October 2019

October 2019


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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

David Mukanga Bill and Melinda Gates Foundation

Silke Vogel Duke-National University of Singapore Medical School

Richard Day University of New South Wales, Medicine, St. Vincent’s Hospital

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

Ling Su Shenyang Pharmaceutical University, Lilly Asia Ventures

Thomas Kühler Sanofi R&D

J. Vijay Venkatraman Oviya MedSafe

Kazuhiro Kanmuri Inter-Professional, Inc.

Inas Chehimi Novartis

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.

New Concepts in Cancer Therapy with Combined Radiation and Drugs

C. Norman Coleman
Radiation Research Program
Division of Cancer Treatment and Diagnosis
National Cancer Institute, NIH

his article focuses on new concepts in drug development related to radiation oncology and describes opportunities uniquely available to radiation sciences that reach into aspects of our world that broadly relate to human health, concluding with concepts that are beyond the more common approaches to human healthcare in the developed world.

Key Takeaways:

  • Radio-chemotherapy in the era of precision medicine offers unique uses for drugs by targeting pathways such as DNA repair so that a drug might work in combination with radiotherapy when it has little efficacy by itself.
  • Radiation dose should consider both the physical dose (Gray or Gy) and the molecular and biological perturbations produced by radiation. Radiation-inducible targets can make a drug effective in cell killing after radiation when it was not effective before.
  • Radiation is not just “radiation,” as the type of radiation (X-ray, particles, systemically targeted radionuclide therapy [TRT]), dose, and fractionation produce different changes. Thus, the pharmacokinetics and pharmacodynamics of radiation delivery can be exploited.
  • Applications of radiation science extend beyond cancer biology to space exploration, energy policy, disaster response, and healthcare to the underserved. Surprisingly impactful opportunities exist for industry.

Advancing Clinical Trial Diversity Through Community Engagement

Richardae Araojo
Office of Minority Health and Health Equity
Tesheia H. Johnson
Yale Center for Clinical Investigation
Yale School of Medicine
Jovonni R. Spinner
Office of Minority Health and Health Equity

s the US population continues to grow increasingly diverse, ensuring appropriate and meaningful representation of racial and ethnic minorities in clinical trials for regulated medical products is fundamental to advancing public health. Racial and ethnic minorities have historically been and continue to be underrepresented in clinical trials and are disproportionately burdened by many chronic and debilitating diseases. Barriers to participation include a lack of trust due to historical abuses. While other barriers may be due to language and cultural differences, religion, trial design, time away from jobs and other commitments, or a lack of awareness and knowledge about what a clinical trial is and what it means to participate, all stand in the way of fuller minority representation in clinical research.


Participatory Medicine Changing Information Exchange

How China is Changing the Clinical Development Landscape
Implications for Global Development Strategy

George Baeder
dMed Biopharmaceutical
Eric Zhang
dMed Biopharmaceutical

n less than 24 months, China has radically altered the global clinical development landscape, creating new pathways to commercialization that alter the traditional drug development paradigm.

Since joining ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) as a full regulatory member in June 2017, the country has refocused its regulatory process on rapid approval of innovative therapies and devices, with non-Chinese biopharmaceutical firms emerging as the main beneficiaries.

In addition to making the world’s second largest market more accessible virtually overnight, the more profound impact on the industry is the way in which China’s policy revamp and emerging global role point to a new and exciting paradigm for future global clinical development and regulatory strategies.

Unlocking the Power of Safety Data with Cloud Technology

Brian Longo
Veeva Vault Safety

oday, the increasing number of data sources (clinical data, electronic patient health records, call center notes, medical literature articles, emails, and social media) means that there are more adverse event reports (AERs) to intake, process, and analyze for safety signal detection. Combination therapeutics, targeted medicines, and global, multi-market product launches with frequent regulatory changes keep adding layers to this information. These challenges are driving the need for drug safety organizations to more efficiently process and analyze a growing volume of complex information while continuing to meet new or evolving health authority requirements.

Unmet Medical Need: An Introduction to Definitions & Stakeholder Perceptions
Unmet Medical Need: An Introduction to Definitions and Stakeholder Perceptions

Around the Globe

Lower Drug Prices in Canada?
Pharmaceutical Policy a Major Pillar in Canadian Federal Election
Judith Glennie
JL Glennie Consulting, Inc.

anadians go to the polls on October 21, 2019 to elect their Federal government representatives. The party that forms the next Federal government will determine whether planned policy initiatives focused on the pharmaceutical system will move forward. While we have covered the early stages of these initiatives in past issues of the Global Forum, the following represents the current state of key policies and their potential impact if the current Liberal government is re-elected.


Real World Data Expanding into Label Expansion

Around the Globe

Jordan FDA Adopts Reliance Review Model
Regulatory Environment Dynamics in the Middle East Region
Inas Chehimi
Novartis Pharma Services AG

017 and 2018 were transformational years in the regulatory dynamics of the Middle East, specifically with reforms targeting the innovative molecules review process, and we have witnessed issuance of new regulations adopting the Reliance Review Model in several countries within this region.

The principle of the Reliance Review Model is in line with the WHO recommendations to optimize resource use and avoid duplication of efforts; in general, review on the basis of Assessment Reports, GMP inspection reports, and/or Certificates of Pharmaceutical Products (CPPs) of the reference authorities is encouraged. Our July Global Forum article previously discussed details of this Model.

This Reliance Model dynamic was kicked off in the Middle East region by the Saudi FDA, and was later adopted by Health Authorities in Egypt, Jordan, and the UAE.


New Ethics and Consent Guidelines Pillars for Safety in India
Career Column
Solidifying Your Soft Skills

Joanna McCormack

Brianna Devitt


hink back to the last time you viewed a job posting. Do you remember seeing “flexibility,” “patience,” and “communication” listed as requirements for the role? While these skills are necessary in any given role, they are rarely included in a job description. They are also difficult to discern from a candidate’s cover letter or resume. Employers are increasingly seeking these abstract skills when looking for the perfect candidate.

Thanks for reading our October 2019 Issue!