Cathy Burgess and Marc Scheineson will be speaking at the 2019 FDLI Annual Conference. The conference addresses complex legal, regulatory, compliance, and policy issues in all facets of the FDA-regulated industry. The two-day event provides in-depth discussions and analyses on a wide variety of timely topics by bringing together experts from the federal government, industry, private bar, nonprofits, patient and consumer advocates, consulting organizations, and academia.
Cathy will be speaking on the panel “Issues in Drug Quality and Manufacturing: ConOps, Quality Metrics, and Outsourcing.” The panel will delve into some of the important considerations manufacturers may encounter, including regulatory requirements for servicing vs. remanufacturing, how to assign vulnerability and risk in virtual manufacturing networks, and how to establish appropriate metrics that are in line with the latest FDA guidance. Also, panelists will discuss inspectional issues including ConOps, OAI classification letters, and risk mitigation opportunities.
Marc will be speaking on the panel “Regenerative Medicine, Gene Therapies, and FDA Regulation.” The panel will discuss the tools provided to the FDA under the 21st Century Cures Act that have been used by CBER to promote the development of new gene, cell, and tissue therapies. We have seen trends emerging in the regenerative medicine/stem cell fields, including science-based development of cell therapies via the RMAT designation in the Cures Act, and efforts the FDA is taking to regulate rogue stem cell clinics.
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