APA - India 2010 Agenda
February 21: Short Course
February 22-24: Conference Workshops
- Regulated Bioanalysis
- Discovery Bioanalysis and New Technologies
- Biotransformation
Bioanalytical Short Course
Course Schedule -- 21 February 2010
| Section | Topic | Time | Speaker |
|---|---|---|---|
| Registration | Short Course Registration | 8:00 - 9:00 | |
| Introduction | Overall course objectives | 9:00 - 9:15 | Tim Olah, Bristol-Myers Squibb |
| ADME | Drug Discovery and Development Process and overview of ADME | 9:15 - 9:45 | Rama Iyer, Bristol-Myers Squibb |
| Mass Spectrometry | Mass spectrometry fundamentals; Mass Spectrometer Choices and Ionization Options | 9:45 - 10:15 | Tim Olah, Bristol-Myers Squibb |
| Discovery Bioanalysis | Bioanalytical strategies in discovery, bioanalytical work flow process, LC-MS/MS-based method development, establishing HPLC and UPLC conditions, sample stability, preparation, analysis, data processing and review strategies, quality control and acceptance criteria, and examples | 10:15 - 11:00 | Tim Olah, Bristol-Myers Squibb |
| Break | 11:00 - 11:15 | ||
| Regulated Bioanalysis | Method validation requirements for various stages of bioanalytical support, Current perspective in Regulated bioanalysis | 11:15 - 12:15 | Shrinivas Savale, Clinigene / VP Shedbalkar Pharma Edge Centre |
| Lunch | 12:15 - 1:15 | ||
| Biotransformation | Common biotransformation reactions and enzymes, reactive metabolites, reaction phenotyping metabolites in safety testing, etc. | 1:15 - 2:15 | Griff Humphreys, Bristol-Myers Squibb |
| Biotransformation | LC-MS methods for detecting and characterizing metabolites, semi-quantitative metabolite profiling approaches, etc. | 2:15 - 3:15 | Ragu Ramanathan, Bristol-Myers Squibb |
| Break | 3:15 - 3:30 | ||
| PKPD | IV vs Oral Pharmacokinetics, Primary vs secondary PK parameters, nonlinear PK, species differences in PK, etc | 3:30 - 4:30 | Punit Marathe, Bristol-Myers Squibb |
Agenda
Monday, 22 February 2010
| Session | Topic | Speaker | Company | Time |
|---|---|---|---|---|
| Registration | 8:00 - 9:30 | |||
| Introductory Comments | Adam Brockman, Timothy Olah, RavishankaraMN | 9:30 - 9:55 | ||
| Session I: | Discovery Bioanalysis and New Technologies Session I - "Facilitating Drug Discovery" | |||
| Session Introduction | Deepak Barot | 9:55 - 10:00 | ||
| The Changing Bioanalytical Environment to Support Drug Discovery and Development | Timothy Olah | Bristol-Myers Squibb | 10:00 - 10:30 | |
| Accelerating Lead Optimization: In vivo Fast PK studies using the Exactive Orbitrap (webcast) | Rohan A. Thakur | Taylor Technology | 10:30 - 11:00 | |
| Bioanalytical Method Development for Complex Molecules | Vijay Raina | Nektar Therapeutics India Ltd | 11:00 - 11:30 | |
| Break | 11:30 - 11:45 | |||
| Session II: | Discovery Bioanalysis and New Technologies Session II - "Lead Optimisation/Modeling" | |||
| Application of in silico Tools in Drug Discovery | Hosahalli Subramanya | Aurigene Discovery Technologies | 11:45 - 12:15 | |
| Technologies for in vitro Permeability Analysis | Murali Ramachandra | Aurigene Discovery Technology Ltd | 12:15 - 12:45 | |
| High-Throughput Screening to Assess ADME Properties | Adam Brockman | Sentrion LLC | 12:45- 1:15 | |
| An Industry-First Integration of LC-MS/MS Contral into LIMS to Provide Critical Time and Cost Savings to the Bioanalytical Workflow | Jonathan McNally | THERMO SCIENTIFIC | 1:15 - 1:45 | |
| Lunch | 1:45 - 2:40 | |||
| Session III: | Discovery Bioanalysis and New Technologies Session III - "Applications in Lead Selection" | |||
| Application of MALDI-MS for ADMET Studies | Dieter Drexler | Bristol-Myers Squibb | 2:40 - 3:10 | |
| Importance of In Vitro - In Vivo Correlations for ADME Properties in Drug Discovery | Raj Nagaraja | Boehringer-Ingelheim | 3:10 - 3:40 | |
| Role of PK-PD Modeling in Discovery and Preclinical Development | Punit Marathe | Bristol-Myers Squibb | 3:40 - 4:10 | |
| Panel Discussion | 4:10 - 4:40 | |||
| Break | 4:40 - 4:55 | |||
| Session IV: | Regulated Bioanalysis Session I | |||
| Requirements for IND and NDA With Respect to Bioanalysis | Anirudh Gautam | Ranbaxy | 4:55 - 5:25 | |
| Regulatory Compliance in Bioanalysis | S. Ravi Sankar | GVK BIO | 5:25 - 5:55 | |
| Break | 5:55 - 6:25 | |||
| FDA Experience and Expectations on Bioanalytical Regulatory Compliance (Webcast) | CT Viswanathan | FDA | 6:25 - 7:10 | |
| Safety Testing of Drug Metabolites – FDA Perspective (Webcast) | Hanan Ghantous | FDA | 7:10 - 7:55 | |
| Evening Reception - THERMO SCIENTIFIC | ||||
Tuesday, 23 February 2010
| Session | Topic | Speaker | Company | Time |
|---|---|---|---|---|
| Session V: | Regulated Bioanalysis Session II: ISR and Repeat Analysis in Reanalysis, Investigations | |||
| Bioanalytical Incurred Sample Reanalysis: Way to Demonstrate Assay Reproducibility | Rajesh Karwa | Glenmark | 9:00 - 9:30 | |
| ISR for Multi-Analyte Methods | Ashutosh Pudage | Accutestindia | 9:30 - 10:00 | |
| Incurred Sample Reanalysis (ISR): Real case studies and the Learning | Arshad Khuroo | Ranbaxy | 10:00 - 10:30 | |
| Panel Discussion | 10:30 - 11:00 | |||
| Break | 11:00 - 11:15 | |||
| Session VI: | Regulated Bioanalysis Session III | |||
| Role of QA in Bioanalytical Method Finalization Including Documentation and Updates | Vinay P Shedbalkar | Pharma Edge Centre (I) Pvt. Ltd | 11:15 - 11:45 | |
| Good Documentation Practices in Regulated Bioanalysis | Ramakrishna Bangaru | Matrix Laboratories Limited | 11:45 - 12:15 | |
| Metamorphosis in Approach to be Adopted to Develop and Finalize a Robust Bioanalytical Method | Manish Singh Yadav | Veeda Clinical Research Pvt Ltd | 12:15 - 12:45 | |
| Comprehensive, Faster, Simpler, More Sensitive Bioanalysis and Metabolite Identification From Discovery to Development | Dr. John P. Shockcor & Robert S. Plumb | WATERS | 12:45 - 1:15 | |
| Lunch | 1:15 - 2:00 | |||
| Pharma Perspective on Working with CROs | Bruce Stouffer | Bristol-Myers Squibb | 2:00 - 2:30 | |
| Conduct of Investigations in Bioanalysis | S. Ravi Sankar | GVK BIO | 2:30 - 3:00 | |
| Break | 3:00 - 3:30 | |||
| Session VII: | Regulated Bioanalysis Session IV | |||
| Qualification and Control Procedures in Managing Computer Systems and Data Applications used in Regulated Laboratory | Rajeev Batra | Ranbaxy | 3:30 - 4:00 | |
| Best Practice Guidelines for the Development and Validation of Immunoassays for Pharmacokinetic Studies of Macromolecules | Russel Weiner | Bristol-Myers Squibb | 4:00 - 4:30 | |
| Method Development, Metabolite Back-conversion and Implementation of ISR and Associated Investigations in Regulated Bioanalysis | Robert Massé | Anapharma | 4:30 - 5:00 | |
| Panel Discussion | 5:00 - 5:30 | |||
| Evening Reception - WATERS | 5:30 - 6:00 | |||
Wednesday, 24 February 2010
| Session | Topic | Speaker | Company | Time |
|---|---|---|---|---|
| Session VIII: | Biotransformation Session I. Moderators Ajai and Ragu | |||
| Keynote Lecture: Cytochromes P450 and Drug Metabolism: A Brief History | Krishna Iyer | Bombay College of Pharmacy | 9:00 - 9:45 | |
| Biotransformation Yesterday and Today: Challenges in Drug Discovery and Development | Ajai Chaudhary | Eli Lilly & Co | 9:45 - 10:15 | |
| MIST guidance: Applications During Drug Discovery and Development. Implications for Industry | Griff Humphreys | Bristol-Myers Squibb | 10:15 - 10:45 | |
| Break | 10:45 - 11:00 | |||
| Human and Animal ADME Studies- Why are they Needed for Drug Discovery and Development? | Ramaswamy Iyer | Bristol-Myers Squibb | 11:00 - 11:30 | |
| Structure Elucidation Using Mass Spectrometry | Sanjeev Kumar | Merck | 11:30 - 12:00 | |
| Panel Discussion | Moderators: Ajai and Ragu | 12:00 - 12:30 | ||
| Lunch | 12:30 - 1:30 | |||
| Session IX: | Biotransformation Session II: Biotransformation Drug-Drug Interactions Moderators: Mani and Girish |
|||
| Drug Metabolism and Its Role in Drug Interactions | Timothy Tracy | University of Minnesota | 1:30 - 2:00 | |
| Evaluation of DDI Potential in Drug Discovery/Development: Industry Perspective | Subrahmanyam Vangala-(Mani) | Saiadvantium | 2:00 - 2:30 | |
| Implementation of FDA Guidance Document Driven, GLP-Compliance Cytochrome P450 Inhibition Testing for Drug Development | Charles Crespi | BD-Gentest | 2:30 - 3:00 | |
| Reactive Metabolites: Metabolism Mediated Hypersensitivity and Toxicity | Amit Kalgutkar | Pfizer | 3:00 - 3:30 | |
| Break | 3:30 - 3:45 | |||
| Animal Models to Predict Human CYP3A4-Mediated Drug-Drug Interactions | Michael Sinz | Bristol-Myers Squibb | 3:45 - 4:15 | |
| Transporter-Mediated Drug Interactions in Drug Discovery and Development | Jasminder Sahi | Invitrogen | 4:15 - 4:45 | |
| Clinical Drug-Drug Interactions: A Bird's-Eye View | Nimish Vachharajani | Advinus | 4:45 - 5:15 | |
| Deuterated Drugs: Possibilities and Limits | Alfin Vaz | Pfizer | 5:15 - 5:45 | |