January 2021
January 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
Yoshiaki Uyama Pharmaceuticals and Medical Devices Agency (PMDA)
Adora Ndu BioMarin Pharmaceutical, Inc.

Patient engagement
Deborah Collyar Patient Advocates In Research (PAIR)
Lode Dewulf Corvalus

VALUE AND ACCESS
Monika Schneider Shionogi

Editorial Staff

Alberto Grignolo, Editor-in-Chief Parexel International

Ranjini Prithviraj, Global Associate Director, Content Collaboration DIA Scientific Communications

Sandra Blumenrath, Science Writer DIA Scientific Communications

Chris M. Slawecki, Senior Digital Copyeditor DIA Scientific Communications

Regional Editors

AFRICA
David Mukanga Bill and Melinda Gates Foundation

ASEAN
Silke Vogel Duke-National University of Singapore Medical School

AUSTRALIA/NEW ZEALAND
Richard Day University of New South Wales, Medicine, St. Vincent’s Hospital

CANADA
Judith Glennie JL Glennie Consulting, Inc.
Megan Bettle Health Canada

CHINA
Ling Su Shenyang Pharmaceutical University, Lilly Asia Ventures

Europe
Thomas Kühler Sanofi R&D

INDIA
J. Vijay Venkatraman Oviya MedSafe

JAPAN
Akiko Ikeda Janssen Pharmaceutical K.K.

LATIN AMERICA
Cammilla Gomes Roche

MIDDLE EAST
Inas Chehimi Novartis

USA
Ebony Dashiell-Aje BioMarin

Young Professionals Editor

Kaley Lugo Medical Affairs, Daiichi Sankyo

DIA Membership

Bringing together stakeholders for the betterment of global health care.

Executive Leadership

Editorial
Farewell and Welcome!
Alberto Grignolo headshot

Alberto Grignolo, PhD
Global Forum
Editor-in-Chief
Fellow of DIA

T

he title of this piece might well refer respectively to 2020 and 2021 (if that had been my intent, I might have titled it Good Riddance and Finally! But it was not).

Rather, as 2020 has come to a close and 2021 has arrived, let’s avoid the much-overused terms used to describe the year just past, and simply thank each of our Editors and numerous Authors for helping make our monthly online publication successful and read regularly all around the world. Indeed, our readership outside US and Canada is routinely half (forty to fifty percent) of the total. We are indeed global, thanks to all of our Editors/Authors and to all of our readers.

We realize that regular contributions to Global Forum require our Editors’ and Authors’ time and effort. We also realize that they have regular jobs, and that this volunteer activity is an additional demand on their busy schedules. For these reasons, we (and our loyal readers) are deeply grateful to them.

Opportunities in 2021 to Fix the Broken Antibiotics Market
Cara Lepore
Wes Kim
The Pew Charitable Trusts
A

s the world deals with the devastating impacts of COVID-19, another public health threat grows increasingly urgent: antibiotic-resistant bacteria. The US Centers for Disease Control and Prevention estimates at least 2.8 million antibiotic-resistant infections occur in the US annually, and more than 35,000 people die. At the same time, investments in new antibiotics to meet the threat are faltering, potentially reducing patient access to life-saving treatments. Fortunately, policy solutions are beginning to emerge.

Podcasts

Found in Translation: A Tumultuous Year in Review

G. Kelloff
D. Parkinson

EU Clinical Trial Regulation: Get Ready. Set. Go!
Ruediger Pankow
Danu Pamungkas
Beate Roder
Bettina Goldberg
Parexel Regulatory and Access, Clinical Trial Regulatory Services
T

he European Union Clinical Trial Regulation 536/2014 (EU-CTR) aims to standardize and harmonize the conduct and management of interventional clinical trials across the European Economic Area (EEA), with legally binding rules on requirements and increased transparency.

This long-anticipated legislation uses one single electronic web-based Clinical Trial Information System (CTIS) to:

  • submit, evaluate (via scientific and ethical review), and authorize clinical trial applications (CTAs);
  • submit any trial-related notifications, reports, and results, up to the clinical study report; and
  • serve as the single communication channel between the sponsor and the Member States Concerned (MSC) in the clinical trial.
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Podcasts

Biosimilar Awareness, Access and Savings Continue to Grow

Hillel Cohen

“As lower cost treatment options, biosimilars have really helped address rising costs within the US healthcare system, hospitals and patient care. For example, the availability of biosimilar filgrastim generated approximately $1.2 billion in savings in the US healthcare system from 2016 to early 2020,” explains Dr. Hillel Cohen, executive director of scientific affairs in the Sandoz division of Novartis and Sandoz representative to the education committee of the US Biosimilars Council. “There are still various barriers that continue to inhibit biosimilars from realizing their full potential driven by market obstacles, formulary challenges and misinformation campaigns.”
Five Types of Misinformation Targeting Biosimilars
  • Information that is factually incorrect
  • Information that is factually correct BUT provided out of context
  • Incomplete information providing only a partial or limited set of facts
  • Factual references used to support incorrect conclusions (create false narrative)
  • Negative framing of factual references to create negative perceptions.

To learn more about the growing global biosimilars market, listen to our podcast with Dr. Cohen below.

Virtual, Remote, and Decentralized
How a pandemic-inspired model for clinical trials will impact clinical research in 2021
Jena Daniels
Rasmus Hogreffe
Alison Holland
Michelle Longmire
Ingrid Oakley-Girvan
Medable, Inc.
@medableinc
If 2019 was the year of personalized medicine, 2020 was the year of decentralized clinical trials (DCTs). The COVID-19 pandemic ushered in a new era of clinical research – the advantages of which are just beginning to surface. Even after the ball drops and the curtains close on 2020, the life sciences industry will see snowball effects as remote trial designs are adopted by a growing group of sponsors, clinical research organizations, sites, and patients. For instance, the industry will see greater patient participation, more real-world data capture for better outcomes, and 50 percent jumps in trial efficiency.

This two-part feature provides a deep-dive into how a decentralized model will shape the clinical environment in 2021…and beyond.

Part 1: Fueling Fast Growth of Hybrid and Fully Decentralized Research

Flexibility Inherent in a Decentralized Trial Model Will Drive Widespread Adoption

The promised decentralized trial revolution has gained traction in 2020, but we have significant progress to make. Industry wide, the decentralized approach to clinical trials is philosophically embraced for all its advantages but operationalizing the model–particularly mid-flight on studies–requires a commitment to overcoming fear of change. The model’s inherent flexibility will be instrumental to calming any concerns and will drive widespread adoption through 2021.

Part 2: Better Clinical Care Driving Transformative Change in 2021

How a Pandemic-Inspired Model for Clinical Trials Will Impact Research in 2021

Ready or not, the COVID-19 pandemic ushered in a new era of clinical research, the biggest advantages of which are just beginning to surface. In 2021, the life sciences industry will see more remote trial designs adopted by a larger and broader group of sponsors, sites, and patients. As a result, patient access and participation will rise to rates never seen before, more real-world evidence will be captured to enable better outcomes for more indications, and dramatic trial efficiency gains will enable more life-saving therapies to reach more people faster and for less.

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White Paper

ACRO: Decentralizing Clinical Trials: A New Quality-by-Design, Risk-Based Framework

White Paper

Establishing a Content Management Process as a Late-Stage Company
Due to evolving regulations governing the pharmaceutical industry, expanded use of social media platforms to communicate key milestone data, and the shift in how content is being utilized, late stage companies have benefited from establishing Content Management Processes earlier in the drug development lifecycle. This shift has led to the wide-spread adoption of best practices as companies look to harmonize their Content Strategy with their people, process and technology. This white paper provides the reader with a clear understanding of evolving best practices and trends as to how to create a Content Strategy that lays the foundation for the Content Management Process.
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Proceedings: DIA China 2020

Proceedings from DIA China 2020

Proceedings: DIA China 2020

digital collage of a map and a silhouette of a head
Real-World Data Studies as Complements to Randomized Clinical Trials
Mary Wang
Boehringer-Ingelheim
C

onversations about the use of “big data” in clinical research and care have also triggered discussions about the relationship between real-world data (RWD), real-world evidence (RWE), and randomized clinical trials (RCTs). The session Real-World Data (RWD) Management and Application in Clinical Research continued these discussions at DIA China 2020.

Proceedings: DIA China 2020

digital collage of a map and a silhouette of a head
China’s New Cancer Ecosystem Evolves to Address Patients’ Needs and Expectations
Iris Zhu
Beigene
C

ancer has been sometimes viewed as more of an ecosystem (in which patients, healthcare professionals, researchers, industry, regulatory authorities, and payers transfer demands and values to and from each other) than a malignant disease. Due to the vast and increasing disease burden attributable to cancer in China, prevention and treatment of cancer has been listed as one of the fifteen goals in the Health China Action Plan released by the Chinese State Council in July 2019.

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Around the Globe

Digital Therapeutics (DTx) for Incontinence and Pelvic Pain in India
Sanjai Murali
Shyam Ramamurthy
JOGO Health
@HealthJOGO
D

igital Therapeutics or DTx, defined as “software as medical device” by the FDA and International Medical Device Regulators Forum (IMDRF), continue to gain traction. According to the Digital Therapeutics Alliance, a non-profit trade association based in the US, Digital therapeutics (DTx) delivers evidence-based therapeutic interventions to patients, driven by high quality software programs to prevent, manage, or treat a broad spectrum of physical, mental, and behavioral conditions.

Podcasts

R2D2 Aligning Regulatory and HTA Review to Quicken Patient Access
Megan Bettle

Around the Globe

CPP Requirements for Drug Registration Processes in the Americas
Celeste Sánchez González
CECMED Cuba
Cammilla Horta Gomes
FIFARMA
T

he report of PANDRH’s Certificate of Pharmaceutical Product (CPP) Project represents the most far-reaching study carried out in the area, a step forward in closing the gaps, and a new opportunity to discuss the healthcare value of CPP in regulatory processes in the Americas.

The Certificate of Pharmaceutical Product (CPP) is the main document in the World Health Organization (WHO) Scheme for the certification of pharmaceutical products that are subject to international commerce. It is a tool that allows the NRAs (National Regulatory Authorities) to share information and avoid duplication of effort. Introduced in 1975, the CPP has been widely used in the submission processes of registration applications for the importation of medicines around the world. Its main purpose is to facilitate assurance of compliance with quality standards for medicines and to communicate key information about these imported/exported medicines.
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Thanks for reading our January 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.