Blank Rome presents “Under the Microscope: Legal Issues in Life Sciences & Healthcare,” a new webinar series examining legal, regulatory, and policy developments in the life sciences and healthcare sectors.
The series of one-hour sessions will be held Wednesday, April 22; Wednesday, April 29; Wednesday, May 6; Wednesday, May 13; and Thursday, May 21, at 12:00 p.m. ET / 11:00 a.m. CT / 9:00 a.m. PT.
Participants can choose to attend any or all of the following sessions:
Wednesday, April 22
GLP‑1s, Regulatory Litigation, and Patents
Rachael G. Pontikes, Emily L. Hussey, Jay P. Lessler, and Shannon E. McClure
This session will examine the rapidly evolving legal landscape surrounding GLP‑1 medications, with a focus on Food and Drug Administration (“FDA”) regulation, emerging litigation, and patent enforcement issues affecting compounded products and related services. As demand for GLP‑1 therapies continues to surge, regulators, brand manufacturers, and market participants are increasingly testing the boundaries of compliance, enforcement, and intellectual property rights.
- FDA activity and enforcement related to GLP‑1 compounding
An overview of the FDA’s current posture toward GLP‑1 compounded drugs, including recent guidance, enforcement actions, warning letters, and policy statements. The session will address how drug shortages, compounding exceptions, and quality‑control requirements are being interpreted and enforced, as well as areas of heightened regulatory scrutiny. - Key litigation trends and patent challenges impacting the market
A discussion of recent and emerging litigation involving GLP‑1 products, including patent infringement actions, challenges to compounding practices, false advertising and consumer protection claims, and disputes involving pharmacy benefit managers, dispensers, and telehealth platforms. The panel will also explore how patent exclusivity, biosimilar considerations, and Hatch‑Waxman–related issues are shaping the competitive landscape. - Practical implications for manufacturers, dispensers, and telehealth companies
Practical takeaways for companies operating in or adjacent to the GLP‑1 market, including risk mitigation strategies, compliance considerations, litigation exposure, and operational best practices. The session will focus on how different market participants can navigate regulatory uncertainty while responding to patient demand and evolving enforcement priorities.
Wednesday, April 29
Practical Implications of AI in Healthcare
Daniel E. Rhynhart, James Petkun (Chief Legal Officer and General Counsel, The START Center for Cancer Research), Sharon R. Klein, and Lisa Casey Spaniel
This session will examine the legal and regulatory risks associated with the growing use of artificial intelligence (“AI”) in healthcare. The presenters will discuss liability, compliance, and governance challenges arising from AI‑driven clinical, operational, and administrative tools, as well as how emerging laws and enforcement trends are shaping risk management strategies for healthcare organizations and technology providers.
Topics Covered:
- Legal liability and risk exposure arising from AI‑assisted clinical and operational decision‑making
- Medical malpractice considerations and responsibility for AI‑generated errors
- Health Insurance Portability and Accountability Act (“HIPAA”), data privacy, and cybersecurity issues related to AI systems and health data
- Algorithmic bias, discrimination concerns, and accountability for flawed or inconsistent AI outputs
- Overview of new and emerging federal and state laws regulating AI in healthcare
Wednesday, May 6
Litigation (IP) Trends & Developments in the Life Sciences Sector
Joseph J. Mellema, Ferlillia V. Roberson, and Joshua S. Reisberg
This CLE session will examine recent intellectual property (“IP”) litigation trends and emerging legal developments across the life sciences sector. The panel will discuss significant case law, enforcement strategies, and regulatory considerations shaping disputes involving pharmaceuticals, biotechnology, and medical technologies. Speakers will highlight how these developments are influencing litigation strategy, competitive positioning, and risk management for both innovators and challengers. Attendees will leave with practical insights to help align IP enforcement and defense strategies with evolving business and regulatory realities.
- Recent IP litigation trends and notable case law developments in life sciences
- Patent enforcement and defense strategies
- The growing role of trade secret and unfair competition claims
- The impact of FDA and regulatory dynamics on IP litigation strategy
- Practical risk management considerations for companies and counsel operating in the life sciences sector
Wednesday, May 13
FDA Changes in Labeling and Advertising
Erica R. Graves and Thomas M. Sundlof
This session will provide an overview of recent FDA developments affecting the wellness industry, with specific focus on wearable tech, including AI-powered clinical decision software, and nutraceuticals. The presenters will discuss evolving regulatory expectations for promotional claims and highlight common compliance risks, recent enforcement activity, and practical steps companies can take to ensure marketing practices do not cause your product to inadvertently cross FDA’s product-jurisdictional lines.
- Recent FDA updates on updated guidances affecting general wellness devices and clinical decision support software
- Regulatory expectations for promotional claims, risk disclosure, and substantiation
- Trends in FDA enforcement for wellness products
- Updates for FDA nutraceutical labeling
- Litigation risks for nutraceuticals
- Practical steps companies should take to mitigate risk of over-regulation
- Advertising considerations across digital, social media, and Health Care Provider‑focused channels
Thursday, May 21
Healthcare Market Consolidation & Vertical Integration: Trends, Legislative Responses, and Strategic Implications
Eric S. Tower and Robert Y. Chow
This session explores how vertical and horizontal integration in life sciences and healthcare—fueled by private equity investment, strategic financing, and M&A activity—is accelerating industry consolidation. Using recent high‑profile transactions as case studies, the panel examines how capital structure, deal strategy, and platform-building models are reshaping care delivery, particularly through physician-led organizations with centralized infrastructure and specialty drug capabilities.
The discussion also addresses what these trends mean for independent practices, transaction readiness, and long-term sustainability, including the growing importance of shared data and analytics, operational scale, and alignment with value‑based care models. Attendees will gain insight into how financing and transactional activity is driving the emergence of integrated, one‑stop, community-based care networks across the healthcare ecosystem.
- Current financing and investment trends driving consolidation and the privatization of healthcare
- How large-scale transactions—such as Cencora’s planned acquisition of OneOncology—reflect evolving deal structures, valuation drivers, and the shift toward physician platforms with centralized infrastructure and specialty drug capabilities
- The impact of private equity ownership, recapitalizations, and platform acquisitions on independent practices, including increased reliance on shared data, analytics, and outsourced operational services to remain competitive under value‑based care models
- Broader implications of M&A and corporate investment in healthcare, including market pressures, changes in care delivery models, regulatory considerations, and the continued growth of integrated, community-based care networks
Question? Please contact Jules Maculewicz at julia.maculewicz@blankrome.com.
