October 28, 2021
DIA Global SmartBrief
News on diagnostic and therapeutic innovations and regulatory scienceSIGN UP ⋅   SHARE
Europe
European regulators have given CE mark certification to Agilent Technologies for its PD-L1 IHC 28-8 pharmDx diagnostic test, which is designed to guide first-line treatment of HER2-negative advanced or metastatic gastric, gastroesophageal junction or esophageal cancers in adult patients.
Full Story: FDAnews (10/27) 
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European regulators have given CE mark certification to Excalibur Healthcare Services for its Excalibur Test To Go app, an artificial intelligence-powered COVID-19 self-testing system. The software allows users to perform a lateral flow test on themselves, record the results and receive fast certification of their status from the company's laboratories.
Full Story: FDAnews (10/27) 
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Asia Pacific
South Korea has authorized Moderna's COVID-19 vaccine produced by Samsung Biologics for emergency use, the country's health ministry announced on Tuesday. According to Moderna, 2.44 million doses made by Samsung have obtained a Good Manufacturing Practice certification from South Korea's drug safety ministry and will be available for distribution this quarter.
Full Story: Reuters (10/25) 
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North America
A study published in the CDC's Morbidity and Mortality Weekly Report found individuals who have received COVID-19 vaccines from Pfizer/BioNTech, Moderna or Johnson & Johnson had lower risk of dying from any cause in the months following vaccination, compared with unvaccinated individuals. The study, based on data from 11 million people, "reinforces the safety profile of currently approved COVID-19 vaccines in the United States," researchers said.
Full Story: HealthDay News (10/25),  CNN (10/22) 
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Precigen has received FDA clearance for its investigational new drug application for PRGN-3007, a chimeric antigen receptor T-cell therapy, to treat advanced hematologic cancers or solid tumors in breast cancers expressing receptor tyrosine kinase-like orphan receptor 1. Researchers used the company's UltraCAR-T therapeutic platform to develop the treatment.
Full Story: Healio (free registration)/HemOnc Today (10/26) 
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An FDA advisory panel voted on Tuesday to recommend emergency use authorization of a reduced dose of Pfizer/BioNTech's COVID-19 vaccine for children ages 5 to 11. The FDA could make a decision within days, and the CDC's vaccination advisers are scheduled to meet on Nov. 2 to discuss vaccination of younger children.
Full Story: National Public Radio (10/26),  HealthDay News (10/26) 
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Global
Clinical trial sponsors, academic research centers and the NIH are taking steps to expand both overall participation in clinical trials and diversity in clinical trial volunteer pools by making it easier for people who don't live near large academic medical centers to participate. Other steps to improve diversity include training investigators on implicit bias, revisiting strict eligibility criteria and establishing interagency collaborations.
Full Story: Healio (free registration)/HemOnc Today (10/25) 
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Moderna reported that a study in children ages 6 to 11 showed strong immune responses to the company's COVID-19 vaccine. The manufacturer said most side effects in this age group were mild to moderate, including headache, fatigue, injection site discomfort, and fever.
Full Story: Reuters (10/26),  NBC News (10/26) 
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DIA News
Innovations in the development of advanced therapies have yielded new and dynamic solutions for the prevention and treatment of diseases where none existed previously. Join us to explore common CMC challenges posed by the development of these increasingly complex products. DIA is pleased to welcome Peter W. Marks, MD, PhD, Director, Center for Biologics Evaluation and Research, FDA as the Keynote Speaker at this year's Advanced Therapies: Innovations in CMC Conference, taking place November 8-10.

Dr. Marks will kick off the event by sharing and discussing the FDA's perspective on the importance of CMC in overcoming hurdles in advanced therapy development.

The sessions and speakers that follow will explore the common CMC challenges posed by the development of increasingly complex products and share multi-stakeholder perspectives, plus relevant case studies spotlighting solutions that enable regulatory compliance, and shorter review timelines, and support post-approval maintenance.
Learn more.
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DIA is excited to add a brand-new meeting to its lineup this fall. Developed specifically for project managers in all stages of the healthcare product lifecycle, DIA’s Impact of Project Management in Healthcare Product Development Conference, taking place November 15-18, will explore perspectives on managing projects during a pandemic and what lessons managers learned related to resource planning, opportunity costs, and trade-offs. You’ll learn how to build resiliency in the workplace, better understand and learn from failures in drug development, and use diverse leadership styles to drive projects forward.

The Impact of Project Management in Healthcare Product Development is a neutral platform for project and portfolio knowledge sharing related to healthcare research and development.

Featured speakers:
Matt Clark, PhD, PMP, Former Lead Program Manager, Vaccine Development, Operation Warp Speed
LTC John Nuckols, PhD, Joint Product Manager at Joint Product Executive Office for Chemical, Biological, Radiological and Nuclear Defense
Kristi Huntington, Senior Advisor, Pharma Project Management - Clinical Capabilities, Eli Lilly and Company
Learn more.
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