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February 19:
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Short Course
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February 20-22:
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Conference Workshops
- Regulated Bioanalysis
- Biotransformation
- Discovery
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Biotransformation Short Course
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Bioanalysis Short Course
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Basic Biotransformation Concepts: Reaction Mechanisms, Enzymology, Metabolite Identification Tools, and Applications of Biotransformation Studies in Drug R&D
Concept of biotransformation studies [Deepak Dalvie, Pfizer]
a) Why study biotransformation of drug molecules? Role in drug discovery and development.
b) Chemistry of biotransformation reactions
c) Enzymes involved in biotransformation reactions (oxidative/reductive, hydrolytic, conjugative)
d) Importance of polymorphisms in metabolic enzymes
e) Time-dependent and irreversible inhibition of enzymes
f) Induction of enzymes
Metabolism Studies: Tools and Techniques [Chandra Prakash, Biogen Idec]
a) In vitro matrices (subcellular fractions, hepatocytes)
b) In vivo in preclinical species and samples from FIH/hADME studies (circulating metabolites, excretory metabolites)
c) Metabolite identification techniques and tools (mass spec XIC including accurate mass, UV, NMR, fragmentation)
Application of biotransformation studies to R&D [Kaushik Mitra, Merck]
a) Improve clearance properties during early screening
b) Bioactivation (protein binding, genetic toxicity) and chemistry interventions to remove liabilities
c) Metabolism-derived toxicity (BMS example of adrenal tox, Efavirenz)
d) Drug-Drug Interactions, value of phenotyping
e) Circulating metabolites and MIST regulatory guidances
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Overview of bioanalysis in drug discovery and development.
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Strategies in effective method development: current practices and challenges
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Bioanalytical method validation and current regulatory guidelines
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Application of bioanalytical methods for discovery sample analysis (in vitro assays)
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Acceptance criteria, ISR, Reanalysis, Special Cases
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Documantation requirements in bioanalysis and Quality Control/Quality Assurance functions in regulated bioanalysis
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Ligand-Binding assays for bioanalysis of large molecules: Technology and Regulatory
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Bioanalytical data generation/handling and interpretation
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Panel Discussion
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WATERS MINISYMPOSIUM
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Regulated Bioanalysis Workshop - Monday, 20 February
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**Times, topics and speakers subject to change
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SESSION
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TOPIC
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SPEAKER
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COMPANY
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TIME
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REGISTRATION & Continental Breakfast
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07:45 - 08:45
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Conference Opening
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Jyoti Paliwal
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NIPER-Mohali
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08:45 - 08:50
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Conference Welcome
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Deepak Barot
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The Boston Society
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08:50 - 08:55
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Workshop Introduction
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Vinay Shedbalkar
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Pharmaedge, India
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08:55 - 09:00
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| PLENARY SESSION |
| KEYNOTE 1 |
Regulatory Challenges |
Dr. Vishwamohan Katoch
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Secretary to Govt. of India, Department of Health Research(Ministry of Health & Family Welfare)
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09:00 - 09:30 |
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KEYNOTE 2
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The Growth of Bioanalytics and GLP in India
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Dr. Satish Bhatia
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Consultant, Clinical Development Services Agency, Department of Biotechnology, Ministry of Science and Technology, Government of India, New Delhi |
09:30 - 10:00
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Session I: Method Development, Validation and Sample Analysis
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Session I Introduction
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Vinay Shedbalkar
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Pharmaedge, India |
10:00 - 10:05
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Establishment of stability of drugs in whole blood: Scientific aspects
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Arhshad Khuroo
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Ranbaxy, India
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10:05 - 10:35
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ISR for assays with multiple analytes
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Vinay Shedbalkar
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Pharmaedge, India
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10:35 - 11:05
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PANEL DISCUSSION |
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11:05 - 11:20
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BREAK
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11:20 - 11:35
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Session II: Regulated Bioanalysis Methods and Biologics
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Session II Introduction |
Vinay Shedbalkar |
Pharmaedge, India |
11:35 - 11:40 |
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Challenges and strategies for bioanalytical methods supporting analysis of endogenous drugs
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Rajesh Karva
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Glenmark
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11:40 - 12:10
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Large molecule LC-MS/MS-based bioanalytical method validations: What should be different?
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Rand Jenkins
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PPD
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12:10 - 12:40
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(Vendor talk)
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Overcoming Time Issue of Ion Mobility Spectrometry: Differential Mobility Spectrometry
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Axel Besa
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AB SCIEX
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12:40 - 13:10
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| LUNCH |
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13:10 - 14:10
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Session III: Software, Other Regulatory Concerns and Harmonization
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Session III Introduction |
Vinay Shedbalkar |
Pharmaedge, India |
14:10 - 14:15 |
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Fancy to Facts – Software Solutions for Regulated Bioanalysis – A way ahead
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Manish Yadav
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Cadila Pharmaceuticals
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14:15 - 14:45
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Immunogenicity Testing for Biologics: Industry Practices
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Renuka Pillutla
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Bristol-Myers Squibb, USA
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14:45 - 15:15
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Harmonization of global bioanalytical guidelines
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Mark Arnold
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Bristol-Myers Squibb, USA
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15:15 - 15:45
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PANEL DISCUSSION
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15:45 - 16:00
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BREAK
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16:00 - 16:15
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Session IV: Newer Technologies
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Session IV Introduction |
Vinay Shedbalkar |
Pharmaedge, India |
16:15 - 16:20 |
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Quantitative Bioanalytical Methods Used in Discovery or Development: Validated, Partially Validated, Qualified, Exploratory
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Mohammed Jemal
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Bristol-Myers Squibb, USA
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16:20 - 16:50
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483: USFDA Regulatory compliance and enforcement action
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Avdhut Laud
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Accutest, India
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16:50 - 17:20
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FDA Update on Regulated Bioanalysis (Preventing 483s)
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Sam Haidar (webcast)
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FDA
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17:20 - 17:50
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Current Issues - An Update
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CT Viswanathan (webcast)
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Independent Consultant
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17:50 - 18:20
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PANEL DISCUSSION: Perspective from CROs across globe (US, Europe, China and India) on "Regulatory Bioanalysis"
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Ashutosh Pudage, Kiran Marthak, Mark Arnold, Venu Madhav
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18:20 - 18:50
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GBC Brief and Open Forum
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GBC Representative
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18:50 - 19:20
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EVENING RECEPTION & ENTERTAINMENT
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Biotransformation Workshop - Tuesday, 21 February
| SESSION |
TOPIC
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SPEAKER
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COMPANY
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TIME
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Opening Comments
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The Boston Society |
08:30 - 08:35 |
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Workshop Introduction
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Murali Subramanian
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BMS-India
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08:35 - 08:40 |
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Keynote
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How ADME Studies Impact Discovery and Development
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Griff Humphreys
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Bristol-Myers Squibb
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08:40 - 09:25
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| Session I - Application of Biotransformation in Drug Discovery |
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Session I Introduction |
Murali Subramanian |
BMS-India |
09:25 - 09:30 |
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Basic Principles of Enzyme Kinetics as Applied to Drug Metabolism Studies
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Krishna Iyer |
University of Bombay |
09:30 - 10:00
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Role of non-P450 enzymes in drug metabolism: Emerging importance of aldehyde oxidase in drug discovery and lead optimization
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Deepak Dalvie |
Pfizer |
10:00 - 10:30
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| BREAK |
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10:30 - 10:45
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New Methods in the Prediction, Generation and Characterization of Drug Metabolites
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Smriti Khera
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Agilent
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10:45 - 11:15
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PANEL DISCUSSION
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11:15 - 11:30
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| Session II - Role of Transporters in Drug Discovery and Development |
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Session II Introduction |
Murali Subramanian |
BMS-India |
11:30 - 11:35 |
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DDI at the level of Transporters, including the Blood Brain Barrier: In vivo studies and IVIVC |
Jash Unadkat |
University of Washington |
11:35 - 12:05
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Comparison and Application of the Drug Transporter Decision Trees and Guidance’s from the FDA and EMA
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Jasminder Sahi
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Jazz Consulting
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12:05 - 12:35
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Studies on BCRP: methods, probe substrates and inhibitors
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Berend Oosterhuis
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SOLVO Biotechnology |
12:35 - 13:05
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PANEL DISCUSSION
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13:05 - 13:20
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LUNCH
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13:20 - 14:20 |
(Vendor Talk)
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What Novel Analytical Technologies Can Enable Better Characterization of Your Biologic Drug?
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Nalini Sadagopan
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Agilent
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14:20 - 14:50
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| Session III - Adverse Drug Reactions |
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Session III Introduction |
Murali Subramanian |
BMS-India |
14:50 - 14:55 |
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Metabolism Studies To Investigate Risk of Genetic Toxicity in Drug Candidates
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Kaushik Mitra
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Merck (USA)
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14:55 - 15:25
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Non-Cyp based metabolism |
Chandra Prakash |
Biogen Idec |
15:25 - 15:55
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| BREAK |
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15:55 - 16:10
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| Session IV - Drug-Drug Interactions (DDIs) |
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Session IV Introduction |
Murali Subramanian |
BMS-India |
16:10 - 16:15 |
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Novel CYP3A4 induction through a non-PXR non-CAR activation mechanism
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Michael Sinz
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BMS
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16:15- 16:45
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Misconceptions of Plasma Protein Binding in Drug Discovery
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Li Di (Webcast) |
Pfizer |
16:45 - 17:15
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Use of Modeling and Simulation for Prediction of Pharmacokinetics and Drug Interaction During Drug Development as Illustrated Through Case Studies
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Bill Smith (Webcast) |
Pfizer |
17:15 - 17:45 |
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PANEL DISCUSSION - Sessions III & IV |
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17:45 - 18:15
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| POSTER SESSION + EVENING RECEPTION (In the Exhibitor Hall): 18:15 - 20:15 |
Discovery Bioanalysis Workshop - Wednesday, 22 February
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SESSION
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TOPIC
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SPEAKER
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COMPANY
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TIME
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Opening Comments
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The Boston Society |
08:30 - 08:35 |
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Workshop Introduction |
Jyoti Paliwal |
NIPER |
08:35 - 08:40 |
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PLENARY
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Ongoing Scenario, Future Trend and a Better Paradigm for Pharma R&D
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Rashmi Barbhaiya
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Advinus
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08:40 - 09:25
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Session I: Small Molecules
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Session I Introduction |
Jyoti Paliwal |
NIPER |
09:25 - 09:30 |
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Implementing Dried Blood Spot Technology: Practical Considerations from Discovery to Development
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Celia D'Arienzo
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Bristol-Myers Squibb, USA
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09:30 - 10:00
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Adopting and Validating Dried Blood Spot Assays
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Enaksha Wickremsinhe
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Eli Lilly
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10:00 - 10:30
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The Effect of Excipient Interactions on Bioanalysis: The Phenomena of Ion Suppression
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Celia D'Arienzo
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Bristol-Myers Squibb, USA
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10:30 - 11:00
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PANEL DISCUSSION
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11:00 - 11:15
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BREAK
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11:15 - 11:30
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Session II: Large Molecules
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Session II Introduction |
Jyoti Paliwal |
NIPER |
11:30 - 11:35 |
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Discovery of Biomarkers and its Bioanalysis
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Deepa Joshi
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BBRC
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11:35 - 12:05
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Biologics PK and differences from small molecules
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Punit Marathe
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Bristol-Myers Squibb, USA
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12:05 - 12:35
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(Vendor Talk)
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Q Exactive™ LC-MS/MS for qualitative and quantitative measurements
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Tim Stratton
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Thermo Scientific
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12:35 - 13:05
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| LUNCH |
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13:05 - 14:05
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Session III: Newer Technologies
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Session III Introduction |
Jyoti Paliwal |
NIPER |
14:05 - 14:10 |
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High Resolution Mass Spectrometry
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Jonathan Josephs
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Bristol-Myers Squibb, USA
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14:10 - 14:40
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Micro dialysis and application in drug discovery
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Jyoti Paliwal
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NIPER
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14:40 - 15:10
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From macromolecules to cellular therapy: Role of stem cells
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Harish Padh
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SP University
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15:10 - 15:40
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PANEL DISCUSSION |
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15:40 - 15:55
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BREAK
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15:55 - 16:10
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Session IV: Applications
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Session IV Introduction |
Jyoti Paliwal |
NIPER |
16:10 - 16:15 |
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Imaging MS by MALDI: A Focus on Eye Tissue
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Prof. Tim Garrett (Webcast)
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University of Florida |
16:15 - 16:45
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Solid phase microextraction
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Dajana Vuckovic (Webcast)
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University of Waterloo
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16:45 - 17:15
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PANEL DISCUSSION: From Discovery to Phase I
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17:15 - 17:45
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