September 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, Managing Editor, Global Forum 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.

A Pragmatic Perspective on the Hype and Hope of Large Language Models in Life Science
Angela Radcliffe
Bristol Myers Squibb

arge language models (LLMs) have been used in drug discovery for some time now, but many in the life sciences industry are just becoming aware of Generative AI: a buzzword that has become increasingly pervasive in society. Frequently and inaccurately associated with OpenAI, the company responsible for creating ChatGPT among numerous tools in the expansive AI domain, this technology garners a wide array of responses: lauded as a transformative innovation at one end of the spectrum and decried as a potential societal threat at the other. This article explores the transformative potential of LLMs underpinning Generative AI, their possible impacts on drug development, the regulatory hurdles they face, and the pressing need for a balanced approach to their utilization. There is a serious need for a judicious blend of innovation, regulatory compliance, and education to reap the maximum benefits of these tools while managing potential risks such as a proliferation of racial bias in healthcare, safety concerns that might arise from the use of AI-enabled decision support, or the undermining of public trust in our healthcare institutions if data is improperly consented for use in training data sets.

Language Diversity and Discrimination in Paediatric Clinical Trials: Cross-Border Access Case Study in Europe
Begonya Nafria Escalera
Sant Joan de Déu Research Institute, Barcelona, Spain

ncreasing racial and ethnic diversity in clinical trials will facilitate the meaningful representation of different patient communities. This will contribute to delivering treatments to the market ensuring security and efficacy for wider patient groups. FDA encourages sponsors to design a Race and Ethnicity Diversity Plan at the stage of the clinical trial protocol conceptualization. This is an important step to connect the eligibility criteria considerations in clinical trials to the real prevalence of a disease.

Pediatric clinical trials are challenging, also in terms of ensuring diversity in the recruitment of patients. These are studies of experimental treatments in the rare disease field. The small population living with these diseases and the limited samples motivate opening sites in a small number of countries. This article explores the opportunities that pediatric cross-border clinical trials entail at the European level. To achieve this important goal, it’s relevant to consider avoiding the use of language as an exclusion criterion and hence excluding non-native speakers from participating in clinical research in a foreign country.
Data Analytics Help Achieve Clinical Trial Diversity
Chris M. Slawecki

s increased diversity of patient populations who participate in clinical trials becomes more entrenched as a modern business, clinical, and regulatory requirement, new trial technologies and tools continue to emerge to help research and researchers meet these obligations. The combined impact of all these forces (see sidebox) is helping to focus research on more specific patient populations and needs. But this impact has built up enormous complexity for clinical trial data management and analysis.

DIA Japan Annual Meeting 2023 Advertisement
New Fellows of DIA Career Circles Mentoring Program
Application Deadline: September 15

IA is excited to announce our new Fellows of DIA Career Circles Mentoring Program as an exclusive new benefit of DIA membership.

This 9-month program is specifically designed to support DIA members who wish to develop their professional and networking skills. Successful applicants will be assigned to small groups of mentees, each group (Career Circle) supported by two DIA Fellows (co-mentors) who can help them along their professional journey. The program is for DIA members who are midlevel career professionals with a minimum of eight years of experience in the life science field. Read the FAQs for more information.

Special Section: Latin America
Interview with PAHO Director General Jarbas Barbosa

he Pan American Health Organization (PAHO) is the specialized international health agency for the Americas and works in partnership with ministries of health and other government agencies, civil society organizations, and numerous other partners throughout the region to improve and protect people’s health. In December 2022, PAHO celebrated 120 years of work in the public health arena of the Americas, collaborating with and supporting countries in the region to improve the health and well-being of their populations.

In this interview, PAHO Director General Jarbas Barbosa shares insights on how the organization is adapting to respond to the diversity of health challenges in the region, with a special focus on collaboration as a driving force for ensuring successful and sustainable solutions.

Special Section: Latin America
Cooperation and Reliance: What’s Next for Latin America?
DIA Europe 2023 Latin America Town Hall
Sérgio Cavalheiro Filho
The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)
Leonardo Semprun

t DIA Europe 2023, representatives from Latin America National Regulatory Authorities (NRAs), multilateral organizations, academia, and industry (see below) shared their collaborative experiences to help the region’s regulators build trust in research and regulation (and more efficiently use resources) in their jurisdictions, in the first Latin America Town Hall presented by DIA Europe.

Special Section: Latin America
Fostering Regulatory Convergence:
US FDA’s Regulatory Impact and Engagement in Latin America
Michelle Rodriguez
Vesa Vuniqi
FDA Latin America Office

023 marks the 15th anniversary of the opening of the US FDA’s first foreign office, in Beijing, China. FDA currently maintains offices in Brussels, Belgium (Europe Office); in New Delhi, India (India Office); and in three cities in Latin America that comprise the Latin America Office: San Jose, Costa Rica; Mexico City, Mexico; and Santiago, Chile. FDA opened these offices in response to a series of public health tragedies in which Americans were sickened or killed by poor quality or adulterated imported products, such as diverted and counterfeit glucose monitor test strips, adulterated heparin, and cantaloupes contaminated with salmonella.

This article explains the history and mandate of the US FDA’s Latin America Office to provide a better understanding of how this office has been collaborating to promote stronger and more resilient regulatory systems across the region.

Special Section: Latin America
How Brazilian Regulator ANVISA is Paving Its Way to Become a Global Reference Agency
DIA Global Annual Meeting 2023 ANVISA Town Hall
Antonio Barra Torres, Patricia Oliveira Pereira Tagliari, Leonardo Dutra Rosa

he DIA Global Annual Meeting 2023 hosted DIA’s first regulatory Town Hall fully dedicated to one regulator from Latin America, as leadership from Brazil’s Health Regulatory Agency, ANVISA, shared updates on the country’s regulatory priorities, the agency’s strategic priorities, and local trends, as well as ongoing regulatory convergence and collaboration initiatives. This article summarizes session highlights with a focus on ANVISA’s short- and midterm priorities, including its objective of being internationally recognized as a reference agency.

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Meeting Highlights: DIA China 2023
Expanding Patient Engagement and Patient Centricity in Clinical Trials in China
Shuting Li
Anhui Jimin Cancer Hospital
Xinfang Fan
Bayer Health Care Ltd.

n recent years, with the Chinese government’s vigorous support and all-round promotion for innovative drugs, more than 3,000 clinical trials with investigational drugs have been conducted annually. In this context, patient engagement has become increasingly important, and how to keep patients informed of progress in drug development and actively participating in clinical trials has become a hot topic in the pharmaceutical industry.

Meeting Highlights: DIA India 10th Anniversary Pharmacovigilance Conference
Wider Therapeutic Options Lead to Growing Scope for Pharmacovigilance
R. Shanmuga Sundaram
Oviya MedSafe
J. Vijay Venkatraman
Oviya MedSafe

s the lack of sufficiently efficacious therapeutic products leaves some medical conditions untreated or undertreated (a problem compounded by the emergence of new disease manifestations), innovative therapeutic options are increasingly considered as alternative or additive therapies. The use of digital therapeutics, biological products, gene therapies, medical devices, cosmetics, and other products opens not only better opportunities for a cure but also opportunities for vigilance platforms and processes to monitor the safety of these products and ensure that patient safety is not compromised.

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Drug labeling has emerged as a vital conduit for relaying essential medication information such as drug names, strengths, indications, contraindications, dosages, and administration instructions to healthcare practitioners and patients. Pharmaceutical companies are exploring innovative technologies to augment (not replace) regulatory professionals for managing and executing label changes. By leveraging the transformative capabilities of artificial intelligence and machine learning, organizations can free up valuable staff time, allowing them to focus on higher-value activities and strategic decision-making.

Around the Globe: Europe

Tribute to Noël Wathion
Emer Cooke
Noel Wathion smiling at the camera
Photo courtesy of EMA website.

oël Wathion worked at EMA from its beginnings in 1996 until just over two years ago and helped shape the agency we know today. At EMA, he was a leader with a very deep sense of commitment to our mission, our staff, European patients, and the network. He stood for everything that is best about EMA and the European Union and had a profound positive impact on both public and animal health in the EU for more than 25 years.

Thanks for reading our September 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.