October 2020
October 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 Shionogi

Editorial Staff

Alberto Grignolo, Editor-in-Chief Parexel International

Ranjini Prithviraj, Global Associate Director, Content Collaboration DIA Scientific Communications

Sandra Blumenrath, Science Writer DIA Scientific Communications

Chris M. Slawecki, Senior Digital Copyeditor DIA Scientific Communications

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.

Cammilla Gomes Roche

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.

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Antibody-Drug Conjugates: Simple Idea, Complicated Matter

Haleh Saber
John K. Leighton
Office of Oncology Disease, Division of Hematology Oncology Toxicology

ntibody-drug conjugates (ADCs) are a class of pharmaceuticals that consist of small molecule drugs (also known as payloads) covalently attached to an antibody via a linker (1,2). While the majority of these products are in oncology, occasionally they are used in non-oncology indications, such as in rheumatoid arthritis (3) and infectious diseases (4). This review will discuss the use of the current generation of ADCs in oncology (i.e., ADCs that contain cytotoxic payloads) and excludes any discussion on conjugated products containing toxins, such as moxetumomab pasudotox (5). Additional information is available in ICH S9 Guidance and ICH S9 Questions and Answers for nonclinical development of ADCs in oncology (6,7) and in ICH S6 Guidance for nonclinical development of biotechnology-derived products (8).

Opportunity in a Crisis: Demographic Inclusion in Clinical Trials

The Challenge of Health Disparities and Clinical Trial Participation

Jonca Bull
PPD Consulting

he race is on—at what is called Warp Speed—to drive urgently needed innovation in addressing the worst crisis in public health of our generation. The coronavirus pandemic has also shined a harsh light on the impact of underlying health disparities. The summer of 2020 highlighted a growing body of public health data demonstrating stark disparities in deaths due to COVID-19 in African Americans and Hispanics. The social determinants of health are clearly a factor: high-density urban environments, poverty, jobs that do not allow working from home, and lack of access to PPE (Personal Protective Equipment). But underlying health conditions, co-morbidities of underlying chronic diseases well known as health disparities, have also been identified as major contributing factors.

Alzheimer’s Disease Early Detection – How Do We Make the Important More Urgent?
Phyllis Barkman Ferrell
Eli Lilly & Company

lzheimer’s disease (AD) is a relentless, fatal disease creating a health crisis for patients, families, and nations worldwide. And while it is not ebola or coronavirus in its speed, rest assured, it is deadly. As our global population ages, this disease, which is crippling families today, will crush our national economies and handicap our global workforce in ways that are immeasurable. With an estimated 44 million people living with dementia worldwide, this is a truly global crisis. However, while solutions must cut across sectors and nations, due to the variability of healthcare systems, solution implementation and policy recommendations will need to be locally understood and supported.

Current AD treatment options are limited to symptomatic treatment and they do not work for everyone. Alzheimer’s is the only one of the top six diseases affecting Americans where there is no treatment to prevent, cure, or slow the disease. And although NIH funding has increased ten-fold over the last several years, the path to a treatment is slow and arduous. While the scientific hurdles are steep, they are only part of the challenge in Alzheimer’s disease. Our current healthcare systems are ill-equipped to deliver improved patient outcomes today and will not allow new therapies to efficiently reach the patients that will benefit most in the future.


Biosimilar Savings and Their Price: BPCIA Turns Ten
Gillian Woollett
Anna Rose Welch
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Toward Greater Diversity and Inclusion in COVID-19 Clinical Trials

As a response to the current pandemic, and with the support of the DIA Knowledge Brigade, we have brought together experts from across the global healthcare product development continuum for an ongoing series of live, virtual panel discussions on how we continue to work towards our shared mission of accelerating therapies to patients, during the coronavirus crisis. Watch Toward Greater Diversity and Inclusion in COVID-19 Clinical Trials below now.

For other webinars in this DIA DIRECT COVID-19 Webinar Series, please visit our COVID-19 Resource Center.

Around the Globe

Post-COVID Medicine Shortages and Product Information Reform Continue in Australia
Richard Day
University of New South Wales

ustralia’s Deputy Secretary for Health Products Regulation in the Department of Health John Skerritt has noted that in addition to managing significant increases in submissions of COVID-19 tests, disinfectants and personal protective equipment, and discussions with companies and researchers around potential and accelerated regulatory submissions for COVID-19 vaccines, the Therapeutic Goods Administration (TGA) has had a very busy time since the COVID-19 pandemic landed on our shores. These initiatives include managing the surge in medicines shortages since the COVID-19 crisis and continued reform in the product information, linked to the consumer medicines information, provided for over-the-counter medicines.

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Around the Globe

Pathway to Patient Access to CAR-T Therapies in Canada

Judith Glennie
JL Glennie Consulting Inc.

he first two chimeric antigen receptor T-cell (CAR-T) therapies were approved for the Canadian market in September 2018 (Kymriah) and February 2019 (Yescarta). They represent a unique approach to treatment that challenged Canada’s standard health technology assessment (HTA) and reimbursement pathways. The innovation they represent demanded reciprocal innovation in how these products were evaluated by HTA bodies and managed by payers.

This article overviews the introduction of CAR-Ts into the Canadian environment and adjustments in HTA processes and closely managed access to these products that may provide lessons for future highly specialized therapies.

Around the Globe

NMPA Moves ICH E2 Forward in China
Key Points of the “Good Safety Information Evaluation and Management Practice during Drug Clinical Trials”

Howe Li

ver the past two years, the Chinese National Medical Products Administration (NMPA) has aggressively implemented a series of ICH E2 guidances. On July 1, 2020, the Center for Drug Evaluation (CDE) of NMPA issued the “Good Safety Information Evaluation and Management Practice during Drug Clinical Trials” (hereinafter referred to as “Practice”); it was effective immediately on a trial basis.

It’s noteworthy that the guidances “Good Clinical Practice,” “Good Management Practice for Development Safety Update Report,” and “Good Practice for Drug Clinical Trial Registration and Information Disclosure” were also effective on the same day. It was a clear indication that the Chinese Regulatory Authority is vigorously standardizing the practice of clinical trials conducted in China, and that it is providing more detailed and instructive guidance to all parties involved in clinical trials.

Around the Globe

Personalized Healthcare in Latin America: The Future of Care
Federico Augustovski
Institute of Clinical and Health Effectiveness, Argentina
Veridiana Cano
Alan Lovell
Economist Intelligence Unit
Gabriel Riveros
Ex Health Minister, Colombia
Clarissa Mathias
President, Brazilian Society of Medical Oncology

ealthcare systems are under intense strain due to aging populations, increased prevalence of chronic diseases, and resource constraints. At this same time, the convergence of medical knowledge, technology and data science brings the potential to revolutionize healthcare. The delivery of care is shifting from the “one-size-fits-all” approach to the application of the right treatment for the right patient at the right time—so-called “Personalized Healthcare.”

In their report “Personalized Healthcare in Latin America: Universalising the Promise of Innovation,” the Economist Intelligence Unit describes the current state, barriers, enablers, and opportunity areas of personalized healthcare across nine countries: Argentina, Brazil, Chile, Colombia, Costa Rica, Ecuador, Mexico, Peru, and Uruguay. To fulfill the potential of personalized healthcare—better patient outcomes with more efficient delivery of care—healthcare systems must evolve in these countries, and the scale of change is significant. It will require strong collaboration among different stakeholders and an integrated approach that interconnects fundamental building blocks to create an ecosystem in which care is tailored to individual needs. The EIU report sets a call to action to policy makers. But is Latin America ready for Personalized Healthcare?

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Thanks for reading our October 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.