BIO Notebook: Policy Problems, ACIP’s Future, BI Is Popular, Makary On FDA-Industry Ties

Trump Policies Draw Warnings From BIO Leadership

US President Donald Trump was never directly called out by name, but BIO leadership discussed the risks posed by his policies on June 17 during the second day of the trade association’s annual convention.

BIO CEO John Crowley said the industry “is at a crossroads.”

“We must recognize that if any nation, whether the United States or elsewhere, fails to support science and innovation, they will fall behind in the race to support their citizens, communities and our collective global society,” he said.

“Health, prosperity and security all hang in the balance today,” Crowley said, seeming to allude to the widespread cuts the Trump Administration has made to the US science ecosystem, particularly the National Institutes of Health.

Crowley said the industry’s current challenges are not science, but manmade.

“Challenges of leadership and policy that create uncertainty and distrust,” he said.

The drug industry often has appeared afraid to comment on actions and policies taken by Trump Administration that likely will negatively impact industry. BIO’s willingness to clearly acknowledge the challenging environment is notable.

Outgoing BIO board chair Ted Love reiterated the message by calling attention to Trump’s trade and drug pricing policies.

“As John [Crowley] said, no nation can rest on its laurels, nor should it work against itself,” Love said. “Yet, when some talk about price controls, the IRA, tariffs and most favored nations, that’s exactly what they’re doing.”

“Pursuing these kind of policies will make it more difficult to advance breakthroughs and solve our biggest health care challenges,” he added.

Incoming board chair Fritz Bittenbender of Roche’s Genentech, who spoke third in the morning session, also reiterated the points.

“A certain and stable policy environment is essential for our industry success,” Bittenbender said. “Strong intellectual property protections, a sustainable and certain reimbursement environment, government funding for early-stage research and a world leading regulatory agency steeped in science and safety are all necessary for our industry to continue to thrive for patients.”

“Unfortunately, doubt driven by policy uncertainty clouds its current environment in the US. It’s impacting our industry,” he added. “Two hundred forty biotech companies are trading below the cash value on their balance sheet. Can you imagine that? Scientific innovation is [at] an all-time high, but the current policy and environment challenges the investment model and companies and eventually patients will pay the price for this uncertainty.”

“We are all concerned about government changes and funding cuts, particularly their impact on the FDA,” Bittenbender said. “We must be fierce advocates for positive, proactive policies, while vehemently opposing ill-informed ideas that harm our companies, diminish hope for patients, and would relegate the United States global leadership position of biosciences to the history books.”

Funding Environment Improves Boehringer’s Dealmaking Popularity

Boehringer Ingelheim does most of its dealmaking at the earlier stages of drug discovery and development. Head of global business development Scott DeWire told Scrip in an interview at the BIO International Convention that the company has seen rising interest and increased success in executing deals because biopharmaceutical companies at that end of the industry spectrum are particularly challenged to raise cash in the current financial markets.

“We partner a bit earlier than most of the other large pharmas,” DeWire said. “My sweet spot for partnering is basically lead identification, lead optimization to clinical candidate selection and early clinical … We feel like that’s where we can bring the most value to the partnership – optimize that molecule, get that early clinical translational design. And then the value from the innovation from the partner, and the value that we bring in those capabilities, is maximized.”

The slowdown in venture capital funding for very early-stage drug development has benefited pharma companies looking to do deals. In more healthy financing environments those companies could pursue another venture capital round or an initial public offering to advance their drug candidates to later-stage, higher-value milestones rather than do a deal.

“I like to joke around with [my] team and tell them that we didn’t get any better looking, but we got a lot more popular the past few years as options for small companies have become limited,” DeWire said. “We feel grateful that we can offer them that. We’re totally open for partnering there.”

The structuring of early-stage deals, because of small companies’ limited financing options, has become “optimized for risk sharing,” he added. Partners are more willing to defer payments under a deal until a program proves its value through achievement of various milestones.

On ACIP’s Future: ‘Hope For The Best, Expect The Worst’

A long-time US Centers for Disease Control and Prevention official was not optimistic in predicting the future of the Advisory Committee on Immunization Practices (ACIP) after US Health and Human Services Secretary Robert F. Kennedy Jr. removed all prior 17 committee members and replaced them with eight new advisors, including two anti-vaccine advocates.

Sherri Berger, a 12-year CDC veteran who served as its chief of staff from 2021-2023, said during a June 17 panel at the BIO convention that public health authorities, nonprofit groups and the biopharmaceutical industry should “hope for the best and expect the worst.”

Berger is now the founder and CEO of SB Strategies.

“It’s top of mind for all of us,” she said, adding that the status and agenda of the ACIP meeting scheduled for June 25-27, is unclear.

“That’s why we’re talking to the coalitions and talking to the partners to begin to envision a world in which maybe the ACIP isn’t going to provide the same information they did in the past,” Berger said. “We still have access to the data. Manufacturers have access to so much data that scientists could use to evaluate effectiveness and safety of vaccines. So, we need to be thinking about worlds in which we don’t rely on [ACIP], but let’s hope for the best and plan for the worst.”

Makary On Helping Industry In Non-FDA Areas, His CEO Forums and More …

US Food and Drug Administration Commissioner Martin Makary wants to use the agency’s power to help industry tackle drug development obstacles not necessarily in the agency’s purview.

“The FDA has a great brand worldwide, and so we also have convening power,” Makary said June 17 during an interview with BIO CEO John Crowley. “So some things that are out of our control, that many of you have to deal with and are frustrated by, those are things that we should also take a look at to see where we can help. Not where we can regulate, but where we can help.”

The FDA may be able to spur conversations about more efficient hospital contracting for clinical trials or push for more centralized and efficient Institutional Review Boards, Makary said.

“These are things outside of the direct domain of the FDA, but we have to think differently,” he said. “IRBs are a massive rate-limiting step for innovation.”

Makary also said he is working with other senior Health and Human Services Department officials on topics beyond the FDA, such as coverage and reimbursement for novel treatments like cell and gene therapy so “we ensure payment of a promising new intervention, and think about that before the FDA makes their decision.”

Makary continues to solicit feedback from industry. He held his fourth CEO Forum at the BIO convention earlier in the day.

Makary said the conversations were held “in a closed-door fashion” because he wanted “unfiltered ideas.”

“We wanted to create a place where you don’t have to worry about what your shareholders are going to think,” Makary said. “You can be open and honest with us.”

One theme that emerged is the FDA can improve communication with sponsors.

“A 15-minute call could save a company months of doing guesswork, and honestly, we owe it to our sponsors,” Makary said.

Makary would not comment on the other ideas that have emerged, saying he does not “want to make news” on them yet. But he will consult his teams at the FDA about them.

Makary argued that the closed-door interaction with industry is not nefarious, notable remarks given that his boss, Health and Human Services Secretary Robert F. Kennedy Jr. has criticized the pharma-FDA relationship.

“In my mind, if you have a great idea and we adopt it, that is not a cozy relationship with industry, that is a healthy partnership, and we can still do it with an impeccably independent scientific review,” Makary said.

“We’re going to continue to protect the scientific review process,” and have a “close partnership” with industry, he said.

[Editor’s note: The BIO notebook is a joint effort by the Pink Sheet and Scrip.]