The Alliance for Regenerative Medicine (ARM) today announced it will host a webinar on clinical trial guidance during the ongoing COVID-19 pandemic, with speakers from the U.S. Food and Drug Administration’s (FDA) Office of Tissues and Advanced Therapies (OTAT). The webinar, which will feature insights from OTAT’s Clinical Deputy Division Director, Tejashri Purohit-Sheth, and Deputy Director, Ilan Irony, will address the impact of COVID-19 (coronavirus) on cell and gene therapy clinical trials, including the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity.
With nearly one million identified cases of COVID-19 worldwide since the beginning of the year, the biopharma sector is working around the clock to identify and mitigate new barriers to the research and development of innovative therapies to treat serious diseases and disorders. BioPharma Dive has reported that, since the beginning of March, more than three dozen companies have reported some sort of disruption to a clinical trial as a result of the coronavirus pandemic, including multiple trials utilizing gene and cell therapies.
This webinar will provide additional information to companies looking to conduct cell and gene therapy clinical trials during the COVID-19 pandemic while maintaining high standards for patient safety, good clinical practice, and data integrity.
Following presentations from Purohit-Sheth and Irony, the audience will have the opportunity to participate in a live Q&A. Registrants are also invited to submit questions ahead of the webinar by email.
The event will be held Friday, April 10, 2020 from 10:00 a.m. to 11:00 a.m. ET. To register, please click here.
This webinar is the first in a new series hosted by ARM that will cover key issues in the gene, cell, and tissue-based therapeutic sector, including challenges presented by the ongoing COVID-19 pandemic. Information on subsequent webinars will be made available on ARM’s website.
About the Alliance for Regenerative Medicine
The Alliance for Regenerative Medicine (ARM) is an international multi-stakeholder advocacy organization that promotes legislative, regulatory, and reimbursement initiatives necessary to facilitate access to life-giving advances in regenerative medicine worldwide. Founded in 2009, ARM works to increase public understanding of the field and its potential to transform human healthcare, providing business development and investor outreach services to support the growth of its 350+ member organizations worldwide. ARM represents the interests of therapeutic developers, academic research institutions, major medical centers, investors, and patient groups that comprise the broader regenerative medicine community and is the prominent international advocacy organization in this field.
ARM has 70+ members across 15 countries in Europe. ARM aims to work closely with European stakeholders, leveraging its membership to create a supportive commercial and regulatory environment to create better conditions for the development and commercialization of ATMPs in Europe; develop strong stakeholder support around proposed solutions to improve patient access to ATMPs; promote clear, predictable and efficient regulatory framework across Europe; and promote international convergence of key regulations and guidance. For more information, visit www.alliancerm.org.