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

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

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.

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

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

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

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

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

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

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

Funding Agencies for Translational research

1) Department of Biotechnology, India

2) Welcome trust

3) PATH

4)Bill &Melinda Gates foundation

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.

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

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.