DIA: Driving Insights to Action

PatientsLikeMe: Patient Value Should Drive Market Value

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 Global Annual Meeting.

Value & Access Experts Explain Price for Progress at EuroMeeting 2017

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!

MHRA Chief Executive: Today’s Learning Will Inform Next Gen Products

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!

 

Can Our Future Afford Today’s Model of Innovation?

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 Council of Regulators Previews Risk Management & Drug Safety Updates

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.”