Gil Roth, President,


"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."

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 put together and forwarded to Congress. 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-19, 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.

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

The current administration has been employing the Defense Production Act (DPA), an industrial policy where the government is able to give suppliers rated orders—if a Covid-vaccine manufacturer is in need, suppliers must sell to them before selling to non-vaccine manufacturers in the sector. 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 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 the 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 They put out a draft guidance for this in late 2021, and my members had a lot of questions.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 ‘harmonization’ 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. That said, a major pharma company complained from the opposite perspective— if their facility is handling a single product and encounters a problem, given the small sample set it will reflect poorly on the facility. 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 — seeing how this will be adapted for other types of illnesses and diseases in future is going to be important. Within the past two years, we have seen the greatest single proof of concept for a product class ever. This is something that literally went from Phase Two/Three to 7 billion doses across the world. So we know the principle itself works and this is why we are seeing all the investment into that space.

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.

Moving forward, we need to ensure we do not go back to 2019. Governments need to understand there has to be public investment to ensure pandemic-readiness.