August 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 Patient Engagement Specialist
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.

Executive Leadership

Message from Global Chief Executive:
Illumination, Information, Innovation, and Inclusion
A portrait of new DIA Global Chief Executive Marwan Fathallah smiling in a dark navy blue suit and white patterned-style button-up dress shirt underneath held together by a multi-colored (blue and black) tie
DIA Global Chief Executive Marwan Fathallah

y first DIA Global Annual Meeting was a tremendous capstone to my first six months with DIA and provides an ideal inflection point to simultaneously look back and look ahead. It is in many ways the beginning and culmination of DIA’s international, yearly conference and workshop calendar in Latin America, the Middle East, Europe, Japan, China, Canada, Singapore, and the US.

The New Frontier of Spatial Biomarkers: Digital Pathology and Spatial Genomics
Angela Qu

arnessing the strengths of spatial biomarkers offered by digital pathology and spatial genomics can give researchers deeper understanding of disease complexity, help pinpoint new therapeutic targets, and forge the path towards more precise and efficacious therapies. These transformative technologies have the potential to revolutionize precision medicine and accelerate the development of novel therapies for various diseases. As a result, major stakeholders, including large biopharmaceutical companies, research institutions, genomics laboratories, diagnostic developers, and data analytics and AI companies, are increasingly focusing their attention and investments on these new frontiers.

Thoughtful Consideration of Disabilities in Clinical Trials
Richie Kahn
Canary Advisors

he prevalence of adults living with disabilities varies widely from country to country. In Malta, 11% of the population has one or more disabilities. In Latvia, the figure is closer to 40%. Across the European Union (EU), an average of 24% are living with disabilities, and the proportion of those with disabilities only increases over time. Those living with disabilities are four times more likely to report that their healthcare needs are unmet, which may well lead them to pursuing clinical research as a care option.

Over the past few years, there’s been an increasing focus on clinical trial accessibility. After all, clinical trials are designed to be representative of the broader population, so it only makes sense to try to include as diverse a sample as possible. Still, there’s plenty of opportunity for thoughtful consideration of the needs of those with disabilities in order to ensure clinical trials are accessible for all.

Of course, awareness of disabilities is just the first step in designing clinical trials that are accessible to patients, irrespective of the particulars of the conditions they’re experiencing.

Life Officially Split in Two
One Appendix Cancer Patient’s Journey through Discovery and Recovery
Chris M. Slawecki

ppendix cancer is truly a silent, deadly killer. Appendix cancer has no effective diagnostic test or monitor. Most patients discover they have appendix cancer when it is found during an unrelated surgical procedure.

Cancer may be silent, but cancer patients are not. Here is the story of our own Katie Hill, DIA Senior Vice President & Managing Director for Learning and Digital Solutions. She, like many others, “accidentally” discovered through another medical procedure that she had appendix cancer. Below, Katie shares how she found her own treatment path and patient advocacy voice, and discovered how her own voice can also benefit others.

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Commentary: How to Build Trust in Clinical Research in Communities of Color
Roberta A. Albany
Cancer in the Know

’ve been to many conferences and heard a lot of talk about how to engage underrepresented populations, especially in Black/African-American communities, to enroll in clinical trials. Far too often, too many conferences place these discussions about enrolling missing populations at the end of their meeting or conference. By that time, the people who would benefit most from these solutions, or need to hear them the most, are often more concerned about getting home to their loved ones or may have already left the conference altogether. (My opportunity to speak was scheduled and presented on the first day of DIA GAM 2023; it was directly after the opening plenary session, while all attendees were still present and energized.)

Meeting Highlights: DIA China 2023
NMPA Plans to Start PIC/S Accession Procedure in 2023
Fang Zhou
Harbour BioMed

ince initiating the process of pre-accession to the Pharmaceutical Inspection Co-operation Scheme (PIC/S) in September 2021, the National Medical Products Administration (NMPA) of China has been actively participating in PIC/S-related activities and the progress has always been a focus of attention of the industry. In June 2023, a dedicated PIC/S symposium was held during the DIA China Annual Meeting where it was officially reported for the first time that NMPA’s pre-accession procedure has been successfully completed and NMPA will make a formal application for accession to PIC/S in 2023. This marks China’s active convergence with international standards to expedite the globalization process.

Meeting Highlights: DIA China 2023
Implementation of China’s Marketing Authorization Holder System:
Opportunities and Challenges
Wen Yin
Pfizer China R&D Center
Wanhe Deng
GSK China Investment

fter a four-year pilot program in 10 provinces, China’s MAH-based regulatory system was officially established with the implementation of the Drug Administration Law on December 1, 2019. Under this system, MAHs are authorized to produce drugs themselves or contract the production to drug manufacturing companies. As a result, the group of “B certificate holding companies” (companies with drug products that have entered the commercialization stage but do not yet have their own production capabilities) has grown significantly, becoming one of the main features of China’s pharmaceutical industry. At this stage of early implementation of a new regulatory mechanism, the trend of rapidly increasing numbers of MAHs entrusting contract development and manufacturing organizations (CDMOs) for drug manufacturing becomes a potential regulatory concern.

Meeting Highlights: DIA India 10th Anniversary Pharmacovigilance Conference
Impact of Technology on the Current and Future States of Pharmacovigilance
R. Shanmuga Sundaram
Oviya MedSafe
J. Vijay Venkatraman
Oviya MedSafe

echnology significantly enhances the advancement of pharmacovigilance, facilitating the development and adoption of more effective practices, and paves the way for a forward-looking roadmap. The 10th annual DIA India Pharmacovigilance Conference 2023, under the theme Redesigning and Transforming PV for Augmenting Patient Safety, explored the influence of technology on the present and future pharmacovigilance (PV) landscape.

White Paper

Technology’s Role in Addressing Potential Drug Safety Risks

White Paper

Technology’s Role in Addressing Potential Drug Safety Risks
While not all safety data sources are amenable to automation (and human review will always remain a critical component), artificial intelligence (AI) and natural language processing have proven to be effective, when properly applied to the right scenario, in drug safety monitoring. This paper discusses key learnings in applying an AI-enabled safety risk detection system to many different scenarios across multiple therapeutic areas and offers recommendations for developing a robust drug safety monitoring program to better comply with regulatory requirements.

Around the Globe: Australia

Retiring TGA Head Maps Australia’s Post-Pandemic Future
In April 2023, Professor John Skerritt retired after 11 years of exemplary public service as deputy secretary of the Health Products Regulation Group and head of the Therapeutic Goods Administration in Australia. “What’s really changed and what will persist after COVID? First, I think regulators have become a bit more comfortable in dealing with uncertainty. Uncertainty is the biggest challenge rather than benefit-risk,” he explains. “International regulatory collaboration became the basis of working together on these new products: We exchanged information on policies, on how the clinical data was developing, on the real-world performance of these drugs and vaccines, and on safety and post-approval requirements. These are going to persist.”

Around the Globe: Latin America

Advancing Biopharmaceutical Innovation and Patient Access: Call to Action for Latin American Regulators
Silvia B. Bendiner
Belkis Romeu

he need for further regulatory convergence and collaboration among regulators in Latin America remains an urgent topic. This article advances this discussion by expressing the strategic vision and professional legacy of Dr. Rafael Pérez Cristiá, a leading advocate for strengthening the region’s medicines regulatory systems. It also proposes how regulators in Latin America can leverage an initiative envisioned during his three-decade tenure as head and director of the Cuban Regulatory Authority (CECMED) and support advancing healthcare innovation in the region through knowledge sharing and training in regulatory sciences.

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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.