September 2022 Global Forum
Getting Under the Skin: Addressing Vaccine Hesitancy in Different Ethnic Communities
CD6: A New Target for Cancer Immunotherapy
The Microbiome's Overlooked Role in Drug Discovery and Development
Digitalization in the ASEAN Pharmaceuticals Market
EU Clinical Trial Regulation: Get Ready to Adapt!
Emergency Regulatory Approval System in Japan
"All I Needed to Do Was…Start!"
Student Reflections on Industry Rotation and GAM 2022 Experiences
DIA Thanks Project Management Community Chair
Slope-FierceBiotech: How to Optimize Clinical Supply Chain Management with Slope
Ilan Kirsch Adaptive Biotechnologies Corp.
Julie O'Brien Pfizer
Young Professionals Editor
Edna Boampong
NHS Shropshire
Telford and Wrekin Integrated Care Board
accine hesitancy among ethnic minority communities has been a challenge to the COVID-19 vaccine program in the UK. This case study explores how the Cheshire and Merseyside Health and Care Partnership addressed this challenge, resulting in significant improvement in vaccine uptake in a short period of time. Among the issues explored in this "deep dive" are reasons for vaccine hesitancy, addressing communication challenges, managing the nuances of different ethnic minority communities, and seeing how aspects of this regional action have been transposed to a national platform.
A few months into the COVID-19 pandemic when I worked in the Cheshire and Merseyside health and care system, I secured funding to commission a program to gather insight into the impact COVID-19 was having on ethnic minority communities. The goal was to find out more about how different ethnic groups were perceiving the vaccine that was about to be rolled out.
As the first and only system in the UK undertaking this effort, the work provided us with an incredible amount of insight ahead of the vaccine rollout and enabled us to massively increase vaccine uptake within ethnic minority groups in Cheshire and Merseyside. It put us ahead of the curve and won three prestigious national awards in 2021: two NHS Communicate Awards ("Best Behaviour Change or Public Health Campaign" and "Use of Insight and Data for Innovation in Communications") as well as the Health Service Journal (HSJ) Award ("NHS Communications Initiative of the Year"). The work now informs not just the Cheshire and Merseyside's communication and engagement approaches, but also their commissioning decisions.
David A. Fox
Rogel Cancer Center and Clinical Autoimmunity Center of Excellence
Feng Lin
Lerner Research Institute
D6 is a cell surface glycoprotein on human lymphocytes, including T cells and natural killer (NK) cells. CD6 is becoming an attractive therapeutic target for many autoimmune diseases because genetic absence of CD6 or treatment with an anti-CD6 monoclonal antibody (mAb) protects against and even reverses autoimmunity. Here, we describe our recent studies strongly suggesting that anti-CD6 should also be evaluated as a new cancer immunotherapy.
The major limitation of what are termed "checkpoint inhibitor" immunotherapies for cancer is induction of autoimmune toxicities. An anti-CD6 mAb termed UMCD6 differs from currently available cancer immunotherapy mAbs in its unique dual ability to stimulate lymphocytes to attack and kill cancer cells of many types while concurrently preventing other lymphocytes from inducing autoimmune conditions. In addition, CD6-targeted antibody-drug conjugates (CD6-ADCs) could be used to treat blood cancers in which the tumor cells themselves express CD6, such as T cell lymphoma, certain chronic lymphocytic leukemias, and NK cell lymphoma.
Cristiano Ruch Werneck Guimarães
Katia Sivieri
Miller Freitas
Stephani Saverio
Nintx – Next Innovative Therapeutics
he human microbiome is a complex ecosystem that can mediate the interaction of the human host with their environment, playing a central role in several cardiometabolic, immunological, and neurological processes. While the importance of the gut microbiota has been acknowledged for many years, the relevance of investigating the complex interactions between the gut microbiome and drugs in preclinical and clinical settings has been generally ignored by researchers and regulatory bodies.
Successful clinical trial execution requires orchestrating multiple moving parts, with everything from protocol design and patient visit schedules to lab kits and biological samples needing to seamlessly line up to ensure on-time, on-budget delivery of high-quality data. Today, increasingly complex clinical trials are straining supply chain management. Sponsors can struggle with this complexity, leading to time and budget overruns, compliance issues, increased patient burden, and data integrity problems. This white paper explains how a sponsor overcame these problems by adopting an eClinical Supply Chain Management platform.
Soon Yee Chow
Helene Sou
@TakedaPharma
ne key pillar of the Association of Southeast Asian Nations (ASEAN) as outlined in the (draft) ASEAN Pharmaceutical Regulatory Policy (APRP) is that:
"ASEAN Member States should seek to ensure that unnecessary regulatory and administrative barriers to intra-ASEAN trade are eliminated. There should be established cooperation and information exchange between regulatory authorities and relevant stakeholders to combat the movement of substandard and falsified pharmaceutical products within the ASEAN region."
EU Clinical Trial Regulation:
Get Ready to Adapt!
Ruediger Pankow
Danu Pamungkas
Bettina Goldberg
Parexel® Regulatory and Access, Clinical Trial Regulatory Services
@Parexel
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 Trials Information System (CTIS) to:
Submit, evaluate (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.
The new EU-CTR promises a harmonized, simplified process designed to decrease the burden resulting from idiosyncratic interpretations of the current EU-CTD. But it also poses new operational challenges to many clinical trial sponsors.
Kaneko Miyuki
Pfizer R&D Japan G.K.
s of May 2022, a new emergency approval system has been established in Japan through partial revision of the Pharmaceutical and Medical Device Act. The purpose of this revision is to "establish a mechanism for promptly approving new pharmaceutical products, medical devices, and regenerative medical products (hereinafter referred to as 'pharmaceutical products, etc.') in an emergency to prevent the spread of health hazards in situations such as the spread of diseases that may seriously affect the lives and health of citizens."
We Are DIA: Career Corner
"All I Needed to Do Was … Start!"
Student Reflections on Industry Rotation and DIA GAM 2022 Experiences
Jazmyne Durrah Simmons
PharmD Candidate
Leslie Sam
Leslie Sam and Associates
David Fryrear
@AstellasUS
n the following three-way conversation, PharmD candidate Jazmyne Durrah Simmons retraces the path that led to her fourth-year pharmaceutical industry rotation, her DIA student membership, and DIA 2022 in Chicago, plus how these experiences reshaped the vision of her own professional future, and how and by whom she was helped along the way.
We Are DIA: Community Report
The DIA community thanks Mark Kryah (Executive Director/Program Team Leader, Ultragenyx) for his four years of service as DIA Project Management Community Chair.
Project management in the biopharmaceutical industry is different than in other industries, Mark explains: "Drug development is iterative, and you have to respond to different data as you receive it. You often need to make big pivots in your plans driven by data you get from different clinical or other experiments. The iterative nature would be the big difference. You just can't predict what science is going to do. That's why we do the experiments.
Thanks for reading our September 2022 Issue!