March 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

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.

“Digital Oncology”–Wearable and Remote Monitoring Devices for Cancer Treatment and Survivorship
Christopher M. Hartshorn
National Center for Advancing Translational Sciences
National Institutes of Health
Michael G. Espey
National Cancer Institute
National Institutes of Health

ortable and wearable consumer electronics for communication, interconnectivity, and information sharing have become firmly woven into the fabric of daily living. These technologies and associated infrastructure have spawned potential for the integration of wearable devices into the cancer-care continuum. Digital biomarkers and digital health approaches are being broadly applied to the multifaceted obstacles cancers present at the levels of prevention, risk, detection, diagnosis, treatment, and survivorship.

In this article, we survey emerging opportunities for integration of “wearable” digital health tools into the patient journey through cancer treatment and discuss challenges posed by this emergent field: Digital Oncology.
Reliance-Based Regulatory Pathways–The Key to Smart(er) Regulation?
Daniela Drago
Aurion Biotech
Murray M. Lumpkin
Bill & Melinda Gates Foundation

OVID-19 exposed many vulnerabilities of our current global healthcare ecosystem. However, it also spurred debate on how to find novel solutions. Examples include the broader use of telemedicine, an increase in decentralized trials, and the provision of timely regulatory guidance. Consensus is growing that reliance pathways are useful in both emergency and routine situations and that more could be done to leverage their benefits. The expert committee members convened by the National Academies of Sciences, Engineering, and Medicine stated in their consensus report that “regulatory reliance is a 21st century best regulatory practice” not only for resource-constrained agencies, but also for better-resourced agencies. This article will 1) define regulatory reliance, 2) discuss national regulatory agencies’ considerations on its use, and 3) outline challenges to implementation and opportunities for fostering this 21st century best regulatory practice.

EuroMeeting 2022
Clinical Trials Prepare for a Digital, Connected Future
Jim Reilly
Veeva Systems

he shift to hybrid, decentralized trials has highlighted the need for better data management and direct digital connections that link sponsors, sites, and patients.

Clinical research has made dramatic advances within the past few years, with new master protocol designs such as umbrella and basket trials emerging. On the operations side, companies forced to adapt to COVID-19 restrictions proved that they could succeed with novel approaches including remote site assessments and decentralized trials.

Meeting Highlights: DIA Cutting Edge Series AI/Digital Symposium 2021 in Japan

DIA Cutting Edge Series AI/Digital Symposium 2021 in Japan

Meeting Highlights: DIA Cutting Edge Series AI/Digital Symposium 2021 in Japan

DIA Cutting Edge Series AI/Digital Symposium 2021 in Japan image of virtual globe with a hand reaching out

Rational Medicine and Digital Technology in Japan: Connecting the Silos

Kazuhiro Kanmuri
Ascent Development Services, Inc.


nnovations such as robotics, artificial intelligence, information technology, and digital technology are creating expectations for improving individual productivity and optimizing organizational resources. These innovations are also creating an emerging vision of “total optimization” not only for organizations but for our broader communities and societies, and the entire world. Discussions of innovation and optimization ultimately lead to “connectivity,” which is fundamental to success in numerous industries and fields.

White Paper Podcast

Bharat Chudasama headshot
White Paper by Syneos Health
The Power of an End-to-End Drug Development Solution
How can a lifecycle mindset accelerate the discovery, development, and delivery of innovative drugs and other therapies? “There’s a real competitive landscape out there when it comes to drug development, and it makes sense for everybody in this equation to get the best out of ensuring that a treatment coming to the market has the best chance of getting there,” explains Bharat Chudasama, Vice President, Syneos One® at Syneos Health. “The product development mindset says: We need to get this treatment prescribed. In order for me to get that treatment prescribed, I need to think about if payers are going to be willing to pay for it. In order for those payers to pay for it, they need to be able to see the evidentiary benefit to patients, to the system, in terms of safety and everything else.”

Special Section: Latin America

Special Section:
Latin America

Special Section: Latin America

two hands, one with a medical symbol and the other with a scale
Report from the 10th Conference of the Pan American Network for Drug Regulatory Harmonization (PANDRH)
Cammilla Gomes

uring the pandemic, regulators have seen the importance of their interactions with the health authorities in their jurisdictions to foster better communication channels that reach beyond their traditional stakeholders and meet the needs of the entire patient population. Knowing what to say has always been important. The pandemic highlighted the importance of knowing when, where, and how to say it.

Special Section: Latin America
two hands, one with a medical symbol and the other with a scale
Pharmacovigilance Systems in Latin America for COVID-19 Vaccines: Brazil, Chile, Costa Rica, and Mexico
Josué Bautista Arteaga
Global Pharmacovigilance Society (GPS)
Americas Region Chairman & LATAM Ambassador

ne of the greatest challenges to pharmacovigilance in Latin America has been the awareness and willingness of the population (patients) and healthcare professionals to report adverse events. With vaccination serving as one of the key instruments in combatting the COVID-19 pandemic, are these pharmacovigilance systems positively influencing this awareness and willingness to be an active part of the surveillance of these vaccines during this public health emergency?

Special Section: Latin America

two hands, one with a medical symbol and the other with a scale
Faster and More Flexible: Regulatory & Industry Leadership in Latin America During the Pandemic
Viktoria Magyar
University of Southern California

riven by increasing workloads, limited medical supplies and expertise, and technological advancements, global healthcare systems underwent serious transformation during the pandemic. The World Health Organization (WHO) initiated the development of guidelines for good regulatory practices (GRP) to support higher quality controls, improve decision-making, and produce better public health outcomes during the pandemic.

Around the Globe

Implementing New GVP in China Requires Digitization and Training
Jessie Zhu
Deltamed Co. Ltd./Pharmaron Clinical
Monica Juping Xu
Taimei Medical Technology

ince China joined ICH in 2017, much effort has been expended in developing national pharmacovigilance standards harmonized with ICH guidelines. The National Medical Products Administration (NMPA), China’s regulatory authority, has announced a series of pharmacovigilance regulations and guidelines including both the pre-market (clinical) and post-marketing phases. After several years of planning and alignment, NMPA announced its guidance for China Good Pharmacovigilance Practice (China GVP) in May 2021, and it became effective on December 1, 2021.

PV Strategies in Europe

Around the Globe

Innovation Is Not Always Fast: EU Clinical Trials Regulation Goes Live 10 Years After Publication
Thomas Kühler

anuary 31, 2022, marked a very important day in European Union (EU) pharmaceutical regulation history. After some 10 years in the making, the EU Clinical Trials Information System (CTIS) went live per the European Commission (EC) decision 2021/1240. With the launch of the CTIS, the Clinical Trials Regulation (CTR) 536/2014, proposed in 2012 to replace the Clinical Trials Directive (CTD) 2001/20/EC, officially became applicable.

Around the Globe

Over a Billion COVID-19 Vaccine Doses: How Did India Do It?
Ananya Chakraborty
Vydehi Institute of Medical Sciences & Research Centre

anuary 16, 2022, was a proud day for India. The country achieved the milestone of completing one year of the world’s largest vaccine drive and celebrated delivering 1.56 billion COVID-19 vaccine doses in the previous year. The health ministry reported upon the completion of this year-long drive that most adults (93%) had received their first COVID-19 vaccine dose, and more than 77% of the adult population had been fully vaccinated. More than half (52%) of children in the permissible age group (15 to 18 years) have received their first dose. One might wonder: How did India do it?

PV Strategies in Europe


Data Intersections Connecting Drug Development with Clinical Care
“The ground is shifting in terms of how we will continue using randomized clinical trial data and real-world data in many different disease settings,” says Veronica Miller, co-author of Use of External Controls in FDA Regulatory Decision Making. In this research article, Miller (Forum for Collaborative Research) and Adora Ndu (Bridgebio Pharma, Inc.) describe where and how FDA has used external controls to support development and approval of drugs for rare and pediatric diseases. “We’re seeing, not just in rare diseases but in many other diseases, this coming together of what used to be totally separate silos. In part, that’s facilitated through electronic health records and other mechanisms of capturing data and being able to follow data at a bigger level, but also just because of understanding the importance of clinical data.”
DIA GAM 2021
Thanks for reading our March 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.