The Shift Toward US Pharmaceutical Manufacturing

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The COVID-19 pandemic brought the global interdependency of pharmaceutical supply chains into sharp focus, exposing weak links and re-igniting discussions around the value of reshoring production.

The global interdependency of pharmaceutical supply chains is widely recognized. The U.S. Food and Drug Administration (FDA) reports 72 percent of facilities manufacturing APIs for American drugs are overseas, with 13 percent in China.

Relying too heavily on a single geographical location for outsourcing opens up considerable risk when it comes to assuring uninterrupted drug supply. Advance planning is vital with specific complexities that must be considered.

In this webinar we will discuss:

1. Drivers to consider including current legislative action, the scope of the onshoring discussion and how we might support cost structures
2. Balancing cost considerations with other factors of importance including production volume, dosage form, regulatory considerations, and the geography in which the product will launch.
3. Dual sourcing to mitigate risk
4. Building robust supply chains with the capacity to handle disruption
5. Supplier qualification
6. Lessons learned from the field and best practices to create resilient supply chains

James F. Grabowski Ph.D., MBA
Vice President, API Manufacturing – Europe and India

Marta Wosińska, Ph.D.
Visiting Fellow
USC-Brookings Schaeffer Initiative on Health Policy

Beth Weinman
Ropes & Gray LLP

Jack Garvey
Managing Partner
Compliance Architects LLC

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