January 2020
January 2020

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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 Servier

Editorial Staff

Alberto Grignolo, Editor-in-Chief Parexel International

Ranjini Prithviraj, Global Associate Director, Content Collaboration DIA Publications

Sandra Blumenrath, Science Writer DIA Publications

Chris M. Slawecki, Senior Digital Copyeditor DIA Publications

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.

MIDDLE EAST
Inas Chehimi Novartis

USA
Ebony Dashiell-Aje FDA

Young Professionals Editor

Kaley Weintraub Medical Affairs, Daiichi Sankyo

DIA Membership

Bringing together stakeholders for the betterment of global health care.

Executive Leadership

Editorial
Electric Guitars, Photoshop®, and Clinical Trials
Alberto Grignolo Headshot

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

A

new sound is in the air as we enter the new decade: the sound of minds being pried open to disruptive change.

When the electric guitar was invented in 1931 to help a quiet instrument sound much louder, there was little expectation that it would revolutionize both recorded music and live performances, and indeed pop culture. Today the electric guitar is ubiquitous, powerful, mesmerizing (and often deafening). The electric guitar has taken music and culture to a new level in many different ways, some good and some not so good.

When Photoshop® was created in 1988, film ruled and had not yet been widely replaced by digital photography. The internet and social media did not exist as we know them now. Today this powerful editing technology can add people and objects to photographs, or it can remove them; it can convert beauty to ugliness, or the sublime to the horrific; it can create “realities” that do not actually exist and spread them to billons around the globe in seconds. Photoshop® has taken the visual arts to a new level in many different ways, some good and some not so good.

Top Ten Global Forum Articles and Podcasts
October 2018 through September 2019

Compiled by DIA Staff

O

ur first Global Forum of 2020 looks back at the ten most popular Global Forum articles and ten most popular podcasts from October 2018 through the end of September 2019. We selected this time period because articles and podcasts published in our October 2019, November 2019, and December 2019 issues have been online for only a few weeks. These issues will be counted in next year’s Top Ten listing.

Thank you to all our editors, authors, interviewees and others who contributed their expertise to our Global Forum over the past year.

Thank you for making the items listed below our ten most popular articles and podcasts.

Excuses, Excuses, Excuses: The “LingoBingo” of Patient Engagement

Emma Sutcliffe
Nexgen Healthcare Communications, UK
I

mproving patient engagement (PE) is a key endeavour for the pharmaceutical industry. Companies have embarked on a plethora of internal and external silo-breaking activities and partnership-seeking opportunities with patient organisations (POs). There are multiple case studies and examples of “good patient practices” (GPAT) in place. Complementing (or perhaps compounding) this are the regular industry events, publications, and overall publicity about PE. It would be easy to assume that the relationship between most pharma and POs is now a great one — underpinned by trust, measured by collaboration, and linked with a common language. However, inertia still prevails that can frustrate and undermine the success of longer-term partnerships in some companies.

Podcasts

Translating Clinical Trials into Clinical Benefit
Clinical Trials and Other Physician-Industry Interactions in Australia
Ric Day
University of New South Wales
@osbornidayius
T

he representative body of the innovative, prescription medicines industry in Australia, Medicines Australia is responsible for administering the Medicines Australia Code of Conduct. This self-regulatory system, underpinned by legislation, sets the standard for the ethical promotion and marketing of prescription medicines in Australia. These standards must be adhered to by member companies. Penalties for breaches of the Code of Conduct can be considerable and are increasing in severity year after year. Breaches of the Code and the resultant fines are published on the Medicines Australia website quarterly along with the comprehensive Code of Conduct Annual Report.

Around the Globe

Central and Eastern European (CEE) Countries Prepare for the Clinical Trial Regulation
Mihaela David
PSI CRO AG, Romania
J

ust like their counterparts in Western Europe, industry, regulatory, and other stakeholders in Central and Eastern European (CEE) Countries are preparing for implementation of the new EU Clinical Trials Regulation (536/2014) that will replace the current Directive 2001/20/EC (the legal framework for clinical trials in the EU since 2001) as soon as the EU clinical trials portal and database are functionally validated by an independent audit.

In October 2019, DIA EMEA presented in Bucharest (Romania) the first in a planned series of Clinical Trials Information Day conferences to help these CEE Countries prepare to implement the new Clinical Trials Regulation (CTR). This conference brought together representatives of regulatory authorities and ethics committees from Austria, Bulgaria, Italy, Poland, Romania, and Slovakia, and also featured Massimiliano Sara, Scientific Secretary of the Clinical Trial Facilitation Group (CTFG) and Camelia Mihaescu from the EMA.

Around the Globe

Should Patient Involvement and Engagement in India Have Minimal and Maximal Limits?
J. Mariano Anto Bruno Mascarenhas
Madras Medical College
Tamil Nadu Government Multi Super Specialty Hospital
W

ords and phrases like “Patient Involvement,” “Shared Decision Making,” and “Engagement” are trending in various medical conferences and journals, and most stakeholders seem to consider them to be the next logical steps in informed consent. Non-governmental and other organizations aggressively push them. Clinicians and administrators are forced to believe that these concepts will work Magic in their hospitals, from reducing the attacks of disease to improving patient satisfaction to growing revenues. All looks so rosy and good.

But do we forget a cardinal principle in medicine? A drug can be a “poison in the right dose” and a poison can be “a drug in an incorrect or overdose.” Anything, from water to common salt or sugar, can damage and even kill a patient when more than needed is taken. Even oxygen can cause toxicity. Isn’t it time to discuss the following pertinent questions?

  1. What are possible toxic effects of “Patient Involvement,” “Shared Decision Making,” “Engagement,” and related terms?
  2. What is the optimal dose of these concepts or phenomena?
  3. If we keep on increasing doses of “Patient Engagement” and related terms, what harms could befall us?

Around the Globe

Placing Patients at the Center of “Rational Medicine” Reflections on Science, Technology, and Ethics to Build Tomorrow’s Healthcare Environment
Tatsuya Kondo
Chief Executive Officer
Medical Excellence Japan
Former Chief Executive, PMDA
W

hat can we do to promote Rational Medicine? In Japan, our universal National Health Insurance (NHI) system has supported Japanese citizens’ healthcare for close to sixty years. The NHI system gives every Japanese citizen the opportunity to pursue the most high-quality and advanced medical care in the world, anywhere and anytime. But when we think about further development of care, we need to resolve various problems in and surrounding the healthcare system in a rational way. Rational Medicine will only be realized when various technologies—including medicine, ethics, regulations, etc.—are applied to rationally work in harmony.

Patients should be placed at the center of promoting Rational Medicine. This ideal will create benefits and trust for future patients (including ourselves) that we could only imagine before now, as we gather all our wisdom in science and ethics in a collaborative movement toward this valued healthcare environment in Japan. No discussion of the unprecedented change that the global clinical trial and drug development industry has undergone over the past decade would be complete without accounting for the regulatory innovation that has correspondingly emerged and spread worldwide.

As Program Chair and former Chief Executive of the Pharmaceuticals & Medical Devices Agency (PMDA), Japan, I captured the essence of current and future challenges in my 16th DIA Japan Annual Meeting 2019 keynote speech.

Around the Globe

Customization Makes A Crucial Difference in Communication
Medical Communication Workshop in Japan
Hiroki Nagahama
GlaxoSmithKline K.K.
Keiko Tsumori
MSD K. K.
M

edical communication activities are designed in cooperation with healthcare professionals, patients, and regulatory authorities to ensure the proper use of a specific medical product by all stakeholders. Many of these activities include creating various documents based on the contents of the Common Technical Document (CTD) and Risk Management Plan (RMP) for shared professional, patient, and regulator use.

However, because various inconsistencies across these materials are widely known, industry and regulatory experts convened in October 2019 at the 2nd DIA Medical Communications Workshop in Japan to promote the proper creation and use of these materials, and to ensure that healthcare professionals receive appropriate communication and information as part of optimal treatment for their patients.

Community Spotlight

GCP-QA Community Creates Tools for ICH E6(R2) for Small- to Medium-Sized Companies

Sandy Mohan
Quality and Compliance
Immune Design
Terry Katz
Global Data Management and Statistics
Merck Animal Health
D

IA’s GCP-QA Community was actively involved in 2018 and 2019 to create tools to support the 2016 revision of ICH E6(R2), the global standard for Good Clinical Practices (GCP) issued by the International Council for Harmonisation (ICH). This Community project followed a previous cross-community DIA Working Group sponsored by the Good Clinical Practices and Quality Assurance (GCP-QA) Community in 2014 and 2015 to solicit comments and concepts from sponsors and CROs for the ICH E6 revision submitted through the European Medicines Agency (EMA).

The updated ICH GCP guideline now states that Quality Management “throughout all stages of the trial process” has become a formal responsibility of sponsors. Many large pharmaceutical companies had adopted tools from TransCelerate to document their compliance. But these tools were fairly elaborate, so developing tools right-sized for use by small- to medium-sized organizations became the goal of the GCP-QA Community project.
Thanks for reading our January 2020 Issue!