John DiLoreto, Executive Director of the Bulk Pharmaceuticals Task Force and advisor to SOCMA's PharmaChem Sector will participate in a panel discussion about Manufacturing and Supply Challenges at a U.S. Food & Drug Administration event sponsored by Duke Margolis Center for Health Policy. The summit on Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions will be held Tuesday, November 27, at the Washington Marriott Metro Center in Washington, D.C.
"I am honored to serve on this distinguished panel. With so many factors impacting drug shortages, as well as challenges related to economic drivers and market competition, this event comes at a critical time as active pharmaceutical ingredient manufacturers refine their business plans and strategy for 2019 and beyond," said DiLoreto.
Key discussion questions for the panel include:
When are manufacturers able to anticipate circumstances likely to precipitate drug shortages? When are manufacturers not able to do so?
What systemic economic conditions and environmental factors affect the supply of APIs and raw ingredients? When manufacturers face challenges acquiring APIs and raw ingredients, what actions do they take?
Are there barriers that keep manufacturers from resolving drug shortages in the most efficient manner?
What factors influence manufacturers actions to invest in production capacity, reliability, or redundancy? What factors influence decisions to withdraw from a market?
How does government policy or regulation impact manufacturing and supply chain decisions on the part of stakeholders?
Other key topics throughout the day will focus on federal efforts to prevent drug shortages, the economics of drug shortages, the health impacts and economic consequences of drug shortages, drug purchasing and demand challenges, and strategies and next steps to reduce adverse clinical and economic consequences and safeguard public health.
This event is open to the public.
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