Stefan Larsson, MD, PhD
2011 Horizons Keynote Speaker
Stefan Larsson is a fellow of the Boston Consulting Group (BCG), leading the firm's global efforts around Value-Based Health Care. He is the leader of BCG's Nordic Health Care Practice Group and the firm’s global Scientist Network. Larsson has broad biopharmaceutical experience including strategy, global sales force effectiveness, research and development effectiveness, regulatory, drug safety, manufacturing, in-licensing and commercial compliance. He also has worked on Health Technology Assessment and payer strategy and a broad range of industry strategy assignments for biotech, healthcare providers and medical technology companies. Larsson holds an MD from Karolinska Institute and completed PhD studies at both Karolinska Institute and Harvard. He is an associate professor at the Karolinska Institute.
Daniel Diermeier, PhD
2011 Horizons Keynote Speaker
Daniel Diermeier is the IBM Professor of Regulation and Competitive Practice, a professor of managerial economics and decision sciences at the Kellogg School of Management and a professor of political science at the Weinberg College of Arts and Sciences, all at Northwestern University. He is director of the Ford Motor Company Center for Global Citizenship and co-creator of the CEO Perspective Program, a joint venture between Kellogg and the Corporate Leadership Center. Diermeier’s work focuses on reputation management, political and regulatory risk, crisis management and integrated strategy. His work has been published in numerous academic journals. He has been an advisor to some of the world’s leading companies, including healthcare product manufacturers Abbott, Baxter International, Johnson & Johnson, Roche Diagnostics and Takeda. In December 2004, he was appointed to the Management Board of the FBI. Diermeier is the author of the new book Reputation Rules: Strategies for building your company’s most valuable asset (McGraw-Hill, April 2011).
Paul LaViolette, MBA
2011 Horizons Plenary Speaker
Paul LaViolette, a venture partner with SV Life Sciences, has more than 28 years of global medical technology marketing and general management experience. Previously, he was chief operating officer at Boston Scientific Corporation (BSC), an $8 billion medical device leader. During his 15 years at BSC, he served as COO, group president, president-cardiology and president-international as the company grew revenues over 20 times. LaViolette integrated two dozen acquisitions and led extensive product development, operations and worldwide commercial organizations. He formerly held marketing and general management positions at CR Bard and various marketing roles at Kendall (Tyco). He served on the boards of Urologix, Percutaneous Valve Technologies and Advamed and currently serves on the boards of Cameron Health, CardioFocus, Conceptus, DC Devices, Direct Flow Medical, DJO Global, Thoratec, Trans 1 ValenTx and Medical Device Manufacturers Association (MDMA). LaViolette holds an MBA from Boston College.
Robert Peterson, MD, PhD, MPH
2011 Horizons Plenary Speaker
Robert Peterson is executive director of the Drug Safety and Effectiveness Network (DSEN), a joint venture of Health Canada and the Canadian Institutes of Health Research established to increase available evidence on drug safety and effectiveness and increase capacity within Canada to undertake high-quality postmarket research. A member of many international boards and an active researcher, Peterson was previously director general of the Therapeutic Products Directorate at Health Canada. He is a member of the WHO Expert Advisory Committee on Drug Evaluation and chairman of the Regulations Advisory Board of the Centre for Medicines Research, International Institute for Regulation Science. Peterson holds an MD and PhD in pharmacology from Yale University and an MPH from Harvard University. Read more »
Larry G. Kessler, Sc.D.
2011 Horizons Speaker
Larry G. Kessler, ScD, is a professor and chair of the Department of Health Services at the University of Washington, School of Public Health. In this role, he directs more than 60 faculty members who provide education in a wide variety of health services disciplines leading to degrees in public health, including a PhD program, Masters of Public Health, Masters of Health Administration, and a recently developed undergraduate major in public health. Previously, Kessler spent 30 years working for the federal government, first at the National Institute of Mental Health, then at the National Cancer Institute and, most recently, at the US Food and Drug Administration’s Center for Devices and Radiological Health. He holds an ScD degree in operations research from the Johns Hopkins School of Public Health. Kessler has published more than 100 peer-reviewed journal articles, as well as numerous book chapters and government reports. His research has concentrated on applications of quantitative methods and health services research to problems in surveillance and public health.
Christopher-Paul Milne, DVM, MPH, JD
2011 Horizons Speaker
Christopher-Paul Milne is associate director of the Tufts Center for the Study of Drug Development (Tufts CSDD). His current research activities focus on: evaluating incentive programs for pediatric studies, fast track diseases, rare disorders and conditions, and neglected diseases; assessing the impact of regulatory policy changes and trends; measuring the impact of challenges to new drug and biologic research and development; identifying and classifying factors affecting innovation efficiency and the globalization of R&D; and tracking the progress of new safety and science initiatives. Formerly a practicing veterinarian, Milne earned an MS in public health from the Johns Hopkins University and a JD from the Franklin Pierce Law Center. Read more »
Hans-Georg Eichler, MD, MSc
2011 Horizons Panelist
Hans-Georg Eichler, MD, MSc, is the senior medical officer at the European Medicines Agency, responsible for coordinating activities between the agency’s scientific committees and giving advice on scientific and public health issues. In calendar year 2011, Eichler is also the Robert E. Wilhelm Fellow at the Massachusetts Iinstitute of Technology’s Center for International Studies, participating in a joint research project under the MIT’s NEWDIGS initiative. He divides his time between MIT and EMA. Previously, Eichler was at the Medical University of Vienna in Austria, where he was vice-rector for research and international relations and professor and chair of the Department of Clinical Pharmacology. He has also served as president of the Vienna School of Clinical Research and co-chair of the Committee on Reimbursement of Drugs of the Austrian Social Security Association. His industry experience includes positions with Ciba-Geigy Research Labs, UK, and outcomes research at Merck & Co., in New Jersey. Eichler holds an MD from Vienna University Medical School and an MSc in toxicology from the University of Surrey in Guildford, UK.
Sabina L. Hoekstra-van den Bosch, MSc, PharmD
2011 Horizons Panelist
Sabina L. Hoekstra-van den Bosch, MSc, PharmD, is senior adviser at the Ministry of Health, Welfare and Sports in the Netherlands. At the Directorate of Pharmaceutical Affairs and Medical Technology she is responsible for international policy and legislation on medical devices, including the relation between medical devices and adjacent product categories, such as pharmaceuticals. She is the coordinator for EU policy of the Directorate. She is a delegate on behalf of the Ministry to the EU Medical Device Expert Group and attached Working Groups, the EU Council Working Party on Pharmaceuticals and Medical Devices and the European Competent Authority Meeting on Medical Devices. In September 2010, Hoekstra was elected vice-chair of the European Central Management Committee on Medical Devices. She is a member of the Expert Group on Advanced Therapy Medicinal Products (ATMPs) of the Medicines Evaluation Board in the Netherlands. She is a member of the European Training Committee of the Drug Information Association. In 2005-2009, Hoekstra was chair of the EU Working Group on New and Emerging Technologies in Medical Devices. In 2006-2009, she was a member of the Global Harmonization Task Force Ad Hoc Working Group on Combination Products. Hoekstra began her career as community pharmacist. Prior to joining the Ministry in 2002, she was manager of the Department of Scientific Advice of the Medicines Evaluation Board in the Netherlands. Hoekstra received a master’s degree in pharmaceutical sciences and graduated as pharmacist at Leiden University.
Grant Ramaley
2011 Horizons Panelist
Grant Ramaley is director of regulatory affairs for Aseptico Inc. For the last 10 years, Ramaley has served as the chairman of the Regulatory Affairs and Standards Committee for the Dental Trade Alliance, which includes more than 200 medical device manufacturers and distributors in North America. His main focus has been to enlighten regulators and others stakeholders in compliance with regard to the needs of small and medium size companies, as well as help them understand the impact on the availability of low and medium risk devices to various healthcare systems. Over the last four years, Ramaley has been working to develop the first globally recognized accredited certification program for ISO 13485.
Michael Ringel, JD, PhD
2011 Horizons Panelist
Michael Ringel is a partner and managing director of The Boston Consulting Group (BCG). He is a member of BCG's healthcare practice area and the firm's scientist network. Dr. Ringel's focus is biotechnology and pharmaceuticals, with an emphasis on R&D productivity, strategy and operations. He has broad experience across biopharmaceutical disciplines, including discovery, clinical development, pharmaceutical development, toxicology/ADME, safety, regulatory, marketing excellence, M&A, corporate development and post-merger integration. Ringel received his PhD in biology from Imperial College, University of London, and was awarded both National Science Foundation and Fulbright fellowships. He has a JD from Harvard Law School.
Michael Gropp
2011 Horizons Speaker/Horizons Planning Committee Member
Michael Gropp is vice president, global regulatory strategy for Medtronic. He began his career in industry with the Medical Devices and Diagnostics Division (MDD) of Eli Lilly and Company, and has held various engineering, regulatory affairs, quality assurance and compliance positions in both the US and Europe with Lilly, Guidant Corporation and Abbott Vascular. Gropp is a special representative for international affairs and policy to the AdvaMed board of directors and Chair of the Eucomed International Affairs Task Force. He is a member of the Global Harmonization Task Force (GHTF) Steering Committee and served on GHTF Study Group 1. He is also an active contributor to the Asia Harmonization Working Party, and a frequent trainer in regional conferences. Gropp has led efforts to include medical device regulatory harmonization in the Asia-Pacific Economic Cooperation (APEC) Life Sciences Innovation Forum and is a member of the advisory board to the APEC Harmonization Center Regulatory Harmonization Steering Committee. He was also a member of the Scientific Advisory Group to the WHO International Clinical Trials Registry Platform project. In October 2010, Mr. Gropp received the Regulatory Affairs Professionals Society (RAPS) Richard E. Greco Award in recognition of his work to help harmonize global medical device regulations and advocate for regulatory professional development. Read more »
John Linehan, PhD
2011 Horizons Speaker/Horizons Planning Committee Member
John Linehan is professor of bioengineering in the McCormick School of Engineering and Applied Science at Northwestern University. He is also a consulting professor of bioengineering in Stanford University's Department of Bioengineering and the Biodesign Program, where he took the lead in developing a program to train young physicians and engineers from developing countries to create innovation programs that address clinical needs in a resource-challenged environment. Linehan holds an MS from Rensselaer Polytechnic Institute and PhD from the University of Wisconsin, both in mechanical engineering. He is a member of the National Academy of Engineering.
Jan Pietzsch, PhD
2011 Horizons Speaker/Horizons Planning Committee Member
Jan Pietzsch is president and CEO of Wing Tech Inc., a management and technology consulting firm active in the fields of technology assessment, advanced systems analysis and strategic design support. He is also a consulting associate professor in Stanford University’s Department of Management Science and Engineering and a core faculty member in Stanford’s biodesign program. Pietzsch’s research interests are in value-based innovation, comparative effectiveness research and risk analysis. A particular focus of his work is the assessment and evaluation of new technologies. A primary application field is medical technology, where early understanding of the health-economic profile and value proposition of emerging technologies is increasingly becoming a critical element of successful product commercialization.
Paul Brooks
2011 Horizons Chair, Horizons Planning Committee
Paul Brooks is vice president and country manager of BSI Product Services in Washington, DC. Brooks leads activities in the medical devices regulatory sector, including EU Notified Body, EU/US Conformity Assessment Body, Health Canada and US FDA recognition. Additionally, he is responsible for supporting BSI’s North American medical device customers of Australian and Asian regulatory programs.
Todd Chermak, RPh, PhD
2011 Horizons Planning Committee Member
Todd Chermak is divisional vice president, Regulatory Affairs Pharmaceutical Products Division, CMC and Business Planning for Abbott. He began with the company in 1994 as an assistant research pharmacist. He has since held several leadership roles in the Pharmaceutical Products Group, including research investigator pharmacist; associate director of regulatory affairs; director of regulatory affairs; director of QA, European operations and divisional vice president of regulatory affairs, US advertising and promotion. Chermak assumed his current role at Abbott in November 2010. Chermak holds an MS in engineering and management sciences from Northwestern University and a PhD in pharmacy from the University of Illinois College of Pharmacy.
Barry Sickels, PhD
2011 Horizons Planning Committee Member
Barry Sickels is vice president, regulatory affairs at AstraZeneca. He has more than 24 years experience in the pharmaceutical industry and has worked in discovery research, clinical research and development and, for the past 17 years, regulatory. The scope of his drug development activities has included GI, oncology, infectious disease, central nervous system, respiratory disease and diabetes. Sickels has also worked for Pfizer/Wyeth as vice president, regulatory affairs, global therapy areas and North America. He holds an MS in toxicology/environmental science from Rutgers University. He also has a master’s of jurisprudence and a doctorate in health law from the Widener University School of Law's Health Law Institute.
Sherry Keramidas, PhD, CAE
2011 Horizons Planning Committee Member
Sherry has served as executive director for RAPS since 1996. Previously, Keramidas served as executive director of the American College of Dentists, associate executive vice president of the American Physical Therapy Association and scientific director of the Cystic Fibrosis Foundation, where she developed and managed a $35 million research and clinical programs portfolio. She also was involved in efforts related to the Orphan Drug regulations. Keramidas served as a research, program evaluation and planning and policy consultant to the National Institutes of Health. Keramidas received her PhD from Purdue University in neurosciences and physiological psychology. She is a fellow of the American Society of Association Executives and of the American Association for the Advancement of Science. She has made more than 300 presentations on health-related issues and management and teaches courses in scientific and non-profit management.