May 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

Julie O’Brien Pfizer

J. Vijay Venkatraman Oviya MedSafe

Ozawa Goshi Real Discovery Outdoors Co,. Ltd.

Cammilla Gomes Roche

Ebony Dashiell-Aje BioMarin

Young Professionals Editor

Kaley Lugo Daiichi Sankyo

DIA Membership

Bringing together stakeholders for the betterment of global health care.

Next-Generation Sequencing (NGS) Informs Therapy Decisions in Patients with Metastatic Cancer
Whom, When, and How Often to Test?
Erin F. Cobain
Arul M. Chinnaiyan
University of Michigan Rogel Cancer Center

ext-generation sequencing (NGS) is routinely used in the clinical care of patients with advanced, metastatic cancer to identify potential therapeutic targets. In some disease settings, NGS has been incorporated into standard-of-care practice to identify a biomarker predictive of benefit from an FDA-approved therapy. In other settings, it is used to identify genomic alterations that may allow for use of a targeted therapy within the context of a clinical trial or off-label. In addition, NGS may also identify inherited cancer predisposition in approximately 15% of patients. Identification of inherited factors that may have contributed to cancer development has important implications for both the patient and family members. Here we explore the evidence that supports use of NGS in all patients with metastatic cancer, as well as the factors that should be considered with regards to timing and type of NGS testing utilized.

Why “Participant Voice and Experience” Matters in Clinical Research
Kendal K. Whitlock
Decentralized Trials & Research Alliance, Research Curriculum
Initiative 3C

uring the early months of the coronavirus pandemic, drug development was accelerated in response to the sudden increase in morbidity and mortality. However, as Emergency Use Authorizations (EUA) were issued but later revoked (e.g., hydroxychloroquine and chloroquine), public confusion grew about which therapies were effective and safe. By summer 2020, clinical research methods were under a global spotlight and trust in science has been on trial ever since.

Without the knowledge of demographic variations (e.g., between men and women, different age groups) derived from a rigorous clinical investigation, the optimal use of medicines remains unknown and is based on a limited participant pool. For future therapies to have broad generalizability, learning from the participant’s voice and experience (PVAE) in clinical research is an urgent necessity. This article highlights key strategies used in clinical research to capture the PVAE based on existing regulatory frameworks.

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New Requirements for Lay Language Summaries of Clinical Trials Are Here—Are You Prepared?
Chi Pakarinen
Patient Engagement and Multi-stakeholder Collaborations
Jo Dewhurst
ICON, Plc.
Dan Bilodeau
ICON, Plc.
Solange Corriol Rohou
Sheila Khawaja
World Alliance for Pituitary Organizations

ay language summaries—sisters to Plain Language Summaries—focus on summarizing clinical trial results in an understandable way to provide increased transparency to the patients and interested general public. The European Clinical Trial Regulation now requires sponsors to provide a lay summary of clinical trials in a set time period following the trial end. To support sponsors, a guidance cocreated and endorsed by the European Commission aims to help implement organizational capabilities to write and share lay summaries.


Complexity Continues to Challenge Clinical Costs
In March 2022, the Tufts Center for the Study of Drug Development (CSDD) issued an impact report that examines clinical trial budgets and factors that drive commonly observed variations and cost. “Part of the focus of all of these studies is to understand how complexity, how increased customization in our trials, more fragmentation as we have different parties involved, contributes to longer cycle times and larger budgets than comparable studies when we control by therapeutic area,” explains Tufts CSDD Executive Director and Professor Ken Getz, who also serves as board chair for the Center for Information and Study on Clinical Research Participation. “Not only are we seeing longer timelines today, and larger budgets, but we see more variation around the mean for any of these measures, which means that it’s getting more difficult for companies to predict or to anticipate and manage an expected timeline or an expected budget.”
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Meeting Highlights: DIA Europe 2022
Meeting Highlights from DIA Europe 2022
Meeting Highlights: DIA Europe 2022
How to Future-Proof the EU Medicines Regulatory System
Nick Sykes

n its Pharmaceutical Strategy, the European Commission intends to “future-proof” the EU medicines regulatory system. What does that mean for a system that has existed for more than two decades but has constantly evolved as science, technology, and societal expectations have changed? DIA Europe 2022 featured much discussion on what “future-proofing” looks like.


Maximizing Regulatory Resources Across Latin America
While COVID-19 sharpened global understanding of the importance of efficient medicines review and regulation, the Pan American Health Organization (PAHO) has been systematically assessing national medicines regulatory authorities in the Americas since 2010. “It’s inevitable that we reflect on what happened during the pandemic but also that we take that as an enormous opportunity to move forward in a way that can take the lessons out of regulation in a time of crisis to prevent crisis,” suggests PAHO Medicines Health & Technologies Unit Chief Analía Porrás in this conversation with Susan Zavala Coloma (DIGEMID, Peru) and Global Forum Regional Editor for Latin America Cammilla Gomes (Roche). “The idea of the assessment is not just to showcase what’s going well in a regulatory authority but, with the regulatory authority, to decide on the priorities for opportunities for improvement. We gained the trust of our regulatory authorities and our other stakeholders like the industry; with that trust, the authorities know that we’re going to push them to be their best.”
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Around the Globe

New Drug Approvals in China in 2021
Xu Wang
Novo Nordisk (China) Pharmaceuticals Co., Ltd.

he number of new drug approvals in China set a new record high in 2021. A total of 61 new drugs were approved by the National Medical Products Administration (NMPA), up from 46 in 2020. “New drug” is defined in this article as new chemical drugs or new biological products approved for the first time in China, excluding any new indications, new dosage forms, or new combination of approved drugs.

Around the Globe

Interview with European Infrastructure for Translational Medicine Scientific Director Toni Andreu
Toni Andreu smiling
European Infrastructure for Translational Medicine Scientific Director Toni Andreu

ATRIS, the European Infrastructure for Translational Medicine, is an EU-funded program that facilitates scientific collaboration amongst public institutions from 14 member states.

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Thanks for reading our May 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.