Day Zero - CEO Forum DayMonday, 28 April 2025 - GMT (Greenwich Mean Time, GMTZ)

Welcome and Introduction - Adam Wicks, Shareholder, Private Equity & Venture Capital Practice Group Leader, Buchanan

The Biotech Startup CEO Forum is an exclusive event for leaders of early-stage biotech companies (seed to pre-Series A). Join 25-30 fellow CEOs in a collaborative, confidential setting to address key business challenges and uncover actionable solutions.
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1:30 PM – Transcending Boundaries: Bringing Biotech Innovation to the U.S.

This discussion will explore the challenges and opportunities associated with bringing biotech innovations to the U.S. market. We will address the regulatory, legal, and business hurdles companies face when transitioning from other markets to the United States. We will discuss the various business challenges and opportunities encountered during the U.S. launch. This session presents a valuable opportunity for entrepreneurs, healthcare professionals, and investors to gain a deeper understanding of the landscape for biotech innovations in the United States.

• Regulatory Landscape Overview: Understanding the FDA approval process and navigating complex regulatory requirements specific to biotech products.
• Funding Strategies for Biotech Ventures: Exploring innovative fundraising approaches, including venture capital, grants, and public-private partnerships tailored for biotech startups.
• Forging Strategic Alliances and Collaborations to Propel Business Growth: Strategies for effectively positioning biotech innovations in the U.S. market

Adam Wicks, Shareholder, Private Equity & Venture Capital Practice Group Leader, Buchanan

Tina Hu-Rodgers, Shareholder, Life Sciences Industry Group Co-Leader, Buchanan

Mythili Markowski, Counsel, Buchanan

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2:00 PM – Bridging the Regulatory Gap – Ensuring Global Readiness
Dianne Lee, CEO, DLRC
Understanding and addressing regulatory requirements is crucial for the success of biotech startups at any stage of development. This session will explore the importance of conducting a comprehensive regulatory gap analysis to align quality, non-clinical, and clinical plans with global expectations.
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2:30 PM – Investor Insight Panel: From Concept to Commercialization
Biotech startups are at the forefront of innovation, turning cutting-edge research into life-changing therapies. However, transitioning from an idea to a fully-fledged startup presents a range of challenges. This panel will offer actionable insights from experienced investors on navigating these hurdles and positioning your startup for success.

Panelists:

Moderator: Adam Wicks, Shareholder, Private Equity & Venture Capital Practice Group Leader, Buchanan

Anne Horgan, Partner, Cambridge Innovation Capital

Pascale Edee, Associate, Apollo Health Ventures

Claire Brown, Investor, Oxford Science Enterprises

Key Discussion Points:

• Securing early-stage investment
• Building a solid R&D foundation
• Crafting a compelling narrative
• Strategic partnerships for growth
• Actionable advice for entrepreneurs

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3:00 PM – Closing remarks and post-forum networking

Successful MedTech companies prioritize early planning. It is crucial to incorporate key milestones for regulatory compliance, market access, market expansion, and stakeholder engagement. By doing so, they position themselves for growth and innovation in the dynamic healthcare landscape. Join our team of clinical development experts for a discussion on innovative pathways to bring your MedTech product to market.

Agenda topics include:

Regulatory Landscape: Is there renewed faith in EUMDR? Explore current and emerging legislative and regulatory dynamics impacting your MedTech products, and how these dynamics can springboard your global expansion plans.

Global Expansion: Will uncertainty around a new administration impact the positioning of the US as the global medtech leader? Explore strategies to successfully bring products to the US market – from the napkin phase to 510k approval.

Overcoming Early Hurdles: The growth of a medtech startup is never straightforward, what measures can you take to protect your business and avoid the most common pitfalls medtech SMEs can succumb to.

Innovative Case Studies: Hear real life examples that demonstrate strategies to de-risk MedTech pathways, achieve regulatory approval, and optimize market access through thorough planning and foresight.

This forum will be co-hosted by TÜV SÜD, and Phoenix DeVentures.