March 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

Julie O’Brien Pfizer

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.

Navigating the Data-Driven Transformation of Clinical Development
Nisarg Shah
Madhur Kakade
Everest Group

rising tide of clinical trial data is flooding the pharmaceutical industry, offering boundless potential to chart new development pathways. But it also introduces complex regulatory rip currents to navigate. As the lighthouse guiding safe passage through swollen seas, the FDA recognizes both the vast promise and potential perils of this data deluge.

Animal-Derived Ingredients in Medicines: A Call to Action
Scott P. Commins
University of North Carolina School of Medicine
Jasmine Uchi
VeganMed, Inc.
Sachin A. Shah
University of the Pacific

any patients must abstain from animal-derived ingredients (ADI) or prefer animal-free (AF) medications due to health, dietary, religious, animal cruelty, or climate change reasons. Based on some estimates, 75% of popular medications may contain ADI (active or inactive ingredients; heparin, thyroid hormone, gummies, gelatin capsules, etc.); ADI are also present in a diverse set of medical products, such as bioprosthetics (e.g., porcine heart valves), surgical mesh, and most vaccines. This poses a problem not only in acute medical care (e.g., medications/devices used during surgery) but also in ambulatory settings.

Defining Gene Therapy Medicinal Products in the EU
Scientific and Regulatory Perspectives
Maren von Fritschen
Charbel Haber
Walter Straus
Christian K. Schneider
Ewa Janosz
Cencora PharmaLex
Ulrike Jägle
Myriam Mendila
Constanze Blume

ene therapy medicinal products (GTMPs), which in the European Union (EU) are a subset of advanced therapy medicinal products (ATMPs), may have the potential to transform the treatment landscape for many diseases ranging from inborn errors of metabolism to malignancies, offering the promise of treating diseases that may range from debilitating to fatal. The science of gene therapy (GT) was catalyzed by breakthroughs in DNA technology that led to research strategies aimed at replacing or adding genes. These techniques often employ viral vectors.

More recently, fundamentally different approaches have been developed, including CRISPR/Cas9 or mRNA technologies. The evolution of GT for such biologically distinct technical approaches requires the evolution of a regulatory framework that promotes innovation, enhances confidence in new technologies, and minimizes the potential for misunderstanding—all for the benefit of patients.
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Meeting Highlights: DIA Innovating Clinical Trials in Europe
Unveiling the Future of Healthcare: EU-Funded Projects Transforming Real-World Evidence and Data Analytics
Claudia Ferreira
Vedran Raguz
“The landscape of healthcare decision-making is undergoing a profound transformation.”

—Jesper Kjaer (NovoNordisk), DIA Innovating Clinical Trials in Europe program committee


he European Union has been at the forefront of fostering innovative research projects aimed at harnessing real-world evidence (RWE) and cutting-edge data analytics to enhance healthcare decision-making.

With the rapid pace of clinical innovation, an increasing number of medicines are gaining marketing approval for specific patient subsets and at earlier disease stages. However, this trend presents a challenge in the realm of clinical evidence gathering, as the pool of eligible patients for recruitment diminishes and achieving conclusive outcomes becomes time-consuming.
Meeting Highlights
Joint DIA-RAPS Summit Produces Pragmatic Solutions for Combination Products in Europe
Denise Fulton
Regulatory Affairs Professionals Society (RAPS)
Nathalie Preiswerk

nderstanding, collaboration, and a one-point-of-contact model were a few of the “asks” from the experts representing regulatory agencies, competent authorities, notified bodies, and industry organizations at the 2024 Combination Products in the EU Summit jointly presented by DIA and the Regulatory Affairs Professionals Society (RAPS) in January 2024 in Brussels.

Can Rapid Dissemination of News on Adverse Drug Reactions Cause More Harm Than Good?
J. Vijay Venkatraman
Oviya MedSafe

n December 2023, one of the often-flashed headlines on daily newspapers and online news portals (both print and digital) in India concerned an adverse drug reaction (ADR) reported by the Indian Pharmacopoeia Commission (IPC) in their monthly Drug Safety Alert. This report was based on preliminary analysis of ADRs from the Pharmacovigilance Programme of India (PvPI) database. Surprisingly, this was neither a hitherto-unknown effect of the drug in question nor was there any new evidence implying a sudden increase in incidence, in either qualitative or quantitative terms, of the said ADR.

Around the Globe: Americas
Stay Tuned: Americas RISE for Health Initiative

nnounced during the Ninth Summit of the Americas in mid-2022, the annual multisectoral forum Americas RISE for Health seeks to harness the collective strengths of the private sector and civil society of the region (comprising countries in North, Central, and South America), in partnership with the participating countries’ governments, to build the hemisphere’s supply chains to be more resilient, enable digital health solutions to reach underserved populations, accelerate regulatory improvements, reduce trade and investment barriers to health financing, create ethical environments so health economies can thrive, and address other areas of need.

Around the Globe: Australia / New Zealand

Contentious Vaping Debate Heats Up Australia
Richard Day
University of New South Wales

here has been a contentious debate about nicotine vaporizers (vapes) in Australia. On one hand, the use of nicotine vapes registered as therapeutic goods as an aid to quitting cigarette smoking is accepted. However, this use required a prescription from a general practitioner and dispensing from a chemist, adding to the product cost.

Around the Globe: India
FDA India Office Director Reflects on Her Vision and In-Country Experience

arah McMullen is the Country Director for the FDA India Office. Her professional experience has included analytical method development and testing for multiple FDA-regulated commodities, establishment inspections, import operations and policy, and foreign office service. Her FDA career has spanned more than 20 years working as a chemist, tissue residue specialist, consumer safety officer, and leader. In the last nine years, she has focused on international arenas, including import operations and foreign office service. She reflects on these experiences and opportunities in the below interview.

Around the Globe: US
Clinical Research Misconduct: Changes in US Clinical Trial Agreements May Be Necessary
Darshan Kulkarni
Kulkarni Law Firm

n October 6, 2023, the US Department of Health and Human Services, in conjunction with the Office of Research Integrity (ORI), proposed updates to revise the Public Health Service Policies on Research Misconduct. The proposal primarily focused on clinical research sites and did not specify how clinical trial agreements would need to be updated. Nevertheless, Clinical Research Organizations (CROs) and Sponsors must pay heed to site-level changes and update their contracts in light of their own exposure to avoid being caught flat-footed or surprised when the changes are confirmed.

Thanks for reading our March 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.