Data Disclosure Considerations and Best Practices for Publicly Traded Drug Development Companies

Data Disclosure Considerations and Best Practices for Publicly Traded Drug Development Companies

• The Lexington
• Wednesday, March 5, 2025 4:00 PM - 6:30 PM EST

Navigating Securities and Exchange Commission (SEC) disclosure requirements and considerations can present some of the most complex, challenging and nuanced questions for in-house lawyers and compliance professionals at clinical-stage and early commercial stage drug development companies. The implementation of rigorous disclosure controls and infrastructure to manage these questions in a compliant and business-oriented manner is essential.

Our panel of SEC compliance, FDA regulatory and securities litigation partners will address the following topics:

• Compliance and disclosure best practices for drug development companies (including the use of trading blackout periods, disclosure review committees, and managing sensitive disclosure windows around other SEC filings and capital markets activity)
• Interacting with the FDA, and guidance on disclosure from the agency
• Recent Regulation FD enforcement actions involving the life sciences/drug development industry
• Assessing materiality for disclosure purposes throughout a company’s life cycle and evolution
• Mitigating risk of liability under the federal securities laws

Event Details

Wednesday, March 5, 2025
4 - 4:30 p.m. Registration & Networking
4:30 - 5:30 p.m. Seminar
5:30 - 6:30 p.m. Cocktail Reception

This event is closed to the media.

Presenters

Megan Gates, Partner - Boston, MA
mgates@cov.com

Michael Labson, Partner - Boston, MA
mlabson@cov.com

Gerald Hodgkins, Partner - Washington, DC
ghodgkins@cov.com

CLE Credit: This program is approved for CLE in California and New York for both newly admitted and experienced attorneys.