We are excited to announce Venable’s inaugural Life Sciences Webinar Series. This month-long series will explore the intricacies and latest developments that shape the life sciences industry. Join us as we hear from our seasoned attorneys across various practices who will share insights and provide a framework for navigating the relevant legal landscape.

Managing High-Stakes Mass Tort MDLs: Updates and Challenges from the Front Lines

October 10, 2023 | 1:00 pm – 2:00 pm ET

Mass tort MDLs now dominate the federal judiciary dockets as sophisticated third parties fund the development of claims and harvesting of claimants, investing heavily in the “if you build it, they will come” model. Instead of being coordinated pretrial proceedings for the convenience of the parties to promote the just and efficient conduct of the litigation, some inside and outside the judiciary have come to perceive MDLs as settlement programs. Our panel will highlight MDL updates and provide a glimpse into some of the battles being waged to steer MDLs in a new direction.


Jason Rose, Partner, Venable LLP

Legal Developments in Artificial Intelligence: The Intersection of Generative Artificial Intelligence, Intellectual Property, and Privacy Law

October 12, 2023 | 1:00 pm – 2:00 pm ET

The panel will give an overview of how generative artificial intelligence (GAI) intersects with patent, trade secret, copyright, trademark, and privacy law. We will provide an update on the growing list of IP-related cases involving GAI and how the potential outcomes might impact the risks of using GAI and issues that GAI creates for procuring and using patents, trademarks, and copyrights (including the implications related to AI not being able to be an author or an inventor of IP). We will also go over the privacy implications of using GAI, including legal pitfalls, and give some best practice recommendations.


Peter Shapiro, Partner, Venable LLP
Kelly DeMarchis Bastide, Partner, Venable LLP
Heather West, Senior Director of Cybersecurity and Privacy Services, Venable LLP

IPRs, PGRs, and the BPCIA

October 17, 2023 |  1:00 pm – 2:00 pm ET

This presentation will provide an update on PTAB challenges to biologics patents and their interplay with district court litigation. We will discuss recent IPR and PGR decisions, focusing on those most relevant to biologics patents. We will explore how challengers in the biologics space are using PTAB proceedings as a tool and how their use of PTAB proceedings has changed over time, compare outcomes at the PTAB vs. district courts, and look at how the Board and district courts are currently approaching parallel proceedings and motions to stay litigation pending IPRs or PGRs.


Ha Kung Wong, Partner, Venable LLP
Christina Schwarz, Partner, Venable LLP

Product Liability Risk Management Strategies in the Pre and Early Litigation Time Frame

October 19, 2023 |  1:00 pm – 2:00 pm ET

Product safety requires comprehensive risk management strategies that must be implemented before litigation ensues. Attendees will learn strategies for managing and minimizing risks in this critical time frame, as well as practical tips regarding internal company communications, external communications, crisis and brand management, and product recall preparedness.


Erin McCloskey Maus, Partner, Venable LLP
Michael Hecht, Partner, Venable LLP

Navigating the FDA Landscape

October 24, 2023 |  1:00 pm – 2:00 pm ET

This presentation will provide a regulatory law update for drugs, biologics, and medical devices, including tips for product developers to navigate these recent FDA developments.


Justin Coen, Partner, Venable LLP
Jeremiah Kelly, Partner, Venable LLP

Current Trends in Life Sciences and Healthcare Enforcement: Understanding and Anticipating Federal and state investigations and Enforcement Actions

October 26, 2023 |  1:00 pm – 2:00 pm ET

Federal and state governments continue to pour substantial resources into investigating and prosecuting program fraud, kickbacks, false claims, and other violations in the life sciences and healthcare sectors. Our panel will highlight current enforcement initiatives and recent court decisions and settlements, and will provide a sneak peek into the likely near future of enforcement priorities in the life sciences and healthcare.


Warren Hamel, Partner, Venable LLP
Matt Murphy, Partner, Venable LLP
Valerie Cohen, Partner, Venable LLP

Current Trends in ANDA Litigation

October 31, 2023 |  1:00 pm – 2:00 pm ET

During this panel, our presenters will discuss recent trends and current hot topics in Hatch-Waxman litigation, such as obviousness-type double patenting, including the Federal Circuit’s decision on OTDP and patent term adjustment (PTA) in In re Cellect; the increasing prevalence of § 112 written description and enablement challenges; recent inducement case law and trends in non-infringement arguments, and considerations for developing and strengthening patent portfolios in view of these issues.


Erin Austin, Partner, Venable LLP
Zach Garrett, Partner, Venable LLP

CLE Accreditation

This activity has been approved for Minimum Continuing Legal Education credit by the State Bar of California in the amount of one hour, of which one hour applies to the general credit requirement, by the State Bar of New York in the amount of one credit hour, of which one credit hour can be applied toward the areas of professional practice credit requirement, and by the MCLE Board of the Supreme Court of Illinois in the amount of one credit hour, of which one credit hour can be applied toward the general credit requirement. Venable certifies this activity conforms to the standards for approved education activities prescribed by the rules and regulations of the State Bar of California, State Bar of New York, and MCLE Board of the Supreme Court of Illinois, which govern minimum continuing legal education. Venable is a State Bar of California, State Bar of New York, and MCLE Board of the Supreme Court of Illinois accredited MCLE provider. This program is appropriate for both experienced and newly admitted attorneys.

For more information on CLE accreditation, please click here.


For more information contact:
[email protected]


    Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website ( Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website ( Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.


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