2017 Regulatory Reflections
How the Industry was Altered & What’s in Store for 2018

Moderator:
Lisa Haile
Partner at DLA Piper 

Panelists:
Joe Lamendola, Ph.D.
Former VP, US Regulatory Affairs at BMS
Current, SVP BioPharma Practice at YourEncore

Minnie Baylor-Henry, J.D.
Former Board Member & Worldwide VP, Regulatory Affairs, Medical Devices at Johnson & Johnson
Current, Head of MDD Practice at YourEncore

Description:
2017 ushered in a period of unique opportunities and challenges for the FDA. At our first Breakfast with Biocom of 2018, we’ll reflect on what changed and preview what’s in store for 2018.

• 21^st Century Cures In addition to the new targets put in place through the User Fee goals for both pharmaceuticals and medical devices, the FDA was presented new goals through the enactment of 21st Century Cures.
• Dr. Scott Gottlieb Sworn in Shortly after the active implementation of 21st Century Cures, the Center for Drug Evaluation & Research (CDER) and the Center for Device Evaluation & Research (CDRH), along with the rest of the agency, welcomed Dr. Scott Gottlieb. Dr. Gottlieb returned to FDA with the unique advantage of having served at the agency during Dr. Mark McClellan’s administration. Dr. Gottlieb was therefore able to “hit the ground running.” He indicated that the implementation of the Cures Act would be integrated into the broader agency efforts. To this end, the Commissioner led the development of a work plan that lays out extensive implementation targets.
• Renewed CDER Focuses Within the CDER, the new Oncology Center of Excellence was created; minimal risk clinical investigations was examined; a framework for regenerative medicine was created; and patient-focused drug development was addressed.
• Medical Device Emphasis In the medical devices area, there was a serious focus on digital health, as well as the creation of a breakthrough devices program. Innovation has become the focal point for medical devices that continuously imagine a world that connects payers, patients and providers in a new way.
• 2018 Matters 2018 promises to bring even more exciting changes. The question of drug pricing and the role of generics will be a priority. Within devices, the continued focus on pragmatic ways to evaluate the reasonable regulation of digital health devices is a priority. The patient will continue to be at the center of most decisions, thus, allowing for greater consideration of real world evidence. These innovative solutions will include countermeasures and cybersecurity devices that will tackle the ever increasing threats.