May 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 Independent Consultant

Patient engagement
Chi Pakarinen MediPaCe
Natasha Ratcliffe COUCH Health
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, 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

Julie O’Brien Pfizer

J. Vijay Venkatraman Oviya MedSafe

Ozawa Goshi Real Discovery Outdoors Co,. Ltd.

Cammilla Gomes Roche

Ebony Dashiell-Aje BioMarin

DIA Membership

Bringing together stakeholders for the betterment of global health care.

Optimizing Clinical Trials through Ethical Technology
A Regulatory Perspective for Non-Technical Users
Mathew E. Rose
IEEE Standards Association

linical trials are critical for advancing healthcare, and technology is playing an increasingly important role in their design and conduct (for example, the use of sensors, telehealth, remote monitoring, AI, etc.). But how does the adoption of these new technologies relate to clinical research ethics and regulation?

What is the Role of Venture Capital in Drug Discovery and Development?
Alexandra Snyder
Generate Biomedicines

he collapse of Silicon Valley Bank (SVB) in March 2023 sent a frisson of concern through the biotechnology and tech industries, given the significant implications the bank’s failure had for some banks and early-stage companies. Because SVB was widely known as the venture capital industry’s leading bank, it immediately raised questions about the role that VCs play in determining the financial fortunes of biotechnology startups. This leads naturally to a related question that I will address in this essay: What is the role of venture capital in drug discovery and development?

Patient Case Studies – When and How to Use Them
Rina Newton
ABPI Code & Compliance Expert, UK

he Prescription Medicines Code of Practice Authority (PMCPA) in the UK has stated that patient case studies are likely to be viewed as promotional, and this obviously significantly limits how and when they can be employed. This article focuses on how compliance with the Association of the British Pharmaceutical Industry (ABPI) Code can still be achieved when case studies differ in their content and use. The ABPI code sets standards for pharmaceutical companies with respect to the promotion of medicines as well as the provision of information to patients.

Healthy Societies Need Healthy Women; Women’s Health Relies on Equitable Clinical Research
Sanskriti Thakur

his Mother’s Day, women across the US and in other parts of the world will be celebrated, but this appreciation is not reflected in scientific research, where women continue to face stark inequities. Today’s approach, investment, and mindset fail to deliver complete healthcare to women and limit data capture. Ultimately, this severely curtails the world’s understanding of disease states that impact women the most.

Banging Down Doors to Breaking Glass Ceilings: Better Health Equity for Women
Pam Diamond
Portrait of Pam Diamond
Pam Diamond, Curavit

ong days and nights with only intermittent hours of sleep are not uncommon for surgical interns of any generation or gender—and such was the case in 1985 when I was doing my General Surgery internship at Strong Memorial Hospital at the University of Rochester in New York. But when I finally got my chance for a few precious hours of rest, I had to bang on doors … literally.

RWD/RWE in 2023: Regulatory Policy World Tour
Elena Popa
Max Wegner
Patrick Brady
Vada Perkins
Shefali Goyal

Ulrike Bodesheim

Bayer AG

he incredibly fast development and rollout of the COVID-19 vaccines would not have been possible without the critical contributions of real-world data and real-world evidence (RWD/RWE). But the race to use, understand, and accept RWD/RWE throughout the drug development life cycle started a long time ago. While regulators such as the US FDA, EMA, and Taiwan FDA (TFDA) have taken a more pragmatic approach in developing guidelines, regulations, and frameworks, we must ensure that the international collaboration and regulatory standards are harmonized and use similar, if not the same, scientific values. Much needs to be done in terms of predictability, data gathering and interpretation, methodologies used, and acceptance by regulators, HTAs, and payers.

Around the Globe: Africa
Stay Tuned: African Medicines Agency Appointing Governing Board and Director General in 2023
David Mukanga
Bill and Melinda Gates Foundation

he Conference of the States Parties of the African Medicines Agency (AMA) moved effectively in 2022 to make a key decision: selecting the first country to host the AMA. Their recommendation was endorsed by the Executive Council of the African Union in July, and Rwanda was announced as host of AMA in August.

Two more critical milestones are expected in 2023: appointment of the Governing Board (GB) and of the Director General (DG). The GB and DG will be responsible for defining and establishing the initial scope of and procedures for AMA’s regulatory activities. Timelines for this definition and scope will be determined by these two AMA structures.
Around the Globe: ASEAN
Improving Vaccine Access in Asia Pacific
A Call to Action
Jun Feng, Alex Best
Janssen Pharmaceuticals,
Kristy Lim
Janssen Pharmaceuticals,
South Korea

accination is one of the most efficient public health interventions available and the main tool for primary prevention of communicable diseases. The COVID-19 pandemic has reinforced the health, social, and economic benefits from timely access to vaccines and other essential treatments. The pandemic has also highlighted two critical preconditions to delivering timely access: First, countries must have a responsive and transparent national immunization program; second, countries must establish procurement and financing arrangements that can rapidly execute commercial arrangements to secure supply.

Around the Globe: Europe
European Health Union: Commission Proposes Pharmaceuticals Reform for More Accessible, Affordable, and Innovative Medicines

n 26 April, the Commission proposed the largest reform to EU’s pharmaceutical legislation in more than 20 years. The revision includes proposals for a new Directive and a new Regulation, which revise and replace the existing pharmaceutical legislation, including the legislation on medicines for children and for rare diseases.

Around the Globe: Europe
Interview with EUnetHTA Executive Board Chair Niklas Hedberg
A portrait photograph headshot of EUnetHTA Executive Board Chair Niklas Hedberg grinning in a black suit
EUnetHTA Executive Board Chair Niklas Hedberg

he much-discussed EU-wide legislative framework on health technology assessment (HTA) will finally be implemented in 2025, explains EUnetHTA Chair Niklas Hedberg. He outlines the need for this framework given the sheer influx of new products and the limited capabilities of individual countries and why the intervening two years will be exceptionally busy for all stakeholders as they work to adapt to a unified system with new requirements. Hedberg ends with a rallying cry to not let minor details derail the rollout of this important new legislation which has been two decades in the making and has had the support of both governments and private companies.

Around the Globe: Latin America
Improving Use of Epidemiological Data to Serve Patients Better: A Colombian Initiative
Julián Camilo Avendaño Gallo
Amalia Catalina Lehmann Oliveros
Juan David Cano Sierra
Andrés Ramírez
MSD, Colombia

pidemiological data are important assets, which support government controls and measures to ensure appropriate public health interventions. The Integrated System of Information of Social Protection (SISPRO, its Spanish acronym) provides an online free-access system of databases with information on healthcare quality, assurance, financing, and other aspects of healthcare services in Colombia. This information management system, achieved through digital technologies, has provided multiple benefits for patients and the healthcare system in Colombia.

DIA Welcomes Shogo Nakamori
New SVP and Managing Director, DIA Japan and Korea
A portrait photograph headshot of new Senior Vice President and Managing Director (DIA Japan and Korea) Shogo Nakamori grinning in a dark navy blue business suit and tie
Shogo Nakamori, Senior Vice President & Managing Director, DIA Japan and Korea

n January 2023, DIA announced the appointment of Shogo Nakamori as Senior Vice President and Managing Director, DIA Japan and Korea.

Shogo is a pharmacist who has worked in the pharmaceutical and CRO industries for more than 25 years. His career began with drug development work at Ciba- Geigy followed by Novartis, Solvay Pharmaceuticals, AstraZeneca, and Mundipharma. He subsequently managed Acronet and Parexel as president of both CROs. Shogo most recently directed the development of cellular medicine under the Mitsubishi Chemical Holdings umbrella. While at Parexel, Shogo represented the CRO industry on a special advisory committee sponsored by the government to promote clinical trials in Japan. Shogo has also served on the Regional Advisory Council for DIA Japan for four years.

Thanks for reading our May 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.