The biotech industry is experiencing significant shifts following President Trump’s return to office. If you’re a drug developer watching these developments unfold, you might be feeling uncertain about what lies ahead.
Trump’s first term saw significant efforts to shorten FDA approval processes and timelines, a trend likely to continue in a second term. While the goal of faster patient access to new treatments is commendable, their implementation remains unpredictable due to ongoing agency layoffs and restructuring. These changes will likely have an impact on the development process—creating ripple effects that could be felt throughout the industry, prompting many to look elsewhere for more stable alternatives.
With thoughtful planning and the right partners by your side, there are clear paths forward. Let’s examine the current landscape and how you can navigate these changes to keep your biotech projects moving ahead smoothly.
The shifting landscape
The Trump administration has implemented substantial reductions to the Food and Drug Administration (FDA) and the National Institutes of Health (NIH). These changes, influenced by input from Elon Musk and officials from the newly established Department of Government Efficiency (DOGE), have led to workforce reductions and adjustments in research funding allocations. Below are three key challenges you might face—along with steps you can take now to make sure you’re prepared to navigate them.
Challenge #1: Slower drug reviews
The issue: With reduced staff and resources, the FDA faces limitations in reviewing new drugs efficiently. This translates to longer waiting periods for companies seeking approvals—affecting not just American firms but also global projects connected to US research. The potential integration of AI into the review process is being considered, but this will require validation first and won’t be available in the immediate future.
How to navigate this:
- Prioritize local processes: Partner with biotech experts who can help you prioritize regional regulatory pathways and identify the most efficient routes to achieve your business goals.
- Implement multi-market approaches: Rather than focusing exclusively on FDA approval, consider pursuing multiple markets simultaneously to distribute risk and potentially accelerate time-to-market in certain regions. The Canadian market, with its regulatory similarities to the US, provides a natural extension to your strategy.
- Engage cross-regulatory experts: Work with specialists who understand various approval systems globally. Finding consultants with proven track records navigating complex regulatory environments can provide invaluable insights during this transitional period.
Challenge #2: Supply chain uncertainty
The issue: Reduced FDA inspections and evolving requirements create cascading effects throughout production processes. Manufacturers may face increasing difficulties maintaining consistent schedules, potentially leading to product availability issues.
How to navigate this:
- Supply chain resilience planning: Conduct thorough risk assessments of your entire supply chain and identify potential vulnerabilities. Establish transparent evaluation criteria for partners to make informed decisions based on reliability and adaptability.
- Budget management for contingencies: Prepare comprehensive budgets that include specific contingencies for regulatory delays. A transparent approach with built-in flexibility helps mitigate financial impacts during uncertain regulatory periods.
- Diversification of suppliers: Establish relationships with multiple suppliers across different regions to reduce dependency on any single source, helping mitigate risks associated with localized regulatory changes and supply chain disruptions.
Challenge #3: Clinical trial delays
The issue: NIH funding adjustments and staff reductions are creating obstacles for clinical trials. Studies that received NIH support face potential delays or modifications, affecting research collaborations globally and complicating patient recruitment efforts.
How to navigate this:
- Consider alternative trial locations. Explore running early-phase trials in countries with stable research environments and efficient regulatory frameworks. Countries like Canada have quicker approval processes and research infrastructure compatible with US standards, plus a population similar enough to the US.
- Tap into local research networks. Many countries have excellent research communities and established clinical trial infrastructures that can support your studies while US processes adapt to new conditions. Canada’s research clusters in cities like Toronto, Montreal and Vancouver feature world-class universities and hospitals with extensive trial experience.
Moving forward with confidence
While the current FDA changes may present challenges for drug developers, they don’t have to derail your development timeline. The biotech industry has successfully navigated regulatory shifts before. With the right strategies and partners by your side, you can continue bringing life-changing treatments to market—no matter what the landscape looks like.
As your general contractor in the biotech industry, KreaMedica understands the complex interplay between regulatory requirements, research needs and manufacturing capabilities. Our team can help you navigate these changes by identifying suitable vendors, preparing and managing budgets, monitoring day-to-day activities and offering guidance on how to remain adaptable.
Canada: Regulatory efficiency and FDA alignment
Canada’s regulatory framework, overseen by Health Canada, aligns well with FDA requirements, ensuring smooth data acceptance and regulatory transitions between the two countries. KreaMedica’s regulatory expertise helps US companies navigate the approval process efficiently, reducing delays and expediting trial completion.
Access to a diverse patient population
Canada’s multicultural and diverse patient population provides an excellent opportunity for US companies to enhance the generalizability of their clinical trial data. This diversity is essential for obtaining comprehensive and globally applicable results, increasing the market potential of new therapies.