"The pandemic highlighted the key role that CDMOs play, and we need a voice to drive consensus internally, face regulators, and ensure we have a seat at the table."

Gil Roth

PRESIDENT, PHARMA & BIOPHARMA OUTSOURCING ASSOCIATION (PBOA)

February 24, 2022

Which are the most important initiatives the PBOA has been involved in over the past year?

Negotiating the third iteration of the Generic Drug User Fee Amendments (GDUFA) between the FDA and industry, which happens every five years, was key. A package has been forwarded to Congress, which is formulating legislation. We also focused on pandemic response and preparedness—how our members are helping license holders and governments stock up and produce vaccines and therapeutics for Covid, figuring out next steps, and how the supply chain will respond. This has involved on-shoring discussions, given the last two administrations have pushed to manufacture more domestically. The PBOA has helped educate lawmakers on what is already here, which policies could help or hinder those efforts, their impact on drug supply chain security, and the costs of manufacturing with smaller scales for a local market.

How has the pharma and biopharma landscape evolved with the Biden administration?

There was a chain reaction starting with the approval of vaccines that led to questions on US manufacturing capacity to ensure access to Americans, and then the world. The current administration has been employing the Defense Production Act (DPA); an industrial policy where the government is able to give suppliers rated orders, so that if a Covid-vaccine manufacturer is in need, suppliers must sell to them before selling to non-vaccine manufacturers. This has led to ensuring adequate supplies of vaccines, but could cause shortfalls throughout the supply chain for components needed by other manufacturers. We have worked with the new administration to highlight potential challenges and solutions on this, especially on the biologic side. PBOA wants to ensure that the DPA is used more judiciously so the supply chain can ultimately achieve equilibrium again.

How is the FDA responding to bio/pharma supply chain issues?

When the US Congress passed the CARES Act in March 2020 for pandemic relief, they mandated that FDA start collecting data on the amount of drug product and API manufactured in each facility that falls under the agency’s umbrella. They put out a draft guidance for this in late 2021, and my members had a lot of questions. One of the challenges was that the comment period ended January 3rd 2022, with the first reporting period being February 15th, 2022. They gave six weeks from release to due date, with no clarity on guidance.

Is FDA making progress on quality metrics?

When it comes to quality metrics, there remains no consensus on definitions — for example, what constitutes a batch? My standard joke for this is that until we all spell harmonisation the same way, we are not going to make a lot of progress. We need to have common language.

Our concern with quality metrics has been the potential for inherent bias against CMO facilities because of the sheer quantity and breadth of products that many of our members make. The FDA have been pushing to create a rating system for all sites, so payers can pressure license holders into revealing their manufacturing site ratings. This involves public shaming, and splits the goal of what Quality Management Maturity Metrics are supposed to do: incentivizing quality vs. identifying potential quality problems that could lead to shortages. There are issues for the whole value chain, not just CMOs.

What noticeable trends are currently driving the sector forward?

The biggest area for a few years now is the growth of cell and gene therapies. Advances in those pipelines, and the different models of manufacturing and patient treatment, are going to redefine medicine. Similarly, messenger RNA was there, but it was never considered a solution for a pandemic until now. Seeing how this will be adapted for other types of illnesses and diseases in future is going to be important. The past two years, we have seen the greatest single proof of concept for a product class ever.

How do you want to evolve as an association in 2022?

The pandemic highlighted the key role that CDMOs play, and we need a voice to drive consensus internally, face regulators, and ensure we have a seat at the table. We want our members to share best practices in areas like ESG to raise industry standards overall, have added a Task Force focused on supply chain issues, and will continue to look for ways to benefit the license holders and patients whom they are trying to treat.

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