Date — Mar 21
3:00 pm - 7:30 pm
The Nippon Club
TOPIC: Trump on Pharma: Policy and the New Administration’s Impact on the Pharma Industry
President Donald Trump’s tweets can send markets into turmoil, and his statements regarding healthcare as well as his intentions towards the pharma industry and repealing/replacing the affordable care act often seem contradictory. His administration and cabinet appointments have been shaking things up across the board, and this program will explore how policy changes the administration has proposed as well as changes already enacted will affect the industry.
Michael McCaughan, Founding Member, Prevision Policy LLC
Mr. McCaughan has 25 years of experience providing analysis and insight about the biopharma industry, including 10 years as Editor-In-Chief of The Pink Sheet and The Pink Sheet DAILY. He speaks frequently on regulatory and policy developments affecting the industry.
TOPIC: The 21st Century Cures Act: Implications for Pharma and Biotech Companies
The 21st Century Cures Act (Cures Act) was signed into law in December 2016 (a rare bipartisan effort), and is a nearly 1,000 page piece of healthcare legislation designed to bring new treatments and cures to patients faster. The law is broad in scope and aims to improve the discovery, development and delivery of breakthrough treatments and cures for a variety of diseases and conditions such as cancer, rare diseases, and neurological disorders by providing new funding through various strategic initiatives.
This program will look at the provisions of the cures act and its implications for pharma and biotech companies.
Phil Katz, Partner, Hogan Lovells
Philip Katz helps pharma/biotech companies successfully navigate FDA and related regulatory matters. He counsels them on compliance; helps anticipate and address regulatory issues in their day-to-day business operations and strategic planning; and advocates for them before the FDA, other agencies, and in court. His clients develop, manufacture, and distribute drugs and biologics, spanning from large public companies with extensive product portfolios to start-ups trying to bring their first product to market.
Phil heads the firm’s Pharma/Biotech Practice Group, which has 20+ lawyers — many with years of experience at the FDA — who work collegially and in collaboration with our clients to help them achieve their business goals in a highly regulated environment in which good long-term relations with the FDA are essential. The excellence of the group is reflected in its Chambers ranking as a Band 1 D.C. Pharmaceutical/Medical Products Regulatory practice.
Phil and his team bring together a detailed and nuanced knowledge of the law and FDA precedents, an informed understanding of the client’s business goals, and an experienced appreciation of the public policy implications to craft thoughtful, creative, and practical solutions. He and his team focus particularly on product development, approval, and lifecycle management; responding to agency enforcement activities; and counseling on business transactions. He has deep knowledge of the Hatch-Waxman Act, Orphan Drug Act, and Biosimilars Price Competition and Innovation Act.
Phil recently served as Chairman of the board of directors of the Food and Drug Law Institute, which capped years of activity at the institute. His leading role in the food and drug bar is reflected in many 2015 recognitions, including Legal 500 – Healthcare/Life Sciences, LMG Life Sciences – Regulatory Star, Best Lawyers in America – FDA Law, Who’s Who Legal – Life Sciences/Regulatory, and Chambers – Recognized Practitioner.
Abram S. Barth, Associate, Ropes & Gray LLP
Abram Barth joined Ropes & Gray in 2015 as an associate in the life sciences and health care practice groups. Abram has a wide range of experience counseling on FDA regulation, with a particular focus on medical devices, combination products, and clinical research.
Prior to joining Ropes & Gray, Abram worked in the Food and Drug Administration’s Office of Chief Counsel, most recently as Associate Chief Counsel, serving as Team Leader of the device practice group.
He has significant experience advising clients on the life cycle of medical devices, including clinical trials (IDEs, IRBs, informed consent), premarket submissions (510(k)s, PMAs), advertising and promotion, quality system regulation (QSR), medical device reporting (MDR), and postmarket surveillance and studies, as well as the premarket and postmarket regulation of combination products. In addition, Abram was a principal attorney advising the FDA and HHS on clinical research compliance and policy, and served as counsel to FDA’s IRB for six years.
Abram has advised FDA on emergency preparedness matters, including serving as the lead device attorney for FDA’s response to the 2014 Ebola outbreak and counsel during the 2009 H1N1 outbreak, regarding exportation, importation, and Emergency Use Authorization of investigational medical devices.
He has been recognized with numerous awards at FDA, including the Commissioner’s Award of Excellence, Commissioner’s Special Citation, Commissioner’s Special Recognition, and Group Recognition.
Abram also has taught FDA Policymaking at George Washington University School of Public Health.