Biden’s Legacy; Trump’s Agenda: Part 2

What can we expect from Trump’s second term? Although Donald Trump is known for his unpredictability, pharma stakeholders can agree on certain policies that are likely to shape the pharma R&D landscape. In part 1 of this discussion, leaders discussed Biden’s legacy and Trump’s pro-business history. In part 2, our experts discuss the withdrawal from WHO, drug pricing, and their hopes – or fears – for the future.

Meet the experts 

What have been the reactions to the US’s intent to withdraw from WHO? 
 

Stella Vnook: Trump’s skepticism of the WHO stems from concerns about global governance over US healthcare policy and pandemic response coordination. Some in the industry support a more independent US approach to public health, believing that it could allow for greater control over regulatory decisions. Others worry that withdrawing from global health organizations could limit international collaboration, particularly in areas such as pandemic preparedness and drug development.  

Ali Pashazadah: In discussions I’ve had with the industry so far, no one wants to go on the record to comment. However, when we asked the same people in the industry what the actions of the WHO were during the COVID-19 crisis, no one can categorically outline the action items. In many ways, what we saw from the WHO during COVID-19 was far less than expected. 

Audrey Greenberg: Following the RFK Jr hearings, there is still no clear strategy on how the US will engage with international health agencies post-WHO withdrawal. This raises concerns about regulatory harmonization, as companies relying on global trial frameworks may face additional hurdles in approvals and commercialization. Senate discussions indicate that the WHO withdrawal remains a contested issue, with some lawmakers pushing for policy adjustments. 

For CGT specifically, I expect reduced regulatory harmonization; the US may have less alignment with other regulators such as the EMA, Japan’s PMDA, and the UK’s MHRA, complicating multi-region gene therapy approvals. There is also potential for delays in global trials. 

Priya Baraniak: The US withdrawal from the WHO could have significant implications for cell and gene therapy, affecting collaboration, regulatory frameworks, access to funding, public health responses, and industry dynamics. To navigate these challenges, it will be essential for stakeholders to engage in alternative international collaborations and rethink strategies to maintain innovation and equitable access to advanced therapies. The more immediate and potentially catastrophic public health implications, with less coordination in responses to global health emergencies and vaccine development and deployment initiatives, cannot be overstated.

Trump’s appointment of Matthew Memoli, a critic of his renowned predecessor Anthony Fauci, has turned a few heads. What do you think we can expect from him? 
 

Vnook: Memoli’s appointment signals a shift toward questioning the public health establishment’s approach to pandemic management. We can expect a stronger emphasis on personal choice, a re-evaluation of vaccine mandates, and potentially a greater focus on alternative approaches to infectious disease management. For the biotech and pharmaceutical industries, this could mean fewer regulatory hurdles for innovative therapies, but also a shift in public health priorities that may impact funding for certain initiatives.  

Greenberg: Memoli's skepticism toward mRNA vaccines suggests a more cautious stance on certain advanced therapies, which could mean more scrutiny of immune responses to AAV-based gene therapies and less emphasis on centralized pandemic preparedness policies. The broader industry impact will depend on whether he shifts NIH funding priorities away from infectious disease and toward chronic disease solutions.  

What could the Trump presidency mean for drug pricing? 
 

Vnook: Trump has consistently advocated for lowering drug prices through increased competition rather than government price controls. His policies may focus on expanding generic and biosimilar approvals, reforming pharmacy benefit managers, and promoting transparency in pricing negotiations. While these efforts could lower costs for patients, the industry will be watching closely to ensure that policies do not inadvertently stifle investment in novel therapies.  

Baraniak: Trump's recent policy decisions are poised to significantly influence drug pricing. One notable action includes imposing a 10 percent tariff on Chinese imports. This move has raised concerns among US hospitals and generic drug manufacturers because the tariffs could lead to drug shortages and increased prices for essential medications. The American Hospital Association highlighted that critical medicines, such as those for cancer and heart conditions, are notably sourced from China, emphasizing the US healthcare system's dependence on international supply chains.  

The administration has also reversed several initiatives aimed at reducing prescription drug costs for Medicare and Medicaid recipients. Experts suggest that most Americans will not experience immediate changes in their out-of-pocket healthcare expenses, but these policy shifts indicate a complex landscape for drug pricing. 

Greenberg: Trump’s approach to drug pricing is likely to be a double-edged sword. While his administration may push for expanded competition through accelerated biosimilar approvals and transparency initiatives, potential cost-cutting measures could have unintended consequences for high-cost, high-value therapies like CGT. A critical question will be whether the administration can balance cost control with preserving investment incentives for transformative treatments.

Tell us one good thing that Biden did for US pharma…
 

Pashazadah: Familiarity and a safe, steady pair of hands.  

Baraniak: The White House launched numerous federal and private "moonshot" programs to tackle some of the most pressing health challenges. These initiatives aim to accelerate progress in areas like cancer, Alzheimer's disease, and mental health. A key player in this effort is the Advanced Research Projects Agency for Health (ARPA-H), established by President Biden to drive high-risk, high-reward biomedical research. These moonshot programs and partnerships represent a significant investment in health research and have the potential to transform the way we prevent, diagnose, and treat diseases like cancer. By fostering collaboration between government agencies, private organizations, and researchers, these initiatives aim to accelerate progress and bring hope to millions of people.

Vnook: Biden maintained funding for biomedical research, including through the Advanced Research Projects Agency for Health, which was designed to support high-risk, high-reward innovation. While the execution of these initiatives has faced challenges, the continued focus on advancing treatments for cancer and neurodegenerative conditions has the potential to benefit long-term biotech R&D. However, the broader regulatory environment under his administration, particularly policies around drug pricing, has created uncertainty for companies looking to invest in breakthrough therapies.  

Greenberg: The Centers for Medicare and Medicaid Services’ Cell and Gene Therapy Access Model was a step toward establishing a sustainable reimbursement framework for CGT. Although still in its pilot stage, this initiative signals progress toward integrating curative therapies into broader healthcare access models. While refinement is needed, it represents an important starting point for addressing pricing challenges in advanced therapies.  

And your great golden hope (or fears) for what Trump may do? 
 

Baraniak: My greatest hope for Trump's presidency is that he fully embraces science and advanced therapies, recognizing them as a key opportunity to shape his legacy in the US. If he champions CGT, he could encourage his supporter base to become more informed and supportive of these groundbreaking treatments. By directing funding into the sector and enacting policies that foster innovation, he could drive significant advances and expand access to transformative medical treatments.  

Pashazadah: In an industry riddled with inefficiencies that has lost the confidence of investors, Trump needs to turn over every card. He really needs to ask the hard questions. I hope he can set challenges to improve efficiency and performance across the sector.    

Vnook: The hope is that Trump will double down on policies that encourage biotech investment, streamline the FDA approval process, and reduce unnecessary regulatory hurdles. Since returning to office, Trump has signaled a renewed focus on reducing the influence of middlemen, which could lead to lower drug prices without stifling R&D. If his administration prioritizes policies that boost industry growth while ensuring patient access, we could see a surge in biotech breakthroughs.  

Greenberg: My biggest hope is that Trump prioritizes the acceleration of new drug approvals and strengthens US biomanufacturing to reduce supply chain vulnerabilities. My biggest fear is that aggressive pricing measures could deter investment in high-risk, high-reward therapeutics, ultimately shifting biotech innovation away from the US. A measured approach to regulatory efficiency and pricing policy will be critical in shaping the industry's trajectory. 

Many welcome the change that others fear. Are the changes you expect Trump to implement to be feared or embraced? Your closing thoughts…
 

Baraniak: Ultimately, much will depend on the duration of funding slowdowns and how quickly and boldly stakeholders adapt. If investors and industry leaders are willing to rethink traditional risk models and investment criteria, this could be a turning point for the sector. Desperation has often been the mother of invention, and I hope we see that principle drive a much-needed influx of capital and strategic innovation.  

Vnook: Regardless of political leadership, the focus should remain on advancing science and ensuring patients have access to life-saving treatments. The biotech and pharmaceutical industries thrive when there is a balance between regulatory oversight, market-driven innovation, and patient-centric policies.