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DIA Global Forum Driving Insights to Action typography logo
June 2025

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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
Stacy Hurt Parexel
Richie Kahn Canary Advisors

Data and Digital
Lisa Barbadora Barbadora Ink

VALUE AND ACCESS
Wyatt Gotbetter Cytel, Inc.

Editorial Staff

Alberto Grignolo, Editor-in-Chief

Sandra Blumenrath, Senior Scientific Project Manager & Executive Editor, Scientific Publications DIA Scientific Communications

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

Linda Felaco, Copy Editor and Proofreader

Regional Editors

AFRICA
Lorraine Danks The Gates Foundation

ASEAN
Helene Sou Takeda

AUSTRALIA/NEW ZEALAND
Richard Day University of New South Wales, Medicine, St. Vincent’s Hospital

CHINA
Li Wang Eli Lilly China

EUROPE
Emma Du Four Independent R&D/Regulatory Policy Professional
Isabelle Stoeckert Independent Regulatory Science Expert

INDIA
J. Vijay Venkatraman Oviya MedSafe

JAPAN
Toshiyoshi Tominaga SunFlare

LATIN AMERICA
Cammilla Gomes Roche

US
Ebony Dashiell-Aje BioMarin

DIA Membership

Bringing together stakeholders for the betterment of global health care.

The Future of Cell and Gene Therapies: Modernizing Systems to Drive Sustainable Development and Access

Q&A with Alliance for Regenerative Medicine
Timothy Hunt
Alliance for Regenerative Medicine (ARM)
Ebony Dashiell-Aje
BioMarin
“F

ifteen of the top 20, or 75%, of the largest pharmaceutical companies by market cap are actively involved in cell and gene therapy,” explains Timothy Hunt, chief executive officer at the Alliance for Regenerative Medicine (ARM). “These companies are also looking down the road at things like cell therapy in autoimmune disorders, cell therapy in solid tumors, and gene therapies in more prevalent conditions. There is significant potential in these areas, and these investments by the larger biopharmaceutical companies are pretty clear.”

Evolving REMS for Complex Therapies: Addressing Safety in Innovation

Balancing Safety, Efficiency, and Access
Siva Kumar Buddha
Indegene
Isaac R. Rodriguez-Chavez
4Biosolutions Consulting
I

n June 2024, FDA expanded its Risk Evaluation and Mitigation Strategies (REMS) program for CAR T-cell therapies to include all six approved therapies, reducing the burden on healthcare providers by removing the requirement to report serious adverse events related to cytokine release syndrome (CRS) and neurological toxicities. At this same time, FDA modified the Opioid Analgesic REMS program to require manufacturers to provide pre-paid mail-back envelopes for safe disposal of unused opioids and updated the REMS for mifepristone to eliminate the in-person dispensing requirement, which allows certified pharmacies to dispense the medication directly to patients with a prescription.

AI in Drug Development: Clinical Validation and Regulatory Innovation Are Dual Imperatives
Sean Khozin
CEO Roundtable on Cancer Project Data Sphere
A

rtificial intelligence (AI) has emerged as a promising, if not transformative, force in drug development, demonstrating significant technical capabilities across various domains, including target identification, in silico modeling, biomarker discovery, digital pathology, and clinical trial optimization. The synergy between machine learning and high-dimensional biomedical data has fueled growing optimism about AI’s potential to accelerate and enhance the therapeutic development pipeline.

AI-Powered Clinical Trial Feasibility and Forecasting: Four Strategic Applications
Jonathan Crowther
Pfizer
Rohit Nambisan
Lokavant
T

he COVID-19 pandemic forced the clinical research industry to rethink how trials are conducted and revealed that we could adapt quickly under pressure. Today, with significant economic headwinds, escalating complexity, and global and domestic uncertainty reshaping the landscape once again, we face a new imperative: to evolve from reactive to proactive, leveraging technology to forecast with clarity and confidence.

Incorporating Patient Needs into Clinical Trial Design and Conduct: A Global Pharmaceutical Company’s Experience
Chris Boisvert-Huneault
Psoriasis Canada
Kimberley Kallsen
Boehringer Ingelheim Pharma GmbH & Co. KG
Tracey Robertson
Boehringer Ingelheim Pharmaceuticals, Inc.
R

ecruitment and retention in clinical trials pose significant challenges, often due to the burdensome nature of participation. Despite widespread recognition that patient input can alleviate these burdens and improve recruitment and retention rates, the industry has been slow to standardize this approach. This article outlines the transformative journey of a leading global pharmaceutical company towards embedding systematic patient engagement in clinical research.

Enhancing Patient-Centric Clinical Trials with the Net Treatment Benefit Methodology
Samuel Salvaggio
One2Treat, Belgium
P

atient-centricity has become a focal point in the evolution of clinical trials, emphasizing outcomes meaningful to patients. The challenge lies in balancing rigorous scientific evaluation with incorporating patient experiences and preferences.

Meeting Highlights: DIA Europe 2025
Collaborative Networks Driving Regulatory Transformation in Latin America

Lessons from the Latin America Town Hall
Leonardo Semprun
MSD
L

atin America is at a pivotal moment in the evolution of its regulatory systems. Factors such as the adoption of emerging technologies, the urgent need to accelerate access to medicines, and the region’s increasing economic integration with the rest of the world have brought forth an inescapable question: How can we make health regulation more efficient, transparent, and sustainable?

Around the Globe: Europe
EU HTA Regulation: Bringing the European Patient Expertise and Voice into the Decision-Making Processes
Finn McCartney, Maria Dutarte
European Patients’ Academy on Therapeutic Innovation (EUPATI)
Petra Adámková
EUPATI Fellow, EUPATI Czechia
Paola Kruger
EUPATI Fellow, EUPATI Italy
A

fter four years of preparation and consultations from key stakeholders, the EU Health Technology Assessment Regulation has been in force since January 2025 and the first two Joint Clinical Assessments (JCA) are in progress, being led by two separate member state HTA bodies/authorities (assessors and co-assessors) including the National Centre for Pharmacoeconomics, Ireland, and the Institute for Quality and Efficiency in Health Care, Germany, on a treatment for pediatric low-grade glioma; and the National Authority for Health, France, and the Agency for Health Technology Assessment and Tariff System, Poland, on an advanced therapy for treatment of melanoma. This regulation aims to simultaneously achieve a high level of protection of health for patients and users and to establish a framework to support Member State cooperation and the measures needed for clinical assessment of health technologies.

Around the Globe: ASEAN
Ensuring Safe, Compliant, Effective Radioligand Therapy in Singapore
Toh Ting Fu
Novartis (Singapore) Pte Ltd
R

adioligand therapy (RLT) is emerging as an important treatment modality in a wide range of cancer types by harnessing the power of radioisotopes to deliver radiation to the target. However, as an innovative technology, RLT presents several regulatory and logistical challenges. In this article, one global pharmaceutical company shares its experience in ensuring accessibility of RLT to patients in Singapore.

Around the Globe: Australia
Medicines Australia Releases Code of Conduct 20th Edition
Richard Day
University of New South Wales, Australia
M

arketing prescription medicines, and how this is done, is more often than not a contentious topic. Although marketing prescription medicines is recognized as an important influence on how medicines are used, getting the right balance between the provision of information and education about prescription medicines on the one hand and inappropriate marketing on the other continues to challenge stakeholders.

We Are DIA
DIA Congratulates Our China 2025 Regional Inspire Award Winners
Our 2025 China Regional Inspire Award Winners:

OUTSTANDING CONTRIBUTION TO HEALTH AWARD – CHINA

Portrait orientation photograph headshot close-up of view of Xiaoyuan CHEN smiling
Xiaoyuan CHEN
Tsinghua University School of Basic Medicine, Changgung Hospital

EXCELLENCE IN SERVICE AWARD – CHINA

Portrait orientation photograph headshot close-up of view of Wei ZHANG grinning
Wei ZHANG
Boehringer Ingelheim
Portrait orientation photograph headshot close-up of view of Mengjuan LI smiling
Mengjuan LI
Executive Coach | Leadership Trainer
Portrait orientation photograph headshot close-up of view of Yifeng SHEN grinning
Yifeng SHEN
Shanghai Mental Health Center
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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.