October 2023
October 2023 Global Forum

Table of Contents

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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 Independent Consultant

Patient engagement
Chi Pakarinen MediPaCe
Natasha Ratcliffe Patient Engagement Specialist
Thomas Smith Independent Patient Consultant

Data and Digital
Lisa Barbadora Barbadora Ink

Young Professionals Editor

Kaley Lugo Daiichi Sankyo

Editorial Staff

Alberto Grignolo, Editor-in-Chief Parexel International

Sandra Blumenrath, Managing Editor, Scientific Publications DIA Scientific Communications

Chris M. Slawecki, Managing Editor, Global Forum DIA Scientific Communications

Linda Felaco, Copy Editor and Proofreader

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

DIA Membership

Bringing together stakeholders for the betterment of global health care.

Some Assembly Required: Solving the Puzzle of Real-World Data/Evidence
T

he subject of real-world data—“big data” from electronic medical records, claims, prescription databases, and other sources—is becoming more and more real, as industry and regulators look to use real-world data as real-world evidence in clinical research and therapeutic product development. Global Forum Regional Editor for Europe Julie O’Brien (Pfizer) leads the below exploration of the current and potential future states of real-world data and real-world evidence from the perspectives of the regulated and the regulators, with Jennifer Dudinak (Bristol Myers Squibb) and Max Wegner (Bayer AG).

Ways and Means to Ensure Quality in Real-World Data in Japan
Yumi Wakabayashi
Janssen Pharmaceutical K.K.
Vicky Han
Johnson & Johnson International (Singapore) Pte. Ltd.
R

eal-world data (RWD) offers the possibility of providing important information to help inform regulatory decision-making. But turning this possibility into reality still depends on the quality and reliability of the data. With appropriate efforts to ensure data quality, RWD can support regulatory decisions in Japan (and other countries/regions as well). Close collaboration between health authorities, study sponsors, and data owners is critical in better understanding and overcoming issues in making this possible.

Equitable Access to Healthcare and Clinical Research
The Importance of Grassroots Health Advocacy and Lay Navigation in Communities of Color
Karen Peterson
Karen’s Club
T

he impact of self-advocacy and the importance it plays in my life as a cancer survivor and patient advocate is significant. Diagnosed with Stage IV triple-negative breast cancer in 2017, I overcame an abundance of medical bias and lack of health literacy to save my life. With an original estimate of a 4% chance of survival, I am now one of the 12% of patients diagnosed with metastatic triple-negative breast cancer to make it to the five-year life expectancy benchmark.

DIA Japan Annual Meeting 2023 Advertisement
Special Section: Latin America
Healthy People, Healthy Spaces, Healthy Caribbean
Interview with Rian Extavour, Caribbean Regulatory System
Portrait headshot photograph of Rian Extavour smiling
Rian Marie Extavour, Caribbean Regulatory System
2

023 celebrates the tenth anniversary of the Caribbean Public Health Agency (CARPHA), formed to strengthen and equip health systems in the regional Member States to address existing and emerging public health challenges and as a public health umbrella to address issues requiring a broad regional response. In this interview, Caribbean Regulatory System Programme Manager Rian Extavour shares the agency’s past, current state, and what it needs to continue to do to ensure the safety of healthcare products and the patients who use them in its jurisdiction.

Special Section: Latin America
Commentary: Closing the Gap in Latin America – Patient Access to Innovative Products Requires Innovative Action
Yaneth Giha
Latin American Federation of the Pharmaceutical Industry (FIFARMA)
D

iscussions about health regulations usually focus on creating laws, regulations, and regulatory processes that, in many cases, address the science of medical products. However, this very technical approach (which is imperative) can lead us to overlook the essentials: the quality of life of patients and their families.

Special Section: Latin America
El Salvador’s Progress toward Innovation in Medicines Regulation
Interview with National Director of Medicines Noe García
T

he National Directorate of Medicines (DNM) is the national regulatory authority of El Salvador. Created in 2012, the DNM is the competent health authority for authorizing the registration, import, manufacturing, price control, and monitoring of the supply chain until the sale to the final consumer of medicines and related products in the country. In recent years, the agency has become one of the most active regulators in Central America and has made important advances towards more agile regulation in collaboration with regional and international partners. In this interview, National Director of Medicines Noe García shares the agency’s history, challenges, and opportunities.

White Paper

Accelerating Alzheimer’s Therapy Innovation: The Power of Blood-Based Biomarkers. This White Paper is Part of DIA’s White Paper Library

White Paper

Accelerating Alzheimer’s Therapy Innovation: The Power of Blood-Based Biomarkers. This White Paper is Part of DIA’s White Paper Library
The escalating global challenge of Alzheimer’s disease demands new approaches to detection, diagnosis, and treatment. Discover how blood-based biomarkers are reshaping Alzheimer’s disease therapy by:

  • Simplifying Diagnosis: Uncover the noninvasive procedures that are making early detection more accessible.
  • Promoting Early Intervention: Explore how blood-based tests enable proactive measures, even before symptoms appear.
  • Facilitating Longitudinal Monitoring: Learn how continuous tracking of disease progression paves the way for personalized therapeutic strategies.
  • Boosting Cost-Effectiveness: Find out how this accessible approach is more economically viable, promoting widespread adoption.
Meeting Highlights: 2023 DIA-CoRE Singapore Annual Meeting
APAC on the Move: Clinical Trials, Cell and Gene Therapies, Product Lifecycle Management, and Regulatory Dialogue
Cheung Ka Lok
Clara See
Pamela Tham
Inez Kwan
Novartis Singapore and Novartis Asia Pacific
T

here has been a shift from late phase to early phase design and toward novel drug development in Asia Pacific (APAC), with particularly significant growth in China from 2012 to 2021. In 2021, one speaker noted, APAC accounted for approximately 50% of new global trials with an increasing trend of phase 1 to phase 4 trials being conducted in the region.

Meeting Highlights: DIA Global Annual Meeting 2023
A Year’s Worth of Progress: Insights from the FDA Town Hall 2023
Tamei Elliott
DIA
Sorcha McCrohan
DIA
F

DA has recently met several significant milestones which underline its commitment to public health and safety. This commitment was highlighted by the 1,000th label change made by the Office of Pediatric Therapeutics (within the last year) to ensure safe and effective medical products for children. FDA has also prioritized updating labels for opioids to provide greater clarity for when and how they should be used. FDA is also working to expand over-the-counter sales of hearing aids, drugs with conditions for nonprescription use, and other products.

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Meeting Highlights: DIA Global Annual Meeting 2023
Needed Collaborations to Illuminate the Future of Generative AI for Patient Benefit
Medicine Development Stakeholders Come Together to Discuss Uncertainties and Opportunities
Lindsay Kehoe
CTTI
Sridevi Nagarajan
AstraZeneca
Hoifung Poon
Microsoft Health Futures
Maria Paula Bautista Acelas
DIA
“e-Patient Dave” deBronkart
Johan Ordish
Roche
G

enerative artificial intelligence (AI) is heralding a transformative era in healthcare, and ChatGPT and other large language models (LLMs) are prominent among these innovations. The profound impact of these applications spans various domains including improved patient communication, drug discovery, medicine and device safety monitoring, and the integration of diverse data sources. Indeed, the potential of these advancements is already shaping the way we approach our work today while stimulating our imaginations about their possibilities for the future.

White Paper

eCTD 4.0 Implementation Including Understanding of Regional Differences and Benefits

White Paper

IQVIA: eCTD 4.0 Implementation: Including Understanding of Regional Differences and Benefits
The Electronic Common Technical Document (eCTD) is the standard format for submitting applications, amendments, supplements, and other regulatory reports to health authorities around the world. eCTD v3.2 has been the default version for more than 10 years since its release in 2008. The initial draft implementation guidelines for eCTD 4.0 were developed between 2015 and 2016 to improve robustness, flexibility, long-term stability, and a more advanced lifecycle management process. After many years of collaboration with regulatory bodies and industry sponsors, eCTD version 4.0 is finally ready for implementation.
Videos
DIA Launches New Community: Artificial Intelligence (AI) in Healthcare
Time and Tide (and now AI) Wait for No One
H

ow can data technology experts effectively communicate the benefits and capabilities of artificial intelligence (AI) to life science professionals in the same way that these professionals learned to explain the benefits and capabilities of medicines to patients? DIA Global Head of Science and Scientific Strategy Courtney Granville explores answers to this question with Sridevi Nagarajan (Head of Digital Regulatory Strategy, AstraZeneca) and Michael Meighu (Director of Consulting and Expert Consultant, CGI) at the DIA Global Annual Meeting 2023 in Boston.

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Videos
Africa: Current and Future Roles in Global Clinical Research and Care
D

IA Global Annual Meeting 2023 Honorary Co-Chair David Mukanga, deputy director of Africa Regulatory Systems for the Bill and Melinda Gates Foundation and DIA Global Forum regional editor for Africa, discusses with Global Forum Editor-in-Chief Alberto Grignolo the emergence and rollout of the African Medicines Agency, the need for local and international partnerships in Africa, the significance of a professional from Africa serving as honorary co-chair this year, and much more.

Around the Globe: Australia/New Zealand
Health Technology Assessments: Australia’s Independent Review, New Zealand’s New Collaboration
TGA Has New Leadership
Richard Day
University of New South Wales
I

n April 2023, the Australian Department of Health and Aged Care launched an independent Health Technology Assessment (HTA) Policy and Methods Review of the Australian government’s funding and subsidy schemes for providing medicines, medical services, immunizations, and life-saving drugs to the citizens of Australia. This review is a major commitment under the Strategic Agreement 2022-27 between the Commonwealth of Australia and Medicines Australia, the leading association of the research-based medicines industry in Australia.

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Thanks for reading our October 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.