20 April 2015
Last week AstraZeneca, in partnership with the National Journal, brought together thought leaders from key patient groups, payers, advocacy stakeholders and media for a thought leadership dinner in Washington, DC. Greg Keenan, Vice President, Medical Affairs and U.S. Head Medical Officer, AstraZeneca, Steve Mohr, Deputy General Counsel, North America and U.S. General Counsel, AstraZeneca and Rich Buckley, Vice President, North America Corporate Affairs, AstraZeneca participated in the first of five events to be hosted this year with the National Journal, with a specific focus on the 21st Century Cures initiative, which AstraZeneca proudly supports.
Earlier this year, the House Energy and Commerce (E&C) Committee released the first draft of its highly anticipated 21st Century Cures initiative. The proposed legislation – and its focus on accelerating the discovery, development, and delivery of new medical treatments and technologies – combined with the report released by the Senate HELP Committee’s “Innovation for Healthier Americans” and President Obama’s Precision Medicine Initiative, have reignited the debate about biomedical innovation and regulation in Washington.
Furthest along in this debate is the E&C Committee’s draft legislation, which has raised important questions about how drug manufacturers can expedite the development of effective, personalized treatments, while ensuring their safety and value for patients. What is the proper role of government in this process? And will legislation on these topics reach the President’s desk by the end of the year?
As a company committed to listening and learning from all sides of the discussion, members of AstraZeneca’s North America leadership team were joined by 17 thought leaders and members of the media, representing companies such as Quintiles, Avalere, National Pharmaceutical Council, Aetna, AARP, National Center for Health Research and Manhattan Institute for Policy Research. Marilyn Werber Serafini, Vice President for Policy at the Alliance for Health Reform moderated the evening’s discussion, which brought forward four key themes attendees felt were fundamental to address in the House’s legislation:
- Importance of enhancing health care professional (HCP) engagement/participation in clinical trials
- Integrating patient-centered approaches into clinical trial design
- Continued funding of NIH and FDA through PDUFA, and holding the FDA accountable to measurable outputs
- Ensure a clear path for innovation that protects patient safety within the drug discovery, development and approval process
The candid discussion elevated a diversity of perspectives around the scope of the proposed legislation. One participant expressed concerns with patient safety coming at a sacrifice to innovation, which should not just mean “new” medicines, but those that meet a true unmet need and are both better and safer for patients.
As an alternative perspective, several attendees saw a clear effort being made by industry to deliver innovative medicines, but recognized there was a need to accelerate and modernize the FDA’s processes in order to bring those treatments to patients sooner.
One guest in particular emphasized the importance of incentivizing physicians to participate in clinical research by removing barriers for this to happen and working within their hospitals and institutions to gain alignment on what this incentive framework looks like.
Despite differences of opinion and a diversity of voices at the table, there was alignment around a fundamental need for a healthy and innovative clinical research landscape that keeps HCPs, patients and patient safety at its core.
The dinner was part of a series of events coordinated by National Journal LIVE, a premier events business that convenes top leaders in the Washington, D.C. area to discuss possible solutions to the country’s biggest challenges.