Dear Biomarker & Precision Medicine (BPM) Community,
To briefly introduce myself, I am Sasha Fraser, Senior Scientist, Bioanalytical Sciences Strategy Group, Regeneron Pharmaceuticals. I am excited to announce I will be joining the team as one of our Community Engagement Manager.
The AAPS PharmSci 360 kicks off this Sunday Oct 22 through Wednesday Oct 25, and there is a lot of interesting content on Biomarker that you do not want to miss! See below for a snapshot of the program related to Biomarkers including presentations from the FDA and Critical Path Institute speakers.
Preclinical and Translational Sciences
- Monday, Oct 23rd, 9:00 AM – 9:30 AM ET Pharmacodynamic Biomarkers Evidentiary Considerations for Biosimilar Development and Approval, Speaker: Lakshmi Manasa S. Chekka, PharmD, PhD – U.S. FDA (311 CD West)
- Monday, Oct 23rd, 9:00 AM – 9:30 AM ET Supporting Rare Disease Drug Development and Use of Biomarkers: Ravulizumab Case Study Speaker: Mark Ma, MD – Biotech (311 AB West)
- Monday, Oct 23rd, 9:30 AM – 10:00 AM ET Critical Path for Rare Neurodegenerative Diseases Initiative for Drug Development Speaker: Colin Hovinga – C-Path Institute (311 AB West)
- Monday, Oct 23rd, 10:00 AM – 10:30 AM ET Neurodegenerative Rare Diseases: Biomarkers in Drug Development and Regulatory Decisions Speaker: Bilal AbuAsal, PhD – US FDA (Location:311 AB West)
- Monday, Oct 23rd, 10:30 AM – 11:00 AM ET Pharmacodynamic Biomarkers as Confirmatory Evidence in Rare Disease Drug Development Speaker: Nayeem Hossain, PhD – US FDA (311 AB West)
- Monday, Oct 23rd, 1:30 PM – 2:30 PM ET Keynote: Biomarker Selection and Utility in Clinical Drug Development Today: Workhorses and Unicorns Keynote Speaker: Lindsay Ewan King, Ph.D. – Pfizer Inc (311 CD West)
- Monday, Oct 23rd, 2:30 PM – 3:30 PM ET Speaker Spotlight: Advances in Predictive Biomarkers for DDIs
- Spotlight Speaker: Manthena V. Varma, PhD – Pfizer Inc (Spotlight Stage B Exhibit Hall West A4-B3)
Bioanalytics
- Tuesday, Oct 24th, 9:00 AM – 9:15 AM ET Integrating Biomarkers in PD-1/PD-L1 Antibody Therapy for Personalized Cancer Treatment Rapid Fire Speaker: Baolin Zhang, PhD – Office of Biotechnology Products (OBP), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) (308 CD West)
- Wednesday, Oct 25th, 9:30 AM – 10:00 AM ET Advancing Drug Development Through Data-Independent Acquisition Mass Spectrometry for Biomarker Discovery and Development Speaker: Veronica Anania, PhD – Genentech (311 GH West)
- Wednesday, Oct 25th, 10:30 AM – 11:00 AM ET LCMS Approaches for Discovery and Quantitation of Biomarkers for Target Engagement and Pathway Modulation Speaker: Faizan Zubair, PhD – Takeda Pharmaceuticals (311 GH West)
- Wednesday, Oct 25th, 1:30 PM – 2:30 PM ET Keynote: When Companion Diagnostics Met Bioanalysis: The Roles of Companion Diagnosis and Bioanalysis in Guiding Treatment Selection and Monitoring Drug Response
- Keynote Speaker: Mark Ma, MD – Biotech (311 EF West)
- Wednesday, Oct 25th, 3:30 PM – 3:45 PM ET Biomarker Challenges: Dilution Linearity or Parallelism?
- Rapid Fire Speaker: Marc-Olivier Pepin, BSc – Charles River Laboratories (311 EF West)
- Wednesday, Oct 25th, 3:45 PM – 4:00 PM ET Parallelism for Biomarker Assays Best Practice, Rapid Fire Speaker: Lindsay Ewan King, Ph.D. – Pfizer Inc (311 EF West)
Note: BPM Community will be hosting a networking event on Monday, Oct 23rd, 4:00 PM – 5:00 PM ET (Spotlight Stage C Exhibit Hall West A4-B3). You are invited to learn more about upcoming community activities and participation opportunities.
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Sasha Fraser, PhD
Senior Scientist, Bioanalytical Sciences
Regeneron Pharmaceuticals
Tarrytown, NY
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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