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FLC Mid-Atlantic Meeting 2014 Innovation and Entrepreneurship Panel.

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Presentation on theme: "FLC Mid-Atlantic Meeting 2014 Innovation and Entrepreneurship Panel."— Presentation transcript:

1 FLC Mid-Atlantic Meeting 2014 Innovation and Entrepreneurship Panel

2 INTRODUCTION TO COMPANY Virtual Company – Delaware S-Corp Key Personnel Scientific Advisory Board Consultants 2

3 VIRTUAL COMPANY ACTIVITIES ManagementInternal InvestmentExternal Investment Identification of Medical Need Phase I Clinical Trial - NIH Grant Internal InvestmentPhase IIb Clinical Trial – NIH Grant Core Management Team (CEO, CFO, CSO) Innovation/PatentGo/No Go Decision Product DevelopmentLicense, Strategic Partner or Venture Capital Consultants Project Specific Commercialization PlanPhase III Clinical Trials FDA Pre-IND MeetingCommercialization Go/No Go DecisionRevenues to Fund Future Investments 3

4 QUITPAK® EXPERIENCE Identification of Medical Need – Nicotine Addiction Internal Investment – Friends, Family, & Sweat Equity Innovation – Fixed-Dose Combination Tablet Containing Bupropion (Zyban®) and Mecamylamine (Nicotine Receptor Antagonist) Patent – Nicotine Addiction Treatment No. 6,197,827, March 6, 2001. Initial Product Development – API Sourcing, Formulation Development, Debt Funding Commercial Plan – Developed Internally FDA Pre-IND Meeting – 505(b)2 NDA High Probability of Technical, Regulatory & Commercial Success Go/No Decision – GO. Phase I Clinical Trial – NIDA SBIR Grant NIDA-Funded Commercialization Assessment 4

5 WHAT EXPERTS SAID ABOUT QUITPAK® “QuitPak’s dual mechanism of action represents a novel approach to smoking cessation that will work better than existing therapies.” Wallace B. Pickworth, Ph.D. Health Research Leader Battelle Centers for Public Health Research and Evaluation “QuitPak represents a new and competitive technology that will be at least as effective as Pfizer’s varenicline (Chantix).” Donald P. Tashkin, M.D. Medical Director of Pulmonary Function Laboratories UCLA Medical Center “QuitPak combination therapy represents a very good approach to smoking cessation. When combined with behavior modification, its success rate could be 45%.” Jed E. Rose, Ph.D. Director Duke University Center for Nicotine and Smoking Cessation Research As reported to Linda Smith of Foresight Science & Technology, during an independent Commercial Assessment of QuitPak conducted at the request of NIH, May 2006. 5

6 QUITPAK® EXPERIENCE Phase IIb Clinical Protocol Developed Based on FDA Guidance for Combination Product Mayo Clinic Developed Budget as the Test Site Funding Application Submitted to NIDA Responding to Par-11-109, Grand Opportunity in Medications Development for Substance- Related Disorders (U01). “Goal is to fund medications closer to FDA approval.” Scientific Review by CSR Impact Score – 60 (Non-Fundable) Significance: 4 Investigator: 3 Innovation: 4 Approach: 8 Environment: 6 Appeal to NIDA Citing Reviewer Conflict of Interest Denied Go/No Go Decision – Project Discontinued Forfivo XL 450 co-developed through FDA approval with IntelGenx Handa Pharmaceuticals P IV generics co-founded with formulation expert 6

7 GRANT APPLICANT FEEDBACK TO CSR Proposed QuestionsAnswer 1.Was the time/investment to submit a grant application reasonable? Yes No 2.Did you feel that the reviewer comments were valuable/insightful/scientifically based? Yes No 3. Was the review fair and unbiased? Yes No 4.Do you believe that the successfully funded applications under the Grant Request responded to the objective of the initiative? Yes No 5.Do you believe that there is adequate transparency oversight and accountability with the Grant Review Process? Yes No 6.Do you believe that the composition of the Review Panel was appropriate? Yes No 7.Do you believe that the successfully funded projects will result in products, which will benefit public health? Yes No 7

8 RECOMMENDATIONS FOR SUCCESSFUL COLLABORATIONS Establish separate funding mechanisms for: – Projects with commercial potential and – Basic research projects (e.g., universities) Require a Letter of Intent for each Grant Application Pre-screen Letters of Intent for quality and relevance before accepting Grant Application. Scientific Program Officer as Gatekeeper Reduce number of Grant Applications by 50% and increase chance of successful awards (currently 1 in 6) Improve transparency and oversight of the process to reduce fraud, abuse, and conflicts of interest “Goal is to fund medications closer to FDA approval.” 8

9 EXAMPLES OF FUNDED GRANT APPLICATIONS ChanBan Clinical Study – Zyban + Chantix Zyban Clinical Trial in Pregnant Women Failed Nicotine Vaccine (NicVax) - > $20 M Cocaine Addiction Vaccine – Cornell Medical Center (> $8 M over multiple years) Nicotine Addiction Combination Bupropion + GSK Compound – Mass General Hospital Lofexidine for Opiate Withdrawal Symptoms ($15 M). PI previously employed by NIDA Study of CV Disease in Drug Abusers with HIV – ($2.9 M) 9

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