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Tuesday, June 29 • 2:00pm - 3:00pm
#248 L: Supporting Quality/CMC Development in Early Access Approaches (PRIME/Breakthrough Designation)

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-583-L04-P; CME 1.00; IACET 1.00; RN 1.00

Scientific and regulatory tools to allow for risk-based flexibility of quality data packages and their application to a number of different innovative products including complex generics, and COVID-19 vaccines, will be discussed in this session.

Learning Objectives

Describe regulatory and scientific flexibilities in CMC aspects for product development as summarized in the recently published draft EU Toolbox guidance to support early access approaches; Discuss FDA’s perspective on the role of GDUFA II Pre-ANDA program on accelerating CMC development of complex generics; Discuss how such principles have been applied to innovative developments (COVID-19 mRNA vaccines); Assess future consideration, including lifecycle impact, by both regulators and industry.


Veronika Jekerle, PhD, RPh


EU Toolbox Guidance for PRIME Products
Marcel Hoefnagel, DrSc, PhD, MSc

GDUFA II Pre-ANDA Program: A Tool to Accelerate CMC Development of Complex Generics
Fang Yuan, PhD

Applying CMC Acceleration with Considerations for Lifecycle Impact
Lisa DeCardenas

CMC Flexibility Applied to COVID-mRNA Vaccine Development
Roger Nosal, PhD

Dolores Hernan Perez de la Ossa, PhD

Laurie Graham

avatar for Veronika Jekerle

Veronika Jekerle

Head of Pharmaceutical Quality, European Medicines Agency, Netherlands
Veronika Jekerle joined the European Medicines Agency in 2006. She has been a Product Team Leader for numerous Biological medicinal products applications including Recombinant proteins, Vaccines, ATMPs and Biosimilar applications. In 2014 she became a Quality Specialist within the... Read More →
avatar for Marcel Hoefnagel

Marcel Hoefnagel

Senior Assessor Biopharmaceuticals, Medicines Evaluation Board
Marcel Hoefnagel is an expert in Biopharmaceuticals working as Senior assessor for the Medicines Evaluation Board (CBG-MEB) the Netherlands. Since 2002 he is a regulator CMC of biopharmaceuticals (registration, GMP and legal aspects) as specialist in vaccines, allergens, biosimilars... Read More →

Fang Yuan

Chemist, OLDP, OPQ, CDER, FDA, United States
Dr. Fang Yuan received her Ph.D. degree in Pharmaceutical Science from University of Nebraska Medical Center. She has been a Chemist in Office of Lifecycle Drug Product since 2016, with expertise in quality assessments of pre-market ANDA submissions and pre-ANDA submissions of complex... Read More →
avatar for Lisa DeCardenas

Lisa DeCardenas

Regulatory Program Director, Genentech, A Member of the Roche Group, United States
Lisa deCardenas is a Regulatory Program Director at Genentech, A Member of the Roche Group in South San Francisco, California. She is a CMC regulatory affairs professional with 19 years of industry experience in biologics development, including global registration of Clinical Trials... Read More →
avatar for Roger Nosal

Roger Nosal

Vice President, Head of Global CMC, Pfizer Inc, United States
Roger Nosal is Vice President & Head of Global Chemistry, Manufacturing & Controls at Pfizer. Roger has contributed to the evolution of Quality by Design & has advocated for global regulatory harmonization through several ICH, PhRMA, ISPE, PQRI, AAPS, IFPAC, ACS & DIA technical committees... Read More →
avatar for Dolores Hernan Perez de la Ossa

Dolores Hernan Perez de la Ossa

Quality Specialist - Pharmaceutical Quality Office, European Medicines Agency, Netherlands
Dolores obtained a Pharmacy degree and a European PhD in Pharmaceutical Technology from the Complutense University, conducting research stays at Virginia Commonwealth University, USA and the Italian National Research Council. She joined the Quality Office of the EMA in 2010, first... Read More →

Laurie Graham

Director, DIPAP, OPPQ, OPQ, CDER, FDA, United States
Laurie Graham is currently the Director of the Division of Internal Policies and Programs (DIPAP) in the Office of Policy for Pharmaceutical Quality (OPPQ) in the Office of Pharmaceutical Quality (OPQ) at the Center for Drugs Evaluation and Research (CDER). DIPAP is responsible for... Read More →

Tuesday June 29, 2021 2:00pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044
  10: RegCMC-Product Quality, Session