DIA: Driving Insights to Action

Bringing Regulators & the Regulated Together: DIAmond Session 412: CDER Town Hall

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.

DIAmond Session 303: Value-Based Health Care Decision Making: The Quest for Smarter Spending

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; Newell McElwee, Merck & Co.; and Benjamin Heywood, Co-Founder, President, & Chief Privacy Officer PatientsLikeMe Inc.

DIAmond Session 302: Europe and the US: Making Outcomes-Based Health Care Possible

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.

DIAmond Session 201: International Regulatory Convergence, Collaboration & Cooperation

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).