May 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 Health Sciences

Patient engagement
Trishna Bharadia Patient Advocate and Media Contributor
Mary Stober Murray National Minority Quality Forum

Monika Schneider Shionogi

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

Judith Glennie JL Glennie Consulting, Inc.

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.


DIA Promoting Community, Pushing Back Misinformation
DIA GCE Barbara Lopez Kunz
How has DIA responded to its communities’ educational and informational needs during the pandemic?

“We’ve always gotten our inspiration and our motivation and our energy from working together, whether it’s with our own team on projects or with subject matter experts and key opinion leaders in our stakeholder community. So that reuniting of the community is really central in our minds right now,” explains DIA Global Chief Executive Barbara Lopez Kunz. “One of the things that you’re going to hear at the Global Annual Meeting coming up in June is this whole topic of misinformation. We’ve had this topic of anti-vaccine commentary in public spaces in our minds, and many of the people around the world in the regulatory community have asked me and our team to help address this. You’re going to hear us talking about how we combat misinformation so that people actually understand what’s going on in health and how they can protect themselves.”

Listen to the complete interview below.
Self-Medication in the Age of COVID: The Country-Specific Role and Acceptability of OTC Medicines
Toshiyoshi Tominaga
Asia-Pacific Self-Medication Industry

he ongoing COVID-19 pandemic has restricted the opportunities of formal medical intervention for patients in general. Hospitals and clinics are explicitly or implicitly requesting patients seeking only elective treatment to postpone their visits, on account of staff and resource exhaustion as well as fear of their inadvertently transmitting the deadly virus to the vulnerable. Many patients are already reluctant to see a doctor, unless they have a serious condition, for fear of contracting the disease in waiting rooms.

At a more macroscopic level, the pandemic has damaged almost every nation’s economy, seemingly leading to an inevitable decrease in the resources that can be allocated to medical care, especially after emergency countermeasures including the free inoculation against the disease. The situation magnifies the importance of self-care. But there are considerable differences in the drugs that can be used for self-treatment across countries or regions, reflecting each country’s or region’s unique risk/benefit judgment. The “new normal” demands, however, re-adjustment of the balance.

Lower Costs, Shorter Timelines, and More Successful Study Outcomes
The Triple Win of Centralized Statistical Monitoring
Steve Young

entralized statistical monitoring (CSM) can identify data quality issues at least three times faster than traditional approaches, saving sponsors hundreds of thousands of dollars and providing robust, credible results.

These were among the findings of a data quality challenge carried out by a risk-based monitoring software company team, who compared the efficacy of real-time CSM analysis of study data to that of standard retrospective methods.

White Paper

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How Life Science Companies Can Engage Stakeholders With a Hybrid Virtual Approach
The COVID-19 pandemic forced life science companies to move many core operations to virtual meetings, from clinical trials to employee training. With an end to the pandemic in sight, many clinical operations teams may wonder whether some of the virtual practices and technologies they’ve adopted should permanently be part of doing business. For most types of work, a hybrid approach combining the best elements of virtual interaction – live and asynchronous – can create efficiency gains and enhance communications across a range of functions in life sciences.

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  • The trend towards asynchronous (over-time) virtual engagement
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Three Steps to More Connected, Efficient Clinical Research

Henry Levy
Veeva Systems

he life sciences industry is accelerating modernization efforts to reduce COVID-19 disruptions, keep existing trials on track, and start new studies faster. Yet, there is still more work to be done to improve information sharing and collaboration across studies. In fact, sponsors and CROs report a need for better information exchange in trials to reduce manual processes (75%) and improve visibility and oversight (58%).

Companies can advance how trials are run by leveraging the FDA’s Technology Modernization Action Plan (TMAP) as a guide to digitize processes, improve how teams work together, and accelerate towards paperless, patient-centric approaches. FDA outlines three parts to TMAP, including guiding decision-making with real-world use cases, bringing external and technology partners into the conversation to drive continued innovation, and modernizing infrastructure with a cloud-first strategy.

Here are three steps to run more connected and efficient studies.

Developing a Drug is Just Like Building A House… Except When It Isn’t
Eric M. Towler

here is well-founded skepticism surrounding the value of Project and Portfolio Management (PPM). Organizations often become enamored with the HOW, the tools and techniques of PPM, for their own sake rather than as a viable solution to a stated problem. Organizational goals would be better served, and PPM would be more valued, if organizations internalized their own vision (the WHY), defined their mission (the WHAT), and only then worried about the individual tools to design the strategy and execute the plan (the HOW). Indeed, this is the right order in which to discuss PPM.

Non-Small Cell Lung Cancer: A Bellwether of Progress in Targeted Therapies in Oncology
Siraj M. Ali
Vincent A. Miller
EQRx, Inc.

recent seminal study in the New England Journal of Medicine reported improvement in mortality from non-small cell lung cancer (NSCLC), the leading cancer killer of men and women in the United States.

These advances have been attributed, in no small part, to the more rapid and efficient development of targeted therapeutics and the willingness of medical oncologists to adopt evolving practice paradigms. Less evidently, several convergent developments in the broader community – such as the more widespread availability of broad-based “regulatory caliber” genomic profiling, more nimble and efficient clinical trial design, and a changed regulatory paradigm focused on speeding the subset of clearly active and safe drugs to patients – have contributed to this improvement in mortality from NSCLC.

To understand the impact of these advances for NSCLC and then to extrapolate to other advanced solid tumors, we briefly review the progress in advanced/metastatic ALK-altered NSCLC, a biomarker-defined subset of the NSCLC patient population, which typically is of adenocarcinoma histologic subtype.

Regulatory and Industry COVID-19 Cooperation for Accelerated Development of Medicines: The New Normal?
Martine Dehlinger-Kremer
Center for Pediatric Clinical Development
PRA Health Sciences

hen on 11 March 2020 the World Health Organization declared the Coronavirus Disease 2019 (COVID-19) a pandemic, regulatory authorities swiftly initiated close cooperation with industry to develop medicines for this virus. A month later, a collaboration through the International Coalition of Medicines Regulatory Authorities (ICMRA) was to expedite and streamline the development, authorization, and availability of COVID-19 medicines. As a result, within only a year of the start of the pandemic, new vaccines were available for adults and adolescents aged 16 and older, and vaccines for younger children will be available imminently. Will our experience gained with speeding up the development of vaccines against the coronavirus accelerate drug development overall?

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The Extraordinary Problem of Medication Nonadherence in Oncology Patients
Cancer is often highly treatable due to new therapies, especially oral agents, that have improved outcomes and survival rates, and allow patients to be treated outside the hospital setting. Yet many patients fail to take their medication consistently, despite the potentially dire consequences of not adhering to the prescribed oncology treatment plan. Nonadherence or suboptimal adherence to cancer treatment regimens must be identified early to optimize outcomes. An accurate, safe, and reliable system that patients and clinicians will trust and use can help to get cancer patients back on track.
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Remote Tools Keep Japan’s Research Moving

Around the Globe

Reliance, Convergence, eLabeling, ATMPs, and Master Protocols: Innovations for Patients in Latin America
Voices from the Latin America Regulatory Conference

urrent global regulatory trends and challenges, how they fit into the regulatory environment of Latin America and the Caribbean, and opportunities for action in the region remain “hot topics” in support of improved regulatory efficiencies in this region. Alongside adoption of reliance approaches, proper product lifecycle management, and identification of regulatory requirements that are convergent with international guidelines and standards, there is an ongoing focus on the key role electronic labelling (eLabeling) plays for improved patient safety in the region, as well as on innovative ways for industry and regulators to respond to new demands and new technologies in the areas of manufacturing and clinical trials.

Around the Globe

Telehealth in Our Post-Pandemic Future
Erin Anthony

t the rate telehealth is growing, it’s not surprising that medical and business professionals forecast it to become a standard service across all care settings. VirtualMed Staff President Jack Williams has predicted that this growth will be sustained for years to come, and telehealth will become easier to access for more people, generating confidence in the approach.

Telehealth’s accessibility is rapidly increasing, and patients are getting more and more comfortable with it. Doctors predict that when the pandemic ebbs away, healthcare will not go back to the traditional approach, which largely involved in-person care sessions. But as the community at large and medical institutions grow more accustomed to telehealth, what will it look like after the pandemic?

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Around the Globe

Importance of the Patient Voice in Drug Development: Eosinophilic Esophagitis as a Case Example
Erica Lyons
Sarrit Kovacs
Matthew Kowalik
Jessica Lee
Division of Gastroenterology, Office of New Drugs, CDER
US Food and Drug Administration

ssessment of the patient voice has become recognized as a vital component in the evaluation of new candidate therapies. To address this, FDA has partnered with stakeholders on multiple patient-focused drug development (PFDD) initiatives to facilitate incorporation of patient and caregiver input into drug review and evaluation. These include the FDA Patient-Focused Drug Development Guidance Series for Enhancing the Incorporation of the Patient’s Voice in Medical Product Development and Regulatory Decision Making.

Here, we present an example of how evaluating the patient experience is essential to assessing the benefit for drugs under investigation for the treatment of eosinophilic esophagitis (EoE). We also present a recommended approach to implementing and analyzing clinical outcome assessment (COA) data to determine clinical benefit to patients in these development programs.
We Are DIA
Work/Life Balance, Co-Worker Connections, and Good Decision-Making in Age of COVID-19
Alex Huelsman
Rutgers Postdoctoral Fellow

ow does one find work-life balance, connect with co-workers, and make good judgement calls and decisions when faced with the grueling limitations placed on us by a pandemic?

After graduating from pharmacy school, I relocated to begin a fellowship program in the pharmaceutical industry. This can be intimidating enough even without the start of a pandemic that confined me to my apartment.

Driven by the COVID-19 pandemic, there are now more home-based jobs in the world than ever before. And, despite the rollout of vaccinations, many industry professionals feel that a hybrid work model will be the new normal, so we need to continue to learn how to adapt.

I interviewed three co-workers in medical affairs (Chris, Saaj, and Tara) to learn about different skills they utilized to successfully transition into a new role remotely in the pharmaceutical industry.

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Thanks for reading our May 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.