January 2023

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Editorial Board

Content stream editors

Translational science
Gary Kelloff US National Institutes of Health
Ilan Kirsch Adaptive Biotechnologies Corp.

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

AFRICA
David Mukanga Bill and Melinda Gates Foundation

ASEAN
Jin Shun Sandoz

AUSTRALIA/NEW ZEALAND
Richard Day University of New South Wales, Medicine, St. Vincent’s Hospital

CHINA
Ling Su Shenyang Pharmaceutical University, Lilly Asia Ventures

Europe
Julie O’Brien Pfizer

INDIA
J. Vijay Venkatraman Oviya MedSafe

JAPAN
Ozawa Goshi Real Discovery Outdoors Co,. Ltd.

LATIN AMERICA
Cammilla Gomes Roche

USA
Ebony Dashiell-Aje BioMarin

Young Professionals Editor

Kaley Lugo Daiichi Sankyo

DIA Membership

Bringing together stakeholders for the betterment of global health care.

Editorial
The New DIA Thought Catalyst Framework:
2023 and Beyond

Courtney Granville
DIA
@DrugInfoAssn

A

s we begin the new year, DIA launches a new Thought Catalyst Framework that builds on our longstanding work to progress innovation and efficiency, and adds new dimensions to drive content, in response to recent global “disruptions” that have altered the landscape of our ecosystem in significant ways.

We Are DIA
A Bigger “Why”:
Highlights from Our Conversation with Departing DIA Global Chief Executive Barbara Lopez Kunz
A

fter a decade at the helm, DIA Global Chief Executive Barbara Lopez Kunz prepares to step into the next chapter of her career. She shared reflections on her DIA tenure with Global Forum Editor-in-Chief Alberto Grignolo.

AG: Beginning at the beginning, Barbara: where were you prior to joining DIA?

BLK: To truly begin at the beginning, as one of six siblings, I was raised to value health, education, hard work, and charity. These priorities have been intertwined in my personal and professional life. I’ve been very intentional about my career, ensuring that the hard work I would deliver had an important overarching purpose; that is, I have ensured a mission orientation in decisions I have made. I spent two-thirds of my career in multinational corporations—namely ICI, DuPont, Thermo Fisher Scientific—developing new drugs, laboratory products, medical devices, and I learned a huge amount.

We Are DIA
DIA Board of Directors Reflections on Barbara Lopez Kunz
A portrait headshot photograph of Minnie Baylor-Henry smiling
Minnie Baylor-Henry: “I remember very vividly the day the search committee interviewed Barbara. Barbara was not only intellectually impressive, but she exhibited a level of confidence and calmness that let us know she was likely the right person at the right time for DIA. Our instincts were correct. From the beginning, Barbara demonstrated in countless ways that she was a visionary leader focused on continuing to build upon the greatness of DIA. Under her leadership, Barbara has systematically and strategically guided DIA to a level that was not imaginable during the early years, but which seems quite perfect upon reflection.”
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Podcasts

Looking Back and Ahead: Translational Science Advances Impacting Patient Care
From microphysiological systems and digital pathology to next-generation-sequencing and diversity in foundational genomic data sets: In this iteration of our annual year in review podcast, Global Forum Co-Editors for Translational Science Gary Kelloff and Lanny Kirsch discuss emergent technologies and approaches that are upending clinical development, diagnostic, and patient care in oncology and beyond.
Optimizing Clinical Research for Pediatric and Underserved Populations
Solange Corriol-Rohou
AstraZeneca R&D, France
E

nforcement of pediatric-specific regulations in both the United States and Europe since 2002 and 2007, respectively, has had a positive impact on pediatric drug development, with more medicines becoming available for children and more information on pediatric use becoming available to clinicians in the product information.

While great advancements in labeling for pediatric populations have been made since various regulatory frameworks were implemented in the US and Europe, important gaps still remain in underserved populations which are currently the focus of exciting and valuable initiatives as addressed in this paper.
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Increasing Access to Care and Efficiency in Healthcare Delivery in Low- and Middle-Income Countries
Ramzi Dagher
Pfizer
Diego Guarin
Merck
Allon Jacobs
Roche
Matthew Lungren
Microsoft
Maia Thrift-Perry
BeiGene USA
Katherine Van Loon
University of California, San Francisco
J. Michael Wrigglesworth
The Max Foundation
Rebecca Vermeulen
DIA Fellow
Rachel Zhang
DIA Board Member
Courtney Granville
DIA Staff
Anna McDermott-Vitak
DIA Staff
S

ocioeconomic inequalities in medical care access and affordability, large out-of-pocket expenses, and vulnerabilities against catastrophic household expenditures continue to be significant barriers to improving health outcomes in low- and middle-income countries (LMICs). Based on 2020 World Bank Data, close to 85% of the world’s population (7.753 billion) resides in LMICs (6.52 billion), and nearly 40% do not have access to essential medicines.

Around the Globe

Optimal Regulatory and HTA Collaboration in the EU
The New European Union Health Technology Assessment Regulation
Edward Mc Gettrick
Sharon Gorman
Pfizer
@Pfizer_UK
I

n December 2021, the European Commission (EC) adopted the Regulation on Health Technology Assessment (EU HTA Regulation; No. 2021/2282). Its main objectives were to strengthen the quality of HTAs across the EU, ensure efficient use of resources, avoid duplication of industry and national HTA body efforts, and ensure long-term sustainability of EU HTA cooperation. The EU HTA Regulation formally entered into force on 11 January 2022 and will apply to Oncologic & Advanced Therapy Medicinal Products (ATMP) products after a three-year implementation period (i.e., 12 January 2025) in the first instance, followed by Orphan Medicinal Products (OMPs) in 2028, and all other Centrally Approved Medicines from 2030 onward.

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Around the Globe

Pharmaceutical R&D in Japan Needs an Upgrade

Fumitaka Noji
MSD KK

A

lthough the importance of open innovation in drug research and development has long been recognized in Japan, it cannot be said that the open innovation ecosystem in Japan is functioning sufficiently when many issues remain problematic or unresolved in terms of systems, funding, and human resources compared to Europe, the US, and China. This situation was made even more evident by the COVID-19 pandemic.

We Are DIA
DIA Congratulates Our 2022 China Award Winners

Our 2022 China Inspire Award Winners

Headshot of Feng Chen
Feng CHEN
School of Public Health, Nanjing Medical University
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Thanks for reading our January 2023 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.