AG Capital Advisors CEO Audrey Greenberg discusses FDA disruption, NIH funding volatility, tariffs, AI ambiguity, and how biopharma leaders can navigate the new political reality across CGT, biologics, vaccines, and small molecules.
Last month, we asked Audrey how the return of the Trump administration was sending shockwaves through the cell and gene therapy sector, but CGT is just one part of the story.
This month, we asked her how Trump-era policies are reshaping the broader biopharma landscape from regulatory shifts and trade policy to research funding and manufacturing strategy. The rules of engagement for innovation are changing fast, and bold leadership is no longer optional, but essential.
What defines this moment for global biopharma under the Trump administration?
Volatility with global consequences. Regulatory frameworks, trade policies, research funding, and healthcare reforms are all being reshaped by political agendas. Whether developing CGT therapies, biologics, vaccines, or small molecules, companies face an environment where policy shifts can derail strategy overnight.
What impact could Marty Makary’s appointment as FDA Commissioner have across modalities?
Makary’s push for faster approvals, reduced animal testing, and streamlined rare disease pathways reflects the administration’s deregulatory focus. His recent initiatives could accelerate market entry, but the risk is inconsistent application and potential erosion of global trust if speed overtakes rigor.
Is regulatory divergence becoming a greater concern for global companies?
Yes, and it is accelerating. The EMA, the UK Medicines and Healthcare products Regulatory Agency (MHRA), and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) are all advancing adaptive frameworks while US uncertainty grows. In a recent poll, most respondents indicated that the US is becoming less attractive for opening Investigational New Drugs and running clinical trials. Firms are actively shifting operations to jurisdictions such as the UK, where regulatory stability is stronger.
Simultaneously, more early-stage research is originating in China, then being licensed or commercialized in the US. This shift reflects how companies are adapting to geopolitical realities. If these trends continue, the US risks losing its position as the central hub for biopharma innovation.
How does federal judicial intervention complicate biopharma’s regulatory landscape?
When courts block or reshape executive policies on diversity, equity, and inclusion, healthcare, or regulatory frameworks, it adds legal unpredictability. Companies now must navigate shifting interpretations from both policymakers and the judiciary, making compliance strategies far more complex.
How is tariff volatility under Trump impacting global manufacturing for CGT, biologics, and vaccines?
Tariffs and sanctions have become core tools of Trump’s economic strategy. The recent 90-day pause on reciprocal tariffs offers no real clarity, especially with pharma-specific tariffs under discussion. China faces a 145 percent tariff, and other key partners could be next.
Bloomberg’s Trade Policy Uncertainty Index is near record highs. BIO reports that 94 percent of companies expect higher manufacturing costs and delays. Regulatory filings and commercial launches are being re-evaluated because of supply chain instability.
Building domestic capacity is essential, but it is a long-term solution. In the short term, these policies risk inflating costs, delaying patient access, and disrupting innovation.
We’ve seen major US manufacturing announcements from Roche, Eli Lilly, and Regeneron. How should biopharma interpret this trend?
These moves are strategic responses to Trump’s “America First” agenda. Companies are accelerating domestic investments to align with political priorities and de-risk supply chains. Domestic manufacturing build commitments from big pharma include Roche’s $50 billion, Lilly’s $27 billion future commitment in addition to the $50 billion invested since 2020, Novartis’ $23 billion, Amgen’s $1.4 billion, and Regeneron’s $3 billion investment – all of which underscore this pivot. However, reshoring advanced manufacturing takes time, capital, and workforce development. While these announcements signal alignment, they do not resolve immediate pressures from tariffs or global dependencies.
How is the Trump administration’s use of economic sanctions influencing biopharma strategy?
Sanctions have become a primary instrument of US policy, impacting everything from supply chains to cross-border partnerships. As highlighted in a recent Young Presidents Organization session I attended led by NYTimes bestselling author Eddie Fishman, this era of economic statecraft forces biopharma leaders to treat geopolitical risk as a core operational concern. Flexibility and proactive risk mapping are now essential.
How should the industry view Trump’s executive order on drug pricing?
Addressing the "pill penalty" offers some relief for small molecule innovation, but broader pricing reforms still risk stifling investment in high-cost, high-risk areas like CGT and rare diseases. Without nuanced policies, these measures could discourage the development of transformative therapies.
How has NIH funding been affected, and what does it mean for biopharma?
Proposed NIH cuts nearing 40 percent, combined with staff reductions and grant freezes, threaten the foundation of early-stage research. While the reinstatement of Women’s Health Initiative funding is a positive reversal, it highlights how unpredictable the funding landscape has become.
Biopharma can no longer assume stable public sector support. Diversified funding and advocacy are critical to sustaining innovation pipelines.
What does the Harvard lawsuit against the Trump administration signal for global science?
It reflects growing political interference in academic autonomy. Since biotech innovation often begins in academia, this instability could fracture global research partnerships. Protecting academic freedom is now an industry imperative.
What does the termination of the global COVID-19 vaccine safety study reveal?
It demonstrates how political agendas can abruptly dismantle critical public health initiatives. For vaccine developers and global health stakeholders, this undermines trust and future collaboration.
How are investors responding to Trump-era biopharma policy?
Investors are cautious and focused on execution. Companies demonstrating resilience, regulatory agility, and cost control will attract capital. Those reliant on favorable policy conditions will struggle.
What is your advice to biopharma leaders navigating this environment?
Engage early with regulators. Build flexible supply chains. Diversify funding sources. Stay close to payers and investors. Most importantly, lead boldly. Do not let political volatility breed hesitation. Those who defend science and act decisively will shape the future of biopharma. This is a time to protect progress, not retreat from it.
Audrey was recently featured in The Medicine Maker Power List for the second consecutive year. Hear more from Audrey and other industry leaders in our recent roundtable discussion, “Biden’s Legacy; Trump’s Agenda”.
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