At BIO 2025, As Political Shifts Continue, Key Leaders Respond

Pharmaceutical Technology® Group was able to interview more than a half dozen executives in the biopharmaceutical industry as part of its coverage of the Biotechnology Innovation Association (BIO) International Convention, which took place in Boston June 16–19, 2025.

The conference was bookended by major developments with impacts to healthcare within United States government agencies, namely US Health and Human Services Secretary Robert F. Kennedy Jr. replacing all 17 members of the Advisory Committee on Immunization Practices, a Centers for Disease Control and Prevention-affiliated body responsible for guiding vaccine policy, followed by FDA suspending certain new clinical trials, pending review, in which US citizens’ living cells are sent to China and other “hostile countries.”

With those policy and personnel changes in mind, the key opinion leaders shaping some of the content presented at BIO were asked how much attention they and their companies were giving to US developments, how those developments figured to impact their business, and the larger implications to their employees and the industry at large.

Unlike at INTERPHEX 2025 in April, there was not one unifying theme expressed by this group; the changes—which by no means are complete—have affected companies small and large, as well as foreign and domestic, in varying ways.

Click the video above to view the responses that were compiled by PharmTech Group.

Click here for all BIO 2025 coverage.

About the speakers

Daniel Fischer is co-founder and chief executive officer, Tevard Biosciences.
John Hoekman, PhD, is co-founder and chief executive officer, Junevity.
Bartłomiej Czubek is director of business development, Mabion.
Brandon Pence is co-founder and chief operating officer, FUJIFILM Biosciences.
Matthew Stober is chief executive officer, Abzena.

Transcript

Editor's note: This transcript is a direct, unedited rendering of the original audio/video content. It may contain errors, informal language, or omissions as spoken in the original recording.

Patrick Lavery

I'm Patrick Lavery for Pharmaceutical Technology® group. As part of our coverage of the Biotechnology Innovation Organization International Convention in Boston in mid-June, we asked key opinion leaders and subject matter experts two questions across the board: To what degree are you keeping your eye on staffing, regulatory, and policy changes within US government agencies, and how do these shifts figure to impact your business? And—how else is the current US political climate impacting you, your company, and the industry overall? As we found out at the earlier INTERPHEX conference in the spring, uncertainty is still looming in the minds of many.

Daniel Fischer

When you wake up every morning to see what's the news, how it's going to impact us. It definitely makes it hard to raise capital.

Patrick Lavery

Depending on the size of a company and its location, some are adjusting their plans and processes, and others are not.

John Hoekman

It almost helps to be a small company at this point where we're doing basic research and preclinical research, I don't think anything has changed from our plans based on the macro stuff that's going on right now.

Daniel Fischer

It's definitely pushed us to be more efficient, much more efficient, definitely cutting all the fat that we can. We've had to sit down, review our goals, review our objectives; anything that drives us toward that, those goals, those value creation points, we keep doing. Anything that doesn't, doesn't.

Patrick Lavery

For companies that don't have major operations in the US, they see opportunity,

Bartłomiej Czubek

While changes at the regulatory or federal level may affect how US companies approach partnerships, I believe our strong track records of collaboration with US clients, and the potential and economic stability of Poland and the EU, create a great opportunity for our region. With the right conditions, Poland can be become a key CDMO hub for American biotech, looking for reliable and cost effective partners in Europe.

Patrick Lavery

For those that do business both here and overseas, they feel in general, they are in good position. And say these shifts are not unprecedented.

Brandon Pence

The way I look at it is, this is a remarkably important and resilient industry, you know, expand a variety of administrations, a variety of approaches.

Matthew Stober

The good news for Abzena is all of our manufacturing is based in the US, and so, you know, we're definitely seeing the tailwinds. It started with [the] BIOSECURE [Act], you know, in the previous administration; it's moved into a conversation around tariffs, and it's moved into a conversation around intellectual property protection, specifically in China.

Brandon Pence

FUJIFILM has done a great job of ensuring that it's insulated, in some regard, from various changes that might come up from some of these directives. We've got manufacturing footprints in multiple geographies. We're closely aligned with our customers and supporting their global needs.

Matthew Stober

Because our manufacturing is primarily in the US, our R&D services are in the UK, we've actually seen, you know, positive benefits from that side of it.

Patrick Lavery

Since the spring, there's been a solid amount of turnover at FDA, both in personnel and policy, and there isn't any way that's gone unnoticed.

Matthew Stober

One of the areas that we continue to watch carefully is what's happening specifically [at] FDA, and you know, does drug development and approvals and things getting into IND [investigational new drug status], does that slow down because of some of the turmoil there? We haven't seen it yet, but we're certainly concerned about it and worried about it, because a lot of our customers are those early-stage companies.

Daniel Fischer

It has to do with the FDA as well, and I think there are three aspects that probably impact us. One is the staffing changes at FDA, the regulatory agency. The second one has to do with drug pricing, and the third one with funding.

Patrick Lavery

Will these changes slow innovation, especially at the university level? That remains to be seen.

Matthew Stober

We see, you know, the reduction of some of the, I'll say, funding that used to flow through some of these government agencies, into the universities that drove innovation. You know, a lot of these small companies get spun out of universities. That's worrying, that innovation could slow down, you know, if these grants that are coming through different parts of the federal government don't continue to go into the university systems, that it slows innovation in the US, and so we're obviously worried about that side of the policy. So, you know, there's always pros and cons with every administration, some of the things turn out to be positive, some of them not as much.

Daniel Fischer

In [regards to] funding toward academic institutions, at the end, it's something that's going to impact all of us.

Patrick Lavery

The bottom line has not changed: getting drugs into clinic, then getting them to market, as quickly, safely and effectively as possible.

Daniel Fischer

There's always a question, how is that going to impact the path to the clinic for not only any drug, but in our case, for innovative and platform technologies. And what we've seen today, actually, they've been communicating the right message, that there's quite a bit of support for accelerated approval for rare diseases using validated endpoints that could make it easier, actually, to approve a drug therapy, a gene therapy, or an overall therapy for a rare disease. We want an effective and safe therapy, so that's what we mostly focus on.

Patrick Lavery

Finally, a reminder of the US’s place in pharmaceutical development and hope that the country is able to stay there for the decades ahead.

Brandon Pence

So while we are certainly paying attention to the directives that are coming, we're listening to our customers, and we know that this industry that's been, you know, a strong growth agent for healthcare over the last 30 years, and will continue to be for the foreseeable future, is one that will require our participation with them.

John Hoekman

We'll see what happens. I think people are nervous about some of the anti-science sentiment going on within the government right now, and just the fact that the US clearly has been the leader in biotechnology and pharmaceutical development over the last 50 years, no question. I think what people are nervous about is us, you know, actively giving up that lead and kind of abandoning that area of important high technology and, you know, letting other countries step into a leadership role there. I hope that doesn't happen, but I think that's what the industry at large is nervous [about], that we're going to move in that direction.