Next Phase Newsletter

By Sougato Das, President and COO, Life Science Nation (LSN)

The FDA’s Center for Devices and Radiological Health (aka CDRH aka the folks who approve med devices) had firings a little more than a week ago, continuing from the layoffs at the NIH and CDC. Early signs indicate a reduction of 10% – 15%. Those who lost their jobs included those funded by medical device user fees and not tax-payer dollars. Since the cuts affected probationary employees the most, recent hires to evaluate newer technologies like AI-assisted imaging and digital health are gone, making it hard to imagine approvals for these modalities would not grind to a halt. AdvaMed’s head, Scott Whitaker, conveyed that AdvaMed had sent a letter to HHS in response, emphasizing the importance of AI and related technologies, the patient-facing effects throwing a wrench in the approval machine would have, and the lack of tax-payer savings. This may have been effective, as in breaking news today, the Associated Press reported that some of the fired individuals received calls and messages reversing their dismissals, stating terminations were “rescinded effective immediately.”

Besides staff cuts, there are other changes in FDA CDRH guidances, such as removal of requirements to have demographically diverse clinical trials. If the Trump administration continues to lower the regulatory hurdles required for approval, approval times could accelerate despite reduced staff, assuming further layoffs do not materialize and funds from user fees are made available again. Of course, this could result in products with less safety testing, which could lead to recalls and trust erosion.

The million-dollar (well, actually billion dollar) question is: how will these changes affect seed and series A-B funding for med tech, health tech and AI? Usually, regulatory uncertainty has a dampening effect on the investment climate. Companies may need to hedge their bets by doubling down on fundraising and partnering activity. How many meetings have you had in the last 3 months? How many leads do you have? How many meetings do you need to close your next fundraise? LSN can help you dramatically accelerate your business development. With the largest and most detailed life science investor/in-licensor database and the largest investment conferences (by number of attending investors) in the world, LSN is poised to help get you funded before any potential downturn. Reach us at: resi@lifesciencenation.com

By Claire Jeong, Chief Conference Officer, Vice President of Investor Research, Asia BD, LSN

With biotech venture capital investment surging by over 33% in 2024 and in-licensing activity remaining strong, optimism is growing in the life science ecosystem. The Therapeutics panel at RESI Europe in Barcelona, taking place at the InterContinental Hotel on April 1, will bring together key investors to explore the evolving landscape of biotech investment and partnerships.

This panel will examine emerging trends and therapeutic breakthroughs, providing insight into the indications and modalities attracting investor interest. Discussions will also highlight the role of venture capital and in-licensing partners in driving innovation, as well as key considerations for biotech companies navigating R&D and scaling operations. Given the high-risk nature of early-stage biotech investment, panelists will share perspectives on how to de-risk opportunities through due diligence and strategic partnerships.

Moderated by Jim McGough of Mid Atlantic Bio Angels, this discussion will feature an esteemed lineup of investor panelists, including Laura Rodriguez of Invivo Partners, Carla Benichou of RV Invest GmbH, and Artemy Shumsky of LongeVC. Their collective expertise will offer a comprehensive look at how investment and collaboration are shaping the future of biotech innovation.

Jim McGough Managing Partner Mid Atlantic Bio Angels (Moderator)	Carla Benichou Senior Investment Analyst RV Invest GmbH
Laura Rodriguez Partner Invivo Partners	Artemy Shumskiy Senior Associate LongeVC

Investment and strategic partnering remain essential in advancing therapeutics that address high unmet medical needs. Whether you are a biotech entrepreneur seeking funding or an investor looking to stay ahead of industry trends, this panel promises valuable insights into the dynamic world of biotech investment.

Join us at RESI Europe to gain firsthand knowledge from top investors and forge meaningful connections that could help propel the next wave of groundbreaking therapies to market.

By Greg Mannix, VP, EMEA Business Development, LSN

When we think of a partnering conference like Redefining Ever Stage of Investment (RESI), we often envision cutting-edge life science startups pitching their technologies to investors and licensing partners – whether through one-on-one meetings or in the Innovator’s Pitch Challenge (IPC). While this is certainly a key aspect of the event, it’s important to note that about 20% of the scheduled and ad hoc meetings at RESI are between investors themselves!

So, why is RESI such a prime venue for investors from around the world? Because cross-border alliances and syndicates are not just common – they’re becoming essential. Consider these key trends:

• Syndicates are the new normal: Single-investor participation in funding rounds is now rare. More often, deals are made through syndicates, which help spread risk and allow investors to tap into broader networks and expertise.
• Expanding geographic horizons: Investors who restrict their focus to just one region may struggle to compete for the most innovative technologies. As a result, many are looking beyond their comfort zones to find the best opportunities.
• The global capital gap: European companies often find it difficult to secure the capital needed for larger rounds within Europe, creating a growing need to partner with US and Asian investors.

On March 30th, right before RESI Europe in Barcelona, LSN will host an exclusive Investor-only  Networking Event, bringing together investors from North America, Europe, and Asia for an evening of tapas, drinks, and new connections. For more information, contact resi@lifesciencenation.com.