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

  Boston Society: Opening Remarks M N Dixit Boston Intl  8:45AM- 8:50AM
  Conference Introduction Deepak Barot Boston Intl 8:50AM-8:55AM
  Conference: Opening Remarks Kaushik Mitra  Chair- APA INDIA 2016 8:55AM-9:00AM
Plenary Talk Globally Networked & Polycentric R&D in Pursuit of Addressing Affordability and Accessibility of Medicines Rashmi Barbhaiya   India 

9:00AM- 9:45AM

Session I: Drug Discovery 
Session Chairs: Ravi Shankar, Sunpharma, India
  Session Introduction     9:45AM- 9:50AM
  New Cost Effective Models in Drug Discovery - The Glass is Half Full Uday Saxsena   India 9:50AM-10:20AM
  Challenges in First-in-class Drug Discovery Programs Murali Ramachandra Aurigene, India 10:20AM - 10:50AM

Panel Discussion

Break       11:20AM-11:35AM
Session II: Bioanalysis of Large Molecules
Session Chairs: Prashant Kole, BBRC, India and Ravi Trivedi, Dr. Reddys, India
  Session Intro     11:35AM-11:40AM
  Challenges in Biomarker Assay Development and Validation: A Case Study          M N Dixit  Accutest, India 11:40AM-12:10PM
  Characterization of Biomarkers         Utpal Tatu     IISc, India 12:10PM-12:40PM

Vendor Talk

High Resolution Accurate Mass       Jonathan Josephs Thermo Fisher  12:40PM- 1:10PM

Panel Discussion

      1:10PM- 1:25PM
Lunch       1:25PM- 2:25PM

Session III: Technological Advancement- Bioanalysis

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

  Session Intro  

IC-LC-MS/MS as a highly sensitive, specific and multiplexed detector to measure targeted biomarkers and drug simultaneously in a clinical environment

Jim Shen  BMS, US   2:30PM-3:00PM
  Antibody Drug Conjugate Development- Case Study to be Included Anand Khedkar  Biocon, India 3:00PM-3:30PM
  Panel Discussion             3:30PM-3:45PM
Break       3:45PM-4:00PM

Session IV: Drug Discovery-Applications

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

  Session Intro     4:00PM-4:05PM
  Overcoming ADME-PK Challenges from Discovery to Market         Punit Marathe       BMS, US 4:05PM-4:35PM
  NKTR-214: Harnessing the IL-2 pathway for cancer immunotherapy         Deborah Charych Nektar, US  4:35PM-5:05PM
  Development of Cell based functional assays - Challenges and Case study      Indraneel Ghosh       Sun Pharma, India 5:05PM-5:35PM
Panel Discussion       5:35PM-5:50PM
 Breakfast presentation Everything from Biologics Product Characterization to Bioanalytical Quantification-A New Solution for New Challenges
 Suma Ramagiri  Sciex, US 8:00AM-8:30AM
Plenary Talk-1 Regulatory Agency Representative Dr. Nilima A Kshirsagar ICMR, NIRRH, Govt. of India 



Plenary Talk-2 CDSCO Procedures for BA/BE, Bioanalytical centers & study protocol approvals & Site Inspections Mrs. Shanthy Gunasekaran Deputy Drug Controller (CDCSO) 


Plenary Talk-2 Outsourcing Scenario in Clinical Research Dr. Kiran Marthak  Lambda, India 


Panel Discussion      


 Tea Break       10:30AM-10:45AM


Tuesday, 01 March, 2016

Session I: Regulatory Guidelines, audits and discussion forum
Session Chairs: Pathanjali, BMS, India and Srinivas Savale, India
  Session Introduction     10:45AM- 10:50AM
  Electronic Submission of BA data and Reports Surendra Bansal Roche, US  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 Natesan S     Advinus, India 11:20AM - 11:50AM

Unexpected Event Investigations in Small Molecule Bioanalysis: Points to Consider

      Deborah Parker       BMS, US  11:50AM-12:20PM
  483 observation’s and recent regulatory concerns during bioanalytical site inspection’s and ANDA review.        Amarnath Jaiswal               Mylan, India        12:20PM- 12:50PM

Panel Discussion

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



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  Diego Rodriguez Cabaleiro  Waters 2:25PM-2:55PM
  Considerations for Bioanalytical Technology Platform Selection: LBA vs. LC-MS Zhang Yan BMS, US  2:55PM-3:25PM
  Emerging Technologies for LM (PK and ADA) Analysis - Pros and cons  Shobha Purushothama UCB, US  3:25PM-3:55PM
    Ramakrishnan Melarkode  Biocon, India  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, 01 March, 2016

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

nSMOL : Simplifying mAB quantitation using LC/MS/MS

        Rashi Kochhar  Shimadzu 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   
  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

Anshul Gupta 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 Gopal Muralidharan 


  Drug-Drug Interaction study with Lipid Lowering Agent 16-dehydropregenalone(80/574): a Potent FXR Modulators Rabi Bhatta

CDRI, India   

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


Session Topics

Regulated Bioanalysis


Discovery Bioanalysis


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