- FEATURE ARTICLES
- The Future of Cell and Gene Therapies: Modernizing Systems to Drive Sustainable Development and Access
Q&A with Alliance for Regenerative Medicine
- Evolving REMS for Complex Therapies: Addressing Safety in Innovation
Balancing Safety, Efficiency, and Access
- AI in Drug Development: Clinical Validation and Regulatory Innovation Are Dual Imperatives
- AI-Powered Clinical Trial Feasibility and Forecasting: Four Strategic Applications
- Incorporating Patient Needs into Clinical Trial Design and Conduct: A Global Pharmaceutical Company’s Experience
- Enhancing Patient-Centric Clinical Trials with the Net Treatment Benefit Methodology
- MEETING HIGHLIGHTS
-
DIA Europe 2025
Collaborative Networks Driving Regulatory Transformation in Latin America
Lessons Learned from the Latin America Town Hall - AROUND THE GLOBE
- EU HTA Regulation: Bringing the European Patient Expertise and Voice into the Decision-Making Processes
- Ensuring Safe, Compliant, and Effective Radioligand Therapy in Singapore
- Medicines Australia Releases Code of Conduct 20th Edition
- WE ARE DIA
- DIA Congratulates Our China 2025 Regional Inspire Award Winners
Subscribe
Editorial Board
Content stream editors
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
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
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.
Alliance for Regenerative Medicine (ARM)
BioMarin
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.”
Indegene
4Biosolutions Consulting
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.
CEO Roundtable on Cancer Project Data Sphere
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.
Pfizer
Lokavant
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.
Psoriasis Canada
Boehringer Ingelheim Pharma GmbH & Co. KG
Boehringer Ingelheim Pharmaceuticals, Inc.
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.
One2Treat, Belgium
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.
MSD
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?
European Patients’ Academy on Therapeutic Innovation (EUPATI)
EUPATI Fellow, EUPATI Czechia
EUPATI Fellow, EUPATI Italy
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.
Novartis (Singapore) Pte Ltd
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.
University of New South Wales, Australia
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.
OUTSTANDING CONTRIBUTION TO HEALTH AWARD – CHINA

Tsinghua University School of Basic Medicine, Changgung Hospital
EXCELLENCE IN SERVICE AWARD – CHINA

Boehringer Ingelheim

Executive Coach | Leadership Trainer

Shanghai Mental Health Center

