DIA will celebrate its 60th anniversary at the 2024 Global Annual Meeting from June 16-20, convening industry, regulators, governments, academics, innovators, and patients to discuss the theme, Charting New Horizons.
USP participation
Breaking Boundaries: Overcoming Policy Crosstalk and Globalization Barriers to Foster Innovation
Monday, June 17, 11:00 am – 12:00 pm PDT
We all want to see innovation in treatments and prevention that meets the many unmet needs of patients globally. And yet, despite this compelling goal, the complexity and uncertainty involved in delivering innovation has baffled policy makers, regulators, healthcare systems and companies at every step of the process. The response has been to establish policies and requirements to “direct” innovation to best effect. The result has been a confused environment where crosstalk of policy measures and requirements collectively and often constrain, rather than enable, innovation. In this forum, we aim to take a more holistic framing of the drive for innovation and explore three recent cases where policy crosstalk risks frustrating innovation.
Chair: Virginia Acha, AVP, Global Regulatory Policy, Merck & Co,
Policy Cross-Talk Case Study Speakers
- Clinical Research: Karen A Noonan, Senior Vice President, Global Regulatory Policy, Association of Clinical Research Organizations
- Supply Chains and Resilience: Christopher Colwell, Vice President, International Government and Regulatory Affairs, USP
- Pricing and Access Policies: Duane Schulthess, Chief Executive Officer, Vital Transformation LLC
Location: Room 6E San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
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Innovation in Manufacturing Globally
Monday, June 17, 2:15 pm – 3:15 pm PDT
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.
Chair: Evdokia Korakianiti, Head of Quality and Safety of Medicines, European Medicines Agency, Netherlands
Speakers
- EU Perspective on Enabling Innovation in Manufacturing: Marcel Hoefnagel, Medicines Evaluation Board (CBG-MEB), Utrecht, The Netherlands
- FDA Perspective on Advanced Manufacturing: Sau Lee, Deputy Director of Science, Office of Pharmaceutical Quality, CDER, FDA, US
- Artificial Intelligence/Machine Learning in Pharmaceutical Manufacturing: The Opportunity for a Low-Risk Deployment of AI: Gert Thurau, Head of Manufacturing Technology Innovation in CMC Regulatory Policy, F. Hoffmann-La Roche Ltd, Switzerland
- Decentralized Manufacturing of ATMPs: Ursula Busse, Head of Regulatory Affairs, Tigen Pharma SA, Switzerland
- Panelist: Benjamin Stevens, PhD, MPH, Director CMC Policy and Advocacy, GlaxoSmithKline
Location: Room 11AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
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Content Hub: Quality in Focus: Diethylene & Ethylene Glycol Challenges
Tuesday, June 18, 11:00 am – 11:30 am PDT
Participants will delve into the US FDA's regulatory guidance, exploring the testing protocols for high-risk drug components and explore the essential requirements and recommended practices to ensure product safety and compliance.
Speaker: Chaitanya Koduri, International Government & Regulatory Director, USP
Location: Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
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Roundtable Discussion: Innovation in Manufacturing Globally
Tuesday, June 18, 11:00 am – 12:00 pm PDT
Join the Digital Acceleration/Regulatory Affairs/Statistics & Data Science Community for a follow up round table discussion tied to session: Innovation in Manufacturing Globally (Monday, June 17 | 2:15PM - 3:15PM PDT). Space is limited.
Chair: Brett Howard, Senior Director, US Government & Regulatory Policy, USP
Location: Ballroom 20 A/ Zone 1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
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Regulatory Policy Roundtable: Pharmaceutical Quality, Generics, Innovative Medicines
Tuesday, June 18, 3:15 pm – 4:15 pm PDT
Industry leaders will discuss how regulatory and industrial policy can support delivering medicines to patients faster, how to assure pharmaceutical quality for innovative and generic medicines, and how regulatory harmonization benefits both sectors and, ultimately, patients.
Chair: Aaron Josephson, Senior Director, Global Regulatory Policy, Teva Pharmaceuticals
Speakers:
- Brett Howard, Senior Director, US Government & Regulatory Policy, USP
- Kristin Willemsen, Vice President, Scientific and Regulatory Affairs, Canadian Generic Pharmaceutical Association, Canada
- Katherine Wilson, Head, Global Regulatory Policy, and Intelligence, Viatris
Location: Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
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Securing the Chain - US and EU Legislative Reforms and Regulatory Actions for Drug Shortage Mitigation
Tuesday, June 18, 3:15 pm – 4:15 pm PDT
With efforts in the US and Europe to increase supply chain transparency and prevent drug shortages, this forum focuses on recent and pending regulatory updates. We examine actions taken to mitigate product shortages following an unpredicted event impacting product shortages and lack of supply predictability.
Chair: Demetra Macheras, Director, Regulatory Policy and Intelligence - Regulatory Affairs, AbbVie
Speakers:
Industry Update
Tony Lakavage, Senior Vice President, Global External Affairs, USPPatient Perspective
Laura Bray, Founder, Angels for ChangeLocation: Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
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Roundtable Discussion: Securing the Chain - US and EU Legislative Reforms and Regulatory Actions for Drug Shortage Mitigation
Wednesday, June 19, 11:00 am – 12:00 pm PDT
Join the Meaningful Change Working Group Community for a follow up round table discussion tied to session: Securing the Chain - US and EU Legislative Reforms and Regulatory Actions for Drug Shortage Mitigation (Tuesday, June 18 | 3:15 PM - 4:15 PM PDT). Space is limited.
Chair: Chaitanya Koduri, International Government & Regulatory Director, USP
Location: Ballroom 20 BC/ Zone 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
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Content Hub: Emerging Standards for Novel Excipients
Wednesday, June 19, 11:15 am – 11:45 am PDT
Participants will delve into the challenges of applying novel excipients to pharmaceutical formulations and conducting safety assessment, while also gaining insights into the crucial regulatory requirements needed to ensure product compliance and safety.
Moreover, the rationale behind the development of emerging standards, their potential impact, and the ways in which they can contribute to elevating the standard of excellence with novel excipients will be presented. Attendees will also learn about emerging standard approaches that will help remove the current barriers to using novel excipients in new therapeutics/advanced formulations.
Chair: Tong (Jenny) Liu, Principal Scientist, Science-Excipients, USP
Location: Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
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Challenges in Quality Control for Cell and Gene Therapy Development: Regulatory Perspectives and Best Practices
Wednesday, June 19, 4:30 pm – 5:30 pm PDT
This session will describe key challenges in quality assessment for cell and gene therapies, focusing on challenges related to raw materials; discuss regulatory perspectives; and present best practices to control and evaluate raw materials.
Chair: Fouad Atouf, SVP, Global Biologics, USP
- Mo Heidaran, Chief Regulatory Scientist, Cellx Inc., Consulting - Qualification and selection of raw material during early stage of development
- Haritha Vallabhaneni, Biological Reviewer, Office of Cellular Therapy and Human Tissue CMC, CBER, FDA - Perspective on the Selection of Raw Materials for Cell Therapy Manufacturing
- Alexandra Beumer Sassi, Global Head of CMC&QA, Voisin Consulting Life Science - Cell and Gene Therapy Products: Global Regulatory Perspective
Location: Room 6E San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
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View the full agenda:
https://www.diaglobal.org/en/flagship/dia2024/program/schedule/agenda
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