2020 PDA Pharmacopeia Conference

Name: 2020 PDA Pharmacopeia Conference
Start: 2020-09-29
End: 2020-10-01

Sep 29 - Oct 01, 2020

Eastern Standard Time | Online

Virtual
Conference

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Online
The Americas

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Closed

Overview
Agenda
Speakers
Additional Information
Registration Fees
Exhibit & Sponsorship
Contact

Overview

Pharmacopeias have a well-established history to help protect and improve the health of people around the world through public standards and related programs that help ensure the quality, safety, and benefit of medicines. This mission is shared by many stakeholders to the pharmacopeias, including regulatory agencies and the bio/pharmaceutical industry. There are several examples of collaborative responses to address issues relating to the quality of medicines, including control of contamination in glycerin, heparin, and – more recently – nitrosamines in “sartans”.

The global COVID-19 pandemic has challenged traditional approaches to nearly every aspect of life, including the manufacture, delivery, and development of new and existing medicines. The 2020 PDA Pharmacopeia Conference will explore the intersection of global pharmacopeias, regulators, and industry in responding to such crises. Join us virtually to discuss the roles of the pharmacopeias and various stakeholders in maintaining the drug supply, developing new treatments, and explore lessons learned to help address future health crises appropriately.

Agenda

Day 1
Day 2
Day 3
Day 4

Pre-Recorded Sessions

Of Pharmacopeias and Pandemics: Setting the Stage
Moderators: Kevin T. Moore, PhD, Senior Manager, Pharmacopeial Collaboration, United States Pharmacopeia and
J. Mark Wiggins, MS, Owner and Compendial Consultant, Global Pharmacopoeia Solutions LLC

Pharmacopeias have a well-established history to help protect and improve the health of people around the world. But the global COVID-19 pandemic has challenged traditional approaches to nearly every aspect of life, including the manufacture, delivery, and development of new and existing medicines. What is the intersection of this public health crisis and the work of pharmacopoeias and stakeholders? This session will provide context for the overall conference, with pre-recorded presentations from the co-chairs and by some of those who have been impacted, including a pharmacist who contracted COVID-19 and a patient advocacy group representative.

Welcome and Opening Remarks from Conference Co-Chair
J. Mark Wiggins, MS, Owner and Compendial Consultant, Global Pharmacopoeia Solutions LLC

From the Ski Slopes to the ICU: My COVID-19 Journey
Marilyn R. Stebbins, PharmD, Professor of Clinical Pharmacy and Vice Chair of Clinical Innovation, University of California, San Francisco, School of Pharmacy

Patients' Perspectives
Pam G. Traxel, Senior Vice President, American Cancer Society Cancer Action Network, Inc.

Conference Lead-in from Conference Co-Chair
Kevin T. Moore, PhD, Senior Manager, Pharmacopeial Collaboration, United States Pharmacopeia

Tuesday, September 29

10:00 a.m. - 2:30 p.m. | Maintaining Drug Supply During the Pandemic: The Role of the Pharmacopeia and Standards
Moderators: James Pound, BSc, Group Manager British Pharmacopoeia & Laboratory Services, MHRA and
Erin G. Wang, MS, Associate Senior Consultant, Eli Lilly and Company

Ensuring the timely and assured supply of medicines to patients is absolutely critical to the global healthcare response to the pandemic. Any interruption to supply could have serious consequences, whether for existing therapeutics in clinical trials for the treatment of COVID-19, medicines needed to support seriously ill patients in hospitals or consumer healthcare products. This session will consider the complex and challenging experiences of the pharmacopeias and industry stakeholders supporting the continued supply of medicines. For example, maintaining the supply of reference standards and the role of standards in supporting a supply chain under stress for both licensed and unlicensed medicines. With speakers from across the world, this will be a unique opportunity to learn how pharmacopeias, regulators and industry have responded and share your experiences and opinions.

10:00 a.m. – 10:05 a.m. | Welcome and Recap of Pre-Recorded Sessions
Kevin T. Moore, PhD, Senior Manager, Pharmacopeial Collaboration, United States Pharmacopeia and
J. Mark Wiggins, MS, Owner and Compendial Consultant, Global Pharmacopoeia Solutions LLC

10:05 a.m. – 10:10 a.m. | Framework for the Session
James Pound, BSc, Group Manager British Pharmacopoeia & Laboratory Services MHRA and
Erin G. Wang, MS, Associate Senior Consultant, Compendial Affairs, Eli Lilly and Company

10:10 a.m. – 10:40 a.m. | USP's Pandemic Response: Helping Ensure the Supply of Quality Medicines
Ronald T. Piervincenzi, PhD, Chief Executive Officer, United States Pharmacopeia

10:40 a.m. – 11:00 a.m. | Drug Shortages: A Creative - Disruptive - Transformative Solution Is Required
Martin G. VanTrieste, BS Pharmacy, President & CEO, Civica Inc.

11:00 a.m. – 11:20 a.m. | Systems Thinking, Pandemics, and Pharmacopoeias
Alistair Gibb, PhD, Editor-in-Chief British Pharmacopoeia, Medicines and Healthcare products Regulatory Agency

11:20 a.m. – 11:40 a.m. |Overview of NIFDC and Support for Regulation
Mingzhe Xu, PhD, Deputy Director, Institute for Chemical Drug Control, China National Institutes for Food and Drug Control (NIFDC)

11:40 a.m. – 12:00 p.m. | Q&A

12:00 p.m. – 12:30 p.m. | Break

12:30 p.m. – 12:50 p.m. | The European Paediatric Formulatry
Dirk Leutner, Head of Pharmaceutical Technology Section, EDQM, Council of Europe

12:50 p.m. – 1:10 p.m. | USP Compounding Standards
Brian Serumaga, PhD, RPh, Senior Manager, Personalized Medicines, United States Pharmacopeia

1:10 p.m. – 1:30 p.m. | Pharmaceutical Industry Reference Standards - Disaster Planning
Matthew W. Borer, PhD, Senior Research Advisor, Eli Lilly and Company

1:30 p.m. – 1:50 p.m. | Japanese Efforts to Ensure Supply of Basic Pharmaceuticals and the Role of Pharmacopoeia
Shigeki Tsuda, MS, Senior Managing Director, Pharmaceutical and Medical Device Regulatory Science Society of Japan (PMRJ)

1:50 p.m. – 2:10 p.m. | Overview of the Chinese Pharmacopoeia 2020 Edition
Zonghua Song, PhD, Deputy Director, Chinese Pharmacopoeia Commission

2:10 p.m. – 2:30 p.m. | Q&A

Wednesday, September 30

10:00 a.m. – 1:30 p.m. | Developing New Treatments: The Role of the Pharmacopeia and Standards
Moderators: Joseph A. Albanese, PhD, Director of Analytical Strategy and Compliance, Janssen Pharmaceuticals R&D, LLC (Johnson and Johnson) and
Cathie Vielle, Head of the Pharmacopeia Europe Department, EDQM Council of Europe

In such unprecedented pandemic situation, all those involved in ensuring that safe and appropriate medicines reached the patient faced new challenges. For example, most of the COVID-19 candidate vaccines developers are small or medium sized enterprises or universities with little or even no knowledge of the regulatory landscape (including Pharmacopeias). Additionally, new, and sometime controversial information about possible COVID-19 treatments using already existing therapies such as remdesivir, hydroxychloroquine, dexamethasone, Interferon β and others were published (e.g. in the media).

This session will give the floor to speakers from different areas (Regulators, Pharmacopoeias, Industry) who will share how they approached this situation to best meet their duties: protection of Public Health and providing the best available treatment to patients in the shortest time possible.

10:00 a.m. – 10:05 a.m. | Recap of Tuesday's Session
Kevin T. Moore, PhD, Senior Manager, Pharmacopeial Collaboration, United States Pharmacopeia and
J. Mark Wiggins, MS, Owner and Compendial Consultant, Global Pharmacopoeia Solutions LLC

10:05 a.m. – 10:10 a.m. | Framework for the Session
Joseph A. Albanese, PhD, Director of Analytical Strategy and Compliance, Janssen Pharmaceuticals R&D, LLC (Johnson and Johnson) and
Cathie Vielle, Head of the Pharmacopeia Europe Department, EDQM Council of Europe

10:10 a.m. – 10:30 a.m. | USP Biologics Vaccine Strategy: Our Approach to Standards and Protecting the Public Health
Sarita K. Acharya, MS, Science & Standards Liaison, United States Pharmacopeia

10:30 a.m. – 10:50 a.m. | Rapid Response to COVID-19: The Role of CEPI in Vaccine Development
Svein R. Andersen, Dr. Sci., Head of Regulatory Affairs - Europe, Europe Coalition for Epidemic Preparedness Innovation (CEPI)

10:50 a.m. – 11:10 a.m. | Impact of Excipients in Vaccines: Material Qualification and Sourcing Issues for Janssen Vaccines
John Schafer, Senior Scientist, Janssen

11:10 a.m. – 11:30 a.m. | Vaccines Q&A

11:30 a.m. – 12:00 p.m. | Break

12:00 p.m. – 12:20 p.m. | Monograph Availability of COVID-19 Investigated Drugs in World Pharmacopeias
Diana C. Kwan, PharmD, Scientific Liaison, United States Pharmacopeia

12:20 p.m. – 12:40 p.m. | Azithromycin: Compatibility and Simulated Dosing with Feeding Tubes
Kimber L. Barnett, PhD, Research Fellow, Pfizer Inc.

12:40 p.m. – 1:00 p.m. | Standards to Support the Development of New Treatments for COVID-19
Christian K. Schneider, MD, Chief Scientific Officer, Medicines and Healthcare products Regulatory Agency

1:00 p.m. – 1:30 p.m. | New Therapeutics and Regulatory View Q&A with Panelist
Chris J. Burns, PhD, Head of Biotherapeutics Division, National Institute for Biological Standards and Control

Thursday, October 1

10:00 a.m. – 11:30 a.m. | Maintaining Transparent Communication in Digitally Overloaded Times
Moderators: Bettine Boltres, PhD, Principal Scientific Affairs, West Pharmaceutical Services and
Kevin T. Moore, PhD, Senior Manager, Pharmacopeial Collaboration, United States Pharmacopeia

With increasing digitalization there is also an increasing challenge of filtering this overload of information, assessing its accuracy, and determining appropriate action. Recent examples are therapeutic and vaccine development for COVID-19, as well as reported glass container shortages. Other examples include contamination concerns: nitrosamines, heparin, and glycerin. You will have a chance to hear from experts, ask questions, and provide your own experience on these important topics.

This interactive session will explore two broad areas of communication:
1. Sources of information (and misinformation) and how that is translated to the public, media, etc.
2. How pharmacopeias, regulators, and other stakeholders share critical information (including Pharmacopeia Forum, Pharmeuropa, and internal company communications).

10:00 a.m. – 10:05 a.m. | Recap of Wednesday's Session
Kevin T. Moore, PhD, Senior Manager, Pharmacopeial Collaboration, United States Pharmacopeia and
J. Mark Wiggins, MS, Owner and Compendial Consultant, Global Pharmacopoeia Solutions LLC

10:05 a.m. – 10:10 a.m. | Framework for the Session
Bettine Boltres, PhD, Principal Scientific Affairs, West Pharmaceutical Services and
Kevin T. Moore, PhD, Senior Manager, Pharmacopeial Collaboration, United States Pharmacopeia

10:10 a.m. – 11:30 a.m. | Panel Discussion
Graham D. Cook, PhD BPharm, Senior Director, Pfizer Inc.
Michael C. Ganio, PharmD, Senior Director, Pharmacy Practice and Quality, ASHP
Sabine Kopp, PhD, Team Lead, World Health Organization
James Pound, BSc, Group Manager British Pharmacopoeia & Laboratory Services, MHRA
Jaap Venema, PhD, Chief Science Officer, United States Pharmacopeia
Cathie Vielle, Head of the European Pharmacopeia Department, EDQM Council of Europe

11:30 a.m - 12:00 p.m. | Break

12:00 p.m. – 2:00 p.m. | Conclusions: What Have We Learned? Where Do We Go From Here?
Moderators: Kevin T. Moore, PhD, Senior Manager, Pharmacopeial Collaboration, United States Pharmacopeia and
J. Mark Wiggins, MS, Owner and Compendial Consultant, Global Pharmacopoeia Solutions LLC

The closing session begins with an exploration of the impact of the pandemic on efforts aimed at achieving global harmonization of pharmacopeias. The moderators will then take stock of prior sessions from the conference, including a summary of key points and outcomes, as well as consideration of possible actions. A panel/round table discussion will provide an opportunity for conference attendees to engage in constructive dialogue to enable even more effective outcomes for future public health crises.

12:00 p.m. – 12:30 p.m. | Global Harmonization Post Pandemic – A Prioritized Wish List
Tina S. Morris, PhD, Executive Director, American Association of Pharmaceutical Scientists

12:30 p.m. – 1:45 p.m. | Panel Discussion
Rafael Hernández, QFB, Technical and Publications Manager, Mexican Pharmacopoeia
Susanne Keitel, PhD, Director, European Directorate for the Quality of Medicines and HealthCare
Gina M. Marsee, Director, Compendial Compliance & Advocacy, Merck & Co., Inc.
Tina S. Morris, PhD, Executive Director, American Association of Pharmaceutical Scientists
Manisha Trivedi, PhD, Scientific Assistant, Indian Pharmacopoeia Commission
Peter Richardson, PhD, Quality, European Medicines Agency
Jaap Venema, PhD, Chief Science Officer, United States Pharmacopeia

1:45 p.m. – 2:00 p.m. | Closing Remarks and Final Wrap-up from Conference Co-Chairs
Kevin T. Moore, PhD, Senior Manager, Pharmacopeial Collaboration, United States Pharmacopeia and
J. Mark Wiggins, MS, Owner and Compendial Consultant, Global Pharmacopoeia Solutions LLC

Highlighted Speakers

Svein R. Andersen

Coalition for Epidemic Preparedness Innovation (CEPI)

Michael C. Ganio

ASHP

Sabine Kopp

World Health Organization

Tina S. Morris

American Association of Pharmaceutical Scientists

Ronald T. Piervincenzi

United States Pharmacopeia

Zonghua Song

Chinese Pharmacopeia Commission

Marilyn R. Stebbins

University of California, San Francisco, School of Pharmacy

Cathie Vielle

EDQM

View All

Learning Objectives

At the completion of this conference, participants will be able to:

Understand the roles of pharmacopeias, regulators, and the bio/pharmaceutical industry in maintaining the supply chain and avoiding drug shortages.
Understand how information is shared – the role of social media and other communications.
Understand the potential benefit and challenges of pharmacopeial standards, including global pharmacopeial convergence/harmonization for the quality and supply of medicines.
Recognize progress toward the development of new treatments, including compounded drugs and unlicensed medicines, re-purposing of existing medicines, discovering new therapies and supportive treatments, and the race to find new preventative medicines/vaccines.
Recognize where we are, what we have done, what we have learned, and where we are going in responding to public health crises.

Registration Fees

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This is a free conference.

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