May 2020
May 2020


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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

Monika Schneider Duke-Margolis Center for Health Policy

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 BioMarin

Young Professionals Editor

Kaley Lugo Medical Affairs, Daiichi Sankyo

DIA Membership

Bringing together stakeholders for the betterment of global health care.

How a Pandemic Accelerated the Adoption of Virtual Trials

Jonathan Cotliar
Science 37
Clinical trial operations worldwide have slowed dramatically during the COVID-19 era, but the adoption of virtual trials has accelerated. A virtual trial doctor explores the transformation.

ike many others, I’ve spent the last four years trying to convince the biopharmaceutical industry that virtual or decentralized trials are the future of drug development. And that, if executed correctly, virtual trials maintain the same level of patient safety and high-quality data that are the cornerstones of traditional, site-based research. Society has arrived at a point at which the powerful mobile device we carry in our pocket—that we use to do everything from ordering our morning cup of coffee to buying a house—can be the tool that dismantles several of the barriers that have historically plagued clinical research.


Latin America’s COVID-19 Regulatory Response

The Challenging Economics of Vaccine Development in the Age of COVID-19, and What Can Be Done About It

Jonathan T. Vu
Brown University
Brown Center for Biomedical Informatics
Benjamin K. Kaplan
QLS Advisors LLC
Shomesh Chaudhuri
QLS Advisors LLC
Monique K. Mansoura
The MITRE Corporation
Andrew W. Lo
QLS Advisors LLC
Santa Fe Institute

he recent destructive outbreak of the novel coronavirus, SARS-CoV-2, that emerged from Wuhan, China, and rapidly spread to Europe and North America, demonstrates beyond doubt that emerging infectious diseases (EIDs) are a clear and present danger to the world and its economy.

Uncontrolled outbreaks of EIDs can devastate populations around the globe, both in terms of lives lost and economic value destroyed. Emerging and re-emerging strains of infectious disease have become more diverse over time, and outbreaks have become more frequent. In 2006, Larry Brilliant stated that 90 percent of the epidemiologists in his confidence agreed that there would be a large pandemic—in which 1 billion people would sicken, 165 million would die, and the global economy would lose $1-3 trillion—within two generations. In 2020, this remarkable statement is playing out with each passing day.

Medical Writing: The Language and Art of Scientific Communication

Nimita Limaye
CSOFT Health Sciences

edical writing is a scientific skill that writers deploy to author a multitude of documents addressing the needs of diverse and demanding stakeholders. This requires not only a deep understanding of therapeutic areas, regulations, and document types, but also soft skills such as strong negotiation skills and project management skills. The ability to present data and communicate the desired message is just one of those skills. This article describes different types of writers who author documents aimed at different objectives, including regulatory submissions, publications, safety, and medico-marketing.

Medical writers (MWs) are professionals from diverse backgrounds who address different business needs. Writers hone their skills over the years and master the art of digesting voluminous and complex information and presenting it in a succinct and objective manner. The diversity of the target audience, and thus the distinct differences in the objectives of scientific communication, poses a significant challenge. Balance this with the need to ensure regulatory compliance, prioritize patient safety, and manage the diverse views of multiple stakeholders from diverse therapeutic areas, and the challenge becomes even more daunting. Finally, the writer also needs to have expertise in evolving tools and technologies, deal with different style guides and increasingly complex and diverse document types, and ultimately deliver a strategically thought-out high-quality document on time.


Partnerships Essential to SAHPRA Pandemic Response

Around the Globe

Revised Drug Registration Regulation Brings New Challenges and Opportunities to New Drug Clinical Trials in China
Jianqing Chang
Tigermed Co., Ltd.

n March 30, after six rounds of seeking public comments over the last several years, the State Administration for Marketing Regulation (SAMR) issued the revised Drug Registration Regulation (DRR), which will be put into effect on July 1, 2020. This is not only the first revision since the current version implemented thirteen years ago, but also a revision with significant changes to support enforcement of the 2nd revision of Drug Administration Law and the newly enacted Vaccine Administration Law, both of which became effective on December 1, 2019.

The DRR was formulated by the National Medical Products Administration (NMPA), an agency within the SAMR. In the process of revising the DRR, the NMPA took into consideration the urgency of the unmet medical needs, industry development and input, best regulatory practices, and the remarkable achievements of the regulatory reform launched in 2015 such as the drug MAH (Marketing Authorization Holder) system pilot and the clinical trial approval process, among others.

Around the Globe

New Drug Approvals in China in 2019

Xu Wang
Novo Nordisk (China) Pharmaceuticals Co., Ltd.

Yuanyuan Diao
BeiGene, Ltd.

n 2019, China’s National Medical Products Administration (NMPA) granted marketing approvals to 34 new chemical drugs and 19 biological products. Among the approvals, oncology drugs, anti-inflammatory drugs, and drugs for the immune system are the top three therapeutic areas.

In this article, “new drugs” refer to the innovative chemical and biological products approved for the first time in China and to drugs already approved for marketing outside China but approved for the first time in China.

Around the Globe

COVID-19: Maybe You’ve Heard Of It?
A European Perspective

Thomas Kühler
Sanofi R&D


colleague of mine recently told me she was maybe more overwhelmed by the COVID-19 news flow than by the actual virus itself. This resonated with me. Of course, it is good to learn that her health was not affected by the virus, but the time and effort required to keep abreast of the COVID-19 news flow was well reflected in one word: overwhelming.

Health Authorities around the globe continue to issue numerous guidelines related to managing the COVID-19 pandemic, and there are no signs that the news stream will dry up anytime soon. In the EU alone, many documents have already been issued addressing diverse and wide-ranging topics such as procurement of medicines, how to best conduct clinical trials to generate evidence on COVID-19 treatments, and free scientific advice to stimulate the development of new pharmaceutical principles.


EFPIA Shares Industry View of EMA Regulatory Framework

Around the Globe

Changing the Game in Oncology Development
DIA Global Oncology Development 2020

Eri Sekine
Novartis Pharma K.K.

he world surrounding cancer treatment continues to evolve rapidly. Emerging products now include immuno-oncology drugs and other new regenerative medicine and medical device therapies which further expand therapeutic choices in cancer treatment. Thanks to rapidly evolving digital applications, such as artificial intelligence (AI) and the Internet of Things (IoT), and their impact on clinical trial operations, clinical development in oncology faces both challenges and opportunities in keeping the evaluation of novel therapeutic products simple and reliable.

Contributing to this global tide, DIA Global Oncology Development 2020, co-chaired by Noboru Yamamoto (National Cancer Center Hospital) and Toshihiko Doi (National Cancer Center Hospital East) and convened in Tokyo this past January, was the first DIA Japan workshop to specifically focus on this therapeutic area. Strong energy to innovate, and recognition of difficulties along the path to innovation, were both evident throughout this workshop. New science and technology are already evident in Japan, but it will take collaboration across academia, regulatory, and industry, from basic research to clinical trials, to deliver innovation to patients.

Around the Globe

Ready for the Next Decade of Biosimilar Development in the US
Re-Evaluating the Need for Comparative Clinical Studies
Sue Lim
Insight Biologics

t’s been ten years since the enactment of the Biologics Price Competition and Innovation Act, which created a new approval pathway for biosimilar products in the US. This new pathway was touted as a critical way to provide broader access to cost-effective biological treatments and has contributed to 26 approved biosimilars for nine different reference products as of March 2020. While much has evolved since the legislation was introduced, what has remained relatively constant is the comparative clinical study (CCS) as a necessary gateway to support the approval of biosimilar products. However, with advances in analytical techniques, improved understanding of the relationship between protein structure and function, and an ever-increasing body of global biosimilar experience, it’s time to re-evaluate the consistent need for CCSs in the next decade of biosimilar development.

Thanks for reading our May 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.