February 19 - February 21, 2017

SundayMonday ( Coronet Hall)Tuesday (Coronet -1) Tuesday (Coronet -2) 
Short Courses
Short Courses run concurrently

Discovery

Regulated Bioanalysis ADME/Biotransformation

Monday, 20 February, 2017

SESSIONTENTATIVE LIST TOPICSSPEAKERCOMPANYTIME
  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   Kevin Brodbeck Nektar US 

9:00AM- 9:45AM

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

9:45AM- 10:30AM

Panel Discussion      

10:30AM - 10:45AM

Break      

10:45AM - 10:55AM 

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

10:55AM - 11:00AM 

 

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

 Tim Olah BMS, USA  11:00AM-11:30AM
  Immunogenicity of Protein Biotherapeutics: case studies  M. N. Dixit   Accutest, USA  11:30AM - 12:00AM

 

Characterization of Biomarkers         Deepa Joshi      TRC, India 12:00AM-12:30PM

Panel Discussion

      12:30PM-12:45PM
Lunch break       12:45PM-1:45PM
         
Session II: Technological Advancement- Bioanalysis
Session Chairs: Ravi Shankar, Sunpharma, India 
  Session Intro     1:45PM-1:50PM
Vendor Talk  High Resolution Accurate Mass       Jonathan Josephs  Thermo Fisher  1:50AM-2:20PM
                 2:20PM-2:50PM

Session III: Small Molecule Drug Discovery & Bioanalysis

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

  Session Intro  
 
2:50PM-2:55PM
 

 

Sushrat Kulkarni  Cadila, India  2:55PM-3:25PM
    Ashutosh Pudage  Accutest, India  3:25PM-3:55PM

Panel Discussion

      3:55PM- 4:25PM
Break       4:25PM- 4:55PM

Session IV: Drug Discovery-Applications

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

  Session Intro     4:55PM-5:00PM
  Small versus Large Molecule: Discovery and Development         Punit Marathe       BMS, US 5:00PM-5:30PM
  Protein binding assessment for highly bound compounds using different dialysis techniques - equilibrium dialysis, RED device, ultracentrifugation etc. Xiaohui Xu   BMS, US  5:30PM-6:00PM
Panel Discussion       6:00PM-6:15PM
 POSTER SESSION FOLLOWED BY EVENING DINNER RECEPTION sponsored by  6:15PM - 8:15PM
SESSIONTENTATIVE LIST TOPICSSPEAKERCOMPANYTIME
Plenary Session        
Vendor Presentation-1     Shimadzu  8:30AM-9:00AM
Plenary Talk-1 Current global scenario and future of bioanalysis: Evolving regulations, harmonization and compliance expectations Binodh Desilva  BMS, US  

9:00AM-9:45AM

 

Plenary Talk-2 High Throughput Analytics Rustom Modi  Lupin, India 

9:45AM-10:15AM

Panel Discussion      

10:15AM-10:30AM

 Tea Break       10:30AM-10:45AM

REGULATED BIOANALYSIS WORKSHOP

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
  Current Regulatory Inspections and trends Amarnath Jaiswal  Mylan, India 10:50AM- 11:20AM
  Defining process for Scientific review of Data in Regulatory environment (Handling rejected data and method trouble shoot in general) Robert Bethem  US   11:20AM - 11:50AM
 

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

 Peter Van Amsterdam               Abott, US  11:50AM-12:20PM

Panel Discussion

 Panel Discussion: " Ask the regulator" Binodh Desilva, Adrieene, M N Dixit, Amarnath Jaiswal 12:20PM-1:00PM

lunch

    1:00PM-2:00PM
 

Session II: Characterization of Large Molecules

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

   Session Intro     2:00PM-2:05PM
 Vendor Talk        2:05PM-2:25PM
        2:25PM-2:55PM
  Characterization of Biologics Pankaj Shah  BMS, US  2:55PM-3:25PM
  Biosimilars Bioanalysis: Challenges and Solutions Shaifali Gupta Cliantha, India 3:25PM-3:55PM
     Renuka Pitualla  BMS, US  3:55PM-4:25PM
Panel Discussion       4:25PM-4:35PM
Break       4:35PM-4:45PM

Session III: Sponsor versus CRO discussion forum

Session Chairs: Deepak Barot, Boston International, India

  Session Intro     4:45PM-4:50PM
 

"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 

     
4:50PM-5:30PM
 Conference concluding session 5:30PM - 5:45PM

Tuesday, 21 February, 2017

SESSIONTENTATIVE LIST TOPICSSPEAKERCOMPANYTIME
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
 

 

           Albert Li IVAL, US  11:50AM-12.20PM
  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   
 
2:05PM-2:10PM
 Vendor Talk       2:10PM-2:40PM
 

Qualification of isolated metabolites as reference standards by Quantitative NMR

Hemantha Kumar  BBRC, India  2:40PM-3:10PM
Panel Discussion                  3:10PM-3:25PM
Break       3:25PM-3:45PM

Session III: Drug –Drug interactions

Session Chairs: Samiulla , Aurigene,India

  Session Intro     3:45PM-3:50PM
 

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

Rabi Bhatta

CDRI, India  

3:50PM-4:20PM
      Bhagwat Prasad  

Uni. of Washington, US  

4:20PM-4:50PM
  Panel Discussion          4:50PM-5:20PM
 Conference concluding session 5:20PM- 5:30PM

 

Session Topics

Regulated Bioanalysis

Biotransformation

Discovery Bioanalysis

Registration

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


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The Boston Society (R) is an internationally-recognized NON-PROFIT organization dedicated to bringing the best scientific ideas to industrial practice through focused, timely workshops and conferences. 501(c)3

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