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#134: Building a Regulatory Landscape to Support CMC Innovation
Monday June 16, 2025 2:15pm - 3:15pm EDT
143ABC
Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-531-L04-P; CME 1.00; RN 1.00

Senior leaders from industry and regulatory agencies will discuss the role of cooperation across regulatory bodies to facilitate innovation in the CMC/product quality sector. Senior leaders will discuss how, despite various internal and external pressures, an agile path forward can be found to advance innovative and high quality medicines.

Learning Objectives

Describe initiatives to streamline regulatory assessment/inspection; Recognize how regulatory initiatives can facilitate innovation in CMC; State comparing perspectives from senior leaders regarding regulatory initiatives and regulatory advancements.

Chair

Demetra Macheras, MBA

Speaker

Panelist
Evdokia Korakianiti, PhD, MSc

Panelist
Ingrid Markovic, PhD

Panelist
Leanne Hickman

Panelist
Jennifer McCafferty, PhD

Panelist
Sean Barry, PhD


Speakers
avatar for Demetra Macheras

Demetra Macheras

Director, Regulatory Policy and Intelligence - Regulatory Affairs, AbbVie, United States
Demetra Macheras is currently Director, Regulatory Policy and Intelligence at AbbVie. She assesses and coordinates comments on proposed regulatory policies for the U.S., Canada, ICH, and WHO regulatory environments and ensures appropriate AbbVie personnel are aware of emerging and... Read More →
avatar for Jennifer McCafferty

Jennifer McCafferty

Senior Vice President, Regulatory CMC and Quality Assurance, Merck, United States
Jennifer McCafferty is Senior Vice President, Quality Assurance and Regulatory CMC in Merck Research Laboratories. Jennifer’s more than 25-year career includes leadership positions across analytical sciences, factory and CMO operations, quality systems, quality control, CMC regulatory... Read More →
avatar for Sean Barry

Sean Barry

Senior Pharmaceutical Assessor, Health Products Regulatory Authority (HPRA), Ireland
Sean is a Senior Biologicals Assessor at the Irish health authority, HPRA, where he reviews CMC data for new product applications, scientific advices, clinical trials, and variations for mAbs, recombinant proteins, vaccines, and cell & gene therapies. Sean is chair of the Biologicals... Read More →
LH

Leanne Hickman

Senior Vice President, Global Quality Analytical Sciences & QC Operations, Eli Lilly and Company, United States
Leanne Hickman, Sr. VP of Global Quality Analytical Sciences and QC Strategy, leads efforts to standardize and transform QC labs across the manufacturing network. She oversees analytical methods, systems, and technologies to support testing for current and pipeline molecules. Her... Read More →
avatar for Evdokia Korakianiti

Evdokia Korakianiti

Head of Quality and Safety of Medicines, European Medicines Agency, Netherlands
Evdokia joined the Agency in 2002. Since 2020, she is leading the Quality and Safety Department, which includes Quality, GxP Compliance, Referrals and PhV. She is the EMA lead of the EU Network's strategic priority to facilitate the uptake of advanced manufacturing approaches. She... Read More →
avatar for Ingrid Markovic

Ingrid Markovic

United States
Ingrid Markovic, Ph.D. is Senior Science Advisor for CMC at the FDA's Center for Biologics where she spearheads CMC policy activities partnering with internal and external stakeholders to ensure consistent application of CMC policies and programs. She led FDA efforts for modernization... Read More →
Monday June 16, 2025 2:15pm - 3:15pm EDT
143ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  10: RegCMC-Product Quality, Session

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