“Paying for clinical trials with an SBIR grant” Our experience obtaining millions of dollars through the NIH's Phase II Competing Renewal program Adapted from a presentation to: Washington Technology Center SBIR Breakfast June 12, 2007 William Ross - Director of Software Engineering, Pathway MRI & Vice-President, VPDiagnostics [email protected]Dr. William Kerwin - Associate Professor, Vascular Imaging Laboratory, University of Washington [email protected]
Transcript
“Paying for clinical trials with an SBIR grant”Our experience obtaining millions of dollars through the
NIH's Phase II Competing Renewal program
Adapted from a presentation to:
Washington Technology Center SBIR Breakfast
June 12, 2007
William Ross - Director of Software Engineering, Pathway MRI & Vice-President, VPDiagnostics
● Vascular Imaging Lab (VIL) researchers developed advanced imaging technology to visualize and quantify atherosclerosis (hardening of the arteries)
● Dr. Kerwin of VIL teamed up with small businessPathway MRI and submitted Phase I & II SBIR proposals to NIH to fund commercialization of the technology
● A software product, the Pathway Carotid Artery Platform (PCAP), was successfully delivered at theend of Phase II
● PCAP was intended to help physicians identify patientsmost at risk for stroke
● #3 cause of death
● #1 cause of long-term disability
● At least 88% caused by atherosclerotic plaque (“hardening of the arteries”)
● “Vulnerable” plaque in the Carotid artery breaks off, travels to brain, blocks blood vessels, causes stroke
Stroke Facts
MRI imaging of Carotid plaque
Carotid plaque specimen
Carotid plaque MRI
Vulnerable plaque
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PCAP 3D display of Carotid plaque
Vulnerable plaque
SBIR Timeline
● Pathway/VIL SBIR Collaboration Agreement since 2002
● Pathway licensed VIL Intellectual Property (IP) in 2005
● 3 Patents Pending
● Phase I: $99K Developed image analysis algorithms
● Phase II: $940K Developed commercial product, submitted “clinical aid” 510K to FDA
● NIH/NHLBI funded Pathway MRI and VIL
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Pathway MRI:● Had completed commercial software product: PCAP
● Had exclusive, worldwide license to UW Intellectual Property
● Had no FDA approval to market
● Was out of money
Result: ● Product & IP license sold to investor to create VPDiagnostics, Inc.
At conclusion of SBIR Phase II
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Main Barrier to Commercial Success
● FDA approval as “Diagnostic” tool requires clinical trials
● Clinical trials require years to perform, cost millions of $
NIH SBIR Phase II Competing Renewal
=A way through the FDA barrier
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“Activities supported by a competing continuation of a Phase II SBIR grant may include an extension and
expansion of preclinical research and development,
clinical testing, and other scientific research and
development activities that would ultimately be useful in
meeting the requirements and expectations of
Federal regulatory processes.”
SBIR Phase II Competing Renewal program
PA-06-079 - NIH/NIMH
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Who is eligible:● SBIR/STTR Phase II grantees (still small business)
● NIH only (NIA, NIAAA, NIAID, NICHD, NIDA, NIDCD, NIDDK, NHLBI, NIMH, and NINDS)
● The product must be one for which Federal regulatory approval is required
● Product can be devices, drugs, vaccines, therapeutics, and medical implants
● Also supports continuing refinements to durable medical equipment (DME) designs
SBIR Phase II Competing Renewal
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What is available:
● Up to $1M/year (varies by Institute/Center)
● Up to 3 years support
SBIR Phase II Competing Renewal
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● Submitted Phase II Competing Renewal proposal 8/2005
