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Thursday, April 12 • 8:30am - 10:00am
Session FF - Bioanalytical Track

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FF-1   EMA Bioequivalence Inspections in the US - What to Expect and How They Differ from US FDA Bioequivalence Inspections

As an international contract research organization studies conducted by Covance are submitted to various regulatory authorities.  The resulting inspections differ significantly and come with different challenges.  During this session details related to the planning, conduct and follow up from one EMA/FDA inspection will be reviewed and discussed.


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FF-2  Bioanalytical Audit Due Diligence and Risk Management

In this session we will discuss how CROs prepare to host and respond to audits: Pre-Qualification, Re-Qualification, and Data (BA/BE & Pivotal Studies) - by identifying the risks sponsors are looking to mitigate, and how Bioanalytical CROs address real and perceived risks.

We will hear from Sponsors, Auditors, and CROs, and their real life experiences.


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FF-3  Investigation of incurred sample reanalysis failure 

5-fluorouracil (5-FU) is a chemotherapy agent for treating breast and colon cancers.  Capecitabine is also a chemotherapy agent for treating those cancers and it is a prodrug which is enzymatically converted to the active drug 5-FU within the tumor.  Incurred sample reanalysis (ISR) of 5-FU were performed for patients dosed with either 5-FU or capecitabine in one clinical trial. ISR analysis on samples from patients that were dosed with 5-FU met acceptance criteria. However, ISR analysis on samples from patients that were dosed with capecitabine in the same study was failed. It was suspected that capecitabine and its upstream metabolites 5’-DFCR or 5’-DFUR, alone or in combination, may convert to 5-FU following sample collection. An investigation was performed. Blank plasma was spiked individually with capecitabine, 5’-DFCR and 5’-DFUR at potential Cmaxconcentrations and were left at testing conditions before analysis for 5-FU. It was confirmed that 5’-DFUR was continuing to convert to 5-FU even after samples had been frozen. To prevent the conversion, a further investigation was performed using different conditions with various inhibitors such as 5-nitrouracil, 7-deazaxanthine or tetrahydrouridine with formic acid, acetic acid, and citric acid. This investigation led to the development of a specialized sample collection procedure. A bioanalytical method was then developed and validated for the determination of 5-FU in human plasma from patients dosed with capecitabine utilizing the above sample collection procedure. This new approach has resulted in acceptable ISR results for 5-FU from patients dosed with capecitabine.


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avatar for Steve Rogenthien

Steve Rogenthien

Director, Quality Assurance, Concord Biosciences/Frontage Laboratories
Mr. Rogenthien is the QA Director at Concord Biosciences, LLC (formerly Ricerca Biosciences) where he oversees the quality programs that support the company's drug safety & metabolism, bioanalytical, and agrochemical product development departments. Prior to joining Ricerca in 2007... Read More →

avatar for Xiao Ding

Xiao Ding

Xiao Ding received her PhD degree in Analytical Chemistry in 1997 from University of Arizona and completed her postdoctoral training in University of Arizona in 1999. Since 1999, she has worked in pharmaceutical industry including Boehringer Ingelheim, Amgen and Genentech. She has... Read More →
avatar for Joe Franchetti

Joe Franchetti

Managing Consultant, JAF Consulting, Inc.
As JAF Consulting Incorporated’s Managing Consultant, Joe Franchetti is an industry leader and teacher for Data Integrity, 21 CFR Part 11, Annex 11, and Computer System Validation in regulated environments. For over twenty-five years, Joe has been involved with the development... Read More →

Timothy R. Olin

Ionis Pharmaceuticals
avatar for Timothy Valley

Timothy Valley

Timothy Valley is an Associate Director Quality Assurance – Regulatory Policy and is responsible for overseeing client and regulatory inspections.  He joined Covance Laboratories in 1992 working 5 years as a bench level chemist followed by various positions in the Quality Assurance... Read More →
avatar for Kim Wheeler

Kim Wheeler

QA Manager, PPD
Ms. Wheeler started in GLPs in December of 1980 at A.H. Robins Research. She has over 10 years’ experience in analytical method development in GLPs /GMPs, having worked for Robins Research Division and Sergeant’s Pet Products.Kim Wheeler is a MLT-AD, ASCP, and managed a hospital... Read More →

Thursday April 12, 2018 8:30am - 10:00am PDT
Platinum 1&2