In this exclusive Q&A, we delve into the imperatives and strategies for reshoring critical medicines within the pharmaceutical industry alongside Kevin Webb, chief operating officer at the API Innovation Center. Webb’s expertise sheds light on the current trends and challenges in onshoring pharmaceutical manufacturing, setting the stage for the upcoming round table at CPHI North America on May 8th from 11:40-12:30 EST, titled, “Reshoring US Pharma: The Realities.” Joining Webb on the panel discussion will be Bikash Chatterjee, president and chief science officer at Pharmatech Associates – a USP company; Dr. Rob York, director for regional affairs at Pacific Forum; Andrew Gonce, vice president of commercial and strategy at Mallinckrodt Specialty Generics; and Christina Smolke, CEO and co-founder of Antheia.

What will you be covering in your session at CPHI North America? What are the trends you’ll be looking at?

Kevin Webb: The session will explore the current state of pharmaceutical manufacturing on American soil, examining drivers, challenges, and outcomes of the onshoring trend within the U.S. pharma industry as well as discussions on examining case studies and success stories that highlight the progress and challenges in realizing onshoring goals within the US pharma market, analyzing the impact of regulatory changes and supply chain disruptions on onshoring efforts, and assessing the nuances of hybrid “Onshoring and Nearshoring” strategies.

My focus with the API Innovation Center will revolve around the imperative of bringing critical medicines back to the United States through domestic manufacturing. While we recognize the necessity of a global manufacturing network, there are medications of utmost importance to the U.S.—particularly those vital to the military and government—that require domestic production capabilities. I’ll delve into what steps are needed to achieve this goal amidst a changing landscape of climate impacts and evolving geopolitics.

Are you seeing a trend where companies are adopting a “China plus one” strategy, potentially looking towards India or other countries for manufacturing?

Kevin: The need to strengthen the pharmaceutical supply chain is paramount for the long term, requiring a multi-year industry and national effort. This includes considerations beyond immediate needs, focusing on preventing recurring shortages of critical medications like chemotherapy agents, antibiotics, antivirals, and pain medications. Implementing advanced manufacturing technologies such as continuous flow is part of the strategy to enhance supply chain resilience and efficiency.

How do advancements in automation and digital technologies influence the feasibility and efficiency of on-shoring API production?

Kevin: Advanced manufacturing technologies offer inherent benefits such as reduced production costs, faster manufacturing timelines, equipment repurposing for new molecules, greener footprints, and higher quality. However, industry adoption requires initial investments and incentives, possibly through federal support to de-risk the transition.

What advantages do U.S.-based pharmaceutical companies have with short lead times and supply chain resilience in on-shoring API production? How does this benefit the healthcare system and the industry?

Kevin: These could be huge and far-reaching, as advanced manufacturing technologies not only reduce costs but also enable faster production timelines, equipment flexibility, environmental benefits, and improved employee safety. These advancements enhance the competitiveness of US-based generic manufacturers while ensuring a stable supply of critical medications for the healthcare system.

With numerous drugs coming off patents, how will this impact the demand for generic APIs in the market? Are there any opportunities for improved processes in certain APIs or starting materials?

Kevin: The generic API market will see gradual changes as drugs come off patents, particularly with biosimilars entering the generic realm. However, immediate opportunities lie in repurposing idle manufacturing capacities with advanced technologies like continuous flow manufacturing. These could be ‘early wins’ that can establish a foundation for broader industry adoption.

Does the U.S. industry need more collaboration to accelerate the shift towards advanced manufacturing technologies and onshoring?

Kevin: Absolutely. Achieving a resilient supply chain and domestic manufacturing requires collaboration across the entire industry and supply chain. This includes commitments from hospitals, pharmacies, distributors, and manufacturers to prioritize domestically produced drugs and APIs.

What would you want the key takeaway from this interview to be?

Kevin: I’m optimistic about the feasibility of reshoring and strengthening domestic manufacturing in the U.S. pharmaceutical industry. We have the technology, infrastructure, and identified molecules to make this a reality. The key lies in a coordinated, long-term approach with a focus on preventing future shortages. It’s about not just solving immediate needs but also ensuring a sustainable and resilient healthcare system for the future.