AHLA: Advising Providers – Legal Strategies for AMCs, Physicians, and Hospitals

Delia Deschaine, Kate Heffernan, and Jenny Nelson Carney, Members of the Firm, speak at Advising Providers: Legal Strategies for AMCs, Physicians, and Hospitals, hosted by the American Health Law Association (AHLA). The conference runs from February 5 to 7.

On February 5, Kate co-presents "Research Misconduct Regulations." Topics include:

• Research Integrity and Misconduct Today
• Recent Trends and Enforcement Activity (e.g., the intersection of research misconduct and the False Claims Act/Civil Monetary Penalties)
• Where Are We Going: The Proposed PHS Rule (key proposed changes will be discussed from the perspective of a respondent vs. an institution conducting the proceedings)

On February 6, Jenny co-presents "Advising Providers on Maternal Health Disparities: Challenges and Opportunities."

On February 7, Delia co-presents "IND Manufacturing in the AMC Setting: cGMP, Contracting, Liability, Commercial Partnerships, COI, and Other Challenges." Topics include:

• Research-intensive AMCs are now manufacturing some of the investigational medical products for use in their own clinical trials. The manufacturing involved may be relatively simple or very sophisticated, with products ranging from mobile device health applications and food flours for allergy testing to cell and gene therapies that require aseptic processing facilities
• Beyond FDA’s IND and IDE regulations, these projects are subject to FDA regulations specific to manufacturing, but the application of these manufacturing regulations to early stage (Phase I and II) clinical trials can be unclear
• The panel consists of two attorneys who have navigated these issues in the AMC and industry environments and an expert regulatory consultant and engineer who is Lead Auditor trained and regularly audits clients for compliance with FDA’s Good Manufacturing Practice (GMP) requirements, including quality systems planning and architecture and risk-based remediation
• Various types of AMC manufacturing projects; the legal, insurance, business, and practical considerations involved in investigational product manufacturing; and the regulatory landscape, including FDA’s interpretation of its own manufacturing regulations in the context of academic manufacturing. The panel also addresses issues that may arise when collaborating with industry to manufacture investigational products in the AMC setting

For more information, please visit AmericanHealthLaw.org.