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February 23 Short Course
February 24-26 Conference Workshops
  Bioanalysis
  Biotransformation
SESSION TOPIC SPEAKER COMPANY TIME
Registration & Breakfast       07:45- 08:30
  Welcome address Sandhya mandlekar Director, The Boston Society Inc.USA 08:30-08:35
  Conference: Introduction Deepak Barot Scienitific Advisor, The Boston Society Inc.USA 08:35-08-40
  Conference: Opening Remarks Vinay Shedbalkar Presiding Chair, APA India 2014 08-40-08-45
Plenary Speaker I Recent Update in Regulatory scenario in India Kiran Marthak Lambda, India 08:45 - 09:30
Plenary Speaker II Analysis and Approval of Biosimilars Dr.Bhaswat Chakraborty Cadila Pharma, India 9:30 - 10:15
Session I: Regulated Bioanalysis Methods and Biologics/Biomarkers
  Proteins and Peptides analysis: Challenges Ahead Anita Krishnan Lupin, India 10:15 - 10:45
  Bioanalytical Challenges with Biologics Kakali Dhar Biocon, India 10:45 - 11:15
Break       11:15 - 11:30
:  "Fit-For-Purpose" Biomarker Assay Development and Validation Deepa Doshi Bristol Myers Squibb, USA 11:30 - 12:00
Thermo Scientific presentation MassSpectrometric Immunoassay in Insulin Analytics Kiernan Urban ThermoScientific 12:00 - 12:30
Panel Discussion       12:30 - 12:45
Lunch Break       12:45 - 1:45
Session II:Method Development, Validation and Sample Analysis
  The Impact of Unstable Metabolites on ISR Vijayabharathi Dr. Reddys, India 1:45 - 2:15
  ISS ( Incurred sample stability)-Methodology and Regulatory perspective Ravi Sankar Santharam GVKBIO, India 2:15 - 2:45
  Quality of Reference Standards. Working Standards for Drugs/Metabolites/ Internal Standards and its impact in Bioanalysis Aslum Khan Reliance Life Science, India 2:45 - 3:15
Panel Discussion       3:15 - 3:30
Break       3:30 - 3:45
Session III: Bioanalytical Laboratory Management
  Readiness for Regulatory Inspection Neerja Somyajee Piramal, India 3:45- 4:15
  Challenges in Bioanalitycal Laboratory: Transition from Small Molecule to Large Molecule Bioanalysis Vinay Shedbalkar Pharmaedge, India 4:15- 4:45
  Efficient Management in Bioanalytical Laboratory: how to handlePatient Samples, Safety Measures and Management related challenges in Global Scenario Manish Yadav Alkem, India 4:45 5:15
Break       5:15 - 5:25
  Regulatory Guidelines - FDA, EMEA, ANVISA: Harmonisation, Guidelines and Updates Mark Arnold (Webinar), Kiran Marthak, Bhaswat Chakraborty, RaviShankar Cordinator: Vinay Shedbalkar 5:25 - 5:55
  Update on GBC Puran Singhal Alkem, India 5:55 - 6:15
Evening snacks/mocktail Reception 7:00 - 8:00
 
SESSION TOPIC SPEAKER COMPANY TIME
Breakfast       7:45- 8:15
Session Introduction   Kaushik Mitra  Merck, USA 8:25 - 8:30
Plenary Impact of BBB Transporters on Delivery and Efficacy of Molecularly-Targeted Agents in Brain Tumors William Elmquist University of Minnesota 8:30 - 9:15
Session I: Transporters
  Session I Introduction  Murali Subramanian  Biocon-Bristol Myers Squibb Research Centre, India 9:15 - 9:20
  Transporter-driven Vectorial Transport of Cationic, Anionic, and Zwitterionic  Drugs in the Intestine Dhiren Thakker UNC Eshelman School of Pharmacy, USA 9:20 - 9:55
   Discovery and Development of CNS Drugs: Viewpoint from an ADME Scientist Jasminder Sahi GSK, China 9:55 - 10:30
  Panel Discussion     10:30 - 10:50
Break       10:50 - 11:05
Session II:
Session Introduction   Ravi Talluri  Glenmark, India 11:05 - 11:10
  Deciphering of Unusual Biotransformations in Real time: Strategy and Impact on Drug Discovery Kaushik Mitra Merck, USA 11:10 - 11:45
  Beta- Glucuronidase and Enterohepatic recirculation of extensively glucuronidated drugs Subramanian Vangala Advinus, India 11:45 - 12:20
Agilent Presentation     Agilent 12:20 - 12:55
Panel Discussion       12:55 - 1:30
Lunch       1:30 - 2:30
Session III:
Session III Introduction   Sanjeevgiri Jubiliant, India 2:30 - 2:35
 

Functional Effect of a NR1l3 (CAR) Promoter Single Nucleotide Polymorphism (SNP) on Enzyme Induction

Michael Sinz Bristol Myers Squibb, USA 2:35 - 3:05
 

Expression and Characterization of Cynomolgus Cytochrome P450 3A4 and P450 3A5

Murali Subramanian Biocon-BMS Research Centre, India 3:05 - 3:40
  Challenges in interpreting unusual PK behavior and projecting human PK curves Dr. Bolger Michael Simulations Plus 3:40 - 4:15
Panel Discussion       4:15 - 4:20
Break       4:20 - 4:35
Session IV        
Sessions IV Introduction   M. V. S Rao Advinus, India 4:35 - 4:40
  Pharmacokinetics-Pharmacodynamics of Biologics Gabriel Robbie MedImmune, USA 4:40 - 5:25
  Application of Accelerator Mass Spectrometry in Early Clinical Development Swamy Yeleswaram Incyte (Webinar) 5:25 - 6:00
Panel Discussion Session IV speakers     6:00 - 6:20
Wrap Up       6:20 - 6:30
Poster Presentation & Evening snacks/ Mocktail Reception 6:30 - 8:00
SESSION TOPIC SPEAKER COMPANY TIME
Breakfast       07:00-08:00
Session Introduction   Deepak Barot The Boston Society Inc., USA & Consultant-Preclinical Research 08:25-08:30
Keynote 1 Animal Ethics, Regulations, and Usage in India Mr. Anjani Kumar National Institute of Animal Welfare, Govt. Of India 8:30 - 9:15
Keynote 2 Overview of Bioanalysis/Drug Discovery and Development Success Stories Jyoti Paliwal Troikaa Pharma, India 9:15 - 10:00
Session I: Drug Discovery-Preclinical Phase
Session I Introduction   Jignesh Kotecha Torrent Research Centre, India 10:00 - 10:05
  Animal Models in the Prediction of Human Drug-Drug Interaction Potential of New Chemical Entities Sandhya Mandlekar Bristol Myers Squibb, USA 10:05 - 10:35
  Low Clearance Compounds: In vitro, In vivo and IVIVE Challenges Punit Marathe Bristol Myers Squibb, US 10:35 - 11:05
Panel Discussion Use of Animals in research ( Ethics/Welfare and practises) Mr. Anjani Kumar, Punit Marathe, Sandhya Mandlekar, Jyoti Paliwal Cordinator: Deepak Barot 11:05 - 11:30
Break       11:30 - 11:45
Session II- Large Molecule Bioanalysis
Session II Introduction   Ravishankar M. N SunPharma, India  
  Bioanalysis of Antibody Drug Conjugates in oncology: Ligand binding assay, MS-based methods and biotransfromation issues Hamanshu Gadgil Intas, India 11:45 - 12:15
  Analysis of biopharmaceutical drug products- the biomolecule is only one component of product Yatin Gokarn Institute of Chemical Technology, India 12:15 - 12:45
Vendor Presentation Key Challenges in Peptide Bioanalysis Sudarshan Mantha Waters India Pvt. Ltd, India 12:45 - 1:15
Lunch       1:15 - 2:15
Session III- Sample Preparation
Session III Introduction   Ravi Trivedi Biocon-Bristol Lyers Squibb Research centre, India 2:15 - 2:20
  Formulation Excipients ( Good, Bad & Ugly) Vijayabhaskar V GVK, India 2:20 - 2:50
  Dried Blood Spot Analysis: An overview Vijay Raina Nektar, India 2:50 - 3:20
  Dried Matrix: Changing Bioanalytical Paradigm, transformation from 'technique' to 'technology' Prashant Kole BBRC, India 3:20 - 3:50
  Micro Liquid Sampling Plateforms: Challenges and Future Perspective Vishwottam kandikere Advinus, India 3:50 - 4:20
Panel Discussion       4:20 - 4:35
Break       4:35 - 4:50
  Session IV- Newer Technologies/Tissue Bioanalysis      
Session IV Introduction   Jignesh Kotecha Torrent Research Centre, India 4:50- 4:55
  Tailoring HRMS approaches based on the hardware/software characteristics of the technology platform. Jonathan Josephs (webinar) Bristol Myers Squibb, US 4:55 - 5:25
  Use of surrogate biomatrix for Tissue Bioanalysis Stacy Ho (Webinar) Sanofi, USA 5:25 - 5:55
  Studies with Radiolabeled Compounds Ramaswamy Iyer (Webinar) Bristol Myers Squibb, US 5:55 - 6:25
APA India 2014 Concluding remarks 6:25