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The Netherlands Area Biotech Discussion Group - May 2020
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14 May 2020 (16:00 - 20:00)

Leiden University Medical Center (LUMC)


 

Due to the current situation with COVID-19, this meeting of the NLab Discussion Group has been postponed.

More information will be shared as soon as it is available.

 

 

Sarah Kennett
Genentech, a Member of the Roche Group

At this NLab meeting, we will meet Dr Sarah B. Kennett. Sarah has worked for many years at the FDA as a reviewer and Review Chief and now works for Genentech as the Principle Regulatory Program Director for Biologics. Last year, Sarah joined the CASSS Board of Directors. Besides extensive knowledge on regulatory topics, Sarah has shown throughout the years that she has a good grip on the practical part of our work, and that she is very willing to share her insights. Over the years, she spoke at several CASSS meetings on a variety of topics such as regulatory perspectives on advanced methods, method validation, QbD for methods, methods used for biosimilar and antibody-drug conjugate testing, laboratory inspection, cell line development, and reference standards.

For this special appearance in the NLab community, we’d like to learn all we can from Sarah so this meeting we will have a slightly different format than usual. We will sit down with Sarah to ask and discuss on many different topics. To make effective use of the time, we would like to start with collecting many of your questions in advance. This gives you an opportunity to submit questions anonymously if you wish, and it gives us the chance to sort and group questions. We will start the meeting with these, and naturally there will also be sufficient opportunity to ask and discuss during the meeting. A link to submit questions will be provided in your registration confirmation email.  We are looking forward to a lively discussion with Sarah and hope to see you there!


Sarah received a B.S. degree in Molecular and Cell Biology (Microbiology minor) from the Pennsylvania State University. She obtained her Ph.D. in Molecular Cancer Biology at Duke University and followed that with postdoctoral training in the Laboratory of Molecular Carcinogenesis at the National Institutes of Health (NIH).

Sarah joined FDA in 2005 as an Interagency Oncology Task Force Fellow in the Office of Cellular, Tissue, and Gene Therapies in the Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration (FDA) where she reviewed early stage cell therapy products in addition to performing research. She joined the FDA Center for Drug Evaluation and Research (CDER), Office of Biotechnology Products (OBP), Division of Monoclonal Antibodies as a reviewer in 2007, became an Acting Team Leader in 2012, and was promoted to Review Chief in 2013. She became the Review Chief for OBP’s Division of Biotechnology Review and Research I when OBP was reorganized. While in OBP, Sarah has been involved in the review of and regulatory actions for a wide variety of antibody-related and other therapeutic protein products throughout their lifecycles and has been involved with numerous manufacturing facility inspections. She has experience with divergent product issues, such as those related to breakthrough products and biosimilars; has been involved with working groups and task forces for topics such as biosimilars, communications with sponsors, investigator-sponsor INDs, compounding pharmacy issues, and counterfeiting issues; and has recently been the OBP contact for FDA’s biological product representative for ICH Q12. Sarah joined Roche/Genentech at the end of 2017 as a Principle Regulatory Program Director for Biologics in Pharma Technical Regulatory and is located in Washington D.C.


 



 
 


Pre-registration is required; there will be no onsite registration.


14 May 2020
17:00 - 20:00

 

Preliminary Schedule:

16:00 - Registration
17:00 - Welcome and Introduction
17:15 - Lecture 
            Discussion and Networking Reception to Follow
20:00 - Adjourn             
 

 

Location:
Leiden University Medical Center (LUMC)
The Netherlands

For more information on upcoming programs, please visit 
the Netherlands Area Biotech (NLab) Discussion Group homepage, 
here

 

 


 
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