July 2023


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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 Independent Consultant

Patient engagement
Chi Pakarinen MediPaCe
Natasha Ratcliffe COUCH Health
Thomas Smith Independent Patient Consultant

Data and Digital
Lisa Barbadora Barbadora Ink

Young Professionals Editor

Kaley Lugo Daiichi Sankyo

Editorial Staff

Alberto Grignolo, Editor-in-Chief Parexel International

Sandra Blumenrath, Managing Editor, Scientific Publications DIA Scientific Communications

Chris M. Slawecki, Senior Digital Copyeditor DIA Scientific Communications

Linda Felaco, Copy Editor and Proofreader

Regional Editors

David Mukanga Bill and Melinda Gates Foundation

Jin Shun Sandoz

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

Ozawa Goshi Real Discovery Outdoors Co,. Ltd.

Cammilla Gomes Roche

Ebony Dashiell-Aje BioMarin

DIA Membership

Bringing together stakeholders for the betterment of global health care.

Human Interaction: Risk-Mitigation Recommendations When Using Technology in Clinical Trials
Bill Barrasso
Clinical Ink

ecent technological advances have expanded accessibility of clinical studies to larger and more diverse populations. However, technology alone will not ensure successful completion of research studies. The human element—how sites, sponsors, and patients use technology within applicable regulatory guidelines—is still the key to maintaining compliance, minimizing risks, and ensuring patient safety.

This article references recent guidance from the FDA (Decentralized Clinical Trials for Drugs, Biological Products, and Devices, Guidance for Industry, Investigators, and Other Stakeholders, May-2023) and EMA (Guideline on computerised systems and electronic data in clinical trials, March-2023). These publications highlight the importance of human involvement when using technology in clinical trials.

The FDA draft guidance provides a good collection of evolving Decentralized Clinical Trial (DCT) best practices. Newcomers to the space will benefit from reviewing the details included therein. There are also key sections regarding site and sponsor responsibilities that are crucial to ensuring compliant trial completion.

The Role of Pharmacies and Local HCPs in Enhancing Diversity in DCTs
Ramita Tandon
Isaac R. Rodriguez-Chavez
4Biosolutions Consulting

he future of clinical trials relies on addressing ways in which we can put diverse patients at the center of the medical product development process. Specifically, we need to listen to the voices of those historically misled and underrepresented in research and demonstrate how clinical trials may be a viable care option. These efforts could directly address the access and diversity issues impacting representativeness in research.

Recently, pharmacy models in clinical research have emerged with quick, specific successes. The latest two FDA guidance documents issued in November 2020 and April 2022 related to diversity in clinical investigations have further validated the need to increase both access and diversity. This article discusses the evolving influence of the pharmacy model and local Healthcare Providers (HCPs) on Decentralized Clinical Trials (DCTs) enabled by Digital Health Technologies (DHTs), exploring key FDA guidance documents for DCTs and diversity initiatives.
Prostate Cancer: The Disparate Burden of the Disease Among Black Men
Lorelei Mucci
William Dahut

American Cancer Society

he burden of prostate cancer is considerable and growing. In 2020, 1.4 million incident prostate cancers were diagnosed and 375,000 prostate cancer deaths occurred globally. By 2040, the numbers will grow to 2.4 million incident prostate cancers and an almost doubling of prostate cancer deaths per year.

Prostate is also the cancer with the largest racial disparities, with the greatest public health impact among Black men. Racial disparities are evident at every stage of the prostate cancer continuum, including an excess cancer incidence, a higher rate of diagnoses of advanced-stage tumors, increased prevalence of metastatic prostate cancer survivors, and an excess prostate cancer mortality. This article discusses prostate cancer racial disparities in the United States and across the globe, and provides a call to action to reduce and eliminate these disparities in order to improve prostate cancer outcomes for all.
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Patient Engagement: Evolution of Who Knows What, Part 1
DIA GAM 2023 Patient Engagement track chair Pujita Vaidya discusses the definition, history, and current state of patient engagement in clinical research and care with cancer survivors and “ePatients” Dave deBronkart and Stacy Hurt (Patient Advocacy Ambassador, Parexel). “Many people were trained for generations to think of patients as poor people who just don’t understand how to save their own lives. I’m here to tell you, we are not only eager to help but we’re tired of being treated as crash test dummies,” Dave says. “Engagement doesn’t just mean invite me into your process. It also means listen to me as a thinking, intelligent person who might have some ideas that you haven’t thought of.”


Patient Engagement: Evolution of Who Knows What, Part 2
In Part 2 of this podcast, “ePatients” Dave deBronkart and Stacy Hurt (Patient Advocacy Ambassador, Parexel) discuss new opportunities in the future of patient engagement in clinical research and care with DIA GAM 2023 Patient Engagement track chair Pujita Vaidya. “This advent and acceleration of artificial intelligence (which should be augmented intelligence) and digital biomarkers should not replace the physician-patient relationship but enhance it,” Stacy explains. “Lastly: If you want sustainable patient insights, don’t only ask a patient, but invest in and hire patients as internal subject matter experts and full-time employees of your organization.”
Digital Technologies Improve Outsourcing Oversight and Information Exchange
Timm Pauli
Jim Nichols

igital innovation is playing an increasingly important role in the regulatory process. As such, it should be an integral part of the outsourcing relationship. Digital technologies are increasingly being integrated into many regulated processes in the pharmaceutical industry. Technology solutions such as artificial intelligence, automation, and natural language processing can now support the pharmaceutical compliance journey.

Effective Partnering between Small Biopharmaceutical Companies and Their Service Providers: A Model That Works
Matthew Barnes
Sheila A. Mathias
Virpax Pharmaceuticals, Inc.

eciding to join a company like Virpax Pharmaceuticals is both exciting and daunting. The authors have both worked for other small biopharmaceutical companies in the past, but with just six full-time employees, Virpax is decidedly one of the smallest companies either author has worked for.

A small company structure promotes nimble decision making, but it can also provide challenges due to the limited bandwidth of the team members. This limits the team’s ability to effectively manage all required tasks and places constraints on the amount of time available to strategize.
From Documents to Digital Data: Clinical Drug Development’s Burning Platform
Rob DiCicco
TransCelerate BioPharma, Inc.
Bill Illis
Dave Evans

espite the stated intent to adopt digital technologies in the clinical development area of R&D, uptake has been relatively slow. There are various reasons for this, not the least of which is how we think about documenting critical regulatory required information. Despite significant technical advances in our ability to document (the verb) this information, we are stuck with documents (the noun) in a way that locks important data in paper or electronic forms of paper (docx, PDF, etc.), often camouflaged in unstructured blocks of text.

Commentary: The Reality of EU CTR—Promise Delivered or Missed Opportunity?
Rose-Marie Swallow
The views expressed in the following article are the opinions of the author and not of DIA.

nyone involved in obtaining approval to conduct clinical trials in the EU who has had to navigate the disparate and complicated systems in place since the Clinical Trials Directive was implemented in 2001 has long dreamt about change. Having a harmonized clinical trial approval system that would relieve the administrative burden and misalignment between countries in the EU so that the region would become the place to conduct clinical research in the future was and remains the goal.

Meeting Highlights: DIA Europe 2023
New Agency for the New Era
African Medicines Agency and the Evolution of Continental Regulatory Systems
Nevena Miletic
Africa Regulatory Network, IFPMA
Ian Hudson
Bill and Melinda Gates Foundation

rom 22-24 March, key stakeholders in global health gathered in Basel for DIA Europe 2023. Under the theme “Advancing Health Priorities,” this conference aimed to Drive Insights to Action by connecting key policy discussions to real-world knowledge and accelerate growth and performance in the drug development ecosystem.

On 23 March, DIA Europe hosted discussions highlighting the important role of the new African Medicines Agency (AMA) in the evolution of regulatory systems across the African continent. The discussion gathered multidisciplinary experts from the African Union Commission, African Union-New Partnership for Africa’s Development (NEPAD), the European Medicines Agency (EMA), World Health Organization (WHO), the South African Health Products Regulatory Authority (SAHPRA), the Bill and Melinda Gates Foundation, and industry, who shared their thoughts on the establishment of the Agency, its future structure and function, how to facilitate regulatory reliance, and perspectives about how the AMA can deliver its objectives, including how the EMA can assist in establishing the AMA.
Around the Globe: Latin America
Strategies to Achieve Greater Competitiveness for Clinical Trials in Latin America
Mariana Abdala
Crystal Research

linical trials in Latin America still face many challenges: Unstable regulations, bureaucratic complications, lack of adequate infrastructure, and an unending need to train researchers, physicians, and related research personnel show how much work remains to be done. Although quality levels and standards have noticeably improved, Latin America produces only about 3% of the world’s research, far behind Europe and Asia, which account for 25% and 29%, respectively. There is vast room for improvement.

Around the Globe: US
US Legal Requirements and Regulatory Guidance to Increase Clinical Trial Diversity
Jewell Martin
Mia Elliott
Nimi Chhina
Ebony Dashiell-Aje
BioMarin Pharmaceutical, Inc.

espite broad awareness and acknowledgement about the lack of diversity in clinical trials, challenges remain. In their 2020 Drug Trials Snapshots Summary report, FDA provided average percent participation in clinical trials by subpopulation for new molecular entities and therapeutic biologics approved in 2020 and the results were stark, with disproportionately high rates of white participants (75% white) and low percentages in other groups (11% Hispanic, 8% Black or African American, and 6% Asian). These disparities were more apparent compared to the US population composition (61.6% white, 18.7% Hispanic, 12.6% Black or African American, and 6% Asian).

We Are DIA
DIA Congratulates New 2023 Fellows and Global Inspire Award Winners

New Fellows of DIA

Judith Ng-Cashin
Judith Ng-Cashin
Immediate Past Chair,
DIA Board of Directors
Stephanie Y. Crawford
Stephanie Y. Crawford
Executive Associate Dean for Faculty Affairs & Strategic
Initiatives, College of Pharmacy

Pharmacy Systems Outcomes & Policy Center Affiliate,
Center for Pharmacoepidemiology & Pharmacoeconomic Research – University of Illinois, Chicago

Barbara Lopez Kunz
Barbara Lopez Kunz
Former President and Global Chief Executive, DIA
Junko Sato
Junko Sato
Director, Office of International Cooperation
Pharmaceuticals and Medical Devices Agency (PMDA)
Thanks for reading our July 2023 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.