Cross-Disciplinary Group Hosts Second Annual Rare Disease Forum

A cross-disciplinary group of Ropes & Gray attorneys and industry executives gathered for the Second Annual Ropes & Gray Rare Disease Forum on May 7 in Cambridge, MA. The group explored new developments in the regulatory framework, compliance risks, transactional considerations and other key topics related to the development and commercialization of rare disease products. The program events included:

• Rare Disease 101: An Introduction to FDA Regulation and Healthcare Laws for Rare Disease Products offered a primer on FDA regulation and healthcare laws relevant to the development and commercialization of rare disease products with panelists life sciences regulatory and compliance partner Josh Oyster, health care counsel Alison Fethke and life sciences regulatory & compliance associate Becca Williams.
• Life sciences regulatory & compliance partner Kellie Combs offered welcome remarks followed by a fireside chat moderated by partner Greg Levine, global chair of the firm’s FDA regulatory group, with National Association for Rare Disorders (NORD) CEO Pamela Gavin.
• The Clinical Trials for Rare Disease Products discussion was moderated by life sciences regulatory & compliance counsel Sarah Blankstein with panelist health care partner David Peloquin.
• The Drug Pricing & Market Access—Global Trends program that highlighted key issues impacting the U.S. and Europe was moderated by Greg Levine with panelists including health care partner Margaux Hall and partner Lincoln Tsang, head of the firm’s European life sciences practice.
• The Deal Trends and Considerations for Rare Diseases—Products and Companies program was moderated by partner Chris Comeau, leader of the firm’s mergers & acquisitions group, with panelists including life sciences licensing partner Amanda Austin and antitrust partner Mike McFalls.
• The Compliance Risks for Rare Disease-Focused Life Sciences Companies discussion on patent support programs and patient privacy considerations was moderated by life sciences regulatory & compliance counsel Beth Weinman with panelists Doug Hallward-Driemeier, partner and head of the firm’s Appellate and Supreme Court practice and health care partner Eve Brunts.
• The Advertising and Promotion for Rare Disease Products discussion that examined disease awareness activities and proactive medical communications was moderated by Josh Oyster with panelist Kellie Combs.

A complete list of panels and speakers is available here.