1. Vaccine Company Perspective Dr Gaurav Gupta, ZYDUS CADILA
EMVDA Annual Conference - May 2011
Vaccine Company Perspective Dr Gaurav Gupta, ZYDUS CADILA

2. KEYS TO SECURE FUNDING TO SUCCESSFULLY TRANSLATE NOVEL TECHNOLOGIES INTO CLINICAL APPLICATIONS
Plugging the execution and translation gap that links academia and the larger manufacturers.
Funding by National and international agencies for translational research in Asia till phase I.
Focusing attention of big pharma and manufacturers for making research and technology platforms relevant

3. Indian Academia
Definition: National and International research institutes, Universities governed by Government mainly Goal: To explore, educate & apply for health care problems of diagnosis, treatment and prevention.

4. Indian Academia Strong points:
Experienced & highly qualified research team with novel ideas.
Long patience to explore
No restriction for IPR protection
Minimal regulatory hurdles
Established animal models for proof of concept studies

5. Indian Academia Weak points:
Lack of knowledge for commercial feasibility (Product yield & Market potential)
Lack of infrastructure & manpower for GMP Production to produce and test clinical trial materials
Lack of Knowledge for Regulatory pathway

6. Industry
Definition: Companies owned by Private entrepreneur or Share holders or Multinational Brands Goal: To make profit by selling products for diagnosis, treatment and prevention

7. Industry Strong points:
Knowledge for commercial feasibility (Product yield & Market potential)
Available Infrastructure & manpower for GMP Production to produce and test clinical trial materials
Knowledge of regulatory pathway

8. Industry Weak points: Many regulatory hurdles
Limited animal models for proof of concept studies
Restriction for sharing the data
Timelines restriction

9. Plugging the Gaps
Identification of diseases Etiology by Academia- 6 main diseases causing deaths worldwide
Pneumonia,
Tuberculosis,
Diarrhoeal diseases,
Malaria,
Measles
HIV/AIDS
Target antigen identification (Epitope mapping) by Academia

10. Plugging the gaps
Proof of concept studies at Academia / Industry under guidance of experts from both
Clinical studies at Industrial level
Regulatory guidance and support from Industry
Commercial feasibility studies at Industry

11. Funding Agencies for Translational research

12. 1) Department of Biotechnology, India

13. 2) Welcome trust

14. 3) PATH

15. 4)Bill &Melinda Gates foundation

16. Consideration points for Attention of Big Industries
Project of interest for Global Problems by developing novel vaccines (Malaria, T.B.,HIV, Diarroheal diseases)
Value addition for present vaccines in terms of delivery systems (Adjuvants, Needle free), safety (Rota virus, IPV), storage conditions (Thermostable) and prolong immune response (viral vectored vaccines) etc.

17. Consideration points for attention of Big Pharma Industries
Either methods of production or methods of analysis or both established at lab scale for developing a novel vaccine
Established proof of concept for safety & efficacy in animal models
Positive image of Institute at National or international level with historical records for successful scientific accomplishments by Patents and Publications

18. Conclusions
Focus of Academia should be on etiology of diseases, target antigens and animal models for testing safety & efficacy of novel vaccines.
Academia should include Industry for execution of proof of concept for safety & efficacy establishment in animal models.
Industry should take over clinical studies
In this way, all funding agencies could be attracted for fruitful mutual association due to expected high valued affordable safe & potent vaccines for global population.