Mark Altmeyer
President and Chief Executive Officer
Otsuka America Pharmaceutical, Inc.

A seasoned and highly successful healthcare executive with over 25 years experience in the pharmaceutical industry, Mark Altmeyer joined Otsuka America Pharmaceutical, Inc. (OAPI) in January 2009 as President and Chief Executive Officer.

Committed to taking OAPI to the next level of growth and development, Mr. Altmeyer has strategically re-aligned its leadership by bringing in a team of accomplished industry leaders to complement the existing corps of talented executives. In addition to immediately strengthening OAPI’s relationships with its development and promotion partners, as president he oversaw the launch of Samsca©, an oral hyponatremia medication, positioning the company to operate in a new and exciting healthcare sphere. He has also embarked on a company-wide initiative to enhance the current sales and marketing organizations with additional best-in-class talent, establishing OAPI as an independent marquis healthcare brand throughout the U.S.

Mr. Altmeyer earned his well-deserved reputation as a drug commercialization strategist and leader prior to coming to Otsuka. Developing an impressive background in pharmaceutical sales and marketing, he spent over sixteen years with Bristol-Myers Squibb Co. rising from Sales Representative to Senior Vice President, Global Commercialization. During those years, he also held positions of increasing importance including product manager, director, senior director, vice president and senior vice president, delivering on premier brands including Pravachol, Glucophage, and ABILIFY.

Extending his successes beyond the U.S. market, Mr. Altmeyer worked internationally as the general manager of BMSs operations in Turkey. This led to his appointment as Senior Vice President, Global Commercialization. In that position, he was responsible for the global marketing of all neuroscience and oncology assets – the therapeutic areas on which Otsuka is focusing, and which will help us drive Otsuka’s future, rapid growth.

Prior to joining BMS in 1992, Mr. Altmeyer devoted his efforts to marketing and development for Cetus Corporation, both as a product manager in oncology and a business development manager. He started his career with Bristol Labs, a division of Bristol-Myers, as a marketing associate and group product analyst.

Mr. Altmeyer earned his Bachelors of Arts Degree from Middlebury College in Vermont, and his Masters in Business Administration from Harvard Graduate School of Business. Active in the healthcare arena as well as his own community, he is on the Board of Directors for both Contact of Mercer County and the Trinity Counseling Service. In addition he also serves as a Middlebury College Alumni Recruiter. He, his wife Sharon, and their three children reside in Princeton, NJ.

 

Mike Chace-Ortiz
Senior Director of Product Strategy
Thomson Reuters

Mike Chace-Ortiz is responsible for managing the long-term development of our products and services for generic companies and innovators. He joined Thomson Reuters (then Newport Strategies) in 2003 and has held a number of roles within the company including leading the Custom Solutions Team, product specialist and new business development Director.

With 15 years in life sciences, Mike has experience of the generic pharmaceuticals industry, APIs, innovator discovery, research, pre-clinical and clinical development, regulatory and commercial processes as well as pharmaceutical information systems. Previously, Mike was a Managing Consultant with PA Consulting Group’s Life Science & Technology practice in Cambridge, MA. He has also held management positions in the Life Science practices of Barnett International/PAREXEL and with Deloitte Consulting in Philadelphia, and Bath, UK.

He obtained a Master of Engineering in Electronics, is a member of the Institute of Electrical Engineers, a Chartered Engineer and in 1985 received the Telecom Equipment Manufacturer’s Association (TEMA) Award for Excellence in R&D.

 

David H. Donabedian, PhD, MBA
Vice President, Strategic Alliances
US CEEDD, GSK

Dr. Donabedian joined the CEEDD in 2009. In his role he will be identifying and evaluating new business opportunities for the US CEEDD. Prior to the CEEDD, Dr. Donabedian was a principal of his own consultancy practice which he started in June 2007, providing business development services to emerging biotechnology companies. He has sourced and closed agreements with biopharmaceutical companies and academic institutions and has served as CEO, COO, SVP and VP of Business Development and in other senior management positions for companies such as BioChemics, Tutorzilla, Surface Logix, Accenture, Dow Chemical and Boston Scientific managing all levels of Business and Strategic Development.

He has been responsible for the development and implementation of business development strategies (in and out-licensing), identifying potential strategic relationships and has led a product development team specializing in developing, and patenting a broad range of technologies to the life sciences industries.

David began his research career as a scientist with SciMed Life Systems (a division of Boston Scientific) where he developed novel bioadhesives to treat abdominal aortic aneurysms. He received an A.B. from St. Anselm College, a Ph.D. in Polymer Chemistry from the University of Massachusetts Lowell and an M.B.A. from the University of North Carolina Chapel Hill.

 

Dimitri Drone
Transaction Services Pharmaceutical and Life Sciences Leader
PricewaterhouseCoopers

Dimitri is the leader of PricewaterhouseCoopers’ Transaction Services Life Sciences sector. Dimitri advises corporate clients on the structuring of complex merger & acquisition transactions, alliances, partnerships and joint ventures, as well as minority and early-stage investments to successfully integrate and address accounting, financial reporting, corporate finance, and valuation challenges. In addition, he is a leading advisor within the Firm to clients on valuation principles, methodologies and critical assumptions employed in various business enterprise, intangible asset and security valuation exercises across the spectrum of companies in the pharmaceutical and life science sectors.

Dimitri is a leader in the Firm’s thought leadership efforts on the financial reporting rules surrounding valuation and has formulated the key implications and strategic insights for deal principals and various industry participants to consider. In addition, he has worked closely with the Firm’s National Office and valuation professionals to understand, interpret and shape the new rules, both from a financial reporting as well as a valuation perspective.

Dimitri, a CPA and a CFA, received his MBA in finance and economics from the University of Chicago and his BS in accounting from Bucknell University.

 

Stephen Evans-Freke
Co-Founder and Managing General Partner
Celtic Therapeutics

Stephen Evans-Freke is Co-Founder and Managing General Partner of Celtic Therapeutics, a global private equity firm focused on the pharmaceutical industry and of its predecessor firm, Celtic Pharma, which he established in 2004.

Mr. Evans-Freke has been associated with the biotechnology industry for thirty years, as an investment banker, asset manager, entrepreneur, company CEO and venture capitalist. During the 1980s, he was lead investment banker to Genentech, AMGEN, Centocor and a number of other leading biotech companies, structured and placed over $600 million of highly successful R&D partnership financings and served on the Development Boards of these companies. During this period, Mr. Evans-Freke was President of PaineWebber Development Corporation and later a member of PaineWebber Inc.’'s Board of Directors.

In 1990 Mr. Evans-Freke left Wall St. and founded Selectide Corporation, one of the first combinatorial chemistry companies, for which he served as Chairman until its sale to Hoechst in 1994. In 1991, Mr. Evans-Freke co-founded SUGEN together with Drs. Joseph Schlesinger and Axel Ullrich as the scientific founders, with the vision to build a drug discovery company focused on small molecule kinase and phosphatase inhibitors. He served as SUGEN Chairman and Chief Executive Officer through its IPO with Morgan Stanley in 1995 and until its sale to Pharmacia for $720 million in 1999. Over this period Mr. Evans-Freke was also a co-founder of Fibrogen, Inc. and Royalty Pharma AG, in the latter case serving as a Managing General Partner and then Board and Executive Committee member until 2004.

Stephen Evans-Freke sits on the Boards of Cibus Global, Ltd. (Chairman) Cross Match Technologies, Inc. and Inspiration Biopharmaceuticals, Inc. Mr. Evans-Freke also serves on the 800-Year Anniversary Appeal Board of Cambridge University, from which he holds a Degree in Law. Mr. Evans-Freke also sits on the Board of the Christopher and Dana Reeve Foundation and on the Cambridge Stem Cell Board. Mr. Evans-Freke is a citizen of the U.K. and Ireland and has been a resident of the U.S. for 28 years.

 

David Fox
Partner
Hogan Lovells US LLP

David Fox has a leading practice in the regulation of new drugs and biological products, and also maintains a practice in the field of combination products.

David served for more than six years with the Food and Drug Administration (FDA), as Assistant Chief Counsel for Enforcement from 1994 to 1995 and as Associate Chief Counsel for Drugs from 1995 to 2000. 

He has extensive experience in the approval process for new drugs and biological products, as well as the regulation of generic and follow-on products. David works with pioneer pharmaceutical and biotechnology sponsors, and is frequently consulted on life cycle management issues, including Orphan Drug, Pediatric, and Hatch-Waxman exclusivity matters, patent listing and Orange Book issues, and implementation of section 505(b)(2) of the Food, Drug, and Cosmetic Act.

 David assists clients in taking a critical approach to exclusivity issues, bioequivalence standards, dosage form innovations, and a range of questions related to pharmaceutical labeling. David works closely with Hogan Lovell’s patent litigation and product liability teams, as well as the firm’s health care and white collar crime groups. He assists clients on corporate transactional matters, including assessment of opportunities in the life sciences markets, and he works closely with our European and Asian offices on providing global regulatory advice to the firm’s pharmaceutical and biotechnology clients. 

David also has extensive experience in the regulation of over-the-counter (OTC) drug products, controlled substances regulated by the Drug Enforcement Administration (DEA), drug naming and medication errors, user fees, advertising and promotion, and clinical trials. While at the FDA, David served as counsel to the Division of OTC Drug Products, counsel to the Office of Generic Drugs, and counsel to the Office of the Ombudsman and Chief Mediator (now the Office of Combination Products). In 2005, he published with a colleague a leading text on the regulation of combination products. Prior to joining the FDA, David spent five years as a trial attorney in private practice.

David has made numerous presentations on Hatch-Waxman issues, the Generic Drug Approval Process, Life Cycle Management for Pioneer Manufacturers, the Regulation of OTC Drug Products, and the FDA’s Regulation of Combination Products.

Chris Garabedian
Vice President, Corporate Strategy
Celgene Corporation

In a career spanning nearly 20 years, Chris has held leadership positions for two of the most successful international biopharmaceuticals companies, and has served in both operational and strategic / business development roles and within all of the primary functional areas of commercial, R&D, and corporate finance.

Chris currently is the Vice President of Corporate Strategy for Celgene Corporation, where he is responsible for supporting the company’s executive management in helping shape the long-term corporate vision, proprietary R&D portfolio and strategic M&A. Chris oversees the company’s annual strategic and financial plan and he played a lead role in executing the company’s $2.9 billion acquisition of Pharmion in 2008.

Prior to Celgene, Chris served in several global leadership roles at Gilead Sciences, including as Vice President of Corporate Deve lopment, Vice President of Marketing, and Vice President of Medical Affairs. During his tenure at Gilead, Chris led the global product launches of four market-leading products in the infectious disease markets of HIV and Hepatitis, which contribute over $5 billion in sales worldwide. Additionally, Chris supported the company’s growth through business development, strategic planning, and alliance management. Chris’ various roles at Gilead contributed to its growth from a market capitalization of less than $1 billion to its current leadership position in the biopharmaceutical industry (with a market capitalization of over $40 billion).

Chris also served in product management and new product development roles at Abbott Laboratories and COR Therapeutics. He started his career as a consultant with Migliara/Kaplan Associates, where he managed numerous strategic projects for pharmaceutical clients across a variety of therapeutic disease areas.

Chris received a BS in Marketing from the University of Maryland and has spoken frequently at industry conferences and leading business schools on a variety of topics related to the biopharmaceutical industry.

 

Simeon J. George, M.D.
Partner
SR One

Simeon joined SR One in 2007. Simeon serves as a member of the Board of Directors of Anaphore and Genocea Biosciences and as an observer at Rib-X and Syntaxin. Prior to joining SR One, Simeon was a consultant at Bain & Company and an investment banker at Goldman Sachs and Merrill Lynch. Simeon earned his M.D. degree from the University of Pennsylvania School of Medicine and his M.B.A. degree from the Wharton School of Business, where he was a Mayer Scholar. He holds a B.A. in Neuroscience from the Johns Hopkins University, where he graduated Phi Betta Kappa.

 

Adam Golden
Partner and Co-Chair, Life Sciences Group
Kaye Scholer LLP

Adam Golden is a Partner and Co-Chair of the Corporate & Finance Department of Kaye Scholer LLP. A leader in Kaye Scholer’s esteemed Life Sciences practice, Mr. Golden heads the firm’s Life Sciences Transactional group.

Mr. Golden’s practice focuses on structuring and negotiating complex business transactions, including mergers and acquisitions, joint ventures, and the full range of licensing and collaboration transactions common to the life sciences sector. He has also represented both issuers and investors in public and private securities offerings, including venture capital, private equity and PIPE financings.

Mr. Golden has substantial experience representing clients for whom intellectual property is a key asset. As a lawyer with a background in science, he brings an in-depth understanding of the technology involved in transactions for the benefit of his clients. His clients include companies in the pharmaceutical and biotechnology, chemicals, information technology, healthcare services, medical devices, defense, consumer products, finance and alternative asset management industries. Mr. Golden’s practice is international in scope, and his clients range in size from multibillion-dollar global businesses to emerging-stage companies.

Chambers USA: America’s Leading Lawyers for Business (2009) recognized Mr. Golden and rated Kaye Scholer’s multidisciplinary Life Sciences practice as being among the strongest in the nation, winning praise for “comprehensive service” with a “results-oriented approach and deep understanding of the market.”

 

Wendy Goldstein
Member of the Firm
Epstein Becker & Green PC

Wendy C. Goldstein is a Member of the Firm in the Health Care and Life Sciences Practice in the firm’s New York office and chairs the Pharmaceutical Industry Health Regulatory Practice Group. Ms. Goldstein concentrates in health care fraud and abuse and government health care program matters relevant to manufacturers and to managed care payors, including:

• Counseling clients regarding the research, manufacture, sale, promotion, distribution, pricing and import/export of pharmaceuticals, biologics and medical devices. Such counsel includes topics relating to fraud and abuse, FDCA, PDMA, third party coverage and reimbursement (government and commercial), Medicaid Drug Rebate and other government pricing programs, corporate compliance, privacy, antitrust, Medicare Part D program and state law issues
• Representing manufacturers with respect to managing government health care program compliance risks, including providing design, implementation and effectiveness assessments of corporate compliance programs, conducting internal investigations and voluntary self-disclosures and preparing OIG advisory opinion requests
• Drafting and negotiating co-promote agreements, drug rebate agreements, supply chain arrangements, fee-for-service agreements and third-party vendor arrangements. Conducts health regulatory due diligences
• Defending pharmaceutical manufacturers in all phases of government investigations and inquiries, and negotiates settlement agreements and OIG corporate integrity agreements on behalf of manufacturers in connection with the resolution of qui tam and other government actions
• Counseling third-party payors in connection with the outpatient prescription drug benefit and specialty drug benefit programs offered under insured (commercial and government) and self-insured products. Such counsel includes topics relating to fraud and abuse, reimbursement, coverage, relationships with vendors such as PBMs and dispensers, Medicare Part D, ERISA, corporate compliance, privacy, antitrust and state law issues

Ms. Goldstein speaks and writes extensively on issues relating to fraud and abuse, government program pricing, corporate compliance, government enforcement activity relevant to the pharmaceutical and managed care industries and health care reform. She is a contributing author to the ABA Health Law Section Pharmaceutical Law treatise. Ms. Goldstein has served as an adjunct professor of health care fraud and abuse at Pace University School of Law.

Ms. Goldstein was ranked by Chambers USA as one of America’s leading lawyers for health care in 2008 and 2009 and was honored as among the “"Top 50 Women Lawyers in New York” by New York Super Lawyers in 2006, 2007 and 2009 and the top lawyers in New York by New York Super Lawyers in 2006, 2007, 2008 and 2009. She also was named as one of Nightingale’s Outstanding Young Healthcare Lawyers in 2007.

Ms. Goldstein serves on the firm’s Strategic Planning Committee. She also is the Chair of the firm’s Health Care and Life Sciences Practice.

 

Elaine V. Jones, Ph.D.
Executive Director, Venture Capital- Worldwide Business Development
Pfizer Inc.

Elaine V. Jones, Ph.D. recently joined Pfizer Venture Investments as Executive Director, Venture Capital. She will be responsible for making and managing venture investments for Pfizer and currently is responsible for PVI investments in Merus B.V. (Utrecht, The Netherlands) and Flexion Therapeutics (Boston, MA). Elaine brings 10 years of venture capital experience and a strong background in research and product assessment, built on her significant experience in pharmaceutical drug discovery and business development to the PVI team.

Most recently, Elaine was a General Partner with the venture fund, EuclidSR Partners. There, she was responsible for the fund’s investments in Acurian, Fluidigm, InnaPhase and Targacept.

Prior to joining ESR, Dr. Jones began her private equity career in 1999 at S.R. One, GlaxoSmithKline’s venture fund, where she managed investments including Adolor, Avantium, Nucleonics, Scynexis and Vicuron. Previously, she served as Director of Scientific Licensing for SmithKline Beecham and was a research scientist in SmithKline Beecham Pharmaceutical R&D.

Dr. Jones is a graduate of Juniata College and received her Ph.D. in Microbiology from the University of Pittsburgh.

 

Jessica Kirk
Vice President - Life Sciences
Gerson Lehrman Group

Jessica Kirk is Vice President, at Gerson Lehrman Group. Jessica leads the relationship management team working with clients in pharma, medical device, and biotech. Prior to GLG, she was Director of Member Services at the Corporate Executive Board, a best practices research firm. She managed relationships with Chief Information Officers and Chief Information Security Officers as they looked to benchmark their organizations. Earlier Jessica worked as an IT consultant at JP Morgan, where she developed and deployed enterprise-wide training on proprietary and packaged tools. She earned her BA in English from Bryn Mawr College.

 

Julius Knowles 
Head, Platforms, Strategic Alliances
Novartis Institutes for BioMedical Research

Julius (Jay) Knowles joined Novartis in 2006 and is currently Head, Platforms, Strategic Alliances. Jay’s team looks for platform technologies and drug discovery collaborations globally across all therapeutic areas through to clinical proof of concept.

Previously, Jay was founder and President of Novalar Pharmaceuticals, a specialty pharmaceutical company that recently launched their first drug. Prior to this, he was Vice President, Business Development, at Structural Genomix, and Director, Research and Development Planning at Vertex Pharmaceuticals. He has an MBA in Finance from Wharton Business School, an M.Sc. from UC Berkeley in Chemistry, and a B.A. in Chemistry with Distinction from Carleton College.

 

Reid J. Leonard, Ph.D.
Executive Director, Licensing & External Research
Merck Research Laboratories

Dr. Reid Leonard is Executive Director, External Research and Licensing for the Merck Research Laboratories, Merck & Co., Inc. His home base is Merck’s research facility in the Longwood Medical Area of Boston, Massachusetts, USA.

Reid’s role is to identify partnering opportunities that fit with Merck’s strategic research and development objectives in key franchise areas. Such opportunities may reside in universities, start-up companies, or established bio-pharma firms. As part of Merck’s global licensing team, Reid is one of several regional scientific assessment professionals deployed around the world to build relationships, provide guidance on Merck’s licensing interests, and serve as a local contact for companies and institutions with which Merck can collaborate to develop best-in-class therapeutics for serious unmet medical needs. Reid’s geographic area of responsibility includes the Eastern United States and Latin America with supervisory responsibility for scientific assessment in Canada and India.

Dr. Leonard’s research career in neuroscience and cell physiology began while an undergraduate at Brandeis University where he earned a B.A. in Biology and Psychology. Reid subsequently earned a Ph.D. in biology from Purdue University and completed postdoctoral training in molecular pharmacology at the California Institute of Technology. He joined Merck Research Laboratories in 1989 to carry out basic and discovery research on ion channels and moved into the scientific licensing organization in 1998. Since that time, Reid has held a variety of assignments contributing to the identification, scientific assessment, and execution of academic and biotech partnership agreements for Merck & Co., Inc.

 

Rod MacKenzie
Senior Vice President, Head of PharmaTherapeutics R&D
Pfizer Inc

Rod MacKenzie is Senior Vice President, Head of Worldwide Research for the PharmaTherapeutics division of Pfizer. He leads the organization responsible for bringing forward the next generation of positive Proof of Concept molecules to Pfizer Business Units, and for executing the overall Research Strategy.

Rod joined Pfizer in Sandwich in 1986 as a Research Scientist and worked in many medicinal chemistry programs in the cardiovascular, GI, Sexual Health, Urology and Allergy & Respiratory Therapeutic Areas. Rod is the co-inventor of darifenacin (EnablexTM).

Rod was appointed as Vice President, Head of Discovery Chemistry in Sandwich in 2000. In May 2001, he relocated to the US to take up a new post as Vice President, Discovery Technology Center in Cambridge, Massachusetts. In November 2003, Rod was named Vice President, Discovery Research, for Pfizer Global Research and Development in Michigan and in 2006 he was appointed to Senior Vice President, Drug Safety R&D and Comparative Medicine. He was appointed Senior Vice President, Head of Worldwide Research in February 2007, and subsequently to his current role in 2009.

Rod graduated from the University of Glasgow in 1981 with a 1st Class Honors degree in chemistry and completed his PhD at Imperial College, London in 1984. He was awarded a NATO Postdoctoral Research Fellowship and spent two years at Columbia University, New York working in the area of molecular recognition.

 

Michael Mentesana
US Pharmaceutical and Life Sciences R&D Advisory Services Leader
PricewaterhouseCoopers

Michael is a dynamic consulting executive with more than twelve years of experience assisting organizations improve business performance by leading the development and deployment of new strategies, processes, and technology. He has global experience in the consulting, pharmaceutical planning and financial services industries. His area of expertise has been assisting firms to achieve transformational change through operations improvement.

Michael is the US Pharmaceutical and Life Sciences R&D Advisory Services Leader for PricewaterhouseCoopers’ and is based in New York City. He is primarily focused on integrated operations and business planning, project management, and organization development. His areas of specialization include: senior management decision support, demand management, portfolio visualization, operational planning and operational strategy development, organization design, process improvement/reengineering. He has developed both strategic and tactical programs to help organizations define and implement desired changes, as well as foster the leadership skills needed for the new environment.

Prior to joining PwC, he was the founder and president of Intendere Consulting, a specialized consultancy established to develop and execute practical integrated operations and business planning strategies for pharmaceutical and biotechnology companies. While at Intendere, Michael led projects for both large- and medium size pharmaceutical organizations, helping them achieve greater efficiency through the development of operations planning organizations, systems, processes and tools. Earlier in his career he was a management consultant in the Life Science Strategy practice at Deloitte Consulting based in New York City.

Currently, Michael is leading a global R&D transformation effort for a multi-national pharmaceutical organization based in Manchester UK with the design, development and implementation of a global R&D operational planning operating model and organization unit. Throughout the past few years Michael has led:

− The design and development of an operational planning operating model and cross-functional organization strategy for a biopharmaceutical research company based in San Francisco

− An executive assessment and review of R&D operations planning for a biopharmaceutical company based in Pennsylvania.

− The design and development of a global complaint management operating model and organizations structure for a major device and generics manufacturer based in Illinois

− The global operational planning strategy development for a major biopharmaceutical firm based in Massachusetts.

− The design of a regulatory operating model/business process and FDA communication strategy for a multi-national pharmaceutical organization based in Paris.

− The design, development and implementation of an operational planning operating model and organization unit for the global operations function of a multinational pharmaceutical organization based in New Jersey.

Michael holds a B.S. in Industrial / Organizational Psychology and a B.S. in Biology from Brooklyn College and a M.A. in Organization Psychology from Columbia University. He is a visiting professor for several universities and teaches Organization Behavior and Leadership. Michael is a program committee member of the DIA.

 

Veronica Mullally
Partner
Hogan Lovells

Veronica Mullally is a partner in the New York office of Hogan Lovells. She concentrates her practice on patent litigation and counseling. Veronica is a registered patent attorney with extensive trial experience. Her litigation experience includes disputes involving a wide range of technologies including: pharmaceuticals, biologics, siRNA, gene sequencing, transgenic plants, cardiovascular stents, LED’s, lighting consoles, medical devices and mechanical products. She has also drafted opinions of counsel for products ranging from drugs and chemicals to DNA microarrays and nanotechnology. Veronica is a member of the Hogan Lovells’ global team providing due diligence services to investors in various technologies.

Before attending law school, Veronica was a biochemist and did post-graduate research in endocrinology. She later joined a leukemia research team at the John Radcliffe hospital in Oxford, UK, studying purine and pyrimidine metabolism. She went on to become a research scientist at Celltech, Ltd., UK, where she helped develop some of the first diagnostic uses of monoclonal antibodies.

Veronica is recognized as a “key individual” in the Chambers Global review of Lovell’s life sciences practitioners.

REPRESENTATIVE EXPERIENCE

• Enforcing pioneering patents on cardiovascular stent devices and obtaining verdicts of infringement in successive jury trials against multiple defendants and obtaining multi-million dollar damages awards against each defendant.
• Multiple biotechnology infringement suits concerning transgenic plant products, all of which were resolved by either favorable settlement or success at trial.
• Multiple Hatch-Waxman infringement cases for a major US ophthalmic pharmaceutical company. All of which were resolved successfully by obtaining a favorable settlement or by obtaining summary judgment.

 

Garry Neil, MD
Corporate Vice President, Corporate Office of Science & Technology
Johnson & Johnson

Garry Neil, M.D. is Corporate Vice President, Corporate Office of Science and Technology (COSAT), Johnson & Johnson. In this role, Garry leads a team that catalyzes sustained growth for Johnson & Johnson by identifying and launching emerging technologies that underpin the creation of future businesses.

Garry has broad experience in science, medicine and pharmaceutical development. He has held a number of senior positions within J&J, most recently Group President, Johnson & Johnson Pharmaceutical Research and Development where he was responsible for maximizing existing strengths and leveraging collective resources to bring innovative new molecular entities (NMEs) to market quickly and cost effectively

. Through a number of new initiatives he helped transform J&J’s pharmaceutical R&D to a much more capable and productive organization and helped recruit a number of top scientists. Under his leadership a number of important new medicines for the treatment of cancer, anemia, infections, central nervous system and psychiatric disorders, pain, and genitourinary and gastrointestinal diseases, gained initial or new and/or expanded indication approvals.

Garry joined J&J in 2002 as Senior Vice President of Drug Development at Johnson & Johnson Pharmaceutical Research & Development (J&JPRD). In 2005, Garry became President of J&JPRD, and in 2006, was promoted to Group President. Before joining J&JPRD, he held senior-level positions with Astra Merck Inc., Astra Pharmaceuticals, Astra Zeneca and Merck KGaA. He has also held a number of academic posts at a number of academic institutes including the Ludwig Institute for Cancer Research, the University of Toronto, the University of Iowa College of Medicine and the University of Pennsylvania (adjunct).

Garry has written more than 50 articles and book chapters. He holds a Bachelor of Science degree from the University of Saskatchewan and a medical degree from the University of Saskatchewan College of Medicine and completed his postdoctoral clinical training in internal medicine and gastroenterology at the University of Toronto. He also completed a postdoctoral research fellowship at the Research Institute of Scripps Clinic. He is a Fellow of the American College of Physicians, a Fellow of the American College of Gastroenterology, a member of the American Association of Immunologists, and the Society for Clinical Trials, and a member of the Life Sciences Leadership Council of the University of Michigan. He is a member of the Boards of the Reagan Udall Foundation and the J&J Development Corporation and is J&J’s representative to, and Chairman of, the Pharmaceutical Research and Manufacturers Association (PhRMA) Science and Regulatory Executive Committee, Chairman of the PhRMA Foundation Board, Chairman of the Scientific Advisory Board of the Center for Advanced Biotechnology and Medicine (Rutgers), a member of the Executive Committee of the Biomarkers Consortium, and Vice Chairman of the Board of Trustees of the Newark Boys Chorus School. He is also the 2007 discovery awardee of the American Geriatrics Society.

 

Richard C. Pasternak, M.D.
VP, Head Global Scientific Affairs and Scientific Leadership
Merck

Since December of 2008 Dr. Richard C. Pasternak has held the position of Vice President, Head of Global Scientific Affairs and Scientific Leadership in Merck Research Laboratories. In this role, his responsibilities include identifying external business, medical, and scientific alliances and the implementation of franchise specific scientific leadership strategies, processes and technologies globally. In addition, he oversees the Merck investigator initiated studies program and the Global Medical and Scientific Publishing department which houses the Merck Index and Merck Manuals. He has served as a key Senior Executive in a communications role for Merck regarding critical issues related to scientific affairs, and has been a policy liaison for medical and scientific issues with the Merck Public Policy group and the Washington DC office, with visits to Capitol Hill and the White House. He has been engaged in Merck’s emerging market activities, particularly in China as the sponsor of the Merck-Oxford-Fuwai collaboration. He also chaired the R & D oversight committee for the Merck-Schering Plough Joint Venture on cholesterol development. Dr. Pasternak joined Merck Research Laboratories in September 2004 as Vice President, Clinical Research, Cardiovascular / Atherosclerosis where he was responsible for all clinical trials and related clinical strategies and activities within a newly merged Cardiovascular/ Atherosclerosis therapeutic area.

Prior to joining Merck, Dr. Pasternak was Director of Preventive Cardiology and Cardiac Rehabilitation at the Massachusetts General Hospital, and an Associate Professor of Medicine at Harvard Medical School. On the Harvard faculty since 1983, he served as Director of the Coronary Care Unit at Beth Israel Hospital, and moved to the Massachusetts General Hospital in 1992 to establish a Section of Preventive Cardiology. He received his B.A. and M.D. from Yale University and completed his medical internship and residency training, and cardiology fellowship at Massachusetts General Hospital.

Dr. Pasternak has had a long-standing research interest in lipid disorders and atherosclerosis, as well as prevention and patterns of practice and disease management in cardiology. He has been a member of the NIH’s Coordinating Committee of the National Cholesterol Education Program (NCEP) and of the third Adult Treatment Panel (ATP III) which issued the most recent set of U.S. guidelines on cholesterol. He has served on many national committees, and in leadership roles, for the American College of Cardiology and the American Heart Association, and he is the author of over 100 publications. He continues to have active roles in both the American Heart Association and the American College of Cardiology. More recently he has spoken nationally and published on cardiovascular drug development, biomedical research, and industry-academic collaboration.

For many years, Dr. Pasternak maintained an active interest in Clinical Cardiology with his own clinical practice at the Massachusetts General Hospital, where he also served as the Medical Director of the Cardiology Practice Plan.

 

Mark Powell
Senior Vice President, Pharmaceutical Development
Bristol-Myers Squibb

Dr. Powell is currently the Senior Vice President and head of Pharmaceutical Development at Bristol-Myers Squibb. He is responsible for the planning and directing of all pharmaceutical development activities for all BMS compounds (small molecules and biologics) in Global Pharmaceutical Development, as well as supporting globally manufactured products as necessary. Pharmaceutical Development laboratories are located on 7 research campuses in the United States, UK, India and Belgium. In addition to his functional responsibilities, Mark was the Head of the Diabetes Exploratory Development Team at BMS from 2000-2005. In that capacity he was responsible for the pharmaceutical, preclinical, and exploratory clinical development and progression of all diabetes compounds transitioning out of discovery and into late phase clinical development.

Dr. Powell obtained his Ph.D. from the University of Washington in 1980 and has worked in the pharmaceutical industry for 30 years. His professional experiences have encompassed all aspects of preclinical, clinical and pharmaceutical development, from discovery lead compound optimization and selection through to final regulatory submission and successful global product launches of both new compounds and life cycle management projects, as he has assumed increasing responsibilities throughout his career.

Dr. Powell has authored and co-authored more than 125 scientific articles and presentations which have been made at the local, national and international level, as well as given numerous invited talks. He has participated in, and moderated, many scientific discussion panels at both national and international meetings and has chaired an international scientific conference.

 

Paunie Samreth
Reporter
mergermarket

Paunie Samreth is a healthcare reporter at mergermarket (part of the Financial Times Group), covering corporate strategy including joint ventures, partnerships, and M&A. mergermarket specializes in providing forward-looking origination and deal flow opportunities integrated with a comprehensive deals database.

 

Dr. Robert J. Spiegel, M.D.
Former Chief Medical Officer and Senior Vice President, Schering-Plough Corporation
and
Founder, Spiegel Consulting LLC

Robert J. Spiegel, M.D., FACP served as Chief Medical Officer and Senior Vice President, Schering-Plough Research Institute (SPRI) until end 2009. He served as medical liaison to the company’s global marketing units as well as to its business development function. Dr. Spiegel also chaired Schering-Plough’s Safety Review Board (SRB) and Preparedness Response Process (PReP) and had direct responsibility for Global Pharmacovigilance.

Dr. Spiegel came to SPRI in 1983 as director, clinical research (oncology), and held positions of increasing managerial responsibility, including Vice President, Worldwide clinical research (all therapy areas). He was also a member of the company’s Strategic Licensing Board and Operations Management Team.

Dr. Spiegel earned his B.A. from Yale University and M.D. from the University of Pennsylvania. Following his residency in internal medicine he completed a fellowship in medical oncology at the National Cancer Institute, NIH. Before joining the pharmaceutical industry, Dr. Spiegel served as director of the Developmental Therapeutics Program at New York University Cancer Center and as assistant professor at New York University Medical Center (Department of Medicine). He served as adjunct assistant professor at NYU until 2005.

Dr. Spiegel has published over 70 scientific papers and serves on the Board of Directors of Cancer Care, Inc. and the Cancer Institute of New Jersey. He has special research interest in biological approaches to cancer therapy. He also has received numerous academic awards and fellowships, including the National Institutes of Health Biomedical Research Support Program Grant; Leukemia Society of America Special Fellowship; Mary Ellis Bell Prize of the University of Pennsylvania; and Student American Medical Association National Research Forum First Prize.

Dr. Spiegel now serves on the Boards of a number of biotechnology companies and is the founder and principle of Spiegel Consulting LLC.

 

Elizabeth Stoner, M.D., M.S.
Managing Director
MPM Capital

Dr. Elizabeth Stoner joined MPM in 2007 following a 22-year career at Merck Research Laboratories. At the time of her retirement from Merck, Dr. Stoner was Senior Vice President of Global Clinical Development Operations with responsibility for the company’s clinical development activities in more than 40 countries. She also oversaw the clinical development activities of Merck’s Japanese partner Banyu, led the clinical development for the Merck/Schering-Plough Joint Venture for Zetia/Vytorin, and played a critical leadership role in Merck’s efforts to transform its worldwide clinical development operations. Earlier in her career at Merck, Dr. Stoner led the entire Proscar clinical development program from inception, establishing Merck as a leader in the field of prostate disease. As Endocrine Therapeutic Head, Dr. Stoner’s responsibilities included all steroid and lipid metabolism, as well as the growth hormone secretagogue clinical research programs. Prior to Merck, she was an Assistant Professor of Pediatrics at Cornell University Medical College. Dr. Stoner received a B.S. in Chemistry from Ottawa University, KS, an M.S. in Chemistry from the State University of New York at Stony Brook, and an M.D. from Albert Einstein College of Medicine.

Present Boards

Metabasis Therapeutics, Inc. (NASDAQ:MBRX)
Momenta Pharmaceuticals, Inc.

Portfolio Assignments

Elixir Pharmaceuticals, Inc.
Solasia Pharma K.K., Scientific Advisory Board

Robert L. Ullmann
Chair, Government Investigations and White Collar Defense
Nutter McClennen & Fish LLP

Robert L. Ullmann is a veteran trial lawyer and former federal prosecutor who heads the government enforcement and white collar practice at Nutter McClennen & Fish LLP in Boston, one of the region’s most extensive practices in defending criminal and civil government enforcement cases.

As a criminal defense attorney, Bob’s courtroom successes include acquittals in health care and securities fraud cases of national import. In numerous criminal probes, he has persuaded the U.S. Justice Department not to bring charges against corporate officers and others who had received “target” letters, signifying probable indictment. He has also handled many high-stakes non-criminal cases, ranging from a $100 million False Claims Act case to a trademark trial, to the defense of legal malpractice matters for one of the country’s largest law firms.

Bob has counseled scores of clients ranging from Fortune 100 companies and their top officers to nonprofit entities and government officials. He has handled significant cases in the areas of health care, securities, government contracts, export control, insurance and tax.

Prior to entering private practice Bob served for more than ten years with the Justice Department, including as First Assistant U.S. Attorney and Chief of the Criminal Division in the U.S. Attorney’s Office in Boston. In 1994, Attorney General Janet Reno appointed him Senior Litigation Counsel, the senior trial attorney position in the Department of Justice. He also served as an Assistant U.S. Attorney in the Southern District of New York where he handled complex civil litigation under the federal racketeering and forfeiture statutes.

Special appointments that attest to Bob’s reputation and experience in enforcement matters include:

• Appointed a special prosecutor to prosecute corruption in one of North America’s largest labor unions through its internal disciplinary system, under the auspices of the Justice Departmen

• Appointed by the Massachusetts Supreme Judicial Court to investigate allegations of improprieties within the judicial system
• Current chair of a bench/bar committee to recommend revisions to the Local Criminal Rules for the District of Massachusetts
• Co-editor of a Harvard University Kennedy School of Government newsletter on China’s criminal justice system

Bob is a Fellow of the American College of Trial Lawyers. He has been named in the top 100 Massachusetts Super Lawyers each year since 2004; ranked among the leading white-collar litigation attorneys in the 2007-2009 editions of Chambers USA; and selected for The Best Lawyers in America since 2005. He received his J.D. from Harvard Law School and his A.B.,magna cum laude, from Harvard College.

 

Hans Vemer
Former Senior Vice President- Women’s Health
Schering-Plough

Hans Vemer, MD PhD, is an independent reproductive health consultant, trained as a gynecologist and reproductive endocrinologist, who worked in academia and in business, with a European and an American background.

Between 2004 and March 2010 he worked for Schering-Plough/Merck as a Senior Vice-President Women’s Health and as the SVP for Global Medical Affairs, responsible for re-engineering that department.

Before that, Hans was employed for 17 years by Organon/AKZO-Nobel, with increasing responsibilities in Research and Development, especially Reproductive Medicine; medical affairs, as Chief Medical Officer; and general management, a.o. as President of Organon International, starting in the Netherlands and later in the USA.

From 1981 to 1987 he was a staff member and later an Associate Professor in the Department of Obstetrics and Gynecology of the University of Nijmegen in the Netherlands, responsible for the Division of Reproductive Endocrinology and Infertility. He (co)authored more than 50 papers and books and coached 5 PhD fellows.

He received his MD degree from the Free University in Amsterdam, later specializing in Obstetrics and Gynecology at the University of Nijmegen, where he also earned his PhD degree.

Hans worked briefly at the Academic Hospital in Leuven in Belgium.

At INSEAD in Fontainebleau, France, he followed an Advanced Management Program and he attended several business courses at the Wharton School of Management, University of Philadelphia.

Presently Hans Vemer is a board member for a few non-profit organizations, among others the Concept Foundation, ICON (subsidiary of IPPF) and the Netherlands America Community Trust, and the chairman of the American Friends of the Royal Concertgebouw Orchestra, while being an Executive Editor for the Global Library of Women’s Medicine (GLOWM.com).

He is associated with the University of Nijmegen as a consultant.

Hans and his wife Wilma are Dutch nationals and permanent USA residents, who live in New Jersey.

 

Mike Wise
Vice President and Partner
A.T. Kearney

Summary of experience

• Nearly 20 years of healthcare industry and management consulting experience
• North American Sustainability Practice Coordinator
• Experience in product commercialization & launch strategy, licensing , M&A and supply chain

Selected consulting engagement experience

• Evaluated analytic capabilities of major home health care and insurance provider, developed road map to create internal competency around and analytic driven organization
• Developed a Corporate Sustainability Strategy and supporting organization for a fortune 500 medical device company
• Assessed market attractiveness and developed commercialization strategy for a molecular diagnostic company
• Partner lead for supply chain integration of two pharmaceutical companies including procurement, distribution and manufacturing
• Assisted a major pharmaceutical packaging company in identifying profitable growth opportunities and implementing a go to market strategy
• Led due diligence effort evaluating multiple Phase II and Phase III in-licensing and product acquisition candidates, assessed commercial value and supported negotiation process
• Developed the commercialization strategy and late stage clinical plan for a new diabetes treatment
• For a major pharmaceutical company, performed a comprehensive assessment of a multi-product development portfolio to create a long range strategy to maximize commercial potential of the therapeutic area.
• For a major pharmaceutical company, led the development of a franchise lifecycle approach to the management of a multi-product portfolio of product.
• Assisted US division of a pharmaceutical company to evaluate a major licensing agreement and develop a renegotiation strategy based on eliminating inefficiencies in the original contract and aligning business terms.
• Led a multi- functional client and consultant team in the development of generic defense strategies around a flagship GI brand. The team a comprehensive program to maintain and maximize the value of the product post patent expir

Education

• Master of Management, Kellogg Graduate School of Management, concentrating in Management Strategy and Marketing
• Bachelor of Science, University of Notre Dame, in Biology

Prior Work Experience

• From 1989 to 1993, worked at Zeneca Pharmaceuticals in sales, market research and marketing.
• Additional work experience includes:
  • • Gen3Partners, Vice President Strategy
    • RxCentric – Executive Vice President of Operations