March 2020
March 2020

March 2020 Global Forum

Table of Contents


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Editorial Board

Content stream editors

Translational science
Gary Kelloff US National Institutes of Health
David Parkinson ESSA Pharma, Inc.

regulatory science
Yoshiaki Uyama Pharmaceuticals and Medical Devices Agency (PMDA)
Adora Ndu BioMarin Pharmaceutical, Inc.

Patient engagement
Deborah Collyar Patient Advocates In Research (PAIR)
Lode Dewulf Servier

Editorial Staff

Alberto Grignolo, Editor-in-Chief Parexel International

Ranjini Prithviraj, Global Associate Director, Content Collaboration DIA Publications

Sandra Blumenrath, Science Writer DIA Publications

Chris M. Slawecki, Senior Digital Copyeditor DIA Publications

Regional Editors

David Mukanga Bill and Melinda Gates Foundation

Silke Vogel Duke-National University of Singapore Medical School

Richard Day University of New South Wales, Medicine, St. Vincent’s Hospital

Judith Glennie JL Glennie Consulting, Inc.
Megan Bettle Health Canada

Ling Su Shenyang Pharmaceutical University, Lilly Asia Ventures

Thomas Kühler Sanofi R&D

J. Vijay Venkatraman Oviya MedSafe

Akiko Ikeda Janssen Pharmaceutical K.K.

Inas Chehimi Novartis

Ebony Dashiell-Aje FDA

Young Professionals Editor

Kaley Lugo Medical Affairs, Daiichi Sankyo

DIA Membership

Bringing together stakeholders for the betterment of global health care.

Chinese Health Authorities, Pharmaceutical Industry, and Healthcare Professionals Race against Time

Fighting Coronavirus Disease 2019 (COVID-19) Epidemic

Sophia Duan
PPC China
Photo courtesy of CDC/Alissa Eckert, Dan Higgins

he Coronavirus Disease 2019 (COVID-19) caused by the coronavirus SARS-CoV-2 (previously known as 2019-nCoV), first identified in Wuhan City in the Hubei Province of China, has led to more than 79,000 cumulative confirmed cases of human infections and at least 2,900 deaths in China (as of March 1, 2020). It has also spread quickly to more than 60 countries beyond China. In China, a series of powerful measures were taken to contain the spread of COVID-19, including the early identification and quarantining of infected patients. Chinese health authorities, pharmaceutical companies, and healthcare professionals are also responding quickly and working around the clock to accelerate the research and development of products for the identification, prevention, and treatment of COVID-19.

Hand-In-Hand with Companion Diagnostics: The Past, The Present, The Future

Elizabeth Mansfield
Elizabeth Mansfield IVD Consulting

ompanion diagnostics are a class of diagnostic devices that has become important not only in personalizing therapy for patients, but also for developers of therapeutic products, who must now consider not only development of the drug or biologic, but also development of a diagnostic test to identify or manage patients who use the therapeutic product.

The US Food and Drug Administration’s (FDA) companion diagnostic policy has created opportunities and issues that require resolution and continued policy development, especially as technological innovation paves the way for new and powerful tests to be developed. Practical issues, such as utilization and payment, also require attention in order to make personalized medicine approaches successful.


RIM Accelerating Efficiencies in Regulatory Pathways

Safety is No Accident
Snapshots of DIA 2020 Pharmacovigilance and Risk Management Strategies Conference

Wayne Pereanu
Science Writer

IA’s 2020 Pharmacovigilance and Risk Management Strategies Conference included thirteen sessions that describe the current regulatory environment as well as primary sources of risk. The sessions, together with a keynote talk by Steven Murray (Exponent), provide a foundation for making informed and up-to-date decisions in a pharmacovigilance program.

Key Takeaways

  • New ICH and CIOMS programs are underway to address evolving issues related to patient engagement and safety data collection.
  • The global regulatory framework for pharmacovigilance has evolved in different regions independently and consequently exhibits a regional focus on different areas of safety and pharmacovigilance practice.
  • The regulatory context surrounding risk management tools, such as REMS and RMPs, continues to evolve in a regional manner, making global risk management a challenging endeavor.
  • Current research findings on topics such as DILI and alloCAR-T therapies will have an impact on the benefit-risk analysis associated with these therapies.
  • Several pharmacovigilance approaches are being pursued to help address the growing concern of medication errors.
  • Regulatory safety assessment is making growing use of real-world evidence using novel approaches.


Risk Inherent in Benefits of Drug/Device Products?

Around the Globe

Pharmacovigilance and Risk Management Strategies in Asia 2020
Updates from China, India, and Japan
E. Stewart Geary
Eisai Co. Ltd., Japan
Rie Matsui
Pfizer R&D, Japan
J. Vijay Venkatraman
Oviya MedSafe, India
Stella Xu
dMed, China

IA’s recent Pharmacovigilance & Risk Management Strategies Conference 2020 opened with experts providing Asia Region Updates from India, Japan, and China, in a session chaired by DIA Fellow E. Stewart Geary and summarized in this report.


Relevance Will Put Europe on Investment Fast Track
Joep Muijrers

Around the Globe

European Regulatory Network Piloting New Regulatory Tool
Simultaneous National Scientific Advice
Thomas Kühler
Sanofi R&D

he significance that sponsors place on soliciting input on their development projects from regulators is evidenced by the steadily growing number of Scientific Advice procedures given by, for instance, the European Medicines Agency (EMA) or US Food & Drug Administration (FDA). Indeed, EMA reported they granted 466 Scientific Advice and follow-up requests in 2018 (the 2019 report has not yet been published) compared to 264 in 2008.

Several studies have shown that (innovative and novel) therapeutic principles will have a higher chance of meeting regulatory requirements, and hence be approved, when the sponsor has sought and obtained Scientific Advice. Hence, Scientific Advice does ultimately benefit society and patients by making a broader pharmaceutical armamentarium available, delivering value beyond regulators and sponsors.


EU Business and Data Needs Converge Through Telematics

Around the Globe

Development and Practical Use of Cell and Gene
Therapy Products

4th DIA Cell and Gene Therapy Products Symposium in Japan
Akiko Ikeda
Jansen Pharmaceutical K.K

he development of regenerative medicines such as cell and gene therapy products was accelerated in Japan by new regulatory and legal systems that came into effect in 2013 and it continues to attract considerable international attention in not only scientific journals but in more general publications. Reports on these development advancements have revealed numerous challenges in the development, distribution, and post-market management of these products.

Since 2016, DIA Japan has convened an annual symposium to help local and global product developers address these challenges. Its agenda has been updated each year to reflect scientific progress in each stage of development, and to articulate global development strategies for these novel therapeutics, culminating in the recent 4th DIA Cell and Gene Therapy Products Symposium held in December 2019 in Tokyo.

Community Spotlight

New Advanced Therapy Community Launching in June

Kirsten Messmer
Richard Dennett

IA is launching a new Advanced Therapy Community for cross-functional discussion of advanced therapy product development from experimental inception through pre-clinical and clinical development, marketing, and beyond. These promising therapies face unique challenges that are often a combination of issues at different functional levels of the overall development program.

Advanced therapies, which include gene and cell therapies as well as tissue engineered products, have appeared as very promising treatments with many highlighted for their ability to provide a curative effect upon only one application. In recent years, the advanced therapy sector has experienced rapid growth due to the increased interest and development activities. In October 2019, the Alliance for Regenerative Medicine reported growth in clinical trials investigating regenerative medicine products from 2014 to 2018 at 32 percent globally. According to a forecast by BIS Research, the 2018 cell and gene market was valued at more than US$ 1 billion and is expected to grow to approximately US$ 10 billion by 2025, with compound annual growth rate (CAGR) predicted to be more than 36 percent in the forecast period (2019 – 2025).

Career Column

Delivering Effective Presentations: Keeping Your Audience Engaged

Nidhi Bhattacharyya

t the beginning of 2019, I walked into the most challenging and intimidating presentation of my life. At that time, I was vying for a fellowship in the pharmaceutical industry and competing against hundreds of pharmacy students from across the country. I was almost at the finish line: After going through four grueling rounds of interviews, I was one of the top candidates. My last and most important step was to deliver a 30-minute presentation.

This was my golden opportunity to distinguish myself and my abilities among some of the top leadership in the company. This could clinch the fellowship of my dreams and jumpstart my career.

But my excitement for this opportunity was also couched by fear: How am I going to stand out? How can I make sure people will remember me?

As I found myself seeking answers to these questions, I searched for guidance from well-known motivational speakers, leaders across all major industries, and most importantly, friends and mentors with considerable leadership experience.

Here’s what I found.

Thanks for reading our March 2020 Issue!
Views and opinions expressed in Global Forum are those of the authors alone and do not necessarily represent those of DIA or any other agency, organization, employer, or company. DIA does not guarantee the accuracy or completeness of any information published in Global Forum and will not be responsible for any errors, omissions, or claims for damages, including exemplary damages, arising out of use, inability to use, or with regard to the accuracy or sufficiency of the information contained in Global Forum.