February 28 - March 01, 2016

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


Regulated Bioanalysis ADME/Biotransformation

Monday, 29 February, 2016

  REGISTRATION & Breakfast     7:00AM-8:35AM
        8:35 AM- 8:45AM
Plenary Talk   Rashmi Barbhaiya  India 

8:45 AM- 9:30AM


Session I: Drug Discovery and Bioanalysis
Session Chairs: 
  Session Introduction     9:30AM- 9:35AM
  Characterization of Biomarkers  Deepa Joshi TRC, India  9:35AM-10:05AM
  Challenges in protein biomarker assay development: what to measure Zhang Yan  BMS, US  10:05AM - 10:35AM
Break       10:35AM-10:50AM
  Metabolomics to be covered associated with Biological process     10:50AM-11:20AM

Vendor Talk


Panel Discussion

Lunch       12:20AM-01:20PM

Session II: 

Session Chairs: Technological Advancement- Bioanalysis

  Session Intro  
  Antibody Drug Conjugate Development- case study to be included Darshana Jani Pfizer, US 1:25PM-1:55PM
  LCMS-MS Analysis of Proteins / Quantification of Proteins Jim Shen  BMS, US  1:55PM-2:25PM
  Immuno affinity sample preparation techniques for protein / peptide quantitative  Bioanalysis   Anjali Karande   IISc, India  2:25PM-2:55PM
  Panel Discussion             2:55PM-3:15PM
Break       3:15PM-3:30PM

Session III: Drug Discovery-Applications

Session Chairs: 

  Session Intro     3:30PM-3:35PM
  Case study describing progression of molecule from non clinical to market with focus on ADME/PK issues         Punit Marathe       BMS, US 3:35PM-4:05PM
  Challenges in characterizing Peglycated Proteins with focus on Efficacy and Toxicology issues         Deb Charych Nektar, US  4:05PM-4:35PM
  Development of Cell based functional assays - Challenges and Case study          4:35PM-5:05PM
Panel Discussion       5:05PM-5:30PM
  Breakfast     7:00AM-8:30AM
Plenary Talk Regulatory Agency Representative     9:00AM-9:45AM
Session I: Regulatory Guidelines, audits and discussion forum
Session Chairs: 
  Session Introduction     9:45AM- 9:50AM
  Electronic Submission of BA data and Reports Surendra Bansal Roche, US  9:50AM-  10:20AM
  Conduct and reporting of Bioanalysis – Compliance requirements and challenges not only to a Bioanalyst but also to quality assurance and facility Natesan S  Advinus, India 10:20AM - 10:50AM
Break        10:50AM -11:05AM
   483’s and other regulatory concerns recently issued to various CRO’s in India during site inspection and also the concern while reviewing the ANDA documents.        Amarnath Jaiswal     Mylan, India  11:05AM-11:35AM
  Regulatory bioanalysis – Monitoring, inspection and accreditation of labs in India for non-clinical studies in compliance with OECD and US FDA        Deborah Parker BMS, US        11:35AM- 12:05AM

Vendor Talk

Panel Discussion Panel Discussion: " Ask the regulator" Surendra Bansal, Natesan, Amarnath Jaiswal and Deborah Parker   12:35AM-1:05PM
Lunch       1:05AM-2:05PM

Session II: Characterization of Large Molecules

Session Chairs: 

  Session Intro  
  Considerations for bioanalytical technology platform selection: LBA vs. LC-MS Zhang yan  BMS, US  2:10PM-2:40PM
  Recommendations on validation of multiplexing assay - White paper  Darshana Jani  Pfizer, US  2:40PM-3:10PM
  Panel Discussion     3:40PM-3:55PM
Break       3:55PM-4:10PM

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

Session Chairs: 

  Session Intro     4:10PM-4:15PM
  Investigations in bioanalysis: no assignable causes, how to approach and review such data          4:15PM-4:45PM
  Bioanalytical Challenges: how to handle endogenous compound     4:45PM-5:15PM
 Conference concluding session 5:30PM - 5:45PM

Tuesday, 01 March, 2016

  Breakfast     7:00AM-8:30AM
Plenary Talk       8:30AM-9:15AM
Session I: Emerging technologies and strategies to understand biotransformation and metabolite coverage 
Session Chairs: 
  Session Introduction     9:15AM - 9:20AM
  Advanced in vitro technologies to assess human metabolism and metabolites (microfluidics,  relay methods etc) Nevena Mollova  Gilead, US  9:20AM-  9:50AM
  Strategies to assess human metabolite coverage in early drug development (matrix matching, pseudo 14C standards etc) Rama Iyer  BMS, US  9:50AM - 10:20AM
Break       10:20AM -10:35AM
  Panel discussion on 3D models of Metabolism       
  Humanized/knock-out models in understanding biotransformation     10:35AM-11:05AM
   Biomimiks as Chemosynthetic Livers     Mukund Chorgade (Invited) US  11:05AM- 11:35AM

Vendor Talk

Panel Discussion       12:05AM-12.20PM
Lunch       12:20AM-1.20PM

Session II: Modeling tools to assess magnitude of drug –drug interactions and hepatotoxicity

Session Chairs: 

  Session Intro  
  Mechanistic modeling of drug disposition and DDI  – PBPK     1:25PM-1:55PM
  Drug-Drug Interactions between NCEs and  therapeutic Biologics Chandra Prakash    Agios, US 1:55PM-2:25PM
  Simulation and prediction of hepatotoxicity (Dilisym) or Role of hepatic transporters in drug induced hepatotoxicity        Anshul Gupta     (Invited)    Alnylam, US 2:25PM-2:55PM
Panel Discussion       2:55PM-3:15PM
Break       3:15PM-3:30PM

Session III:  Biotransformation challenges in early drug development

Session Chairs: 

  Session Intro     3:30PM-4:05PM
  Recent advances in understanding the role of reactive drug metabolites in IDT.. or DDI with metabolites          Kaushik Mitra     Merck, US 4:05PM-4:35PM
  Challenges in dealing with multiple drug-metabolizing enzymes and transporters in ADME for NCEs in discovery          4:35PM-5:05PM
  CYP/transporter quantification – Utility in induction potential asessments          5:05PM-5:35PM
 Conference concluding session 5:35PM- 5:45PM


Regulated Bioanalysis


Discovery Bioanalysis



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