Final Agenda
March 26, 2012 (Monday)
07:30am-05:00pm: Registration desk open
08:00am-05:00pm: Course 1:
"LC-MS/MS Bioanalytical Advanced Method Development Course"
Breakfast, Lunch and Morning/afternoon Refreshments are provided during the courses.
Breakfast and onsite registration from 7:30am to 8am
March 27, 2012 (Tuesday)
07:30am-8PM: Registration desk open all day long until 8pm in the evening
Come to pick up your conference program book with all the presentations from all the speakers.
08:00am-05:00pm: Course 2a:
"Bioanalysis of Large Molecule & Biomarkers: Advanced Ligand Binding Assays (LBA) Method Development and Troubleshooting"
08:00am-05:00pm: Course 2b:
"Bioanalytical Method Validation and Sample Analysis (BMV & SA): Challenges, Solutions, Applications, Global Industry Standards, and New Regulations"
Breakfast, Lunch and Morning/afternoon Refreshments are provided during the courses.
Course Breakfast and onsite registration from 7:30am to 8am
* Please note that Course 2a and 2b will take place in parallel.
05:30pm-07:00pm: Welcome Reception Sponsored by 
March 28, 2011 (Wednesday)
07:00am-12:00pm: Registration desk open
Come to pick up your conference program book with all the presentations from all the speakers.
07:00am-08:00am:
08:00am-08:30am:
Continental Breakfast
Dr. Fabio Garofolo, VP Bioanalytical Services, Algorithme Pharma
"Follow up on "unresolved" 2011 White Paper discussion topics - Bioanalysis (2011)3(18) & Need-to-Know from 2011 Major Bioanalytical Conferences: NBC, Land O' Lakes, BSAT-APA, PSWC/AAPS/FIP, EBF"
Findings from Audits/Inspections SCIENTIFIC PERSPECTIVE Session
08:30am-09:00am:
09:00am-09:30am:
09:30am-10:00am:
10:00am-10:10am:
10:10am-10:30am:
10:30am-11:00am:
11:00am-11:20am:
11:20am-11:30am:
Dr. Mario Rocci, President, ICON Development Solutions
"Recent findings/483s/observations from the GCC for LC-MS/MS and Ligand Binding Assays, and open discussion with Pharmas and Regulatory Agencies"
Dr. Roger Hayes, VP/GM of Laboratory Sciences, MPI Research
"Lessons Learned from an Untitled Letter"
Dr. Eric Woolf, Senior Director, Merck Research Laboratories
"Beyond Incurred Sample Reanalysis Criteria: Recent Experience with Inspections/Audits"
Dr. Eric Woolf, Senior Director, Merck Research Laboratories
"Findings on co-administered/co-formulated drug stability and specificity"
Dr. Stephen Lowes, Senior Vice President Scientific, Advion BioServices
"Data from GCC co-administered/co-formulated drug survey on stability and Open Letter"
Networking Morning Break
Dr. Surendra Bansal, Research Director Bioanalytical R&D, Non-Clinical Safety, Hoffmann-La Roche
"Co-administered/co-formulated drug specificity perspective"
Dr. Brian Booth, Dr. Eric Woolf, Dr. Stephen Lowes, Dr. Surendra Bansal
"Panel Discussion on Co-administered/co-formulated drug stability and specificity"
Findings from Audits/Inspections REGULATORY PERSPECTIVE Session
11:30am-11:50am:
11:50am-12:10pm:
12:10pm-12:30pm:
12:30pm-01:00pm:
01:00pm-02:00pm:
Dr. Sam Haidar, Chief GLP and Bioequivalence Investigations Branch, Division of Scientific Investigation, Office of Compliance, US FDA
"FDA Regulatory Findings from Inspections: Learning from the Regulators"
Mr. Joao Tavares Neto, Coordinator of Bioequivalence from General Office of Drugs, Brazil ANVISA
"Recent Regulatory Findings and Observations from ANVISA Audits"
Dr. Olivier Le Blaye, Inspector France AFSSAPS
"AFSSAPS Recent Regulatory Findings from Audits/Inspections"
Dr. Brian Booth, Dr. Sam Haidar, Dr. Olivier Le Blaye, Mr. Joao Tavares Neto, Dr. CT Viswanathan, Dr. Mario Rocci, Dr. Roger Hayes, Dr. Eric Woolf, Dr. Stephen Lowes, Dr. Surendra Bansal
"Panel Discussion on Regulatory Findings"
Networking Lunch
PARALLEL SESSION A: Innovations in Bioanalysis: From DD to DD (Drug Discovery to Drug Development) Session
Session Chair: Dr. Gabriella Szekely-Klepser, Sr. Director of Bioanalytical Sciences and Scientific operations, Allergan
02:00pm-02:20pm:
02:20pm-02:40pm:
02:40pm-03:00pm:
03:00pm-03:20pm:
03:20pm-04:00pm:
04:00pm-04:30pm:
Dr. Mohammed Jemal, Senior Research Fellow, Bristol-Myers Squibb
"Therapeutic Protein Bioanalysis by LC-MS/MS: Recent Insights"
Dr. Jean Lee, Scientific Director, PKDM, Amgen
"A General LC-MS/MS Method Approach to Quantify mAbs using a Common Whole Ab Internal Standard and Immune Affinity Capture"
Dr. Magnus Knutsson, Director, Bioanalysis LC-MS/MS, Ferring Pharmaceuticals
"Focus on Peptides: How to Get More Sensitivity"
Dr. Kevin Bateman, Distinguished Senior Investigator, Merck
"HRMS in Regulated Bioanalysis? Advantages of Qual/Quant High Resolution/Accurate Mass in Regulated Bioanalysis"
Dr. Gabriella Szekely-Klepser , Dr. Mohammed Jemal, Dr. Jean Lee, Dr. Magnus Knutsson, Dr. Kevin Bateman
"Panel Discussion on from DD to DD"
Networking Afternoon Break
Method Development Challenges in Bioanalysis: SMALL MOLECULES & LC-MS/MS Session
04:30pm-05:00pm:
05:00pm-05:30pm:
PARALLEL SESSION B: Advanced and Focused Roundtable on Scientific Updates from Large Molecules Harmonization Teams for a Unified Bioanalytical Guidance: Face-to-face GBC L1-L6 HTs
Session chair: Dr. Binodh DeSilva, Executive Director Bioanalytical Sciences-Biologics, Bristol-Myers Squibb
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:
"Large Molecule Specific Run Acceptance - L1"
"Large Molecule Specific Assay Operation - L2"
"Assay Formats- L3"
"Reagents and Their Stability - L4"
Networking Afternoon Break
"Automation Practices in Large Molecule Bioanalysis - L5"
"Anti-Drug Antibody (ADA) Interference of PK Assessments - L6"
05:30pm-06:30pm: Networking Reception
March 29, 2011 (Thursday)
07:30am-09:00am: Registration desk open
Continuing Method Development Challenges in Bioanalysis: SMALL MOLECULES & LC-MS/MS Session
08:00am-08:30am:
08:30am-09:00am:
09:00am-09:30am:
Method Development Challenges in Bioanalysis: LARGE MOLECULES & LBA Session
Session chair: Dr. Binodh DeSilva, Executive Director Bioanalytical Sciences-Biologics, Bristol-Myers Squibb
Session chair: Dr. Russell Weiner, Executive Director - Clinical Development Lab, Merck Research Laboratories
09:30am-10:00am:
10:00am-10:30am:
10:30am-11:00am:
11:00am-11:30am:
11:30am-12:00pm:
12:00pm-12:30pm:
12:30pm-01:30pm:
Dr. Joseph Marini, Associate Director, Janssen Research and Development
"Bioanalytical Challenges of Biosimilar Drug Development"
Dr. Dominique Gouty, Senior Director, Intertek/ALTA Immunochemistry
"Technology Advances in Overcoming Drug Tolerance in Immunogenicity Assays"
Networking Morning Break
Dr. Surinder Kaur, Group Leader Bioanalytical Sciences, Genentech
"Bioanalytical Challenges of Antibody-Drug Conjugate Therapeutics"
Dr. Lauren Stevenson, Principal Scientist, Development Translational Medicine, Biogen Idec
"Analytical Challenges with Large Molecule Biomarker Assays"
Dr. Sherri Dudal, Senior Investigator I, PK/PD Bioanalytics, Novartis Pharma AG
"Outside the Realm of ELISA: Assay Criteria for Alternative Platforms"
Networking Lunch
Year of the NEW Guidances in Bioanalysis
01:30pm-01:50pm:
01:50pm-02:10pm:
02:10pm-02:30pm:
02:30pm-02:50pm:
02:50pm-03:10pm:
03:10pm-03:30pm:
03:30pm-04:00pm:
04:00pm-04:30pm:
Dr. Brian Booth, Deputy Director, Office of Clinical Pharmacology, US FDA
"The New FDA Bioanalytical Guidance and the Biomarkers Regulatory Guidance" (if the new guidance became available) OR "Bioanalytical Failures and Their Impact - A Collection of Experiences Part 2" (if the new guidance did not become available)
Mr. Joao Tavares Neto, Coordinator of Bioequivalence from General Office of Drugs, Brazil ANVISA
"The New ANVISA Bioanalytical Guidance and Brief Overview of the Recently Published ANVISA Guidance for Biological Products (RDC 55/2010)"
Mr. Toshinari Mitsuoka, Senior Analyst, Evaluation and Licensing Division, Japan MHLW
"Updates on the Status of the Bioanalytical Guidance in Japan"
Mr. Eric Ormsby, Manager, Office of Science, Bureau of Policy, Science and International Programs, Canada TPD
"Updates on Canada Bioanalytical Guidance: Section 2.6 Bioanalytical Methodology"
Dr. Jan Welink, Europe-EMA representative / Senior Pharmacokinetic Assessor Dutch MEB
"The New EMA Guideline"
Ms. Jin Ju Li, Director, Office of GLP and GCP Accreditation, China SFDA
"The New China SFDA Bioanalytical Guidance (Guan on Quantitative Analysis of Biosamples)"
Networking Afternoon Break
Dr. CT Viswanathan, Dr. Brian Booth, Dr. Sam Haidar, Dr. Olivier Le Blaye, Dr. Jan Welink, Mr. Joao Tavares Neto, Mr. Eric Ormsby, Mr. Toshinari Mitsuoka, Ms. Jin Ju Li
"Panel Discussion on New Guidances"
Panel Discussion for 2012 WHITE PAPER
04:30pm-06:00pm: All Speakers and Session Chairs
"Panel Discussion on 2012 Hot Topics in Bioanalysis - "2012 WHITE PAPER"
2012 Workshop White Paper will be completed and published on Journal "Bioanalysis" from Future Science Group.
Meeting Highlights
This 2-day full immersion workshop on Recent Issues in Bioanalysis, at its 6th edition now, is where regulators and the industry convene for working together in the field of bioanalytical sciences and regulations to improve global health.
It focuses on helping attendees cope with the latest challenges the bioanalytical industry is facing. The attendees will
- Learn new method development strategies from experts in the field to achieve scientific excellence;
- Improve compliance to regulations with the advices from global regulatory agencies' representatives;
- Implement new bioanalytical approaches in drug development from the lessons learnt in drug discovery.
Like the previous editions, this workshop will be
- Very practical with a variety of hot topics/contents;
- Highly interactive with thought-provoking Q&A dialogs and panel discussions
- Very informative with the active participation from global regulatory agencies
- Well formulated with excellent balance of science, regulation and process
High quality, better compliance to regulations and scientific excellence are the foundation of this workshop!
Come with your questions, and go back with the solutions!
