August 2022


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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 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.

Patient-Centricity and Product Quality: A Global Leadership Opportunity
Sarah Pope Miksinski
AstraZeneca Pharmaceuticals
Gregory Rullo
AstraZeneca Pharmaceuticals

n today’s increasingly complex and intricate pharmaceutical landscape, industry and regulators alike frequently state the same core aim: to ensure that pharmaceutical products offer significant benefit to patients. This concept is captured via varied phrasing including reference to the voice of the patient, benefit/risk analysis, confidence in the next dose, and patient centricity, among many others. However, in all cases, fundamental benefit to patients is essential and is broken down into three pillars: efficacy, safety, and quality. Accordingly, in the pharmaceutical quality landscape, it is critical to develop common ground among regulators and industry when discussing patient centricity.

Involving Patients as Authors of Company-Sponsored Journal Publications
Part A—Patient and Industry Perspectives
Dawn Lobban
Envision Pharma Group
Richard Stephens
Research Involvement and Engagement, BMC
Veronica Porkess
UCB Pharma

atient authorship of peer-reviewed publications is increasing, with patients not only presenting their own or academic research, but also participating as co-authors of pharmaceutical company-sponsored research. In this two-part series we:

  • highlight the drivers and value of involving patients as authors from both the patient and industry perspectives (Part A), and
  • discuss how journals are evolving to facilitate inclusion of the patient voice in peer-reviewed publications and extend the reach of publications to lay audiences (Part B).
Patients as Authors of Company-Sponsored Journal Publications
Part B—Publisher Perspective
Laura Dormer
Future Science Group
Richard Stephens
Research Involvement and Engagement, BMC
Caroline Halford
Medical Education, Springer Healthcare

atients are becoming increasingly involved in medical publications. This includes taking an active role in the publication process, as well as reading peer-reviewed journals that have traditionally considered their audience to be healthcare specialists. As academic publishers have traditionally worked with researchers and professionals across academia and industry, they are less familiar with working with patient communities or members of the public. This has led to a need to develop new ways of working that are appropriate both for the publishers, and for the patients and patient representatives with whom they are engaging.

In Part B of our series on patients as authors of company-sponsored journal publications, we discuss the ways in which patients are already working with publishers, the challenges that can be encountered, and how these can be and are being addressed.
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Optimize Additional Risk Minimization Measures with End-to-End Drug Labeling
Cham Williams

harmaceutical labeling is continuously in the spotlight, due to FDA regularly issuing new guidelines, including these in May 2022, to which manufacturers must adhere. Historically, the management and tracking of labeling required a “mishmash” of different solutions for various aspects of the labeling operation, including programs like Microsoft Project for planning and monitoring. The regulatory agency also requires drug companies to create a risk minimization plan, particularly for sensitive medications such as those that can affect pregnancy.

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Meeting Highlights: DIA Global Annual Meeting 2022

Meeting Highlights from DIA Global Annual Meeting 2022

Meeting Highlights: DIA Global Annual Meeting 2022
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The Future of Healthcare Is…
Inclusive, Global, Individual, Digital

n Association executive, two regulators, two professors, a patient advocate, a patient, and a graphic artist walked into a packed congress hall. Inspiration ensued.

The DIA Global Annual Meeting 2022 celebrated DIA’s first post-pandemic global in-person meeting. Convened in Chicago (IL) under the theme Collaborate to Innovate, the opening plenary set the tone for the week and explored the question What is the Future of Healthcare? from four connected perspectives—Inclusive, Global, Individual, Digital—that were documented in real time by graphic artist Alison Vellas (Ink Factory).
Financial Return on Investment of Decentralized Clinical Trials
Pam Tenaerts (Medable) and Ken Getz (Tufts Center for the Study of Drug Development) recap their DIA GAM 2022 presentation about employing the expected net present value (ENPV) measure to determine the financial return on investment in decentralized clinical trials (DCTs).

“This was a nice way for us to understand the impact of DCT deployments in clinical trials and compare performance. And we learned through those comparisons that DCT-supported protocols generated or yielded faster cycle times, not only in the study initiation phase or during the study closeout phase,” Ken explains. “When we dug deeper, we found that some of the partial explanation for this speed advantage improvement in the DCT-supported trials was associated with recruitment and retention improvements, as well as a reduction in the number of protocol amendments.”

“Financial return on investment is obviously valuable and good,” Pam continues. “But we also need to think about the patient experience in these trials and how that might be improved. As you make trials easier for people to participate in, we can start reaching people that represent the disease and not just the ones that are able to participate. As an industry, we have the responsibility to provide data to show the promise that we always say DCTs will bring. That will also accelerate responsible adoption, giving us a pathway to having more evidence for all these other diseases that we don’t quite have evidence for.”

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WHO Pilot Formalizes CSA Process to Assist Developers
The World Health Organization has initiated a pilot coordinated scientific advice (CSA) procedure whereby product developers may obtain WHO advice on the most appropriate way to generate evidence on a product’s benefits and risks. “WHO has been interacting with health product developers for many years but there wasn’t a standardized or formalized approach to do it. We’re quite well-positioned to be a coordinated and single entry point to initiate that dialogue,” explains WHO Science Division Unit Head Anna Laura Ross. “We have additional considerations around the needs of lower- and lower-middle-income countries or settings with limited resources,” says Science Division Technical Officer Mercedes Perez Gonzalez. “For example, the need for inclusion of specific populations, where you would find certain concomitant infections not necessarily present in higher income settings.”

Around the Globe

African Union Selects Rwanda to Host African Medicines Agency

n July 16, 2022, the Executive Council of the African Union (AU) announced that Rwanda had been selected to host the first headquarters of the African Medicines Agency (AMA).

The AU approved the treaty for establishing the AMA in February 2019 after five years of consultations across the African continent led by a task force established by the World Health Organization (WHO) and AU Commission. The Agency was formally established after the minimum number of 15 ratifications by AU countries was reached in November 2021. In fact, as of May 2022, 31 of the 55 nations in the AU have signed/ratified the treaty (19 ratified and deposited + 3 ratified but not yet deposited + 9 signed but not ratified).


Medication Errors Emerge as Global Patient Safety Issue
In 2021, the 74th World Health Assembly adopted the Global Patient Safety Action Plan (GPSAP) 2021-2030 towards eliminating avoidable harm in healthcare. “Here in the United States, the Office of the Inspector General reports that one in four Medicare patients suffer harm in US hospitals,” says Sue Sheridan, a founding member of Patients for Patient Safety US, formed to advance this global plan in the United States. “Medication error is a huge global issue,” continues US founding member Soojin Jun in this interview with Mary Stober Murray (National Minority Quality Forum).
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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.