March 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 COUCH Health
Thomas Smith Independent Patient Consultant

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, 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

DIA Membership

Bringing together stakeholders for the betterment of global health care.

Evolution of Cancer Modeling Drives Drug Discovery
Beverly A. Teicher
National Cancer Institute, NIH

he models used in anticancer drug discovery are imperfect but have, over the past 40 years, continued to improve and improve again. As the tools for cancer drug discovery continue to improve, the lessons learned from earlier models are merged into the next generation of models, steadily moving toward models that more closely recapitulate the patient and the disease. We are closing in on the cure.

A Roadmap to Get Started With Quality by Design in Clinical Trials
Elvin Thalund
Digital QbD

ood clinical practice (GCP) has been implemented solely by directives on how, what, and when specific documentation must be available, without any relation to operational study risks and mitigation. Protocols are designed too late in the process, with limited time to assess efficiency or operational feasibility. The result is an immobilized and tangled industry with localized regulations and inefficient standard operating procedures (SOPs), taking an average of seven years and over $2.9B to bring a medical product to market.

To overcome this challenge, the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) issued E8(R1), General Considerations for Clinical Studies, introducing quality by design (QbD).

Can QbD be the panacea to untangle the current quality testing-based GCP? Yes, for two reasons. First, it provides an approach to identify risks many months before a protocol is approved. Second, it uses principles to design the simplest and most cost-effective solution to mitigate risks.

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What Does the Future of Patient Engagement Look Like?
Chi Pakarinen
Natasha Ratcliffe
COUCH Health
@COUCH Health
Thomas Smith
Life Sciences Public Engagement Specialist

atient engagement in medicines development (and largely in health research) is nowhere near the aspired systematic engagement that brings value to all involved stakeholders. Why hasn’t it been taken up and why is it still not a widespread approach if it is said to be a win-win for all?

Chi Pakarinen, Thomas Smith, and Natasha Ratcliffe discuss the future of patient engagement and their new role as Patient Engagement Editors of DIA Global Forum. They also have an important question for you, the reader, at the end.

White Paper

eCTD 4.0 Implementation Including Understanding of Regional Differences and Benefits

White Paper

IQVIA: eCTD 4.0 Implementation: Including Understanding of Regional Differences and Benefits
The Electronic Common Technical Document (eCTD) is the standard format for submitting applications, amendments, supplements, and other regulatory reports to health authorities around the world. eCTD v3.2 has been the default version for more than 10 years since its release in 2008. The initial draft implementation guidelines for eCTD 4.0 were developed between 2015 and 2016 to improve robustness, flexibility, long-term stability, and a more advanced lifecycle management process. After many years of collaboration with regulatory bodies and industry sponsors, eCTD version 4.0 is finally ready for implementation.
Special Section: Clinical Research in Ukraine
Protecting Clinical Research, Researchers, and Research Participants in Ukraine
Special Section Introduction
Francis P. Crawley
Good Clinical Practice Alliance – Europe (GCPA)

Strategic Initiative for Developing Capacity in Ethical Review (SIDCER)

Victoriia Dobrova
National University of Pharmacy, Ukraine
Kotone Matsuyama
Ethics Working Group, International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP)
Courtney Granville, Chris M. Slawecki

he ongoing Russian-Ukrainian war disrupted the global clinical trials and research ecosystem in an unprecedented way, challenging patient safety, continuity of care, and trial integrity. The immediate response of the Ukraine State Expert Center of the Ministry of Health and the clinical research community to maintain the continuity of clinical research and patient care has been exemplary. At the same time, the international clinical research community has come together in a committed and sustained manner to support Ukraine’s clinical research enterprise while remaining engaged in staff and patient support. While we have read and heard much about how the international clinical trials community collectively supported research during the COVID-19 crisis, there is much less awareness of how regulatory, ethics, and medicines support has been provided during this acute crisis in Ukraine.

Special Section: Clinical Research in Ukraine

Cancer Trial Continuity in Ukraine Is a Shared Responsibility and a Global Imperative

Oleksandr Stakhovskyi
National Cancer Institute (NCI), Ukraine

Ukrainian Society of Clinical Oncology (USCO)

Leonid Shylovskyi
Clinical Trials Assistance LLC, Ukraine
Richard Sullivan
King’s College London
Igor Bondarenko
Dnipro State Medical University, Ukraine

eople living with cancer often participate in clinical trials because that is their only, or the best, available care option. Participation in oncological trials gives them access to verified diagnosis, novel treatment approaches, and qualified and trained physicians mostly inaccessible compared to the average patient. The invasion of Ukraine poses a serious risk and threat to clinical research continuity that also constitutes patient care.

Special Section: Clinical Research in Ukraine
Responding to the Wartime Needs of Ukraine’s Patients with Rare Diseases
Anastasiia Saliuk
EURORDIS – Rare Diseases Europe

t the start of the war in 2022, as many as two million people in Ukraine were living with a rare disease. The disruption of care and access to medicines caused by the conflict was a major challenge.

As early as March 2022, EURORDIS launched a project to address urgent gaps in the procurement of orphan medicines and other needs expressed by people living with a rare disease, including the conduct of a survey to understand their reality.

Special Section: Clinical Research in Ukraine
Ethical Considerations: Clinical Research in Wartime Ukraine and Beyond
Chieko Kurihara
Kanagawa Dental University, Japan
Victoriia Dobrova
National University of Pharmacy, Ukraine
Francis P. Crawley
Good Clinical Practice Alliance – Europe (GCPA)

Strategic Initiative for Developing Capacity in Ethical Review (SIDCER)


ivilized society has constructed rules and protective measures to prevent repeating grievous human mistakes and to protect human health, safety, and rights. These include the CIOMS (Council for International Organizations of Medical Sciences) health research guidance on ethics, medical product development, and safety, the Declaration of Helsinki, and other guidelines which declare protection of life, human rights, and diversity of cultures.

Special Section: Clinical Research in Ukraine

Ethics: Giving Voice to the Unheard
Part 1:
Ethical Considerations for Research with War-Affected Populations

Ghaiath Hussein
Trinity Biomedical Sciences Institute, Dublin

o understand the impact of armed conflict on research ethics, and the obligation to involve the war-affected population in these ethical discussions, we must understand the impact of war on research itself.

Research is typically conducted by a group of researchers affiliated with a research institute, hospital, or academic institution. These researchers can plan because they have funding, know what the funded items are, have the study population, have the study area, and everything is generally settled. Ethical oversight is done by a regular institutional review board (IRB) which assesses each study protocol against national and international guidelines, a set of principles very standardized in terms of consent, respect for privacy, confidentiality, and data protection. There’s monitoring and follow-up. Publication ethics and standards are clear.

Special Section: Clinical Research in Ukraine

Ethics: Giving Voice to the Unheard
Part 2:
Ethical Consideration for Children in Wartime

Thalia Arawi
American University of Beirut Medical Center

hallenges abound in conducting research with children who have experienced war. Risks (physical and otherwise), awakening of traumatic experiences, informed consent, power relations, personal attachments, and methodological challenges must all be addressed with this vulnerable population.

Special Section: Clinical Research in Ukraine

Ethical Considerations on Clinical Trial Participation and Management in Wartime Conditions
Perspective from the IFAPP Ethics Working Group

Sandor Kerpel-Fronius
Semmelweis University, Hungary

o draw conclusions from the war in Ukraine which might be used in other catastrophic situations, we must evaluate events and facts carefully and objectively. It is useful to refer to the original concept of the Red Cross movement, which states that victims of war should be protected irrespective of which warring party they belong to. We should be guided by the principles of humanity, impartiality, neutrality, independence, and universality.

Special Section: Clinical Research in Ukraine
From COVID-19 Pandemic to War: Clinical Trial Industry Powers On Under Extreme Conditions
Anina Adelfio
Association of Clinical Research Organizations (ACRO)

he years 2020 and 2021 shaped how clinical trials are currently operationalized. When the COVID-19 pandemic began in early 2020, sponsors and Clinical Research Organizations (CROs) were up against unforeseen changes, including site closures and a shift to remote monitoring of source data. Sponsors and CROs set up business continuity teams to keep trials running despite the site closures they were seeing and unprecedented circumstances they were up against, and were able to deploy remote technologies while prioritizing patient safety and data integrity.

We Are DIA
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Solve and Sustain,
Leave Your Legacy:

New DIA GCE Marwan Fathallah
Hello my name is name tag
A portrait of new DIA Global Chief Executive Marwan Fathallah smiling in a dark navy blue suit and white patterned-style button-up dress shirt underneath held together by a multi-colored (blue and black) tie
New DIA Global Chief Executive Marwan Fathallah

n January 30, DIA announced that it had named Marwan Fathallah as President and Global Chief Executive. Mr. Fathallah will lead the organization to help drive thought leadership and innovation in therapeutic development to improve the health of people worldwide. Marwan took time from his onboarding schedule for this Q&A with Global Forum Editor-in-Chief Alberto Grignolo.

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Thanks for reading our March 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.