February 2022


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Editorial Board

Content stream editors

Translational science
Gary Kelloff US National Institutes of Health

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

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.

Is It Time to Screen for and Treat Early Multiple Myeloma?
Irene M. Ghobrial
Dana-Farber Cancer Institute
Ilan “Lanny” Kirsch
Adaptive Biotechnologies

ultiple myeloma (MM) is a blood cancer that evolves from the early precursor conditions of monoclonal gammopathy of undetermined significance (MGUS). MGUS progresses to overt myeloma at a slow rate, and early diagnosis and treatment are critical to ease the personal and economic burden to patients. This article discusses why early detection matters, who should be screened, and the need for precise risk stratification.

Enabling Diversity in Clinical Trials: New US Law Opens Door to Clinical Research for Millions of Low-Income Patients
Mary Stober Murray
National Minority Quality Forum

n 2020, the United States Congress passed the Clinical Treatment Act, a law “to promote access to life-saving therapies for Medicaid enrollees by ensuring coverage of routine patient costs for items and services furnished in connection with participation in qualifying clinical trials, and for other purposes.” The law became effective in January 2022, yet a 2021 diversity and inclusion survey of eight major pharmaceutical sponsors reported that none of the respondents indicated that they are actively encouraging “sites to recruit Medicaid beneficiaries to participate in our active cancer clinical trials.”

What is Medicaid and whom does it serve? Why does the Clinical Treatment Act matter for increasing representation in clinical trials? How can clinical development professionals learn to engage the Medicaid population and facilitate clinical trial participation?

This article aims to answer each of these questions, outline stakeholder perspectives for clinical development, and recommend next steps for organizations and individuals.

Key Takeaways

  1. The Clinical Treatment Act removes a financial barrier for Medicaid beneficiaries to participate in qualifying clinical trials across disease areas, including cancer.
  2. Medicaid is a public health insurance program covering about 1 in 5 people in the United States, including about 40% of America’s children, as well as low-income adults and disabled individuals.
  3. Racial and ethnic minorities represent a disproportionately high fraction of Medicaid beneficiaries, and nearly two-thirds are living with one or more chronic conditions.
  4. Organizations can continue to transform their culture toward patient-centricity by learning how to reflect the clinical experience and social needs of the Medicaid population in medicines development processes and operations.
  5. Individuals can take the lead by educating themselves and advocating internally within their organizations for collaborative, community-based strategies that reach the Medicaid population and other patients where they live.


Sharing Cloud-Based Data as They Emerge: Accumulus Synergy Part 1
In January 2021, 10 of the world’s leading biopharmaceutical companies announced the formation of Accumulus Synergy, a nonprofit corporation intended to enable global, real-time collaboration and data exchange and submission between industry and health authorities. “Our aim is to be at the intersection of where those who develop medicines, and those who approve them, can interact differently,” explains CEO Francisco Nogueira. “Our technology will provide the ability for a sponsor to work with as many regulators as that sponsor chooses to in a much more streamlined fashion. We will enable the platform. We will enable it with the know-how and the technology. But ultimately the business rules remain with the business.”
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Envisioning a Future for Including Patient Involvement in Vocational Training in the Life Sciences Industry
Liz Clark
Independent Pharmaceutical Physician
Trishna Bharadia
Patient Leader at The Spark Global
@ TrishnaBharadia

atient involvement is becoming an embedded part of the life sciences industry; however, often patients are still not involved simply because industry professionals do not know how to involve them. Could the answer lie in including patient involvement as a key part of the curriculum for vocational training in the life sciences and medical technology industries? Examples from the UK show how this could be done and what it might mean for the future of professional training in these industries.


Sharing Cloud-Based Data as They Emerge: Accumulus Synergy Part 2
In Part 2 of this interview, Chief Executive Officer Francisco Nogueira discusses the practicalities of data capture, data management, and machine learning within the framework of Accumulus Synergy’s proposed global cloud-based platform for regulatory submissions. “In terms of enthusiasm and shifting to database- from dossier-based submissions, this work had started before Accumulus was even conceived,” he explains. “Many companies already have data lakes in how they gather and collect and house the data that they are working through today. What I’m seeing in the ecosystem, both our sponsors and nonsponsors, is a high level of enthusiasm and high level of engagement towards what we define as data-centricity.”
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Digital Technology Adoption at Clinical Sites: Fast-Paced but Room to Grow
Francesca Properzi
DT Consulting
Sudip Sinha

n September 2021, DT Consulting, an Indegene company, launched the 2nd DT Digital Tracker, a methodology to assess the current state of digital technology adoption by clinical trial sites globally. The inaugural survey, which was published in February 2021 (see April 2021 Global Forum), showed that many clinical trial sites were still reluctant to integrate digital technologies into their processes and that cost, complexity, and finding the right technologies were the main barriers to digital adoption. The second wave of results shows that digital adoption is increasing and that concerns about patients’ ability to use digital tools is now the main barrier to digital adoption.

Oncology: Surprising Therapeutic Area Ripe for Decentralized Research
Candice Del Rio
Curavit Clinical Research

iven the complexity of cancer, some researchers are skeptical about the use of a decentralized clinical trial (DCT) model for oncology research. However, DCTs offer tremendous benefit, particularly in decreasing patient dropout rates and increasing patient engagement, two critical factors for oncology.

White Paper

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Phlexglobal Guide: Best Practices for RIM Business Process Automation
Regulatory teams at life science companies are finding that effective regulatory information management (RIM) has become critical to operations. The increasing complexity of regulatory processes remains a key obstacle to realizing the full benefits of RIM systems. A recent industry survey of regulatory professionals identified “defining and implementing globally standardized business processes” as their top business challenge. Business process automation designed for life sciences regulatory and incorporated into end-to-end RIM software is emerging as an important enabling technology to meet this challenge.

Meeting Highlights: DIA Japan 2021

Meeting Highlights from DIA Japan 2021

Meeting Highlights: DIA Japan 2021

DIA Japan 2021 conference logo of red and white plus signs

Japan and the Pandemic: New Challenges, New Solutions

Rie Matsui
Pfizer R&D Japan

Stewart Geary
Eisai Co., Ltd.


he theme of DIA Japan 2021, “New Challenges, New Solutions: To Overcome With People All Over the World,” reflected the current background of marshaling resources from regulatory authorities, industry, and academia to develop innovative new therapies in the midst of an unexpected public health emergency while simultaneously transforming daily work practices during lockdowns and limited public access to hospitals.

Meeting Highlights: DIA Japan 2021

DIA Japan 2021 conference logo of red and white plus signs
Future Frameworks for Unpredictable Infectious Diseases
Japanese Academic, Industry, and Government Perspectives on Lessons Learned from COVID
Akiko Ikeda
Janssen Pharmaceutical K.K.

eclaration of the global pandemic signaled the beginning of an unprecedented global race to develop COVID-19 vaccines and drugs. Japan’s rapid approval of a vaccine (in February 2021) while continuing development of other therapies can be viewed as a success. On the other hand, these efforts also illustrated the unpredictability of infectious diseases and the importance of preparing countermeasures for the unknown, in Japan as elsewhere, during “normal” times.

Around the Globe

Assessment of Regulatory Submissions in East Africa and West Africa
Sybil Nana Ama Ossei-Agyeman-Yeboah
West African Health Organization
Jane H. Mashingia
East African Community Medicines Regulatory Harmonization Programme
David Mukanga
Bill & Melinda Gates Foundation

he following report provides updates on the state of joint assessment procedures in the East African and West African communities.

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Thanks for reading our February 2022 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.