ACI’s Forum on Orphan Drugs Boasts a “Who’s Who” of FDA Regulatory

Sept. 11, 2012 - PRLog -- American Conference Institute (ACI) has announced that it will be holding its inaugural Legal, Regulatory and Compliance Guide to Orphan Drugs and Rare Diseases in Boston at the Hyatt Regency on November 28-29, 2012. This unique program features a distinguished faculty of over two dozen leading legal and regulatory orphan drugs and rare diseases experts - including the former director of FDA’s Office of Orphan Products Development, senior in-house pharmaceutical counsel, leading patient advocates, and preeminent FDA and patent attorneys - who will address the intricacies of the FDA’s orphan drug designation process as well as the challenges affecting orphan drug development and commercialization and overall patent portfolio considerations.  

Also, in light of recent cases concerning FDA enforcement of orphan exclusivity, the conference will feature a spotlight session on “Protecting Orphan Drug Designation and Proactively Guarding Against Potential Liability.”

“The growing focus on rare diseases and precision medicine means that understanding how to operate in the complex orphan drug space will become more and more important for companies in the future,” said Geoffrey Levitt, Associate General Counsel, Worldwide Regulatory and Policy Law at Pfizer Inc.  “The ACI conference provides a comprehensive forum for the industry to discuss the latest legal and regulatory developments affecting orphan products and therapies for rare diseases and to analyze the strategic  considerations concerns in drug development aimed at providing which can provide patients facing an unmet medical need with safe and effective life changing therapy.”

More information about this event, including a full agenda, faculty list, and brochure can be accessed at:
http://www.americanconference.com/orphandrug


About American Conference Institute
A unique organization, American Conference Institute is devoted to providing the business intelligence that senior decision-makers need to respond to challenges both here in the US, and around the world.

Staffed by industry specialists, lawyers and other professionals, American Conference Institute operates as a think tank, monitoring trends and developments in all major industry sectors, the law, and public policy, with a view to providing information on the leading edge.