February 19 - February 21, 2017

Short Courses
Short Courses run concurrently


Regulated Bioanalysis ADME/Biotransformation

Monday, 20 February, 2017

  REGISTRATION & Breakfast    

7:00AM- 8:35AM

  Boston Society: Opening Remarks & Conference Introduction Deepak Barot Boston Intl  8:45AM- 8:55AM
  Conference: Opening Remarks M N Dixit Chair- APA INDIA 2017 8:55AM-9:00AM
Plenary Talk-1 New Pathways to Smarter Medicines Kevin Brodbeck Nektar US 

9:00AM- 9:45AM

Plenary Talk-2 Leveraging analytical technologies to maximize information from biological systems Adrienne Tymiak  BMS, US 

9:45AM- 10:30AM

Plenary Talk-3 High Throughput Analytics Rustom Mody  Lupin, India 

10:30AM - 11:15AM

Panel Discussion      

11:15AM - 11:25AM 


11:25AM - 11:35AM 

Session I: Bioanalysis and Characterization of Large Molecules
Session Chairs: Prashant Kole, BBRC, India and Ravi Trivedi, Dr. Reddys, India
  Session Introduction    

11:35AM - 11:40AM 


Assessing Drug-Target Engagement in Tissue Biopsies Using the Hybrid LBA-LCMS Platform

 Tim Olah BMS, USA  11:40AM-12:10PAM
  Immunogenicity of Protein Biotherapeutics: case studies  M. N. Dixit   Accutest, USA  12:10PM - 12:40PM

Panel Discussion

      12:40PM- 1:00PM
Lunch break       1:00PM-  2:00PM
Session II: Technological Advancement- Bioanalysis
Session Chairs: Ravi Shankar, Sunpharma, India 
  Session Intro     2:00PM-2:05PM
Vendor Talk  The use of High Resolution Accurate Mass (HRAM) to Maximize Selectivity in Quantitative Analysis       Jonathan Josephs  Thermo Fisher  2:05AM-2:35PM
  Highly Selective Tool for LCMS/MS based Quantitation        Anoop Kumar    Sciex 2:35PM-3:05PM

Session III: Small Molecule Drug Discovery & Bioanalysis

Session Chairs: Vijay Raina, Nektar, India and Tausif Ahmed, Dr. Reddys, India

  Session Intro  


Sushrat Kulkarni  Cadila, India  3:10PM-3:40PM
    Ashutosh Pudage  Accutest, India  3:40PM-4:10PM

Panel Discussion

      4:10PM- 4:25PM
Break       4:25PM- 4:45PM

Session IV: Drug Discovery-Applications

Session Chairs: Jignesh Kotecha, Torrent, India & Deepak Barot, India

  Session Intro     4:45PM-4:50PM
  Pharmacokinetic optimization in drug discovery: fact or myth ?         Punit Marathe       BMS, US 4:50PM-5:20PM
  Protein binding assessment for highly bound compounds using different dialysis techniques - equilibrium dialysis, RED device, ultracentrifugation etc. Xiaohui Xu   BMS, US  5:20PM-5:50PM
Panel Discussion       5:50PM-6:00PM
Plenary Session        
Breakfast       8:00AM-9:00AM
Plenary Talk-1 Current global scenario and future of bioanalysis: Evolving regulations, harmonization and compliance expectations Binodh Desilva  BMS, US  



Plenary Talk-2

Discovery and Development of first in class PPAR agonist

for the treatment of Diabetic Dyslipidemia 

Mukul Jain  ZRC, India 


Panel Discussion      


 Tea Break       10:30AM-10:45AM


Tuesday, 21 February, 2017

Session I: Regulatory Guidelines, audits and discussion forum
Session Chairs: M N Dixit, Accutest, India
  Session Introduction     10:45AM- 10:50AM
  Scientific review of Data in Regulated Bioanalysis Robert Bethem/ Shrinivas Savale   US/ India    10:50AM- 11:20AM

Importance of reviewing Pk/BA/BE studies from a bioanalytical perspective

Peter Van Amsterdam     Abott, US  11:20AM - 11:50AM
  Current Regulatory Inspections and trends Amarnath Jaiswal  Mylan, India  11:50AM-12:20PM

Panel Discussion

 Panel Discussion: " Ask the regulator"

Binodh Desilva, Adrienne, M N Dixit, Peter Van

Amarnath Jaiswal, Robert Bethem




Session II: Characterization of Large Molecules

Session Chairs: Srinivas Savale, India & Vikas Kumar, Dr. Reddys, India

   Session Intro     2:00PM-2:05PM
  Total Solution for LC/MS Quantification of Critical Components of Antibody Drug Conjugates (ADCs) Diego Rodriguez Cabaleiro   Waters  2:05PM-2:35PM
  Size will not matter! Deepti Bhandarkar  Shimadzu 2:35PM-3:05PM
  Characterization of Biologics Pankaj Shah  BMS, US  3:05PM-3:35PM
  Biosimilars Bioanalysis: Challenges and Solutions Shaifali Gupta Cliantha, India 3:35PM-4:05PM
  An Integrated Bioanalytical Strategy for Understanding Pharmacokinetics, Pharmacodynamics and Immunogenicity of Antibody Drug Conjugates  Renuka Pillutla  BMS, US  4:05PM-4:35PM
Panel Discussion       4:35PM-4:50PM
Break       4:50PM-5:05PM

Session III: Sponsor versus CRO discussion forum

Session Chairs: Deepak Barot, Boston International, India

  Session Intro     5:05PM-5:10PM

"Current Challenges to CROs and Sponsors including method transfers and sample transfers"

"Transformation from small molecules to large molecules Bioanalysis: challenges and opportunities"

M N Dixit, Amarnath Jasiwal, Tausif Monif,

Venu Madhav, Arshad Khuroo, Naveen Sharma 

Binodh Desliva, Tim Olah and Peter Van Amsterdam 

 Conference concluding session 5:40PM - 5:55PM

Tuesday, 21 February, 2017

Session I: Strategies to understand biotransformation and metabolite coverage 
Session Chairs: Zainuddin, Jubilant Biosys, India and Laksmikant Bajpai, BBRC, India
  Session Introduction     10:45AM - 10:50AM
  Advance in the Characterization of Eleclazine Biotransformation Nevena Mollova  Gilead, US  10:50AM-  11:20AM
  Evaluation of 2D/3D in vitro systems for understanding the biotransformation of NCEs Rama Iyer  BMS, US  11:20AM - 11:50AM


  Predicting Human Clearance of Drugs Metabolized by Glucuronidation Using Human and Monkey Models          Michael Sinz       BMS, US 12:20PM -12.50PM
Panel Discussion       12:50PM - 1:05PM
Lunch       1:05PM - 2:05PM

Session II:  Emerging technologies Metabolite identification

Session Chairs: lakshmikant, BBRC, India

  Session Intro   
 Vendor Talk     Beckmann Coulter 2:10PM-2:40PM

Qualification of isolated metabolites as reference standards by Quantitative NMR

Hemantha Kumar  BBRC, India  2:40PM-3:10PM

Using ICP-OES Technology for various Bioequivalence studies

Devina Bharadwaj Intervein, India 3:10PM-3:40PM
  Metabolite Identification Techniques  Lakshmikant Bajpai    BBRC, India 3:40PM-4:10PM
Break       4:10PM-4:25PM

Session III: Drug –Drug interactions

Session Chairs: Samiulla , Aurigene,India

  Session Intro     4:25PM-4:30PM

Pharmacokinetic-Pharmacodynamic modeling of the anti-hypertensive drug interaction between azilsartan, medoxomil and chlorthalidone 

Rabi Bhatta

CDRI, India  

  Quantitative Proteomics and Physiological Modeling in Optimizing Pediatric Drug Efficacy and Safety   Bhagwat Prasad  

Uni. of Washington, US  

  Panel Discussion          5:30PM-5:45PM
 Conference concluding session 5:45- 5:55PM


Session Topics

Regulated Bioanalysis


Discovery Bioanalysis


Click here to register for the APA-India 2017 conference online.

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