November 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

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.

Avoiding “Therapeutic Misperception” in the Clinical Setting
Perspectives on FDA’s Accelerated Approval Program
Sarah V. Ferranti
Epstein, Becker & Green

he US Food and Drug Administration’s (FDA’s) controversial approval of the Alzheimer’s drug aducanumab (AduhelmTM) has kicked off a firestorm of debate, placing the Accelerated Approval Program (AAP) in the hot seat. The AAP seeks to balance the need for evidence of clinical efficacy with the need for access to novel drugs for seriously ill patients with no adequate options, a high-risk but potentially high-reward proposition.

Increasingly, patient advocacy groups are leading the charge for earlier access to new drugs through the AAP, citing patients’ willingness to accept the risks and uncertainty for the chance of benefit. However, recent experience suggests that the road to demonstrating clinical efficacy after accelerated approval is long and bumpy, meaning that patients could be exposed to unproven drugs for years, possibly while believing erroneously that the drugs have been definitively demonstrated to be effective to treat their condition.

While it is clear that FDA and drug sponsors must work together to proactively plan and diligently implement clinical trials for the collection of data sufficient to “convert” accelerated approval into traditional approval, equally important is ensuring that while clinical trials are pending, patients who receive AAP-approved drugs in the clinical setting fully understand the program, its limitations, and the tradeoffs they are making.

Patient Entrepreneurs: The New Driving Force for Developing Health Solutions
Karin Hehenberger

atient entrepreneurs are another emerging category of patients, along with groups like patient influencers, who are changing the landscape of healthcare and drug development. They are a new driving force behind the development of health solutions that are “by the patient, for the patient.” Industry partnerships with patient entrepreneurs are growing, and they are increasingly paving the way for further embedding patient-centricity into the healthcare ecosystem. But how and why is this happening?

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Around the Globe

Australia Aiming Targeted Therapies Toward Truly Personalized Medicine
Conversation with Australian Pharmaceutical medical and scientific Professionals Association (APPA) Past President David Grolman
Richard Day
University of New South Wales
David Grolman headshot
David Grolman
Past-President, APPA
University of South Wales
Pfizer, Australia and New Zealand

e are entering an extremely exciting time for pharmaceutical medicine in Australia,” says David Grolman, past president of APPA (Australian Pharmaceutical medical and scientific Professionals Association). “The global emerging technological trends impacting every single industry will present huge opportunities for us to improve the quality of patient therapies and ultimately patient outcomes.”

David currently serves on the Advisory Board and is a part-time lecturer in Pharmaceutical Medicine at the Faculty of Health Sciences of the University of New South Wales in Sydney, Australia. He is concurrently Medical Director and Head of Medical Affairs for the Pfizer Hospital business unit in Australia and New Zealand.


EU Regulatory Strategies Shaping and Shaped by Pandemic Response
COVID has demonstrated the importance of regulatory systems that ensure the safety and efficacy of therapeutic products as well as patient access to these products, especially in the complex network of healthcare, scientific, pharmaceutical, regulatory, and patient communities in Europe. “Regulators and industry have worked day and night over the last two years to bring vaccines and therapies forward. We know very clearly that sustainability of the system is an issue. More regulatory resources and simpler processes are desperately needed,” explains Isabelle Stoeckert, Bayer AG vice president and head of regulatory affairs for Europe, Middle East, and Africa. “Many countries have learned that reliance and collaboration between regulators is a really good thing. COVID-19 has really shown that,” suggests Henrik Nielsen, Novo Nordisk vice president of global regulatory sciences. “And I think this will stay, so we will see more reliance between regulatory sources, and we’ll probably see increased use of different collaboration schemes around the world.”
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Around the Globe

Policies to Promote Development of AI-Based Medical Devices in Japan
Shohei Nakano
Japan Association for the Advancement of Medical Equipment

n December 2018, the first AI-based medical device–the AI software to support discrimination between tumor/nontumor colorectal lesions using endoscopic images–was approved in Japan. Although nearly three years have passed since then, the number of AI-based medical devices approved in Japan is still low compared to Europe and the US.

However, if you were to ask me if there will be more artificial intelligence-based medical devices in Japan in the future, I would certainly answer Yes. This is because Japan has become one of the countries with the most advanced policies on artificial intelligence-based medical devices.

Around the Globe

Aligning Stakeholder Partnerships in Latin America
Best Practices from Cuba and Mexico
Lawrence Liberti
Temple University School of Pharmacy
Mario Alanis
Centre for Innovation in Regulatory Science (CIRS)
Pravin Chopra
IFAPP Academy
Silvia Bendiner
Wessx Consulting

he COVID pandemic precipitated sweeping changes in established policies and practices and emphasized the confluent dynamics of disease burdens, optimized healthcare systems, and the socio-economic influences of globalization. We now stand at the crossroads of an unprecedented global challenge which demands that researchers, regulators, policy makers, and governments address multiple dimensions that go far beyond the implications of any one healthcare scenario.

The favorable outcome of accelerated vaccine development triggered an increasingly empowered patient voice advocating for access to investigational treatments and biopharmaceutical innovation. It has also drawn attention to revisiting traditional tenets for future approvals of new drugs, and the likely longer-term considerations for medicine development paradigms.
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Around the Globe

Making COVID-19 Global Vaccine Distribution Safer and More Efficient
Dhiraj Behl
Harikesh Kalonia
Amity Institute of Pharmacy, Amity University, India

early two years have passed since we began to face the COVID-19 pandemic, and while its global consequences have been catastrophic, the situation has also catalyzed profound change in our overall health ecosystem. The progress we have experienced in drug development, transformative therapeutic innovation, and regulatory cooperation and harmonization continues to spread. Global health awareness has grown significantly, and global stakeholders continue to focus on exploring new areas of health science and technology for innovation, framing regulatory strategies and policies, and developing new leadership for this changing healthcare world.

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We Are DIA

Dr. Tatsuya in a professional headshot against a blue background
BLK and Kondo
Dr. Tatsuya Kondo at the DIA Awards
Dr. Tatsuya in a professional headshot against a blue background
Dr. Tatsuya Kondo at the DIA Awards smiling and holding a DIA newsletter
Kondo with Dr. Gerald Dal Pan standing with arms wrapped around each other posing for a picture
Dr. Tatsuya Kondo with BLK and (former) Board President Sandra Milligan
Dr. Tatsuya Kondo: “A visionary leader and friend”

IA honors the life and work of Tatsuya Kondo, a long-time leader, mentor, and friend of many in our community, who died on September 26, 2021.

We Are DIA
DIA Congratulates Our 2021 Japan Award Winners

Our 2021 Japan Inspire Award Winners

Takuko Sawada

Takuko Sawada, Shionogi & Co., Ltd.

Daisaku Sato

Daisaku Sato, Ministry of Health, Labour and Welfare (MHLW)

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Thanks for reading our November 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.