Halloran’s Regulatory Lens – What We’re Watching in 2025

This blog features a Q&A with Jillian Farrel and Shawn Roach.

With Q1 behind us, and a few lessons learned from 2025, I sat down with Shawn Roach, PhD, Associate Principal Consultant of Regulatory CMC at Halloran, and asked what he and the regulatory team are watching as the rest of the year unfolds, and what complementary content we may expect to see from this team to support product developers navigate the ever-changing regulatory landscape. 

The tariffs on the biotech industry have the potential to disrupt supply chains that are critical to development and manufacturing progress. What consequences do you see playing out? 

Tariffs on goods imported from Canada, the European Union, and China will likely go into effect in 2025, likely including the possibility of materials needed for the manufacture of biotherapeutics. For companies without big pockets, the impact of tariffs on their supply chains may pose a threat to their budgets. 

For now, consider having conversations with your materials broker and/or your supply chain experts to understand the ramifications of tariffs associated with your materials. In addition, seek to understand the materials that are and are not exempt from tariffs.  We recommend companies begin planning alternative scenarios in case of a supply chain disruption due to tariffs.   

Our advice to industry and clients will evolve as the impact unfolds. However, please read our latest blog on this topic, “Risk Mitigation Planning for Pharmaceutical Tariffs.” 

Navigating the regulatory landscape, particularly those that haven’t done it before, requires relentless focused planning. Do you have any new considerations considering the recent FDA personnel changes? 

Our focus and recommendations on the regulatory landscape remain the same, and even more so considering recent personnel changes at the FDA. 

We remain focused on supporting companies to move the right programs through the early phase of development as quickly as possible, supported by productive, positive interactions with the FDA, to propel development towards approval. Even more now, we must make the FDA review process as efficient as possible considering the reduction in staff.  

We will be monitoring the impact of the FDA personnel changes on the industry and will provide strategic recommendations when appropriate.  

Read our observations and recommendations from a recent Town Hall. 

What advice do you have for companies as they look to advance from research to development? 

Whether companies are heading into the early phases of development or towards their marketing application (i.e., New Drug Application (NDA) or Biologics License Application (BLA)), they’ll need to have the appropriate funding to carry them across the development cycles well in advance. We are no longer in the time for funding just to reach the next milestone. Strategic considerations in 2025 are different and the strategy drives the funding approach. 

In addition, risk management will be a company’s competitive advantage. Those with a nimble approach, with well thought out backup plans and strategies, will have a better chance of success navigating funding and partnering options. Those that are recognizing and retiring risk are the ones that will likely come ahead.  

Still, a promising product with good, quality data, and the right team in place with solid backup strategies are elements that may weather a small biotech through the fundraising storm.  

What content may we expect from you and your team this year? 

We’re committed to providing our observations, advice, and points of view on a continual basis as we navigate the ever-changing regulatory landscape. Throughout 2025, stay tuned for fresh content published on the Halloran Insights page.