDA employee or
consultants (2 this week, 12
total)
Major hurdle that can be
overcome with time,
patience, data, and $.
Engage regulatory
expertise in Phase II.
Business
development folks
are a key customer
and gatekeeper.
Business dev at potential
partner (1 this week, 4 total)
Business dev at potential
collaborator (2 this week, 5
total)
Large number of ways to
partner.
Need to draw out likely
possibilities then
prioritize.
Investors (VCs) will
not take on this
deal
VC (1 this week, 10 total) WRONG! VCs will look at
any deal, even a PMA. It’s
the technology, deal
structure, and market size
that matter.
Keep VC/other equity
investors in mind,
especially with regard to
deal structure in
partnerships.
FTO will allow
unrestricted sales
IP attorneys (2 this week, 8
total)
Confirmed. Details on
when & how evolving.
Will conduct FTO and set
up ongoing maintenance
in IP surveillance space.
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Business Model Canvas – Current Version
+ 4 MORE
+ 3 MORE
CATEGORIZED
ADDED
REVISED
PRIORITIZED
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VS
Not necessarily a Pivot, but a new set of Priorities
Need to accelerate development of the drug coated balloon
• Longer regulatory pathway
• Second line of therapy
• Market size trending
downward
• Shorter regulatory pathway
• First line of therapy
• Market size trending
upward
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WHERE WE ARE NOW…
• We have learned that we need to think ahead,
find the ‘customers’ and find out what drives
their decisions.
• It is OK to pivot or re-prioritize. Both come
with a new set of VPs and KAs.
• We have reaffirmed that we have a viable
business and we will pursue it diligently after
this class.
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With respect to submitting an SBIR/STTR Phase II
application, we are making the following decision:
Go with a nominal pivot: The feasibility data
generated in the Phase I grant provide the
appropriate technical foundation for a Phase II
application, AND we are largely targeting the
customer segments that we had originally
anticipated
Investment Readiness Level (IRL) = 4
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Business Model Canvas Evolution
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