The global COVID-19 pandemic has challenged traditional approaches to the development, manufacture and delivery of new and existing medicines and has created unprecedented pressures on those involved in bringing quality medicines to patients worldwide.
In this crisis, pharmacopeias around the world, in partnership with regulators and industry, have been working to foster science- and health-based solutions to ensure that patients continue to have access to quality medicines and dietary supplements and continue to have trust in these products.
The 2020 PDA Pharmacopeia Conference, occurring virtually September 29 through October 1, will explore the intersection of global pharmacopeias, regulators and industry in response to this health crises. This event is PDA’s third pharmacopeia conference and the first intended to be “hosted” in the U.S., although the complete proceedings now will be conducted virtually as a result of continued caution in the face of the pandemic.
The 2020 conference will set the stage by bringing in pharmacists and patient advocacy professionals to discuss the urgent need for quality medicines in an environment where drug shortages and a lack of patient access to needed medications remain real risks. The opening session will also present the role of science-based pharmacopeias in ensuring the quality, safety and benefit of medicines.
Representatives from the following regional pharmacopeias will be involved in discussions throughout the meeting: U.S. Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), Japanese Pharmacopoeia (JP), British Pharmacopoeia, Chinese Pharmacopoeia (ChP) and International Pharmacopoeia (Ph. Int.). Regulatory representatives from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and experts from pharmaceutical manufacturers from all over the world will also participate.
On the first day, Ronald T. Piervincenzi, PhD, Chief Executive Officer, USP, will present the organization’s initiatives to ensure the supply of quality medicines. Professionals from the other pharmacopeias, industry representatives and regulators will also discuss how they have maintained timely patient access to medicines during the pandemic, offering lessons about how to maintain drug supply. Martin G. VanTrieste, President and CEO of Civica Rx, will describe a potentially transformative solution to drug shortages. Shigeki Tsuda, Executive Director, Pharmaceutical and Medical Device Regulatory Science Society of Japan, will detail the agency’s efforts to ensure the supply of basic pharmaceuticals and the role of pharmacopeias. Zonghua Song, PhD, Deputy Director, ChP, will provide an overview of the recently published ChP 2020. Matt W. Borer, PhD, Senior Research Advisor, Eli Lilly and Company, will consider disaster planning for reference standards used by the pharmaceutical industry.
On Oct. 1, the conference will move into more specific discuss ion of the development of treatments and vaccines during this public health crisis.
Pharmacopeia, regulatory and industry leaders will provide insights into their approaches and describe how they maintain focus on the goal of protecting the public health. USP's Sarita K. Acharya will present USP’s strategy on vaccines, and Diana C. Kwan, PharmD, will give an overview of an interactive dashboard of investigated COVID-19 drugs in world pharmacopeias.
To deliver a rapid response to the COVID-19 pandemic, Svein R. Andersen, PhD, Head of Regulatory Affairs–Europe, Coalition for Epidemic Preparedness Innovation, will describe the role of CEPI in vaccine development. An industry perspective on the approaches and challenges of developing vaccines and new therapeutics will be provided by representatives from Janssen Pharmaceuticals and Pfizer Inc., while a regulatory view will be provided by Christian Schneider, MD, Director, MHRA National Institute for Biological Standards and Control, and others. This session of the conference will enable attendees to recognize the progress being made toward discovering new therapies and supportive treatments and the race to find new preventive medicines and vaccines.
The final day will provide two panel discussions drawing on prominent experts in pharmaceuticals, regulations and pharmacopeial science, including James Pound, MHRA/British Pharmacopoeia, Editor-in-chief, Gina Marsee, Director of Compendial Compliance & Advocacy, Merck & Co., Inc., and representatives from the World Health Organization, USP and Pfizer Inc. The first panel will tackle the issue of maintaining transparent and accurate communications in these challenging times. When there is an overload of information, it can be difficult to assess the accuracy of the information being received. The panel also will discuss how pharmacopeias, regulators and industry can share best practices and communicate critical information to the public, even when face-to-face communication is impossible.
The second panel will begin with a prioritized wish list of global harmonization in a post-pandemic world, presented by Tina S. Morris, PhD, Executive Director, American Association of Pharmaceutical Scientists, and will continue by bringing together what has been learned from prior sessions of the conference and discussing possible actions to enable even more effective outcomes for future public health crises.
For pharmacopeia, regulatory, and industry professionals across a wide range of job functions and departments, from research and development to quality assurance and regulatory affairs, it will be well worth your time to attend the 2020 PDA Pharmacopeia Conference. Where else can you learn more about the exciting and critical work being done by scientists to ensure the continued supply of safe and effective medicines for patients worldwide, and to better understanding the role of pharmacopeias in supporting the global supply chain for quality medicines. We hope to see you (virtually) in September!
About the Authors
Kevin T. Moore, PhD, Senior Manager, Pharmacopeial Collaboration, U. S. Pharmacopeia, leads the strategic, technical and scientific aspects related to USP’s harmonization and collaborative activities with global pharmacopeias. He manages USP’s technical activities in the Pharmacopeial Discussion Group, coordinates prospective and retrospective harmonization activities with partner pharmacopeias, collaborates with WHO through the International Meeting of the World Pharmacopeias and supports ICH initiatives through USP’s observer status to the ICH Assembly.
Previously, a Scientific Liaison and Manager for Pharmacopeial Harmonization in the Excipients Group, Dr. Moore has nearly 20 years’ experience in the fields of compendial science and pharmaceutical analytical support.
J. Mark Wiggins, Owner and Compendial Consultant, Global Pharmacopoeia Solutions LLC, formed his own company after more than 30 years’ experience in the pharmaceutical industry. As Director of Compendial Affairs at Merck & Co., Inc., he gained more than 15 years’ experience submitting new and revised monographs to pharmacopeias, as well as optimizing processes for review and response to proposed compendial changes from around the world.
Mr. Wiggins has been an active participant in pharmaceutical industry associations in the U.S., UK and Europe, and represented PhRMA on the ICH Q4B Expert Working Group to harmonize pharmacopeial general chapters. He has published numerous papers, has co-authored articles on pharmacopoeia compliance and has been an invited speaker at international meetings on compendial harmonization.