H.A.E.Konarowski, Chemrar High-Teck Center


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H.A.E.Konarowski, Chemrar High-Teck Center

  1. 1. 1 st International Conference on Innovative Growth for Pharmaceutical and Medical Industry in Russia. Integrating Academic and Industrial Science MIPT, 12 May 2011 Henrik A. E. Konarkowski ChemRar High Tech Center www.chemrar.ru
  2. 2. <ul><li>The hard way to make a Medicine: </li></ul><ul><li>Less than 1 in 100,000 compounds tested eventually reaches consumers. </li></ul><ul><li>Only 1 of every 5 compounds that enter clinical testing reaches the market. </li></ul><ul><li>Only 3 of 10 drugs that reach the market ever earn enough money to match or exceed the average R&D cost per new medicine. </li></ul>THE COST OF A DELAY DAY (SELECT BLOCKBUSTER DRUGS) Note: The average drug generates $1.3 million sales daily Source: IMS Health, 2002 and PhRMA Profile, March 2007 The Cost of Developing a Drug
  3. 3. DISTRIBUTION OF BIG PHARMA R&D SPENDING Source: PhRMA Annual Survey, 2006
  4. 5. <ul><li>Money </li></ul><ul><li>Time </li></ul>Or Accessing
  5. 6. <ul><li>Money </li></ul><ul><li>Time </li></ul>Or Accessing <ul><li>New Technologies </li></ul>
  6. 7. Source: Contract Pharma Second Annual Outsourcing Survey, 2006
  7. 8.       Price Trust Independence Collaboration <ul><li>Co-investment </li></ul><ul><li>Shared business objectives </li></ul>Source: Modified from Price Waterhouse Coopers Am.Pharm.Outsourcing 6,01:30-32 and J. Wilmer, Prime Trials Outsourcing Clinical Trials CRO Perspective , 2004 Value Ordering Tactical Outsourcing Strategic OutPartnering Insourcing Catalogue / Menu Fee for Service Preferred Fee for Service Partner Collaboration Alliance Localized Integration
  8. 9. <ul><li>Contracting out – fee for product business </li></ul>
  9. 11. <ul><li>Contracting out – fee for product business </li></ul><ul><li>Preferred vendor status, based on </li></ul><ul><li>1) Price 2) Quality, </li></ul><ul><li>Russia: since early 1990s </li></ul><ul><li>Asia: since early 2000s </li></ul>
  10. 12. <ul><li>Contracting Out by fee for service </li></ul>
  11. 13. Completion of the required data package paid for by time used
  12. 14. i.e. special Chemistry on Demand
  13. 15. <ul><li>Contracting Out by fee for service </li></ul><ul><li>Preferred vendor status is based on: </li></ul><ul><ul><li>1) Reliability (confidentiality, relationship, timeliness) </li></ul></ul><ul><ul><li>2) Quality </li></ul></ul><ul><ul><li>3) Cost </li></ul></ul><ul><li>– drift from cost based outsourcing </li></ul><ul><li>to quality based (value builder) </li></ul>
  14. 16. <ul><li>Variety of business models in a broad partnership </li></ul><ul><li>ChemRar experience from mid 2000s with companies </li></ul><ul><li>Avalon, Eli Lilly, Merck KGaA, Genentech, Solvay, Abbott </li></ul>
  15. 17. <ul><li>Risk share based platfo r m R&D </li></ul><ul><ul><li>Chem Rar prosecutes assets for: </li></ul></ul><ul><ul><ul><li>P artial R&D payment, success based development milestones . 12 Targets to generate 2 Clinical Candidates </li></ul></ul></ul><ul><ul><li>Solvay’s assets: </li></ul></ul><ul><ul><ul><li>Targets, Hit series, L e ads from Pharma </li></ul></ul></ul><ul><li>Potential Deliverable </li></ul><ul><ul><li>POC </li></ul></ul><ul><ul><li>Bring more later stage aassets in </li></ul></ul><ul><ul><li>Create more value for: </li></ul></ul>Hit series Lead series Leads Clinical Candidates 2 year FHD POC « We are very happy to consolidate a portion of our external research activities that are currently being outsourced to several different contract research organizations as this we believe will shorten development timeline. Moreover we are pleased to have found a partner that shares our business model approach » Frédéric Cren, Head of Research at Solvay Pharmaceuticals 4 year
  16. 18. Clinical Candidate FHD POC PII PIII NDA
  17. 19. <ul><li>Variety of business models in a broad partnership </li></ul><ul><li>Preferred vendor status is based on such competitive features as: </li></ul><ul><ul><li>Long term relationship building </li></ul></ul><ul><ul><ul><li>Usually diversify an established “tactical” relationship </li></ul></ul></ul><ul><ul><ul><li>Value building for Sponsor’s R&D at “Milestones”: </li></ul></ul></ul><ul><ul><ul><li>Lead, IND, POC(PII), PIII </li></ul></ul></ul><ul><ul><ul><li>Shared risk / reward element </li></ul></ul></ul><ul><li>ChemRar experience from mid 2000s with companies </li></ul><ul><li>Avalon, Eli Lilly, Merck KGaA, Genentech, Solvay, Abbott </li></ul>
  18. 20. Передача лицензии на территорию России Проведение доклиники иили клиники в РФ Производство инновационного препарата в РФ Передача результатов клинических исследований Коммерциализация за рубежом Руб. Кросс-Роялти % Финансирование От Российских партнеров Модель трансферта разработок инновационных лекарственных средств $$$ Иностранный партнер Российский партнер Иностранный партнер Российский партнер
  19. 21. <ul><li>Money </li></ul><ul><li>Time </li></ul>Or Accessing
  20. 22. <ul><li>Money </li></ul><ul><li>Time </li></ul>Or Accessing <ul><li>New Markets </li></ul>
  21. 23. CSC starts chemistry servies in Russia CHEMRAR incorporat. New Research Institute in Khimki, Moscow licensed 1st Russian Patent in liquid crystal technology to Hoffmann La Roche, Basel Formulation, Pilot GMP, API with MIT support The first LP in Western VC incorporation CITOLEX – first manufacturing project in RUSSIA ID - first biotech in Yaroslavl Univ. with Federal Innov. agency support Clinical Research Organization Health Care Ventures IX The first IP transfer project with ROCHE The first biotech in USA JV with RUSNANO ($160M venture project) Active partnering with few Life Science Venture funds 84 90 95 00 05 07 08 09 10 Open labs in San Diego CA New wave as RVC partner 11 04
  22. 24. From 2008 ChemRar experts prominently participated in drafting of the “Russian Federation Innovative Development Strategy for the Pharmaceutical Industry through the year 2020” (Pharma2020). December , 2010: Prime Minister Vladimir Putin visiting ChemRar with Ministers of Industy and Health
  23. 25. Bringing into Russia innovative development projects at various stages, from Biotarget stage, to clinical candidates, and developing them into Medicines In-Partnering Development Projects Globally 20 years, more than 1200 partners
  24. 26. first line Service Research Organizations Biotech Companies Manufacturing & Market Access
  25. 27. Partnering with Russia’s Scientific Institutions <ul><li>Moscow State University </li></ul><ul><li>M oscow Institute of Physics and Technology (MIPT) </li></ul><ul><li>D. Mendeleyev University of Chemical Technology of Russia </li></ul><ul><li>YSPU Yaroslavl University </li></ul><ul><li>State Research Center for Applied Microbiology & Biotechnology (FSIS SRCAMB) </li></ul><ul><li>M.M. Shemyakin and Yu.A. Ovchinnikov Institute of bioorganic chemistry of the Russian Academy of Sciences </li></ul><ul><li>Moscow Centre for HIV/AIDS Prevention </li></ul><ul><li>and Treatment </li></ul>7 programs funded 8 in various funding stages 15 programs suggested for funding 250k to 2.5M for seed 5-30M for development 65 programs selected for evaluation 200 partners identified 2007-2009
  26. 28. <ul><li>ChemRar seed funds </li></ul><ul><li>Co-funding relationship with </li></ul><ul><ul><ul><li>Rosnanotech ($5.5B investment bank), </li></ul></ul></ul><ul><ul><ul><li>Russian Venture Corporation ($1,5B fund of funds) </li></ul></ul></ul><ul><ul><ul><li>Ministry of Production and Trade « med-pharma » federal program initiated Y2011 ($4B) </li></ul></ul></ul><ul><ul><ul><li>Russian « SBIR » ( $100m per year) </li></ul></ul></ul><ul><ul><ul><li>SKOLKOVO </li></ul></ul></ul><ul><li>Partnership with Health Care Ventures, Celtic, Avalon Ventures, Domain, 5AM, other private equity and angel investors </li></ul><ul><li>Established JV for late stage co-development and market access with Pharmstandart, R-Pharm, Protek and other local players </li></ul>