Dr. Sudershan. K. Arora is presently associated with Ranbaxy Laboratories Ltd. as President – R&D (Generics, NDDS, Clinical & Drug Development) has expertise of more than 30 years in the field of pharmaceutical industry. Before joining Ranbaxy, he held as President – R&D at Lupin Limited, Pune. Dr. Arora has completed his PhD in Synthetic Organic Chemistry from Kurukshetra University and D.Sc from Bundelkhand University. In a career spanning over three decades, Dr. Arora has worked with leading Indian and global pharmaceutical companies like Greenwich Pharmaceuticals Inc. USA, Medicarb Inc. USA, Biogen Inc., USA, Ranbaxy Laboratories Limited, Lupin Limited and Sandoz, Austria. He has a wide experience in Drug Discovery, pre-clinical and clinical development of products in various therapeutic areas like Tuberculosis, Psoriasis, Migraine, Metabolic Disorder, BPH, Asthma, Rheumatoid Arthritis & Malaria among others. He also has experience in leading research programs for design, synthesis and pre-clinical development of NCEs / natural products. Dr. Arora has more than 40 patents to his credit and the numerous publications he has in reputed scientific journals bear testimony to his technical achievements. He has been an active and prominent speaker at various domestic and international scientific forums and is also on the governing bodies of a number of academic institutions in India.

Lee E. Babiss, Ph.D., is Global Head, Pharma Research at Roche in Basel Switzerland where he is responsible for leading and managing Research within Roche Pharma across the five Disease Biology Areas: virology (Palo Alto, California), oncology (Nutley, NJ), metabolic diseases (Basel, Switzerland), inflammation (Palo Alto), and central nervous system (Basel), as well as research in Shanghai, China. Babiss is also a member of the Roche Pharma Executive Committee, Strategic Portfolio Committee and Chairs the Roche R&D Center China Scientific Board. Prior to July 2007, Babiss was vice president, Preclinical Research and Development for Roche in Nutley, N.J., where he was responsible for developing and directing oncology, metabolic diseases and inflammation research strategy. As a member of the International Research Management Team, he was involved in developing global research strategy, and Chaired the Roche Biomarker Leadership Team, a cross-divisional effort within the pharmaceuticals and diagnostics divisions that develops and implements the company’s biomarker strategy. Prior to joining Roche, Babiss was vice president of Biological Sciences and Genetics at Glaxo Wellcome where he focused on the development of antisense technology and cancer therapeutics, headed the Department of Molecular Cell Biology, and played a key role developing and implementing the Cell Cycle Program. Babiss was also a member of the U.S. Research Senior Management Team, which formulated and implemented Glaxo’s U.S. research strategy and was involved in creating the Glaxo Wellcome Corporate Genetic Strategy, which led to the creation of the company’s Genetics Division. Babiss attended graduate school at Columbia University, College of Physicians and Surgeons, in New York, where he earned his Ph.D. in Microbiology in 1982 studying DNA tumor viruses. He then began his postdoctoral career at the Rockefeller University in New York where he studied the molecular regulation of hepatocyte gene expression. Later, Babiss was promoted to assistant professor in Cell Biology, studying adenovirus genetics. An author on more than 70 publications, Babiss currently serves on the board of the Center for Advanced Biotechnology and Medicine at UMDNJ, the Finance Board of the American Society of Microbiology, the Biotechnology Industry Organization, the Scientific Board of the Pharmaceutical Research and Manufacturers of America, and the R&D Council of New Jersey.

Dr. Mohan Bangalore received his Ph.D. in Molecular Biology from Iowa State University (ISU), USA and then conducted his Postdoctoral training at The University of Pennsylvania Medical School in Philadelphia, PA, where he worked on the biology of Herpes Simplex Virus. In early 2000, Dr. Bangalore joined SmithKline Beecham (SB) in Philadelphia, as a Senior Scientist and worked on Hepatitis C Virus. After SB's merger with Glaxo, Dr. Bangalore worked as a Principal Investigator at GlaxoSmithKline (GSK) in the Department of Clinical Pharmacology, where his lab performed testing of all biomarkers for clinical studies. Later Dr. Bangalore led GSK's Biomarker Outsourcing group in which he outsourced clinical lab tests to external CROs. In 2005 he received his MBA from Temple University in Philadelphia, PA. Dr. Mohan Bangalore joined Wyeth Pharmaceuticals in 2005 as Associate Director of Biomarker Outsourcing. Near the end of 2006, Dr. Bangalore accepted a long-term international assignment to help develop Wyeth's global clinical operations in Bangalore, India. He relocated to Bangalore in February 2007, where he is currently the Senior Director and Site Head of Wyeth's India Clinical Research Center (ICRC) in Bangalore, India. In June 2009, Pharmaceutical Executive Magazine (New York) selected Dr.Bangalore as one of the "2009 Emerging Pharma Leader", who has the skill, spirit, and insight to become the next generation pharma leader.

Arani Chatterjee, MBBS, MPhil, PGCPM joined Panacea Biotec Ltd. in July 2004. Dr. Chatterjee completed his graduation from Christian Medical College, Vellore and post-graduation from National Institute of Mental Health and Neuro Sciences, Bangalore. In addition, he has completed a Post-Graduate Certificate Program in Management from Indian Institute of Management, Indore. Before joining Panacea Biotec, he was a Research Physician at Dr. Reddy’s Laboratories (Discovery Research), Hyderabad for six years. He also has a continuing appointment as a visiting faculty at University of Pune and as a Governing Body member at Institute of Clinical Research (India). His experience includes participation in pre-IND meetings at FDA, regulatory meetings at WHO, scientific advice meetings at Bundesinstituts für Arzneimittel und Medizinprodukte, expert group meetings on review of Indian GCP guidelines, Schedule Y of the Drugs and Cosmetics Rules and National Technology Advisory Group on Immunisation. Dr. Chatterjee has successfully undertaken numerous clinical research projects in India. He has published ten papers in national and international peer-reviewed journals.

Bharatt Chowrira, Ph.D., J.D. joined the Company as Chief Operating Officer in May 2008. His responsibilities include overseeing and managing all research and manufacturing operations across the Company, as well as corporate functions including business development, licensing and marketing. He will also serve as Chairman of Nektar India Pvt., Ltd. Dr. Chowrira had previously served as Executive Director, Worldwide Licensing & External Research at Merck & Co. in San Francisco. He was responsible for identifying and evaluating R&D, licensing and partnering opportunities across all therapeutics areas, therapeutic modalities (including small molecules, biologics, vaccines and oligonucleotides), and technology platforms, throughout Asia. Dr. Chowrira was a key member of the team that established collaboration agreements between Merck and leading pharmaceutical firms in India such as Nicholas Piramal and Ranbaxy Labs. Dr. Chowrira also served as Vice President of Sirna Therapeutics, a wholly owned subsidiary of Merck, where his responsibilities included strategic planning and licensing. Prior to Merck, Dr. Chowrira was a member of the executive management team at Sirna Therapeutics, a development-stage biopharmaceutical firm focused on the discovery and development of RNAi-based drugs that selectively target disease-causing genes and viruses. As Vice President at Sirna, he played a pivotal role in the restructuring and 2003 relaunch of the company, the development of its pipeline and intellectual property portfolio, and ultimately the sale of Sirna to Merck. He led the effort to identify research opportunities that resulted in corporate collaborations and licensing agreements with all of Sirna's partners, which included industry leaders such as GlaxoSmithKline, Allergan, and Eli Lilly & Co. Dr. Chowrira earned his Ph.D. in Microbiology and Molecular Genetics from the University of Vermont and his J.D. degree from the College of Law at the University of Denver. He earned his M.S. in Molecular Virology from Illinois State University and his B.Sc. in Microbiology from the University of Agricultural Sciences, Bangalore, India.

Dr. Gopal Dasika is presently Senior Vice President – R&D at Actis Biologics and has about 20 of experience in biotechnology, ranging from molecular and cell biology, virology, cancer biology and protein therapeutics. Prior to joining Actis, he was Head, Biology Research at Reliance Life Sciences. He is an adjunct Faculty, Department of Biotechnology, University of Mumbai. Dr. Dasika holds a professional doctorate in Veterinary Medicine from UAS, Bangalore and a PhD in Molecular Virology and Oncology from University of Wisconsin-Madison, USA. His past appointments include, Susan G. Komen Fellow in Molecular Medicine at University of Texas Health Sciences Center, San Antiono and Director of Gene Transfer Technologies at Cancer Therapy and Research Center, San Antonio, TX., USA.

Matt Devalaraja is the head of pharmacology, pharmacokinetics and toxicology at Human Genome Sciences, Rockville, MD. He successfully established and led Pharmacology, Pharmacokinetics and Toxicology groups at HGS and is an integral part of interactions with US and European regulatory agencies for various clinical programs and BLA filings. He is actively involved in both discovery and development of various programs in Immunology, Infectious Diseases, Oncology and Bio-Defense. Prior to joining HGS, Matt worked for 8 years at Pfizer, AnnArbor, MI, most-recently as the Head of Biologics Discovery for the site. While at Pfizer, he initiated the first Pfizer Inflammation biotherapeutic project and also the first biologic project for Pfizer Ann Arbor. He initiated and led multiple discovery projects successfully to file INDs and was also the discovery leader on the RA biologics’ development teams. He is well versed with Discovery and Preclinical Development of both Biologics and Small Molecules. Matt obtained his Ph.D. from University of Kentucky, Lexington, KY and post-doctoral fellowship at Vanderbilt University, Nashville, TN.

Dinesh Dua, is currently the Chief Executive Officer of M/S Nectar Life sciences Ltd.-a US$ 200 Mio. Niche company in life sciences which also has identified Biologicals as the ‘Way Forward”. Immediately prior to NLL, he was President of Wockhardt Ltd’s International & Biotechnology Strategic Business Unit ( SBU) Mr. Dua holds a Masters in Business Management (M.B.A.)-1979 batch from the Indian Institute of Management Ahmedabad. He has over 29 years of professional experience across varied industries such as Healthcare and Pharmaceuticals, Petrochemicals and Consumer goods, having worked in multinational organizations such as Hoechst (Sanofi Aventis) & Berger Paints, and large Indian Corporates like Reliance, Jubilant Organosys & Zydus Cadila Healthcare. He has also served as a member of various subcommittees of the Confederation of Indian Industry (CII), one of the major Industry Associations of India. He is also a visiting faculty to leading & reputed Management institutes in India.

Dr. Favorov is a medical epidemiologist with more than 30 years of experience in a wide range of activities focusing on infectious diseases, including field surveillance studies, discovery of viruses, developing new assays, and leading efforts with groups of countries to develop regional approaches to disease prevention. Dr. Favorov has two doctoral degrees in infectious disease, studied hepatitis non A, non B, and later contributed significantly to the discovery of hepatitis E virus (HEV). From 1991 to 2008, he worked for the U.S. Centers for Disease Control and Prevention, including for eight years as Director of the Central Asia Regional Office. His major accomplishments: developed diseases specific surveillance for various types of hepatitis (A, B, C, D, E); playing a key role in establishing policy, regulatory guidelines, and participation countries government committees for the implementation of universal hepatitis B immunization, hepatitis A-D control, Typhoid Fever surveillance and infant mortality prevention; establishing infectious disease surveillance systems, including national routine case-based tuberculosis and HIV sentinel surveillance; conducting numerous outbreak investigations and control in developing countries; organizing training programs in emerging infectious diseases; and non-inferiority vaccine effectiveness studies.

Over 15 years hands on and proven experience combining a unique blend of experiences & skills of:
1. Managing Business P&Ls (several P&L responsibilities) or Sustainability of projects undertaken
2. Product Development through its complete life cycle starting with need, to concept, to laboratory research, to production, to clinical trials (phase I to IV) and finally to release and marketing. Includes NCEs / NBEs / NDDSs through various stages.
3. Creating and Managing Effective Public Private Sector partnerships for sustainable, culturally relevant health technologies solutions influencing policy makers and communities for uptake and introduction.
4. Regulatory expertise in process mapping and requirements for product approvals and advocacy in India
5. Knowhow of Medical Sciences and cutting edge technologies, instrumentation / devices across different therapy areas, and their application in Health care management and processes.
6. Managing Teams, particularly teams of scientists and technocrats
7. Passion to make a difference to human lives

Dr Fiona M. Greer is a founding Director of M-Scan (Mass Spectrometry Consultants and Analysts), a group of contract analytical laboratories specializing in the analysis of pharmaceuticals and biopharmaceuticals. Following a Ph.D. in Protein Biochemistry from Aberdeen University, she joined M-Scan Ltd in 1984, an independent company started by Professor Howard R. Morris, to found the Biochemical Services Department and develop and exploit new and emerging mass spectrometry techniques for biopolymer analysis. During this time, she pioneered and applied developments in MS for the structural characterisation and sequencing of peptides, proteins and carbohydrates. With expansion of the group, she was appointed Director of Biochemical Services in 1988. At the same time, she was instrumental in establishing an M-Scan facility in the United States (M-Scan Inc, founded 1984 in West Chester, PA) where she was appointed Vice President. Since then, M-Scan has grown from a small start-up to become a world leading contract analytical laboratory for biopharmaceutical characterisation, now comprising four laboratories (UK, USA, Switzerland and Germany). Dr Greer is also responsible for directing Quality Assurance across the group. With over 25 years experience in the structural analysis of proteins and glycoproteins using instrumental techniques, and many publications in this area, she is involved in the analysis of a diverse range of biotechnology products. She is particularly specialized in the use of mass spectrometry and other instrumental techniques to fulfil regulatory characterisation requirements and consults to companies throughout the world. She is regularly invited to give presentations and workshops at international meetings and has designed and presented various technical training courses, both for M-Scan and other organisations.

Scientific management executive with background at Bayer, Novartis, Bristol-Myers Squibb, GlaxoSmithKline and Merck. Experienced in both biotechnology and pharmaceuticals. Worked with corporate partners, improved products, processes, trained scientists, cut costs and handled cGMP and regulatory compliance. Fields include expression systems (microbial and mammalian), process development and validation, virology, and cell biology. Strong education credentials gained at the University of London. Well published with 26 publications (12 as lead author) in prominent journals including Science and J. Biol. Chem., and 3 patents. PhD, Immunology – University of London. MS, Biochemistry – All India Institute of Medical Sciences. BSc, Chemistry, Zoology & Botany – Meerut University. Member, American Association for the Advancement of Science.

Fadel has an extensive background in the strategy and execution of process improvements initiatives. His Lean Six Sigma experience started in the semiconductor industry where he was a pioneer in introducing process improvement principles into the high volume high product mix manufacturing environment. Over the last seven years, Fadel worked in the biotech industry at Amgen and Genentech. As an innovator, Fadel has been transforming the culture in biotech to ensure the successful deployment of Lean Six Sigma mindset. Fadel’s background combines skills in operations, manufacturing , quality, technical management, and strong leadership. He is a frequently requested speaker at International conferences. Fadel holds a doctorate in mechanical engineering from UC Berkeley and he is an ASQ certified six sigma black belt and quality engineer.

DR. GÜNTER JAGSCHIES holds a Ph.D, in Biochemistry from the University of Münster in Germany. He joined GE Healthcare (GEHC) in 2004 via the acquired former Pharmacia Biotech and Amersham business where he began in 1985 and has held senior commercial, marketing, and R&D management roles. His current position is Director Customer Applications at R&D for GEHC Life Sciences based in Uppsala Sweden, in charge of industrial collaborations and a portfolio of activities to study biopharmaceuticals development workflow as well as the design and economy of manufacturing processes for protein drugs. During his career he has worked as head of Sales in Europe and of Marketing for the global GEHC bioprocessing business. Prior to that he has been in charge of R&D portfolio management with focus on industrial separations technology and has run the company’s Fast Trak customer training centre in Europe. His technical experience includes chromatography process design and technology handling, regulatory issues incl. validation planning, and process economy analysis.

Sara Kenkare-Mitra is currently Vice President of the Development Sciences a translational sciences organization that spans R&D at Genentech. In this role she has the ultimate responsibility for ensuring the successful translation of promising molecule-discoveries from Research into the Development phase. Sara's group is also responsible for developing and successfully implementing Genentech's pharmacokinetic, toxicologic, immunogenicity and biomarker strategies, to enhance the company's success rates with the discovery, preclinical and clinical phases of development and ultimately with regulatory approval from the FDA. Dr. Kenkare-Mitra joined Genentech in 1998 as a Scientist and has held several different positions leading up to Vice President. She has a successful track record with biotherapeutics and small molecules highlighted by her increasingly greater organizational responsibilities leading to significant contributions to Genentech's key product approvals including Avastin, Tarceva, Lucentis, and Xolair; and the greater than 20 Investigational New Drug applications filed by her organization with the FDA. Sara has a background in pharmacy (B Pharm, India), a PhD in Pharmaceutical Chemistry (focused on Pharmacokinetics and Metabolism) from UCSF and a post-doctoral fellowship in Clinical Pharmacology from UCSF in the area of PK/ PD modeling and simulation. She also holds adjunct faculty positions at UCSF in the Department of Biopharmaceutical Sciences and the University of the Pacific in Stockton. Sara has a passion for developing drugs to meet significant unmet medical needs with a strong scientific basis and an emphasis on personalized medicine.

• Currently, Dr. Murtaza Khorakiwala is the Managing Director of Wockhardt Limited.
• Prior to this he was the Executive Director of Wockhardt Limited. He headed the Biotechnology and Active Pharmaceutical Ingredients (API) Business.
• Dr. Khorakiwala also provides leadership to the Biotechnology and Drug Discovery Research Programmes at Wockhardt. He plays an active role in new business developmental initiatives of the company.
• Prior to this he was a Head of Strategic Business Unit at Wallis Laboratories UK, which was Wockhardt’s first trans-national acquisition.

Dr K R S Krishnan is the Executive Director in HLL Lifecare Limited (HLL), India, a wholly owned company of the Government of India. HLL is a rapidly diversifying company in the areas of contraceptives (all types), pharmaceuticals, medical devices, diagnostics and now vaccines. Dr Krishnan is responsible for Strategic Planning, Research & Development and Corporate Quality Assurance of the Company. He is engaged in strategizing of the new diversification projects of the company, which include the Vaccines project. Also, he heads the Corporate R&D centre of HLL. Prior to joining HLL, (1989 to 2006) Dr Krishnan had been working with the Department of Science & Technology (DST), Government of India in implementation of R&D Projects & infrastructures and Centres of Excellence in different areas of engineering and technology. He has worked as Project Leader in Technical Assistance Projects of UNDP Country Programme. Prior to DST, he worked in Indo Dutch Cooperation Programme (1986-1988) and Investigation, Design and Research Organisation (1984-86). Also, he served in Corps of Engineers during 1977-83. He holds a PhD in Environmental Engineering from Indian Institute of Technology, Delhi and Masters Degree in Engineering with specialization in hydro electric projects. He areas of specialization are: Research & Development, Technology management and Intellectual Property Rights.

John Maki is President and CEO of Vicus Therapeutics, a privately held biopharmaceutical company dedicated to bringing breakthrough multi-drug treatments to patients with cancer. Previously, Managing Director, Technology Directors, Inc., 2001-2005, 1997-1999; Managing Director, Audax Group, 1999-2001; Principal, Bain Capital, 1988-1997; Consultant, Bain & Company, 1983-1988;. Research Assistant, National Bureau of Economic Research, 1980-1983; Mr. Maki has over 25 years of industry experience and has been founding investor and/or board member of eleven life science companies. In addition, three of his portfolio companies had successful IPOs and grew to a combined market capitalization exceeding $1.4 billion. He serves on the boards of 3DMatrix, Addition Technology, and BioNJ. He holds an AB from Harvard University.

Mr. U N Misra is an M.Pharm from Institute of Technology, Banaras Hindu University. He completed his Masters in 1973 and thereafter joined M/s. Roussel Pharmaceuticals at Mumbai in July 73 in Formulation / analytical development. After 2 years, he went to Dalhousie university Canada to complete his second masters in Pharmacy in 1976. After his return, he shifted from Roussel to M/s. Sarabhai international and was posted as QC Manager of their Malaysian Plant. During 10 years of his stay in Malaysia, he was one among the team responsible for commissioning a new Pharma Formulations Plant - M/s. Pharmmalaysia. In 1987, he returned back to India and joined M/s. Ranbaxy Laboratories as QA Manager for Formulations Plant at Devas. In 1991 shifted from Quality to Production in Ranbaxy and then joined M/s. Cyanamid India Limited as GM-Pharma Production in Mar, 1992. Later, in 1995 joined Wockhardt Limited as GM - Manufacturing at Aurangabad looking after several plants. In Astra he joined in Jan 1997 as GM - Technical and is now working as VP-Operations looking after Production, Supply Chain, Purchasing, Distribution, Process & Formulation R&D, Engg & Projects, Quality and Technical Services, SHE and oversees administratively Plant HR / IS/IT and Operations Finance.

Alan J. Morrison is a partner at the firm of Cohen Pontani Lieberman & Pavane LLP in New York. Mr. Morrison’s practice has included all aspects of U.S. and international patent prosecution in the biotechnology and pharmaceutical areas, as well as opinion work relating to infringement, invalidity, patentability and the Hatch-Waxman Act. He has represented universities, research institutes and corporations in protecting groundbreaking inventions such as recombinant antibodies, catalytic nucleic acids, microarrays, targeted stem cell delivery methods and DNA sequencing techniques. His practice has also encompassed preparing biotechnology-related contracts such as licenses, joint development agreements, feasibility study agreements and technology transfer agreements, and counseling clients regarding the negotiation of these contracts. Mr. Morrison lectures both domestically and internationally on topics in U.S. patent law such as special topics regarding biotech and pharmaceutical inventions, inventorship determination, claim drafting, and intellectual property aspects of mergers and acquisitions. Prior to joining Cohen Pontani Lieberman & Pavane, Mr. Morrison was a partner at the New York firm of Cooper & Dunham LLP, in-house counsel at Johnson & Johnson, and associate attorney at the New York firm of Rogers & Wells. Mr. Morrison earned his B.A. in biochemistry from U.C. Berkeley, his M.S. in biological chemistry from the University of Michigan, his M.Phil. in biochemistry and molecular biophysics from Columbia University, and his J.D. from Yeshiva University. He is registered to practice before the U.S. Patent and Trademark Office, and is a member of the American Bar Association, the American Intellectual Property Law Association and the New York Intellectual Property Law Association. Mr. Morrison is a co-chair and founding member of the advisory board for the Bellevue/NYU Program for Survivors of Torture. He is also a member of the advisory boards for the Stem Cell Partnering Series and the Columbia University Biotechnology Association.

Dr.P.M.Naik obtained a B.Sc. degree from Madras University, B.Pharm and M. Pharm from Banaras Hindu University and Ph.D. from Bombay University. He also did his Post Graduate diploma in industrial management equivalent to MBA and Masters in Finance Management (MFM) from Bombay University. He is a fellow of Royal Society of chemistry FRSC (UK) and fellow of institute of chemist and Indian Pharmaceutical Association. He has 46 years of wide experience in pharma Industry mostly in Senior management position. Has contributed in many ways to pharma profession and was recently recognized by 2 Awards. Eminent Pharmacist for the year 2005 and Excellence in Pharma Profession 2009. Currently he is associated with Zydus Cadila as Project Director, he has delivered several lectures and also chaired many session during prominent National Pharma Seminars. He was external examiner for M.Pharm / Ph.D. of many Indian Universities.

• Doctorate of Medicine from VSS MC Sambalpur University, Orissa. Seven years of academic experience of teaching in Medical colleges and over 14 years of experience in the pharmaceutical industry, Presently working as V.P. – Medical services and clinical research she is poised to lead LG Life Sciences achieve its vision of creating innovative business values, enhancing marketing capabilities and become a leading clinical research service provider in life sciences company.
• Has extensive experience working with National and International companies like Modi-Mundipharma, Purdue Frederick - US, Napp Laboratory - UK and Mundipharma Basel – Switzerland, Pohl-Boskamp - Germany, Viofer International - Switzerland, Gan and Lee - China, Kureha, Asahi Kasei Medical, Toray Medical Co. - Japan. She has been responsible for coordinating and ensuring scientific and technical support to the marketing, sales and regulatory departments in multinational companies.
• Has over 7 yrs of experience in overseeing all the clinical trials sponsored by HQ LG Life Sciences, Korea for KFDA and WHO prequalification.
• Some of the major achievements include new product launches in the Indian and International market and working with the regulatory and legal departments in resolving critical pending issues.
• Over a year experience in working on clinical operations, regulatory, pharmacovigilance and new drug development areas in Korea.
• Presently working on setting up of an independent CRO business in India.
• Has many publication and Speaker at various domestic and international scientific forums.
• Has membership of the “Drug Safety Executive Council (DSEC), US” and “Medical Sub-Committee of OPPI.”
• Honoured by Association of Private Medical Practitioners of Bhopal 2000-2001 for the contributions to pharma industry.

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.

Clinical Research (Phase I to Phase IV, PK / PD), Medical Information, Data Management, Medical Statistics, Medical Writing, Global Pharmacovigilance, Regulatory (Domestic: Complete, International : Clinical Development), Business Development (Inlicensing, Outlicensing, Acquisitions, Due diligence, Co-developments)
• 8 years of academic experience of teaching in Medical colleges
• 17 years of professional experience in the Pharmaceutical Industry
• More than 50 scientific publications in national and international journals
• More than 20 Guest Lectures in national and international conferences
• Member of Medical Sub-Committee of IDMA, OPPI
• Member of DCGI Committee for modifying Schedule Y and redrafting Indian ICH GCP Guidelines
• Author of 5 textbooks in Medicine and Clinical Pharmacology
• Executive Member – Indian Society For Clinical Research

Dr. Patankar is the Chief Technical Officer at Intas Biopharmaceuticals Ltd, Ahmedabad, India, where currently he is leading the development and manufacture of biosimilar drugs for international markets and also expansion and establishment of manufacturing facilities for its new products. In his 12 years in the Indian biopharmaceutical industry, he has handled the development of seven recombinant biological products which are currently marketed in India. Dr. Patankar is a Chemical Engineer and did his B.Tech from Indian Institute of Technology, Mumbai (India), and MS and PhD from the University of Utah, (USA), followed by a postdoctoral fellowship at Rutgers University (USA) for 2 years. Intas Biopharmaceuticals is a leading biotechnology company in India. It is the only biopharmaceutical facility in India with EU-GMP certification, and the world’s only manufacturer of a biosimilar Pegfilgrastim. The company is currently in clinical trials with its filgrastim biosimilar in Europe. In 2004 Dr. Patankar was an industry representative on the National Task Force in India for the streamlining of the regulatory approval procedure for biopharmaceutical products.

Senior management executive with twenty-five years technical management experience in Global Biopharmaceutical industry.

ANURAG S. RATHORE is a consultant of Biotech CMC Issues. He is also a faculty at the Department of Chemical Engineering, Indian Institute of Technology, Delhi, India. His previous roles included management positions at Amgen Inc., Thousand Oaks, California and Pharmacia Corp., St. Louis, Missouri. His areas of interest include process development, scale-up, technology transfer, process validation, process analytical technology and quality by design. He has authored more than 100 publications and presentations in these areas and serves on the Editorial Advisory Boards for Biotechnology Progress, BioPharm International, Pharmaceutical Technology Europe and Separation and Purification Reviews. Dr. Rathore has edited books titled Quality by Design for Biopharmaceuticals: Perspectives and Case Studies (2009), Elements of Biopharmaceutical Production (2007), Process Validation (2005), Electrokinetic Phenomena (2004) and Scale-up and Optimization in Preparative Chromatography (2003). He has a Ph.D. in Chemical Engineering from Yale University.

Alice Redmond is CQ Technical Director with PM Group, has over 20 years experience in R&D, Pharmaceutical (API, Formulation Fill, Solid dosage) and Biotechnology industry. Alice graduated with a BSc in Biotechnology in 1987, PhD in Biotechnology in 1991 and a MBs in 2001. Current responsibilities include oversight of regulatory compliance, GEP, quality, commissioning, qualification and validation strategies on a corporate level for PM Group. Alice has led number CQ projects for numerous multinational clients and is currently actively working on Consultancy assignments including ASTM E2500-07 implementation, lean CQ and practical risk assessment strategies. Alice is an active member of the ISPE and PDA, she co-chaired and presented at the ISPE GEP ICQ conference in Copenhagen in 2006, ISPE Singapore 2008, 2009, ISPE Sweden 2009.

Business Development and Strategic International Alliances
Centre for Cellular and Molecular Platform Technologies (C-CAMP)
National Centre for Biological Science-Tata Institute of Fundamental Research (NCBS-TIFR)
A Govt. of India-Dept. of Biotechnology Initiative

Dr. Rahul Singhvi is a recognized vaccine specialist, manufacturing expert and business leader in the pharmaceutical industry with over 14 years of experience. Since assuming his current position of CEO in 2005, Rahul has lead the restructuring of Novavax to focus on product innovation and development through programs such as its influenza vaccine development utilizing the company’s novel virus-like particles to address major unmet medical needs around the globe. Dr. Rahul Singhvi’s manufacturing expertise has also helped shape the company’s focus on leveraging disposable and ready to use manufacturing components thereby creating significant commercial opportunities such as regional or in-border vaccine facilities. Dr. Singhvi has successfully repositioned Novavax on vaccine product innovation and development, leveraging the Company’s novel virus-like particle (VLP’s) technologies. Since his appointment as CEO, Novavax’s Market Capitalization has increased from $35 million to $200 million. The Company has several vaccine candidates in the pipeline with its most advanced programs in the Pandemic influenza and Seasonal influenza VLP vaccines area and currently manufacturing H1N1 (Swine Flu) vaccine. Rahul has also acted to secure significant financing means for the company attracting a strong set of long term investors. Before joining Novavax, Dr. Singhvi spent 10 years at Merck & Co., most recently in vaccine manufacturing operations where production increased by 25 percent at the two plants he oversaw. Dr. Singhvi received his M.S. and Sc.D. degrees in Chemical Engineering from the Massachusetts Institute of Technology. He also holds an M.B.A. from the Wharton School.

Ted Torphy is Chief Scientific Officer and Head of External Research & Early Development (eRED) for Johnson & Johnson’s Pharmaceuticals Group. The eRED is responsible for building and managing a portfolio of external venture partner and pharmaceutical R&D collaborations on product and technology opportunities that are of strategic interest to Johnson & Johnson. Before assuming his current role in 2007, Ted was Corporate Vice President & Head of the Corporate Office of Science & Technology, a corporate function that identifies transformational healthcare technologies for all of Johnson & Johnson’s business sectors. Ted joined COSAT in 2003 after spending three years at Centocor, the biopharmaceutical arm of J&J, where he was Senior Vice President for Discovery and Preclinical Development. Prior to joining Centocor, he spent 17 years with SmithKline Beecham, most recently as Vice President of Research for the Cardiovascular, Pulmonary and Metabolic Diseases. He is the author of more than 120 journal articles, review articles, book chapters, and patents. He serves on the editorial advisory boards of eight scientific journals, chairs the Board of Directors of the Cystic Fibrosis Therapeutics, Inc., and is a board member of several other non-profit academic, research, greenhouse and venture organizations. Ted holds a B.S. degree in Pharmacy from the University of Wisconsin and a Ph.D. in Pharmacology and Toxicology from West Virginia University. He completed his postdoctoral training at the University of California, San Diego.

Dr. Tsutomu Une is a Member of the Board, Senior Executive Officer of Daiichi Sankyo Company, Limited (Daiichi Sankyo). He also serves as the Chairman of Ranbaxy Laboratories Limited. Dr. Une joined Daiichi Pharmaceuticals Co. Ltd. (Daiichi) in 1970 as Research Microbiologist and worked through various functions including research and development, global business development, and corporate planning & administration. In 1995 he was delegated to New Jersey, USA to assume the position of President, Daiichi Pharmaceutical Corporation. In 1997 he returned to Japan and since then, he filled important positions mainly in the R&D coordination, business development & licensing, and corporate strategy. In June, 1999 Dr. Une was elected to a Board Director of Daiichi. He was then promoted to a Managing Director in 2002, and in June, 2006 became a Representative Director, Senior Managing Director of Daiichi. In September 2005, Daiichi Sankyo, a holding company of Daiichi and Sankyo Company, Limited was established and Dr. Une was elected to a Member of the Board of the Company. He was then promoted to a Member of the Board, Senior Executive Officer in the following year. He was inducted as a Director on the Board of Ranbaxy Laboratories Limited on December 19, 2008 and appointed as Chairman on May 24, 2009. Dr. Une graduated from Hokkaido University in 1970, where he majored in Veterinary Medicine. He received Ph.D. degree in Microbiology in 1977.

Dr. V. K. Vinayak, had his educational qualifications (Master’s in Medical Microbiology & PhD. in Medical Microbiology) from All India Institute of Medical Sciences, New Delhi. He was elected as Fellow of Royal Society of Tropical Medicine & Hygiene (London) and Fellow of Indian College of Allergy and Applied Immunology (New Delhi). He had special training in Protozoal Immunology at London School of Hygiene & Tropical Medicine (London). He joined Postgraduate Institute of Medical Education and Research, Chandigarh (North India) as an Assistant Professor in 1973 and rose to become Additional Professor in 1986. Thereafter in 1993, he moved to the Department of Biotechnology (DBT), Ministry of Science and Technology, Government of India, New Delhi as Medical Advisor and rose to become Sr. Advisor. He took up the current assignment as President and Head of Biopharmaceutical (R&D) at Panacea Biotec Ltd. in 2003 and has been instrumental in setting up a new R&D center for Biopharmaceutical programs of Panacea Biotech in 2005. He has more than 30 years of experience in Research, teaching and scientific administration in relation to medical biotechnology discipline. During his tenure in DBT, New Delhi he was instrumental in designing and implementing medical biotechnology and human genome programs for the country. He has also been an inactive member of INDO-US vaccine action activity of DBT. His main research interests are related to Medical Microbiology, Immunology, Molecular Biology, Vaccinology, and Medical Biotechnology. He has published more than 225 research papers in International and National Medical journal of reputes high impact factors and has got ten National Awards for his Bio medical research activities. These awards have been conferred by Indian Council of Medical Research, Medical Council of India, National Academy of Medical Sciences and other scientific specialty bodies. He has guided more than 32 students for their Doctorate degree programs and has also been member of a “large numbers” of Scientific Advisory Committee/bodies both at National and International level.

Dr. Winkler is Biogen Idec’s Senior Vice President of Asia-Pacific and Global Government Strategy with a broad range of responsibilities for new business initiatives including the development of markets, M&A and corporate branding activities in the Asia-Pacific region, as well as global government relations. He joined Biogen Idec in Cambridge, MA, in 1988 as research scientist. Since joining the company he has developed Amevive, an immunomodulator for the treatment of psoriasis, and held various managerial positions in clinical development, program management, and corporate administration. Dr. Winkler was born and educated in Austria, and holds an M.S. and Ph.D., in biochemistry, from the University of Vienna. He completed his postdoctoral research at the University of Medicine and Dentistry of New Jersey. His academic achievements include discoveries related to structure-host relationship of flavivirus proteins, has published more than 30 articles, and received an award for innovative research from the Austrian Society of Microbiology.