Dr. ta presentatio


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Dr. ta presentatio

  1. 1. PHARMA RESEARCH EMERGING CHALLENGES Arulmoli, Ph.D Vice President-R&D SeQuent Scientific Ltd., Mangalore August 19, 2011
  2. 2. <ul><li>INTRODUCTION </li></ul><ul><li>Turnover in 2008-09 </li></ul><ul><li>Global Pharma US $ 820 billion </li></ul><ul><li>Indian Pharma US $ 21.04 billion </li></ul><ul><li>Indian Pharma on global Pharma map: </li></ul><ul><li>By volume : 3 rd largest </li></ul><ul><li>By value : 14 th rank </li></ul><ul><li>Growth rate : 8-9% per annum </li></ul>PHARMA RESEARCH – EMERGING CHALLENGES Ref: IMS Health Data
  3. 3. <ul><li>By 2020 : Pharma Market is expected to reach US $ 35 Bn </li></ul><ul><li>By 2015 : MNCs will sell drugs worth US $ 8 Bn </li></ul><ul><li>By 2012 : Sale of drugs is expected to increase from US $ 9.6 Bn to US $ 19.2 Bn </li></ul><ul><li>India is already labeled as a LUCRATIVE DESTINATION for clinical trials for global growth. </li></ul>Indian Pharma – Expectation in future
  4. 4. <ul><li>Possible reasons: </li></ul><ul><li>Competitive work force: </li></ul><ul><ul><li>High Managerial, technical competence, Skilled work force </li></ul></ul><ul><ul><li>Professional services are easily available </li></ul></ul><ul><ul><li>English as a medium for communication </li></ul></ul><ul><li>Cost effective chemical synthesis: </li></ul><ul><li>Expertise in reverse engineering </li></ul><ul><li>Expertise in quick process optimization. Short time for development of variety of drugs, Exports of recent drugs. </li></ul>cont… Why India ?
  5. 5. <ul><li>IT: Good net work of educational institutions, IT Strength. </li></ul><ul><li>Legal & Finance frame work : </li></ul><ul><li>Solid legal frame work, Strong financial markets, presence of international financial institutions. </li></ul><ul><li>Globalization: </li></ul><ul><li>Free market economy, middle-class market still growing. </li></ul><ul><li>Consolidation: </li></ul><ul><li>Acceptable generalized process for integration, collaboration, M & A. </li></ul>cont… Why India ?
  6. 6. <ul><li>Strong IP protection: </li></ul><ul><li>Post 2005 era is the catalyst for new inventions and generation of IP wealth. After India started allowing product patent, the MNCs find India a safe place for their research with proper IP protection. </li></ul><ul><li>Despite above all, no new molecules launched </li></ul><ul><li>from INDIA ? </li></ul>Why India ?
  7. 7. Status of New Molecules (NCEs) trials by Indian Cos. New Chemical Entities from Indian Pharma Companies - Status NCEs Company Therapy area Status Target to launch Market Size Global players                     IN-105 Biocon Diabetes-Insulin Phase -III 2011 in India US $ 13 Bn Nova Nordisk, Eli Lilly         2015 in ROW                   T 1h Biocon Psoriasis, rhematoid Phased -II Not mentioned US $ 15 Bn Astella, BMS, ABBOTT     arthritis   Completed     Amgen                 DRF 2593 Dr Reddy Diabetes   Phase -III Not mentioned US $ 7 Bn Glaxo, Takeda, Abbott 307 IN   PPAR agonists       Solvay                 Crofelemer Glenmark Diarrhoea   Phase-III 2011   US $ 2 Bn Glaxo                 Sun -1334 H Sun Pharma Allergy   Phase -II Not mentioned US $ 5 Bn Sanofi-Aventis, Pfizer       Completed       P 276 Piramal Life Cancer   Phase -II To file for market US $ 48 Bn Roche, Eli Lilly, Pfizer         approval in 2011   Glaxo                 GRC 8200 Glenmark Diabetes   Phase-II 2013-14   US $ 1-2 Bn Merck       DPP IV inhibitor Completed                     Arterolane Ranbaxy Malaria   Phase -III To apply for market US $ 1 Bn Novartis   Maleate +       approval in 2010     Piperaquine                  
  8. 8. NCEs From Global Pharma cont…
  9. 9. NCEs From Global Pharma cont…
  10. 10. <ul><li>Cost of a NCE to become a drug: $ 1.3 Bn </li></ul><ul><li>Time involved for overall development and launch: 10-15 years </li></ul><ul><li>Failure rate in clinical trial especially in phase II: 95% </li></ul>NCE: Cost and Time to bring to Market
  11. 11. Traditional Pharmaceutical R&D
  12. 12. <ul><li>Pharma research plays a major role in reducing the cost and time of the Development of a NCE </li></ul>
  13. 13. <ul><li>Integration of different basic Sciences & Engineering Team (interlinking chemistry, microbiology, pharmacology, pharmacokinetics, pharmacodynamics, toxicology etc.) </li></ul><ul><li>Greater involvement of Mathematic, IT & Bioinformatics enabled analytical tools viz. Molecular modeling </li></ul><ul><li>Greater industry – academia interaction for sharing the knowledge </li></ul>Challenges to overcome the failure rate
  14. 14. <ul><li>Educational institutions role in creating professionals: </li></ul><ul><li>“ Institutions of Pharmaceutical Sciences and Pharma Industries need to evolve an integrated and comprehensive National Pharma Vision to meet the challenges of design to drug development, production and marketing. The major challenge before pharma community is to prevent the entry of spurious drugs and eradicate its presence in the market” </li></ul><ul><li>- Dr. A.P.J. Abdul Kalam </li></ul><ul><li>Honorable Ex. President of India </li></ul>Challenges to overcome the failure rate
  15. 15. Educational institutional role <ul><ul><li>Establishing good infrastructure for learning and experimenting. </li></ul></ul><ul><ul><li>Changes in curriculum to include subjects like : </li></ul></ul><ul><ul><li>Bioinformatics: </li></ul></ul><ul><ul><li>- Gene expression data analysis </li></ul></ul><ul><ul><li>- Mapping DNA & protein sequences </li></ul></ul><ul><ul><li>- 3-D models of Protein structures </li></ul></ul><ul><ul><li>- Understanding Human genome </li></ul></ul>
  16. 16. Educational institutions role: <ul><ul><li>Chemo informatics: </li></ul></ul><ul><ul><li>Drug lead identification and optimization </li></ul></ul><ul><ul><li>Target interaction, model creation </li></ul></ul><ul><ul><li>in-silico analysis </li></ul></ul><ul><ul><li>High-throughput screening </li></ul></ul>
  17. 17. Educational institutions role <ul><li>Nanotechnology : </li></ul><ul><li>“ Wave of the future in Biotech & Pharma” </li></ul><ul><li>Potential market : $ 220 billion by 2015 for nano enabled </li></ul><ul><li>compounds. </li></ul><ul><li>Early candidates : </li></ul><ul><li>Paclitaxel ( Abraxane) - Albumin nanoparticle - approved in 2005 </li></ul><ul><li>Fenofibrate (Tricor) – Nanocrystal - approved in 2005 </li></ul>
  18. 18. <ul><ul><li>Pathophysiology: </li></ul></ul><ul><ul><li>To understand disease & functional changes in body </li></ul></ul><ul><ul><li>Anatomy: How human body works at molecular level </li></ul></ul><ul><ul><li>Combinatorial chemistry: </li></ul></ul><ul><ul><li>To have a library of compounds </li></ul></ul><ul><ul><li>QSAR </li></ul></ul><ul><ul><li>Mathematics : </li></ul></ul><ul><ul><li>Creation of working models for data analysis </li></ul></ul>
  19. 19. <ul><li>Low productivity </li></ul><ul><li>Multiple Patent Protection </li></ul><ul><li>Rising cost of R&D </li></ul><ul><li>High attrition rate of Compounds in phase II </li></ul><ul><li>High regulatory hurdles </li></ul><ul><li>Concern about adverse effects and so on. </li></ul>Innovation challenges
  20. 20. Awareness on Intellectual Property <ul><li>Intellectual Property: </li></ul><ul><li>Creation of Human intellect </li></ul><ul><li>Knowledge Asset – Tradable commodities Capital </li></ul><ul><li>Key component for success in Business </li></ul><ul><li>Tool for competitiveness </li></ul><ul><li>New wealth of nations </li></ul>
  21. 21. IP Knowledge – We must do…. <ul><li>Promote Cultivation of IP Culture </li></ul><ul><li>Increase Capacity to Create IPRs </li></ul><ul><li>Encouraging IP- Commercialization and Utilization </li></ul><ul><li>Expediting Development of Legal System for IP </li></ul><ul><li>Strengthening IP- Administration, examination and registration </li></ul><ul><li>Formulate and implement region and industry-specific strategies on IP </li></ul><ul><li>Strengthen IP-information dissemination and international cooperation </li></ul><ul><li>Enhance professional training so as to raise the competence </li></ul>
  22. 22. Empower using IP Knowledge <ul><li>Each student must to know basic of IP aspects. </li></ul><ul><li>Academia & Industries must contribute by working together for creating awareness and training of </li></ul><ul><li>students on IPR. </li></ul>
  23. 23. Pharma research Students role….. <ul><li>They are on the cutting edge in Drug industry. </li></ul><ul><li>Has role in developing research for all kinds of new </li></ul><ul><li>medicines for Human & Animals. </li></ul><ul><li>Students must </li></ul><ul><li>To develop excellent skills in math, chemistry & all the </li></ul><ul><li>life sciences. Understand interdisciplinary subjects. </li></ul><ul><li>To take advantages of class room teachings & lab techniques. </li></ul><ul><li>Must be good at Communication </li></ul><ul><li>Must be detail-oriented, good at record-keeping. </li></ul><ul><li>Have excellent organizational skills. </li></ul><ul><li>Be prepared to start at the bottom </li></ul><ul><li>Love education – Be an ever learner </li></ul>
  24. 24. Government role <ul><li>Promote research programs: </li></ul><ul><li>- Funds, reduce tax burden </li></ul><ul><li>Control regulatory measures: </li></ul><ul><li>- Simplify filing procedures </li></ul><ul><li>Speeding up approval processes: </li></ul><ul><li>- Create more approval centers </li></ul><ul><li>Drug price control: </li></ul><ul><li>- Is a Common man benefited? </li></ul>
  25. 25. Govt’s Role
  26. 26. Govt’s Role to control drug price
  27. 27. Summary <ul><li>Life-saving medicines don't grow on trees. The &quot;miracle&quot; drugs that improve our health and extend our lives must be discovered. They would not exist were it not for the enormous investments of time and money made by the men and women who work in the pharmaceutical industry. It takes the ingenious effort of thousands of individuals and hundreds of millions of dollars to bring a single drug to market. </li></ul><ul><li>Challenges are the useful noise factors in the pharma research, we must face them wisely and effectively. </li></ul>
  28. 28. Thanking you for your attention