Bioinsider’s Upcoming Friday Roundtables Focus on Immunogenicity, Drug Shortage, and Clinical Trial Challenges due to COVID-19

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BOSTON–October 15, 2020  Bioinsider, the group that facilitates discussion among the scientific community, is presenting three brainstorming sessions in the form of Friday Roundtables: The Impact of COVID-19 on Immunogenicity of Biologics (Oct. 23); Drug Shortage Challenges in the Time of COVID-19 (Oct. 30); and Addressing Clinical Trials during COVID-19 and the Dialogue with Regulatory Agencies (Nov. 6). These virtual events are moderated by select groups of academic and industry experts to address timely issues in life sciences and healthcare.

A limited number of participants will have direct access and face-to-face interactions with experts, moderators and other participants throughout the event, including a speed-networking session and open discussion on the issues.

To register, visit: www.bioinsidernetwork.com/friday-roundtables/

Event details and moderators:

October 23, 2020 – Impact of COVID-19 on Immunogenicity of Biologics

Dr. Vibha Jawa, director and lead of predictive and clinical immunogenicity at Merck, along with Dr. Narendra Chirmule, CEO of SymphonyTech Biologics and CSO of AcuImmune are co-moderating this brainstorming session with the goal of addressing the following questions:

  • What is the influence of the inflammasome activation?
  • What are the roles of the inflammasome in activation of IL-6, IL-18, and IL1b, and regulation of cytokine storm?
  • What is the influence of the Th1/Th2/Th17 immune regulation?
  • Can SARS-COV2 infection lead to enhanced risk for autoimmunity?
  • What is the influence of COVID-19 on B cell responses?

October 30, 2020 – Drug Shortage Challenges in the Time of COVID-19

Dr. Mina Tadrous, scientist at Women’s College Hospital Institute for Health System Solutions and Virtual Care; and Dr. Barry Power, editor-in-chief of the Canadian Pharmacists Association are co-moderating this brainstorming session with the goal of addressing the following questions:

  • Reasons behind the growing number of worldwide drug shortages over the last decade
  • How the COVID-19 pandemic has worsened this problem and the unique problem it has presented
  • Explore potential solutions for protecting the global supply chain learning from other industries

November 6, 2020 – Addressing Clinical Trials during COVID-19 and the Dialogue with Regulatory Agencies

Dr. Mohamed Hassanein, associate director and clinical assay lead at Pfizer and Dr. Michael Partridge, associate director of bioanalytical sciences at Regeneron Pharmaceuticals are co-moderating this brainstorming session with the goal of addressing the following questions:

  • Rethinking the traditional workflows for sample collection (patient-centric), shipment and analysis
  • Regulatory expectations for EUA or BLA during the pandemic, especially for COVID-19 therapeutics
  • What is the FDA’s position on using non-validated PK/ADA assays for EUA submission package for COVID-19 therapeutics?
  • Is banking samples and testing later acceptable for EUA?
  • Are we prepared for the next wave or future pandemics?

The events are currently free to both academic/non-profit and commercial attendees, and are limited to 15 participants per event to ensure effective discussion. Attendees working on any of these fields can join these discussions as thought leaders or participants and are encouraged to register early as these fill up fast. To register, visit https://www.bioinsidernetwork.com/friday-roundtables/.

To view full event details and future events, visit www.bioinsidernetwork.com

About Bioinsider

Founded in 2020, Bioinsider LLC is a group of like-minded individuals dedicated to creating a quality-driven, unbiased virtual meeting platform for communication among the scientific community, policymakers and business leaders. The goal of these events is to create connections, enrich knowledge, foster collaborations, drive the success of research, and spark innovations. For more information, visit bioinsidernetwork.com.

 

Media contact: Tim Cox of ZingPR, tim@zingpr.com

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