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Workshop

[Free Online Workshop] Regulated Large Molecule Bioanalysis: Fundamentals, the New FDA Guidance and Beyond


Speakers: Surinder Kaur, Cynthia Woods, Teresa Davancaza, Rachel Basile, Keyang Xu, Rebecca Elliott, Ihsan Nijem, Weili Yan (Genentech); Yanmei Lu, Daniel Richards (Sangamo Therapeutics, Inc); Christina M. Satterwhite (Charles River); Edward Tabler (PPD Laboratories)
Organizers: Rebecca Elliott, PhD, Weili Yan, PhD and Surinder Kaur, PhD (Genentech)
Date: 2020-09-17- 9/18/2020
Time: 8:30-12:00 Pacific Time
Registration fee: (USD): Regular: $0
Location: Online via Zoom
Major Sponsor: (2)Frontage Laboratories, Inc.; QPS, LLC
Vendor show vendors registered to date:
Registration: http://www.PBSS.org
Registration deadline:2020-09-16  (it will close sooner if the seating cap is reached)

About the Topic

Validated bioanalytical methods for the quantitative evaluation of large molecule drugs and biomarkers in a given biological matrix are critical for the successful conduct of nonclinical and clinical studies. These validated methods under the regulated GxP environment provide critical data to support the safety and effectiveness of drugs and biologic products. Ligand binding assays (LBA) and emerging new technologies are widely used for regulated large molecule bioanalysis.

The workshop includes an introduction to regulated bioanalytical method development/validation and sample testing, focusing on new FDA guidance and future global harmonized guidance for large molecule bioanalysis. Applying general bioanalytical principles to emerging new technologies and/or new drug entities such as cell and gene therapy to meet health authorities’ compliance requirements will also be presented by industry recognized experts.

The following topics will be covered:

  •  Introduction: Fundamentals of large molecule bioanalysis- method development, regulated validation and sample testing
  •  2018 FDA bioanalytical method validation guidance, changes from previous guidance, future global harmonized guidance
  •  Hybrid LBA/LC-MS bioanalytical method
  •  New technologies in large molecule bioanalysis
  •  Cross validation
  •  Life cycle management of bioanalytical method (critical reagents)
  •  Bioanalysis in gene and/or cell therapy (backup topic)
  •  Method transfer, validation, production from the CRO perspective

AGENDA

Thu, Sept 17, 2020

8:30 am - 8:40 am       Welcome & Introduction to Large Molecule Bioanalysis - Challenges and Opportunities (Surinder Kaur, Genentech)

8:40 am - 9:10am       1. Ligand Binding Assay (LBA) Bioanalysis of Large Molecules  - Fundamentals, Challenges and Opportunities (Cynthia Woods, Genentech)

9:10 am - 9:35 am        2. Emerging New Technologies: Microfluidic Ligand Binding Assay Platforms (Quanterix and ELLA) for Biomarkers (Teresa Davancaza, Genentech)

9:35 am – 9:55 am      3. LC-MS/MS Assays for Clinical Bioanalysis (Keyang Xu, Genentech)

9:55 am - 10:05 am    Major Sponsor Presentation

10:05am - 10:20 am   Break

10:20 am - 10:40 am    4. Hybrid Immuno-Affinity Capture LC-MS/MS Bioanalytical Methods – Special Considerations for Validation and Outsourcing (Rachel Basile, Genentech)

10:40 am - 11:10 am    5. Cross Validation of PK Assays (Ihsan Nijem, Genentech)

11:10 am – 11:30 am.  6. 2018 FDA Bioanalytical Method Validation Guidance, Changes from Previous Guidance, Future Global Harmonized Guidance (Rebecca Elliott, Genentech)

11:30 am - 12:00 pm  Q&A and panel discussion (All)

Fri, Sept 18, 2020 

8:30 am - 8:40 am       Introduction (Weili Yan, Genentech)

8:40 am - 9:10am       7. Bioanalytical Strategies for Drug Development of Genomic Medicines (Yanmei Lu, Sangamo Therapeutics, Inc)

9:10 am - 9:40am       8. The development and qualification of a multiplexed RT-qPCR assay to quantify transgene expression (Daniel Richards, Sangamo Therapeutics, Inc)

9:40 am - 10:05 am      9. Critical Reagent Strategies for Maintaining LBA Assays at CROs during Clinical Development (Weili Yan, Genentech)

10:05 am - 10:15 am   Major Sponsor Presentation

10:15 am - 10:30 am   Break

10:30 am - 11:00 am    10. New Modalities Test Existing Bioanalytical Methods and Platforms (Christina M. Satterwhite, Charles River)

11:00 am - 11:30 am    11. Increasing Role of CROs in Harmonizing and Shaping Industry Best Practices (Edward Tabler, PPD Laboratories)

11:30 am - 12:00 pm    Q&A and panel discussion (All)

 


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