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DIA Global Forum Driving Insights to Action typography logo
December 2024
December 2024 Global Forum
Table of Contents
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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 Parexel

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 Bayer AG Pharma

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.

Breaking Financial Barriers: Making the Shift to Reasonable Compensation for Clinical Trial Participants
Donna Libretti Cooke
Clinical Operations Specialized Consultant
Kelly Fitzgerald
WCG
Lindsay McNair
Equipoise Consulting, LLC
Carie Pierce
DIA
Sam Whitaker
Mural Health
C

linical trials play a crucial role in bringing new therapies to market. However, participation rates in many trials remain alarmingly low, particularly among underrepresented groups, despite numerous initiatives designed to address this challenge. A significant barrier is the financial burden placed on participants. The absence of sufficient financial support is overwhelmingly a factor that limits participation in clinical trials, especially those from lower-income backgrounds*.

Data Quality Assessment for EU Regulatory Decision-Making

EFPIA’s Perspective on Implementing EMA’s Data Quality Framework (DQF)
Eleanor Caplan
Janssen Research and Development, LLC, A Johnson and Johnson Company
Meritxell Sabidó
Merck Healthcare KGaA
Kaushal Desai
Merck & Co., Inc.
Rima Izem
Novartis
Pamela Dobay
Biogen
Kevin Pollock
BMS
Dara Stein
BMS
Jing Wang-Silvanto
Astellas
Nicole Mahoney
Novartis
R

eal-world evidence (RWE) can potentially complement clinical trials and support regulatory decision-making, but only if underlying real-world data (RWD) are sufficiently relevant and reliable and if quality measures are applied during collection, handling, and processing. Regulators and other stakeholders would benefit from alignment of frameworks for evaluating RWD quality. As a first step towards this, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a Data Quality Framework (DQF) in October 2023, with a real-world evidence DQF annex expected in 2024. In response, the European Federation of Pharmaceutical Industries and Associations (EFPIA) sought to assess available tools for implementing the DQF, with the goal of trying to operationalize the framework and informing future efforts. EFPIA’s findings and recommendations were presented and discussed with EMA in May 2024 and are illustrated in this article.

Implementation of Critical to Quality Factors (CtQ) in a Clinical Trial
Terry Katz
Daiichi Sankyo
Melissa Cabuang
Genentech, Inc.
C

ritical to Quality (CtQ) factors, cited and explained in ICH E8 (R1), are designed to confirm that a clinical study is designed to answer the research questions and to focus on monitoring variables that matter. Application of CtQ factors, as part of Quality by Design, can eliminate nonessential activities and data collection from the study. This streamlined approach, from application of CtQ factors within the Common Technical Document (CTD) dossier, can assist Health Authorities with their review of a product application. However, during an interactive Content Hub at the DIA Global Annual Meeting 2024, the DIA Good Clinical Practice & Quality Assurance Community attendee survey revealed that only 10 of approximately 150 attendees (6.7%) stated that their company used CtQ factors.

A Continuously Learning Ecosystem: How AI Unlocks Hidden Stories in Millions of Patient Data Points
Noga Leviner
PicnicHealth
The FDA’s guidance on real-world evidence (RWE) in observational research marked an important step forward this year. It clarified how sponsors can use real-world data (RWD) to demonstrate substantial evidence of drug safety and effectiveness. The agency’s recommendation comes at the perfect time, as many traditional study methods can no longer meet the demands of modern evidence generation.
Keys to Unlocking Regulatory Excellence

New eBook Explores and Explains the Value of Regulatory Information Management
Venkatraman Balasubramanian
VB Insights, LLC
Pat Shafer
FTI Consulting
T

he new eBook Achieving Excellence in Regulatory Information Management compiles industry knowledge and experience representing the spectrum of Regulatory Information Management (RIM) capabilities. For mature regulatory teams, the eBook provides best practices across the capability areas. For a young company investing in RIM for the first time or bringing its first product to market, there’s no better way to get educated on the scope of RIM processes, data, and documentation and how RIM capabilities leverage these assets. The eBook also gives an idea of the scale and magnitude of what is required to effectively implement a regulatory information management solution, including cross-functional interfaces.

White Paper

Cover of Beyond Needlesticks: Multi-Chamber Bags Enhanced with Smart Injection and Infusion Technology

White Paper

Navigating the AI Landscape: Understanding Trends, Jargon, and Data Readiness
Analyzing publication data from the past decade reveals a remarkable surge in artificial intelligence-related research outputs, reflecting the increasing interest and investment in AI across academia and industry. This white paper looks at the growing importance of AI as evidenced across various metrics (including research publications, research funding, and patents), provides insights to better understand common AI terminology and concepts, and provides an overview of the importance of data readiness for successful AI integration.
Special Section: Representative Clinical Trials
Improving Clinical Trial Representation: Clear Progress or Stuck in the Muddy Middle?
Kevin Freiert
Salem Oaks Consulting
Rare New England
Vanessa Cahee
VCahee Consulting LLC
Sabrena Mervin-Blake
Clinical Trials Transformation Initiative (CTTI)
Jacqueline Woodruff
AnthroSci LLC
Dyan Bryson
Inspired Health Strategies, LLC
C

linical trials do not yet adequately reflect the populations who use the drugs once they are approved. This article introduces four challenges that could slow down progress in clinical trial representation.

Special Section: Representative Clinical Trials
DEI Fatigue Misses the Point
Jacqueline Woodruff
AnthroSci LLC
Vanessa Cahee
VCahee Consulting LLC
Kevin Freiert
Salem Oaks Consulting
Rare New England
Sabrena Mervin-Blake
Clinical Trials Transformation Initiative (CTTI)
Dyan Bryson
Inspired Health Strategies, LLC
H

ealth disparities exist across racial and ethnic groups, income levels, and geographies. Recent heightened awareness of inequities in quality healthcare sparked a renewed social justice movement. DEI (diversity, equity, and inclusion) appears to be taken more seriously not only in healthcare, but across industries. It was in this charged environment that the US FDA released its final guidance on Enhancing the Diversity of Clinical Trial Populations in 2020 and updated Diversity Action Plan (DAP) draft guidance in 2024.

Special Section: Representative Clinical Trials
How to Address Misalignment in Clinical Trial Representation
Vanessa Cahee
VCahee Consulting LLC
Kevin Freiert
Salem Oaks Consulting
Rare New England
Sabrena Mervin-Blake
Clinical Trials Transformation Initiative (CTTI)
Jacqueline Woodruff
AnthroSci LLC
Dyan Bryson
Inspired Health Strategies, LLC
M

isalignment on diversity in clinical trials continues. Some sponsors have proactively implemented Diversity Action Plans for their clinical programs ahead of FDA requirements, for example, while other sponsors choose to wait until firm requirements are in place. Even during implementation, some team members find diversity or representation critical; some don’t find it necessary; still others consider diversity a nice gesture but don’t prioritize it.

Special Section: Representative Clinical Trials
Barriers to Stakeholder Collaboration
Vanessa Cahee
VCahee Consulting LLC
Kevin Freiert
Salem Oaks Consulting
Rare New England
Sabrena Mervin-Blake
Clinical Trials Transformation Initiative (CTTI)
Jacqueline Woodruff
AnthroSci LLC
Dyan Bryson
Inspired Health Strategies, LLC
On Behalf of the DIA Diversity & Inclusion in the Life Sciences Community
C

onversations about including diverse populations in clinical trials have been ongoing for decades. It has been well established that trial representation should reflect the population of those affected with the disease or condition.

Special Section: Representative Clinical Trials
Operational Changes Necessary to Ensure Representative Clinical Trials
Dyan Bryson
Inspired Health Strategies, LLC
Vanessa Cahee
VCahee Consulting LLC
Sabrena Mervin-Blake
Clinical Trials Transformation Initiative (CTTI)
Kevin Freiert
Salem Oaks Consulting
Rare New England
Jacqueline Woodruff
AnthroSci LLC
I

t is a fundamental principle of drug development for sponsors to understand who is likely to use their product to manage their disease or condition. To ensure that clinical trials accurately represent the population who will potentially use the products once approved, we have to change how we work.

White Paper

Cover of AI in the Healthcare Industry: Driving Efficiency and Better Patient Experiences

White Paper

Building a Successful Omnichannel Digital Strategy for HCPs
How to plan and implement exceptional experiences that improve HCP engagement, build long-term brand trust, and embrace a smart approach to innovation.
To compete in today’s pharmaceutical industry, companies need to deliver best-in-class experiences that exceed the expectations of healthcare providers (HCPs). In this eBook, read about the proven paths to transforming your digital tools and strategy with an omnichannel approach that sets you apart. Whether you’re focusing on digital HCP experiences, content strategy, or AI integration, this eBook provides the insights you need to stay ahead in the evolving pharma landscape.
Meeting Highlights: DIA India Annual Meeting 2024
Bridging Tradition with Modern Safety Standards: Pharmacovigilance of Traditional Ayurveda and Unani Medicines
Rajesh Kumawat
Himalaya Wellness Company
Syed Ziaur Rahman
Jawaharlal Nehru Medical College
Aligarh Muslim University
J. Vijay Venkatraman
Oviya MedSafe
T

he integration of pharmacovigilance (PV) with traditional medicine systems is an important yet underexplored area. As regulatory science, pharmacovigilance has grown considerably in the past two decades, predominantly focusing on modern medicinal products. However, the world of Alternative Medicine—comprising Ayurveda, Yoga, Unani, Siddha, and Homeopathy (AYUSH)—offers a vast array of health solutions that are used by millions globally. Despite their popularity, these systems have not yet been subject to the same level of scrutiny from a safety and efficacy standpoint as modern pharmaceuticals.

Around the Globe: Africa
Local Manufacturing of Medical Products in Africa

Pipe Dream or Realistic Aspiration?
John M. Mwangi
Bayer Pharmaceuticals
R

ecent pandemics have triggered calls for deglobalization in the production of medical products to ensure that these products are manufactured closer to those who need them.

In recent times, Africa, like many other countries and regions of the world, has seen renewed calls for local manufacturing of medical products. These calls have attracted the attention of the continent’s highest political players, with African country presidents and heads of government led by South Africa President Cyril Ramaphosa and Rwanda President Paul Kagame calling for acceleration of plans towards self-sufficiency of Africa, starting with vaccines, perhaps because of the lessons from the COVID-19 pandemic.
Around the Globe: Europe
European Medicines Agencies Network Strategy (EMANS) to 2028: Q&A with EMA and INFARMED
Interview with Melanie Carr (Head of Stakeholders and Communication Division, EMA) and Rui Santos Ivo (President, INFARMED & Member of HMA Management Group)
T

he draft European Medicines Agencies Network Strategy EMANS to 2028 has recently been through a public consultation and is expected to be finalized in March 2025, with a workshop with stakeholders planned for February 2025.

Portrait photograph headshot close-up view of Melanie Carr (Head of Stakeholders and Communication Division, EMA) grinning in a dark navy blue business blouse
Melanie Carr
Head of Stakeholders and Communication Division, EMA
Portrait photograph close-up view of Rui Santos Ivo (President, INFARMED, Member of HMA Management Group) grinning with his hands closed next to each other as he is seated in a chair in front of an Infarmed logo banner background
Rui Santos Ivo
President, INFARMED
Member of HMA Management Group
In this interview, Melanie Carr and Rui Santos Ivo share their thoughts on why the EMANS is critical for the success of the EU regulatory network and how it will contribute to fostering EU innovation and competitiveness.
Around the Globe: India
The Evolving Regulatory Framework in India: Impact on the Pharmaceutical Industry
Shagun Sharma, Vipul Kumar Gupta, and Helene Sou
Takeda
S

ince 2001, the regulatory environment for clinical research and drug development in India has undergone a substantial transformation. Key regulatory changes have significantly impacted the pharmaceutical industry and led to ongoing and upcoming regulatory developments in India. These industries will need to adapt to this new environment to remain competitive on the local and international markets.

Thanks for reading our December 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.