June 2023


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
Ilan Kirsch Adaptive Biotechnologies Corp.

regulatory science
Isaac Rodriguez-Chavez Independent Consultant

Patient engagement
Chi Pakarinen MediPaCe
Natasha Ratcliffe COUCH Health
Thomas Smith Independent Patient Consultant

Data and Digital
Lisa Barbadora Barbadora Ink

Young Professionals Editor

Kaley Lugo Daiichi Sankyo

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

Linda Felaco, Copy Editor and Proofreader

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

DIA Membership

Bringing together stakeholders for the betterment of global health care.

A New Tool to Assess Patient Engagement Efforts Across Organizations
Jennifer Kim
Tufts University
Ellyn Getz
CSL Behring
Valerie Fraser
Patient & Research Advocate
Keri McDonough
Syneos Health
Maria Paula Bautista Acelas

atient engagement is defined as inspiring and mobilizing stakeholders beyond clinical research professionals, including patient advocacy groups, healthcare providers, and policy makers, to amplify and incorporate the patient voice in the development and delivery of new medical treatments. While efforts have been undertaken to incorporate the patient voice, the patient engagement movement has remained aspirational and tokenistic. Though there have been calls to grow the patient engagement movement, the number of trials reporting patient engagement remains extremely low. This article briefly discusses the reasons driving this gap and presents potential solutions that organizations can incorporate into their strategies to engage patients.

Addressing Cancer Health Disparities in Latinos via Clinical Trials
Jorge Gomez
Center for Genomic and Precision Medicine, Texas A&M University

ealth disparity is defined as the unequal burden of disease in a population due to race, ethnicity, gender, education, socioeconomic status, disability, geographic location, sexual orientation, or cultural or religious beliefs. In this article, the term Latino includes individuals that migrated from Mexico, Central, and South America, and from Latino members of the Caribbean population. These individuals have a diverse racial makeup and heterogenous genetic ancestry that must be considered when studying Latino populations at various levels including clinical trial outcomes.

PHUSE’s Educational Videos on Data Privacy and Data Sharing in Clinical Trials
The Power of Collaboration in Enhancing Health Literacy and Making Information Accessible to All
Devaki Thavarajah
PHUSE Data Transparency Working Group
Deborah Collyar
Patient Advocates in Research (PAIR)

here is increasing interest in data privacy and data sharing in clinical trials, and most publicly available information is targeted toward individuals with training, experience, or expertise in these areas. In response to the increased misinformation and misconceptions in society about clinical trials during the global pandemic, PHUSE—a global community of data science professionals, founded under the acronym Pharmaceutical Users Software Exchange—began a collaborative project to produce a video series focused on creating engaging content organized into logical sections in the form of bite-sized videos.

New members are welcome to join at any time during the lifecycle of this project and contribute their ideas to make their mark in this exciting initiative. This video series includes an introduction and six short videos covering frequently asked questions by the general population (any member of the public regardless of their sector or profession) about data privacy and sharing in clinical trials. Learnings from the co-creation and user testing processes of the first two finalized pilot videos will be applied to the development of the next ones in the series. Pilot videos are embedded in this article.
Meeting Highlights: DIA Europe 2023
Advancing Use of Patient Evidence in Decision-Making
Magda Chlebus
Jan Frich
Norwegian Institute of Public Health
Jan Geissler
WECAN: Workgroup of European Cancer Patient Advocacy Networks
Juan Garcia Burgos
Virginie Hivert
Álmath Spooner

he task of promoting the generation and use of meaningful patient-generated data in drug development is a shared one. An interactive DIA Europe 2023 session concluded that collaborations between regulators, industry, academia, and patient advocates will drive patient-focused medicines development.

Meeting Highlights: DIA Europe 2023
Regulatory Reliance in Action Making a Difference for Patients
Regulators and Industry Come Together to Discuss Practical Solutions
Angelika Joos
Susanne Ausborn
Reliance* is considered the hallmark of a modern, efficient regulatory framework and a 21st century regulatory tool. (See Annex 10 page 243 of this WHO report.) Yet many roadblocks still need to be removed to bring reliance into action around the world and at the same time streamline the different pathways established over the last 20 years. Senior regulatory experts representing health authorities from all around the world joined industry representatives at a DIA Europe 2023-affiliated workshop to discuss more effective and efficient information sharing to enable risk-based reliance reviews, the interpretation of product sameness, and the impact of the diverging country-specific requirements which are not necessarily justified from the point of view of modern regulatory science. This open dialogue and experience sharing increased the mutual understanding between different stakeholders and identified concrete next steps to bring reliance into more widespread practice.
Special Section: Digitization and Digitalization
How Generative AI May Transform Content Development in the Life Sciences
Tarun Mathur
Sameer Lal

ecently, Generative artificial intelligence (AI) has emerged as a popular technology that has taken the world by storm. As a prime example, ChatGPT had already crossed 100 million users in January 2023, setting a record in just two months.

Special Section: Digitization and Digitalization
Pitfalls and Possibilities: EHRs to RWD via EDC
A Conversation with Terry Katz

t’s been more than five years since FDA issued its first regulatory approval using real-world evidence (RWE), a new indication for a medical device approved exclusively based on data from the electronic health records (EHRs) of patients who actually used the product in “real life” instead of data from randomized clinical trials. This approval was heralded as the onset of a new era in drug and medical device development and regulation: the systematic use of RWE based on data (real-world data, or RWD) from actual use.

Repurposing and analyzing EHR data for clinical research seems logical and productive. But the adage that “no opportunity comes without challenges” has proven especially pertinent here.
Special Section: Digitization and Digitalization
Seven Best Practices for Adopting a Clinical Data Workbench
Pavel Burmenko
Veeva CDB

n recent years, the data workbench has emerged as a powerful tool for aggregating and reviewing data from multiple study sources. The data workbench—often called the clinical data platform—reduces cleaning cycle times and speeds the preparation of analysis-ready data. With 87% of sponsors and CROs deploying decentralized clinical trials and the volume and variety of non-EDC data expanding, the need for consolidated data management and review will only intensify.

This article explains seven best practices for adopting a modern data workbench solution. But we must first understand the true root of the problem.
Special Section: Digitization and Digitalization
Data Analytics Could Enable Trial Diversity and Meet New Regulations
Rohit Nambisan

ttempts at improving diversity, equity, and inclusion (DEI) access across US healthcare is a much-welcomed, if not long-overdue, development in recent years. Substantive DEI legislation was signed into US law in December 2022 (and went into effect in February 2023), helping to correct significant disparities (explained below) and holding sponsors responsible for ensuring that their trials include participants from diverse groups. As we learned from vaccine development during the pandemic, clinical trials must address diverse participant populations to determine the real-world impacts on safety and efficacy for novel therapies. Data analytics tools can help.

Special Section: Digitization and Digitalization
Digital Transformation is Much More Than a Noun
Act Today for Modern Collaboration Tomorrow
Maria Barhams Sagoua
Ashley Jones-Mitchell
Allison Mari
Jack Quigley
Accumulus Synergy


ransformation is defined in the Cambridge Dictionary as “the process of changing completely the character or appearance of something in order to improve it.” This definition will also tell you that transformation is a noun — but it is much more. As industry continues to extend the frontiers of science, the interactions and information exchange between regulators and the regulated is relatively unchanged. A paradigm shift from a document-centric mindset to a data-driven approach is needed to get therapies to patients more quickly and efficiently. It is time to turn digital transformation into a verb by reimagining the way these entities collaborate and exchange data.

DIA Congratulates EMEA and Americas 2023 Regional Inspire Award Winners

Our 2023 EMEA Regional Inspire Award Winners

Portrait photograph headshot of Tony Humphreys (European Medicines Agency) smiling
Outstanding Contribution to Health Award
Tony Humphreys
European Medicines Agency
Portrait photograph headshot of Sibilia Quilici (Vaccines Europe) grinning
Outstanding Contribution to Health Award
Sibilia Quilici
Vaccines Europe
Portrait photograph headshot of Isabelle Stoeckert (Bayer) smiling
Excellence in Service Award – Europe
Isabelle Stoeckert
DIA Thanks Outgoing RA Community Chair Linda Bowen
Portrait photograph headshot of Linda Bowen (Regulatory Affairs [RA] Community Chair) smiling
Linda Bowen

IA thanks Regulatory Affairs Community Chair Linda Bowen, who has stepped down after more than a decade of service to this DIA Community.

“I started in the biopharmaceutical industry in 1983 in the laboratory (as many people do), then moved to various roles in quality assurance. I moved into regulatory affairs in 1993, so I have been in regulatory for 30 years, and am currently Chief of Staff and lead the Centers of Regulatory Excellence at Seagen, Inc., a medium-sized oncology biotech company,” Linda explains.

What aspects of regulatory affairs improved the most during her career?

Thanks for reading our June 2023 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.