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Speakers

Session 2 - AI in Medtech and Life Sciences: Navigating the Regulatory Landscape FDA and Practical Challenges
April 10, 2025 | 2:10 - 3:00pm EDT

Moderator

Adam Wicks

Shareholder, VC Practice Lead - Buchanan Ingersoll & Rooney

Adam Wicks is shareholder in Buchanan's Pittsburgh office and leads the firm's Private Equity and Venture Capital Practice Group. As a strategic, business-minded negotiator, Adam's business transactions practice focuses on representing private equity and venture capital firms, independent sponsors, family offices and other sources of private capital and their portfolio companies in their corporate development, investment and acquisition strategies. Additionally, Adam regularly represents private business owners exploring the sale of their business and other strategic transactions.

Adam also serves as outside corporate counsel to clients ranging from startups to publicly-traded companies, advising on entity formation and corporate governance, financings and offerings, mergers and acquisitions (M&A), federal and state securities law compliance, commercial matters, and connecting his clients to key professionals and experts in other practice areas within Buchanan as various needs arise.

Adam's clients span a variety of industries including software, retail, security and fire alarm and protection, sports and gaming, medical devices, residential and commercial services, manufacturing, and professional services. Adam has received Best Lawyers: Ones to Watch recognition in the Corporate Law and Securities / Capital Markets Law categories since 2021, and Super Lawyers Pennsylvania Rising Stars recognition since 2023.

Panelist

Brad Holden

CEO - Resilient Lifescience

Brad brings medical device experience from GE Healthcare, Edwards Lifesciences, and Spry Health. He holds a B.S. from Carnegie Mellon and an MBA from Harvard.

In addition to his medical device experience, he has technology product and operations experience from Autodesk and Infinitus systems. Brad served as a Marine Corps Officer, leading troops in combat operations.

  • Carnegie Mellon, Harvard Business School
  • Captain, US Marine Corps
  • Scaling operations for healthcare venture (Infinitus)
  • Wearable sensor device development, Spry Health (Acquired by Itamar / Zoll, 2021)
  • Public Health Business Development, UrSure (Acquired by Orasure 2020)


Panelist

Tina Hu-Rogers

FDA, Shareholder & Life Sciences Industry Group Co-Leader - Buchanan Ingersoll & Rooney

Tina is Co-Leader of the firm's Life Sciences Industry Team, and a shareholder in the FDA/Biotechnology group. She focuses her practice on issues related to the approval, regulation, promotion, sale and reimbursement of drugs, medical devices, biologics, dietary supplements, foods and cannabis-related products.

Tina assists clients in their interactions with various federal agencies including the following:

• Food and Drug Administration (FDA)

• Centers for Medicare & Medicaid Services (CMS)

• Drug Enforcement Administration (DEA)

• Federal Trade Commission (FTC)

In addition to advising clients on how to obtain approvals for their FDA-regulated products, Tina's experience includes reviewing and revising the labeling of drugs, medical devices, foods and dietary supplements to ensure compliance with the FDA law and regulations. She works with clients to petition the FDA to ensure the safety and effectiveness of drug products on the market, and assists clients in a wide range of compliance and enforcement matters. She also advises clients on user fee issues, federal and state Sunshine Act reporting obligations, state price transparency disclosure rules, and state licensing requirements.

Tina is a thought leader on artificial intelligence and machine learning in the life sciences industry. She has spoken frequently and published several articles on AI/ML in drug discovery and development as well as FDA's regulation of AI/ML-powered medical devices.

Tina is also a member of the firm's cannabis group, where she assists companies in navigating federal and state law issues related to the promotion and sale of cannabis-related products. Tina has helped companies work to bring FDA- approved cannabinoid drug products to market, as well as helped clients to navigate sale of cannabis and hemp-related products.

Tina chairs the Buchanan B.O.L.D. Affinity group, and is conversant in Mandarin.

In 2019 and 2020, Tina was named to the Washington, D.C. Super Lawyers Rising Stars list. Most recently, in 2024, Tina was named the Rising Star Award winner by the Leadership Council on Legal Diversity.


Panelist

Jenna Kulp

Associate Director, Legal Operations - Prelude Therapeutics

With a fine arts degree and more than a decade of experience in marketing, Jenna brings a creative and strategic approach to legal operations and compliance oversight. Jenna's career journey has fueled her passion for driving efficiency, optimizing processes, and fostering cross-functional collaboration to meet the legal needs of stakeholders. As the Associate Director of Legal Operations at Prelude Therapeutics, Jenna is fortunate to align her strengths with her passion - leveraging innovation and operational excellence to support our teams in developing groundbreaking cancer treatments. She has a deep interest in AI and its transformative potential in the biotech industry, particularly as it relates to legal operations, drug discovery, and clinical trials. As AI continues to reshape the field, managing its risks, ensuring accuracy, mitigating bias, and maintaining regulatory and data privacy compliance will be crucial to unlocking its full potential responsibly.