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February 22 Short Course
February 23-25 Conference Workshops
  Bioanalysis
  Biotransformation
SESSION TOPIC SPEAKER COMPANY TIME
Registration       07:45- 08:30
  Welcome address     08:30-08:35
  Conference: Introduction     08:35-08-40
  Conference: Opening Remarks     08-40-08-45
List of Invited Speakers

Dr.Surendra Bansal, Roche, USA                                  Dr.Rustom Modi, LUPIN,India                                           Dr. Tim Olah, BMS, USA                                                    Dr.Gopal Krishna, HOSPIRA, India                                    Dr. Bala Reddy, HERRO, India                                           Dr. Renuka Pittula, BMS, USA                                         Dr. Shailesh Singh, Ajantha, India                                   Dr. Anitha, LUPIN, India                                                    Dr. Vikas Kumar, DRL, India

     
Plenary Speaker II       9:30 - 10:15
Session I: Bioanalysis : Large & Small Molecules
 

 Immuno Assay using LCMS - Challneges and case studies

Ligand binding assays: Specificityof Critaical reagents

    10:15 - 10:45
   Optimizing cell based  assays  for immunogenicity assessment     10:45 - 11:15
Break       11:15 - 11:30
   Invitro cell based  assay as  a prefered application  for  detection of neutralizing antibodies     11:30 - 12:00
   "Bioanalytical Challenges for Development of LC-MS/MS Biomarker Assays - Case Studies": Recent develoment in Biomarker Assays     12:00 - 12:30
Panel Discussion       12:30 - 12:45
Lunch Break       12:45 - 1:45
Session II: Method development & Sample Preparation
  Handling of endogenous compounds: Bioanalytical challenges-case studies     1:45 - 2:15
   ADA Assays  when and whre  you need?     2:15 - 2:45
   Method transfers: Key troubleshooting tips     2:45 - 3:15
Panel Discussion       3:15 - 3:30
Break       3:30 - 3:45
Session III: Bioanalysis: Newer Technologies
 

Beyond sensitivity: improving the performance, productivity and compliance of the bioanalytical assay process

HRMS in Regulated Bioanalysis? Advantages of Qual/Quant High Resolution/Accurate Mass in Regulated Bioanalysis

    3:45- 4:15
  Application of ICP-MS and LC-ICP-MS in Drug Development     4:15- 4:45
 Session IV:  Bioanalysis: Regulatory Aspects      
 

Perceptions about Regulatory Agency Inspections and reflections on current Guidances : Industry and Regulators (e.g. ANVISA, US FDA draft, EMEA guidelines)

Updates on Global regulatory guidelines on BMV and harmonization

Recent regulatory issues on bioanalysis and  impact on GDUFA (Generic drug user fee program)-a case study 

    5:15 - 5:25
   The Most Recent Update on Using Dried Blood Spots (DBS) in Regulated Bioanalysis     5:25 - 5:55
        5:55 - 6:15
Evening snacks/mocktail Reception 7:00 - 8:00
 
SESSION TOPIC SPEAKER COMPANY TIME
         
Session Introduction       8:25 - 8:30
Plenary       8:30 - 9:15
Session I: Drug Discovery-Preclinical Phase
  Session I Introduction     9:15 - 9:20
     Punit Marathe  BMS, USA 9:20 - 9:55
     Krishna Iyer  Bombay Unv.India 9:55 - 10:30
  Panel Discussion     10:30 - 10:50
Break       10:50 - 11:05
Session II: Large Molecule Bioanalysis
Session Introduction       11:05 - 11:10
  Bioanalysis of Biologics/biosimilars: challenges & path forward  Tim Olah  BMS, USA 11:10 - 11:45
  Quantitation of endogenous protein biomarker’s and challenges: case studies  Himanshu Gadgil  Intas, India 11:45 - 12:20
  Quantitation of Therapeutic Proteins (mAb/ Fc-fustion proteins and ADCs etc.) Anand  Biocon, India 12:20 - 12:55
   Discovery Research- early Pharmacology &
Bioanalytical aspects on a novel therapeutic protein: PEGylated Protein
 Murali Adipali  Nektar, India 12:55 - 1:30
Lunch       1:30 - 2:30
Session III: Small Molecules Bioanalysis & Sample Preparation
Session III Introduction       2:30 - 2:35
 

 Dried Blood Spot Analysis Work: stabilization for hydrolyzable compunds

 Vijay Raina  Nektar, India 2:35 - 3:05
 

 

    3:05 - 3:40
        3:40 - 4:15
Panel Discussion       4:15 - 4:20
Break       4:20 - 4:35
Session IV  Newer Technologies/Tissue Bioanalysis      
Sessions IV Introduction

Protein Analysis: Digestion & Triple Quad or Low resolution & high resolution HRMS.

 Jonathan Josephs  Thermo, USA 4:35 - 4:40
        4:40 - 5:25
        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
         
Session Introduction       08:25-08:30
List of invited speakers

Neil Lomberg, BMS, USA                                                                                              Swami Yeleswaram, Incyte, USA                                                                                Sheela Peters, Astrazeneca,USA                                                                                            Aarti  Sawant,Pfizer,                                                                                                                 Charles Crespi                                                                            

    8:30 - 9:15
Keynote 2       9:15 - 10:00
Session I: Recent Advances : BTX pathaways
Session I Introduction       10:00 - 10:05
   Unusual Biotransformation Pathways
 Kaushik Mitra  Merck, USA 10:05 - 10:35
   Advanced in vitro technologies to predict human metabolism & metabolites, Structure based metabolism predictions  Deepak Dalvie  Pfizer, USA 10:35 - 11:05
Panel Discussion       11:05 - 11:30
Break       11:30 - 11:45
Session II-  Metabolite coverage and Safety evaluation
Session II Introduction        
   How to handle a disproportionate metabolite (MIST)     11:45 - 12:15
   Metabolite DDI     12:15 - 12:45
Vendor Presentation       12:45 - 1:15
Lunch       1:15 - 2:15
Session III- 
Session III Introduction  Translation of invitro DDI liability into clinic     2:15 - 2:20
   How to translate in vitro DDI liabilities in early discovery to clinical DDI: Utility of modelling and simulations     2:20 - 2:50
     Rama Iyer BMS, USA  2:50 - 3:20
   Muclear Receptors and CYP Induction     3:20 - 3:50
     Dr.Nilima Kshirsagar ICMR, India 3:50 - 4:20
Panel Discussion       4:20 - 4:35
Break       4:35 - 4:50
Session IV-   Transporters      
Session IV Introduction   Dhiren Thakker  UNC 4:50- 4:55
    Jasminder Sahi  GSK, Shanghai 4:55 - 5:25
APA India 2015 Concluding remarks 5.15