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Monday, June 17 • 2:15pm - 3:15pm
#141: Innovation in Manufacturing Globally

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-541-L04-P; CME 1.00; RN 1.00

There is a rapid increase in the use of advanced manufacturing technologies in medicine. The session will provide an overview of the initiatives regulators take and discussion with industry on learnings and the opportunities ahead.

Learning Objectives

Describe the initiatives that regulators take to support the rapid technological growth in medicines manufacture that offers opportunities for better quality of medicines and increased robustness in supply chains leading to increased medicine availability.

Chair

Evdokia Korakianiti, PhD, MSc

Speaker

EU Perspective on Enabling Innovation in Manufacturing
Marcel Hoefnagel, DrSc, PhD, MSc

FDA Perspective on Advanced Manufacturing
Sau L Lee, PhD

Artificial Intelligence/Machine Learning in Pharmaceutical Manufacturing: The Opportunity for a Low-Risk Deployment of AI
Gert Thurau, DrSc, PhD

Decentralized Manufacturing of ATMPs
Ursula Busse, PhD, MBA

Panelist
Benjamin Stevens, PhD, MPH


Speakers
avatar for Ursula Busse

Ursula Busse

Head of Regulatory Affairs, Tigen Pharma SA, Switzerland
Ursula is the Head of Regulatory Affairs at Tigen Pharma, a clinical stage biotech company focused on cell-based cancer therapies. She has over 20 years of experience in Regulatory Affairs, Quality Assurance, Manufacturing and R&D thanks to global leadership roles in both large Pharma... Read More →
avatar for Marcel Hoefnagel

Marcel Hoefnagel

Senior Assessor Biopharmaceuticals, Medicines Evaluation Board , Netherlands
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 →
avatar for Evdokia Korakianiti

Evdokia Korakianiti

Head of Quality and Safety of Medicines, European Medicines Agency, Netherlands
Evdokia has joined the Agency in 2002. Since 2020, she is leading the Quality and Safety Department, which ensures that patients take medicine that are safe, are of the best possible quality and are manufactured in compliance with EU and international standards. She leads the Agency’s... Read More →
avatar for Sau Lee

Sau Lee

Deputy Super Office Director, OPQ, CDER, FDA, United States
Sau (Larry) Lee is a Senior Biomedical Research Scientist (SBRS). He is a Deputy Director of the Office of Testing and Research in the Office of Pharmaceutical Quality (OPQ), and the chair of the OPQ Emerging Technology Team. He is leading the effort in advancing OPQ research and... Read More →
avatar for Benjamin Stevens

Benjamin Stevens

Director CMC Policy and Advocacy, GlaxoSmithKline, United States
Ben Stevens is a Director of CMC Policy and Advocacy at GlaxoSmithKline and has nearly 15 years of drug discovery and regulatory experience. Prior to GSK, Ben was a Director of Regulatory Affairs CMC at Alnylam, a Principal Consultant at PAREXEL and an acting Branch Chief in the Office... Read More →
avatar for Gert Thurau

Gert Thurau

Head of Manufacturing Technology Innovation in CMC Regulatory Policy, F. Hoffmann-La Roche Ltd, Switzerland
Dr. Gert Thurau leads Manufacturing Technology and Innovation Advocacy at Hoffmann-La Roche, Basel, Switzerland. He advocates for advanced technology adoption in GMP manufacturing, including continuous processing, process models, robotics, advanced analytical technology, but also... Read More →

Monday June 17, 2024 2:15pm - 3:15pm PDT
Room 11AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  10: RegCMC-Product Quality, Session