3 questions with…Brian Mullan

What are the biggest challenges in the advanced therapy industry?

In my opinion, there are numerous challenges, but one of the biggest is our current level of understanding of the products. Our general understanding of the mechanism of action, pharmacology, etc., is poor. Problems still occur during clinical evaluation, which may lead to clinical delays that also affect similar products under development. Therefore, clinical development may be somewhat “stop-start”, to some extent while the industry learns from these events and continuously tries to ensure product safety and an appropriate risk-benefit ratio. This also links to the analytical methods we use (which product quality attributes are we following? What are their links to the target product profile?). Related to this is an evolving regulatory landscape.

What advanced therapy innovations are you most excited about?

Continued automation of process flows! Reducing the need for human intervention in the manufacturing process would have a major impact on many product categories, including advanced therapies. In the last few years, there has been no significant progress toward real-time control or reliable automated transitions between manufacturing steps, and I think we need more opportunities to promote their widespread acceptance and implementation.

What are your predictions for the next 5 years for the Advanced Therapy Industry?

Within five years, I would hope to see an industry with a more mature understanding of the product, a wider range of technology offerings, and a better-understood manufacturing process. Given the interest and investment in the advanced therapy sector, I am confident that this will happen – especially with the increasing number of products going through regulatory approval and entering the market. However, more technology offerings are also needed (e.g., new chromatography resins for viral vector purification) as the overall solution offering remains quite limited.