February 2021
February 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 International

Patient engagement
Trishna Bharadia Patient Advocate and Media Contributor
Mary Stober Murray Bristol-Myers Squibb

VALUE AND ACCESS
Monika Schneider Shionogi

Editorial Staff

Alberto Grignolo, Editor-in-Chief Parexel International

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
Jin Shun Sandoz

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

CANADA
Judith Glennie JL Glennie Consulting, Inc.

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

USA
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.

Cancer Immunotherapy: Successes and Challenges on the Bumpy Route from Scientific Concept to Clinical Reality

Part 1: Cancer Immunotherapy as a Novel Promising Treatment Option

Alessandra Cesano
ESSA Pharmaceuticals
C

ancer immunotherapy – a treatment that harnesses the immune system’s exquisite specificity and “memory” properties to fight cancer – has revolutionized the field of oncology in a way that could not have been anticipated just ten years ago (1).

In the decade following the approval of the first checkpoint inhibitors, immunotherapy has shifted the paradigm for cancer treatment, delivering effective and durable responses for a subset of patients with histologically different types of advanced solid tumors refractory to standard of care (SOC) treatments (1).
Encouraging Post-Market Evidence Generation for Transformative Therapies
Policies that Could Reduce the Data Collection Burden on Healthcare Providers
Beena Bhuiyan Khan
Rebecca Ray
Duke-Margolis Center for Health Policy
@DukeMargolis
I

nnovations in medical technology have led to a proliferation of transformative therapies that promise to alter treatment paradigms and even reverse disease progression. The promise of treatment outcomes can make these technologies eligible for expedited regulatory pathways that do not require extensive clinical trial data for market approval.

As more novel technologies, such as cell and gene therapies and other high cost technologies, are approved faster based on promising early clinical data, it is critical to encourage evidence generation in the post-market setting that evaluates long-term safety, effectiveness, and durability. Currently, data collection is mostly undertaken through traditional prospective clinical registries. With advances in data systems and platforms for real-world evidence (RWE), there is an opportunity to further enhance evidence generation while also addressing limitations and challenges in collecting data through traditional registries.
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Protecting Patient Data in the Age of Hacking
Angela Sanderson
Eleven Fifty Academy
@elevenfifty
I

f you’re a stakeholder in the healthcare industry, you know the cybersecurity challenges that healthcare providers face. While data protection is a primary goal, they must ensure that patient privacy is maintained. Providers must also deliver high-quality services while conforming to strict requirements by HIPAA, the EU’s GDPR, and other legislative and regulatory bodies.

Other than being valuable for individuals and various legal entities, protected health information (PHI) is also sought-after by criminals. Organizations face hefty fines and penalties for failing to transmit, use, or handle patient information as outlined. Today, it is essential to protect the privacy and security of health information; fortunately, a number of tools and approaches already exist to make protection more feasible. But a disciplined and thorough approach is required.
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Around the Globe

African Medicines Regulatory Harmonization
Plans to Collaborate on COVID Vaccine Emergency Use Authorization
David Mukanga
Bill and Melinda Gates Foundation
@gatesfoundation
T

he 2nd African Medicines Regulatory Harmonization (AMRH) Week took place virtually beginning December 9, 2020, due to wide travel restrictions in many countries because of the COVID-19 pandemic. Attended by more than 120 participants from Africa and other parts of the world, these discussions included collaboration among regulators and ethics committees regarding COVID-19 clinical trials review, preparations for authorization and monitoring of the safety of COVID vaccines, as well as the listing of medical devices, including in vitro diagnostics and personal protective equipment (PPEs) as part of COVID-19 response.

Around the Globe

Digital Health Regulation in Asia-Pacific: Overview and Best Practices
Nathan Carrington
Roche Diagnostics
Manan Hathi
Stryker
Roberta Sarno
APACMed
Jinyao Su
Diagnostics Development Hub
John Thornback
Diagnostics Development Hub
Varun Veigas
Roche Diagnostics
T

he Asia-Pacific Medical Technology Association (APACMed) is the trade association for the MedTech industry in Asia-Pacific. Following the 2020 launch of its Digital Health Committee, APACMed is seeking greater harmonization on topics such as regulation, interoperability, and cybersecurity in digital health.

This paper reviews regulatory measures for digital health (DH) solutions in Singapore, Australia, Japan, and the US, and proposes a best practices framework for regulators to use as they implement fit-for-purpose regulation for DH solutions.

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Around the Globe

New Drug Approvals in China in 2020

Xu Wang
Novo Nordisk (China) Pharmaceuticals

Xiaoxi Wang
Shanghai Center for Drug Evaluation & Inspection
I

n the tumultuous year of 2020, the COVID-19 pandemic did not appear to hinder the progress of regulatory reform and new drug approvals in China. The National Medical Products Administration (NMPA) continued to implement many regulations and guidelines. The number of drug applications and the timeline of review and approval were not negatively impacted.

A total of 46 new drugs were approved in 2020 (less than the 53 approved in 2019), including 28 chemical drugs and 18 biological products. In this article, “new drug” is defined as innovative chemical drugs and biological products approved for the first time in China, and drugs already approved outside China but approved in China for the first time.

Around the Globe

After Brexit: Focus on the New Pharmaceutical Strategy for Europe
Thomas Kühler
Sanofi R&D
A

fter four and a half years of Brexit discussions and negotiations, the UK and the EU have managed to arrive at a trade agreement at the eleventh hour and avoid a hard Brexit. In the absence of an agreement, a hard Brexit would have been the default and would have had immediate and severe implications on (timely) access to medicines for patients. The deal applies provisionally as of 1 January 2021, as it still must be ratified by, among others, the European Parliament. Notwithstanding, the trade agreement is welcomed by many stakeholders in the sector as it has lessened the uncertainty around the future relationship between the EU and the UK and has allowed for more clarity on future business operations.

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Around the Globe

ICH Turns 30: Perspectives from Japan
Mami Ueda
Ryu Mochizuki
Nobumasa Nakashima
Pharmaceuticals and Medical Devices Agency (PMDA)
T

he International Conference for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was established in 1990 to achieve greater harmonization worldwide to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner. In 2015, the organization and operations were renewed (this was called “ICH reform”) as a legal entity under Swiss law, and its name was changed to the International “Council” for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).

DIA Communities

Big Changes Coming to DIA Communities

Luke Zimmer

We’re excited to kick them off with this introduction from Luke Zimmer, DIA Communities interim manager. In addition to this year’s new look and feel, we’re refining our overall strategy to help plan for new features that we’ll roll out to you in the coming months. Stay tuned to your weekly Breakfast Briefing and communities.diaglobal.org for more information, and if you have any questions, please share them with us there!
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Thanks for reading our February 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.