Managing Director,Biological E. Limited, India
Ms. Mahima Datla is a Graduate in Business Administration Management from Webster University, London. She is working with Biological E. Limited for the past 12 years and is currently in the capacity of Sr. Vice President. During her experience at BE, she has been involved in strategy and business development functions. She is currently heading the Biotechnology & Projects group, responsible for project management and execution, building the quality systems, driving the operations, public policy with GOI as well as DCVMN and GAVI.
Dr Suresh Jadhav
Executive Director,Serum Institute of India Ltd, India
Dr.Suresh Jadhav, M.Pharm., Ph.D. is the Executive Director of Serum Institute of India Ltd., one of the largest vaccine manufacturers from the developing countries, supplying vaccines to more than 140 countries through U.N. Agencies at affordable prices. Dr. Jadhav also led the project of development and introduction of Meningococcal A Conjugate Vaccine in Sub-Saharan African belt, the development of Seasonal & Pandemic Influenza Vaccines and also played major role in acquisition of Bilthoven Biologicals, a Netherlands based Govt. Vaccine manufacturing company. Dr.Jadhav is associated with Developing Countries Vaccine Manufacturers’ Network (DCVMN) since its inception in 2000 and was the President of DCVMN from 2003 till 2008. He is currently member/alternate member on various boards i.e. GAVI, European Vaccine Initiative, FastVac, and Health Innovation in Practice Board besides GAVI PPC member. He is closely associated with various advisory committees e.g. Task Force of Sabin Vaccine Institute, WHO IVR-IVAC and Decades of Vaccines (DoV) etc. Dr.Jadhav is also affiliated with several Indian universities, AICTE, UGC, State Directorate of Technical Education etc. He is Chairman of Expert Committee on Vaccines and other Biologicals and also a member on the Scientific Body of Indian Pharmacopoeia Commission. He has participated in several collaborative studies for making revisions in international reference standards for WHO, NIBSC, NVI etc. and has published more than 60 technical papers in national & international journals, with extensive travel throughout the globe. He has to his credit two patents in his name.
Dr Raj Mehta
Head, South East Asia Cluster,Novartis Vaccines and Diagnostics, Singapore, India
Dr Raj Mehta is an entrepreneurial business leader with 25 years of extensive experience in vaccines, biotech and pharmaceutical industry with innovative vision for sales, marketing and new business development across US and South East Asia in both Public and Private sector. He is currently responsible for SEA Cluster (Thailand, Philippines, Vietnam, Singapore, Indonesia, Malaysia, Hong Kong, Taiwan, Macau, Bangladesh and Pakistan). With a clear understanding of Vaccines Development, R&D, Manufacturing-GMP, fill and finish, labeling and packaging, quality control, technical transfer, localization projects, clinical trials and protocols, product inception from launch to post marketing, he has launched 8 new vaccines with GSK- Havrix-(Hepatitis A), Infanrix (Dtap), Pediarix (HepB, Polio and Dtap) Twinrix (Hep A&B combo), Boostrix ( TdaP), Cervarix( HVP), Fluvirix,( Flu), Kinrix ( Dtap, Polio) in US Market. He has also successfully launched 4 new vaccines-Meningococcal, Rabies, Japanese’s encephalitis and Flu (Seasonal and Pandemic) in South East Asia (11 Countries) for Novartis Vaccines. On top of that, his strong leadership and team building skills with the proven ability to build dynamic, success-oriented sales and marketing teams demonstrated his ability to successfully manage in diverse, complex, and rapidly-changing business environments.
Scientific Director, Influenza Vaccine Project,PATH, U.S.A
Dr. Vadim Tsvetnitsky joined Vaccine Development Global Program at PATH in 2010. In his current position of Scientific Director he is responsible for managing influenza vaccine project (IVP) partnerships with developing countries vaccine manufacturers and he oversees technical and project management activities of the influenza vaccine manufacturing project in Vietnam conducted in collaboration with the WHO. His role includes providing scientific and technical expertise in vaccine process development, analytical and preclinical testing and manufacturing tech transfer and scale-up. Prior to joining PATH, Dr Tsvetnitsky founded and operated consulting practice, helping emerging companies move protein drugs and vaccine candidates through development to manufacturing.
Between 1999 and 2007 Dr Tsvetnitsky directed therapeutic proteins and monoclonal antibodies product development activities at Cangene, one of the largest biotech companies in Canada. His undergraduate degree was awarded in Chemical Engineering in Moscow, Russia in 1988, followed by Ph.D. in Protein Biochemistry from the University of London, U.K. in 1994, and he subsequently completed postdoctoral training in Denmark and Canada.
Dr Kutub Mahmood
Scientific Director of the Polio Vaccine Development Project,PATH, U.S.A
Dr. Kutub Mahmood is the Scientific Director of the Polio Vaccine Development Project, at the nonprofit organization PATH, based in Seattle, Washington. The polio vaccine project is part of PATH’s broader effort to develop low-cost vaccine supplies for the global markets. Dr. Kutub Mahmood focuses primarily on conducting technical assessment for vaccine manufacturers and providing support to help them achieve WHO pre-qualification for their vaccine products. He also works to identify potential partnerships with multinational pharmaceutical companies, biotech firms, and public/private enterprises. He joined PATH in March 2012 after 20 years leading vaccine discovery and product development efforts in private industry, with stints at Medimmune, Novavax, and other start-up vaccine companies including Vivaldi Biosciences. Dr. Mahmood made numerous contributions to the successful development of the FluMist®, a live attenuated influenza vaccine.
CEO,Shantha Biotechnics, India
Harish Iyer is CEO of Shantha Biotechnics since June 2011, and is responsible for operations and executing long term strategy.
He has extensive experience in the biotechnology industry and was previously Vice President and Head of Research & Development, Biocon (2001-2011). At Biocon, with a team of 300+ top scientists, Harish worked on numerous projects including recombinant human insulin & analogues, BioMAb EGFR antibody and novel discovery projects such as oral insulin and other first-in-class biologics in the Biocon R&D pipeline.
Prior to joining Biocon, Harish worked in Process Sciences at Genentech (1995 -1998), South San Francisco and Biogen-IDEC, San Diego (1998-2001). He graduated in 1995 with a Ph.D. in Chemical Engineering from the Rensselaer Polytechnic Institute, Troy, New York. He also has a Bachelor's degree in Chemical Engineering from the Indian Institute of Technology, Madras. In 2010. Harish also completed an executive education course on Leadership & Strategy in Pharmaceuticals & Biotechnology at Harvard Business School in Cambridge, Massachusetts.
Prof. V. S. Chauhan
Group Leader,ICGEB; Governing Body, MVDP, India
Dr. Chauhan did his B.SC (Hons), M.Sc. and Ph.D in chemistry at Delhi University. In 1974 he was awarded a Rhodes scholarship to study at Oxford, where he worked for a D.Phil in Chemistry. A national level athelete, he represented the University of Delhi and Oxford University in track and field. After returning to India, he taught at St. Stephen’s College, Indian institute of Technology, Kanpur and Delhi University (1981-1988). In 1988 he joined the International Centre for Genetic Engineering and Biotechnology (ICGEB), from its inception, as the group leader for Malaria Research. He became the Director of ICGEB, New Delhi in 1998, a position he continues to hold.
His major research interests and contributions are in the fields of Malaria vaccine and drug development, and in design and synthesis of peptides of biological importance. In the area of peptides, the main focus is on design of conformationally defined peptides scaffolds as immunogen for HIV, novel antibiotics, self organizing systems and drug delivery platforms for diseases like cancer.
Secretary for the Rhodes Scholarship (UK), the Inlaks Scholarships and the Felix Scholarships, given to Indian students to study at Oxford University (UK) and other major institutions worldwide.
He was awarded the Padma Shri (2012) for his scientific and human resource development work, clinical trials in humans, first of its kind in India, of a recombinant malaria vaccine developed by his group have been completed. He has published 210 peer reviewed research papers and has guided more than 50 students for their research work. He is member of all National academies of science, and also a member of the UGC.
Dr. K. Anand Kumar
Deputy Managing Director,Indian Immunologicals Ltd, India
Dr. K.Anand Kumar has a Ph.D in Microbiology from Indian Council of Medical Research and has over 21 years experience in the biotechnology/pharma Industry working in India and abroad.
He is presently Deputy Managing Director at Indian Immunologicals Ltd. He earlier was the Vice President - Quality for four years at Wockhardt Biotech Park. Prior to that he worked for companies such as Pfizer Global Manufacturing in Australia and Schering Plough in New Zealand. He also had a brief stint as Investment Manager-biotech with the New Zealand Government.
He was an executive committee member of Parenteral Drug Association (PDA), Australia and currently is on the expert panel on the analytical methods related to Vaccines with United States Pharmacopeia (USP) and Indian Pharmacopeia (IP).
He has been through the Senior Management Development Programme at IIM, Ahmedabad.
He has vast experience in various fields related to the biotech/vaccine Industry including Project management, Bioprocess manufacturing, Technology transfer, Quality control, Quality assurance, R&D, Aseptic manufacturing, Cold chain management etc.
He has actively contributed to the commercialization of various recombinant biotech products including hepatitis B vaccine, recombinant Human Insulin, Erythropoietin, Insulin Glargine, Interferon., Epidermal Growth Factor. He has handled products belonging to all three major expression systems such as yeast, bacteria and mammalian cells.
Dr Ananda Amarasinghe
Adviser, WHO Global Advisory Committee on Vaccine Safety (GACVS); Senior consultant Epidemiologist,Ministry of Health, Sri Lanka
Dr Ananda Amarasinghe (MD), has completed medical degree with honors, at Kharkov State Medical Institute, former USSR and Postgraduate studies in Community Medicine at the PGIM, Colombo. He has been trained in advanced Epidemiology at the New castle Upon Tyne University, UK, CDC Atlanta and National Institute of Epidemiology, Chennai, India.
Dr Amarasinghe is a senior consultant Epidemiologist at the Epidemiology Unit, Ministry of Health, Sri Lanka, since 2000. He is the leading technical advisor to introduce new vaccines and lead introduction of Hepatitis B and Penta-valent DTP_HepB_Hib vaccines and the adoption of new health technologies including auto-disable syringes. He has developed guidelines for AEFI surveillance, Sentinel Site Surveillance, cMYP and FSP for the national immunization programme, Sri Lanka. In 2008-2010, worked at the Pediatric Dengue Vaccine Initiative (PDVI), International Vaccine Institute (IVI), in Seoul, Korea, and was responsible for dengue vaccine development project activities in Asia. At present his main responsibility at the Epidemiology Unit, MoH is vaccine safety.
Dr Amarasinghe is an adviser for several WHO Committees, including the Global Advisory Committee on Vaccine Safety (GACVS), WHO. He has been a Short Term Consultant to WHO and has successfully undertaken numerous programmed projects, training activities, particularly in vaccine safety and introduction of new vaccines into the EPI in most of the WHO regions. He is the lead author of revised guidelines on Immunization Safety, published by WHO/WPRO.
He is the author or co-author of more than 30 peer reviewed publications.
Dr. Arani Chatterjee
Senior Vice President, Clinical Research,Biological E. Limited, India
Head of Vaccine Division,National Institute of Biologics, India
Dr. Bernd Eisele
CEO and Chief Medical Officer,Vakzine Projekt Management GmbH, GermanyBernd Eisele
M.D. is CEO since 2008 and Chief Medical Officer of VPM since 2003.
From 1997-2002 he was Medical Director and Head of Medical Marketing of Region 6 in Solvay Pharmaceuticals GmbH, Hannover. Region 6 comprised Canada, Asia, the Middle East, India, Australia, and South Africa. Bernd was responsible for the planning and conduct of local and region-wide marketing campaigns for Solvay’s influenca vaccine and for its cardiovascular, gastroenterology, gynecology, and psychiatry products.
Additionally, Bernd planned and supervised the company’s pivotal trials within the Region which were needed for local registrations (e.g., for PR China). In 2002, he was appointed Global Product Director for psychiatry and became responsible for the world-wide marketing of Solvay Pharmaceuticals’ psychiatry products. Bernd had joined Solvay in 1996 and was responsible for the international phase III development program of one of Solvay´s leading cardiovascular products.
Bernd Eisele began his career in the industry as a Clinical Project Manager at Behringwerke AG in 1988. In various positions Bernd was responsible for the clinical development of recombinant and transgenic products in clinical phases I – III.
Bernd Eisele holds a doctorate in medicine from Heidelberg Medical University (1986).
Dr Ingmar Hoerr
Founder & Chief Executive Officer,CureVac, Germany
Chief Executive Officer, founded CureVac with colleagues Florian von der Muelbe and Steve Pascolo during his PhD work at the University of Tuebingen. His scientific background includes working with Professor Guenther Jung and Professor Hans-Georg Rammensee, renowned scientists in organic chemistry and immunology, respectively.
During his one year stay in India he also carried out field studies on leprosy and HIV in collaboration with the World Health Organisation (WHO) at Madurai Kamaraj University. Ingmar Hoerr received his PhD in biology from Tuebingen University, and an MBA from Danube University in Krems, Austria
Dr. Josemund Menezes
Regional Director, Clinical Development Sanofi Pasteur, Asia Pacific
Dr. Josemund Menezes is the Regional Director, Clinical Development for Asia-pacific at Sanofi Pasteur, the vaccines division of Sanofi.
Josemund is based at the Indian Affiliate Head Office in Mumbai & is part of the Asia-pacific Clinical development team working on “New Vaccines”. He is responsible for spearheading Dengue vaccine clinical development activities in India, besides supporting sanofi pasteur’s research activities on Pneumonia, C.difficile, Japanese Encephalitis & Rabies in Asia.
Josemund holds an MBBS degree from the MUHS University, Maharashtra followed by advanced certifications in Project Management, Vaccinology & Clinical Research certification from ACRP, USA.
Prior to Sanofi Pasteur, Josemund’s previous assignment at Sanofi aventis Clinical Study Unit (2008-2010) as Medical Advisor & Clinical Project Leader involved project management of 8 drug trials in Phase II-III development & CRO relationship management.
Prior to Sanofi, he has served as Site Medical Monitor for India’s first ever Phase I AIDS vaccine trial from 2005-2007 at NARI, Pune and TB Research Center, Chennai.
K V Balasubramiam
Managing Director,Indian Immunologicals Ltd. , India
Mr K V Balasubramaniam, Managing Director, Indian Immunologicals Ltd holds a graduate degree in Mechanical Engineering from the Madras University (1979), a Masters Degree in Management from the Indian Institute of Management, Ahmedabad (1981) and a Post Graduate Diploma in Patents Law from the NALSAR University (2008).
He has over 30 years experience in managing industrial enterprises, with nearly 25 years in the pharmaceutical industry. He joined Indian Immunologicals in 1996 as Chief Executive and has been instrumental in reviving the fledgling unit of the National Dairy Development Board and making it a professionally managed, performance driven and result oriented vaccine player. He was inducted into the Board as Managing Director in 1999.
Indian Immunologicals Ltd (IIL) is today the No 1 animal vaccine player, the 3rd largest animal health company, 4th largest vaccine company- both in human and animal vaccines, and the 7th largest pharma biotech company in India. IIL has a mission of making “Biotechnology in Healthcare Affordable and Accessible” and has been involved with several path breaking initiatives in immunization in India, both for animal health and human health.
Shri Balasubramaniam has been a speaker on both the subject of management and on biotechnology in various national and international forums. He has been a regular speaker on topics concerning human and animal health, vaccine manufacture, vaccine development and access in developing countries and emerging markets.
Dr. K Zaman
Head, Vaccine Surveillance Research Group; Senior Scientist and Epidemiologist,ICDDR, Bangladesh
K. Zaman, MBBS, MPH, PhD has been working as senior scientist and epidemiologist at the International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), in the Centre for Child and Adolescent Health. After completion of MBBS from Bangladesh, he obtained MPH and PhD from the Johns Hopkins University, USA in control of infectious diseases. For the last 32 years he has gained extensive experience in the design, implementation, and analysis of data from clinical and community-based epidemiological/vaccine studies. His primary interests are to conduct researches on vaccines and infectious diseases. Besides clinical studies on ORS, drug trial, vaccine studies, vitamin A supplementation and hospital surveillance, he has been involved in community-based research on diarrhoeal and respiratory diseases and other public health problems in Bangladesh. Currently he is the Principal Investigator of several Flu, pneumococcal, polio, Japanese encephalitis (JE) and rotavirus vaccine studies and epidemiological studies on tuberculosis in icddr,b. The vaccine studies included all phases I,II, III, IV and with ICH GCP maintained.
Dr. Zaman received several awards and has more than 120 publications in international journals and had 115 conference presentations.
Dr. Mahalaxmi Andheria
Vice President- Intellectual Property Cell,Panacea Biotec Ltd, India
Dr. Mahalaxmi Andheria brings with her an experience of more than 15 years in the Pharma & Biotech Industry. She has been actively involved in Formulation R&D for 5 years before she decided to switch to IPR and thereafter IPR has been her primary area of focus. Dr. Andheria is a PhD in Pharmaceutics from ICT (former UDCT, Mumbai) and a post-doctorate from University of Cincinnati, USA.
Dr. Andheria started her career in IPR from Sun Pharmaceuticals, following which she took up the role of Heading the IP Department at Panacea Biotec, a Pharma and Biotechnology based Company. During her association with Panacea Biotec since the last 7 years, she has been instrumental in setting up the IPR Department consisting of specialists in diverse fields including pharmaceutical formulations, biological, & synthetic chemistry area. She has established a seamless collaboration with Business Development and R&D expanding the horizon of her department beyond traditional IPR, broadening the outlook into portfolio planning, strategizing innovation and through creative participation in collaborations.
Dr. Andheria finds it extremely satisfying to share her understanding of this field and takeaways from her experience with students, inventors and business professionals interested in understanding the impact of IPR on their business decisions.
Dr Nikolai Petrovsky
Professor of Medicine, Flinders University, Founder, Vaxine Pty Ltd, Australia
Nikolai Petrovsky is Professor of Medicine at Flinders University and founder of Vaxine Pty Ltd. Known internationally for his vaccine adjuvant research he has held several large Adjuvant Development contracts from the U.S. National Institutes of Health. His research has won many awards including the 2010 Ernst & Young Entrepreneur of the Year Award, 2011 BioSpectrum Asia-Pacific Emerging Company of the Year Award, a 2011 Vaccine Industry Excellence Award for Most Innovative Asian Biotech and 2013 Biopharma Asia, Asian Executive of the Year Award. He has taken multiple vaccines, including for influenza, hepatitis B and allergy from the bench to the clinic and has authored over 100 research papers.
Prasad S. Kulkarni
Medical Director, Serum Institute of India Ltd, India
Prasad S. Kulkarni, M.D., is a graduate and post-graduate of B.J. Medical College, Pune with specialization in Clinical Pharmacology. His first assignment was of a teacher of Pharmacology in a medical school in Pune. He joined Serum Institute of India Ltd., Pune in 2000 as Asst. Medical Director, and is now its Medical Director. Today, Serum Institute is the largest manufacturer in the world for DPT & MMR Group of Vaccines. Dr. Kulkarni has been involved in many clinical studies on vaccines; especially on BCG, Measles, Rubella, MMR, DT, Td, DTP, Hepatitis B, Hib, their combinations, Rabies, live attenuated as well as inactivated H1N1 vaccines, Rotavirus, Influenza vaccines etc. He has also worked on clinical trials of therapeutic products. He has more than 30 publications in international peer-reviewed journals like the New England Journal of Medicine, Pediatric Infectious Diseases Journal, Clinical Infectious Diseases, Vaccine, Clinical and Vaccine Immunology etc.; three book chapters; and around 12 posters in international conferences. He has been a faculty in many national and international conferences; workshops and seminars and has delivered more than 25 lectures. He is an expert in good clinical practices, pharmacovigilance and regulatory practices, and has also been involved in the scientific and pre-clinical development of new vaccines of Serum Institute of India. He has also been a temporary advisor to WHO.
Dr. Priya Pereira
Sr Medical Advisor - Pediatric Vaccines, GlaxoSmithKline Vaccines, India
Dr. Ramesh Matur
Senior Vice President, Research & Development, Biological E. Limited, India
Dr. Ramesh Matur returned to India in 2008 after 18 years career in Biotechnology in the USA. Since January 2011 he has been leading a large Research and Development group working on human and veterinary vaccines (bacterial and viral) at Indian Immunologicals Ltd, (IIL) in Hyderabad. In the USA he worked for Wyeth Research at Pearl River, New York in preclinical development division. He was trained in Drug Discovery and Development at Wyeth. Dr. Matur has strong interdisciplinary cross functional research experience from discovery stage projects to cGMP clinical trial material manufacture. He developed economic processes for chiral drug molecules and recombinant proteins, and polysaccharides from pathogenic bacteria and recombinant E. coli to facilitate testing them in lab animals. With cross functional research experience he develops strategies for back integrating the commercial manufacturing constraints and demands into early R&D product and process development activities with a focus on technology development to eliminate bottlenecks in technology transfer towards commercialization. Dr Matur focuses on strategies for turning concept to product, taking discovery through development pathway using process economics, value integration and regulatory requirements into vaccine development activities. He led the Biotechnology R&D at DuPont knowledge center, Hyderabad from 2008 to 2010.
Dr. Matur has a Master’s degree in Microbiology and PhD in Biochemistry with four patents and several publications. Before starting the industry career he did his post doctoral research in molecular biology and biochemistry aspects of enzymes in the Dept of Biochemistry at Michigan State University and on the lung infections by opportunistic pathogens in immuno-compromised hosts at The Ohio State University Biotechnology Center, Columbus, Ohio.
Dr. Ravi Dhar
Senior Consultant,Biotechnology Research Assistance Council (BIRAC), India
Dr. Ravi Dhar is currently, the Senior Consultant at the Biotechnology Industry Research Assistance Council (Govt. of India Enterprise, under Department of Biotechnology), New Delhi where he plays a strategic role in policy making, IP& Technology Management issues and mentors a young group of colleagues to take forward various programs. He also actively supervises the Biotechnology Incubator Development Scheme (BISS) of BIRAC & a new program to develop University Incubation Clusters (UICs) with National Knowledge Commission. Apart from these programs, he coordinates the Technology Mapping of DBT institutes and to identify industrial partners which would lead to product development.
Dr. Dhar has been a Visiting Scientist/Post Doctoral Fellow at the Bloomberg School of Hygiene & Public Health, Johns Hopkins Medical Institutions (JHU), Baltimore, USA (1993, 1997-98 & 2003); & Louisiana State University, Baton Rouge, New Orleans, USA 2003-2005). His research interests include biology of malaria parasite including molecular aspects, and has participated in the transmission blocking vaccine program at JHU.
In his immediate past position as Senior Scientist at the National Institute of Immunology (NII), he was the Head of Intellectual Property & Technology Transfer Offices. Besides these, he handled the public information and public relations portfolios (inter-institutional) at NII, and thus has a great administrative experience of various sorts. He is also a member of Technology Transfer and Knowledge Cell, Department of Biotechnology (DBT), Government of India, New Delhi, (since 2007).
Dr. Dhar has recently been elected Fellow of STEM (f-STEM) & also Inducted founding member 700 for Science (700forscience.com) by invitation on 24.1.2012.
Dr. Dhar has also been the First (1st) Visiting Fellow at the Technology Management & Transfer Offices, Boston University, U.S.A. & an International Trainee at the Office of Technology Transfer, National Institute of Health, U.S.A. (2006). He has actively participated in several national and international conferences including at the Kellogg’s School for Business Management, Centre for Biotechnology, NorthWestern University, U.S.A. (2008). He has published several peer reviewed publications and articles. Dr. Dhar also lectures and writes on aspects of IP & Technology Management.
Dr. Dhar was asked to frame a National Policy Road Map for Public Health, IPR & Technology Transfer (2009) on elements 4 & 7 on “Innovation and Access to Medicines for Diseases affecting Developing Countries” under Global Strategy & Plan of Action (GS&POA) on Public Health, Innovation & Intellectual Property (Action Plan draft submitted to Ministry of Health & Family Welfare, Govt. of India (MHFW) on December 25th, 2009).
More recently, Dr. Dhar participated along with colleagues from THSTI, BIRAC & WHO, Delhi office in writing and analyzing Policy Document on "Norms and Standards on Health R&D for CRO countries as follow up of the CEWG Recommendations" 2013 . This was discussed by CRO countries at Bangkok on July 25-26, 2013.
Dr. S.D. Ravetkar
Executive Director,Serum Institute of India Ltd, India
Dr. S.D. Ravetkar is Executive Director with Serum Institute of India Ltd. Apart from his Doctorate he holds degrees in Management and Finance. He has authored various research articles in national and international journals. He is also on advisory board of various national and international organizations and journals. He has more than 41 years techno-commercial experience in biotech industry in various areas like QC, production, projects & research. At present his major responsibility is manufacturing of Bacterial combination vaccines mainly Penta vaccine. He has extensively worked on microbial and bioengineering aspects of vaccinology and also has got expertise on technology transfer. He has widely travelled worldwide.
Dr Sanjay Singh
Chief Executive Officer,Gennova Biopharmaceuticals Ltd., India
Dr. Sanjay Singh obtained his Masters in Biochemistry from Lucknow University (1987) and a Ph.D. in Biochemistry (1992) from The Central Drug Research Institute, Lucknow. He then joinedthe International Center for Genetic Engineering and Biotechnology, New Delhi as a Research Scientist (1996) and worked on malaria vaccine development. In 2000, Dr. Singh joined theNational Institute of Health, USA (NIH) and continued his research on malaria vaccines.Between 2000 and 2003, Dr. Singh was able to take two recombinant vaccine candidates from gene design to phase I human clinical trials. After several promotions, he was appointed as the Head of the Antigen Research Section in 2006. In October 2006, Dr. Singh decided to leave his position at the NIH, and start a biotech company. Gennova Biopharmaceuticals Limited (GBL), a company that Dr. Singh leads today, is a spinoff from Emcure Pharmaceuticals Ltd.
During Dr. Singh’s academic career, he perfected the concept of producing recombinant antigens using protein folding technology. This accomplishment allowed him to take four malaria vaccine antigens from target identification to phase I human clinical trials. Further, Dr. Singh’s entrepreneurial career led to the development of five bio-similar products from lab to market, a process that included building up the research & development, process development, production, clinical trial and marketing teams. In 2008, Dr. Singh decided to diversify GBL into vaccine research specifically in the area of infectious diseases. Gennova now has vaccine programs (Malaria, HPV, Leishmaniasis and Tuberculosis) partnerships with the Department of Biotechnology (DBT), and Tata Memorial Hospital in India, the Malaria Vaccine Initiative (MVIPATH), Johns Hopkins University (JHU), and Infectious Disease Research Institute (IDRI) in the US, the Statens Serum Institut (SSI) in Denmark, the London School of Hygiene and Tropical Medicine (LSHTM) in the UK, the Radboud University Nijmegen Medical Centre (RUNMC) in the Netherlands and The Walter and Eliza Hall Institute (WEHI) in Australia.
Dr Sonali Kochhar
Clinical Research & Drug Development Specialist,PATH, USA
A medical doctor and clinical researcher, Dr. Kochhar leads efforts to develop safe, affordable, and accessible drugs and vaccines for infectious diseases prevalent in the developing world, including HIV/AIDS. In her previous position as Medical Director for the International AIDS Vaccine Initiative, she provided leadership for the first AIDS vaccine trials in India. Currently, Dr. Kochhar is responsible for global clinical trials for PATH, a non‐profit international organisation operational in 70 countries. She has been responsible for providing leadership for Clinical Development Strategy, Design, Implementation and Medical Oversight for international multi-centric, multi-country trials. She has provided Clinical and Regulatory support for Phase I - IV international trials for Vaccines and Drugs conducted in adult and paediatric populations in the USA, Europe, India, Africa and Asia.
She has also been responsible for scientific advocacy and partnership development with International and National Government Partners, Public Health Authorities, Regulatory Bodies, Pharmaceutical Companies, Local Communities and the Media. She works with Government partners for National Policy and Program Development, including for Care and Treatment Guidelines for trial participants in the country. She has worked with vulnerable communities affected with HIV (including female sex workers, Men who have Sex with Men and Transgenders).
Dr. Kochhar received her MD in Pharmacology from Delhi University, India; has done International Advanced Vaccinology courses from the University of Geneva and Fondation Mérieux, Annecy, France (ADVAC), and Seoul, Korea (Advanced Course on Vaccinology in Asia-Pacific Region) and Epidemiology from the London School of Hygiene and Tropical Medicine. She has served as Guest Faculty for International Vaccinology and Clinical Research Professional Programs, is a member of international groups involved in the development of a WHO globally integrated Vaccine Safety Monitoring system, Safety Standards for Malaria, Tuberculosis and AIDS Vaccine trials, the Harvard University Multi-Regional Clinical Trial Steering Committee Member, the Global Health Clinical Consortium Leadership Group set up by the Gates Foundation and the Vienna Vaccine Safety Initiative working on global clinical research and safety. Dr. Kochhar serves on International Scientific Advisory Boards and has published numerous scientific papers and written book chapters on vaccine and drug development.
She was a Yale World Fellow for 2011 (Yale University’s International Leadership Program). She has been awarded the Vaccinology Fellowship Award for significant achievements in Vaccinology from Fondation Mérieux and University of Geneva; Global Leadership Awards from Eli Lilly & Company, Indianapolis, U.S.A; Bharat Jyoti (Light of India) Award for medical achievements and the Serviers Young Investigator Award by Institute de Recherches Internationales, Servier, France for Clinical Research.
Prof. Suniti Solomon
Founder-Director,Y. R. G Care, India
Prof. Suniti Solomon was born on October 14, 1939 in the Gaitonde family in Chennai, Tamil Nadu. She holds an M.D in microbiology from Madras University in 1973. She has trained in Pathology in the United Kingdom and the United States. She is the Founder-Director of the Y.R. Gaitonde Center for AIDS Research and Education (YRG CARE), a premier HIV/AIDS care and support centre in Chennai. YRG CARE currently provides medical and psychosocial care for more than 18,000 persons with HIV disease in Southern India.
She and her colleagues documented the first evidence of the HIV infection in India in 1986. When she served the Madras Medical College and Government General Hospital as a Professor of Microbiology in 1986-1993, she set up the first HIV Voluntary Counseling and Testing centre and an AIDS Research Group in Chennai. In 2006, YRG CARE in collaboration with Indian Red Cross Society opened its first satellite clinic in Nellore, inaugurated by Smt. Panabaka Lakshmi, Hon. State Minister for Health & Family Welfare, Govt. of India.
Prof. Solomon is a member of the National Technical Team on women and AIDS, a member of the advisory board of International AIDS Vaccine Initiative-India, member of the Scientific Committee of the National AIDS Research Institute, Pune, Government of India, a permanent member of the Microbicides Committee of the Indian Council for Medical Research (ICMR), and is a member on the board of AVAHAN, the India HIV/AIDS Initiative of the Bill and Melinda Gates Foundation; Trustee At-Large of the International Association of Physicians in AIDS Care; and member of the Asia Data Safety Monitoring Board of the Division of AIDS, NIH, USA.
Prof. Solomon is the Indian Principal Investigator of several pioneering HIV research studies: the US National Institute of Mental Health's multi-country HIV/STD Prevention Trial; the US National Institute of Allergy and Infectious Diseases' HIV Prevention Trial Networks; NIH award that will measure stigma in health care settings in Southern India; and a NIH study to focus on immune correlates of mucosal transmission of HIV-1 to women in Chennai, India.
Prof. Solomon has published extensively on HIV epidemiology, prevention, care and support, biomedical research, research ethics and gender issues. She has contributed to the HIV and STD Guidelines of the World Health Organization (SEARO), New Delhi.
She is the Director of the Southern India program of the Brown-Tufts Fogarty AIDS Training and Research Project. Dr Solomon’s experience covers a wide range of aspects related to HIV infection, from biomedical to socio-economic. She has deep interest in community education and mobilization and leads an effort that supports a Phase I HIV vaccine trial at Chennai with community education and volunteer enrollment.
She has been awarded Dr. G.V. James Prize in Surgery, MBBS, in 1963, The Chipper Field Gold Medal in Clinical Surgery, and Ballock Gold Medal in Clinical Medicine, MBBS in 1965. She received a Lifetime Achievement Award for her work with AIDS from the State Government's Medical University in December 2001 and a second Lifetime Achievement Award in 2005 from the Tamil Nadu State AIDS Control Society. She was also awarded honorary doctoral degree in 2006 from Brown University, RI, USA and National Women Bioscientists Award for the year 2009 by the Department of Biotechnology, New Delhi, Fellow of the National Academy of Medical Science, New Delhi in 2009, Sivananda Eminent Citizen award in 2009 from the Sanathana Dharma Charitable Trust, Secunderabad, and N’Galy-Mann Award at the 17th Conference on Retroviruses and Opportunistic Infections (CROI 2010) in San Francisco, USA.
Prof. Solomon has been constituted as a member of the State Planning Commission under the aegis of the Chief Minister, Dr. M. Karunanidhi.
Dr. Mandeep Singh Dhingra
Chief Clinical Officer [CCO] & Chief PV and CQA Officer,Shantha Biotechnics Limited (A Sanofi Company), India
Mandeep is currently the Chief Clinical, Pharmacovigilance and Clinical QA Officer.Mandeep joined Shantha in 2006 and has been involved in setting up and establishing a GCP compliant clinical research team with expertise in vaccine research and experience in working in the Indian regulatory scenario. He has also set up the Pharmacovigilance and Clinical QA departments at Shantha.Mandeep completed his medical training from the Government Medical College, Patiala, Punjab in 1999 and subsequently specialized in Clinical and Experimental Pharmacology from Government Medical College, Amritsar. He has worked in Infectious Diseases and Emergency Surgery prior to joining Shantha. He also participated in and completed a course in Advanced Vaccinology (ADVAC) from University of Geneva/ WHO, and Biostatistics and Bioethics from SGPGI/ John Hopkins School of Public Health. He has various publications to his credit and has also contributed towards chapters in books on Pharmacovigilance and Herbal Research. One of his researches during MD was awarded the prestigious global ‘Student Researcher Award’ by the American College of Clinical Pharmacology.