July 2022
July 2022 Global Forum

Table of Contents


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Editorial Board

Content stream editors

Translational science
Gary Kelloff US National Institutes of Health
Ilan Kirsch Adaptive Biotechnologies Corp.

regulatory science
Isaac Rodriguez-Chavez ICON plc

Patient engagement
Trishna Bharadia Patient Advocate and Media Contributor
Mary Stober Murray National Minority Quality Forum

Editorial Staff

Alberto Grignolo, Editor-in-Chief Parexel International

Sandra Blumenrath, Managing Editor, Scientific Publications 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

Ling Su Shenyang Pharmaceutical University, Lilly Asia Ventures

Julie O’Brien Pfizer

J. Vijay Venkatraman Oviya MedSafe

Ozawa Goshi Real Discovery Outdoors Co,. Ltd.

Cammilla Gomes Roche

Ebony Dashiell-Aje BioMarin

Young Professionals Editor

Kaley Lugo Daiichi Sankyo

DIA Membership

Bringing together stakeholders for the betterment of global health care.

Meeting Highlights: DIA Europe 2022

Meeting Highlights from DIA Europe 2022

Meeting Highlights: DIA Europe 2022

clipart of a globe with a play button on it
Patient Engagement Action Plan
Seven Steps to Move the Needle
Dimitrios Athanasiou
European Patients’ Forum World Duchenne Organization

Annette Bakker
Children’s Tumor Foundation Europe

Nicholas Brooke
The Synergist

Melanie Carr

Magda Chlebus

Sharon Gorman

Álmath Spooner


nvolving patients in drug development and decision making drives efficiency and ensures that new therapies address the real needs of patients. Industry, regulators, research foundations, and patients are actively working to improve the use of meaningful patient experience data in this process, but more action is needed. An interactive session at DIA Europe 2022, co-hosted by the European Federation of Pharmaceutical Industries and Associations and the European Patients’ Forum, explored how the system can be optimized by placing the patient and patient experience data at its center.

White Paper

Three Challenges Facing Study Start Up and the Low-Code Automation Solution

White Paper

Three Challenges Facing Study Start Up and the Low-Code Automation Solution

The life sciences industry has been exploring ways to accelerate the study start up (SSU) process to get products to patients who need them faster for quite some time. However, managing the complex SSU process end-to-end, from study award to first patient in, can be lengthy and complicated. Read this white paper to see how a low-code automation platform can help the study start up and the life sciences product lifecycle, including:

  • Sharing source data
  • Initiating handoffs between functional areas
  • The swivel chair effect.

Around the Globe

Progress Toward African Medicines Agency and Vaccine Manufacturing in Africa
David Mukanga
Bill and Melinda Gates Foundation

African Medicines Agency (AMA)


ince the minimum number of 15 ratifications by African Union (AU) countries was reached to establish the AMA in November 2021, the AU has stepped up efforts, through the African Union Commission and the African Union Development Agency, to prepare for the opening of the AMA Secretariat. They have developed a joint workplan, with elements including a continued push for further ratification by additional countries, developing an AMA roadmap for the first year and subsequent years, setting up AMA’s core activities and detailed procedures, and developing AMA business processes (including enterprise resource planning).

Around the Globe

EU Mobilizes Cooperation with the African Medicines Agency
Victoria Palmi Reig
Béatrice Durvy
Martin Harvey Allchurch
International Affairs, European Medicines Agency

n February 15, 2022, the European Union (EU) announced that Team Europe—the European Commission, the European Medicines Agency (EMA), and EU Member States Belgium, France, and Germany—and the Bill & Melinda Gates Foundation will mobilize more than €100 million over the next five years to support the recently established African Medicines Agency (AMA) and other African medicines regulatory initiatives at regional and national levels.

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Around the Globe

Accelerating Use of Healthcare Data
Asia-Pacific Digital Health and Data Consortium
Fabio Bisordi, Gracy Crane, Finny Liu
Roche Pharmaceuticals
Dorothee Grimaldi
Merck Sharpe and Dohme
Ellen Sem, Vicky Han
Johnson & Johnson
Helene Sou
ADDC Consortium

group of industry partners have formed the APAC Digital Health and Data Consortium (ADDC) to serve as a platform for collaboration between industry and other organizations such as policy think tanks and regulators to shape digital health data frameworks in the APAC (Asia-Pacific) region.

Over the past few years, we have observed several notable shifts in the potential to deliver patient-centered healthcare across the world. First, we have seen the rapid rise in the use of digital technologies in various areas of our lives, including digital healthcare (which combines ways of addressing healthcare needs by digital technology). This is specifically a fast-growing area across Asia, created by the opportunity to use digital health technologies, or DHTs (as defined by the FDA), and solutions to address chronic disease, aging, and other population healthcare issues.

Around the Globe

Australia’s New Clinical Trials Activity Initiative
Focus on Rare Diseases and Cancers
Richard Day
University of New South Wales

n March 2022, the Australian Government announced the Clinical Trials Activity initiative. This initiative will support national and international clinical trials of new treatments, initially focused on rare cancers and diseases as well as unmet medical needs, and aims to attract investigator-led, international clinical trials in any disease facing unmet need. It has been funded through the Medical Research Future Fund (MRFF), a $20 billion (AUD) long-term investment supporting Australian health and medical research that has transformed health and medical research in Australia since its inception in 2015.

Around the Globe

India Moving Toward Patient-Centric Healthcare
The National Patient Safety Implementation Framework
Arshia Bhandari
PhVFIT, India

n April 2018, the India Ministry of Health and Family Welfare launched the National Patient Safety Implementation Framework 2018-2025 (NPSIF), a comprehensive guideline and roadmap toward strengthening the safety of patients in India that also aligns with India’s goal of universal health coverage by 2030.

Prepared after extensive research by experts, the NPSIF outlines the gaps, scope, and way forward for strengthening patient safety in India through a seven-year plan that outlines strategic objectives and a communication strategy to implement the framework at all levels of healthcare in India. Six strategic objectives, clearly defined with 21 priorities and 81 interventions, address implementation of this framework.
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Around the Globe
Regulatory and HTA Landscape in Latin America
What are the Needs, Challenges, and Opportunities?
Hector Castro

ecision making in healthcare is a complex process that takes place along a continuum that moves from evidence generation to evidence review and deliberation, to decision making, and to communication of decisions made. In many low- and middle-income countries (LMICs), this process is often not systematic, deliberative, or transparent. This article highlights the links between Health Technology Assessment (HTA) and regulatory practices, including harmonization and collaborative efforts, in Latin America.


What We Are Missing by Not Including “Who?”
In April 2022, FDA issued new draft guidance on Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Subgroups in Clinical Trials. Because this guidance applies to all medical products, CDER, CBER, and CDRH all contributed, but this draft was led by Project Equity from FDA’s Oncology Center of Excellence (OCE). “It is important that we be able to evaluate new therapies in the context of a diverse population that will use these medical products because the diseases for which these products are intended present in variable fashion across the population and because populations respond variably to medical products,” explains OCE Project Equity Lead Lola Fashoyin-Aje. “But we should reconsider the question regarding why diversity in clinical trials is important. Because the question really ought to be: What are we missing when trials are not diverse, when the study population in the clinical trial is not diverse? What are the missed opportunities for advancing science or advancing clinical medicine and, ultimately, for driving improvements in population outcomes?”
We Are DIA: Community Report
RIM Reference Model: Improving Efficiency, Compliance, and Interoperability
V. “Bala” Balasubramanian
Orion Innovation
Vanessa Brewer-Yizar
Gan & Lee Pharmaceuticals USA Corp
Joel Finkle
BeiGene Corp
Vahe Ghahraman
Apellis Corp
Don Palmer
Patterson Shafer
FTI Consulting
Cary Smithson
Vahe Ghahraman
Apellis Corp
Don Palmer
Patterson Shafer
FTI Consulting
Cary Smithson
DIA RIM Working Group

The Dilemma

Regulatory affairs is evolving from a document-centric to a data-centric practice. Historically, companies have tracked and managed registrations, submissions, health authority interactions, release requirements, variation impact assessments, and other key regulatory activities through spreadsheets, homegrown systems, or data hidden in documents. There is increasing emphasis on global marketing of products; the need to comply with changing global regulatory requirements increases volume and complexity of information. Managing this new reality in traditional ways is not sustainable.
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We Are DIA
DIA Welcomes New Fellows
Congratulations to Global, EMEA, and Americas Regional 2022 Inspire Award Winners

New Fellows of DIA

Lingshi Tan headshot
Lingshi Tan (Chair)
Chairman and CEO
Zili Li headshot
Zili Li
Vice President, Head of Asia Pacific R&D
Janssen Research & Development, LLC
Craig Lipset headshot
Craig Lipset
Founder and Advisor
Clinical Innovation Partners
Agnes Saint Raymond headshot
Agnès Saint-Raymond
Head of International Affairs, Head of Portfolio Board
European Medicines Agency
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Thanks for reading our July 2022 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.