FABA Event Report – Research and Development of Vaccines: Issues, Challenges and Opportunities

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Federation of Asian Biotech Associations (FABA) in association with PC2 Solutions and C.R Rao AIMSCS organized a one day Symposium entitled “ Research and Development of Vaccines: Issues, Challenges and Opportunities” on the 19th May 2018.

The symposium was graced by world renowned scientist Prof Dr Manuel Elkin Patarroyo who is creator of the first chemically synthesized vaccine (SPF66 ) against malaria. He in his kind gesture donated the patent of malaria vaccine in 1995 to World Health Organization (WHO) to ensure a cheap and accessible cure for people in developing countries. Prof. Patarroyo in his keynote address to the symposium talked about his continued scientific efforts to produce novel peptide based malaria vaccine and is hopeful that it will be effective for more than 90% of the populations. The candidate vaccine is completing pre-clinical studies and hopeful of entering clinical trials by the end of this year.

The Guest of Honour, Dr Eswara Reddy , Drugs Controller General Of India, from central Drugs Standard Control Organization, in his address mentioned that the process for getting approvals and resolving pending issues for drugs and biologicals have been streamlined and the process is made very transparent and predictive of time lines. He further said that a separate cell has been created within the DCGI office, where anyone can come without appointment and raise the issues or get their doubts clarified. He also elaborated on the steps taken for preventing the circulation of spurious drugs entering the market. In this connection he invited suggestions from the public as well as the industry.

The inaugural session was also presided by Prof D.N Reddy, the Director of C. R Rao AIMSCS. Dr. Dasari V Ravi Kumar, Director of PC2 Scientific Services, pointed out that Hyderabad is producing about 33 per cent of global vaccines dosages and 35 per cent to the pharmaceutical production in the country. This was followed by interesting talks by eminent scientists, Dr. Deepak Gaur from JNU, New Delhi; Dr. Manuel Alfonso Patarroyo Gutierrez from Columbia and Dr. Mrinal Bhattacharya from University of Hyderabad, presenting the Global as well as Indian scenario on malaria vaccine Development over the last couple of decades. The speakers opined that it is very difficult to develop a universally effective vaccine, as the parasite changes its expression pattern of antigens quite frequently and the only way forward, pointed by Prof. Mrinal Bhattacharya is: “Know Malaria to reach the goal of No Malaria” Prof T S Rao from the Department of Biotechnology, Govt. of India talked about the prospects and challenges faced by the Govt. and Industry for development and implementation of a successful vaccination program in India. He advised the industry and academy to follow the successful model employed by Bharat Biotech for Rotavirus vaccine development, involving various national and multinational organisations. He also spoke about Department of Biotechnology’s efforts to give a major boost for the development of new vaccines for the control of infectious diseases apart from Malaria.

Prof. Anand Kondapi reviewed the current status and the challenges in HIV vaccine development, while Dr. Kuppusamy of Tergene Biotech highlighted on the importance of adjuvants in vaccine development and the need for development of novel adjuvants.

The highlight of the symposium in the Panel discussion on “Vaccine Research and Development: Triumphs and Challenges”.

These Panelists included Prof Patarroyo , Dr Eswara Reddy, Dr TS Rao and heads of Biotech and Vaccine manufacturing companies like Dr Partha Kumar Sarkar(Associate Vice President, Shantha Biotechnics-A Sanofi Company), Dr K Anand Kumar (Managing Director, Indian Immunological Ltd.), Dr Dilip Mathai, (Dean, Apollo Institute of Medical Sciences and Research, Hyderabad), Dr Sunil Gairola, (Director Quality control, Serum Institute of India Pvt. Ltd., Pune), Dr Anand Govindaluri, Founder and Executive Director &CEO, Govin Capital, Singapore & Startup Accelerator India Pvt Ltd.) and Dr Guntaka R Reddy, (the scientist behind the release of the first Hepatitis B recombinant vaccine by Santha Biotech from University of Tennessee Health Science center, TN, USA). The session was moderated very elegantly by Dr Uday Saxena, Co Founder, Kareus Therapeutics, Ex CSO, Dr Reddys.

The panelists discussed about the challenges faced by the industry in developing new vaccines for disease eradication and meeting the demands of the market. The panelists also discussed how we should be moving out of the generic vaccine production and take more steps to innovation and create environment where entrepreneurs among biotechnology startups can work together with industry and academic institutions. The way forward is that the academy should focus on high risk discovery part and the industry should focus on capital intense development phase of novel drugs.

One major hurdle that emerged out of the discussion was lack of contract research facilities for pre-clinical testing of drugs, specifically on primates. It is suggested that an effective representation should be made to the Union Government by all the stake holders, involving academy, industry and organisations like FABA, FICCI and CII. The panel discussion overall was very engaging and stimulative and aroused a lot of interest amongst the audience. Delegates from Several Biotech, Pharma and selected Indian Vaccine manufacturers and academic institutions participated in the workshop. Critical topics of importance such as novel strategies for development of new vaccines against infectious diseases and the importance of partnership between Academic institutions and industry to expedite the novel vaccine development program in India. Members also discussed on the most commonly observed non-conformities and regulatory issues in monitoring the safety of Drugs and their efficacy deliberately in the symposium.

This one day symposium was jointly organized by Federation of Asian biotech Associations, (FABA: biofaba.com), PC2 Solutions and Prof. CR Rao Advanced Institute of mathematics, Statistics and Computer Science, in the majestic auditorium of the CR Rao Institute located within the campus of University of Hyderabad.

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