April 2022


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Editorial Board

Content stream editors

Translational science
Gary Kelloff US National Institutes of Health

regulatory science
Isaac Rodriguez-Chavez ICON plc

Patient engagement
Trishna Bharadia Patient Advocate and Media Contributor
Mary Stober Murray National Minority Quality Forum

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

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

Thomas Kühler Sanofi R&D

J. Vijay Venkatraman Oviya MedSafe

Ozawa Goshi Real Discovery Outdoors Co,. Ltd.

Cammilla Gomes Roche

Ebony Dashiell-Aje BioMarin

Young Professionals Editors

Kaley Lugo Daiichi Sankyo
Saloni Patel Acorda Therapeutics

DIA Membership

Bringing together stakeholders for the betterment of global health care.

Immunogenic Cell Death Can Overcome Resistance to Checkpoint Inhibitors
J. Milburn Jessup
Magnolia Place Consulting

heckpoint inhibitor therapy with ipilumumab, nivolumab, pembrolizumab, or similar antibodies has produced outstanding clinical responses in some patients with advanced carcinomas or melanomas. However, most patients are resistant to checkpoint inhibitors because their immune responses are blocked by an immunosuppressive tumor microenvironment (TME). Resistance is characterized by a lack of immune cells infiltrating tumors, stromal macrophages and fibroblasts that release pro-metastatic cytokines, and immune cells that are exhausted and dysfunctional. To address this resistance, we focus on a process called immunogenic cell death (ICD) that rejuvenates antitumor immunity and changes the TME to an antitumor state.

Unlocking Scientific Research for Lay Audiences
Putting Recommendations for Plain Language Summaries into Practice
Lauri Arnstein Williams
Jacqui Oliver
Envision Pharma Group

lain language summaries (PLS) of publications form part of the wider democratization of science, enabling a broader audience to access and potentially understand scientific and healthcare research. However, many practical questions around these important summaries remain: what types of PLS should we be writing, which publications should have a PLS, and where should PLS be published? Three key sets of recommendations for PLS were released in 2021. This article explores what these recommendations mean in a practical sense and what more is required to further the development of PLS in terms of support and guidance.

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Meeting Highlights: DIA Global Pharmacovigilance and Risk Management Strategies
DIA Global Pharmacovigilance & Risk Management Strategies

Meeting Highlights: DIA Global Pharmacovigilance and Risk Management Strategies

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Pharmacovigilance: Artificial Intelligence and Global Regulatory Changes During the Pandemic
Shyreen Kamal
Maria Paula Bautista Acelas
Drug Information Association

OVID-19 transformed many aspects of pharmacovigilance (PV) practice and reshaped the future of drug and vaccine development. Collaborative efforts between many stakeholders, especially pharmaceutical companies and regulatory bodies, made it possible to develop and approve safe and effective COVID-19 vaccines in a short period. The adverse event (AE) collection process evolved due to the enormous number of safety reports received globally in 2021, resulting, for example, in a shift toward automation (artificial intelligence) in handling safety data to reduce the chance of human error in the process, and in a number of important regulatory changes around the world.

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Around the Globe
Australia National Medicines Policy Revision Reshaped by Community Feedback

Richard Day
University of New South Wales


ustralia’s National Medicines Policy (NMP), gazetted in 2000, is being revised and the draft policy was made available for final, widespread community and stakeholder feedback. Final public consultations closed on March 2, 2022.

Around the Globe

Shaping Future-Oriented R&D Talent Innovation in China
Part 1: Introduction and Strategic Frameworks
DIA China Leadership and Career Community

ver the past five years, China’s pharmaceutical innovation industry has experienced what has been called the Cambrian explosion: significant acceleration in the launch of innovative products, rapid expansion in the number of R&D pipelines, and increasing capital investment in R&D.

Around the Globe

Shaping Future-Oriented R&D Talent Innovation in China
Part 2: Education Reforms and Capability Enhancements
DIA China Leadership and Career Community

o meet the challenges of new requirements for R&D talent in the context of global pharmaceutical innovation trends, pharmaceutical R&D innovation leaders in China must exhibit strategic thinking, efficient cross-departmental communication and collaboration, and an agile working model in addition to their drug-development expertise.

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Around the Globe

Interview with EMA Head of Advanced Therapies Ana Hidalgo-Simon
EMA Head of Advanced Therapies Ana Hidalgo-Simon
EMA Head of Advanced Therapies Ana Hidalgo-Simon

MA’s Head of Advanced Therapies Ana Hidalgo-Simon discusses steadily growing numbers of regulatory applications in the advanced therapy field, the vital importance of patient group insights, RWE collection and curation, hospital exemptions, manufacturing challenges, and more.

Around the Globe

Ensuring Data Privacy in EU Pharmacovigilance
Gro Laier
BASE life science

he protection of natural persons in relation to the processing of personal data is a fundamental right in the European Union. Data privacy regulations support these fundamentals. However, the right to protection of personal data is not an absolute right: e.g., it must be balanced against other fundamental rights, in accordance with the principle of proportionality.

Around the Globe

Pharmaceutical Industry Perspective on Use of RWD/RWE in Brazil

eal-world data (RWD) and real-world evidence (RWE) are increasingly used to inform regulatory decisions around the world. As a rapidly evolving regulatory topic, current discussions including regulators and industry highlight the need to clarify the regulatory standards for data quality, acceptable data sources, and analytical methods that support expanded use of RWE in assessing product efficacy/effectiveness and demonstrating its benefits, as well as evaluating product safety. This article presents the results of a 2021 survey organized by industry associations in Brazil to assess the local regulatory environment and use of RWE/RWD studies in regulatory submissions to ANVISA, as well as the challenges and learnings from multiple companies.

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Automation in Scientific Writing Improving Healthcare Products Communication
Joseph Cheng
Daiichi Sankyo, Inc.

ver the past few decades, advances in technology have resulted in progressive automation in every industry. This trend has also touched the scientific writing community. Programmed automation features can be found even in the world’s most popular word processor and a gold standard in the writing industry, Microsoft WordTM. It is evident that progress in artificial intelligence and deep learning will result in substantial automation of how scientific documents are created.

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Thanks for reading our April 2022 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.