First Plenary Session - Monday, May 20 9:00-10:30
The Dawn of Disruption in the Health Sector: Will Innovative Technologies Require Innovative Ways of Thinking?
The healthcare sector has recently witnessed several landmark moments in the development of the next generation of medical care. While media attention has rightly focused on milestone regulatory approvals for several groundbreaking curative treatments and devices, the best is likely yet to come: over 2600 clinical trials of gene therapies are either completed or ongoing; nearly 1000 trials of regenerative medicine are in progress worldwide; and more than 7000 trials for medical devices ranging from bionic eye brain implants to spinal cord stimulators are underway. Disruption will not be limited to drugs and devices, however. Advances in the applications of 3-D printing as well as artificial intelligence have the potential to generate powerful new tools for disease prevention, diagnosis, and treatment. In short, innovations that have long been the stuff of science fiction may no longer be distant points on the horizon. Are we entering a “golden age” of disruptive innovation in medical care? What new challenges and opportunities will these technologies bring? How can a health sector attuned to an old way of doing things truly prepare for treatments that break the mold? This plenary session will begin with an overview of the current and future landscape followed by a discussion among leading experts. Emerging challenges and opportunities presented by disruptive technologies will be addressed from the perspective of regulators, payers, manufacturers, providers, and patients.
Second Plenary Session - Tuesday, May 21 9:00-10:30
No More J'accuse: How Do We Prevent Another "Implant Files" Case in The Medical Devices Sector?
Over the last few months the global investigation known as “Implant Files”, released by the International Consortium of Investigative Journalists (ICIJ), has reignited the debate on how medical devices are tested, approved, marketed and monitored to ensure safety and effectiveness for patients and users. The investigators claimed health authorities have failed to protect millions of patients from poorly tested implants and manufacturers have repeatedly put patients at risk. The report blames low regulatory standards in place, even for high-risk devices, as well as a lack of transparency and harmonization on safety warnings and recall practices across the globe. After previous medical device-related scandals, this latest accusation arose despite policy changes recently initiated by regulators to improve patients’ safety. The new EU Medical Devices Regulation ((EU) 2017/745) will come into force on 26 May 2020 and is intended to “ensure a high level of safety and health while supporting innovation”. Other regulators such as the FDA are also instituting major changes to their medical device regulations. How will these new regulations better guarantee patients’ safety and restore the loss of confidence following the release of the ICIJ report? How will our healthcare systems avoid future medical device-related controversies? Have regulatory changes contributed to improving medical device- safety? What still needs to be done in this respect? Does the guidance by the FDA on the use of real-world evidence help improve the generation of relevant evidence to support better regulatory decision-making for medical devices? Does the increasing number of post-market recalls point to better vigilance systems or to failures of the pre-market regulation systems? This plenary will start by reviewing the global investigation followed by a discussion among major stakeholders that will bring their perspectives on what can be done to improve regulation systems.
Third Plenary Session - Wednesday, May 22 11:15-12:30
Is Affordability Driving a Need to Revolutionize Drug Pricing?
Promoting rapid and equitable access to promising therapies in an affordable manner is a laudable goal for all health systems. However, with the explosion of high cost, disruptive, and innovative drugs-- many of which are promising a cure--payers are facing a crisis of affordability. We are in an era with six-figure cancer treatments, curative and costly gene therapies, ultra-high cost drugs for treating Orphan diseases, and even expensive drugs for more common diseases. It is an exciting and promising time for patients, clinicians, and pharmaceutical companies, and a challenging time for payers who must now look beyond cost-effectiveness to address affordability. The ISPOR 2019 Top 10 HEOR Trends report identified drug spending and pricing as the top trend. In the United States, President Trump launched his Blueprint to Lower Drug Prices in May 2018, and a recent paper from the University of Chicago reported that average total drug spending per hospital admission increased 18.5% between 2015 and 2017. Affordability of pharmaceuticals has become a truly global issue. Is it time for a revolution in how we price, fund, and manage drugs? Are there innovative approaches that can promote access, manage affordability, and still foster innovation? What can be done to significantly improve the transparency of drug prices? How do we ensure equitable access to low- and middle-income countries and disadvantaged populations?