February 2024


Love Global Forum’s new online format? Subscribe today and never miss an issue.

Editorial Board

Content stream editors

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

regulatory science
Isaac Rodriguez-Chavez 4Biosolutions Consulting

Patient engagement
Natasha Ratcliffe Patient Engagement Specialist
Thomas Smith Independent Patient Consultant

Data and Digital
Lisa Barbadora Barbadora Ink

Wyatt Gotbetter Parexel

Editorial Staff

Alberto Grignolo, Editor-in-Chief

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

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

Toshiyoshi Tominaga Keio University Hospital, Clinical and Translational Research Center

Cammilla Gomes Roche

Ebony Dashiell-Aje BioMarin

DIA Membership

Bringing together stakeholders for the betterment of global health care.

US Drug Pricing and Reimbursement: Players, Payers, PBMs, and Prospects
A Conversation with Two Experts

n late 2023, The Wall Street Journal published the article Generic Drugs Should Be Cheap, but Insurers Are Charging Thousands of Dollars for Them (subscription only). This article examined interactions between patient health insurance prescription benefits, pharmacies, and pharmacy benefit managers (PBMs), and their collective impact on the prices that patients pay for their prescription drugs in the United States.

Drug Shortages in the Global South: A Proposed Parallel Tech and Reg Transfer Framework
Verena Pfaffinger
Ilona Baraniak-Lang

he COVID-19 pandemic exposed significant challenges in the pharmaceutical global supply chain, leading to severe shortages of drugs and vaccines worldwide. This resulted in a pronounced inequity in distribution, particularly disadvantaging the Global South. This disparity is largely due to the dependency of low- and middle-income countries (LMICs) on pharmaceutical manufacturing in more industrialized nations. To mitigate this inequity and ensure supply of medicinal products across the globe, manufacturing of medicinal products needs to be decentralized through the establishment of manufacturing sites in LMICs.

Future Pharmacovigilance: Industry Survey Reveals Trends and Strategies

Sameer Lal
Nikesh Shah

n the intricate world of life sciences, where patient safety and regulatory compliance are paramount, pharmacovigilance (PV) stands as the guardian. To understand this dynamic landscape, a survey was recently conducted with a diverse pool of 100 PV professionals across the US and Europe. The findings unveiled a tapestry of compelling insights, spanning diverse themes encompassing PV team strategies, technology maturity, and the emergence of GenAI, etc. Notably, the survey (see details below) spotlighted intriguing statistics around the acceleration of automation, the embrace of AI/ML technologies, and the strategic evolution toward smart outsourcing, painting a vivid picture of the industry’s current trajectory.

Benefits of Integrating Patient Engagement with Diversity, Equity, and Inclusion in New Medical Product Development: A Call for Action

Jessica Scott
Vivian Larsen
Lori Hall
Legacy Health Strategies

ver the past decade, the importance of patient engagement (PE) has surged, reflecting a move towards integrating patient experiences and insights into research processes. This evolution aims not just to involve patients but to empower them as research partners. Concurrently, there’s a burgeoning urgency to incorporate diversity, equity, and inclusion (DEI) principles into the drug development process, though largely as a separate and distinct effort.

Clinical Trial Results on ClinicalTrials.gov: Limited Value and Utility to Patients and Professionals
Kimbra Edwards, Emma Olshin, Kenneth Getz
Center for Information and Study on Clinical Research Participation (CISCRP)

ccess to reliable, complete, accurate information on clinical trial results will inform the best treatment options for patients and instill greater trust between patients, healthcare providers, clinical research professionals, and the public.

Until relatively recently, information about clinical trial results was not provided in language that is clear, accessible, and easy to understand (plain language) to most patients. Instead, information was only available in scientific and technical language (e.g., peer-reviewed medical journals, professional society presentations and proceedings, and scientific and research-oriented websites).
Fair Pay for Patient Engagement: Navigating the Evolving Landscape of Remuneration
Nicole Wicki
Patient Focused Medicines Development

atient engagement across the medical innovation lifecycle has accelerated rapidly in recent years. The depth and breadth of patient engagement activities are flourishing, with increasing efforts around fit-for-purpose product development, Patient Experience Data, and value for patients who have the most to gain or lose from medical innovation and access.

The Importance of Regulatory Due Diligence During the Acquisition Process

Darshan Kulkarni
Kulkarni Law Firm


ue diligence is the cornerstone of the acquisition process, particularly when considering the acquisition of companies regulated by the Food and Drug Administration (FDA) like pharmaceutical, medical device, food, pharmacy, or cosmetics companies. It determines not only the risks involved in the acquisition, but also the downstream impact of the risks.

Some companies, in the haste to close a deal, may overlook the depth and breadth of FDA-related due diligence. However, this oversight can lead to severe ramifications down the road, including overpaying for a transaction, increased risk, and even inadequacy of products the acquirer thought they purchased, which may be deemed adulterated or misbranded by the FDA due to inappropriate risk assessments. Accordingly, the due diligence process is much more than a procedural step; the assessment of a company’s interactions with the FDA and compliance with FDA regulations is a critical component in assessing the value, risks, and potential of an acquisition. The following is a list of factors to explain why FDA due diligence is critical.

White Paper

AI & Global Labeling: How Next-Gen Tools Are Streamlining Structured Component Authoring Effectively and Compliantly

White Paper

AI & Global Labeling: How Next-Gen Tools Are Streamlining Structured Component Authoring Effectively and Compliantly

Outside of the physical drug product itself, global labeling plays the most fundamental role in helping pharmaceutical companies deliver safe and effective therapies to the population. But the process behind global labeling—the authoring, editing, collaborating, translating, and publishing of drug labels—is both incredibly complex and time-consuming. This guide explores how AI-powered tools are helping teams simplify and accelerate their in-house authoring workflows, without sacrificing compliance. It also explains how, by using such tools, companies can transform not just the way they work but also the entire “last mile” of the drug development lifecycle.

Around the Globe: Africa

Industry’s Window to Express Interest in Africa Continental Product Evaluation Pilot Closes End of February 2024
Alex J. Ismail, Chimwemwe Chamdimba
African Union Development Agency-NEPAD

o support operationalization of the African Medicines Agency (AMA), the Evaluation of Medicinal Products Technical Committee (EMP-TC) has issued a Call for Industry Applications: Pilot of the Continental Listing of Medicinal Products. This pilot project has been designed to pressure test the continental procedures and processes for evaluating medicinal products developed and endorsed by the African Medicines Regulatory Harmonisation (AMRH) Steering Committee and the assembly of the 9th African Medicines Regulators Conference (AMRC).

Around the Globe: ASEAN

Accelerating Adoption of eLabeling in Singapore: One Company’s Journey
Anna Litsiou, Priti Shah
AstraZeneca UK
Lee Mei Liew, Pearle Liew, Sau Wei Wong
AstraZeneca Singapore

lectronic labeling (eLabeling hereafter), or the utilization of digital labels on packaging, is an example of digital transformation for medicinal products gaining international momentum.

eLabeling benefits both users and the environment. For patients, caregivers, and healthcare professionals (HCPs), timely communication of approved and accurate product information from a trusted source has the potential to build confidence.

DIA Europe 2024 Advertisement
Thanks for reading our February 2024 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.