July 2020
July 2020


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Editorial Board

Content stream editors

Translational science
Gary Kelloff US National Institutes of Health
David Parkinson ESSA Pharma, Inc.

regulatory science
Yoshiaki Uyama Pharmaceuticals and Medical Devices Agency (PMDA)
Adora Ndu BioMarin Pharmaceutical, Inc.

Patient engagement
Deborah Collyar Patient Advocates In Research (PAIR)
Lode Dewulf Servier

Monika Schneider Duke-Margolis Center for Health Policy

Editorial Staff

Alberto Grignolo, Editor-in-Chief Parexel International

Ranjini Prithviraj, Global Associate Director, Content Collaboration DIA Publications

Sandra Blumenrath, Science Writer DIA Publications

Chris M. Slawecki, Senior Digital Copyeditor DIA Publications

Regional Editors

David Mukanga Bill and Melinda Gates Foundation

Silke Vogel Duke-National University of Singapore Medical School

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

Judith Glennie JL Glennie Consulting, Inc.
Megan Bettle Health Canada

Ling Su Shenyang Pharmaceutical University, Lilly Asia Ventures

Thomas Kühler Sanofi R&D

J. Vijay Venkatraman Oviya MedSafe

Akiko Ikeda Janssen Pharmaceutical K.K.

Cammilla Gomes Roche

Inas Chehimi Novartis

Ebony Dashiell-Aje BioMarin

Young Professionals Editor

Kaley Lugo Medical Affairs, Daiichi Sankyo

DIA Membership

Bringing together stakeholders for the betterment of global health care.

Ethnic Differences, Regulatory Policies, and COVID-19

Toshiyoshi Tominaga
Japan Self-Medication Industry

he ICH E5 guideline “Ethnic factors in the acceptability of foreign clinical data” and E17 guideline “General principles for planning and design of multi-regional clinical trials” present harmonized methodologies to efficiently develop drugs in multiple regions while considering ethnic differences in drug responses.

While the regulatory authority of a country is expected to judge if its jurisdictional population reacts uniquely to the tested drug to warrant inclusion in a Multiregional Clinical Trial (MRCT), the science often does not inform the judgement, for want of necessary evidence—especially in the earlier phases of development. Instead, the judgement often reflects a country’s policies on drug development in general. Recent development of anti-COVID-19 agents affords some relevant insights.

Six Guiding Principles for Pharmaceutical Companies to Achieve Global Quality

Henrietta Ukwu
Otsuka Pharmaceutical Development & Commercialization, Inc.

OVID-19 has ushered in a new age of urgency for pharmaceutical companies, one that simultaneously requires increased regulatory flexibility and unwavering commitment to quality. Now more than ever, companies recognize the importance of ensuring quality at each of their units and sites around the world. To achieve oversight of their quality outputs across the globe under these challenging circumstances, organizations must globalize the quality function rapidly but also thoughtfully.

Globalizing any technical function is a daunting proposition, so here I share a blueprint for successfully globalizing quality: six guiding principles distilled from decades of experience in globalizing functions (Table 1). By following this blueprint to achieving global quality, organizations can reap the benefits of quality culture, including compliance excellence and competitive advantage.

Patient Engagement in COVID Times: Looking Behind the Numbers

Lode Dewulf

atients have been asking to be heard and engaged for decades. More recently, their call has been echoed by academics and providers. Today, Patient Engagement in the development, launch, and use of medicines has become an accepted necessity. Indeed, the historical risk of engaging patients has been surpassed by the future risk of not engaging patients.

And then COVID happened…


DIA Keynote Calls for Expanded COVID-19 Trial Parameters
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Improving Access to CAR T Therapy: It’s Not Just Payment

Michael Kolodziej
ADVI Health
Ira Klein
Marc Samuels
ADVI Health

he development of chimeric antigen receptor (CAR) T therapy for patients with advanced hematological malignancies represents one of the greatest successes in bringing basic tumor immunology to the bedside. The ability to potentially cure patients with end-stage acute lymphocytic leukemia (ALL) and diffuse large B-cell non-Hodgkin lymphoma (DLBCL) with a personalized immunotherapy seems science fiction. And yet the rate of uptake of this therapy has been slow, particularly in US Medicare beneficiaries.

At least part of this is related to Medicare’s reimbursement methodology, antiquated for the advent of cell and gene therapies. But this isn’t the only factor holding back access; challenges inherent to the complexity of cell therapy will need to be solved in order to move this forward. Other cell therapies that are in the pipeline will likely be in the same boat, so now is as good a time as any to solve these issues. These solutions will require collaboration of all the stakeholders in the oncology ecosystem.

We have identified three major areas that should be addressed:

  1. Measuring what matters: recognizing real world value.
  2. Patient flow and practice management: enhancing the patient experience.
  3. Payment policies for cell therapies: acknowledging and fixing Medicare’s shortcomings.


COVID-19: Diagnostic Testing Now and in the Future

As a response to the current pandemic, and with the support of the DIA Knowledge Brigade, we have brought together experts from across the global healthcare product development continuum for an ongoing series of live, virtual panel discussions on how we continue to work towards our shared mission of accelerating therapies to patients, during the coronavirus crisis. Watch COVID-19: Diagnostic Testing Now and in the Future below now.

For other webinars in this DIA DIRECT COVID-19 Webinar Series, please visit our COVID-19 Resource Center.

Around the Globe: Global

Global Electronic Labeling Initiatives: Updates from Japan, Canada, Europe, US, and Asia
Rie Matsui
Pfizer R&D, Japan
Deborah Bebbington
Bayer Plc, United Kingdom
Shinobu Uzu
PMDA, Japan
Craig Anderson
Health Canada
Aimad Torqui
MSD, Netherlands
Nathalie Lambot
pharma.be, Belgium
Mark Hendrickson
Leavitt Partners

lectronic labeling is the focus of many ongoing initiatives across regions. eLabeling can deliver the latest labeling information immediately and in an efficient and customer-friendly way for patient safety. Also, eLabeling is driven by the acceleration of digital disruption and must consider patient-centricity.

DIA’s recent Global Labeling Conference 2020 opened with industry and regulatory experts discussing the current landscape of electronic labeling initiatives in Japan, Canada, Europe, Belgium and Luxembourg, US, and Asia.

Key Takeaways

  • Japan’s Pharmaceuticals and Medical Devices Act was amended to introduce eLabeling officially, replacing paper labeling and adding a necessary scheme that allows all healthcare professional access the up-to-date labeling information.
  • Health Canada is taking steps to transition the product monograph to a new structured format based on Extensible Markup Language (XML), Health Level 7 (HL7) standards, and controlled vocabularies.
  • Together with other relevant stakeholders, European regulators have established high level key principles that will guide future work in establishing, for example, common electronic standards, processes, and governance that all need to benefit public health.
  • The US Food and Drug Administration (FDA) has long sought to leverage digital platforms for prescription drug labeling intended for physicians and pharmacists, allowing for distribution of prescribing information in a timely manner.

Around the Globe

Review of COVID-19 Clinical Trial Applications: Regional Readiness in Africa
Bartholomew Dicky Akanmori
Diadié Maiga
Eun Mi Kim
World Health Organization Regional Office for Africa
David Mukanga
Bill & Melinda Gates Foundation

OVID-19 has brought us all into unchartered waters. Many African countries, following the advice of the World Health Organization (WHO), have implemented detection and control measures including the lockdowns of entire countries. According to the WHO and other public health experts, health systems in Africa are predicted to become overwhelmed by the COVID-19 burden if aggressive measures to prevent the spread of coronavirus are not implemented. As of May 31, 2020, the cumulative COVID-19 cases in Africa were over 100,000 (Source: WHO Coronavirus disease (COVID-2019) situation reports).

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Around the Globe: Europe

The European Commission Roadmap:
From Sector Strategy to the Dynamic e-PIL
Thomas Kühler
Sanofi R&D

n June 2, the European Commission (EC) published a Roadmap detailing the future Pharmaceutical Strategy with the telling subtitle Timely patient access to affordable medicines. The pharmaceutical sector is important to the EU economy, and in 2018 it offered approximately 850,000 jobs in the sector and created a €91 billion trade surplus. To this end, the Roadmap is important to the European Union (EU) pharmaceutical industry as it aims to ensure that the sector remains a competitive innovator and world leader in advancing regulatory science for the benefit of patients worldwide.

Work on the Pharmaceutical Strategy has been ongoing, but the current COVID-19 crisis has highlighted additional opportunities for Europe – that is, expanding the ambition beyond “future-proofing” the healthcare system to also incorporating learnings from the pandemic and “crisis-proofing” the healthcare system.


Digital Tools Powering More and Safer Clinical Trials
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Around the Globe: Japan

Impact of COVID-19 on Clinical Trials & Research in Japan: Identifying Issues at Clinical Sites, Pharmaceutical Companies, and CROs

Hajime Saijo
DIA Japan


The first reported case of COVID-19 in Japan was confirmed on January 16, 2020. The number of cases increased steadily thereafter and by mid-March more than 1,000 cases had been reported. In early April, the infection rate began to increase rapidly with several hundred new cases confirmed daily. By April 17, more than 10,000 cases had been reported.

As the crisis evolved, clinical trials and research at medical institutions in Japan began to be greatly affected. In April and May, DIA Japan convened a series of online workshops that brought together industry, government, and academia to share the following insights.

Key Takeaways:

  • Different interpretations of risk caused by COVID-19 among sponsors have resulted in inconsistency in decisions to continue or suspend clinical trials in Japan.
  • Source data verification and monitoring are among the aspects of clinical trials most negatively impacted by COVID-19, but some of these impacts have been and may continue to be ameliorated by the growing application of remote and digital tools.
  • This pandemic has also highlighted the importance of crisis management strategies and skills that require further examination and improvement to ensure a better response to future crises.

Around the Globe: Latin America

Good Regulatory Practices: ANVISA’s Regulatory Model for Brazil
Gabrielle C B C e Cysne Troncoso
Daniel M. Mota
Brazilian Health Regulatory Agency – ANVISA
Cammilla H. Gomes
Alice Hamahiga

ntroduction: In the past twenty years, the Brazilian regulator ANVISA has been increasingly working to improve regulatory processes and gain credibility in the field of health regulation. The Agency’s current position as a regional and global leader is the result of different efforts, and this article brings information about one of them – its adoption of Good Regulatory Practices.

The normative acts referred to below are any decisions enacted by ANVISA establishing norms, rules, standards or obligations. These include, among others, Resolutions, Norms, Normative Instructions, or Joint Acts with other government bodies.

The Brazilian Health Regulatory Agency (ANVISA) is an autonomous organization linked to the Ministry of Health and is part of the National Health System (SUS) as coordinator of the Brazilian Health Regulatory System (SNVS). ANVISA’s role is to promote the protection of the population’s health by controlling the production, marketing, and use of products and services subject to health regulation.

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Thanks for reading our July 2020 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.