June 2024


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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 4Biosolutions Consulting

Patient engagement
Natasha Ratcliffe Patient Engagement Specialist
Thomas Smith Independent Patient Consultant

Data and Digital
Lisa Barbadora Barbadora Ink

Wyatt Gotbetter Parexel

Editorial Staff

Alberto Grignolo, Editor-in-Chief

Sandra Blumenrath, Managing Editor, Scientific Publications DIA Scientific Communications

Chris M. Slawecki, Managing Editor, Global Forum DIA Scientific Communications

Linda Felaco, Copy Editor and Proofreader

Regional Editors

David Mukanga Bill and Melinda Gates Foundation

Jin Shun Belief BioMed

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

Ling Su Shenyang Pharmaceutical University, Lilly Asia Ventures

J. Vijay Venkatraman Oviya MedSafe

Toshiyoshi Tominaga Keio University Hospital, Clinical and Translational Research Center

Cammilla Gomes Roche

Ebony Dashiell-Aje BioMarin

DIA Membership

Bringing together stakeholders for the betterment of global health care.

Editor-in-Chief Message
My First Forty Years at DIA
Alberto Grignolo
Editor-in-Chief, DIA Global Forum

became a DIA member in 1984 when I was an entry-level Regulatory Associate in a large pharmaceutical company. I knew very little, but I knew that I needed to learn a great deal more.

In 2024, I am the Editor-in-Chief of DIA Global Forum and a Fellow of DIA.

In between, I grew up as a professional and I learned many things, in good measure thanks to DIA.

But now, there is so much more to be learned to build our future. And DIA, in this 60th anniversary year and beyond, is a really cool place to find it, to learn together, and to build our future together.

Back to (Communication) Basics: Reducing Site Burden and Establishing a Sponsor/CRO-of-Choice Relationship with Investigative Sites
Beth Harper, Ken Getz
Tufts CSDD
Teri Karcher

linical investigative sites face unprecedented operating challenges, from increasing protocol complexity to resource constraints, protracted budget negotiations, and workforce turnover, to contending with myriad new technologies. At the same time, sponsors and CROs (Clinical Research Organizations) attempt to determine how best to collaborate with the sites and aim to become a top “sponsor/CRO-of-choice” in their quest to improve site performance. Inspired by the findings of a survey the Tufts Center for the Study of Drug Development (CSDD) conducted in 2022, as well as their own mission to improve site partnering, a global CRO was interested in further exploring opportunities to obtain a deeper understanding of root causes related to the complexities of sponsor/CRO/site relationships and address site operating challenges.

The Role of RWD and RWE in Shaping Global Regulatory Practices
Jeffrey S. Brown
TriNetX, LLC

he widespread availability of data in electronic health records (EHRs), patient registries, and administrative claims databases has ignited an evolutionary shift in life sciences, propelling the field towards a data-centric paradigm across the drug development and post-approval lifecycles. This shift, while touting new possibilities for medical innovation, introduces a complex set of challenges around data integrity, fitness-for-purpose, statistical and epidemiologic methods, patient privacy, data security, and institutional confidentiality.

“Real” Evidence Generating Real Pre- and Post-Market Benefits
Wyatt Gotbetter
Kourtney Davis
Johnson & Johnson

he continuing growth of real-world data (RWD) sources and better-quality real-world evidence (RWE) is changing pharmaceutical development and regulatory decision making for sponsors. For example, in 2023, FDA issued new guidance to industry on the use of RWE to support regulatory decision making, a strong signal of their shift toward more acceptance of these less traditional data sources. As a complement to randomized clinical trials, real-world evidence holds tremendous promise for the future of pharmaceuticals, patient care, equitable access, and how we develop and bring drugs to market.

Demystifying AI in Healthcare: Common Challenges AI Can Help Solve
Part 1: R&D Applications and Approaches
Sridevi Nagarajan
Michael Meighu
Co-Chairs, DIA AI in Healthcare Community

his article is first in a series that explores the potential of AI in the healthcare sector and paves the way to uniting the global community of patients, data scientists, medical professionals, and clinical representatives. Subsequent articles in future issues of Global Forum will examine specific use cases within healthcare, the regulatory landscape surrounding AI implementation, the integration of human-centric AI, change management strategies, and optimizing synergy between artificial and human intelligences.

Special Section Part 2: Identification of Medicinal Products (IDMP)
IDMP and Cross-Border Healthcare: Eliminating Language Barriers
(Part 4)
Panagiotis Telonis
Ta-Jen Chen
Ron Fitzmartin

Julia Nyman
Malin Fladvad


dentification of Medicinal Products (IDMP), a suite of five standards developed by the International Organization for Standardization, provides an international framework to uniquely identify and describe medicinal products with consistent documentation and terminologies, and facilitates the exchange of product information between global regulators, manufacturers, suppliers, and distributors. When fully implemented globally, the standards will facilitate the unique identification of medicinal products in the context of pharmacovigilance, drug shortages, and the safety of medications (and patients who take them) throughout the world. The following fictional use case illustrates a potential benefit of the Global Pharmaceutical Product Identification (PhPID) of IDMP.

Special Section Part 2: Identification of Medicinal Products (IDMP)
The Global IDMP Working Group Focus on a Framework for Global Implementation
(Part 5)
Global IDMP Working Group Co-Chairs
Isabel Chicharo
Panagiotis Telonis

Ta-Jen Chen
Ron Fitzmartin

Malin Fladvad
Olof Lagerlund


he International Organization for Standardization (ISO) developed a suite of five standards for the Identification of Medicinal Products (IDMP) to internationally harmonize specifications for the identification, description, and exchange of medicinal products between regulatory agencies and biopharmaceutical companies. These standards support the global regulatory activities related to the lifecycle management of medicinal products. When fully implemented globally, the standards, and specifically Pharmaceutical Product Identification (PhPID), will facilitate the unique identification of medicinal products in the context of pharmacovigilance, drug shortages, and the safety of medications (and patients who take them) throughout the world.

Meeting Highlights
Collaboration, Alignment, and Harmonization Must Drive Healthcare Innovation
Actionable Insights from DIA Europe 2024
Vedran Raguz

ne of the overarching themes of DIA Europe 2024 was the imperative of alignment and harmonization across regulatory bodies and stakeholders. Representatives from the European Medicines Agency (EMA), World Health Organization (WHO), US Food & Drug Administration (FDA), and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) echoed the importance of increasing regulatory convergence, particularly in real-world evidence (RWE) guidance for drug safety assessments. Collaborative efforts at the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the International Coalition of Medicines Regulatory Authorities (ICMRA) have proven instrumental in driving this agenda forward and have paved the way for more streamlined processes and enhanced regulatory coherence.

Around the Globe: India
Implementing Internal Quality Review: A Potentially Important Step towards a Self-Reliant Clinical Trial Site
Deepti Goel
Harrison’s Tech Consultants

n a recent Global Forum interview, FDA India Office Director Sarah McMullen reflected on her vision and in-country experience in India. As Director McMullen explained, India is one of the world’s largest producers of generic drugs, with 40% of generics in the US coming from India, and many of the bioavailability and bioequivalence (BA/BE) studies done to support those applications are conducted in India. Approximately 30% of FDA’s foreign trial inspections are done in India, per this interview, with the majority of those relating to BA/BE trials. She mentioned that although this has led to India being a key player in the global pharmaceutical industry and a major supplier of affordable medications worldwide, it is disheartening to continue to see clinical trial conduct issues in India.

Around the Globe: Japan
Positive Trends in the Drug Pricing System in Japan: Efforts to Reduce the Drug Lag
Mamoru Narukawa
Kitasato University, Graduate School of Pharmaceutical Sciences

rug expenditure as a percentage of healthcare costs in Japan has been stable at approximately 22% in the past quarter-century. As Japan’s society ages, overall healthcare costs have increased and drug costs have increased in parallel, a trend observed worldwide. However, according to one industry report, Japan’s share of the global pharmaceutical market showed continuous decline in the past 20 years, from 12.0% in 2003 to 5.1% in 2022. Market share often reflects the market’s attractiveness to industry investment as well as the foundation to directly support pharmaceutical innovation. Japan is now struggling to sustain universal healthcare coverage and encourage innovation in the industry at the same time.

White Paper

Dimensions White Paper

White Paper

The Role of Digital Tools in Medical Affairs

How the medical affairs function overcomes critical pain points with digital and AI tools
As digital technology has quickly grown, so has the role of medical affairs, a trend that will continue in the future. Medical affairs professionals are no longer solely responsible for medical accuracy but are now driving overall medical strategy and need as much support as possible to carry out these activities efficiently and effectively. Discover why efficiently assigned resources and new technologies are pivotal to the success of medical affairs teams.
DIA 60th Anniversary
Global Communication, Interaction, and Cooperation
DIA 60th Anniversary Q&A with Ling Su
Portrait close-up headshot photo view of Ling Su grinning
Ling Su
DIA Fellow and former Board President
DIA: Ling, as we continue to celebrate DIA’s 60th anniversary, would you please introduce yourself, your work, and your engagement with DIA?

Ling Su: I’m Ling Su. I’m currently a venture partner in LAV (Lily Asia Ventures), where I support evaluation and post-investment management of our biotech portfolio companies. I’m also the Chief Development Officer in Skyline Therapeutics, a clinical-stage gene therapy biotech company.

DIA Congratulates 2024 China Regional Inspire Award Winners
Our 2024 China Regional Inspire Award Winners:

Our 2024 DIA China Outstanding Contribution Award Winner

Portrait headshot photo view of Zili Li smiling
Zili Li
DIA Fellow, FDAAA At-Large Board Member

Our 2024 DIA China Excellence in Service Award Winners

Portrait headshot photo view of Hualong Sun grinning
Hualong Sun
Meta Clinical Technology Co., Ltd.
Portrait headshot photo view of Zhaohua Chen smiling
Zhaohua Chen
Pfizer (China) Research & Development Co., Ltd.
Portrait headshot photo view of Xingli Wang smiling
Xingli Wang
Shanghai Fosun Pharmaceutical (Group) Co., Ltd.
Thanks for reading our June 2024 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.