Life Sciences Boot Camp 2022 - McDermott Will & Emery

Life Sciences Boot Camp 2022

Overview


Life sciences organizations have become some of the world’s most watched businesses and the industry as a whole is facing heightened scrutiny in light of the COVID-19 pandemic. As a result, there are many legal and business factors facing life sciences companies, including increasingly complex transactional and regulatory issues as well as enforcement risks.

Join our cross-functional team in person for a Life Sciences Boot Camp, which will bring together seasoned lawyers from across our practice groups for a half-day CLE program tailored to life sciences in-house counsel.

Explore the full agenda

An Industry Under Scrutiny: In-House Compliance and Government Oversight

In the face of an active and evolving enforcement environment, life sciences companies continue to find their businesses under the government microscope through the use of familiar tools such as the False Claims Act, the Anti-Kickback Statute, and other laws and regulations. This panel will discuss how your organization can best position itself to tackle these challenges by establishing a strong compliance program based on the most current considerations and guidance. We will also review effective response strategies if, despite your best efforts, your organization becomes the focus of government scrutiny.

Evolving Cybersecurity and Data Considerations for Life Sciences Companies

As medical devices and other life sciences products become increasingly connected, the risk of a security breach is similarly on the rise. Data and systems breaches are often costly, cause reputational damage, and can significantly impact the safety and effectiveness of devices used by consumers. During this panel, our team of healthcare privacy and cybersecurity lawyers will share the evolving cybersecurity and data considerations — including FDA-specific and healthcare data governance issues — that life sciences companies should heed to mitigate risk and protect their products.

FDA Exclusivities & IP Considerations

This cross-disciplinary panel will focus on patent strategy and portfolio development for small and established companies, and the intersection between patent strategy and your technology’s FDA/regulatory pathway. Topics will include generics and biosimilars, orphan and special product exclusivities, patentable subject matter, patent term extensions, and trademarks and product naming.

Key M&A Considerations: Pre- and Post-Acquisition

Major transactions are continuing to reshape the industry landscape and capital market trends suggest a potential round of consolidations ahead. This panel of tax and transactional lawyers will discuss how to prepare for M&A activity, and review issues to keep in mind during post-merger integration.

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