CBER’s Five-Year Plan

Addressing CBER’s new direction for regulatory, quality and compliance oversight is a must to stay compliant.

CBER’s 2021-2025 Strategic Plan is a clear response to current threats posed by COVID-19 and the agency’s focus on incorporating lessons learned for future pandemics to streamline supply chains and mitigate product shortage risks. Its goals require incorporating innovative technologies to more quickly develop safe and effective biologics.

Know this: CBER’s emphasis is on incorporating advanced manufacturing processes and using machine learning (ML) and artificial intelligence (AI) along with real-world data (RWD) and real-world evidence (RWE). Will you be left behind?

Kalah Auchincloss, JD, MPH and Madeleine Giaquinto, JD of Greenleaf Health, Inc. will share how to implement strategic engagement and planning and develop a quality and compliance strategy that aligns with CBER’s regulatory expectations.

Ms. Auchincloss is executive vice president and deputy general counsel and a former FDA staffer in CDER’s Office of Compliance as well as former deputy chief of staff to the FDA commissioner, while Ms. Giaquinto is manager of regulatory affairs.

Webinar Takeaways:

The relevance of CBER’s four overarching goals for FY 2021-2025, which makes up the structural framework of its Strategic Plan, the objectives of each goal and the proposed strategic activities required to achieve each objective
What you must understand about CBER’s four priorities that will inform its policy decisions for the next five years, including addressing the COVID-19 outbreak; developing a regulatory program for individual or bespoke therapies; facilitating compliance with human cells, tissues and cellular and tissue-based product regulations; and advancing manufacturing technologies for biologic products
An analysis of the role CGT and personalized medicine development, advanced manufacturing technologies and AI/ML, RWE and RWD will play in CBER’s strategic and regulatory activities
An overview of new legislation enacted since the last plan was published and designed to accelerate medical production development, including the Cures Act, the FDA Reauthorization Act of 2017 (FDARA) and the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (PAHPAIA)
Additional factors that may impact CBER’s Strategic Plan, including the American Rescue Plan Act of 2021, Biden administration executive orders calling for review of pharmaceutical supply chains, FDA’s COVID-19 PREPP Initiative Report and FDA/NIST MUO on “Accelerating the Adoption of Advanced Manufacturing Technologies to Strengthen Our Public Health Infrastructure”

If you’re developing or producing CBER-regulated products, this is a must-attend webinar.

Kalah Auchincloss, JD, MPH
Executive Vice President and Deputy General Counsel
Greenleaf Health, Inc.

Kalah Auchincloss, JD, MPH is executive vice president and deputy general counsel at Greenleaf Health, Inc., providing strategic counsel to clients on compliance, enforcement and policy matters. She spent six years at FDA prior to joining Greenleaf in 2017, including time in CDER’s Office of Compliance and as deputy chief of staff to the FDA commissioner. Ms. Auchincloss was also a primary point of contact in the immediate Office of the Commissioner for the six FDA centers and other components of the Commissioner’s Office.

Madeleine Giaquinto, JD
Manager of Regulatory Affairs
Greenleaf Health, Inc.

Madeleine Giaquinto, JD is a manager of regulatory affairs at Greenleaf Health, Inc., where she provides clients with timely analysis of FDA regulations, policies and guidance documents as well as strategic advice on FDA engagement regarding compliance-focused issues and good practice standards for FDA-regulated products. Ms. Giaquinto advises clients on strategic engagement with the FDA regarding a range of compliance issues. She has published articles on topics ranging from the root causes of drug shortages along global supply chains, the DOJ’s evaluation of corporate compliance programs in the context of FDA-regulated products and FDA’s regulatory activities in response to COVID-19 and in future pandemic preparedness efforts.

Kate Cook
Principal, Regulatory Policy
Greenleaf Health, Inc.

Kate Cook joined Greenleaf following a distinguished career of more than 20 years with the U.S. Food and Drug Administration (FDA). During her FDA tenure, Kate provided crucial direction on strategic initiatives related to the regulation of drugs, biological products, and medical devices. Kate continues her commitment to public health at Greenleaf as Principal, Regulatory Policy, providing strategic consulting services and working with clients to bring innovative medical products to patients.

Kate’s FDA career began in the Office of the Chief Counsel, where she served for more than 15 years as a legal counsel on FDA issues related to biosimilars, gene therapy, vaccines, allergenics, human tissue and cellular products, blood products, medical devices, and combination products. She also provided guidance on human subject protection and advertising and promotion. Kate went on to serve as Associate Director for Regulations and Policy within the FDA’s Center for Devices and Radiological Health (CDRH), where she led strategic development and implementation of policies and regulations applicable to medical devices and radiation-emitting products. Later, as Senior Advisor in the FDA’s Center for Biologics Evaluation and Research (CBER), she played a pivotal role in the development and implementation of regulations and regulatory policy related to biological products, combination products, and medical devices regulated by CBER.

From 2016 to 2021, Kate was Executive Vice President with Greenleaf’s Drug and Biological Products Team. In 2021, she was enlisted to support the federal government’s pandemic response efforts. She returned to Greenleaf as Principal, Regulatory Policy, and now leads the firm’s services focused on supporting clients with expertise and guidance on FDA regulatory policies and programs. Kate is the recipient of numerous FDA awards, including the FDA Award of Merit, the Secretary’s Award for Distinguished Service, the Commissioner’s Special Citation, and the CDRH Director’s Special Citation.

A graduate of Swarthmore College, Kate received her law degree from the New York University School of Law.

Webinar Takeaways:

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