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that some of the fired individuals received calls and messages reversing their dismissals, stating terminations were “rescinded effective immediately.”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.

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

The buzz among biotech execs and investors gathered at RESI JPM 2025 was if the last year of pharma deals falling to a decade-low was reversing with a rapid-fire source of new lower-risk drug candidates: China. With one-third of the therapeutic molecules bought by pharma coming from China last year, including the better-than-Pembro hopeful of Summit Therapeutics licensed from Chinese Akeso, US investors including Atlas, Bain, Forbion, General Atlantic and RTW are making major investments in Chinese biotech. Merck, Novartis, GSK, Gilead and other large pharmas have inked a slew of Chinese deals and have indicated they will do more, mainly in the areas of obesity, cardiovascular, immunology, liver diseases and oncology, many with novel MoAs. With relatively dry organic venture funding in China, Chinese companies are aggressively seeking Western suitors. China’s out-licensing is accelerating, with $46B in 2024, $38B in 2023 and $28B in 2022.  

Of course, the first question is how is Summit’s drug candidate going to get FDA approval with Chinese-only studies? The strategy here is to reduce risk by licensing ‘biobetters’ that have shown clinical success in China and then running late-stage clinical studies in the US for approval. Chen Yu, formerly of Vivo Capital, was quoted as saying. “Why would we do any early-stage development in the U.S. anymore? Why wouldn’t we just get clinical PoC in China and then bring it over to the U.S. for the expensive clinical development when we actually know the drug works? …that could be a revolutionary new way for our industry to become more efficient.” 

Not to be outdone, Merck announced it would license a competitive asset to Summit’s – and it was also from China. 

Clinical trials in China can recruit faster than US-based trials with less cost, allowing a startup to go from formation to clinical trials in less than 18 months due to: 

• Large populations that have not taken drugs for their disease are available at a multitude of regional hospitals 

• Obtaining experimental drugs for free is a strong incentive for patients to enroll 

• Less tightly regulated investigator-initiated trials are rapidly proliferating 

• Regulatory flexibility and lesser fees/overhead 

Investment and licensing is not the only Western-Chinese deal types being made. M&A has been on the rise. Examples include Genmab’s acquisition of ProfundBio ($1.8B) and BioNTech’s of Biotheus at ($950M). 

With the speed of early-stage development in China, US startups may face new challenges. Alex Borisy, founder of Curie.Bio, cautioned that the usual process of publishing or presenting/postering at scientific meetings could “launch a thousand ships” in China, and advised early-stage biotechs to author patents in such a manner as to make it difficult to do so. 

What could all this mean with a pro-tariff Trump presidency? That is TBD. However, Paul Hastings, CEO of Nkarta and former BIO Board Chair, remarked that it would be hard to imagine that raw materials and innovation would be exempted from future tariffs. 

One of the best places to meet with early-stage Chinese companies is RESI. With Life Science Nation’s copious reach into the Chinese market, RESI conferences feature a multitude of attractive Chinese firms, eager to partner and pitch their technologies. 

This article is a summary/digest of various general and biotech news articles; it is not original journalism. 

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

The hot topic is that government grants are fundamentally broken in Life Science. RFK Jr. is calling out NIH-funded studies as problematic and seeks to fix them by having Senate committees review proposals, restructuring and/or laying off NIH staff, and reducing infectious disease research while increasing chronic disease funding.

A 2023 study showed that nearly all FDA New Drug Applications from 2010 to 2019 relied on NIH funding in the early stages. Yet the biotech startup failure rate is 90%, according to Health Tech World and CBI Insights. So what is the disconnect, and what are the lessons Life Science Nation has learned from 12 years of helping startups get funded? One of the factors that can contribute to this failure rate: scientists and academics control the selection and evaluation process, and they often remain in the mix long after their expertise is most relevant. While they play a crucial role in assessing technical feasibility, when should they step aside when plotting the journey to commercialization?

The problem isn’t just that academic scientists struggle with translating discoveries into commercial products – such as navigating the FDA, clinical trials, and regulatory approvals – but that grant programs themselves fail to address the fundamentals essential for success. Instead of equipping grantees with the real-world skills needed for sales, business development, and strategic partnering, the “commercialization training” typically amounts to little more than teaching them how to prepare for a partnering event and deliver a 30-minute pitch deck.

This is the equivalent of bringing a knife to a gunfight. Securing funding and forming industry partnerships requires far more than a polished presentation. It demands a deep understanding of market positioning, deal structuring, sales strategy, and long-term capital planning – areas where most scientific founders are left unprepared. Until grant programs integrate commercialization expertise and ensure leadership transitions to business professionals at the right stage, billions in non-dilutive funding will continue to be wasted on technologies that never reach patients.

Innovative funding strategies that bridge the gap between academic research and commercial viability should be explored. Additionally, creating a supportive ecosystem that connects scientists with investors, industry partners, and mentors with funding and partnering expertise is crucial to guiding them through the commercialization process.

By Greg Mannix, VP, EMEA Business Development, LSN

Life Science Nation’s (LSN) is bringing RESI back to Barcelona on Monday, April 1, at the InterContinental Hotel. Co-organized with Biocat, RESI Europe will feature an in-person conference followed by two days of virtual partnering on April 2-3. The event will include Investor Panels, the Innovator’s Pitch Challenge, and Entrepreneur Workshops led by industry experts. One-on-one partnering meetings will be available throughout all three days, providing valuable opportunities to connect.

RESI Europe will welcome investors from venture capital firms, big pharma, private equity, angel groups, family offices, and more. Investors invited and registered have been vetted by LSN’s investor research team to ensure alignment with the fundraising companies in attendance. The RESI Partnering Platform allows participants to efficiently match with the most relevant contacts, creating meaningful opportunities to build relationships and advance business goals.

With its global reach, RESI provides a premier platform for life science companies and investors to connect, whether in Barcelona or at upcoming RESI conferences. Take a look at some of the investors registered for RESI Europe, and make sure to register now for a chance to meet with them!