November 2023
November 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

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.

Whole Person Health: An Approach to Closing Health Gaps
Helene M. Langevin
US National Center for Complementary and Integrative Health

ounting evidence points to concerning health trends worldwide. In the US, provisional data reported by the Centers for Disease Control and Prevention (CDC) show that life expectancy, at 76.1 years, is the lowest it has been since 1996. COVID-19 has taken a high toll, but the pre-existing crises of chronic pain, opioid misuse, and obesity and its related conditions like heart disease, kidney failure, and diabetes fuel the loss of not just years but also quality of life.

Developing and Launching Successful Digital Health Products: Five Considerations
Baris Ersezer

igital health products (such as digital therapeutics, mobile health, telehealth, and personalized medicine) development has been on the rise in recent years, promising to transform healthcare delivery. However, the challenges faced in developing, commercializing, and marketing successful digital health products are significant, including market access and reimbursement; regulatory challenges due to lengthy and costly regulatory approval processes and the reality that ongoing compliance can be a burden even after approval; data privacy and security concerns; a highly competitive field; and reimbursement and revenue models. To minimize risks and maximize the chances of success, companies need to prioritize five key considerations discussed here: user expectations, digital environment, data, go-to-market strategy, and agility.

New FDA Guidance Addresses Challenges with Cell and Gene Manufacturing Comparability and Complexity
Francesco Lanucara

evelopment of cell and gene therapy (CGT) products is often challenged by the need to demonstrate product comparability following changes in the manufacturing process. Issues include limited process and product knowledge at different stages of product development compared to more conventional biotherapeutics, the complex mechanism of action, the limited and sometimes variable nature of the starting materials, and analytical methods which are often still in development during a comparability study.

3 Ways to Rethink and Improve Pharmacovigilance Outsourcing
Better Oversight, Data Ownership, and Technology Can Power Speed and Agility
Christina Kim
Veeva Vault Safety

or the more than 1 billion drugs provided or prescribed to patients in the US, what if an adverse event is missed or not reported quickly? That question looms heavily for biotech companies that outsource pharmacovigilance, regardless of whether the company is clinical-stage or commercial-stage.

Statistics Powering Risk-Based Quality Management

luePoints Co-Founder and Chief Product & Technology Officer François Torche discusses the challenges of collecting clinical trial data with digital or remote tools (eCOA, ePRO, etc.) without putting the quality of that collected data at risk in the below interview.

DIA Moving Forward with Decentralized Clinical Trials Advertisement
Clinical Trial Inclusivity, Diversity, and Equity in Action

n 2022, FDA’s Draft Guidance on Diversity Plans and passage of the Food and Drug Omnibus Reform Act (FDORA) significantly changed the landscape for diversity and inclusion in clinical trials. In the below interview, Curavit President and Co-Founder Dave Hanaman and Clinical Research Business Development Manager Natalia Husby discuss Curavit’s new Inclusivity, Diversity, and Equity in Action (IDEA) service offering with DIA Scientific Programs Associate Director Tamei Elliott.

Special Section
Solving the Rubik’s Cube of Competing Forces to Realize the Future of Clinical Research
Part 1: AI and Data Quality in a Decentralized World
Steve Young

rtificial intelligence (AI) has massive potential to advance clinical research. A scoping review in 2022 found that use of AI in the design and conduct phases of clinical trials has a positive impact on efficacy, safety and cost containment. From accelerating recruitment and enhancing patient selection, to identifying data quality issues through enhanced statistical analysis, machine learning (ML) and deep learning (DL) approaches are unlocking new possibilities.

Special Section
Solving the Rubik’s Cube of Competing Forces to Realize the Future of Clinical Research:
Part 2: Maximizing Patient-Centricity While Minimizing Site Burden through Strategic Partnerships
Sam Whitaker and Jason Dong
Mural Health

linical trials have always required a huge number of interconnecting elements to operate, but the recent proliferation of patient centricity-enabling clinical trial technologies is compounding this complexity. In an open letter to sponsors and contract research organizations (CROs), the Society for Clinical Research Sites said: “As our industry undergoes rapid change and transformation, sites are experiencing unforeseen, unprecedented, and historic increases in costs centered around patient-facing research staff and overhead.”

Special Section
Solving the Rubik’s Cube of Competing Forces to Realize the Future of Clinical Research
Part 3: Maintaining the Human Touch Amidst Digital Transformation
Sandra Webb and Stephanie Katz

n oft-quoted benefit of hybrid studies and decentralized clinical trials (DCTs) is that they increase recruitment and retention by making it easier for people to take part. A global survey of more than 11,000 trial participants found travel was a top participation burden. The same survey revealed ways to relieve study participation burden, which can include making study visits virtual, reducing travel times and distances, and allowing at-home visits from medical staff.

White Paper

Pankaj Desai

White Paper

University of Cincinnati Online White Paper Podcast: Master of Pharmaceutical Sciences in Drug Development Online Program
Drug development is a complex, lengthy, and expensive process requiring extensive training and experience in numerous areas. The University of Cincinnati’s fully online Masters in Pharmaceutical Sciences in Drug Development program—a collaboration between academia, industry, and government—prepares students for the multidisciplinary process of translating a therapeutic concept from lab bench to bedside. “This curriculum provides details that would take an individual working in a particular field a long time to get good exposure to, and what you need to be aware of before you can initiate any human trials, to how you make the best of the opportunity,” explains program director Pankaj Desai, chair of the university’s Pharmaceutical Sciences Division. “Working with human patients is a great privilege. We have to be very mindful of the respect and ethical issues that go along with that.”
Meeting Highlights: DIA Global Annual Meeting 2023
Revolutionizing the Life Sciences:
How Diversity, Innovation, and Artificial Intelligence are Accelerating the Future of Health

It is not the strongest of the species that survives, nor the most intelligent, but the one most responsive to change.”
—Charles Darwin


echnology has helped bring us to the cusp of several crucial conversations in which stakeholders across the entire life sciences and health ecosystems must engage. Diversity, innovation, and AI can create a hugely powerful synergy that drives transformation across the health and life sciences. But clever ideas and inventions are no longer enough;—for these innovations to breathe new life into the real world, we must also work to create an environment ready to receive and adopt them.

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White Paper

Pankaj Desai

White Paper

Indegene White Paper Podcast: Digital Tools Building Data Speedway from Bench to Market
How can current clinical data expertise incorporate real-world data (RWD), artificial intelligence (AI), and machine learning (ML) to make research more effective and efficient? “Informed by patient feedback via surveys and other mechanisms, real-world evidence could influence study design and protocol optimization by ensuring hybrid configurations and allowing for diversity, equity, and inclusion,” explains Indegene Head of Enterprise Clinical Ram Yeleswarapu. “From bench to market, discovery leading to development and launch of safe and effective therapies will get accelerated by AI-ML. This will perhaps reduce or eventually obviate testing in animals and humans and enhance digital twins simulating these behaviors. AI-ML could play a very disruptive role as we look ahead.”
Around the Globe: Canada
Canadian Medical Information Benchmarking Survey: MILE Framework for Digital Provision of Medical Information for Healthcare Professionals
Marie-Ange Noué
EMD Serono Inc.
Joanna Rizos
Eli Lilly Canada Inc.
Dan Quinn
Boehringer Ingelheim Canada Ltd. (retired)
John K. Wong
Regulatory Consultant

n pharmaceutical companies, Medical Information (MI) departments serve a key role in providing balanced scientific and medical information in response to unsolicited requests, through various channels, from healthcare professionals (HCPs).

Around the Globe: Europe
EU Acts on the Promise of Artificial Intelligence for Medicinal Products
David Isom and Monica Mihedji
Pfizer, Inc.

egulators are advancing information technology and data modernization initiatives to drive more efficiencies and to become more responsive to industry use of digital technologies in drug development. These include digital health technologies to promote decentralized trials, cloud-based platforms to enable more capacity and external collaboration opportunities, and machine learning (ML) technologies including artificial intelligence (AI) to transform review of high-volume data, including real-world evidence programs. A key milestone took place in July of 2023, with the release by the European Medicines Agency (EMA) of a reflection paper sharing their views on the use of AI in the regulation of medicines.

Career Circles Mentoring Program Announces 2023-’24 Cohort

IA has announced enhancements to our DIA Fellows Mentoring Program

This year’s program will be administered in a Career Circles format. The program provides mentees the opportunity to connect with experienced mentors (DIA Fellows) who can help them envision their career path and accelerate their professional growth as well as providing mentors an opportunity to share their time and expertise to help develop and nurture the next generation of both the global DIA community and life sciences workforce.
Thanks for reading our November 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.