January 2022


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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
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

Judith Glennie JL Glennie Consulting, Inc.

Ling Su Shenyang Pharmaceutical University, Lilly Asia Ventures

Thomas Kühler Sanofi R&D

J. Vijay Venkatraman Oviya MedSafe

Ozawa Goshi Real World Data 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.

Liquid Biopsy and Precision Medicine in Oncology
Caroline C. Sigman
CCS Associates, Inc.
David R. Parkinson
ESSA Pharma
Gary J. Kelloff
National Cancer Institute

iquid biopsy-based biomarkers are increasingly used in precision medicine strategies to replace or complement tissue biopsy and imaging. They are used as predictive, response, resistance, and early detection biomarkers. Development of liquid biopsy-based biomarkers is challenging. They can be complex, being based on advanced ’omics and single-cell analysis; they need to reflect cancer biology; and they should be detectable at low levels and precisely enough to allow patients to be monitored effectively. The FDA and several international collaborative initiatives are now addressing the much-needed standards for developing and using liquid biopsy-based biomarkers. ctDNA is the most frequently studied liquid biopsy analyte, and the ctDNA research described in this article provides examples of the current and future status of liquid biopsy.


Advanced Tests and Therapies Making Daily Care Anything But Routine
Global Forum Co-Editors Gary Kelloff and David Parkinson discuss translational science milestones in 2021 against the backdrop of disruptive technologies advancing disease diagnostics and therapies. “The sensitivity of the diagnostic assays is getting better and better, and so is the analytical validation,” says Gary. “We have now the opportunity with liquid biopsies that allow from 20 cc of blood whole exome sequencing, whole transcriptome sequencing, and therefore deep DNA and RNA interrogation, real biology characterization. And that has fantastic opportunities for drug development, for patient diagnosis and prognostication, but also for the longitudinal monitoring of patients,” concurs David.
Developing Digital Health Technologies for Patients in the Real World
Benjamin Vandendriessche

eveloping and commercializing digital health technology (DHT) is a truly multidisciplinary undertaking. “Multiple stakeholders are involved” as the somewhat clichéd saying goes. Like more traditional drug development and clinical diagnostic tools, DHTs have wide-ranging applications, but a feature that sets them apart is the more prominent involvement of the patient (consumer). Does that mean that these “end users” are by default the most important stakeholders during DHT design and development? They should be, but it often depends on the specific incentive for developing the DHT in the first place.

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Special Section: Pharmacovigilance

Special Section: Pharmacovigilance

See December 2021 for Part 1 of our Special Section on Pharmacovigilance

Special Section: Pharmacovigilance

scientist pointing to graphics of scientific icons
Artificial Intelligence Can Save Pharmacovigilance in Australia
Julia Chan, David Liew, Jana Stojanova, Chris McMaster
Austin Health, Melbourne
St. Vincent’s Hospital Sydney

or healthcare professionals in Australia, pharmacovigilance is a mix of centralized and decentralized processes. The pillar of these processes is the spontaneous report. In Australia, spontaneous reporting of adverse drug reactions (ADRs) may come from any source ranging from rural general practitioners, to urban hospital pharmacists, to patients themselves. Depending on the setting, these reports may go through thorough assessment and vetting (e.g., by a hospital ADR committee), or they may go through no such process. Heterogeneity is both a feature and a bug in this system. And this is a problem.

Special Section: Pharmacovigilance

scientist pointing to graphics of scientific icons
Emerging Pharmacovigilance Framework Ensuring Safe COVID-19 Vaccines in China
Sophia Duan
PPC China

ince the breakout of COVID-19, many pharmaceutical companies in China have worked to develop preventative vaccines. In response, China’s regulatory authority (RA), the National Medical Products Administration (NMPA), worked closely with the World Health Organization (WHO) and COVID-19 vaccine evaluation experts to establish a standard review system, release relevant clinical development and review guidelines, and provide 24/7 support to facilitate COVID-19 vaccine development. The NMPA has released seven relevant guidelines, including Technical Guidelines for the Development of COVID-19 Vaccine (Trial version), to guide, monitor, and accelerate the development of COVID-19 vaccines in China.

Special Section: Pharmacovigilance

scientist pointing to graphics of scientific icons
Positioning Pharmacovigilance During the Pandemic in Japan
Stewart Geary
Eisai Co., Ltd.

Junko Sato
Pharmaceuticals and Medical Devices Agency (PMDA)


he 18th DIA Japan Annual Meeting 2021 featured senior regulatory authorities, industry scientists, and physicians sharing the challenges and their responding adaptations for pharmacovigilance and post-marketing surveillance during the COVID-19 pandemic: Gerald Dal Pan from the US FDA and Kiyohito Nakai from Japan’s Ministry of Health, Labour and Welfare (MHLW) joined DIA board member Peter Honig (recently retired from Pfizer) in a panel discussion chaired by Junko Sato (PMDA) and Stewart Geary (Eisai).

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Future Proofing: Key DIA GAM 2021 Themes Inform Global Pharmacovigilance and Risk Management Strategies 2022

Alan Hochberg
Jeremy Jokinen
Bristol Myers Squibb Company
Meredith Smith
Alexion Pharmaceuticals

hen the DIA community gathered for DIA GAM 2021 last June, the pandemic had turned clinical safety and benefit-risk balance into household words. Both industry and governments worldwide were endeavoring to manage a flood of continuously evolving data and interpret it for the public under conditions of high uncertainty. Ultimately, one key contemporary challenge for pharmacovigilance has been high-quality communication: transmitting accurate information regarding both vaccine safety and efficacy in a clear, transparent, timely, and actionable manner, spanning numerous purposes and various stakeholders. What might this recent past mean for our future?

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Around the Globe

Growing Scope and Opportunity for Healthcare Digitalization in Asia Pacific
Baishali Das

igitalization across various segments of the healthcare value chain continues to grow more prevalent and accessible around the world. This rise in popularity had made regulatory policies for digital health (DH) essential in guiding digital health companies’ provision of safer (and better) DH services. Digital health technologies empower consumers to make more informed choices about their own healthcare and provide healthcare professionals with new options in terms of disease prevention, diagnosis, and management. Digital health can help low- and middle-income countries (LMICs) in particular overcome traditional barriers to better healthcare.

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Around the Globe

Access Consortium Work-Sharing Initiative: An Industry Perspective
Innovative Medicines Canada

rotecting and promoting public health in a time of increasing globalization with unprecedented advances in technology and medicines is the single greatest challenge facing medicines regulatory authorities today. COVID-19 effectively illustrated this point. Regulatory bodies and other stakeholders were forced to think creatively about adopting new technologies, sharing resources and expertise, and working more efficiently on a global scale. Many view regulatory cooperation among health authorities as imperative to navigating these rapid therapeutic advances in both emergency and nonemergency situations. Various forms of regulatory reliance and cooperation have developed in recent years. This article reports on Canadian industry experience with one such consortium, the Access Consortium (previously called ACSS).


Innovation Without Access Will Never Meet Patient Needs
Innovations in therapeutic product development will only be effective when patients can access and use them. But establishing and explaining the value and price of these innovations among so much unmet need, and ensuring access by patients who need them, has proven difficult throughout Europe and elsewhere. “Policymakers more often or too often have a short-term view, short-term perspective, rather than a long-term perspective, and sometimes are driven more by political goals than promoting patient access in a real way,” suggests Andras Incze, Akceso Advisors. “We want the breakthrough innovations to reach patients throughout Europe. We want the best products and to get them to patients as fast as possible,” explains Rick Vreman, Utrecht University, the Netherlands. “But then it gets a bit more tricky when we start to think about what we need to make that happen.”

Around the Globe

The Philosophy and Pathway for Implementation of Regulatory Science in Pharmaceutical Regulation—PMDA’s 10-Year Record and Prospects

Tatsuya Kondo
Chief Executive Emeritus
Pharmaceuticals and Medical Devices Agency, Japan

n recent decades, progress in medical science and healthcare has been rapid, and people’s expectations of medical treatment have risen accordingly. However, some expectations have been blunted by unexpected adverse events associated with new drugs. For example, cases of HIV/AIDS and HCV/hepatitis in the early 1980s were associated with the use of coagulation factors derived from unheated plasma. Such events led to a cautious approach to the approval of new drugs. This in turn resulted in a long-standing issue of late approval of drugs and medical devices in Japan, compared with Western countries, and the terms drug-lag and device-lag were coined to describe the time lag between approvals of the same new product in Western countries and in Japan. In addition, public criticism of inadequate post-marketing safety measures for medicines led to calls for administrative reforms.

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Thanks for reading our January 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.