March 2021


Love Global Forum‘s new online format? Subscribe today and never miss an issue.

Editorial Board

Content stream editors

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

regulatory science
Isaac Rodriguez-Chavez PRA Health Sciences

Patient engagement
Trishna Bharadia Patient Advocate and Media Contributor
Mary Stober Murray Bristol-Myers Squibb

Monika Schneider Shionogi

Editorial Staff

Alberto Grignolo, Editor-in-Chief Parexel International

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

Jin Shun Sandoz

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

Judith Glennie JL Glennie Consulting, Inc.

Ling Su Shenyang Pharmaceutical University, Lilly Asia Ventures

Thomas Kühler Sanofi R&D

J. Vijay Venkatraman Oviya MedSafe

Ikeda Akiko Janssen Pharmaceutical K.K.

Cammilla Gomes Roche

Ebony Dashiell-Aje BioMarin

Young Professionals Editors

Kaley Lugo Daiichi Sankyo
Saloni Patel Acorda Therapeutics

DIA Membership

Bringing together stakeholders for the betterment of global health care.

Cancer Immunotherapy: Successes and Challenges on the Bumpy Route from Scientific Concept to Clinical Reality

Part 2: Navigating the Road Ahead

Alessandra Cesano
ESSA Pharmaceuticals


art I of this article, published in the February 2021 issue of Global Forum, provided a brief overview of the clinical successes and currently remaining challenges in the field of immune-oncology. The second part of the article discusses considerations for navigating the road ahead in this rapidly evolving field.

Ongoing challenges include the relatively low percentage of refractory solid tumor patients benefiting from monotherapy with these agents, the heterogeneity in primary resistance mechanisms, the inability to accurately predict treatment efficacy and patient response, the development of secondary resistance, and high treatment costs. So where do we go from here?
Inclusive at the Start, from the Top
Improving Inclusive Thinking and Patient Engagement to Boost Clinical Trial Diversity
Clare Grace
Annette Jack
Maimah Karmo
Tigerlily Foundation
Shanda Cooper
Tigerlily Foundation
Lizzie Wittig
Tigerlily Foundation

arely does a one-size-fits-all approach succeed in business, education, or politics, and it should be no different for the delivery of quality healthcare. To ensure everyone has access to safe, effective medications and treatments targeted to each respective population’s needs—regardless of race, ethnicity, gender, age, or socioeconomic status—the treatments we develop must be researched, studied, and evaluated, with representation from diverse populations.

This is critical because ethnicity, gender, age, and disease severity all significantly influence how individuals respond to medications. When studies are conducted and evaluated only in older white males, for example, we cannot extrapolate the impact from these data on Hispanic women, African American men, adolescents, or Asian populations.

The consequences are real: One study revealed that approximately 20 percent of drugs approved within the previous six years had different exposure and/or response among racial and ethnic groups. Yet, despite a renewed push for diversity, most clinical trials conducted today still fail to represent the demographic diversity of populations that drugs aim to serve.

Essentials of EU Regulatory Intelligence Training Course Advertisement


DARWIN EU: Evolution in Europe’s Use of Big Data
Thomas Kuhler
Nikolai Brun
Critical Elements in Communication of Vaccine Trial Results
Ivan S.F. Chan
Pritibha Singh
Jerald Schindler

he COVID-19 pandemic has posed enormous challenges to the healthcare systems and economies around the world. As a result of tremendous public-private partnerships, several vaccines are being developed at an unprecedented speed. Because of the complexity of study designs and interim analysis strategies, it is important that communication of clinical trial results (by, e.g., press release) be as clear as possible so there is a good public understanding of the efficacy and safety of these vaccines.

For example, two mRNA COVID vaccines, one developed by Moderna and the other co-developed by BioNTech and Pfizer, received emergency use authorization (EUA) by the US Food and Drug Administration (FDA) in December 2020 based on interim results from their phase 3 trials. The vaccine codeveloped by AstraZeneca and Oxford University was approved by the UK for emergency use based on interim results of two phase 2/3 trials conducted in the UK and Brazil. Clear and accurate communication of trial results like these is instrumental in building public confidence in new vaccines and supporting the rollout of mass vaccination programs after approval.


Master Protocol Efficiencies Speeding COVID-19 Treatments

Lisa LaVange
Richard Zink

DIA/ FDA Biostatistics Industry and Regulator Forum Advertisement

Around the Globe

Harmonization of GMP Inspection and Benefits to ASEAN Economic Community
Sia Chong Hock
Health Sciences Authority (HSA), Singapore

he ten ASEAN Member States (AMS) have very diverse racial, religious, socio-cultural, political, economic, and geographical backgrounds. Each of these ten AMS faces strong economic competition from other Asian countries and the world at large, especially those with bigger geographical size and population – e.g., South Korea (50 million), Japan (130 million), the two Asian giants India (1.3 billion) and China (1.4 billion), and further away in the western world, the US (300 million) and the EU (450 million). But collectively as a ten-member group, ASEAN is not small.

ASEAN inspectorates are aware that no regulatory authority in this globalized world can work in isolation. The way forward is collaboration, collaboration, and MORE collaboration with ALL stakeholders for a win-win-win outcome: a win for these regulators, a win for the industry, and a win for patients!

Around the Globe

Australia Aligns with WHO, ICMRA & Access Consortium for COVID-19 Products
Richard Day
University of New South Wales

he early months of 2021 have been in stark contrast to those same months in 2020 where much of Australia was ablaze from destructive, devastating, and unprecedented bush fires. Through the La Niña effect, our summer (when the country tends to “shut up shop”) has been wetter, cooler, and, at least on the eastern seaboard, there have been fewer fires. Sadly, Perth, Western Australia has recently lost many homes due to fire, reminding us of the escalating impacts of climate change.

DIA Direct webinar Advertisement

Around the Globe

Canadian Federal Consultations: National Strategy for Drugs for Rare Diseases
Judith Glennie
JL Glennie Consulting Inc.

n January 27, 2021, Health Canada launched a consultation on the development of a National Strategy for High-Cost Drugs for Rare Diseases. The consultations (open until March 26, 2021) are intended to engage Canadians and invite them to share their ideas and views on what a national strategy could look like. The foundation of the consultations is a discussion paper describing key considerations and questions for developing a national strategy for high-cost drugs for rare diseases. Feedback is being solicited through an online questionnaire, written submissions, and/or participation in virtual public town halls.

Around the Globe

Are Antidiabetic Drugs Safe in the Long Term?
Clinical and Research Perspectives from India
V. Mohan
Diabetes Specialities Centre and Madras Diabetes Research Foundation
This report shares the perspective of a physician who has been practicing in diabetes for more than forty years on the safety of various anti-diabetic drugs that have been used for several decades in millions of patients.

n India, it is generally believed that modern scientific medicines (or “allopathic medicines,” as scientific medicines are called in India) in general–and anti-diabetic drugs in particular–have a lot of side effects and hence should not be taken for long periods of time. I have never really understood how this false belief came about, but it’s quite deeply entrenched in our community. This probably stems from the fact that the ancient Indian systems of medicine such as Ayurveda and Siddha use plant based/herbal products which people perceive to be “safe.” On the other hand, many of these same people believe that modern scientific medicines are believed to be “chemicals” which can cause side effects, if taken for years. Few people realize that plants are also chemicals and that, conversely, many modern scientific medicines are derived from plant products.

Diversity, Equity, and Inclusion in the Drug Development Lifecycle Meeting Advertisement

Around the Globe

Accelerated Regulatory Assessment of Innovative Medicines in Latin America
Ana Padua
EMD Serono

he Latin America region offers a number of registration pathways to accelerate the regulatory assessment of innovative medicines. As the authors of the recent publication Registration pathways to accelerate regulatory assessment of innovative medicines in Latin America in the Journal of Public Health Policy (JPHP), we conducted and published an extensive review of regulatory information collected from 2017 to 2019 for nineteen Latin America (Latam) countries by characterizing the regional regulatory scenario related to accelerated registration pathways and identifying similar opportunities for countries in Latin America. Those findings published in JPHP are summarized here.

Around the Globe

NAVREF: Prioritizing Clinical Research Partnerships at the US Department of Veterans Affairs
Rick Starrs
National Association of Veterans’ Research and Education Foundations (NAVREF)

he US Department of Veterans Affairs (VA) is the largest integrated healthcare system in the US. VA delivers care to more than nine million enrolled Veterans at 1,255 healthcare facilities, including 170 VA medical centers and 1,074 outpatient sites of care of varying complexity. This makes the VA system a highly attractive environment for the conduct of clinical research and clinical trials, and a valuable research partner for the biopharmaceutical industry.

The size, scope, and quality of VA research is impressive:

VA Research – By the Numbers

  • 79 VA-affiliated non-profit research corporations
  • >60% of VA researchers also provide direct patient care
  • ~70% of the country’s healthcare providers receive medical training at a VHA facility
  • > 100 research sites nationwide
  • >3,500 active principal investigators
  • >7,000 active funded research projects
  • > 10,000 published research articles each year
  • ~ $2 billion annual research budget

But these numbers, as usual, only tell part of the story.

DIA Global Annual Meeting 2021 Advertisement
Thanks for reading our March 2021 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.