Dr. Salah U. Ahmed is the Executive Vice President of Global Research and Development and Chief Scientific Officer at Barr Laboratories, Inc. He is responsible for the development of generic and proprietary pharmaceuticals as well as API and biotechnology products. Barr’s product portfolio encompasses diverse Drug Delivery Systems including parenteral, nasal, ocular, oral, transmucosal, transdermal, and intrauterine routes of administration. The corporation runs its research and development operations in five states in the USA and several countries in Europe. Dr. Ahmed received his MS in industrial Pharmacy and PhD in Pharmaceutical Sciences from St. Johns University, New York. He has more than a quarter century of pharmaceutical experience, of which about 15 years is at Barr Laboratories, Inc. His leadership role in product development has significantly contributed to Barr’s transformation to a specialty pharmaceutical company and a world leader in the generic pharmaceutical industry. Dr. Ahmed has a distinguished track record in pharmaceutical research involving special DDS, solid-state interactions, statistical design and mathematical modeling in product development research, and in-vitro/in-vivo performance of dosage forms. His research work in these areas originated more than 40 patents. He authored or co-authored more than 60 research papers, abstracts and book chapters. He has been invited to speak at many European and US conferences.

Dr Ramani A Aiyer is Chief Scientific Officer, Actis Biologics Private Limited, Mumbai (INDIA), a start-up biotechnology company focused on discovery and development of innovative and novel bio-therapeutic products. Prior to that he was Senior Vice President, Strategic Planning, R&D at Nicholas Piramal India Limited, Mumbai, where his responsibilities included Business Development & Licensing and Project Management of new drug discovery and development programs. Prior to this he was Chief Operating Officer at Avesthagen, a start-up biotechnology company in Bangalore. Before moving to India, Dr Aiyer had over 17 years of experience in the biotechnology industry in the USA. He held senior positions in R&D and Business Development at biopharmaceutical companies including Genentech, LifeScan (subsidiary of Johnson & Johnson) and Sugen (subsidiary of Pharmacia/Pfizer). He received an MBA from University of California, Berkeley, has a PhD in Biochemistry from Harvard University, and did post-doctoral research at Stanford University.

Mr Ballal is currently heading India’s only EMEA approved biopharmaceutical plant at Intas Biopharmaceuticals Ltd where the manufacturing set up included two independent suites for microbial and mammalian cell culture based products. He is also heavily involved in manufacturing microbial and mammalian cell culture based biotherapeutics. Mr Ballal has been associated with the Indian biotechnology industry for the last 12 years and has served in the area of R&D followed by manufacturing of biotherapeutics. He joined Intas in 2000 to start up the Biotechnology Division and has played a key role in the set up of the R&D division followed by the manufacturing plant for biologics. He is also involved in development of the contract manufacturing business at Intas. Prior to Intas, he was working in the R&D Division of Wockhradt Ltd. Mr Ballal received his Master of Science in Marine Biotechnology from Goa University in 1995 and currently holds professional membership at PDA and ISPE.

Dr. Jayaram was associated with recombinant proteins and biogenerics for the past eight years. An MBA from Cornell (1994) and a PhD in Biochemical Genetics (1988), Dr Jayaram has had a distinguished career both in science and industry. Earlier, Jayaram has had a stint as Associate Consultant with The Wilkerson Group, New York City and as Technology Transfer Consultant at the Center of Advanced Technology Cornell University, Ithaca, New York. He was also a founder and Vice President of Viral Therapeutics, Inc, New York, where his responsibilities included development and marketing of recombinant proteins for therapeutic and diagnostic use. Dr Jayaram was also the Executive Vice President of Emerging Businesses (Biotechnology, Oncology and Diagnostics) and International Branded Formulations Marketing at Dr Reddy's (RDY). He has been instrumental in establishing Dr Reddy’s presence in many emerging markets of the world. He was also the Managing Director of Zenovus Biotech (a wholly owned subsidiary of Dr. Reddy’s).

Patrick Daoust has been working with Viropro in the areas of business development and prject management since October 2005. Before coming to Viropro International, he worked for ProMetic Life Sciences between 2002 qnd 2005. His work focused in the areas of business development and process management and was subsequently assigned responsibility for the scientific coordination of bio-generic development. Mr. Daoust has an MSc from the Dept of Mircobiology and Immunology of the University of Montreal.

Dr. Gerson received his Ph.D. in Biophysics from McGill University in Montreal in 1972. He taught and did research at the University of Western Ontario in the Biophysics Department and in the Department of Chemical and Biochemical Engineering for 7 years. He was at the Basel Institute for Immunology as an independent researcher from 1979 to 1982 under Professor Niels Jerne, and did research on the initiation of the immune response. Dr. Gerson then established and ran the Biotechnology Department as a contract manufacturing facility at the Alberta Research Council for 5 years. At Connaught Laboratories in Toronto, he was VP of Manufacturing and Process Development for Human Vaccines for 5 years. As VP Research & Development at Apotex Fermentation, Inc., he developed a new patented process for the production of Lovastatin, built a manufacturing plant in Canada and established a subsidiary Joint-Venture for manufacturing in China. As Managing Director of Vaccine Manufacturing at Wyeth-Lederle Vaccines in Pearl River, NY, for 7 years, he was responsible for the production of DTP, OPV, Pnu-Imune, Hib-Titer and the transfer from Development to Manufacturing, and launch, of Prevnar, a Pneumococcal-conjugate vaccine for pneumonia in children. As VP Manufacturing and Development of Acambis, he developed the process for and manufactured more than 200 million doses of Smallpox Vaccine for the United States Government. As Managing Director, Manufacturing and Development at the International Aids Vaccine Initiative, (IAVI), a non-profit organization dedicated to the development of an AIDS vaccine, he was responsible for manufacturing clinical trial materials, process development, and planning for eventual worldwide manufacturing of a vaccine against HIV. At present, he is COO and President of the Technology and Manufacturing Division of Celltrion, Inc., a contract manufacturer of mammalian cell produced protein biopharmaceuticals in Seoul, Korea.

Mr. Samir Ghosalkar is currently Executive Head in Production at Biocon Biopharmaceuticals, Bangalore, India’s first and largest MAb manufacturing facility. He is responsible for cGMP protein purification activities for production of BIOMAb EGFR™ - commercial monoclonal antibody for treatment of cancer. His experience includes design, Scale-up and transfer of milliliter to kiloliter scale process of mammalian as well as bacterial origin. Prior to joining Biocon, he worked in Biologics Pilot Plant at USV Ltd, Mumbai, India. Mr. Samir received Master’s degree in 2004 with specialization in Chemical Engineering from Mumbai University Institute of Chemical Technology (UDCT) and Bachelors degree in Chemical Engineering from University of Mumbai. He is co-author of one patent on protein separation process. He currently holds professional membership with ASQ, ACS, PDA, & ISPE.

Sven has been working in the Life Science industry for the last 15 years. He is currently General Manager for Asian Growth Markets for GE Healthcare, Life Sciences. He joined GE in 2005 as Head of Marketing for Protein Separations in Uppsala, Sweden and later became the CMO for the Life Science business. In that role, Sven was responsible for marketing, strategy and business development. Sven came to GE from the Monitor Group, the strategy consulting firm, where he was a senior member of the Pharma / Biotech practice based in San Francisco and Paris. Prior to that he was a San Francisco based product and account manager for Incyte Genomics and research scientist for Bayer Corporation. Sven received a B.S. (1989) and M.S. (1993) in molecular biology from the University of Duesseldorf, Germany and spent 1993 to 1996 as a PhD student in HIV research with Luc Montagnier at the Pasteur Institute in Paris.

Dr. Subhash Vinayak Kapre is currently with the Serum Institute of India Ltd., as an Executive Director on the Board. He has been with the company for over three decades. In this long tenure, he has actively participated in obtaining different technologies and product developments. Being involved in all these developments on a personal basis, his learning curve extends from setting up of all kinds of Bacterial Vaccines to Viral Vaccines, purifications and other auxiliary needs of the plant that would be needed to produce them. His successful achievements are the pre-qualification approvals that he got along with his colleagues from the WHO for most of the products that are produced at the Serum Institute of India Ltd. By virtue of supplying vaccines to UNICEF and PAHO, and being a vaccine major in the supplies, the principal responsibility of achieving quantity with a quality flag was inevitable. High quality drags away the bottom line towards the upper side making a product more expensive. This has been brought down substantially by innovative packing, innovative processes and high outputs, utilizing modern GMP, modern plants and modern infrastructure. In this backdrop, and the establishing of very high capacity plants, his choice of using disposables needs attention. It also gives a message that innovative use of disposables does not cause a change in the cost structure due to the factors developed by his company in reducing the bottom line. Apart from being an active working member of the company, he has also contributed in research publications and has been academically connected through universities around Pune. His expertise ranging in the totality of product development helps one to have all information under one human mind.

Ms. Parminder Kaur is a Regulatory Affairs professional with Global expertise. Ms. Kaur gained post-graduate degree in Biotechnology from GGU, India prior to joining industry in 1998.She has been working in the field of regulatory affairs for the last 10 years and gained expertise for major markets in the world during her tenure. Ms. Kaur has hands-on experiences in pharmaceutical and biotechnology industries and interaction with major Regulatory Authorities. She has provided strategic input for regulatory matters regarding new product development aimed for global launch, development of Biosimilars for EU market as well as registration of old vaccines in the EU. Ms. Kaur is highly involved with advising and preparation of Clinical Trial and Marketing Authorisations Applications, Variations Applications, Drug Master Files, Orphan Drug Designations, Paediatric Investigational Plans (PIP) and Scientific Advice Briefing Books including writing, and editing various technical documents as per CTD format. She has also been highly involved in the Pharmacovigilance set-up at various companies and has been involved to a great extent with writing and managing pharmacovigilance plans, risk minimization plans and SAE reporting. Ms. Kaur has also proposed routes for non-EU companies on CE Marking for medical devices, as required for submission to regulatory authorities including advice and preparation of Device Master File. She has assisted various companies during Inspections and Audits conducted by Regulatory Authorities. She has also played a major role in setting the QA systems in compliance with the European legislation at various companies throughout her tenure. In March 2007, Ms. Kaur had been selected by the European Federation of Pharmaceutical Industries and Association (EFPIA) for her global expertise and also had an honour to be the Scientific Representative from India for the year 200-2001, duly sponsored by UNESCO. Ms. Parminder Kaur is currently based in Amsterdam, The Netherlands.

Dr. Ashok Khar has done his Bachelors from Jammu & Kashmir University, Masters from Calcutta University and Ph.D. in Biochemistry from Panjab University. Dr Ashok Khar has made consistently outstanding contributions in the fields of reproductive biology, endocrinology and tumor biology / immunology, the research areas in which he has been engaged since the last 40 years. While his contributions in endocrinology and reproductive biology are equally illustrious, his work in tumor biology and immunology are more recent and are internationally recognized. He developed successfully the first histiocytic tumor cell line from rats, which bears his initials AK-5 and which is the only rat macrophage tumor cell line available in the world. This cell line has served as an in vitro model to study antitumor immune response and is being used by several laboratories all over the world. Dr Khar has been the first scientist in India to demonstrate the role of programmed cell death / apoptosis in killing of cancer cells leading to tumor regression. Programmed cell death processes have important implications not only for cancer immunotherapy but also for understanding processes involved in ageing and degenerative diseases. Dr Khar’s most of the work in the areas of reproductive biology, endocrinology, tumor biology, tumor immunology and apoptosis has been cited/recognized by a large number of researchers in these areas. Dr Khar has 146 scientific publications and his work has been cited widely in the scientific literature. Dr. Khar was Director-Grade-Scientist at the Centre for Cellular and Molecular Biology, Hyderabad, after working in CCMB for 25 years, he has joined Shantha Biotechnics Limited as Head, Research and Development, where he is from the last 3 ½ years. Awards and Honours received: • Fellow of the National Academy of Sciences • T.B. Patel Oration award in cancer research, 1994. • NIH Physician’s Recognition Award of the American Medical Association, 1995. • P.B. Rama Rao award of the Society of Biological Chemists, for outstanding research in cancer, 1997. • Indian Immunology Society, Senior Scientist Award, 2001. • Prof. Y.T. Thathachari Prestigious Award in Science, 2003. • Dr. M.G. Deo Oration award in Cancer Research 2006

Gerhard F. Klement currently serves as CEO & President for Reliance Biopharmaceuticals. Reliance Biopharmaceuticals is part of Reliance Industries, the largest company in India. He is with Reliance since July 2006. The main goal of Reliance is to establish a global Biotechnology company. Within his role he is responsible for the production of recombinant Proteins and MAB, Blood Plasma Products, Vaccines and API’S. Prior to joining Reliance he served as VP Manufacturing & Technical Operations for ALTUS Pharmaceuticals. Within this role he was leading the manufacturing, process development, formulation and analytical operations for ALTUS. Mr. Klement served as Chief Technology Officer for the worldwide Biologics and Chemicals Group at Lonza, where he was responsible for new technologies and business development. From 2003 to 2005 Mr. Klement was the Head of Operations, USA and Chief Operating Officer Biopharmaceuticals, Worldwide at Lonza Biologics. Previously, Mr. Klement held various positions in manufacturing and engineering at Serono and Centocor. Mr. Klement also serves on the Scientific Advisory Board of the New Hampshire Chamber of Commerce and the Scientific Advisory Board of Laureate Pharmaceuticals. He served as well on the board of directors for the New Hampshire. Mr. Klement holds a B.SC. from the University of Agriculture in Vienna, Austria. He received executive training in general management and leadership from IMD and Babson College.

Narender Mantena is the Senior Vice President – Strategic Business Development at Biological E. Limited (BioE). He joined this position in 2003 and is responsible for business development, strategic alliances and licensing activities in the vaccines and biopharmaceuticals divisions. BioE has been one of leading vaccines and biologics companies in India and it has made significant investments to build capability for development, manufacturing and commercialization of vaccines and biopharmaceuticals for the global markets. BioE has a exciting portfolio of candidates at various stages in the pipeline in vaccines and biopharmaceuticals. Some of key partnerships that BioE has entered into include a strategic alliance with Intercell/Novartis for the development and commercialization of a novel Japanese Encephalitis vaccine which has completed phase 2 studies. Prior to joining this position at BioE, Narender has been in a leadership position in the following IT companies: Vasishta Technologies and SemanticSpace. He began in career at Biological E. in 1992. He has completed his MS in Systems Engineering from Michigan State University in 1991.

Mr. Mashaal has more than 30 years' experience in the pharmaceutical industry. He started his career with Syntex Laboratories Ltd., (now Roche Bioscience Inc.) in Canada and continued with Syntex International S.A. where he was responsible for the management of systemic steroid products. In 1973, Mr. Mashaal joined the 3M Company and was given responsibility for assisting in the creation of a clinical research group and managing the clinical research development of new molecules in the field of non-steroidal anti-inflammatory (NSAID) analgesic and cardiovascular products. In 1975, Mr. Mashaal was given responsibility for international business development in the health and sciences sector at 3M. In 1980, Mr. Mashaal founded Mashaal Enterprises Ltd, a holding company with interests in healthcare and biotechnology-related companies, for the investment in and development of emerging companies in the fields of health and sciences. In 1987, Mr. Mashaal founded SciTech Medical for the international market development of pharmaceuticals, medical devices and diagnostics. Mr. Mashaal is Chairman of both Mashaal Enterprises Limited and SciTech Medical. In 1988 Mr. Mashaal founded SciTech Genetics to develop, manufacture and market biotechnology-derived products, first in the Asia Pacific region and later in the markets of Europe and the Americas. In 1999, when Sonic made a substantial equity investment, SciTech Genetics underwent a name change to SciGen Pte Limited and Mr. Mashaal remained as the Chief Executive Officer. In 2003 Mr. Mashaal relinquished his position as the CEO and was given the position of Executive Vice Chairman. In 2005, after Bioton became the majority shareholder Mr. Mashaal was asked to resume his position of CEO and in addition was appointed Chairman.

Dr. Jian Ni is CEO and Chief Scientist of Human Antibodomics Inc., Chairman of Human-Human Hybridomas LLC. He is Chairman, Committee of Medicinal Biotech，Vice President, Shanghai Society of Biotechnology, Chairman, Committee of Interferon and Other Cytokines, Executive Director, Chinese Society of Microbiology, Director, Committee of Monoclonal Antibody, China Medicinal Biotech Association, Co-Chairman, Committee of Key Laboratory of Antibody Technique, Ministry of Health, President, Chinese Biopharmaceutical Association, USA, 2001-2003, Director, Chinese Biopharmaceutical Association, USA, 1999-2007. He received many honors and awards, such as Award for national outstanding returned scholars, 2003, Shanghai excellent returned scholars, Scientific foresight advisor for Shanghai government, Privileged expert of China Department of State (2005), Award for outstanding achievement in development of Pudong New Area (2005). He served as an advisor to several government and professional organizations, has been frequently invited to be Meeting Chair, Session Chair or Committee Member for several major international conferences for Biopharma and Antibody . He is currently a Visiting Professor of Shanghai Jiao Tong University， Second Military Medical University and Nanjing Medical University. Dr. Ni co-founded Human Antibodomics Inc., Shanghai Fuchun Zhongnan Biotech Inc., CYBRDI, Inc., USA and ShanXi Chao Ying Biomedicine R&D Ltd., China. Dr. Jian Ni obtained his M.D. from Second Military Medical University and Ph.D. from University of Cambridge. Dr. Ni was a Post-doctoral Fellow at the National Cancer Institute and University of California, Irvine. He is an American Society of Clinical pathologists board certified Specialist in Immunology. Dr. Ni was a Senior Scientist of Human Genome Sciences, Inc., and has many years of experience in biomedical research, immunology, oncology and protein chemistry, and industrial experience in functional genomics, therapeutic protein and antibodies discovery and development. He has published more than 80 scientific articles in top scientific journals (IF >600), Inventor of 148 issued US patents, three of the HGS genomic derived clinical trial antibodies were based on his patents. A few apoptosis related genes discovered by Dr. Ni and his collaborators were reviewed by Science Journal as top ten breakthroughs of the year 1996.

Dr. Vikram Paradkar is the Vice President of Process Development in Reliance Biopharmaceuticals in Navi Mumbai, India. He is responsible for providing guidance and oversight to process development, technology transfer and technical support for all aspects of therapeutic protein manufacturing. The portfolio of products under development include proteins derived from microbial fermentation, mammalian cell culture and plasma fractionation include cytokines, receptor proteins, monoclonal antibodies, enzymes and plasma proteins. Current technology transfer projects underway at Reliance Biopharmaceuticals involve manufacturing facilities spanning a range of capacities, equipment set-ups and overall production requirement. His prior assignments were as the Director of Process Technical Services in Wyeth Biotech in Massachusetts, USA; the Manager of Protein Purification in Bayer Biological Products in California, USA and the Manager of Bioprocess in Monsanto Corporation in Wisconsin, USA. He received his PhD in Chemical and Biochemical Engineering from University of Iowa, USA and his Bachelors in Chemical Engineering from University Department of Chemical Technology from Mumbai, India.

Dr. Patankar has been heading the development and manufacturing of recombinant biotechnology products at Intas Pharmaceuticals for the past 6 years. He has a total of 11 years of experience in the Indian Biotechnology industry. In his career he has been associated with th development of 7 recombinant products which are currently marketed in India. Dr. Patankar is a chemical engineer from IIT Mumbai and did his Masters and PhD from the University of Utah in the US, followed by a postdoctoral fellowship at Rutgers University in the US. In 2004 Dr. Patankar was an industry representative on the National Task Force headed by Dr. Mashelkar for the streamlining of the regulatory approval procedure for Biotechnology products.

Dr. Register is currently the founding President and CEO of Trusgen, LLC, headquartered in Sparta, New Jersey, USA. His career started at the Salk Institute Biotechnology Industrial Associates when the science of mammalian gene transfer and gene expression was just emerging. In the mid-1980’s, Merck Research Laboratories recruited Dr. Register specifically for his expertise in these new technologies. At Merck, he embarked on a distinguished 17-year research career, which focused on the cloning and expressing of multiple therapeutic gene targets—culminating in numerous scientific breakthroughs, publications, and patents. In 2002 he transitioned into Merck’s US Human Health sales and marketing division as a scientific liaison for Vioxx. After its withdrawal, Dr. Register joined Bayer HealthCare, as International Medical Director, Global Marketing for OTC analgesics. Dr Register developed and implemented health care professional global marketing strategies and managed global key opinion leaders. In addition, he organized and led Bayer HealthCare’s scientific symposia and advisory boards in the U.S. and Europe. In September 2007, he merged his successful scientific and marketing careers by forming a new company, Trusgen LLC, which creates biologics outsourcing partnerships between biotech and pharmaceutical companies in the U.S. and Europe with CRO/CMOs in Asia.

S.-Gopalan Sampathkumar was born in Triplicane, Chennai, India in 1969. He obtained BSc and MSc degrees in chemistry from RKM Vivekananda College, University of Madras, Chennai and a PhD in organic chemistry from the Indian Institute of Science (IISc), Bangalore under the supervision of Prof. Sosale Chandrasekhar. He spent post-doctoral stays with Prof. Dr. Andrea Vasella at Eidgenössische Technische Hochschule (ETH), Zürich and Dr. Vince Pozsgay at National Institutes of Health (NIH), Bethesda, MD as a carbohydrate chemist before joining the Yarema Laboratory at the Johns Hopkins University (JHU), Baltimore, MD where he developed ‘chemical biology’ methods for carbohydrate based drug development and stem cell engineering. Since Oct 2007, he has moved back to India as a faculty scientist at the National Institute of Immunology (NII), New Delhi. His current research interests are application of metabolic engineering for inhibition of matrix metalloproteinases (MMP), delivery of carbohydrates across the blood brain barrier (BBB), de novo synthesis of bacterial carbohydrate antigens for conjugate vaccines and stem cell glycomics.

Kim Sandell joined Pfizer in Strängnäs, Sweden 1999. He holds a master degree in chemical engineering from Royal Institute of Technology Stockholm, Sweden. Kim is currently holding a position as project director for a new biotech plant under construction in Strängnäs. He is responsible for the end user representation and start-up activities for this new facility. Kim has held a range of position at the site starting as a process engineer moving into project lead and quality support to projects. He then resumed responsibility for the manufacturing at the site until he joined the project team for the new facility. Strängnäs is a site focused in biotechnological API production with bacteria as expression systems. Staring up the new facility will also mean that two new processes for the API for Genotropin® and Somavert® will be transferred to the site this is also within Kim’s responsibility.

Dr. Subbarao received her Ph.D. in Bio-organic Chemistry from the Indian Institute of Technology, Bombay, India. She has more than 13 years of hands-on industrial experience in leading laboratory operations for both biologics and conventional drugs. During this time, her achievements included leading a project to construct and qualify the Stability Facility and set up of the Biologics Stability Program, leading the Analytical R&D program from research to regulatory submission and coordinating multiple projects to upgrade Quality Systems to comply with the cGMPs. She has extensive experience in evaluation of analytical methods and method validation for products ranging from clinical to commercial phases. She is currently a Senior Consultant with the Biologics Consulting Group specializing in Analytical GLP/GMP Quality Systems from development to commercial phase for conventional drugs, well characterized proteins, vaccines, cell therapy and gene therapy products.

Dr Swaminathan Subramaniam heads Business Development at the Danish biopharmaceutical company Rheoscience A/S. In addition, he holds responsibility for managing Rheoscience A/S activities in India. Rheoscience A/S has a portfolio of projects spanning early stage discovery to Phase 3 clinical development. A large part of its discovery portfolio is outsourced to Indian drug discovery services companies, as well as partnered with Indian biotechnology companies. Dr Subramaniam has an MD and postgraduate training in clinical pharmacology from India and a PhD in pharmacology from the University of Pennsylvania. His career started with positions in research and progressed with increasing responsibilities in management in the Indian pharmaceutical and CRO sector at Dr Reddy’s Laboratories, Aurigene Discovery Technologies and Procitius Research/Bangalore Genei (Sanmar Speciality Chemicals). Dr Subramaniam has attended executive training programs at Stanford, London School of Economics, Indian School of Business and Indian Institute of Management. In 1999 he was the recipient of a Chevening scholarship awarded by the British Foreign and Commonwealth Office.