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Vaccine Development and India

Vaccine Development and India. Dr. Tarit K. Mukhopadhyay Dept. of Biochemical Engineering, UCL. Historical Perspective (1980). Source: United States CDC, 2001. Historical Perspective (2000). Source: United States CDC, 2001. The Vaccine Market. Vaccine Manufacture in India. Very active

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Vaccine Development and India

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  1. Vaccine Development and India • Dr. Tarit K. Mukhopadhyay • Dept. of Biochemical Engineering, UCL

  2. Historical Perspective (1980) Source: United States CDC, 2001

  3. Historical Perspective (2000) Source: United States CDC, 2001

  4. The Vaccine Market

  5. Vaccine Manufacture in India • Very active • One out of every two children in the world is immunized by a vaccine made by the Serum Institute of India • Primarily motivated through cost savings of production • Manufacture old vaccines, less profitable, but no IP • That landscape is changing with MNC / Public Institutions collaborating with Indian companies – facilitating tech transfer

  6. MNC Expand market base Increase manufacturing capacity Additional regulatory pathway Public Institutions Provide access to manufacturing process Specialist knowledge Technology transfer - Transferring

  7. 22% pipeline products with MNC Fill bulk Restrictive market access 70% pipeline products with academic and public research institutions Better equity of benefits Full knowledge transfer Technology transfer - Receiving

  8. Impact on Hib-vaccines

  9. Bharat Biotech Int. Contract with Pfizer for Hib NIH (US) license agreement for rotavirus HepB vaccine patent Biological E Working with NVI to develop new Hib combination vaccine Collaborate with small biotechs, divide profits and global market share Companies of Note

  10. Panacea Biotec Experienced IP management DTP-HepB-Hib combination vaccine with Novartis V&D Serum Institute of India Avoids MNC - Past work based on scale up Focus more on PPP Meningitis Vaccine Project (MenA) WHO (aerosol measles vaccine) Companies of Note

  11. Cost based analysis of manufacture (2010) MVP SynCo Bio Serum Institute of India FDA less 0.50c/dose WHO - Regulatory Pathway

  12. Shifting Disease Profile

  13. Neglected Diseases

  14. Primary Funders

  15. Final Remarks • Historically, India focused on less innovative, old off patent vaccines • Highly trained persons capable of licensing in new technology • Converging markets due to shifting disease profile • Opportunities to collaborate and gain on cost reduction strategies • More competition – cheaper healthcare for all?

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