The 3rd Workshop on
Recent Issues in Regulated Bioanalysis

08:00am-08:30am:

08:30am-09:00am:
 

09:00am-09:30am:

09:30am-10:00am:
 
 
 

10:00am-10:30am:
 

10:30am-11:00am

11:00am-11:30am:
 

11:30am-12:00am:
 

12:00am-12:30am:
 

12:30pm-01:30pm

01:30pm-02:00pm:
 
 

02:00pm-02:30pm:
 
 

02:30pm-03:00pm:
 

03:00pm-03:30pm

03:30pm-04:00pm:
 
 

04:00pm-04:30pm:
 

04:30pm-05:00pm:
 
 

05:00pm-05:30pm:
 

05:30pm-05:45pm:

06:30pm-09:00pm

Registration & Breakfast

Brief Review of the Main Topics discussed during the 2008 North American Bioanalytical Workshops and in other similar recent international meetings & conferences: "Bringing everyone up to speed!"

Introduction to the 2009 Discussion Topics

Eric Ormsby, Acting Manager, Health Canada TPD - "What's New From Health Canada TPD? New Bioequivalence Guidelines and how they will affect CROs and Pharmas; Foreign Study issues and Good Clinical Practice Guidelines; Second-entry Inhaled Corticosteroid for treatment of Asthma Guideline."

Dr. Stephen Lowes, Senior Vice President Scientific, Advion BioServices - "Bioanalytical Incurred Sample Reanalysis Failure and Scientific Investigation into the Out of Specification Results"

Coffee & Refreshment Break

Michael Lindsay, Director, Bioanalytical Laboratory, Bioanalytical Development, Apotex - "Method specificity: a systematic approach for concomitant medications"

Dr. Rupinder Phull, Director PK/BE, Barr Laboratories - "Challenges in the Bioanalysis of Endogenous Drugs"

Dr. Robert Masse, Vice President, Bioanalytical Division, Anapharm - "Labile Metabolites and their potential impact on bioanalytical data reliability: Typical case-stories"

Lunch

Dr. Mario L. Rocci, Jr, Executive Vice President, Prevalere Life Sciences - "Challenges with Bioanalytical Method Development, Qualification & Transfer...one CRO's approach to addressing these challenges"

Dr. Brian P. Booth, Deputy Director, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration - "Status of FDA Guidance and FDA Experience after 1 Year of ISR Data"

Dr. Patrick T. Vallano, Bioanalytical Laboratory, Mylan Pharmaceuticals - "Considerations for the Assessment of Processed Sample Stability"

Coffee & Refreshment Break

Peter van Amsterdam, Head of Global Bioanalytics, Solvay Pharmaceuticals - "EBF's recommendations on Incurred Sample reproducibility and other bioanalytical and regulatory challenges & issues EBF is currently working on"

Dr. Douglas M. Fast, Director, Bioanalytical Research Pharmacokinetics, Dynamics, and Metabolism, Pfizer - "US GLP Modernization Activities - Perspectives and Suggestions for Revisions"

Louise Mawer, Senior GCP Inspector, U.K. MHRA - "EMEA Bioequivalence Guidance; MHRA Examples from License-related Triggered and Routine Systems Inspections; GCP/GLP Interface and the Guidance Available to MHRA Clinical Laboratories"

Dr. Fabio Garofolo, VP Bioanalytical Services, Algorithme Pharma - "When and How Much Do Anomalous Results Need to Be Investigated?"

Audience Questions Gathering and Preparation for Panel Discussion

Invited Speakers Working Dinner & Panel Discussion Preparation

08:00am-08:30am:

08:30am-08:45am:
 

08:45am-12:00am:
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

12:00pm:

Attendee Breakfast

Summary of Panelists' Conclusions on the 2009 Discussion Topics and Consensus Points
Natasha Savoie , Compliance Manager, Algorithme Pharma

PANEL DISCUSSIONS

• Latest Bioanalytical Techniques (U-HPLC, FAIMS, MS3, HRES, etc.)

  • Can they really Improve Quality in Regulated Bioanalysis?
  • Myth or Reality?
  • What is your experience?

• Worldwide ACN Shortage

  • What are your strategies for addressing the worldwide ACN shortage?

• Manually Modified Chromatograms - Following the EMEA Draft Guidance for Bioequivalence:

  • How are you reporting manually modified chromatograms?
  • What is your procedure regarding manually modified chromatograms?
  • Do you have a cutoff criteria which allows for a modification (ex. 5% difference in response)?

• Metabolite Testing

  • What evaluations do you perform when there are unstable metabolites?
  • Do you perform these tests during the validation?

• Investigating Acceptable Results

  • When data are acceptable but "borderline", do you investigate?

• Anticoagulant Counter-Ions Changing anticoagulant counter-ions (Na, K2/K3, Li):

  • Are you performing counter-ions tests in validation?
  • What validation parameters should be evaluated (matrix effect, stabilities)?
  • Have you found any true case on counter-ion impact so far?

• Variable Injection Volumes

  • Do you test the impact of variable injection volumes?
  • Do you perform this test in validation?

• OTC Testing

  • What is your procedure regarding the testing of OTCs?
  • Do you also test for all their metabolites?
  • Do you test for contraceptives? Which ones?

• Hemolysis Testing

  • What evaluations are required for hemolysis testing?
  • What level of hemolysis is required?
  • How do you determine the level of hemolysis in incurred samples?

• Blood Stability Testing

  • What is your maximum processing time of clinical samples?
  • Is this based on blood stability?
  • How do you perform blood stability?

• INCURRED SAMPLE REANALYSIS - Following the FDA presentations at BSAT and GHPH conferences,

  • What is your approach for ISR?
  • Are you analyzing 10% of samples?
  • What do you do if ISR fails?

Closing Remarks and Adjournment