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DIA Global Forum Driving Insights to Action typography logo
February 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
Natasha Ratcliffe Patient Engagement Specialist
Thomas Smith Independent Patient Consultant

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
David Mukanga Bill and Melinda Gates Foundation

ASEAN
Jin Shun Belief BioMed

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

CHINA
Ling Su Shenyang Pharmaceutical University, Lilly Asia Ventures

EUROPE
Emma Du Four Independent R&D/Regulatory Policy Professional

EUROPE
Isabelle Stoeckert Independent Regulatory Science Expert

INDIA
J. Vijay Venkatraman Oviya MedSafe

JAPAN
Toshiyoshi Tominaga Keio University Hospital, Clinical and Translational Research Center

LATIN AMERICA
Cammilla Gomes Roche

US
Ebony Dashiell-Aje BioMarin

DIA Membership

Bringing together stakeholders for the betterment of global health care.

Editorial
DIA Reaffirms Commitment to Global Collaboration that Improves Patient Outcomes and Public Health
Marwan Fathallah
Global Chief Executive
DIA (Drug Information Association)
DIA President and CEO Marwan Fathallah
Marwan Fathallah, Global Chief Executive, DIA
A

t DIA, we believe global collaboration is essential for advancing biomedical science and derisking medical product development by promoting innovation and providing a forum for multistakeholder discussions. Now more than ever, the world faces complex health challenges that require a united effort across nations, organizations, and disciplines.

AI-Powered Translation: Use Cases Transform Global Communication in Life Sciences
Sahil Shah, Joanne Hathaway, Neal Shekar, and Mark Martinez
Genmab
I

n the fast-paced world of biotechnology and pharmaceuticals, innovation knows no borders. Research collaborations, clinical trials, and regulatory submissions span continents, connecting teams and processes in ways that were unimaginable decades ago. But with these opportunities come new challenges—particularly in communication.

Navigating US Regulations for Dispensing Investigational Drugs in Decentralized Clinical Trials
Gerald E. Finken
RxE2
D

ecentralized clinical trials (DCTs) are transforming clinical research by enhancing accessibility and convenience for participants. By reducing the need for travel to traditional trial sites, enabling remote monitoring, and facilitating home-based interventions, DCTs are increasing participation rates and improving diversity in trial populations. The incorporation of local pharmacies into the DCT model further expands these benefits, particularly for underserved communities, creating opportunities for community pharmacists to engage in clinical trials. These roles include recruiting patients, serving as local clinical support sites, and, most importantly, dispensing investigational medicinal products (IMPs). This is new and different than the role played by hospital pharmacists who dispense IMP in centralized clinical trials (CCTs). But it is also important to remember that these roles are subject to regulatory requirements.

Data Standards Fatigue?
Sridevi Nagarajan
AyusArogya Ltd.
DIA AI in Healthcare Community Co-Chair
Venkatraman Balasubramanian
VB Insights, LLC
DIA RIM Working Group
T

he pharmaceutical industry has been experiencing a paradigm shift in recent years with the increasing importance of data-centric submissions and new guidance around AI and digital transformations. This, in turn, has increased the importance of data standards, which hold the promise of improving data quality, interoperability, and regulatory compliance. However, given the accelerating intent to adopt and keep pace with rapid evolution in technology, this transition has introduced “Data Standards Fatigue,” the overwhelming feeling experienced by organizations and individuals when faced with the continuous introduction and evolution of data standards from standards organizations and regulatory bodies.

White Paper

Cover of Docuvera: AI + Structured Content

White Paper

AI + Structured Content
A new era of pharmaceutical documentation

AI and structured content are transforming how organizations manage pharmaceutical documentation. Together, they create a powerful solution that enhances compliance, efficiency, and adaptability in global markets. In this whitepaper, you’ll discover how:

  • AI accelerates documentation with automation, ensuring speed, accuracy, and multilingual accessibility.
  • Structured content provides governance, traceability, and reuse for regulatory compliance.
  • Together, they streamline processes, reducing manual effort and improving efficiency.

Future-proof your documentation strategy. Download the whitepaper today!

Commentary
Invitation to Comment:
Warp-Speeding Regulatory Decisions
Antoniu Fantana, John April
Lilly
Dominique Lagrave
Accumulus Synergy
Peter Caetano
Ipsen
Aaron Fier
Moderna
Nancy Jackson
Gilead
Waheed Jowiya, Louise Lind Skov
Novo Nordisk
Pascal Piedbois
One2Treat
Steve Lupo
West Monroe
Katherine Sigg
20/20 Onsite
Cary Smithson
LeapAhead Solutions
Theresa Eastwood-Kiefer
Roche
D

ata transparency, more collaboration, and technology will lead to faster, more thorough, data-driven decisions and speed up medicine development.

Commentary
Why Do Sponsors and CROs Need a Trade Association Dedicated to Multisite Research Corporations?
Jim Kremidas
Association of Multisite Research Corporations
T

he clinical trial ecosystem has become increasingly complex, with the number of drugs in development nearly doubling between 2012 and 2022. This growth, coupled with rising patient recruitment demands and the need for diverse trial endpoints, has highlighted the limitations of the traditional site model.

Meeting Highlights: DIA India Annual Meeting 2024
Cosmetovigilance: Safeguarding Consumer Health in the Global Beauty Market
John Praveen
Accenture, India
Fahd Khan
Emmes, India
Thirumalai Velu Swaminathan
Galderma India Pvt Limited, India
T

he cosmetics industry has seen unprecedented growth over recent decades, bringing a flood of new cosmetic products and ingredients to the market. With this rise, today’s consumers have access to a vast range of cosmetic options tailored to every beauty goal, from skincare and anti-aging products to hair care and fragrances. Advances in technology and formulation have enabled the development of highly specialized treatments, with innovations such as personalized skincare regimens and smart beauty devices becoming more accessible. The influence of social media and celebrity endorsements has further fueled this boom, creating a culture where beauty products are more than just personal care items—they have become status symbols and lifestyle statements. However, as the industry expands, safety concerns also escalate.

Meeting Highlights: DIA Latin America Annual Meeting 2024
Regulatory Systems, Trends, and Innovations in Latin America and the Caribbean
The Future of Medical Product Development and Approval
Maria Paula Bautista Acelas, Tamei Elliott, Maria Vassileva
Drug Information Association (DIA)
Camilla Horta Gomes, Raphael Elmadjian Parechi
Roche, Brazil
Lawrence Liberti
The Kim Center/USC DRQS
Viktoria Magyar
USC Alfred E. Mann School of Pharmacy & Pharmaceutical Sciences
Barbara Nardi
Thermo Fisher Scientific, Brazil
Maria Antonieta Tony Roman
Novartis, Mexico
I

n the dynamic landscape of global regulatory practices, Latin America (LATAM, including the Caribbean) is embarking on transformative initiatives to strengthen its international standing as a large global region and align with the World Health Organization’s (WHO) Global Benchmarking Tools (GBT) for evaluation of national regulatory systems.

White Paper

Glemser: Next Gen Clinical Liability Cover

White Paper

Next-Gen Clinical Labeling
Streamlining Authoring and Management Workflows with Structured Content AI

Accurate clinical labels are crucial to the pharmaceutical industry because they directly impact patient safety, regulatory compliance, and clinical trial integrity. The current systems that most companies use typically slow down the overall labeling process, require integration with other systems, and create unnecessary challenges. Thankfully, AI-powered structured content tools and platforms are helping companies transform their internal processes around authoring, collaboration, management, artwork, and submission.

Around the Globe: Global
Sustainable Healthcare: Balancing Patient Care and Environmental Impact
Samantha Holmes, Fiona Adshead
Sustainable Healthcare Coalition
Ania Mitan
Drug Information Association (DIA)
S

ustainable healthcare provides high-quality care in the present without compromising the health of future generations and our planet. The healthcare sector must play a critical role in delivering sustainable healthcare and achieving this balance for the following reasons: healthcare is itself a significant contributor to greenhouse gas emissions; we must address the risk that climate change presents to the operations of healthcare as an industry; and we must consider the impact of climate change on population health, which in itself places further demand on already stretched healthcare systems. Mitigating climate change through making healthcare more sustainable is imperative. It offers numerous co-benefits: Not only is it good for patients and their health, but it is also a business derisking activity.

Around the Globe: Global
Navigating the Digital Age:
A Global Pharmaceutical Company’s Journey in eLabeling
Benjamin Tan, Clara See
Novartis (Singapore) Pte Ltd.
Inez Kwan, Kum Cheun Wong
Novartis Asia Pacific Pharmaceuticals Pte Ltd.
Maria Antonieta Roman
Novartis Farmacéutica S.A. de C.V.
E

lectronic labeling (eLabeling) generally refers to the distribution of the approved product information of medicinal products via electronic means. This in turn allows prompt communication of current safety information to patients and healthcare professionals (HCPs). If local regulations allow the removal of hardcopy leaflets (HCL), eLabeling can also reduce paper consumption.

Around the Globe: Europe
Accession to the EU: How Can the EMA Pre-Accession Assistance Program Help?
Judit Barniol, Katre Rugo, Michiel Hendrix, Martin Harvey Allchurch
European Medicines Agency
Biljana Tubic
Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina
Arian Ahmeti
Kosovo Medicines Agency
Mira Kontić, Gordana Boljević Stanojević
Institute for Medicines and Medical Devices of Montenegro
Biljana Strojmanovska
Food and Veterinary Agency of North Macedonia
Merjem Hadjihamza
Agency of Medicines and Medical Devices of North Macedonia
Pavle Zelić
Medicines and Medical Devices Agency of Serbia
F

or any country to become a member of the European Union, a clear set of steps and rules has been established. Such a transition is complex and consists of different stages: the European Council grants countries potential candidate, candidate, or accession status, depending on the status of negotiations. Nine states are currently recognized as candidates for membership in the European Union: Albania, Bosnia and Herzegovina, Georgia, Moldova, Montenegro, North Macedonia, Serbia, Türkiye, and Ukraine. Kosovo formally submitted its application for membership in 2022 and is considered a potential candidate by the European Union.

Around the Globe: Japan
Cannabis-Derived Drugs in Japan: New Legislation and Outlook
Toshi Tominaga
Keio University
O

n December 12, 2024, Japan enacted its amended Cannabis Control Law (CCL) and Narcotics and Psychotropic Substances Control Law (NPSCL). The new regulations opened the possibility of cannabis-derived drugs in Japan, especially those containing cannabidiol (CBD).

Around the Globe: US

DIA/Tufts CSDD Research: AI Saving Time in Drug Development
DIA and the Tufts Center for the Study of Drug Development (Tufts CSDD), in collaboration with 16 biopharmaceutical companies and CROs, conducted a study to map current use of and experience with artificial intelligence (AI) and machine learning (ML), and their ability to reduce time across activities, in the drug development lifecycle. “We benchmarked various applications of AI and ML to 36 activities within clinical operations and development. We focused on design and planning, execution, and regulatory submissions, and looked at time reductions from investments in the use of AI and ML in a typical development program,” explains Tufts CSDD Director of Sponsored Research Mary Jo Lamberti in this interview with Stephanie Rosner (Scientific Program Manager for AI, DIA). “We expect to see higher levels of full implementation across all activities over the next few years.”
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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.