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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     08:45-08:50
  Conference: Introduction     08:50-08:55
  Conference: Opening Remarks     08:55-09:00
Plenary Speaker I Bioanalysis: Paradigm shift from small molecule to large molecules Rustom Mody Lupin, India 9:00 - 9:45
Session I: Bioanalysis : Large & Small Molecules
 

Session Introduction

     
 

Planning for Successful Ligand-Binding Assay Transfers  

Bruce Stouffer BMS, USA 9:45 - 10:15
  Biomarker Assay: A  case  study of  measuring Cholesterol efflux  for evaluating Lipid Lowering  drugs M N Dixit Clinigene, India 10:15 - 10:45
Break       10:45 - 11:00
  Biosimilars :  “Suitability of 'One Assay' for Immunogenicity Assessment of Both Innovator and Proposed Biosimilar Drug Products” Vikas Kumar Dr. Reddys, India 11:00 - 11:30
  Method Development (Calibration curve and Qcs) Gopalkrishna Dasika Hospira, India 11:30 - 12:00
  A window to the making of Adcetris and kadcyla Anita Krishnan Lupin, India 12:00 - 12:30
  Vendor Talk     12:30 - 1:00
Lunch Break       1: 00 -2:00
  ADA Assays  when and where  you need? and  Optimizing cell based  assays  for immunogenicity assessment Aparna Kasinath Clinigene, India 2:00 -2:30
Panel Discussion       2:30- 2:45
Session II: Bioanalysis: Newer Technologies
  HRMS in Regulated Bioanalysis? Advantages of Qual/Quant High Resolution/Accurate Mass in Regulated Bioanalysis     2:45 - 3:15
  Beyond sensitivity: improving the performance, productivity and compliance of the bioanalytical assay process     3:15 - 3:45
Panel Discussion       3:45 - 4:00
Break       4:00 - 4:15
 Session IV:  Bioanalysis: Regulatory Aspects      
 

Recent regulatory issues on bioanalysis and  impact of GDUFA (Generic drug user fee act) on regulated Bioanalysis 

Amarnath Jaiswal Mylan, India 4:15 - 4:45
  Perceptions about Regulatory Agency Inspections and reflections on current Guidances : Industry and Regulators (e.g. ANVISA, US FDA draft, EMEA guidelines) Bruce Stouffer, Rustom Mody, M N Dixit, Amarnath Jaiswal   4:45 - 5:15
Panel Discussion       5:15 - 5:30
Evening snacks/mocktail  6:00 - 7:30
 
SESSION TOPIC SPEAKER COMPANY TIME
         
Session Introduction       8:25 - 8:30
Plenary-I Challenges and opportunities in India-Discovery aspect     8:30 - 9:15
Plenary-II The Continuing Development of Quantitative Bioanalytical Methods to Support Drug Discovery and Development Tim Olah BMS, USA 9:15 - 10:00
Session I: Sample Preparation
  Session I Introduction     10:00 - 10:05
  Microsampling for Pharma development case study and DBS for an environmental application Timothy Sangster CRL, USA 10:05 - 10:35
   Dried Blood Spot Analysis Work: stabilization for hydrolyzable compunds Vijay Raina Nektar, India 10:35 - 11:05
  Panel Discussion     11:05 - 11:20
Break       11:20 - 11:35
Session II: Large Molecule Bioanalysis
Session Introduction       11:35 - 11:40
  Quantitation of endogenous protein biomarker’s and challenges: case studies Himanshu Gadgil Intas, India 11:40 - 12:10
  Quantitation of Therapeutic Proteins (mAb/ Fc-fustion proteins and ADCs etc.) Anand Khedekar Biocon, India 12:10 - 12:40
  Discovery Research -Early Pharmacology & Bioanalytical Aspects on a Novel Therapeutics Protein: PEGlylated Protein  Murali Adipali Nektar, India 12:40 - 1:10
  Vendor Talk     1:10 - 1:40
Lunch       1:40 - 2:40
Session III: Newer Technologies/Tissue Bioanalysis
Session III Introduction        2:40- 2:45
 

Identification and Characterization of Proteins 

Jonathan Josephs  Thermo, USA 2:45 - 3:15
 

Development and applications of Biosensor for determination of Biomarkers

Raman Suri Inst. of Microbial tech, India 3:15- 3:45
  Surface Plasma Resonance Technology for determination of biointeractions like protein receptor binding along with case studies Dhanashree Jagtap National AIDS Res.Inst.India 3:45 - 4:15
Panel Discussion       4:15 - 4:30
Break       4:30 - 4:45
Session IV Drug Discovery-Preclinical Phase      
Sessions IV Introduction

ADME-PK issues with Large Molecules

Punit Marathe BMS, USA 4:45- 5:15
  Role of Biotransformation in Drug Discovery and Development Krishna Iyer Bombay Uni. 5:15 - 5:45
Panel Discussion  "Outsourcing in India: Preclinical Drug Discovery and Development" Tim Olah, Jonathan Josephs, Punit, Krishna Iyer,   5:45 - 6:15
Poster Presentation & Evening snacks 6:30 - 8:00
SESSION TOPIC SPEAKER COMPANY TIME
         
Session Introduction       08:25-08:30
Plenary Talk Monoclonal Antibodies for Cancer Immunotherapy Nils Lonberg BMS, USA 08:30- 9:15
Session I: Recent Advances : BTX pathaways
Session I Introduction   Murali  Subramanian BBRC, India  
  Discovery and pre-clinical development of vismodegib
Harvey Wong

Genentech,  USA

09:15 - 09:45
Panel Discussion       09:45- 10:00
Break    

 

10:00 - 10:15
Session II-  Metabolite coverage in Safety evaluation
Session II Introduction   Ravi Talluri Glenmark, India  
  Prediction of the magnitude of induction response (AUC change) using calibrated human hepatocytes. Charles Crespi BD Corning 10:15 - 10:45
  Induction-based Drug Drug Interaction Studies in Preclinical & Clinical Development Jasminder Sahi GSK, Shanghai  
  Mechanistic static and dynamic population
models for prospective predictions of drug-drug interaction
Sheila Peters AstraZeneca, Sweden 11:15 - 11:45
Vendor Presentation Use of very high resolution and fine isotope patterns for structural elucidation and creation and use of very rich and deep MS/MS libraries (m/z Cloud). Tim Stratton ThermoFisher 11:45 - 12:15
Lunch       12:15- 1:15
Session III- 
Session III Introduction   Sandhya Mandlekar BBRC, India  
  Organic anion transporters: Gateways for drugs
and tools to study transporter genetics
Bruno Steiger University Hospital, Zurich 1:15-   1:45
  Role of four transporters in the intestinal absorption of metformin Dhiren Thakker UNC  1:45 -  2:15
Panel Discussion       2:15-  2:30
Break       2:30-   2:45
Session IV-   Transporters      
Session IV Introduction   M V S Rao Advinus  
  Metabolites in safety testing: six year after
the guidance
ChandraPrakash  Biogen, USA 2:45-   3:15
  Mitigation of Reactive Metabolites in Drug Discovery Vinayak Hosagraha  Astrazeneca, USA 3:15-   3:45
  Non-P450 (MAO) metabolism Arti Basak Sawant

Pfizer,    USA

3:45- 4:15
Panel Discussion       4:15- 4:30
APA India 2015 Concluding remarks 4:30