Dr. Susan Forda serves as Vice President of International Regulatory Affairs for Eli Lilly & Company Limited in the UK. She also contributes her expertise to various committees for the European Federation of Pharmaceutical Industries and Associations (EFPIA) and will serve as Co-Chair for DIA’s EuroMeeting 2017. In this interview with DIA Global Forum Editor Dr. Alberto Grignolo, Dr. Forda explains her perspective on health care and regulatory challenges facing Europe and on the EuroMeeting theme, From Bench to Bedside and Back. “This theme is really important at this juncture because we know that patients are increasingly taking an active role in their health care, and this connectivity is enabled by rapid improvements in technology – for instance, through the immediate availability of credible information in the palm of our hands,” she suggests. “The patient can provide access to knowledge that no one else does.” To learn more, register for our DIA EuroMeeting 2017 in Glasgow!
Early access, real-world evidence and data generation, and Brexit are just a few of the high-level challenges facing European health care and regulatory systems. DIA’s EuroMeeting 2017 will discuss ways to approach these challenges in forums such as Major European Regulatory Science Challenges, which will be co-chaired by Dr. Karl Broich, President, Federal Institute for Drugs and Medical Devices in Germany (BfArM). “You will learn about early access to innovative products, that we have all our regulatory tools available. However, you will see as well that we have to improve our methodology and find ways into real-world evidence in addition to our usual randomized, controlled trials,” explains Dr. Broich. “They will complement each other in future clinical development plans, particularly if we are discussing early access for patients.” To learn more, register for our DIA EuroMeeting 2017 in Glasgow!
As Co-Founder, President, and Chief Privacy Officer, Ben Heywood has overseen the tremendous expansion of PatientsLikeMe, a free website where people can share their health data to track their progress, help others, and change medicine for good. In this exclusive podcast, Ben discusses aligning clinical trials with real-world data, and PatientsLikeMe’s new partnership with digital life company iCarbonX. “In an ideal environment, we’d measure what patients care about in the real world and that would be the dominant measure that trials use to measure the effect of drugs,” Ben explains. “That alignment needs to happen.” Learn more about this alignment of clinical and real-world evidence at DIA's EuroMeeting 2017 and DIA’s 2017 Annual Meeting.
Through breakthrough therapy designations, adaptive designs and other innovations, the global regulatory environment is evolving to deliver therapeutic products to patients more quickly, although sometimes with less clinical data. Claes Buxfeldt, Global Price and Reimbursement Director at AstraZeneca in Sweden, and Ana Palma, Lead, Global HTA and Patient Access at Sobi in Belgium, explain how payer and health technology assessment processes are evolving to assess the value of these products, and preview Theme 8: HTA, Value & Access, which they will co-chair at DIA’s EuroMeeting 2017 in Glasgow. “There’s no point in reaching an internal agreement within a company and then eventually an agreement with a regulatory agency if down the road we will hit a wall with the reimbursement agency,” Ana explains. Register for our DIA EuroMeeting 2017 in Glasgow!
Dr. Ian Hudson serves as Chief Executive for the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom, and is Program Co-Chair of DIA’s EuroMeeting 2017 in Glasgow, Scotland. In this exclusive podcast, Dr. Hudson explains his views on the global “access versus evidence” debate, regulatory supports (and hurdles) to innovation, and the timeliness of the EuroMeeting theme, From Bench to Bedside – and Back. “This theme clearly emphasizes the life cycle approach that both companies and regulators take,” he explains. “It’s all the way through, from the bench to the bedside, getting products to the patients; and then, once products are being used extensively in the marketplace for the benefit of public health, key learnings from that can be taken back in to perhaps the next generation of products.” Register for DIA EuroMeeting 2017 in Glasgow!
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. Register for DIA EuroMeeting 2017 in Glasgow!
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; Newell McElwee, Merck & Co.; 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.