A Bold Goal: Reshoring 25% Of Small Molecule API To The U.S. in 5 Years

BACKGROUND

Our nation’s overreliance on China and India for most of our active pharmaceutical ingredients (APIs) is impacting the availability of essential medications in the U.S. As a result, our national health security is being compromised. The National Economic Council (NEC) Director and the National Security Advisor (NSA) called for a “new approach” aimed at guaranteeing Americans reliable access to essential medications.

The Office of Science and Technology Policy (OSTP) laid the foundation for this strategy in their plan, Bold Goals for U.S. Biotechnology and Biomanufacturing R&D. Their initiative aims to deploy broad syntheticbiology and biomanufacturing capabilities in the U.S. within 5 years to produce 25% of all APIs for small molecule drugs.

BOLD GOALS API INITIATIVE: Pathway to Build Supply Chain Resilience for Critical Drugs

To achieve this goal, 15 subject matter experts convened during a plenary event titled Pathway to Build Supply Chain Resilience for Critical Drugs in November 2023 at the API Innovation Center (APIIC) in St. Louis, Missouri. APIIC is a non-profit public benefit organization that works to facilitate partnerships and connections with key organizations and stakeholders in the industry to provide collective expertise and
collaboration on the advancement of the pharmaceutical supply chain through advanced manufacturing.

PANEL RECOMMENDATIONS

The panelists provided immediate, short, and long-term actions necessary to return API production to the U.S.

Panelists
  • Andrea Adamo, Ph.D., Founder and CEO, Zaiput Flow Technologies
  • William Foley, MBA, Process Analytics, Subject Matter Expert
  • Matt Hancock, Ph.D., Director, Business Management API, Thermo Fisher Scientific
  • Kyle Hoelting, PharmD, BCPS, Sr. Clinical Mgr, Drug Info & Shortages, Vizient Center for Pharmacy Practice Excellence
  • Dennis Hall, MBA, Vice President, Advanced Manufacturing Technologies, U.S. Pharmacopeia
  • Stephen Schondelmeyer, PharmD, Ph.D., Professor, U. of Minnesota, College of Pharmacy
  • David Thompson, Ph.D., Co-Founder and Chief Technology Officer, Continuity Pharma
  • Andrew Gonce, MBA, VP, Commercial & Strategy, Mallinckrodt Pharmaceuticals
    Ed Price, Former CEO, PCI Synthesis
  • Fernando Muzzio, Ph.D., Professor of Chemical Engineering, Rutgers University
  • Karthik Raghavan, Founder and Chief Executive Officer, Sentio Biosciences
  • Laura Bray, MBA, Chief Change Maker, Angels for Change
  • Stephen Colvill, MBA, Assistant Research Director, Duke-Margolis Center for Health Policy
  • Marcus Lumpuy, U.S. Vice President, Hospital Business Unit, Pfizer Biopharmaceuticals
  • Guest Contributor: Bayan Takizawa, M.D., Co-Founder and Chief Business Officer, CONTINUUS Pharmaceuticals
Moderators
  • Adam Fisher, Ph.D., Director, Science Staff, Office of Pharmaceutical Quality, CDER, FDA
  • Kurt Karst, Hyman, Phelps & McNamara, P.C., Co-Founder of the FDA Law Blog

Download the White Paper

Watch the API Innovation Center’s Plenary Event: Pathway to Build Supply Chain Resilience for Critical Drugs

PLENARY EVENT

Pathway to Build Supply Chain Resilience for Critical Drugs Gallery