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conference details
Conference:
Pre-conference workshop
18 Nov 9:30am - 4:30pm
Day 1
19 Nov 8:30am - 5:30pm
Day 2
20 Nov 8:30am - 5:30pm
Post-conference workshop
21 Nov 9:30am - 4:30pm
 
Workshops:
Pre-conference workshop: Pricing, reimbursement and distribution systems for generic medicines in US
Post-conference workshop: Regulatory update

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look back at the European event
 
  • 2007: 70+ attendees
  • 2008: 120+ attendees
  • › view 2008 European agenda

     


     
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    Meet our speakers
     
    Mr Stephen R Auten,
    Vice-President, Legal — Intellectual Property,
    Sandoz, Inc. (Princeton, NJ)
    Stephen Auten is the Vice-President of Intellectual Property for Sandoz, Inc., a Novartis company. He received his B.S. in chemistry with high distinction in 1994 from the University of Illinois at Urbana-Champaign, completing a senior thesis on the separation of enantiomers under the direction of Dr. William H. Pirkle, a recognized pioneer in the field. He graduated in 1997 from the Chicago-Kent College of Law where he was a member of Moot Court. He is a registered patent attorney with the United States Patent & Trademark Office. Within Sandoz, he specializes in Hatch-Waxman strategies, portfolio development and litigation management. Sandoz is competitive in the generics industry with its leading presence in key markets, including the U.S. and Germany, and a comprehensive product portfolio of more than 600 active pharmaceutical ingredients in more than 5,000 dosage forms. With Omnitrope®, Sandoz received the first approval from FDA for a follow-on version of a previously-approved recombinant biotechnology drug. Prior to joining Novartis/Sandoz, he litigated Hatch-Waxman cases with a well-known IP law firm in Chicago. On a personal note, Steve is an active member of the International Traditional Karate Association and the Japan Karate Association. He can be contacted at stephen.auten@sandoz.com or (609) 627-8752.
    Mr James Baker,
    US Regulatory Affairs and Clinical Operations Director ,
    Catalent Pharma Solutions
    Jim has over 25 years experience in drug development. Prior to joining Catalent, he worked at Sterling-Winthrop and Mallinckrodt Pharmaceuticals. His background includes directing research in preclinical and clinical Drug Metabolism and Pharmacokinetics, as well as Regulatory Affairs.
    Mr Douglas Boothe,
    Executive Vice President and Chief Operating Officer,
    Actavis US
    Doug Boothe is the Executive Vice President for Actavis' US Generic Pharmaceutical Business. In this role, Doug has commercial P&L responsibility for US Operations, which currently represents over 30% of Actavis' global portfolio. Specific functions reporting to Doug include Sales, Marketing, Product Selection, In Licensing/Business Development, Finance, Human Resources, IT, Legal and Intellectual Property. Doug is also a member of Actavis' Global Management Board reporting directly to Chief Executive Officer Robert Wessman. Doug has been with Actavis since the acquisition of the Alpharma global generics business in December 2005. At Alpharma, Doug was Vice President and General Manager for US Generics since 2004. Prior to joining Alpharma, Doug was at Pharmacia Corporation as Vice President, Channel Development, Sales Operations and Global eBusiness. Prior to that, Doug was Vice President/General Manager for various business units within Xerox Corporation, including xerox.com, Office Document Products and Small Office/Home Office business units. Doug holds a BS in Mechanical and Aerospace Engineering from Princeton University and an MBA from the Wharton School at the University of Pennsylvania. He currently resides in Chester, NJ with his wife Beth and four children.
    Mr Mazen Darwazah,
    General Manager,
    Hikma Pharmaceuticals, Jordan
    2005 to date Chairman and CEO Hikma MENA (Middle East and North Africa) 2000 to date. Board Memberships: Capital Bank, Jordan International Insurance Company, Jordan Investment and Resources Company, Operation Smile/Jordan Chapter. Vice-Chairman: Jordan Exporters Association, Arab Business Council.
    Dr William M Egan,
    Executive Director,
    Pharmanet Inc., USA
    Dr Tony Ellery,
    Head Life Cycle Management ,
    Novartis Pharma Portfolio Management, Switzerland
    Mr Tony Foreman,
    CEO Almus and and Director of Commercial Affairs,
    Alliance Healthcare, United Kingdom
    Mr David Goodman,
    Chief Executive Officer,
    Pharmascience, Canada
    Dr. Goodman is the Chief Executive Officer of Pharmascience, a Canadian fully-integrated pharmaceutical company involved in the development, manufacture and distribution of a broad line of generic and innovative products. Today Pharmascience is the second largest privately owned pharmaceutical company in Canada. Dr Goodman obtained his B.Sc. degree in Commerce from McGill University and a Ph.D. in pharmacology from the University of Virginia. Upon graduation, he began his career at Pharmascience in Business Development and has gained significant experience in progressively senior international and domestic roles. He most recently headed the company’s International operations as Executive Vice President. Under Dr. Goodman’s leadership, Pharmascience has gone from being a strictly Canadian company to becoming an important player on the global stage, with worldwide sales now in excess of $500 million – a growth rate of 25% over the past five years.
    Ms Mary Alice Hefford,
    Research Scientist, Centre for Biologics Research, Biologics and Genetic Therapies Directorate, ,
    Health Canada , Canada
    Dr. Hefford is a research scientist in the Centre for Biologics Research in the Biologics and Genetic Therapies Directorate at Health Canada. She has an undergraduate degree in organic chemistry, and has worked as a formulations chemist and a synthetic organic chemist. Dr. Hefford obtained her Ph.D. from the University of Ottawa where she studied protein chemistry and structure-function relationships in polypeptide hormones. She has post-doctoral training at the Clinical Research Institute in Montreal and the National Research Council of Canada in the areas of molecular biology and protein engineering. Dr. Hefford has also worked Agriculture Canada where she led a research group that focused on the de novo protein design. In 1996, Dr. Hefford joined Health Canada where she focuses on the development of physico-chemical methodology to assess the structure/folding of therapeutic protein in order to assure their safety and efficacy. Dr. Hefford is a member of the Biologics and Genetic Therapies Directorate Working Group on Subsequent Entry Biologics (follow-on biologics) Policy and Regulation. She is also an adjunct professor in the Department of Biochemistry, Microbiology and Immunology at the University of Ottawa.
    Dr Wei Huacheng,
    Chairman,
    Double-Crane Pharmaceuticals, China
    Dr. Huacheng Wei, holds position of Chairman of the Board at both Beijing Pharmaceutical Group Co., Ltd. and Beijing Double-Crane Pharmaceutical Co.,Ltd. two of leading pharmaceutical manufacturers and Marketers in China, and Chairman of Medical & Pharmaceutical Commercial Association of China Federation of Industry & Commerce. As one of China pharmaceutical industry leaders, Dr. Wei has been dedicated to the study and practice on “Theory of Longevity Enterprise”. In the paper of “Research of the longevity corporation—Corporate Culture and the Living Company” Dr. Wei has presented the model of the long-life corporation including the model of the living corporation. He has published many papers of corporate culture and globalization of China Pharmaceutical Company, etc. Dr. Wei networks also very actively with international pharmaceutical organizations and associations such as the BayHelix Groups, the Sino-American Pharmaceutical Association(SAPA) and so on. He has been invited to many international conferences as speaker. He received his PhD at China Huazhong University of Science & Technology (2005), MBA at Tsinghua University(1999).
    Mr Vijay Karwal,
    Managing Director - Healthcare Sector,
    The Royal Bank of Scotland
    Vijay Karwal is a Managing Director of The Royal Bank of Scotland (RBS), and is responsible for RBS' Healthcare Sector corporate finance coverage in the United States, based in New York. In addition, Vijay is actively involved in driving RBS' advisory coverage of the Specialty and Generic Pharmaceutical sector globally. With over 13 years of investment banking experience, Vijay was previously head of ABN AMRO's Healthcare Banking group in the United States. Prior to joining ABN AMRO's Healthcare group in 2003, Vijay spent over five years as a senior member of ABN AMRO Rothschild - the global equity capital markets joint venture between the Rothschild and ABN AMRO groups - based in London and New York, where he was responsible for all equity capital markets transactions in the healthcare sector. Having first joined the ABN AMRO group in Amsterdam in 1995, Vijay started his career as a member of ABN AMRO's North American Structured and Corporate Finance teams in Chicago. During his time at RBS and ABN AMRO he has been involved in a wide variety of advisory and (debt and equity) financing transactions for clients in the healthcare and other sectors, with a particular focus in specialty and generic pharmaceuticals. Vijay is a regular speaker at pharmaceutical industry conferences globally and has been a contributing author and commentator on the topic of generic pharmaceuticals to industry and popular media. He is also the host and chairman of RBS & ABN AMRO's landmark Annual Healthcare Conference traditionally held in Mumbai, India. He is a Chartered Financial Analyst, a member of the New York Society of Investment Analysts, and the UK Society of Investment Professionals.
    Dr Jeffrey Kelman,
    Chief Medical Officer, Center for Beneficiary Choices,
    Centers for Medicare & Medicaid Services
    Mr Markus H Meier,
    Assistant Director, Healthcare Division,
    Federal Trade Commission
    Markus H. Meier is the Assistant Director of the Health Care Division of the Federal TradeCommission’s Bureau of Competition in Washington, D.C. In this capacity, he has day-to-daymanagement responsibility for an office comprised of more than thirty lawyers, paralegals, andsupport staff. Markus also leads investigations and litigation involving alleged violations of theantitrust law by physicians and other health-care professionals, pharmaceutical companies,hospitals, and health plans. Markus joined the FTC in 1990.In January 1998, Markus left the FTC and was with the law firm of Collier, Shannon, Rill &Scott for a year and a half, where he worked on private antitrust litigation and counseling, andrepresented clients before the FTC and Department of Justice. Markus also has served as aSpecial Assistant United States Attorney, prosecuting criminal cases in the Eastern District ofVirginia, and a resident advisor to the Indonesian Competition Commission in Jakarta.Prior to joining the FTC, Markus served as an officer in the United States Army. He is agraduate of the George Mason School of Law, has a Masters in Public Administration degreefrom Old Dominion University, and a Bachelor of Arts degree from the University of Virginia.
    Dr Eric Mittleberg,
    Executive Vice President, Pharmaceutical Research & Development,,
    Par Pharmaceutical Companies, Inc.
    Dr. Eric Mittleberg is currently the Executive Vice President of Pharmaceutical Research and Development for Par Pharmaceutical, Inc. in Woodcliff Lake, New Jersey. In this capacity, Dr. Mittleberg is responsible for research and development, scientific and regulatory affairs and all pharmaceutical development efforts for Par’s Generic Division as well as for Par’s Branded Product Division, Strativa. Prior to joining Par, Dr. Mittleberg held the position of Vice President, Scientific/Medical Affairs for the IVAX Corporation. In this role, he was responsible for all generic product development, pharmacokinetic and regulatory affairs efforts for IVAX generic products, as well as responsible for operations of the medical affairs organization. Additionally, Dr. Mittleberg had operational responsibilities including technical services and technology transfer functions across multiple sites. He held global development responsibilities and chaired the Global Generic Development Steering Committee for IVAX. This steering committee managed all generic development globally and included subcommittees addressing global regulatory affairs, global intellectual property and global bioequivalence management. As Managing Director, IVAX India, he directed and managed these operations in multi-national development projects. Prior to his tenure at IVAX, Dr. Mittleberg held positions of progressive responsibility with Johnson and Johnson, Schering-Plough, Key Pharmaceuticals, Lederle Laboratories and Roche Laboratories. Dr. Mittleberg’s vast industry experience and demonstrated track record building and leading world class Scientific Affairs organizations uniquely qualifies him as an expert in these areas.
    Mr Tom Moore,
    President, Global Pharmaceuticals,
    Hospira
    Thomas G. Moore serves as president, Global Pharmaceuticals, for Hospira, where he is responsible for the long-term growth, global business strategy and management of Hospira's pharmaceutical product portfolio. Moore has 23 years of experience in the pharmaceutical industry. At Hospira's inception in 2004, Moore was named vice president and general manager, Specialty Injectable Pharmaceuticals. In this role, which he held until January 2007, he spearheaded the growth of Hospira's specialty pharmaceuticals business. Prior to his career with Hospira, Moore worked for Abbott Laboratories, where he held several management positions in operations, marketing, executive sales, contract marketing and new business development. He earned a bachelor's degree in microbiology from Loyola University of Los Angeles and a Doctor of Pharmacy degree from the University of Southern California.
    Ms Cathrin Petty,
    Partner,
    Apax Partners, United Kingdom
    Cathrin Petty is a Partner in the healthcare team focusing on global pharma and generics. She joined Apax Partners in 2000. She has spent the last 11 years in private equity, investing globally in biotech, medtech, pharma and generics companies from early stage to buy-outs. Her investments include Affymax Inc., Intercell AG, Zymogenetics Inc., Zeneus Pharma Ltd, Xanodyne Inc.and Qualitest Inc. Prior to joining Apax she was at Schroder Ventures Life Sciences and Schroders Investment Management. Cathrin has an MA in Natural Sciences from New Hall, Cambridge and a Diploma in Management Studies at the Judge Institute, Cambridge.
    Dr CB Rao,
    Deputy Managing Director ,
    Orchid Chemicals & Pharmaceuticals, India
    Mr Richard Silver,
    Senior Vice President ,
    Lehman Brothers
    Richard B. Silver is a senior vice president and senior research analyst with Lehman Brothers health care equity research team. His research coverage currently includes specialty pharmaceutical companies focused on generic drugs, mid-cap brand pharmaceuticals and drug delivery technology. Rich has been ranked in Institutional Investor magazine's annual "All-America Research Team" survey of equity analysts, most recently achieving Third Team status in 2007 in the Specialty Pharmaceuticals category. He has also been ranked highly in the Greenwich Associates survey. Rich's work experience includes 15 years as a senior specialty pharmaceutical analyst. Prior to joining Lehman Brothers, he was with Chase Manhattan Bank for four years as a credit analyst. Rich earned a B.A. from the University of Connecticut.
    Mr Vijay Soni,
    Executive Vice President – IP,
    Glenmark Pharmaceuticals
    Mr David Stark,
    Deputy General Counsel, ,
    Teva North America
    Mr Shashank Upadhye Esq,
    Vice President - Global Intellectual Property,
    Apotex, Canada
    Shashank Upadhye is the Vice President- Global Head of Intellectual Property Law for Apotex, Inc., a multinational pharmaceutical company. There, he manages the intellectual property department on a global basis, with emphasis on I.P. analysis, acquisition of I. P. rights, enforcement and defense litigation, and business development. Shashank is a recognized expert in the area of pharmaceutical regulatory & I.P. law. He has managed projects on a U.S. and global basis. He has litigated cases as a trial lawyer and appeals lawyer, including at the U.S. Supreme Court as amicus counsel. He advises his clients on I.P. and Regulatory law and policy, including legislative changes to them. A prolific author, he is the sole author of a 650 page seminal treatise on U.S. patent and FDA law, entitled Generic Pharmaceutical Patent and FDA Law, published by Thomson-West publishing. He is also the author of many full law review articles and other journal articles. Shashank regularly lectures at industry and legal events on key areas of patent law and litigation strategies, regulatory developments and law, and related antitrust issues. He also lectures on the practical, commercial, and strategic significance of legal developments. Shashank is the keynote speaker or Chair of some of the industry’s most important events.
    Mr Patrick Vink,
    Senior Vice President, Global Head of Biologics,
    Mylan Inc , Switzerland
    Patrick Vink is a citizen of the Netherlands, who, in addition to his doctorate of Medicine holds a post-doctorate Masters of Business Administration. Starting his professional career in the 80ies he held different positions at the Dutch affiliate of Sanofi until he became general manager Nutricia (a dutch babyfood company) in Hungary. Returning at Sanofi in Paris he was appointed as Vice-President global business unit Cardiovascular & Thrombosis. After joining Biogen he served as Vice-President Sales International. In 2002 he became a member of the worldwide executive committee at Sandoz as Global Head Business Unit Biopharmaceuticals at Sandoz. In this role he lad Sandoz’s activities in the Follow-on Biologics area. After leaving Sandoz in 2006, he was an independent advisor in the Life Sciences Industry and Investors in this industry. Per March 1, 2008 he is appointed at Mylan, holding global responsibility for all biologics business.
    Henry A Waxman,
    Congressman,
    US Congress
    Representative Henry A. Waxman represents California's 30th Congressional District. In 2007, Rep. Waxman became Chairman of the Committee on Oversight and Government Reform, the principal investigative Committee in the House. From 1997 to 2006, Rep. Waxman served as Ranking Member of the Government Reform Committee, conducting investigations into a wide range of topics from the high cost of prescription drugs to waste, fraud, and abuse in government contracting. He formed a Special Investigations Division that prepared hundreds of investigative reports on local and national topics for Members of Congress. From 1979 to 1994, Rep. Waxman chaired the Commerce Committee's Subcommittee on Health and the Environment. He served as the Subcommittee's Ranking Member in 1995 and 1996. Rep. Waxman continues to serve on the Committee on Energy and Commerce. Rep. Waxman has been involved in health issues since 1969, when he was appointed to the California State Assembly Health Committee. In Congress, Rep. Waxman has sponsored a long list of health bills that have been enacted into law. These measures include the Ryan White CARE Act, the Nutrition Labeling and Education Act, the Breast and Cervical Cancer Mortality Prevention Act, the Safe Medical Devices Act, the Patent Term Restoration and Drug Competition Act, and the Orphan Drug Act. Rep. Waxman has also passed legislation that improves the quality of nursing homes and home health services and that sets policy for childhood immunization programs, vaccine compensation, tobacco education programs, communicable disease research, community and migrant health centers, maternal and child health care, family planning centers, health maintenance organizations, and drug regulation and reform. Throughout the 1980s, Rep. Waxman championed national health care reform and improvements in the Medicare and Medicaid programs. He successfully led the fight for improved prenatal and infant care for low-income families, for protection against impoverishment for the spouses of persons in nursing homes, and for more services in the community for people needing long-term care. He has also been an advocate for prescription drug coverage in Medicare for people with high drug expenses. Prior to his election to Congress, Rep. Waxman served three terms in the California State Assembly, where he was chairman of the Health Committee, the Committee on Elections and Reapportionment, and the Select Committee on Medical Malpractice. He was the author of such major legislation as the Fair Campaign Practices Act, the Fair Credit for Women Law, and the legislation establishing standards for Health Maintenance Organizations in California. Rep. Waxman holds a bachelor's degree in political science from UCLA and a J.D. from the UCLA Law School.
    Mr Scott White,
    Chief Executive Officer,
    Aurobindo Pharma USA Inc.
    Mr. Scott White has over 15 years of experience in the generic pharmaceutical industry. In his most recent role as C.E.O., Mr. White has spent the last 2 years with the global pharmaceutical company Aurobindo Pharma, heading up their US operations. Before joining Aurobindo, Mr. White spent 7 years with IVAX Pharmaceuticals, prior to the acquisition of IVAX by Teva Pharmaceuticals. His generic pharmaceutical experience spans from injectables to inhalation and oral solid delivery systems for both generic and branded generic pharmaceuticals. Mr. White has a BS in Marketing and vast experience in the generic pharmaceutical business.
    Mr Andrew Willis,
    Vice President, Regulatory Affairs & Consulting Services, ,
    Catalent Pharma Solutions, United Kingdom
    Andrew Willis, VP, Regulatory Affairs & Consulting Services, Catalent Pharma Solutions. Andrew has over 20 years of experience in regulatory affairs and pharmaceutical development, with specific experience of EU and US registrations, CMC regulatory requirements and multiple clinical aspects related to successful registration of drug products. Andrew currently works for Catalent Pharma Solutions, and is a qualified chemist from the University of Glamorgan, he furthered his understanding of pharmaceutical development whilst working as a research chemist with Parke Davis. He had 8 years manufacturing and analytical experience prior to entering regulatory affairs as a Senior Executive Officer with responsibility for submission of European MAAs and project management of development programs. He has been an active member of BIRA (initially) and now TOPRA, presenting at symposiums and training seminars. He has significant experience in both OTC and generic development, presenting and providing advice to multiple clients on such developments. In addition, he is considered as an expert in life-cycle management, including management of life cycles for products with global turnover in excess of $1bn.
     

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