October 2022


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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

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

Young Professionals Editor

Kaley Lugo Daiichi Sankyo

DIA Membership

Bringing together stakeholders for the betterment of global health care.

Addressing the Microbiome’s Role in Drug Discovery and Development
Cristiano Ruch Werneck Guimarães
Katia Sivieri
Miller Freitas
Stephani Saverio
Nintx – Next Innovative Therapeutics

he drug discovery and development field established over the years a range of in vitro and in vivo tools to model host-drug interactions and better estimate the pharmacodynamics (PD), pharmacokinetics (PK), and toxicity of drug candidates in humans. However, the microbiome’s role was generally ignored (see article in September Global Forum). The range of effects that the gut microbiome might have on administered drugs can produce unexpected outcomes on PK, PD, and toxicity. In turn, drugs may impact the gut microbiome and its interactions with the host cells (intestinal epithelial cells, immune cells, nerve cells, and enteroendocrine cells), perturbing normal body homeostasis. At the extreme end, such as with antibiotics, disruption to the microbiome can lead to dysbiosis and aggravate diseases.

This article summarizes emerging approaches that could be routinely used in preclinical development to investigate the complex drug-microbiome interactions and ultimately the drug-microbiome-host triad. A better understanding of these interactions can be instrumental in fully unraveling the mechanisms of action of drugs and their metabolites, identifying root causes of side effects, reducing attrition in clinical trials, and developing safer and more efficacious therapies.
Microphysiological Systems in Discovery and Pre-Clinical Development: A Call to Action
Katherin Patsch
Seungil Kim
Jerry S. H. Lee
Shannon M. Mumenthaler

Ellison Institute

Photo Credit: Wikimedia Commons

icrophysiological systems (MPS) are platforms for in vitro modeling of a specific tissue or organ by exposing cells to a microenvironment that mimics the physiological aspects important for their function. Coupled with functional drug testing, MPS could contribute to the ongoing transformation of the drug-development process by recapitulating organ-level pathophysiology and clinical response. A major challenge lies in integrating multiscale, context-specific data to demonstrate the utility of these emerging technologies and establish context-of-use. Here, we highlight the current use of MPS for drug safety testing, suggest expansion to discovery and pre-clinical development of oncology drugs, and advocate for systematic data collection and data sharing for successful integration.

Representation Bias in Genomic Research Data Propagates Structural Inequity in Cancer Care
Lynda Chin
Dell Medical School, UT Austin
Apricity Health

egulators and drug developers are intensely focused on boosting diversity among clinical trial participants, in part because so many of the new precision oncology drugs prove less effective in real-world populations than they do in highly selected clinical trials. Many factors contribute to this loss of effectiveness in real-world care, and increasing diversity in clinical trial participation alone is necessary but insufficient.

Among major drivers is the structural bias inherent in today’s drug development pipeline, specifically the lack of diversity and inclusiveness in research data that shape the pipeline. By the time a drug is in clinical trials, the bias introduced upstream at decision points of target selection and clinical trial design is already baked in, because the foundational genomic data such decisions are based on is often skewed in its representation of the real-world patient population. Therefore, we must consider equitable representation in these foundational genomic data sets as a requisite first step towards ensuring equitable access to effective anticancer treatment.
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The Five Key Decisions for Every Biosimilar Development Program
Kurt Brorson
Cecil Nick

n 2015, FDA approved the first biosimilar drug for the US market. Since then, the agency has approved 33 biosimilars, 21 of which were available commercially as of January 2022. By 4Q 2021, the number of compounds enrolled in FDA’s biosimilar biological product development program had reached 100. The momentum of biosimilar development is building, with development pathways evolving at different rates in different regions. That said, every sponsor will face important decisions along the way that will require careful consideration. This article discusses five of the most critical junctures in biosimilar development.

Novel Global Regulatory Agilities: Impact on Multiple Stakeholders
Brenda J. Huneycutt
Virginia Acha

OVID-19 pushed regulatory science and practices to new heights and brought stakeholders together in unprecedented ways to deliver safe and effective vaccines and medicines to patients in record time. While we cannot expect work to continue at this breakneck pace forever, some agilities proved themselves to be of significant value. To ensure that these regulatory lessons from the pandemic are not lost, it is critical to understand the impacts to and perspectives of stakeholders beyond regulators and industry. This article presents a brief summary of the discussions and conclusions of a multistakeholder workshop that allowed the understanding of diverse views on select agilities, which can inform if and how pandemic agilities are incorporated into routine agency practice.

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Improving Access to Cancer Clinical Trials by Reimagining Clinical Trial Conduct
Esther Howard

ar too many cancer patients are not getting the treatment they need because they do not know about, do not have access to, or are not able to participate in a clinical trial. It is estimated that fewer than 5 percent of adult patients participate in clinical trials, and yet approximately 70 percent of cancer patients are willing to do so. This gap between participation rates and the willingness to participate is one the clinical research industry is dedicated to resolving.

To bridge the gap, two changes would make a significant difference:

  1. More sites need to be able to participate in research, especially in communities that are too far from academic institutions where most oncology clinical research is conducted.
  2. Clinical trial design needs to be reimagined to simplify patient participation and personalize their experience in a trial.
The Changing Face of Medicine:
Shaping an Adaptable, Agile, and Sustainable Future for Patient Care
Charlie Bell
University of Cambridge
Pali Hungin
Newcastle University
Elizabeth Lamb
Newcastle University
On behalf of The Changing Face of Medicine

he COVID-19 crisis forced substantial transformation upon healthcare systems; staff were rapidly repurposed, facilities and services were reconfigured, additional hospitals were created within days, and the fields of biomedicine and engineering advanced at unprecedented rates.

Meeting Highlights: DIA Global Annual Meeting 2022

Meeting Highlights from DIA Global Annual Meeting 2022

Meeting Highlights: DIA Global Annual Meeting 2022

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Assessing and Integrating Patient Preferences into Clinical Research and Care Decisions
Maria Paula Bautista Acelas
Drug Information Association
Rosanne Janssens
KU Leuven, Belgium
Kevin Marsh
Evidera, UK

s the end users of healthcare products, interventions, and related research, eliciting and incorporating patient preferences into clinical treatment and clinical trial design have become paramount in reconciling the different and often difficult trade-offs related to healthcare decision-making. Meaningful involvement of patients as active and equal research partners, through which they can formulate and express preferences resulting from their own cognition and experience, can be especially effective early in the healthcare product development lifecycle.

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Around the Globe

Patients Need Not Wait: Evolving Compassionate Use and Named Patient Programs Across Asia Pacific
ChongXiang Tan
Fengyun (Vicky) Han
Annetta C. Beauregard
Janssen Pharmaceutical Companies of Johnson & Johnson

hrough compassionate use programs (otherwise known as named patient programs or special access schemes), patients suffering from critical, life-threatening conditions can access potential life-saving therapeutic options which have not been formally approved by the responsible health authority in an ethical and regulated way. Many health authorities in Asia Pacific (AP) have defined the compassionate use of unapproved therapeutic products in their pharmaceutical acts or regulations so that medical practitioners can request, on behalf of their patients, the import of unapproved medicines for treatment.

Around the Globe

New Australia TGA Website and First NASWSI Consortium Approvals
Richard Day
University of New South Wales

any of us can relate to the challenge of navigating regulatory agency websites, but there is good news from Australia’s Therapeutic Goods Administration (TGA). The TGA website has been redeveloped and was officially launched this past August 30 with subsequent improvements planned to continue over the next 12 months. There were over 46,000 documents on TGA’s previous website, so it was not surprising that finding information on it was challenging. Content from the previous version has been archived with the National Library of Australia web archives on a site called TROVE. In TROVE, you can find just about anything written about or from Australia. It also provides guidance about retrieving archived TGA documents. Nothing has been lost and everything can be found.

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China Sets New Record for Local Drug Approvals in 2021

DIA Global Forum’s annual review of new drug approvals in China has shown growth in both the number and types of new drugs approved in China from 2019 through 2021: from 34 new chemical drugs and 19 biological products in 2019 to 37 new chemical drugs and 24 biological products in 2021. This podcast explores this growth in the context of the regulatory reform begun in China in 2015. “The annual number of new drug approvals reached a record high of 61 in 2021,” explains Global Forum China Regional Editor Ling Su (Shenyang Pharmaceutical University Yeehong Business School; Venture Partner, Lilly Asia Ventures). “In 2021, among the 61 new drugs approved, 31–slightly over 50 percent–were developed by local companies, and this was the first time that domestic companies received more new drug approvals than foreign companies in a given year.”
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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.