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:
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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.