Final Program Agenda
PRE-CONFERENCE EVENTS
January 11, 2011 (Tuesday): 8am - 5pm
Short Course: Tutorial in Regulated Bioanalysis: Bioanalytical Method Validation (BMV) and Sample Analysis for Chromatographic and Ligand Binding Assays (LBA)
January 11, 2011 (Tuesday): 8am - 5pm
Registration Desk Open
THE First ASIA PACIFIC CONFERENCE ON RECENT ISSUES IN REGULATED BIOANALYSIS
January 12, 2011 (Wednesday):
08:00am-08:40am – Registration desk open
08:40am-09:00am – Dr. Fabio Garofolo, VP Bioanalytical Services, Algorithme Pharma, CANADA "Introduction & Review of the Main Hot Topics discussed during the previous Canadian Workshops and in other similar recent international meetings & conferences"
SESSION 1: Hot topics & Scientific Challenges in SMALL MOLECULES BIOANALYSIS
- Dried Blood Spots (DBS)
- LC-MS/MS Ion Suppression and Matrix Effect
- Metabolite Quantification
- Unstable Metabolites
- Incurred Sample Reanalysis (ISR)
- Chiral Methods
- Method development of Sirolimus, Tacrolimus and Everolimus
09:00am-09:25am – Dr. Eric Yang, VP Worldwide Bioanalysis & Systems Management, DMPK, GlaxoSmithKline, USA "The Most Recent Update on Using Dried Blood Spots (DBS) in Regulated Bioanalysis"
09:25am-09:50am – Ms. Elizabeth Thomas, Global Discipline Leader, Bioanalysis, AstraZeneca, UK "Regulatory Aspects of DBS Validation - an AstraZeneca Approach"
09:50am-10:20am – Networking Coffee & Refreshment Break and Audience Questions Gathering
10:20am-10:45am – Dr. Niklas Lindegardh, Laboratory Director, Associate Professor, Mahidol Oxford Tropical Medicine Research Unit, THAILAND "DBS for Pharmacokinetic Studies of Antimalarial Drugs - Benefits, Challenges and Limitations"
10:45am-11:10am – Dr. Eric Woolf, Senior Director of Bioanalytical Research, DMPK department, Merck Research Laboratories, USA "Ion Suppression and Matrix Effect: Do we need full or partial validation for the same compound in different species?"
11:10am-11:35am – Dr. Nobuhiro Kobayashi, Head Bioanalysis Group, Daiichi Sankyo, JAPAN "Our Approach for Quantitative Metabolite Assessments according to MIST Guidance"
11:35am-12:00pm – Mr. Manish Yadav, Head - BE & Bioanalytical, Cadila Pharmaceuticals, INDIA "Reassuring the Integrity of Bioanalytical Data through Incurred Samples Reassays (ISR) - Real Case Studies & Lessons Learnt"
12:00pm-01:00pm – Networking Lunch
01:00pm-01:25pm – Dr. Richard Lelacheur, Bioanalytical Vice President, PharmaNet, USA "Impact of Unstable Metabolites on the Reproducibility of ISR"
01:25pm-01:50pm – Dr. Joo-Youn Cho, Professor, Seoul National University College of Medicine and Hospital, KOREA "The issues of developing a bioanalytical method for new chemical entity in First in Human study"
01:50pm-02:15pm – Dr. Fabio Garofolo, VP Bioanalytical Services, Algorithme Pharma, CANADA "Method Development Challenges in Quantitative LC-MS/MS: The Macrolide Immunosuppressant (Sirolimus, Tacrolimus and Everolimus) Drugs Case Study"
SESSION 2: Hot topics & Scientific Challenges in BIOMARKERS
- Small molecule biomarker
- Large molecule biomarker
02:15pm-02:40pm – Dr. Steve Lowes, Senior VP Scientific, Advion, USA "Bioanalytical Challenges for Development of LC-MS/MS Biomarker Assays - Case Studies"
02:40pm-03:05pm – Dr. Russell Weiner, Executive Director - Clinical Development Lab, Merck Research Laboratories, USA "Fit-For-Purpose Biomarker Assay Development and Validation: What you don't know will hurt you"
03:05pm-03:35pm – Networking Coffee & Refreshment Break and Audience Questions Gathering
SESSION 3: Hot topics & Scientific Challenges in LARGE MOLECULES BIOANALYSIS
03:35pm-04:00pm – Mr. Bruce Stouffer, Director Analytical and Bioanalytical Development Late Phase and Operations, Bristol-Myers Squibb, USA "Regulated Ligand Binding Assays (LBA) Implementation"
04:00pm-04:25pm – Dr. Dongbei Li, Director Bioanalysis LBA, Wuxi AppTec, CHINA "Ligand Binding Assays (LBA) – Challenges in cross-lab assay transfer"
04:25pm-04:50pm – Dr. Mark Ma, Director LM bioanalytical Pharmacokinetics and Drug Metabolism, Amgen, USA "LBA Free/Total & LBA new technologies available: pros and cons"
05:00pm-06:00pm – Networking Reception
January 13, 2011 (Thursday):
SESSION 4: Regulatory Agencie & Health Authority Updates
08:30am-08:55am – Ms. Jin Ju Li, Director, China SFDA "Current China Biloanalytical lab GLP accrediation status"
08:55am-09:20am – Dr. Tao Sun, Head of Scientific Drug Evaluation/Investigation, Center for Drug Evaluation of China SFDA "The Principle and Practice of Clinical/Preclinical Pharmacokinetics and Key Elements of Bioanalytical Method Validation and Scientific Drug Evaluation in China"
09:20am-09:45am – Dr. CT Viswanathan, Associate Director, USA FDA "The FDA Bioanalytical Methods Guidance - An Update: White Papers, New Issues and Cautionary Notes, and Perspective on Global Harmonization of the Bioanalytical Guidance"
09:45am-10:10am – Dr. Jan Welink, Senior Pharmacokinetic Assessor, Europe EMA / Dutch Medicines Evaluation Board, the Netherlands "New Bioanalytical Guidance from European Medical Agency (EMA) - Has anything changed after the Consultation Period? and View on Global Harmonization of the Bioanalytical Guidance"
10:10am-10:40am – Question & Answers
10:40am-11:05am – Networking Coffee & Refreshment Break and Audience Questions Gathering
11:05am-11:30am – Dr. Noriko Katori, Senior Researcher, Japan MHLW-NIHS "State of GLP in Japan and Statistical Considerations in the Bioanalytical Guidance"
11:30am-11:55am – Dr. Youngsoo Kim, Scientific Officer, South Korea KFDA "Current Status and Topics of BE Study and Bioanalytical Regulations in Korea"
11:55am-12:00pm – Question & Answers
12:00pm-01:00pm – Networking Lunch
SESSION 5: Bioanalytical Method Validation (BMV) and Sample Analysis
- Hemolysis testing
- Metabolite testing in sample processing and in-source fragmentation
- Variable injection volumes, saturation of system
- Cross-validation between different anticoagulant salt forms
- Internal Standards: Trend analysis
01:00pm-01:25pm – Dr. Dafang Zhong, Professor of Pharmacy, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, CHINA "Comparison among the China SFDA guidance, EMA draft guidance, FDA 2001 Guidance and Crystal City III White Paper"
01:25pm-01:50pm – Dr. Eric N. Fluhler, Executive Director, Bioanalysis and Compliance - Pharmacokinetics, Dynamics and Metabolism, Pfizer, USA "New or Emerging Guidelines on Method Development and Bioanalytical Method Validation (BMV)"
01:50pm-02:15pm – Dr. Maria Cruz Caturla, CEO, Anapharm Europe, SPAIN "Variability of the Internal Standard"
02:15pm-02:40pm – Dr. Luigi Colombo, VP and General Manager, Global Head of Bioanalytics, Merck-Serono, ITALY "Regulated Bioanalysis: How to survive in 'grey area'"
02:40pm-03:05pm – Mr. Shrinivas Savale, General Manager - Bioevaluation Centre, Torrent Research Centre, INDIA "Regulated Bioanalysis: Regulatory guidelines versus operational challenges"
03:05pm-03:30pm – Dr. Niklas Lindegardh, Laboratory Director, Associate Professor, Mahidol Oxford Tropical Medicine Research Unit, THAILAND "Hemolysis - a major pitfall during analysis of antimalarial peroxide drugs, the problem and the solution"
03:30pm-04:00pm – Networking Coffee & Refreshment Break and Audience Questions Gathering
SESSION 6: Status of the Global Harmonization of Bioanalytical Guidance - Chaired by Dr. Daniel Tang
04:00pm-04:25pm – Dr. Daniel Tang, Vice President of Bioanalysis and DMPK, Frontage Laboratories, China "APAC Perspective on Global Harmonization of Regulated Bioanalysis"
04:25pm-04:50pm – Dr. Surendra Bansal, Scientific Director, Roche, USA "Importance of Ensuring Regulatory Compliance and High Quality of Bioanalysis in a Global workplace & Review of Multiple National Guidance and Limited Comprehensive Guidance"
04:50pm-05:15pm – Mr. Philip Timmerman, European Head of Bioanalysis, Johnson & Johnson, BELGIUM "Importance of a Globally Harmonized Guidance for both the Regulators and Practitioners of Bioanalysis and its main Characteristics"
05:15pm-05:30pm – Panel Discussions
05:30am-05:35pm – Closing Remarks and Adjournment
POST-CONFERENCE SITE VISITS AND TOUR
January 14, 2011 (Thursday): 8am - 8pm
Site visits to three different local bioanalytical laboratories (SFDA lab, Academia lab and CRO lab) followed by a tour to Expo China Pavilion, Yu Garden, Oriental Pearl Tower, and Huangpu River Cruise along the Bund
