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Workshop

Small-Molecule Bioanalytical Method Validation & Regulated Bioanalysis: Fundamentals, the New FDA Guidance and Regulatory Trends


Speakers: Mark Rose, CHDI; David Humphries, Covance; Kristen Harman, ChemoCentryx; David Scharberg, Pharmaceutical Outsource Solutions; Steve Lowes, Q2 Solutions; Eric Woolf, Merck; Deqing Xiao, Gilead
Organizers: Thomas Tarnowski, Gilead; Kristen Harman, ChemoCentryx
Date: 2019-10-03
Time: 8:45-17:00 Pacific Time
Registration fee: (USD): Regular: $195; Academic: $125; For unemployed or students: $30; For vendor-show rep: $35; For major-sponsor rep (incl lunch): $0
Location: SF Bay Area: Foster City Crowne Plaza
Major Sponsor: (3)Alturas Analytics; Eurofins Bioanalytical Services; WORLDWIDE CLINICAL TRIALS
Vendor show vendors registered to date: (17)AB Sciex; Absorption Systems; Adesis Inc.; BASi/Seventh Wave; BioDuro; Charles River Labs; ICON Clinical Research; Intertek; KCAS Bioanalytical & Biomarker Services; Lovelace Biomedical; Medpace; MicroConstants; Pacific BioLabs; Q2 Solutions; Quintara Discovery (QDI); SEKISUI XenoTech; WuXi AppTec
Registration: http://www.PBSS.org
Registration deadline:2019-10-01  (it will close sooner if the seating cap is reached)

About the Topic

Regulated bioanalysis (RBA) is required in the key parts of drug development that involve evaluations of drug safety, bioequivalence, and pharmacokinetics, and RBA data quality directly impacts the reliability of such assessments. RBA Method Validation requires compliance with various national method validation guidances, which will soon be superseded by harmonized guidance from the International Conference on Harmonisation (ICH).

To ensure successful assay applications and regulatory submissions, bioanalytical methods are extensively evaluated and validated for accuracy/precision, selectivity, specificity, sensitivity, recovery, and stability under various operational conditions. Data generated for validation and sample analyses and all documentation necessary for reconstructing the validation study and sample analyses, (e.g. experimental data, protocols, reports, staff training records, SOPs, etc.) needs to be maintained and available for data audit and inspection.

Presenters at this workshop are internationally recognized experts on RBA and regularly present at international bioanalytical conferences. The workshop includes a general introduction to regulated bioanalytical method development/validation and sample analysis, as well as presentations of things to consider when partnering with a bioanalytical contract research organization (CRO) to perform such work. Presenters will also cover how to comply with the guidances and regulations, and discuss recent topics relating to the newest FDA Bioanalytical Method Validation guidance and the draft ICH guidance.


Workshop Agenda:

8:45 - 9:00   Welcome - S.Miao & T.Tarnowski

9:00 - 10:30    1. Introduction to Regulated Bioanalysis - Mark Rose, CHDI Management, Inc.

10:30 - 10:40    Major Sponsor Presentation - Alturas

10:40 - 11:00    Break

11:00 - 11:30    2. Quality and Compliance for Regulated Bioanalysis - David Scharberg, Preclinical Outsourcing Services

11:30 - 12:00    3. Working successfully with Bioanalytical CROs (CRO Experience) - David Humphries, Covance

12:00 - 12:20   4. Working successfully with Bioanalytical CROs (Sponsor Experience) - Kristen Harman, ChemoCentryx

12:20 - 1:20   Lunch (Sponsored by Eurofins Bioanalytical Services)

1:20 - 2:15    5. Interpretation and Application of the 2018 FDA Guidance on Bioanalytical Method Validation - Steve Lowes, Q2 Solutions

2:15 - 2:25    Major Sponsor Presentation - Worldwide Clinical Trials

2:25 - 2:45    Break & Raffle

2:45 - 3:40    6. ICH M10 The Road to a Global Harmonized Bioanalytical Method Validation Guidance - Eric Woolf, Merck

3:40 – 4:20   7. Strategies for Determination of Small-Molecule Analytes in PBMCs - Deqing Xiao, Gilead

4:20 - 4:50  Q&A for Speaker Panel - All


2020-09-17, Regulated Large Molecule Bioanalysis: Fundamentals, the New FDA Guidance and Beyond
2020-10-19, [New Date] Preclinical and Clinical Development of Cell-based Immunotherapies: Translational PKPD, Safety, Biomarker, CMC, Clinical Pharmacology & Clinical Trials
2021-07-29, Development of Inhalation Therapeutics (a joint symposium by AAPS-BADGE / PBSS / Genentech)
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