Tag Archives: venture capital

Navigating the FDA: Why Early Strategic Planning is Critical   

26 Aug

By Claire Davies, Shareholder, Polsinelli (Special Guest Contributor)

claire-davies

Life sciences companies are constantly innovating with the goal of developing groundbreaking medical products. Unfortunately, the most novel products often face more uncertainty about their regulatory pathway to market—with several factors heightening that uncertainty today. These include the loss of many FDA policy and scientific staff over the past six months and multiple changes in leadership, such as at the head of the agency’s drug and biologics programs. Although significant personnel change may present opportunities for companies that would benefit from a change in the agency’s historic regulatory approach, it also unsettles precedent for the FDA’s expectations. In addition, as numerous companies explore applications of generative AI, the agency itself has indicated that generative AI-enabled products present challenges to existing (often decades old) laws that govern FDA’s regulatory framework.

With these factors in play, companies may be tempted to hold off on spending resources to map out their regulatory strategy and get feedback from the agency. But incorporating regulatory considerations into early business plans remains key for a number of reasons:

  • Efficient Product Development: Whether and how FDA will regulate your product determines the level of evidence and type of application needed to enter the market. (Does your AI-enabled product fall within an exception from regulation as a medical device? If not, it may require an FDA application supported by significant data.) An early understanding of the regulatory pathway can help companies budget development costs more accurately. It can also help them anticipate and proactively address regulatory hurdles, ultimately shortening the time it takes to get the product to market.
  • Raising capital: Regardless of scientific promise, companies that underestimate the regulatory complexity of getting a medical product to market or that lack an experienced in-house or external advisory team in this area may be viewed as a risky proposition for investors. In contrast, a thorough understanding of the regulatory pathway and plan for navigating the challenges to commercialization can help distinguish a company from the crowd.

Ultimately, an early and proactive approach to your regulatory strategy is a critical investment that can help shorten time to market and increase your company’s attractiveness to investors.

Claire Davies is a Shareholder in Polsinelli’s FDA practice where she provides strategic counsel to help clients navigate FDA regulatory and compliance challenges. Claire has handled a wide range of issues involving medical devices, biological products, drugs and human cells, tissues and cellular and tissue-based products (HCT/Ps). Prior to joining Polsinelli, Claire spent nearly a decade as an attorney in the FDA’s Office of the Chief Counsel. Her work at FDA often involved advising agency leadership on high-profile and significant matters, such as responses to emerging public health threats and user fee negotiations with industry.

About Polsinelli

Polsinelli is an Am Law 100 firm with more than 1,200 attorneys in over 25 offices nationwide. Recognized as one of the top firms for excellent client service and client relationships, Polsinelli is committed to meeting our clients’ expectations of what a law firm should be. Our attorneys provide value through practical legal counsel infused with business insight, offering comprehensive corporate, transactional, litigation and regulatory services with a focus on health care, real estate, finance, technology, private equity and life sciences. Polsinelli PC, Polsinelli LLP in California, Polsinelli PC (Inc) in Florida.

RESI Europe Moves to Portugal on March 23, 2026

19 Aug

Redefining Every Stage of Investment comes to Lisbon 

By Dennis Ford, Founder & CEO, Life Science Nation (LSN)

DF-News-09142022Life Science Nation (LSN) is excited to announce that the RESI (Redefining Every Stage of Investment) Europe Conference is moving to Lisbon, Portugal. RESI Europe will take place in person on March 23, 2026, at the EPIC SANA Lisboa Hotel (Av Eng. Duarte Pacheco, 15, 1070-100 Lisboa, Portugal), followed by two days of virtual partnering on March 24–25, 2026.

This move aligns RESI Europe with BIO-Europe Spring, bringing the value of RESI’s curated investor network and partnering platform to Europe at a pivotal time for innovators seeking global connections.

What RESI Europe Offers

RESI: Redefining Every Stage of Investment is designed to connect life science and healthcare companies with the most relevant investors and strategic partners. Each RESI conference convenes hundreds of investors actively seeking opportunities across the 4Ds:

  • Drugs/Therapeutics
  • Medical Devices
  • Diagnostics
  • Digital Health

The RESI Experience

At RESI Europe in Lisbon, attendees will benefit from all the core components that set RESI apart:

  • Partnering for One-to-One Meetings – A structured matchmaking system aligning entrepreneurs with investors and partners who fit their stage, sector, and capital needs.
  • Investor Panels – Insights from leading global investors on emerging trends, investment priorities, and expectations from early-stage companies.
  • Workshops – Practical sessions led by industry experts on fundraising, deal-making, and market entry strategies.
  • Innovator’s Pitch Challenge (IPC) – Companies pitch to a dedicated panel of investors who provide interactive feedback. IPC participants also receive partnering access, exhibit space in the RESI Exhibition Hall, and the chance to win complimentary registration for a future RESI conference.
  • Networking and the Collision Factor – Opportunities beyond formal partnering to meet new stakeholders, explore synergies, and spark collaborations.

Why Lisbon

Lisbon is a rising life science and technology hub, making it a strategic new home for RESI Europe. With BIO-Europe Spring taking place in the same city, attendees can maximize their time and connections by participating in two premier global partnering events during one trip.

Register for RESI Europe

Impact Investors & Venture Philanthropy Panel 

19 Aug

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

As healthcare innovation continues to accelerate, the role of impact investors and venture philanthropists has become increasingly vital. These funders are not only focused on financial returns but also on advancing health equity, improving patient outcomes, and addressing pressing unmet needs across the life science ecosystem.

At RESI Boston this September, the Impact Investors & Venture Philanthropy Panel will spotlight how this unique group of investors deploys capital to drive meaningful change in healthcare. Panelists will share their perspectives on how they define and measure impact, what differentiates their investment approach from traditional venture capital, and how they partner with founders to align their mission with milestone-driven growth. Attendees will gain a deeper understanding of how these organizations catalyze innovation in areas often overlooked by mainstream funding.

This discussion will feature:

David-Fogel Jonathan-Behr Andres-Hurtado-Lorenzo
David Fogel
Member of Screening & Due Diligence Committees
Mass Medical Angels
(Moderator)
Jonathan Behr
Partner
Dementia Discovery Fund
Andres Hurtado-Lorenzo
SVP, Translational Research & IBD Ventures
Crohn’s and Colitis Foundation
Ron-Levin Stephanie-Oestreich
Ron Levin
Managing Partner
Alumni Ventures
Stephanie Oestreich
Managing Director
Myeloma Investment Fund

The panel will highlight strategies that are shaping a more inclusive and outcomes-focused future for healthcare through impact-driven investing.

Register today to join this discussion and connect with investors, entrepreneurs, and innovators at RESI Boston.

Longevity Global Shapes the Longevity Track at RESI Boston

19 Aug

By Justin Taylor, Vice President of Communications, Longevity Global (Special Guest Contributor)

Innovation and Investment to Beat Aging and Age-Related Disease

Longevity Global is coming to RESI Boston on Wednesday, September 17, with a full day of programming dedicated to innovation and investment in the longevity space. This curated track will highlight cutting-edge science, startup founders, and investors who are accelerating solutions for aging and age-related diseases.

The day begins with coffee, networking, and opening remarks, followed by a keynote from Eric Morgen, Co-founder of BioAge, setting the stage for thought-provoking discussions on advancing longevity research. Morning sessions feature presentations from leaders such as Raghav Seghal (Yale), Christin Glorioso, MD, PhD (CEO, NeuroAge and Longevity Global), and Spring Behrouz (Vincere Bio), who will share perspectives on mitochondrial aging and fundraising in the field.

A Pharma Chat with Suguna Rachakonda (VP, Insilico) and Jon McClain (Executive Director, Lilly) will provide an industry lens on where big pharma sees opportunities in longevity.

The afternoon program kicks off with a keynote from Sharon Rosenzweig-Lipson (CSO, Life Biosciences), followed by Umbereen S. Nehal, MD, MPH, MBA (Founder, HER Heard, MIT) on the importance of women’s health interventions in extending lifespan and healthspan. Additional sessions include Ethan Berg (Founder, Winthrop Estate) on the case for investing in longevity, alongside an Investor Panel featuring Sally Wang (Managing Partner, XPanse Ventures), Ruta Laukien (VP, US Capital; Managing Partner, GrayBella Capital), and Fiona Miller (Managing Partner, quadraScope).

The Innovation Panel, moderated by Tom Zuber (Managing Partner, Zuber Lawler), will showcase voices across legal, biotech, and clinical perspectives, with speakers Frank Gerratana (Partner, Calyx Law), Shane Hegarty (CSO, AXONIS), and Jay Luthar, MD (Founder, Lutanen Health).

The program culminates with the Longevity Global Pitch Competition (Series A), where startups will showcase their technologies to a panel of seasoned investors. Winners will be announced by Daniel Dacey and The Engine, which will also award the winning company a full year of lab space—an invaluable resource for advancing early-stage science.

The day closes with the RESI Cocktail Hour, featuring wine and hors d’oeuvres, offering attendees the chance to network and celebrate innovation.

By bringing Longevity Global to RESI, this track provides an unparalleled platform for entrepreneurs and investors focused on combating aging and age-related disease. From scientific insights to investment strategies, the agenda is designed to drive meaningful dialogue and new connections in this rapidly advancing field.

Join us at RESI Boston to connect with the innovators and investors defining the future of longevity. Learn more

Pullan’s Pieces #4 – January – A Corner on Market Sentiments – Seed to Series A

19 Aug

As the saying goes, “What’s in a name?  That which we call a Series A by any other name would smell as sweet.”  Er… something like that, right? Hmmm, maybe it went a little bit differently.

But whatever it be, or not to be😊, the Seed Round is the new Series A. Clearly. I think we’ve all felt it for sometime but the data is in and the good ‘ole Series A just don’t buy what it used to.  Nahhh… the Seed round does that, and it may buy more (equity) than it used to as a Series A (more data hunting and crunching required but one gets a sense that the venture capitalists are, well, capitalizing).

Labiotech does a really nice job collecting and summarizing a variety of topics related to financings and dealmaking in the biotech sector and the 2024 breakdown of funding offers the following approximations (roughly, with some rounding made by this author):

The internal breakdowns for amounts invested look like this:

Readers of this corner will know that we keep a close eye on the XBI

As usual, the outliers can skew the numbers (more on this in a moment) but the median amounts invested into these rounds puh-rihhhty much drive the nail in the coffin of the old thinking about Series dynamics. This data could be charted in another way in which an inverted bell curve would appear and a GAPING hole between $20M and $50M would stare back at you.  Think about that for a moment… if you can’t get to value inflection for ~$15-20M, you better be raising $60-75M and have multiple reasons to do so as a cursory view of the companies listed in the dataset further indicates that the lower outliers (sub-median) on the Series A were generally geared for “finding out” about a single asset in the clinic.

Back to that previously mentioned outlier that can skew the averages… it also happens to bring even more of a spotlight to those famed words from Shakespeare which began this Corner on Market Sentiments.  One of the companies in the 2024 data set raised a whopping $100,000,000 … as a Seed Round!!  Indeed, a rose by any other name…

Recent Life Sciences Deal Trends

12 Aug

By Andrew Merken, Shareholder, Polsinelli (Special Guest Contributor)

Andrew-Merken

Keep the faith.   

When it comes to life sciences industry transactions, the business cycle is alive and well. After a spectacular second half of 2020 and all of 2021 – which took most everyone by surprise given COVID – the past three years have seen a marked decrease in the volume – though not the dollar value – of activity. The number of venture capital financings, Merger & Acquisition (M&A) transactions, licensing deals and Initial Public Offerings (IPOs) dropped – in some cases fairly significantly – in 2022 through 2024. 

Underlying the 2022-2024 slowdown was inflation, a rise in interest rates and a slackening economy. From a borrowing perspective, higher interest rates raised the cost of capital, requiring companies to lean less on debt and more on equity in financing their operations and transactions. At the same time, however, those same higher interest rates caused investors to cycle away from the stock market and to park more capital in bonds. As the IPO markets cooled, so did public market liquidity opportunities for venture capital investors, resulting in less new capital available for new investments. And as the economy slowed, venture capital investors were forced to reserve more capital to keep existing portfolio companies afloat, exacerbating the lack of funding available for new investments. By one estimate, US venture capital funding declined from $47 billion in 2021 to $34 billion in 2022 (a 22% decrease), to $25 billion in 2023 (an additional 27% drop), before increasing slightly to $27 billion in 2024. Drug discovery and therapeutics companies tended to be the most active recipients of VC funding. 

Interestingly, though, while the overall amount of capital invested decreased as did the number of deals, the average deal size increased. Investors pivoted toward later stage deals – Series B, C and D rounds – which tend to be less risky but which require more capital and, arguably, a number of well-known life sciences VCs transitioned to being growth equity investors in their most recent funds. Early-stage (Series Seed and Series A rounds) investing decreased. At all stages, premoney valuations fell, with down rounds becoming more frequent and, often, dramatic.  

M&A activity showed similar trends; in the US life sciences industry, M&A deals dropped in value from $180 billion in 2021 to $70 billion in 2022 (a 61% decrease) before increasing to $113 billion in 2023 and then decreasing again to $111 billion in 2024. The number of transactions also decreased, by 31% from 2021 to 2022 before increasing by a modest 5% in 2023 and then decreasing again by 23% in 2024. As with VC investing, though, the median average deal size increased during this same timeframe – from $110 million in 2021 to $160 million in 2022, before decreasing to $100 million in 2023 and increasing again to $199 million in 2024 – as did the trend of transactions favoring later stage, less risky assets (late stage development/early commercialization) over early stage ones, in part because strategic acquirers looked to acquisitions to supplement declining revenue growth. The big winners in M&A were companies focusing on oncology, immunology and neurology. Licensing deals also decreased, from 215 in 2021 to 182 in 2022 (a 15% decrease) and then again to 134 in 2023 (an additional 26% decrease).  

Following a strong 2021 in which there were 99 life sciences IPOs that raised a total of $15.6 billion, 2022 saw only 17 life sciences IPOs ($2.4 billion) and only 13 IPOs in 2023 ($2.7 billion). The flight to debt and the slowing economy were to blame, with the trickle-down effect of less IPO liquidity impacting the venture capital markets and lower stock prices of already public companies making stock acquisitions more difficult. In addition, much like in venture capital and M&A, IPOs have been trending toward less risky later stage, clinical asset companies.   

Then, as the calendar turned to 2025, there was a renewed sense of optimism.  Those who were in San Francisco in January 2025 for the JPMorgan Healthcare Conference noticed that attendance was back to pre-COVID levels, partnering meetings for companies raising capital with potential investors were for the first time in a number of years being scheduled with ease, and overall there was a palpable sense of excitement about the coming year. 

Toward the end of January, however, policy changes in Washington served to change the environment.   The uncertainty around the regulatory framework – FDA staffing and priorities, the FTC’s approach to mergers, NIH funding, HHS’ approach to vaccines and the SEC’s oversight of the capital markets, along with the discussion around and imposition of tariffs – put a fairly quick stop to the optimism.  Interest rates and inflation that had decreased in the second half of 2024 – resulting in lower costs of borrowing and a renewed trend toward equity – and which were expected to jump start the economy became less favorable. Term sheets that were expected to be signed were shelved, deals for which the transaction documents were being negotiated were put on hold, and overall a renewed sense of anxiety washed over the ecosystem. 

According to JPMorgan, VC financings and IPOs continued their downward trend in the first half of 2025: 

  • VC deals in therapeutics and drug discovery totaled $11.2 billion, as compared to $14.2 billion in the first half of 2024. 
  • There were only 5 biopharma IPOs over $15 million in the first half of 2025, versus 10 in the same period of 2024. 

However, M&A and licensing deals turned the corner in the first half of 2025, according to JPMorgan: 

  • M&A deals totaled $42.5 billion, which is a significant increased from the $15.9 billion in the first half of 2024. 
  • Licensing deals totaled app. $120 billion announced deal value in the first half of 2025, versus $76.3 billion for the first half of 2024.  

JPMorgan and others attribute these increases to several factors, primary among them Big Pharma’s need to replace revenue lost to the impending patent cliff –  with the patents on a significant number of blockbuster drugs expiring between 2025 and 2033 – and the continued shift to acquiring less-risky later stage assets versus funding more risky earlier stage assets. 

In addition to the uptick in M&A and Licensing deals for later stage companies, there is also good news for early-stage companies.  Over the summer, we have started to see a slight thaw – not the supercharged environment that we saw in early January, but a slight uptick in activity.  Companies who have not given up and who have been persistent in sourcing investments are starting to find new opportunities. Some NIH funding has also been restored – at least temporarily.  The uncertainty seems to be lessening, and the industry is learning to work around the new realities.  The ordinary course business cycle upturn that started in early 2025 seems to have derailed, but the ultimate uptick will not be precluded – simply delayed. It’s very possible that January 2026 will bring what January 2025 signaled.  While that optimism doesn’t pay the bills or get the deal done, it will hopefully be of some comfort to those who had hoped 2025 would be their breakthrough year.   

Andrew Merken is a Shareholder in Polsinelli’s Venture Capital and Emerging Growth practice where he focuses on corporate and transactional matters for life sciences clients covering the entire business life cycle, from start-up (formation and organizational matters) to seed and venture stage funding to growth stage (later stage funding, corporate collaborations and buy-side M&A) and ultimately exit (sell-side M&A or IPO).  

About Polsinelli 

Polsinelli is an Am Law 100 firm with more than 1,200 attorneys in over 25 offices nationwide. Recognized as one of the top firms for excellent client service and client relationships, Polsinelli is committed to meeting our clients’ expectations of what a law firm should be. Our attorneys provide value through practical legal counsel infused with business insight, offering comprehensive corporate, transactional, litigation and regulatory services with a focus on health care, real estate, finance, technology, private equity and life sciences. Polsinelli PC, Polsinelli LLP in California, Polsinelli PC (Inc) in Florida. 

China’s Biotech Boom: Innovation, Influence, and Rising Tensions 

5 Aug

By Sougato Das, President and COO, LSN

Sougato-Das

As 2025 progresses, China’s biotech and pharmaceutical sectors are not just growing—they’re reshaping the global industry landscape. With skyrocketing innovation, bold regulatory reform, and a deepening rivalry with the U.S., Chinese biotech firms are asserting their global presence at unprecedented speed. The GSK / Hengrui Pharma deal, involving a major collaboration potentially worth up to $12.5 billion, is the latest example. The deal focuses on developing up to a dozen drug candidates, primarily in respiratory diseases, immunology, infection, and oncology. GSK will pay Hengrui an upfront fee of $500 million, with the potential for significant milestone payments and royalties if the collaboration is successful. China will continue to play a major role in the worldwide biopharma ecosystem as…

China Emerges as a Global Drug Development Powerhouse

  • Record Licensing Activity: China-to-West drug licensing hit a record $41.5 billion in 2024, a staggering 66% jump from the previous year. Nearly 30% of global innovative drug assets now trace their origin to China.
  • Biotech Licensing Leadership: In 2024, 42% of all global biotech licensing deals over $50 million involved Chinese firms—up from 22% in 2023.

Drug Discovery Is Going East

  • Rapid Shift in Molecule Sourcing: One in three externally sourced molecules by global biopharma firms now comes from China—a dramatic rise from virtually none in 2019. Chinese biotech firms are lauded for their speed, efficiency, and low-cost synthesis of new compounds, positioning them as preferred partners for drug discovery.

Clinical Trials and Regulatory Momentum increases in China

  • China’s Clinical Surge: In 2023, nearly 28% of global clinical trial sponsorships originated from China—up from just 4% a decade ago. Registrations alone rose by 26% last year.
  • Faster to Market: Thanks to reforms by China’s National Medical Products Administration (NMPA), investigational new drugs can now be approved for human testing in just 60 working days.
  • FDA Recognition: Chinese trials are increasingly qualifying for FDA priority pathways, challenging the traditional dominance of U.S.-based clinical development.

China is at the Cutting Edge of Gene Editing

  • CRISPR Leadership: Chinese startups like YolTech (in vivo CRISPR therapy) and Huidagene (brain-targeted CRISPR trials) are leading in next-gen gene editing.
  • Global Recognition: According to Goldman Sachs, China is at the forefront of CRISPR and CAR-T research.

Tensions and Regulatory Hurdles deepen with the US

  • Geopolitical Pressure: Proposed U.S. legislation—the BIOSECURE Act—would prohibit drugmakers with federal contracts from using Chinese firms like WuXi AppTec and WuXi Biologics after 2032. This could disrupt global supply chains and complicate R&D strategies for U.S. companies.
  • Scientific Chilling Effect: Fears of increased scrutiny are causing some Chinese and Chinese-American researchers to avoid applying for NIH grants, impacting U.S.-China scientific collaboration.
  • Investment Headwinds: Despite innovation, venture capital investment in Chinese biotech has declined due to geopolitical uncertainty.

Cross-Border Deals Multiply

  • Western Biopharma Engagement: U.S. and European firms are actively pursuing licensing and partnership deals with Chinese biotechs—particularly in ADC and bispecific antibody platforms, expanding beyond oncology.
  • Investor Sentiment Splits: Some U.S. investors advocate for protectionist strategies, while others see China’s rise as an opportunity for strategic alignment and access to novel therapies.

What Does All This Means for the Industry>

China is no longer simply a “fast follower” in biotech. It’s now an originator of breakthrough science, shaping the future of global drug development, even as geopolitical tensions threaten to redraw the map of international collaboration.

As global biopharma leaders and investors reassess their strategies, one thing is clear: ignoring China’s biotech ascent is no longer an option.