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Rice Bioentrep Pres Nov 2009 (D)

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Rice Bioentrep Pres Nov 2009 (D)

  1. 1. PLx Pharma Inc. Next Generation NSAIDs Improving GI Safety Rice University Jason E. Moore, M.S., M.B.A. Vice President, PLx Pharma Inc. November 10, 2009
  2. 2. Presentation Overview • A little about my career in biotech • Positioning yourself for a leadership career in biotech • About PLx Pharma and the challenges we face • Some take-aways
  3. 3. Positioning Yourself • Be strategic in identifying companies/ technologies – You’re going to be with them for a while – What is the fit with your goals – Assess companies, technologies and their risks Economics and Risk in Drug Development Life Science Entrepreneurship Certificate Program Rice University Jason E. Moore, M.S., M.B.A. Vice President, PLx Pharma Inc. April 18, 2008 Economics and Risk in Drug Development Life Science Entrepreneurship Certificate Program Rice University Jason E. Moore, M.S., M.B.A. Vice President, PLx Pharma Inc. April 18, 2008 Framework for Technology Assessment Life Science Entrepreneurship Certificate Program Rice University Jason E. Moore, M.S., M.B.A. Vice President, PLx Pharma Inc. April 5, 2008 Framework for Technology Assessment Life Science Entrepreneurship Certificate Program Rice University Jason E. Moore, M.S., M.B.A. Vice President, PLx Pharma Inc. April 5, 2008
  4. 4. Technology Assessment Stating the Obvious • The technology should lead to a useful, commercially valuable product • The technology/product should be adequately protected and other IP must not block the path to commercialization • There must be a clear business model/strategy that can be formulated for generating a profit from the technology’s commercialization • The technology should address a need in a large and growing market • There should be sufficient clarity concerning the path to market and the regulatory environment • Every technology is unique • Life science product development is development research, is very complex, and is defined by its many uncertainties and assumptions • Evaluating early-stage technologies is difficult
  5. 5. Due Diligence Establishing an Approach • Conducting Due Diligence – Have and use a thorough framework for technology assessment – Be thorough and systematic – Ask for, and expect, access to all data (with CDA) – Look at source data, when possible – Critically evaluate all claims and data, including published articles – Use experts routinely; don’t rely only on your own intellect or scientific knowledge • Caveat emptor – “I have the cure for cancer.” – “This will be on the market in [less than 10] years!” – “There is no competition.” – Institution has no interest in the technology/inventor is the only owner "There is an increasing concern that in modern research, false findings may be the …vast majority of published research claims. A new claim about a research finding is more likely to be false than true."
  6. 6. Due Diligence Establishing an Approach • Assess – The technology itself (the scientific basis and its applications) – Intellectual property – Path-to-market – Commercial opportunity/valuation – Licensing deal structure/economics – Feasibility and “other” • Complete assessment within a global framework (eg, SWOT) – Strengths – Opportunities – Weaknesses – Threats/Risks • Understand the psychology of inventor and investor – Group think – Wishful thinking – Need to Believe! • Define licensing criteria prospectively* (aka, know your strategy) – Time-to-market – Deal terms (up-fronts, royalty rates, etc.) – Therapeutic area – Relative aggregate risk – Valuation or annual sales target
  7. 7. Understanding Risks An executive’s primary job is to understand and manage the risks to the success of his or her products. Some sources of risk: - Financial - Technical - Regulatory - Operational - Commercial/competitive - Legal (eg, liability, IP)
  8. 8. Sources of Development Risk
  9. 9. Sources of Development Risk (cont)
  10. 10. “Fifty percent of the time the person you are talking to won’t believe in your company or technology…” – Nancy Chang, PhD
  11. 11. “Knowledge Risk” Technical, Regulatory, and Commercial
  12. 12. Management: Start-upManagement: Start-up ExperienceExperience Started in 2003 – Virtual Approach - 7 employees • CEO: Ron Zimmerman ~ life science investor, former CEO & CFO, investment banker • COO: Gary Mossman ~ former CEO and COO with Pharma & chemical industries • SVP: Upendra Marathi, PhD, MBA ~ former researcher and VC ~ BCM Technologies, MD Anderson, St. Jude • VP: Jason Moore, MS, MBA ~ regulatory and project management ~ Amgen, Antigenics, Aronex, Introgen • CSO: Len Lichtenberger, PhD ~ technology inventor ~ University of Texas Health Science Center at Houston
  13. 13. Managing Knowledge RiskManaging Knowledge Risk • Develop an experienced management team – Chairman of the Board: David Anderson ~ life science investor, former COO of Tanox – CEO: Ron Zimmerman ~ life science investor, former CEO & CFO, investment banker – COO: Gary Mossman ~ former CEO and COO with Pharma & chemical industries – SVP: Upendra Marathi, PhD, MBA ~ former researcher and VC ~ BCM Technologies, MD Anderson, St. Jude – VP: Jason Moore, MS, MBA ~ regulatory and project management ~ Amgen, Antigenics, Aronex, Introgen – CSO: Len Lichtenberger, PhD ~ technology inventor ~ University of Texas Health Science Center at Houston • Use investors and KOLs as resources • Consider a CEO advisory group
  14. 14. Managing Knowledge RiskManaging Knowledge Risk • Develop an experienced advisor/consultant team – Ferid Murad, PhD, MD: Nobel Laureate and former VP of R&D for Abbott Labs – Barry Marshall, MD: Nobel Laureate – Andrew C. von Eschenbach, MD: former head of FDA and NCI – James T. Willerson, MD: President of Texas Heart Institute – Lee Simon, MD: Former head of the FDA’s Arthritis, Analgesic & Ophthalmologic Drug Product Division – Lawrence Goldkind, MD: Formerly with the FDA, in both the Gastroenterology Products Division and Arthritis, Analgesic & Ophthalmologic Drug Product Division – Daniel A. Shames, MD: Former head of FDA’s Gastroenterology Products Division – Winifred Begley: Oversaw the regulatory issues for Searle/Pharmacia/Pfizer for analgesic and anti-inflammatory drugs, including Celebrex®, on a global basis – Sharon Heddish: Former VP of Regulatory Affairs Worldwide Wyeth Consumer Health – Frank Lanza, MD: Developed the Lanza Score and has worked on clinical trials for most NSAIDs on the market – Byron Cryer, MD: Influential thought leader on NSAID/Coxib GI safety was consultant to the FDA Arthritis Advisory Committee. – Deepak L. Bhatt, MD, FACC, FAHA: Currently Chief of Cardiology with the VA Boston Healthcare System, Director of the Integrated Interventional Cardiovascular Program at Brigham and Women’s Hospital and Senior Investigator with the TIMI Study Group.
  15. 15. Financial/Funding Risk
  16. 16. Some Funding Options • Venture Capital • Private Investors (“Angels”) • Grants • Texas Emerging Technology Fund
  17. 17. 1717 PLx Equity Funding History Equity – $700,000 ~ Seed Series A ~ $.50 per share, Jan. 2003 – $778,000 ~ Seed Series A Second Close ~ $.85 per share, April 2004 – $3,310,000 Series B ~ $1.60 per share, March 2005 – $6,418,225 ~ $1.92 per share closed March 31, 2007 o Series C $4,418,225 million o $2 million from Texas Emerging Technology Fund in warrant for common stock – $3,106,961 Series D ~ $1.92 per share, May 2009 – Total Equity Capital Raised ~ $14.3 million
  18. 18. PLx Grant Funding History • Grants ~ $6.2 million approved – NIH: o $858,000 DDK SBIR Phase I & Phase I o $1,500,000 renewal of Ph. II o $1,000,000 NIAMS Ph I/Ph II – Army: o $1,800,000 to UTHSCH o $830,000 SBIR Phase I & II – State of Texas: $250,000 – NIH: multiple under review: Indo-PC IV for PDA, IBU-PC for oral mucositis, NAP-PC for endoscopy trial support, IBU-PC for OTC bioequivalence trials, ASA-PC for colon cancer prevention
  19. 19. Other Funding Take-Aways • Know you products, competition, and markets – better than those to whom you “pitch” • Credibility is a (the?) key to funding • Cultivate relationships with investors and investor communities • Pursue non-dilutive funding approaches (grants) aggressively • Watch the space (see BioCentury)
  20. 20. Career Ideas • Regulatory Affairs • Project Management • Clinical/Medical Affairs • Medical Writing • Manufacturing • Business Development • Marketing/Sales • Strategic Planning • What about Venture Capital?
  21. 21. http://www.fda.gov/jobs/default.htm
  22. 22. Career Tips for Biotech • Manage expectations • Relationships get jobs – network, network, network! • Develop bona fide expertise in an important discipline – Technical/scientific discipline – Regulatory: Regulatory Affairs Certification (RAC) through RAPS – Product development – Other professional certifications: o Project Management Professional (PMP) o Certified Clinical Research Associate (CCRA) o Medical Writing and Editing • Obtain and leverage internships
  23. 23. • Osteoarthritis in the US o Prevalence of 27 million 1 o 750,000 new cases per year 2 o Total cost (all forms of arthritis) of $128 billion 3 o Direct medical care cost per patient with OA: $5,700 1 Cost of Osteoarthritis 1 Helmick, Estimates of the Prevalence of Arthritis and Other Rheumatic conditions in the United States, 2008. 2 Alliance for Aging Research, A Cost-Effective Approach to Treating Osteoarthritis, 2003 3 MMWR, Prevalence of Arthritis – United States, Morbidity and Mortality Weekly Report, 2001 13 • Osteoarthritis in the US o Prevalence of 27 million 1 o 750,000 new cases per year 2 o Total cost (all forms of arthritis) of $128 billion 3 o Direct medical care cost per patient with OA: $5,700 1 Cost of Osteoarthritis 1 Helmick, Estimates of the Prevalence of Arthritis and Other Rheumatic conditions in the United States, 2008. 2 Alliance for Aging Research, A Cost-Effective Approach to Treating Osteoarthritis, 2003 3 MMWR, Prevalence of Arthritis – United States, Morbidity and Mortality Weekly Report, 2001 13 Antiplatelet Drug Summary Note: Ticagrelor data taken from Phase II Clinical Trial, not Phase III. Effient price is based on press release estimate of 18% markup over Plavix in the US Drug Ticagrelor (Brilinta) Sponsor(s) Sanofi Aventis, Bristol-Myers Squibb Daiichi Sankyo, Eli Lilly AstraZeneca Price (Lowest Dose) $4.53 ~$5.35 N/A GI bleeds compared to Plavix -- ↑↑ ↑ Rate of MACE compared to Plavix -- ↓ Same as Plavix PPI Interaction Yes Possible No Antiplatelet Drug Summary Note: Ticagrelor data taken from Phase II Clinical Trial, not Phase III. Effient price is based on press release estimate of 18% markup over Plavix in the US Drug Ticagrelor (Brilinta) Sponsor(s) Sanofi Aventis, Bristol-Myers Squibb Daiichi Sankyo, Eli Lilly AstraZeneca Price (Lowest Dose) $4.53 ~$5.35 N/A GI bleeds compared to Plavix -- ↑↑ ↑ Rate of MACE compared to Plavix -- ↓ Same as Plavix PPI Interaction Yes Possible No Types of use of acute treatment by migraineurs • Half of migraineurs use NSAIDS for treatment • Migraineurs are 2.7 times more likely to take an NSAID than a triptan 0.6% 2.9% 2.9% 6.0% 18.7% 30.6% 50.0% 68.4% 0% 20% 40% 60% 80% Ergots Opioids Isometheptene Barbiturates Triptans Combination OTCs NSAIDS Paracetamol Types of use of acute treatment by migraineurs • Half of migraineurs use NSAIDS for treatment • Migraineurs are 2.7 times more likely to take an NSAID than a triptan 0.6% 2.9% 2.9% 6.0% 18.7% 30.6% 50.0% 68.4% 0% 20% 40% 60% 80% Ergots Opioids Isometheptene Barbiturates Triptans Combination OTCs NSAIDS Paracetamol Internships at PLx • We host 1-2 internship positions each summer • Excellent experience with Rice MBA and Rice/Baylor MBA/MD candidates Pricing 6 • Aspirin + PPI Cotherapy pricing for high risk patients Prices found on CVS website 1 Scheiman, Cost-effectiveness of Proton Pump Inhibitor Cotherapy in Patients Taking Long-term, Low-Dose Aspirin for Secondary Cardiovascular Prevention, 2008 Prilosec OTC 20mg $0.79 Rx Omeprazole 20mg $3.84 1 Bayer Aspirin 325mg $0.10 $0.89 $3.94 CVS Aspirin 325mg $0.02 $0.81 $3.86 Product prices are the average of the per dose prices for bottles with different counts Pricing 6 • Aspirin + PPI Cotherapy pricing for high risk patients Prices found on CVS website 1 Scheiman, Cost-effectiveness of Proton Pump Inhibitor Cotherapy in Patients Taking Long-term, Low-Dose Aspirin for Secondary Cardiovascular Prevention, 2008 Prilosec OTC 20mg $0.79 Rx Omeprazole 20mg $3.84 1 Bayer Aspirin 325mg $0.10 $0.89 $3.94 CVS Aspirin 325mg $0.02 $0.81 $3.86 Product prices are the average of the per dose prices for bottles with different counts March 9, 2009March 9, 2009 The Clinical and Market Opportunities for Aspirin-PC March 9, 2009 The Clinical and Market Opportunities for Aspirin-PC March 9, 2009
  24. 24. Professional Organizations • Training, education, networking • U.S./internat’l drug and device regulation • Regulatory Affairs Certification (RAC): www.raps.org • Training, education, networking • All areas of drug development • www.diahome.org • Training, education, networking • All aspects of biotech industry • Business focus • www.bio.org • Training, standards, networking • Project and program management across all industries • Professional certifications: • Project Management Professional (PMP) • Program Management Professional (PgMP) • www.pmi.org • CRA training, certification • www.socra.org • Training, education, networking • All aspects of medical writing and editing • Writing and editing certifications and other professional development • www.amwa.org
  25. 25. Other Resources • U.S. Food and Drug Administration: www.fda.gov – Center for Drug Evaluation and Research (CDER): www.fda.gov/cder – Small Business Assistance Web Page: http://www.fda.gov/cder/about/smallbiz/default.htm – **Online Training Seminar: “Drug Review and Related Activities in the United States”: http://www.connectlive.com/events/drugdev/ • Food and Drug Law Institute: www.fdli.org • The Tufts Center for the Study of Drug Development : http://csdd.tufts.edu • Pharmaceutical Research and Manufacturers of America (PhRMA): www.phrma.org • BioHouston: www.biohouston.org • Bio/Medical Technology Club of Houston: www.bmtchouston.org
  26. 26. Jason E. Moore, M.S., M.B.A. jason.moore@plxpharma.com | 713-842-1249 x207 Thank you!!

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