April 2024


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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

Wyatt Gotbetter Parexel

Editorial Staff

Alberto Grignolo, Editor-in-Chief

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 Belief BioMed

Richard Day University of New South Wales, Medicine, St. Vincent’s Hospital

Ling Su Shenyang Pharmaceutical University, Lilly Asia Ventures

J. Vijay Venkatraman Oviya MedSafe

Toshiyoshi Tominaga Keio University Hospital, Clinical and Translational Research Center

Cammilla Gomes Roche

Ebony Dashiell-Aje BioMarin

DIA Membership

Bringing together stakeholders for the betterment of global health care.

Executive Leadership

Why in the World Should You Come to San Diego?
Marwan Fathallah
Global Chief Executive, DIA

his June in San Diego (California), DIA simultaneously celebrates 60 years at the forefront of global life sciences and embarks on a journey to explore uncharted territories.

Our DIA 2024 Global Annual Meeting (DIA 2024, June 16–20) promises to transcend other annual life science events. It’s an inspiring gathering where we navigate challenges and unveil solutions in a dynamic and neutral global setting—an immersive experience dedicated to shaping the future of health.
Unleashing the Power of Reliance for Post-Approval Changes with 48 NRAs
Francesca Mangia
Melly Lin
Susanne Ausborn

F.Hoffmann-La Roche, Basel
John Armando
F.Hoffmann-La Roche – Genentech
Srinivasan Kellathur Nadathur
F.Hoffmann-La Roche, Singapore

ost-approval changes (PACs) are an essential part of product lifecycle management to ensure continuous supply of life-saving medicines in case of increased demand, to support continuous improvement and optimization of the manufacturing process, to remain state-of-the-art with analytical techniques, and to ensure continuity to comply with the updated regulatory requirements. However, bringing chemistry, manufacturing, and controls (CMC) changes through global health authority (regulatory) systems can be a complex, lengthy process that can take several years. At the same time, PACs represent a large proportion of regulatory submissions and their timely approval is critical to maintaining and ensuring continuous supply of quality medicinal products.

Towards the “Dossier In The Cloud” to Democratize Global Access to Medicines
A Conversation with Accumulus Synergy CEO Francisco Nogueira

n February 2024, the nonprofit industry association Accumulus Synergy announced the launch of its initial cloud-based information and data exchange platform through a regulatory reliance pilot project. This is in line with the overall mission of Accumulus to dramatically accelerate critical therapies to citizens of the world by using technology to simplify regulatory interactions and by bringing forward the much-anticipated concept of “a dossier in the cloud” to support real-time information exchange between those that develop medicines and those that review and approve them.

Beyond the App: Bringing Clinical Research to the Patient Using In-Home Patient-Centric Technology
Erica Smith
Spencer Health Solutions

ong-term retention of patients in clinical trials is both difficult and costly, which is challenging in an era in which drug development costs are increasing while success rates decrease. High dropout rates are likely to compromise study power and lead to trial failure, which can have catastrophic financial implications for drug developers. Clinical trial dropout can exceed 30% in pivotal phase 3 trials, and nearly 85% of trials fail to retain enough patients. Recruiting a single clinical trial patient can cost nearly $7,000, and the cost to replace patients that have dropped out is nearing $20,000. High dropout rates also place additional burdens on study recruitment, as failing to recruit sufficient numbers of patients is itself a cause of clinical trial failure.

Patient & Public Involvement – Stranded on the Adoption Curve?
Liz Clark
King’s College London
Amy Rogers
University of Dundee

atient and public involvement (PPI), or patient engagement (PE), is a positive development that aligns with broader patient empowerment movements. People affected by health conditions should have a say in the decision-making processes that will impact them. Moreover, when patients are involved in developing and testing new healthcare solutions, outcomes should be more patient-centered. Why has this knowledge not yet been translated into widespread action? This article explores why we seem stuck on the PPI adoption curve and how to get moving again.

Cancer Treatment: Advances in the 20th and 21st Centuries
Catherine L. Higgins, Stephen M. Rosenberg, Benjamin R. Schroeder, Sarah B. Hart, Julian Adams
Stand Up To Cancer, Los Angeles, CA

he reviewer of cancer research history can only marvel at the acceleration of drug discovery and development plus the multimodal and multidisciplinary innovations. The landscape imagines incredible potential, while maintaining ethical guidelines. Here, cancer treatment advances are explored with the future of artificial intelligence (AI) and machine learning (ML).

IQVIA RIM Smart Content Management Advertisement
DIA 60th Anniversary
Six Decades of Impact: DIA’s Global Journey
Developing an Idea into Action
Chris M. Slawecki

n October 1964, a group of pharmaceutical and medical communication and information professionals gathered in Philadelphia (PA) for conversations which culminated in the formation and inaugural meeting of the Drug Information Association (DIA) in Washington, DC, on October 9, 1965.

DIA 60th Anniversary
Globalization: The DNA of DIA
60th Anniversary Q&A with Minnie Baylor-Henry

IA: We are celebrating 60 years of DIA, and you’re one of the luminaries and a former DIA President. Let’s begin at the beginning: Please introduce yourself, your career, and your current work.

Minnie Baylor-Henry: I am Minnie Baylor-Henry, and I am a pharmacist and an attorney. I attended the College of Pharmacy at Howard University, am a proud Howard University graduate, and continue to engage in the university’s work, including as a member of the Howard University Board of Trustees—the only pharmacist on the Board, I might add. I am a huge advocate for the importance of the College of Pharmacy at Howard University.
Around the Globe: China
New Drug Approvals in China Reached Record High in 2023
Chunrong Yu
Gracell Biotechnologies
Xu Wang
Novo Nordisk (China) Pharmaceuticals

n 2023, the first full year after the COVID-19 pandemic, the National Medical Products Administration (NMPA) set a new record by approving the highest number of new drugs in China in a single year.

Around the Globe: Japan
Bridging the Gap in Open Innovation Between Academia and Pharmaceutical Companies in Japan
Fumitaka Noji
Moderna Japan
Takeshi Kono
Nippon Boehringer Ingelheim Co., Ltd.
Makoto Nagaoka
BeiGene Japan GK
On Behalf of DIA Japan’s Open Innovation Community

lthough open innovation in drug research and development has long been recognized as important in Japan, it has not yet become widely adopted practice, and there are significant gaps in understanding and expectations between academia and pharmaceutical companies. For example, when there is an excellent research outcome, academia seeks recognition and research grants for subsequent research through publication of the outcome; whereas pharmaceutical companies generally tend to keep the research results confidential to maintain their competitive edge. This article discusses current gaps and primary challenges to resolving them, aims to deepen understanding of the issues that both parties face, and proposes measures for improvement.

Thanks for reading our April 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.