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      

9:00AM- 9:45AM

Plenary Talk      

9:45AM- 10:30AM

Panel Discussion      

10:30AM - 10:40AM

Break      

10:40AM - 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 

     Tim Olah BMS, USA  11:00AM-11:30AM
     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
 

 

    2:55PM-3:25PM
        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
            Punit Marathe       BMS, US 5:00PM-5:30PM
              5:30PM-6:00PM
                6:00PM-6:30PM
Panel Discussion       6:30PM-6:45PM
 POSTER SESSION FOLLOWED BY EVENING DINNER RECEPTION sponsored by  6:45PM - 8:30PM
SESSIONTENTATIVE LIST TOPICSSPEAKERCOMPANYTIME
 Breakfast presentation Everything from Biologics Product Characterization to Bioanalytical Quantification-A New Solution for New Challenges
    8:30AM-9:00AM
Plenary Talk-1 Regulatory Agency Representative    

9:00AM-9:45AM

 

Plenary Talk-2      

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: Pathanjali, BMS, India and Srinivas Savale, India
  Session Introduction     10:45AM- 10:50AM
  Current Regulatory Inspections and trends Amarnath Jaiswal  Mylan, India 10:50AM- 11:20AM
  Conduct and Reporting of Bioanalysis – Compliance Requirements and Challenges not only to a Bioanalyst but also to Quality Assurance and Facility      11:20AM - 11:50AM
 

Unexpected Event Investigations in Small Molecule Bioanalysis: Points to Consider

              11:50AM-12:20PM
  483 observation’s and recent regulatory concerns during bioanalytical site inspection’s and ANDA review.                      12:20PM- 12:50PM

Panel Discussion

 Panel Discussion: " Ask the regulator" Surendra Bansal, Natesan, Amarnath Jaiswal and Deborah Parker 12:50PM-1:20PM

lunch

    1:20PM-2:20PM
 

Session II: Characterization of Large Molecules

Session Chairs: Rajan Kombu, Aizant, India & M N Dixit, Accutest, India

   Session Intro     2:20PM-2:25PM
  New kit-based approach for a simplified, standardized and reproducible LC-MS protein quantification via the surrogate peptide approach     2:25PM-2:55PM
  Considerations for Bioanalytical Technology Platform Selection: LBA vs. LC-MS     2:55PM-3:25PM
  Emerging Technologies for LM (PK and ADA) Analysis - Pros and cons     3:25PM-3:55PM
        3:55PM-4:25PM
Break       4:25PM-4:40PM

Session III: Small Molecule Bioanalysis (Method development, challenges and path forward)

Session Chairs: Manish Yadav, Ethixinn, India

  Session Intro     4:40PM-4:45PM
  Bioanalytical Challenges to Support PK of Novel Drug Delivery Systems  Shrinivas Savale              India 4:45PM-5:15PM
  Panel Discussion     5:15PM-5:30PM
 Conference concluding session 5:30PM - 5:45PM

Tuesday, 21 February, 2017

SESSIONTENTATIVE LIST TOPICSSPEAKERCOMPANYTIME
Session I: Emerging technologies and strategies to understand biotransformation and metabolite coverage 
Session Chairs: Ravi Talluri, Glenmark, India & Lakshmikant, BBRC, India
  Session Introduction     10:45AM - 10:50AM
  Characterization of the In vitro Metabolism Across Species of the Novel Iate Na+ Current Inhibitor Eleclazine Nevena Mollova  Gilead, US  10:50AM-  11:20AM
  Strategies to Assess Human Metabolite Coverage in Early Drug Development Rama Iyer  BMS, US  11:20AM - 11:50AM
Vendor Talk

 

           11:50AM-12.20PM
Panel Discussion       12:20PM -12.50PM
Lunch       12:50PM - 1:50PM

Session II:  Mechanistic role of metabolism and transporters in drug induced organ toxicity

Session Chairs: Rama Iyer, BMS, US and Samiulla, Aurigene, India

  Session Intro   
 
1:50PM-1:55PM
  Recent Advances in Understanding the Role of Reactive Drug Metabolites in IDT.. or DDI with Metabolites Kaushik Mitra Merck, US 1:55PM-2:25PM
 

siRNA, A New Therapeutic Modality: Challenges and Successes

  Alnylam, US 2:25PM-2:55PM
Panel Discussion                  2:55PM-3:25PM
Break       3:25PM-3:45PM

Session III: Drug –Drug interactions

Session Chairs: M. V. S Rao, Advinus, India & Zainuddin, Jubilant, India

  Session Intro     3:45PM-3:50PM
  Drug -Drug Interactions: The silent yet Potent Factor Causing Adverse Reactions in Clinics  

India  

3:50PM-4:20PM
  Drug-Drug Interaction study with Lipid Lowering Agent 16-dehydropregenalone(80/574): a Potent FXR Modulators  

CDRI, India   

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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