April 2021


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Editorial Board

Content stream editors

Translational science
Gary Kelloff US National Institutes of Health
David Parkinson ESSA Pharma, Inc.

regulatory science
Isaac Rodriguez-Chavez PRA Health Sciences

Patient engagement
Trishna Bharadia Patient Advocate and Media Contributor
Mary Stober Murray National Minority Quality Forum

Monika Schneider Shionogi

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

Judith Glennie JL Glennie Consulting, Inc.

Ling Su Shenyang Pharmaceutical University, Lilly Asia Ventures

Thomas Kühler Sanofi R&D

J. Vijay Venkatraman Oviya MedSafe

Ozawa Goshi Real World Data Co. Ltd.

Cammilla Gomes Roche

Ebony Dashiell-Aje BioMarin

Young Professionals Editors

Kaley Lugo Daiichi Sankyo
Saloni Patel Acorda Therapeutics

DIA Membership

Bringing together stakeholders for the betterment of global health care.

Advancing Precision Oncology: TADRUCA, A Model for Global Collaboration
Susan Halabi
Duke University
Pam Mangat
American Society of Clinical Oncology
Elizabeth Garrett-Mayer
American Society of Clinical Oncology
Hanneke van der Wijngaart
Vrije Universiteit Amsterdam, The Netherlands
Henk M. W. Verheul
Radboud University Medical Center, The Netherlands
Emile E. Voest
Netherlands Cancer Institute, The Netherlands
Lillian Siu
Queens University, Canada
Daniel J. Renouf
University of British Columbia, Canada
Janet Dancey
Queens University, Canada
Richard L. Schilsky
American Society of Clinical Oncology

nnovations in molecular and genomic analysis have advanced our understanding of cancer biology and progression. It is now clear that cancer is a heterogeneous group of diseases and many of the available therapies may work only in a subset of patients. Furthermore, it is well-established that tailoring treatments to specific oncogenic drivers in patients with various cancers leads to improved clinical outcomes.

Despite remarkable advances in tailoring treatments, the impact of precision medicine has yet to be fully realized in many clinical settings. Nevertheless, this field has been ignited, and we have seen a surge in prospective trials that match patients to drugs based on their tumor’s genomic alterations to identify signals of drug activity.

Linking Regulations with Diversity, Inclusion, and New Opportunities in Decentralized Clinical Trials
Isaac R. Rodriguez-Chavez

raditional clinical trials have created a series of deficiencies in diversity and inclusion (D&I). Decentralized clinical trials (DCTs) enabled by digital health technologies (DHTs) offer new opportunities to improve D&I. These trials offer advantages driven by increasing convenience for participants by breaking geographic barriers with the use of technology. However, the implementation of these trials alone will not be enough to address D&I deficiencies. Multipronged approaches are needed to overcome barriers and to realize the benefits of enhancing D&I in DCTs enabled by DHTs. These approaches should include D&I plans at the regulatory, organizational, and trial participant level.

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Co-Creating Global Capacity for Systematic Patient Engagement
Mary Stober Murray

ecognizing the need to build reliable industry-wide capacity for systematic patient engagement, several multi-stakeholder initiatives have introduced patient engagement toolkits, training programs, and individual guidance over the past few years. This article describes key organizations, initiatives, and resources driving the convergence towards establishing systemic patient engagement capacity and operational practices. Stakeholders can access resources to pursue patient engagement credentials independently and to implement functions and practices within their organizations.

Key Takeaways

  • Individuals involved in medicines development now can receive professional credentials in patient engagement.
  • Organizations can transform culture towards patient-centeredness by leading the adoption of co-created patient engagement training, toolkits, and tools that value and reflect input from patients, caregivers, and advocates in operational activities, including compensation and contracting, protocol design, and quality measurements.
  • Many of the trainings and toolkits are available now for free or at low cost to individuals and organizations to facilitate adoption, influence standard operating procedures, build capacity, and drive the culture shift towards a common view of patient engagement throughout medical product development.
Digital Adoption at Clinical Research Sites Still A Work in Progress
Francesca Properzi
DT Consulting (An Indegene Company)
Sudip Sinha

igital technologies, defined as the electronic tools and devices that can produce, analyze and store data, have the potential to transform clinical trials by supporting virtual interactions between patients and researchers and clinicians. In April 2020, it looked like more than half of investigative sites were shifting to virtual methods of patient interaction. However, results from DT Consulting’s inaugural clinical trial survey indicate that many clinical trial sites are still reluctant to integrate digital technologies into their process and that cost, complexity, and finding the right technologies are the main barriers to digital adoption. This, despite the extraordinary disruption and halting of trials after the outbreak of COVID-19.

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Around the Globe

Aligning Combination Products Regulations in Asia-Pacific: A Distant Dream?
Dhiraj Behl
Amity Institute of Pharmacy, Amity University, India
Janine Jamieson
International Pharmaceutical Quality, Sweden
Harikesh Kalonia
Amity Institute of Pharmacy, Amity University, India

n the current innovation era and in the wake of COVID-19, two topics of rising importance for enabling patient access to newer treatment modalities are regulatory harmonization and drug-device combination products.

For patients and healthcare systems globally, there are enormous potential benefits of drug delivery devices designed for:

  • Improved targeting of treatments,
  • Enabling home treatment, and
  • Realizing the potential for digital technologies to optimize and monitor clinical outcomes.

Innovative, integrated delivery devices are useful for vaccines as well as treatments required for cancer, heart disease, multiple sclerosis and many more serious and chronic diseases. Drug-device combination product types include the classic prefilled syringes and pens, auto-injectors, metered-dose inhalers, dry powder inhalers, and increasingly the inclusion of connected software. However, regulation of these products is complex.

Around the Globe

Importance of Reliance to Support Strengthening Latin American and Caribbean Regulatory Systems
Maria Cristina Mota Pina
Abbvie on behalf of FIFARMA Regulatory & Biologics Working Group

egulatory reliance is increasingly used around the world by National Regulatory Authorities (NRAs) with different levels of maturity. This concept is actively promoted by organizations such as World Health Organization (WHO), the Pan American Health Organization (PAHO) as a mechanism for NRAs to better manage resource capacity issues while simultaneously strengthening regulatory systems. This article presents some practical considerations and opportunities for a successful implementation of regulatory reliance with a focus on the specificities of NRAs in Latin America and the Caribbean.

Regulatory reliance is defined as the act whereby the National Regulatory Authority (NRA) in one jurisdiction may take into account and give significant weight to assessments performed by another NRA or trusted institution, or to any other authoritative information source, for purposes of reaching its own decisions. The relying authority remains independent, responsible and accountable regarding the decisions taken, even when it relies on the decisions and information of others.

Regulatory reliance is anchored in the overarching Good Regulatory Practices (GRP) and provides a process for sound and effective regulation of medical products (i.e., medicines, vaccines, blood and blood products and medical devices including in vitro diagnostics and other health products), as an important part of strengthening health systems. Countries with efficient regulatory systems will serve their patients by ensuring that safe, quality, and effective medical products are approved and are accessible to patients in a timely manner. Clear public health priorities based on medical needs, availability of medical innovation and regulatory capacity assessments should guide NRAs approaches to regulatory reliance.


Japan Healthcare 2035: Focus on Basic Science & Economics
Kanmuri Kazuhiro
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Around the Globe

Latin America Regulatory Conference: Regulators’ Response to COVID-19
Cammilla Gomes
Viktoria Magyar
University of Southern California
Regulators at the Latin America Regulatory Conference 2021 highlighted the region’s response to the COVID-19 pandemic among their updates. Look for our upcoming article on other Conference themes in our next issue.
Part 1: COVID-19 Regulatory Response

Several national activities, formalized organizations, and mechanisms were highlighted in light of the world’s ongoing pandemic emergency.

The US FDA continues to support faster exchange of COVID-19 related information, ongoing participation in international initiatives to respond to the pandemic (such as creation of the Emergency Use Authorization [EUA]), and the continuous assessment and dissemination of lessons learned.

Part 2: Regional Tour: Regulatory Updates
Beyond the response from regulators to the health emergency, there are several other important updates to report from the regional regulatory agencies in Latin America.

Brazil’s ANVISA has organized its 2020-2022 Strategic Plan into principles, objectives, and initiatives that will guide the transformation of government through digital technologies in Brazil. This transformation will also deliver efficiency gains for public management, issuance of the International Certificate of Vaccination and Prophylaxis, an established digital trajectory for both the government and the economy, and strategic alignment between government actions and other measures to stimulate an increasingly digitized, dynamic, productive, and competitive Brazilian economy.

Around the Globe

Practice Follows Principles: Creating More Inclusive Patient-Centered Development & Commercialization
Hilary Wilson
Boehringer Ingelheim
Cleonette D. Cudjoe
Patient Advocate
Jen Horonjeff
Savvy Cooperative

nderrepresentation of Black and Indigenous people of color (BIPOC) and other racial and ethnic minorities in clinical trials is a longstanding issue. The disparate impact that COVID-19 has had on BIPOC, Hispanic, Latinx, and Asian communities, combined with the underrepresentation of these subgroups in some COVID-19 clinical trials, has brought a sense of urgency to address this historic challenge. Within the past year, the Pharmaceutical Manufacturers of America (PhRMA) released the first industry-wide principles on clinical trial diversity; the Multi-Regional Clinical Trials Center published the “Achieving Diversity, Inclusion, and Equity in Clinical Research” guidance; and the US FDA released a final guidance to encourage the inclusion of groups that are often overlooked in clinical trials.

Industry will not be able to address underrepresentation of racial and ethnic minorities in clinical trials if the approach is a reactive scramble each time a trial launches. Instead, inclusive design should be built into the entire process. Inclusion is a core principle of patient-centric drug development and requires directly engaging with patients to co-create solutions that address unmet patient needs. It is paramount to ensure that diverse patients are included in this process, otherwise one risks innovating only for a subset of the population and exacerbating health disparities.
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We Are DIA
Time to Review Your Promotional Review?
Best Practices in the US
Erica Dankiewicz
Acorda Therapeutics Inc.

he promotional review committee is a critical function within pharmaceutical companies actively promoting their prescription drug products. Comprised of a core team representing Medical, Legal, and Regulatory professionals, the goal of a review committee is to approve advertising, promotional, and educational materials. This brief review illustrates the principles of promotional review and industry best practices.

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Thanks for reading our April 2021 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.