August 2021


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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

Monika Schneider Shionogi

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.

Cancer Growth Kinetics Inform the Design of Chemotherapy Regimens
Joshua Z. Drago
Larry Norton
Memorial Sloan Kettering, New York

he search for more effective and less toxic therapies for cancer has rightfully focused on the discovery and development of medications that challenge the viability of cancer cells. But in addition to finding the drugs themselves, it is critical to define their best applications, which should include considerations of dose level and schedule. In this regard, there is much to gain from studying the growth kinetic behavior of cancerous masses over time. It has proven to have immediate applications, especially in the design of the most effective adjuvant chemotherapy regimen for primary breast cancer. It is also one that may well be relevant to one of the most stimulating innovations in contemporary cancer therapy: antibody-drug conjugates, which will be discussed in a later essay.

Two of the most influential papers in the philosophy of cancer are Hanahan and Weinberg’s description of its so-called hallmarks. This seminal body of work provides a roadmap for conceptual advances including the definition of drug targets. But while its list of features is close to comprehensive, it does omit the fact that cancers universally follow a pattern of growth called sigmoid. Sigmoid growth cannot, as discussed in a follow-up essay, be the simple consequence of cancer cell autonomy. This observation is key to a better understanding of cancer with practical implications.

Urgent Need for a More Aligned Regulatory Approach for Clinical Trials
Ginny Beakes-Read
Amgen Inc.

ll stakeholders involved in executing clinical trials during the pandemic faced enormous challenges, creating disruptions in clinical trial execution and delays in providing products to patients. The advice that global regulators provided to help address those issues was invaluable, and industry members are extremely grateful for that assistance. However, many different approaches were deployed by regulators across the globe. Those differences presented issues as industry tried to navigate the various requirements to continue clinical trials as safely as possible for patients. Many regulators are currently evaluating the impact of these flexible approaches and may continue to allow certain flexibilities in the future. This article highlights differences in regulatory guidance, suggests a deeper evaluation of the reasons for the various approaches, and advocates for appropriate alignment of guidances consistent with learnings from the pandemic.

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Meeting Highlights: DIA China 2021

Meeting Highlights from DIA China 2021

Meeting Highlights: DIA China 2021

China Focusing Innovation Through ICH Global Regulatory Vision
Jessica Zhou
Tigermed Consulting Co.

n June 2, 2017, China officially joined the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and truly began to integrate into the international drug regulatory system. Only one year later, in June 2018, China’s health regulatory authority (National Medical Products Administration, NMPA) was elected as a member of the ICH Management Committee to further participate in international drug development and registration.

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Meeting Highlights: DIA China 2021

Cancer Clinical Trial Sites Moving Globalization and Professional Development Forward
Wu Dawei
National Cancer Center / Cancer Hospital, Chinese Academy of Medical Sciences

ince China implemented the filing system of drug clinical trial institutions in December 2019, the capacity of clinical trials in medical institutions has been steadily upgraded and a large number of new sites have emerged. According to the National Medical Products Administration (NMPA) database, the total number of drug clinical trial sites registered nationwide exceeded 1,000 by the end of 2020. Improving the quality and efficiency of their own trials by improving the knowledge and training of their study staff, and integrating into the global drug development process, have become key issues for Chinese clinical trial sites.

Meeting Highlights: DIA China 2021

Implementation of ICH Q12 for Post-Approval CMC Changes in China
Fei Zheng

n the International Council for Harmonisation (ICH) Q (quality) series guidance for industry, Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management provides a framework to facilitate management of post-approval chemistry manufacturing and controls (CMC) changes more predictably and efficiently, increase transparency between industry and regulatory authorities, and support continual improvement and innovation in drug lifecycle management.

In joint discussions at ICH Day during DIA China 2021, experts in industry and regulatory agencies from China (NMPA, formerly SFDA), Japan (PMDA), and the US (FDA) agreed that real use cases and experiences with the ICH Q series in more developed regulatory systems will help China implement ICH Q12 from both the policy and technical perspectives.
Around the Globe
Health Technology Assessment in the EU
Back and Forth in Giant Strides
Thomas Kühler
Sanofi R&D

ore than three years ago, in January 2018, the European Commission published a draft Regulation on Health Technology Assessment for the EU. The intention was to secure timely patient access to novel therapies, to avoid duplicative assessment work at the Member State level, and to provide a predictable and consistent process for the benefit of all stakeholders.

As background, Member States had not adopted an aligned approach but instead applied their own respective procedural measures and scientific standards when conducting Health Technology Assessments (HTAs). This meant duplicative and repetitive work across the EU network and hence higher costs for both companies and society at large. More importantly, it also delayed patient access to novel therapies. It was not a positive benchmark in terms of proper stewardship of available resources.
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eLabeling More than Moving from Paper to Digital
Electronic or digital documents helped manage and disseminate clinical research data and information during the pandemic and are now being explored for potential use at the other end of this pipeline: the product safety and other information in the (paper) package insert. “Whether we are speaking of paper or electronic formats, this is the basic right, at the end of the day, for patients: to allow them that access and informed decision making about the use of their product,” suggests Aimad Torqui, executive director, Global Regulatory Policy, MSD (The Netherlands), and chair, Product Information Inter-Association Task Force (PI IATF). “It sounds very easy to move from one format to another. But there’s a lot of details to go through: How do we do submissions? How do we do approvals? Where is it published? How do people get access to it?”

Around the Globe

COVID-19 Pandemic in Japan: Treatments, Vaccines, and Remote Study Audits
Kotone Matsuyama
Nippon Medical School

atients with COVID-19 in Japan were first identified in February 2020. This was only the first wave. A state of emergency was issued, and a lockdown of major cities was implemented from April 7 to May 25. Gradually, the second wave was confirmed in the summer of 2020. The third wave occurred around October 2020, and the state of emergency was reissued on January 7, 2021.

These important developments and consequent actions taken in response were overviewed by IFAPP, IFAPP Academy, and JAPhMed in the webinar COVID-19 Pandemic in Japan: Facts and Expectations sponsored by DIA Japan and reviewed below.


New PAHO Report: Strength in Regulatory Reference and Reliance
In April 2021, the Pan American Health Organization (PAHO) issued Regulatory System Strengthening in the Americas: Lessons Learned from the National Regulatory Authorities of Regional Reference to overview the Americas’ regulatory landscape and regulatory responses to COVID-19. “The pandemic has highlighted the crucial role that the national regulatory authorities need to play in a public health emergency,” explains PAHO Assistant Director Jarbas Barbosa to Cammilla Gomes, regulatory policy lead for Latin America, Roche, and DIA Global Forum regional editor for Latin America. “The regional pharmaceutical market is growing, products are becoming more complex, and countries are spending more in providing access to these products. Yet the resources and capacities are not growing at the same pace in most regulatory authorities, and we want to ensure that our countries are able to oversee and enforce the regulations to ensure the safety, effectiveness, and quality of all products.”
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We Are DIA

In Memoriam: Jordi Llinares Garcia
Jordi Llinares Garcia headshot

IA honors the memory and the service of Jordi Llinares Garcia, head of research and innovation for the European Medicines Agency (EMA), who passed away in his sleep on July 22, 2021, in his hometown of Barcelona (Spain). He was 52.

“Jordi worked at EMA since 2002 and was a passionate, hard-working and kind manager, who inspired and cared for his teams, friends and colleagues. Many of you may have worked with him or met him during his almost two decades at the Agency,” wrote EMA Executive Director Emer Cooke. “He will always be remembered for the positive impact he had on everyone at EMA and his invaluable contribution to public health.”

Jordi served as panelist in the DIAlogue session on Unmet Medical Need at DIA Europe 2021 this past March and chaired the DIA Global Annual Meeting 2021 session Advancing Medicines’ Regulation in Europe: Key Strategies to 2025 in June.

“Jordi was a constant contributor to DIA’s scientific conversations and content, freely and openly sharing his knowledge and perspectives to advance research into areas of healthcare that need the most help, in particular pediatrics, rare diseases and orphan products, other unmet medical needs, and the opioid epidemic,” said DIA Global Chief Executive Barbara Lopez Kunz. “We will deeply miss both his expertise and the generosity with which he shared it.”

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Thanks for reading our August 2021 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.