The 4th 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:
 

12:00pm-01:00pm

01:00pm-01:30pm:
 

Registration & Breakfast

Dr. Fabio Garofolo, VP Bioanalytical Services, Algorithme Pharma - "Introduction & Review of the Main Topics discussed during the previous Canadian Workshop and in other similar recent international meetings & conferences"

Dr. Christopher Evans, US Head, Bioanalytical Science & Development, GlaxoSmithKline - "Use of Dried Blood Spots (DBS) in Regulated Bioanalysis: Practical Considerations, Applicability, and Future Directions"

Dr. Eric Woolf, Senior Director, Merck Research Laboratories - "Bioanalytical Run Assessment - Factors to Consider Beyond the White Paper"

Coffee & Refreshment Break

Dr. Mohammed Jemal, Senior Research Fellow, Bristol-Myers Squibb - "Bioanalytical Method Quality vis-a-vis Method Development, Qualification, Validation and ISR"

Dr. Robert Masse, Vice President, Bioanalytical Division, Anapharm - "A CRO Perspective on ISR: Real Case Examples in an Evolving Regulatory Landscape"

Dr. Mario Rocci, Jr, Executive VP, ICON Development Solutions - "Investigation and Resolution of Incurred Sample Reanalysis Failures - Two Case Studies"

Lunch

Dr. Marc Lefebvre, VP Scientific & Regulatory Affairs, Algorithme Pharma - "Impact of Bioequivalence/PK Study Design on the Development of Bioanalytical Methods"

01:30pm-02:00pm:
 

02:00pm-02:15pm:
 

02:15pm-02:30pm:
 
 

02:30pm-03:00pm

03:00pm-03:30pm:
 

03:30pm-04:00pm:
 
 

Dr. Stephen Lowes, Senior Vice President Scientific, Advion BioServices - "Bioanalytical Considerations for Development of Regulatory Guidance around LC-MS Biomarker Assays"

Louise Mawer, Senior GCP Inspector, U.K. MHRA - "Considerations on Follow-on Biologics and Biosimilars"

Patrick Bedford, Senior Policy Analyst, Office of Policy and International Collaboration, Biologics and Genetic Therapies Directorate, Health Canada - "Health Canada's Guidance for Subsequent Entry Biologics"

Coffee & Refreshment Break

Dr. Joseph Marini, Associate Director, Centocor Research & Development, Johnson & Johnson - "Ligand Binding Assay Validation and Bioanalysis: Challenges and Solutions"

Dr. Joleen White, Senior Research Investigator, PCO-BioAnalytical Sciences, Biologics, Bristol-Myers Squibb - "The Value of Including Incurred Samples in Immunoassay Cross-Validation"

04:00pm-04:30pm:
 

04:30pm-05:00pm:

05:00pm-06:00pm

06:30pm-09:00pm

Peter van Amsterdam, Head of Global Bioanalytics, Abbott - "EBF Perspective on the New EMA Guidelines on Bioanalytical Method Validation (BMV) and Input on Global BMV Harmonization"

Audience Questions Gathering and Preparation for Panel Discussion

Networking Reception

Invited Speakers Working Dinner & Panel Discussion Preparation

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:
 

12:00pm-01:00pm

Breakfast

Dr. Surendra Bansal, Research Director Bioanalytical R&D, Non-Clinical Safety, Hoffmann-La Roche - "International Harmonization of Bioanalytical Guidance."

Dr. Brian Booth , Deputy Director, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US FDA and Dr. CT Viswanathan, Associate Director, Division of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, US FDA - "The FDA Bioanalytical Guidance Revision - Will There be Harmony?"

Arthur Leonardo Lopes da Silva, Specialist in Regulation and Sanitary Monitoring, Bioequivalence Coordination (COBIO), Brazil ANVISA - "The ANVISA Bioanalytical Method Validation Guidance and its Global Harmonization; Support of Submission in Brazil; CRO's Certification and Bioequivalence Guidelines "

Coffee & Refreshment Break

Dr. Jan Welink , Senior Pharmacokinetic Assessor, Europe-EMA representative / Dutch Medicines Evaluation Board - "A perspective on the EMA Bioanalytical Method Validation; Status and Introduction of the New Draft EMA Bioanalytical Guideline and View on Harmonization"

Eric Ormsby, Manager, Office of Science, Health Canada Therapeutic Product Directorate - "The Health Canada Bioanalytical Guidance and Possible Harmonization; Status of the New Health Canada Bioequivalence Guidelines; Foreign Study Submission issues; and GLP/GCP Canadian Certification"

Louise Mawer, Senior GCP Inspector, U.K. MHRA - "A Perspective on Inspections that may Include Bioequivalence Studies; UK GLP and GCP Risk-based Inspections and Phase I Accreditation"

Lunch

01:00pm-01:15pm:
 

01:15pm-04:30pm:
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

04:30pm-04:40pm:

Summary of Panelists' Conclusions on the 2010 Discussion Topics and Consensus Points
Natasha Savoie , Compliance Manager, Algorithme Pharma

PANEL DISCUSSIONS

1. Global Harmonization of Bioanalytical Method Validation and Sample Analysis

   • Is harmonization possible?
   • What is the best/fastest way to achieve it? ICH Guidelines or OECD Guidelines or a Bioanalytical World Congress with the active participation of both industry and regulatory agencies?

2. Lipemic and hemolyzed plasma samples. Is it allowed to just define these samples as "Not Reportable" values or further method development is needed to analyze them?

3. Statistical challenge to the current validation criteria (recent literature). How well does pre-study validation predict the quality of individual incurred sample results?

4. Urine and tissues analysis. Tissue analysis is not controlled until the sample is homogenized and urine analysis is not controlled during sample collection and sampling. What is your approach?

5. Multi analyte assay, repeat analysis and failed runs:

   • If repeating for failure on one analyte, do we need to regress and report repeat analytes concentrations that passed previously?
   • Where does an assignable cause for failed runs finish and a non-assignable cause start?

6. Preparation of calibration standards. Prepare in bulk and freeze aliquots versus prepare them fresh. There are pros and cons for both techniques. Often, individual labs choose one over the other as a matter of their practice, not because the assay would require it. What is the best technique to use? Is it possible to agree upon a standard uniform approach?

7. Critical reagent stability and assignment of expiration date for large molecule. When conjugates from reference material are produced how do you establish the new expiration date?

8. Sample Handling: From Receipt to disposal. Regulatory Agencies constantly target the sample handling during audits: collection, storage, chain of custody in LIMS system, and sample labeling. What are the many issues in the sample handling, monitoring and tracking and how to fix them? How can we improve sample tracking to better meet Regulatory Agencies' requirements?

9. Challenges in endogenous analyte assays (e.g. Vitamins, hormones, coenzymes, etc.). What are the implications for regulated biomarker bioanalytical methods? What are the regulatory agency perspectives? Are the bioanalytical method validation guidelines good enough for endogenous analytes?

10. Carryover criteria. Is it feasible to perform a sample-by-sample assessment of potential impact if carryover greater than 20% of the LLOQ is suspected? What does this measurement estimate? Are new carryover criteria (i.e. 5% possible contribution from previous injection) accepted by regulatory agencies? What are the industry standards after Crystal City III and the use of non-randomized sequences?

Closing Remarks and Adjournment