Dr. Hans-Georg Eichler, Senior Medical Officer of the EMA, EU, will co-chair Theme 2, Innovation of Health Care Product Development – What Are the Key Success Factors?, at our DIA EuroMeeting 2017 in Glasgow, Scotland. “Over time, we have realized that regulators also have a role in supporting innovation,” he explains. “They’re not just gatekeepers – they’re also enablers.” In this exclusive podcast, Dr. Eichler overviews the impact of the Clinical Trial Regulation on therapeutic innovation, how patients and payers might contribute to such innovation, and the opportunities and challenges ahead, in Europe. “The barriers, as usual, are our own conservativism and difficulty in letting go of all of our usual ways,” he suggests.
Chair of DIA’s Council of Regulators, Dr. Gerald Dal Pan has served since 2005 as Director of CDER’s Office of Surveillance and Epidemiology. A member of the World Health Organization Advisory Committee on the Safety of Medicinal Products, he has also served on working groups for the ICH and the Council of International Organizations of Medical Sciences, and will chair the FDA Update session at DIA’s annual Pharmacovigilance and Risk Management Strategies Conference 2017. In this exclusive podcast, Dr. Dal Pan discusses how big data impact evidence generation and drug safety, and previews these FDA Updates, including how the FDA Guidance on Best Practices for Pharmacoepidemiological Studies relates to postmarketing requirements. “We’re very pleased to be participating in DIA’s Pharmacovigilance and Risk Management Strategies Conference,” he explains. “My colleagues here at FDA and I have participated in it for many years.”
Each DIA Annual Meeting features an extended, live Q&A session with senior leadership from the FDA Center for Drug Evaluation & Research. Highlights of the interactive CDER Town Hall held at DIA2016 included: Dr. Richard Pazdur, acting leader of the FDA's Office of Excellence in Oncology, will help establish this program to develop consistent policies/practices for oncology products across all FDA review centers; the package of proposed industry-FDA recommendations for reauthorization of PDUFA is in Obama Administration review; and FDA continues to work closely with China, the world's second largest pharmaceutical market, to help establish quality standards for the drug supply chain. Moderator: Nancy D. Smith, PhD, FDA Alumni. Featured Speakers: Leah Christl, PhD, Associate Director for Therapeutic Biologics, TBBS, OND; Gerald J. Dal Pan, MD, Director, Office of Surveillance and Epidemiology; John Jenkins, MD, Director, Office of New Drugs; Michael Kopcha, PhD, RPh, Director, Office of Pharmaceutical Quality; Theresa M. Mullin, PhD, Director, Office of Strategic Programs; and Lynne Yao, MD, Acting Director, Pediatric and Maternal Health Staff, OND.
Discussions around value are not new, but health care spending based on value decisions and assessments is. Implementation of providing value in health care, particularly around the dollars and cents needed to do so, varies greatly worldwide. At DIA2016, an esteemed panel addressed this issue through Value-Based Health Care Decision Making: The Quest for Smarter Spending. “What’s different today than what we’ve seen in the past is this notion of transparency in how people are making these value decisions,” suggested Jennifer Snow. Facilitator: Jennifer Snow, MPH, Director, Reimbursement Policy Insights, Xcenda. Featured Speakers: Professor Sarah Garner, PhD, BPharm, Associate Director, Science Policy and Research, NICE, UK; Richard Willke, PhD, Chief Science Officer, International Society for Pharmacoeconomics & Outcomes Research; and Benjamin Heywood, Co-Founder, President, & Chief Privacy Officer PatientsLikeMe Inc.
At DIA2016, a panel discussion with experts from regulatory, academic research, industry and information technology explored the health care industry’s next beachhead: Europe and the US: Making Outcomes-Based Health Care Possible. Panelists focused on the topics of clinical data, real-world data, and their relationships to evidence that more adequately address questions of value to support this value-based wave of change. “I would argue that randomized clinical trials, our so-called ‘gold standard,’ will only show you the tip of the iceberg,” said DIA 2016 Co- Chair Dr. Hans-Georg Eichler. Moderator: Duane Schulthess, Managing Director, VitalTransformation. Featured Speakers: Dr. Hans-Georg Eichler, Senior Medical Officer, European Medicines Agency, EU; Dr. Gigi Hirsch, Executive Director, MIT Center For Biomedical Innovation; Richard Bergström, Director General, European Federation of Pharmaceutical Industries and Associations (EFPIA); and Steve Rosenberg, Senior Vice President and General Manager, Health Sciences Global Business Unit, Oracle Health Sciences.
DIAmond Session 203: “Innovation is Clearly Happening”: Next Generation Collaboration: Transforming the Industry
The DIA2016 panel discussion Next Generation Collaboration: Transforming the Industry focused on convergence, collaboration and cooperation in drug development. These activities, performed early and often amongst all stakeholders, can drive greater innovation, reduce time to market and increase efficacy in product development: There are 560 drugs currently in development for rare diseases; HIV, once a death sentence, is now a chronic disease; Hepatitis has a cure; and Melanoma, long considered untreatable, is now managed by a number of new drugs. In 2015, the FDA approved 51 new drugs, all new class agents, the largest number of approvals over the past 66 years. Featured Speakers: Dr. Dalvir Gill, CEO of TransCelerate BioPharma, Inc.; Dr. Christopher Austin, Director, National Center for Advancing Translational Sciences, National Institutes of Health; Dr. C. David Nicholson, Allergan Executive Vice President, Brand R&D; Dr. Jonathan Jarow, Senior Medical Advisor to the Center Director, CDER, FDA; Margaret Anderson, Executive Director, FasterCures, A Center of the Milken Institute; and Drew Schiller, Co-Founder and Chief Technology Officer, Validic.
The DIA2016 DIAmond session International Regulatory Convergence, Collaboration, and Cooperation, convened a senior panel of global regulators to share with attendees the challenges in their respective jurisdictions, domestically and internationally, and discuss mutual reliance activities, including and especially the emerging International Coalition of Medicines Regulatory Authorities (ICMRA). Featured Speakers: Part I: Emer Cooke, Head of International Affairs, EMA; Dr. Tatsuya Kondo, Chief Executive, PMDA, Japan; and Dr. Robert Califf, Commissioner, FDA. Part II: ICMRA Chair Anil Arora, Health Products & Food Branch, Health Canada; ICMRA Vice-Chair Dr. Lorraine Nolan, Health Products Regulatory Authority, Ireland; Jonathan Mogford, Medicines & Healthcare Products Regulatory Agency, UK; Dr. John Skerritt, Department of Health, Australia; and Dr. Jarbas Barbosa (Agência Nacional De Vigilância Sanitária, Brazil).
The current US Prescription Drug User Fee Act, commonly referred to as PDUFA V, will sunset at the end of 2017. At the first Public Meeting on PDUFA Reauthorization, Center for Drug Evaluation and Research Director Dr. Janet Woodcock said, “PDUFA has been generally considered successful. We continue to meet or exceed nearly all our application review goals…And these accomplishments are, in part, made possible by the resources provided by this program.” In this exclusive podcast, Dr. Woodcock and Dr. Theresa Mullin, Director of FDA’s Office of Strategic Programs, discuss PDUFA, the need for reauthorization into PDUFA VI, and its progress since the initial 1992 legislative authorization. Update: Dr. Woodcock will also share her expert regulatory insights through her Keynote Address at Advancing the Science of Study Endpoints; she will be joined by Dr. Mark McClellan, Director, Duke-Robert J. Margolis Center for Health Policy, Duke University, to share their perspectives on the development of study endpoints, Where Are We Now and Where Are We Going?
While they do not present new treatment options, biosimilars make tried and trusted, highly effective but very expensive biological cancer therapies more widely available at a more affordable price. With their potential for improving access to effective biological therapies through reduced costs, biosimilars have garnered great interest among industry, regulators, patients and payers. Program Chair Cecil Nick, who has worked for more than three decades in clinical development and regulatory affairs, explores the science, global regulatory pathways, clinical evidence for and other aspects of biosimilars that will be discussed at DIA’s Biosimilars 2016 Conference.
In August 2016, DIA welcomed Dr. Sudip Parikh as Senior Vice President and Managing Director for the DIA Americas region. Dr. Parikh previously served as Vice President and General Manager of Health and Consumer Solutions at Battelle; he has also served as senior liaison for the US Senate Appropriations Committee in budget negotiations with the pharmaceutical and biotechnology industries, and research universities, centers and hospitals. What was the most important lesson he learned while working on Senate Appropriations? “At the biggest level, it’s never let the perfect get in the way of the good,” he explains. “There are many, many stakeholders at the table, and the perfect IS the enemy of the good.”