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The current development process across the life science industry is unsustainable. The cost of R&D within the pharmaceutical industry has increased by more than 200% in the last 10 years and the investment required to achieve one successful drug launch is now estimated to be approximately $1.8 billion. In addition, companies are facing an increasing number of external pressures such as impending patent expirations and more stringent requirements by the FDA that place further stress on R&D leaders to develop more efficient processes. Please join our leaders across the pharmaceutical, biotech, and medical devices fields to understand how they have overcome productivity obstacles in the past, discuss their current R&D challenges, and outline strategies that could impact future R&D productivity.
Partner, Oliver Wyman
Mr. Hewitt is a Partner in Oliver Wyman's Health and Life Sciences Practice. He specializes in R&D Portfolio Strategy, 3rd Party Evaluation in support of Transactions, and Product & Franchise Strategy. He has assisted over a dozen major Life Sciences companies in improving R&D decision-making to increase productivity; he has supervised a series of fast-paced and high-stakes engagements for companies considering important transactions; and he has conducted dozens of product and franchise strategy engagements. Mr. Hewitt is currently leading an Oliver Wyman internal study designed to offer perspective on the R&D productivity challenge. Before joining Oliver Wyman, Mr. Hewitt was the Americas Practice Leader for IMS Health's Product & Portfolio Strategy practice. Prior to this he was a Senior Partner in the Life Sciences practice at Strategic Decisions Group, a boutique consultancy known internationally for its work in portfolio optimization and decision making. Mr. Hewitt holds a B.A. from Amherst College and an M.B.A. from Stanford University.
Bruce Ewenstein, M.D. Ph.D.
Vice President, Clinical and Medical Sciences, Baxter BioScience
Bruce currently serves as Vice President in the Baxter Global R&D organization with primary responsibility for Clinical and Medical Affairs in the Hematology/Hemophilia Therapeutic Area. He received his BA from Cornell University (Ithaca, NY) and his MD and PhD degrees from the Albert Einstein College of Medicine in New York City. Before joining Baxter in 2002 as Global Medical Director for Hemophilia Therapies, Dr. Ewenstein was an Assistant Professor of Medicine at Harvard Medical School, where he served as founder and Director of the Boston Hemophilia Center for some 17 years. He has held staff appointments at Brigham & Women's Hospital, the Dana-Farber Cancer Institute and Children's Hospital/Boston. Dr. Ewenstein is an active member of the American Society of Hematology and the International Society on Thrombosis and Haemostasis. He was a long-standing member of the Medical and Scientific Advisory Council (MASAC) of the National Hemophilia Foundation, where he served as co-chair, and has served on several FDA, NIH and CDC advisory boards and panels. He currently serves on the NHLBI Gene and Cell Therapy DSMB. He has authored over 100 scientific articles and reviews in the areas of hemophilia, protein chemistry, immunology, and vascular cell biology.
Senior Vice President, Portfolio Management, Merck
Before joining Merck, Dr. Zweidler had a distinguished 22-year career in the oil and gas industry. He headed the Global Exploration Planning and Portfolio for Royal Dutch Shell in the Hague. He joined Merck Research Laboratories (MRL) in 2008 as senior vice president of Research Planning and Integration (RPI). In that role, Dr. Zweidler successfully aligned the organization with the fundamental concepts of the Business of Science: strategy, portfolio management, business planning pipeline execution and performance review. Dr. Zweidler's current role will allow him to focus his efforts in the key arena of R&D portfolio management, coupled with scientific and business strategy. A recognized authority in portfolio management and optimization, Dr. Zweidler has lectured extensively on the subject and has also published numerous articles, several of which serve as reference material for the business planning and portfolio management industry. Dr. Zweidler studied at Université de Neuchâtel in Switzerland, where he received both his master's and his doctorate in geology.
Adrian Mckemey, Ph.D
Practice Leader, Development & Commercialization, The Consulting Group at Quintiles
Dr. Adrian McKemey leads the Business Transformation consulting practice at Quintiles Consulting. Some recent relevant case work includes: Streamlining of end to end development process and organization in a top 5 pharma company; Development of biomarker strategy for a top 5 biotech company; Assessment and gap analysis of a portfolio of early stage assets for a top 5 pharma company discovery/ED spin out, including due diligence preparedness; Creation of new cross functional business unit within clinical development for a top 10 pharma company. Prior to assuming leadership at Quintiles Consulting, Adrian was a Principal with the Boston Consulting Group (BCG) working in the Life Sciences practice in New York. Since 2000, he has helped large pharma clients with business process reengineering and organizational change, along with new product R&D Commercialization strategies. He has also worked with several PE firms focused on the life sciences industry. Prior to BCG, Adrian was an independent strategy consultant in London and Menlo Park for pharmaceutical and diagnostic companies. He was also a tenured faculty member at Brunel University in London and visiting professor at Stanford. Adrian has a BSc (First Class) from London University, Westfield College and a PhD from London University, Royal Holloway College and CERN Geneva in high energy particle physics
Roland Andersson, Ph.D
Senior Partner, Accenture
Dr. Andersson has more than 20 years of experience working with biotechnology, pharmaceutical, medical device and diagnostic companies, with primary expertise in strategy, transaction support, post-merger integration and R&D management. Dr. Andersson has previously served as Senior Partner and co-founder of Back Bay Life Science Advisors and previous to this, Senior Managing Director of Leerink Swann Strategic Advisors, where he built the group to become a major part of the firm. Prior to joining Leerink Swann Strategic Advisors, Dr. Andersson held positions as Senior Partner at Strategic Decisions Group and the Global Practice Leader for Arthur D. Little Inc. Dr. Andersson started his career at Pharmacia Corporation, where he held a number of management positions in Development, Marketing and Quality Assurance. Dr. Andersson received an MS in Engineering and a Ph.D. (Teknisk Licentiat) degree in Management from Linkoping Institute of Technology (Sweden). His research work was in the area of integrated product development processes within industrial companies, and his thesis work, published as a book, is currently in the third printing.
Andrea Ippolito, MBA 2012
Next Generation Technologies
While most companies focus on incremental advances in medical technology, a bold few are working to advance cutting-edge science and business models with the potential to change the way we think about healthcare. These companies face tremendous risk and uncertainty, but successfully introducing a disruptive innovation can yield unparalleled returns—both for investors and for patients. Please join our distinguished panel of entrepreneurs and venture capitalists as they discuss the unique challenges associated with developing next generation technologies, the critical factors in their success, and their outlook on the greatest opportunities for innovation in the healthcare space.
Partner, Third Rock Ventures and CEO, Foundation Medicine
Alexis Borisy is a Partner at Third Rock Ventures, where he focuses on the formation, development and strategy of new companies, including Foundation Medicine for which he serves as founding CEO. A successful biotechnology entrepreneur with more than 15 years of experience building and operating innovative science based organizations, Alexis joined Third Rock Ventures in 2009. Prior to joining Third Rock Ventures, Alexis founded CombinatoRx in 2000, serving as its CEO, and bringing the company public on the NASDAQ in an IPO. He has raised $750 million in financing and business development deals, and has authored numerous scientific papers and patents. Trained in chemistry and chemical biology at Harvard where he was a Howard Hughes Predoctoral Fellow, Alexis was honored as the MIT Technology Review Innovator of the Year. He was also chosen as the New England Entrepreneur of the Year in Life Sciences and was honored as a Presidential Scholar. Alexis's undergraduate degree in chemistry is from the University of Chicago, and he did his graduate work in the laboratory of Dr. Stuart Schreiber at Harvard University. Alexis serves on the Board of the Biotechnology Industry Organization, is an Overseer at the Boston Museum of Science, and is the Chairman of Forma Therapeutics.
Edward Kerslake, PhD
CEO, Topera Medical
Edward Kerslake is the CEO of Topera Medical, a Lexington, MA company which has developed a system to target and eliminate electrical source rhythms shown to sustain heart disorders such as atrial fibrillation. Dr Kerslake was most recently Corporate VP Portfolio Management at Boston Scientific where he led the effort to to create & manage the corporate portfolio and also the tools the company uses to assess R&D performance, technical risk and financial return.
Before Boston Scientific, Dr. Kerslake was COO at MDdatacor, an innovative cardiology / Healthcare IT company started by the founder of WebMD and backed by Siemens Ventures and Fisher Scientific. Previously he spent five years at The Monitor Group, a global strategy consulting firm based in Cambridge, MA.
Before Monitor, Dr. Kerslake worked as Senior Scientist and as Head of Formulation for Allergan (NYSE:AGN) at its European R&D Headquarters in France and at its headquarters in California. While at Allergan, Dr Kerslake invented and now holds the pivotal patents protecting Allergan's Alphagan P Glaucoma portfolio (a ~$400M/yr suite of products).
Robert S. White
President and CEO, TYRX Inc.
Bob assumed leadership of TYRX in January 2010. He has over 20 years of senior management experience in the medical technology industry through numerous positions of increasing responsibility with Medtronic Inc., Instromedix-LifeWatch, ALARIS Medical Systems, Eli Lilly, and General Electric. Most recently, Bob served as President of Medtronic Kyphon following the $3.9 billion acquisition of the spinal treatment business. During his time with Medtronic, Bob also served as President of Physio Control, Chief Development Officer responsible for all corporate development activities, and Vice President of U.S. Sales and Global Marketing where he was responsible for commercial operations for the Medtronic Cardiac Rhythm Management business.
Bob began his career with General Electric. In 1989 he joined Eli Lilly and through successive promotional opportunities became the International Marketing Manager for IVAC based in Europe for 3 years. At ALARIS Medical Systems, a $400 million infusion therapy company, his last role was as Vice President, Corporate Development. Bob then became Founder and CEO of Liquid Borders, a healthcare software development company. At Instromedix-LifeWatch, which specializes in selling non-invasive cardiac monitoring solutions, he served as President and CEO.
Bob holds an MBA from Cornell University and a BS degree in Aerospace Engineering from the University of Missouri-Rolla.
President and CEO, SmartCells, Inc.
Todd C. Zion, Ph.D. founded SmartCells, Inc. (Beverly, MA) in 2003 to develop SmartInsulin™, the first glucose-regulated, injectable formulation for treating diabetes. As President and CEO since the company's founding, Todd was instrumental in raising over $9.5M in equity financing from individual investors and over $10M in government grants to support basic research and clinical development. In December 2010, Merck and Co. acquired SmartCells for over $500M in cash and clinical milestone payments.
Dr. Zion developed the SmartInsulin™ technology as part of his doctoral thesis work in Chemical Engineering at the Massachusetts Institute of Technology. At M.I.T., Todd won the Robert P. Goldberg Grand Prize in the 2003 M.I.T. $50K Entrepreneurship competition. Prior to enrolling at M.I.T., he worked as a polymer development engineer at Eastman Kodak, where he invented and was issued several patents for the novel synthesis of polymer particles for imaging applications. Todd graduated from Cornell University summa cum laude with a B.S. in Chemical Engineering.
General Partner, Polaris Ventures
Alan Crane is a general partner in the Boston office of Polaris Venture Partners. He joined Polaris in 2002 and focuses his investments in life sciences.
From 2006 to 2009, Alan co-founded and served as CEO of Cerulean Pharma (a nanotechnology focused pharmaceutical company in phase 2 clinical trials in oncology) and co-founded Visterra, Inc. (an infectious disease company based on technology out of MIT). From 2002 until 2006, Alan was President and CEO of Momenta Pharmaceuticals. He joined Momenta as the fifth employee and built the company into a public company, creating an advanced and diversified pipeline, entering into two strategic collaborations with the Sandoz division of Novartis, and raising $275 million. Momenta achieved its first drug approval in July 2010, and its product is producing revenues at an annual run rate in excess of $1B. Prior to this, he was senior vice president of global corporate development at Millennium Pharmaceuticals, where he was responsible for leading Millennium's strategic partnering, mergers and acquisitions, and licensing activities, generating over $2 billion in partner funding and acquiring 19 development stage products. Prior to Millennium, Alan was a marketing executive at Dupont-Merck and a consultant with the Boston Consulting Group and Arthur D. Little.
He serves on the boards of Visterra (Chairman), Ceruelan Pharma (Chairman), Ocular Therapeutix, T2 Biosystems, Hydra Biosciences, Seventh Sense Biosystems, Calorics, and Vaccinex. Previously, he served on the boards of Momenta Pharmaceuticals (NASDAQ: MNTA), Sirtris Pharmaceuticals (NASDAQ: SIRT, acquired by Glaxo SmithKline) and Adnexus (acquired by Bristol Myers Squibb). He serves on several non-profit boards including the trust board of Children's Hospital Boston, the Autism Consortium, and Medicine in Need.
He received his M.B.A. in 1992 and his B.A. summa cum laude and M.A. in 1986, all from Harvard University. Alan also attended Harvard Medical School from 1986 to 1988 before pursuing a business career.
Chris Wilfong, MBA 2012
Emerging Markets: Best Practices for Market Entry and Growth
As companies increasingly look to opportunities in emerging markets, questions arise over when and how to approach these geographies to be successful in both developing and commercializing new innovations. Adding to the complexity is that market entry considerations are very different across countries. Please join our panel of country experts who will provide real-life lessons on how their companies have successfully established a presence in Brazil, India, and China with products spanning orphan drugs, vaccines, and primary care.
Rogério Vivaldi, MD
President, Renal & Endocrine, Genzyme
Rogerio Vivaldi is the Senior Vice-President of Genzyme Corporation and President of Genzyme's Renal and Endocrine Business Unit. In 1997, Dr. Vivaldi founded Genzyme in Brazil, having performed different roles including scientific assessor, medical director and President, Genzyme do Brazil Ltda. In January 2005, he became Senior Vice-President and President of Genzyme Latin America, responsible for Genzyme's growth and diversification in the entire region, growing from $90M in 2004 to over $350M in 2009. In June 2010, he was promoted to President of the Renal and Endocrine business unit, relocating from Rio de Janeiro to Boston.
Prior to Genzyme, Dr. Vivaldi had his own private practice in the clinical specialty area of Diabetes and Endocrinology for 18 years. He was the first Brazilian doctor to treat a patient in Brazil with enzyme replacement therapy for Gaucher in 1992 and has authored several publications on Gaucher disease. He was the founding partner of Latin American Group on Gaucher.
Dr. Vivaldi recevied his medical degree form Universidade do Rio de Janeiro (UNIRIO) Medical School, and completed his residency in Endocrinology at Universidade do Estado do Rio de Janeiro (UERJ) and his fellowship at Mount Sinai Hospital Center in New York in the Department of Genetics with emphasis on Gaucher disease. He received his MBA degree from Copead – Universidade Federal do Rio de Janeiro (UFRJ).
President and CEO, AMAG
Brian J. G. Pereira is Professor of Medicine at Tufts University School of Medicine and the Sackler School of Graduate Biomedical Sciences in Boston, and the President and CEO of AMAG Pharmaceuticals in Lexington, MA. He had previously served as President & CEO of the physician corporation and interim Chief Operating Officer at Tufts Medical Center. He was the Past President and member of the Board of the National Kidney Foundation. He currently serves as Chairman of the Board of the Harvard-MIT Biomedical Enterprise Program, Member of the Board of Advisors of the Harvard-MIT Health Sciences & Technology (HST) Program, and member of the Board of Directors of Biodel, and Youth That Care.
His research on hepatitis C and G in dialysis and transplantation have led to design of policies to reduce transmission in dialysis units, use of donors with HCV infection and management of the HCV infected transplant candidate. Dr. Pereira's work on cytokines and biocompatibility of dialysis membranes, impact of water quality and reuse, and gene polymorphisms and oxidative stress have opened the doors to understanding the role of inflammation in CKD. Also, his research on the impact of the timing of nephrology referral and optimization of pre-dialysis care on morbidity, mortality, and costs in CKD patients has led to greater focus on CKD care.
He received his MBBS from St. John's Medical College in India and MBA from the Kellogg School of Management at Northwestern University.
Global Policy Director – Novartis Vaccines & Diagnostics
Tom has worked at Novartis in Cambridge since 2009 and as Global Policy Director is currently responsible for leading public policy initiatives and managing relationships with international policy-making and funding bodies. He previously was the Head of Strategy for Vaccines & Diagnostics and was in charge of mid-term strategic planning and related projects.
Prior to Novartis, Tom worked at McKinsey & Company, consulting life sciences companies on a range of business strategy and organization topics. He was based on New Jersey for 5 years and then in the Tokyo office from 2006 to 2009.
Tom is a chemical engineer by training and began his career at Merck & Co. Inc., where he held a variety of engineering and operations management roles in the Pharmaceutical Manufacturing Division.
Tom holds a BE in Chemical Engineering from University College Dublin (Ireland), an MSc in Pharmaceutical Engineering from the University of Manchester (UK), and an MBA from Columbia Business School.
Rehan A. Khan
Country Head & GM, Abbott Nutrition India
Rehan Khan is the Country Head & General Manager of Abbott Nutrition India (ANI – India). ANI India is a 700 person strong team responsible for marketing leading brands in Pediatric and Adult Nutrition which include Pediasure, Isomil, Ensure, Glucerna and Mama's Best. Abbott Nutrition is a division of Abbott Labs, one the world's most diversified healthcare and pharmaceutical companies.
Rehan joined Abbott from AstraZeneca's India affiliate where he was the Vice President of Sales and Marketing. Prior to relocating to India in 2007, he spent 11 years in the US, UK and Continental Europe (Switzerland, Germany, Holland and Sweden) in marketing, strategic planning and operations/turnaround roles with Novartis AG, Accenture and Venture Media LLP.
Rehan has an MS in Biomedical Science from Harvard / MIT (The Harvard MIT Division of Health Sciences), an MBA from Drexel University and BS from the University of Wisconsin – Madison.
He enjoys playing squash and is passionate about contemporary art.
Vice Chairman and U.S. Life Sciences Leader, Deloitte LLP.
R.T. (Terry) Hisey is the Vice Chairman and U.S. Life Sciences Leader for Deloitte LLP. In this role, Terry leads the firm's service efforts in the areas of audit, tax, strategy, performance improvement and technology consulting to assist clients in achieving sustainable competitive advantage through strategic change. His life sciences experience spans the entire value chain including drug discovery & development, commercial operations, production & distribution, and regulatory compliance. As Chairman of the Life Sciences Advisory Board for Deloitte Research and Steering Committee member for the Deloitte Center for Health Solutions, Terry guides thought leadership and advises clients on transformative opportunities in the industry including comparative effectiveness, informatics, social media and globalization.
In addition to his client work, Terry is a noted industry authority, frequent speaker, a Strategy Advisor to Pharmaceutical Executive Magazine, and guest lecturer at several schools including the University of Pennsylvania, and the University of California at Berkeley. Terry is also a member of several industry associations and advisory boards.
Eliza Kamenetsky, MBA 2012
Important regulatory and policy questions surround demonstrating value through comparative effectiveness research. Each stakeholder has a different concern, whether it be how to make decisions on clinical trials, creating pharmacoeconomic evidence for reimbursement levels, or balancing health outcomes vs. cost. While comparative effectiveness has the potential to reduce cost in the overall system, the most effective or innovative medical treatments do not usually correlate to the lowest cost. What approaches should firms take to align incentives across stakeholders, for individuals, and society at large?
Michael Del Aguila
Senior VP, Genentech
Michael del Aguila has worked in health services, health economics and outcomes research for fifteen years, in managed care, consulting, and the biotech pharma industry.
In his current position in Genentech, Michael leads a multidisciplinary group within Medical Affairs that is responsible for helping to craft and execute phase IIIb and IV research programs to support marketed medications in the United States. This group leads Genentech's efforts in comparative effectiveness research, in collaboration with other global functions within Roche.
Michael has spent five years at Roche/Genentech. Previously he worked with Aetna Health Information Systems, and with Delta Dental and the Department of Veterans Affairs. Michael received his PhD in epidemiology from the University of Washington, and lives in Northern California with his wife and children.
John Gordon, MBA
Partner, Putnam Associates
John Gordon is a Partner of Putnam Associates, a 50-person strategy consulting firm based in Burlington, MA, dedicated to advising the pharmaceutical, biotechnology, diagnostics, and medical device industries on a global basis.
Mr. Gordon has been with Putnam Associates since 1992, and has over 20 years of strategy consulting experience. John has counseled senior executives at numerous leading pharmaceutical and biotech companies, providing strategic support and recommendations on a wide array of issues, including pricing, contracting and reimbursement strategies, corporate strategy, new product commercialization, clinical trial development, and sales force optimization strategies. John has extensive experience in specialty pharmaceutical markets that include Oncology, Immunology, Cardiovascular Disease and Anti-Infectives. He is published in peer-review literature as a co-author on a study examining the cost effectiveness of a novel immunological agent used in solid organ transplantation. John has been a speaker and moderator at healthcare conferences featuring topics on healthcare technology commercialization, R&D innovation, and pharmaceutical industry growth challenges.
Prior to joining Putnam, John worked for an economics consulting firm providing expert testimony in matters of corporate and personal litigation. John currently serves on the Board of Directors for the National Tay-Sachs & Allied Diseases Association, Inc.
John earned a BA in economics summa cum laude, phi beta kappa from Tufts University and an MBA from Harvard Business School.
Senior VP, Pfizer
Greg Simon has joined Pfizer Inc as Senior Vice President, Worldwide Policy. He comes to the company from the presidency of FasterCures, where he led efforts to reform policies governing biopharmaceutical discovery and development, with the goal of bringing a greater number of lifesaving medicines more quickly to doctors and patients.
Mr. Simon joined FasterCures, an independent, nonpartisan organization, in 2003. A center of the California-based Milken Institute, FasterCures proposes and pursues improvements in the biomedical research and development process. Last October, Mr. Simon was named by the journal Nature Medicine as one of "Ten People to Watch" in health care policy, noting that he was among "a handful of influential people who quietly keep the wheels of biomedical science turning."
Mr. Simon was chief domestic policy advisor to Vice President Al Gore from 1993 to 1997. In that capacity, he oversaw a number of key initiatives, including programs at the National Institutes of Health, the National Cancer Institute, the Food and Drug Administration, and the Human Genome Project. He was also instrumental in crafting the regulatory framework that is now the foundation for the biotechnology industry. From 1985 to 1991, Mr. Simon was Staff Director of the Investigations and Oversight Subcommittee of the U.S. House of Representatives Committee on Science, Space and Technology. He served as Sen. Gore`s Legislative Director from 1991 to 1993. Immediately prior to joining FasterCures, Mr. Simon was CEO of Simon Strategies/Mindbeam, a consulting firm focusing on science and technology issues.
He received his law degree from the University of Washington in 1983. He has a B.A. in history from the University of Arkansas.
Heather Steinfield is a Partner at Simon-Kucher & Partners Strategy & Marketing Consultants in Boston. She has 16 years of experience providing strategic consulting services to pharmaceutical, biotech and medical device clients. Throughout her career, she has assisted clients with various aspects of commercialization strategy for new products including the payer environment, product marketing and positioning, health economics requirements and the distribution environment.
Before joining Simon-Kucher & Partners, Ms. Steinfield worked as a senior strategist for Quintiles Strategic Research Services, combining brand strategy with Phase IIIb and IV clinical research. She also worked at Lewin Group as a senior manager in the reimbursement strategy group. Prior to that, she served as PAREXEL's Manager of Reimbursement Programs in its Medical Marketing Services Division and as a Market Analyst, conducting strategic market assessments and other pre-launch activities.
She focuses on activities such as development of global payer value stories and tools for their implementation, moderation of payer/market access advisory boards and internal client workshops, assessment of US public and private payer policy, development of pricing and market access strategies, development of reimbursement strategic plans and specialty distribution programs, HCPCS and CPT coding assessments, and coding applications.
Ms. Steinfield holds a Bachelor's degree in Health and Society from the University of Rochester.