Webinar: Due Diligence for Life Science Companies

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Join ArentFox Schiff Partners Stephanie Trunk, a recognized authority in government pricing and compliance, and Jacques Smith, a leading health care litigator with extensive experience guiding life science companies through government inquiries, as they share key insights and aim to equip participants with the knowledge to effectively manage due diligence in life science mergers and acquisitions.

Darshan Kulkarni will delve into the FDA-related facets of due diligence, covering critical areas such as clinical research, drug advertising, and clinical trial transparency. This segment will highlight the importance of understanding FDA regulations to avoid potential pitfalls that could derail a merger or acquisition.

Stephanie Trunk will complement this discussion by addressing Government Pricing reporting diligence, emphasizing the need for thorough evaluation of compliance with Medicare and Medicaid regulations. Her insights will help participants understand the complexities of CMS compliance and its impact on the valuation and success of M&A transactions in the life sciences sector.

Jacques Smith, leader of the firm’s Investigations Group, will add his views on what a company should look for in conducting due diligence in the heavily-regulated life sciences industry and what to think about when facing a government investigation.

Proposed Takeaways:

  1. Comprehensive Understanding of FDA Regulations: Participants will gain a deep understanding of how FDA regulations affect life science M&As, including the intricacies of clinical research, drug advertising, and clinical trial transparency. This knowledge is vital for identifying regulatory risks during the due diligence process.
  2. Navigating CMS Compliance: Learners will understand the critical role of Government Price reporting and reimbursement for life science M&As, including how Medicare and Medicaid regulations influence the transaction. Stephanie Trunk’s insights will provide a roadmap for assessing Government Pricing compliance, ensuring that potential legal and financial liabilities are identified and managed.
  3. Fraud and Abuse and Compliance Considerations: Learn about the importance of understanding and navigating fraud and abuse risks under the OIG Guidance, Anti-Kickback Statute, the Sunshine Act, the FCA, and the FCPA when considering a transaction. Jacques Smith will also provide key insights on enforcement trends and mitigating risk after the close if the government makes an inquiry.

Click here to register for the event.


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