February 25 - February 27, 2018

Sunday Monday Tuesday Tuesday
Short Courses
Short Courses run concurrently

Regulated Bioanalysis/ Biotransformation/Chemistry, Manufacturing and Control

Regulated Bioanalysis / Discovery/Biotransformation

 Chemistry, Manufacturing and Control

Monday, 26 February, 2018

SESSION LIST OF TOPICS SPEAKER COMPANY TIME
  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 Role of Biomarkers in Drug Development; Considerations for successful Biomarker Bioanalysis in Regulated Environment  Darshana Jani Pfizer, US 

9:00AM- 9:45AM

Plenary  Talk-2 CMC Development of Biotherapeutics: Challenges and Opportunities  Satish Singh Lonza, US 

9:45AM- 10:30AM

Break

 

 

   

10:30AM - 10:45AM

Plenary  Talk-3

Pursuing the holy grail of predicting and verifying tissue drug concentrations: A proteomics and PET-imaging approach Jash Unadkat   Uni. of Washington, US  

10:45AM-11:30AM

Plenary  Talk-4 Ananlysis of immune pharmacodynamics effects of novel oral checkpoint antagonists in cancer therapy Murali Ramachandra  Aurigene, India 

11:30AM - 12:15PM 

Panel Discussion      

12:15PM-12:30PM

Lunch      

12:30PM - 01:30PM 

BIOTRANSFORMATION WORKSHOP

Session II: Strategies and techniques to understand Biotransformation and metabolite coverage    
Session Chairs: Lakshmikant (BBRC) and Samiulla (Aurigene)
  Session Introduction    

1:30PM - 1:35PM 

  Role of Biotransformation in translation medicine Pratibha Nadig VIMS, India  1:35PM-2:15PM
  Metabolomics by NMR spectroscopy and its implications to Human health Research Prof. Raja Rao  CMBR, India 2:15PM - 2:55PM
        2:55PM-3:35PM

Panel Discussion

      3:35PM- 3:45PM

BREAK

      3:45PM- 4:00PM

DISCOVERY BIOANALYSIS WORKSHOP

Session II: Challenges with Bioanalysis of Different Matrices
Session Chairs: Jignesh (Torrent Pharma) & Deepak Barot (Boston Intl)
  Session Introduction     4:00PM-4:05PM
  Optical Tissue Analysis : Technical & Regulatory Perspective Robert Bothem US(to be confirmed)  4:05AM-4:45PM
  " When LC-MS/MS is not the answer" Pancreatic insufficiency and the PD markers to be measured: total fat and total nitrogen excreted in the feces    Sudipta Basu      Abbott, US  4:45PM-5:25PM
PANEL DISCUSSION       5:25PM-5:35PM

PARALLEL SESSION (26 Feb, 2017): REGULATED BIOANALYSIS

Session I: Bioanalysis and Characterization of Large Molecules

Session Chairs: Ravisankar (Dr. Reddys)

  Session Introduction  
 
1:30PM - 1:35PM 
 

Bioassay Development: Regulatory Requirement

Jennifer Bharucha

Lupin, India 1:35PM-2:05PM
  Immunogenicity of Protein Biotherapeutics Mallikarjun Dixit Accutest, India 2:05PM-2:35PM

 

Biomarker bioanalysis : Case studies Shaifali Gupta Cliantha, India 2:35PM- 3:05PM
Panel Discussion       3:05PM- 3:20PM
Break       3:20PM- 3:35PM

Session II: Technological Advancement 

Session Chairs: Vijay Raina (Nektar)

  Session Intro     3:35PM-3:40PM
  Tool for Bioseparations Rashi Kochar Shimadzu 3:40PM-4:10PM
               TBD                                                                                      Thermo, US 4:10PM-4:40PM
  TBD    Sciex     4:40PM-5:10PM
PANEL DISCUSSION       5:10PM-5:25PM

COMBINED SESSION: DISCOVERY, BIOTRANSFORMATION, REGULATED BIOANALYSIS & CMC

PANEL DISCUSSION Startup Contract Research Organizations in Preclinical And Clinical development area: Current status and future prospects Panelist:  Moderator  5:25PM- 6:00PM
Cliantha, Vimta, Bioneeds, Accutest   Deepak Barot 

PARALLEL SESSION (26 Feb, 2017): Integrated Drug Development: Chemistry, Manufacturing and Control (CMC)

Session I: Drug Delivery/ Early Phase Development

Session Chairs:

Session Intro       1:30PM - 1:35PM 
  Pediatric formulations: challenges and key aspects of formulation development 

 

Parag Borde Novartis, India  1:35PM-2:20PM
  PBPK Modeling in Dosage Form Design and Development: Current Status and Future Potential Neil Mathias   Bristol Myers Squibb, USA 2:20PM-3:05PM
  Current perspectives in complex genetics drug product development Sridhar Desikan   Dr. Reddys, India    3:05PM- 3:50PM
 Break       3:50PM- 4:15PM
  Developability and Assessment of Product Quality for Biologics M.S. Ramakrishnan Biocon, India 4:15PM- 5:00PM
 Panel Discussion       5:00PM-5:30PM
 

 POSTER SESSION FOLLOWED BY EVENING DINNER RECEPTION sponsored by 

 

6:00PM - 8:00PM
SESSION TENTATIVE LIST TOPICS SPEAKER COMPANY TIME

Breakfast

                              

8:00AM-9:00AM

Session II: Bioanalysis and Characterization of Large Molecules

Session Chairs: Prashant Kole (BBRC) & Ravi Trivedi (Dr. Reddys)

  TBD Binodh Desilva BMS, US

9:15AM-9:55AM

  TBD Anita Krishnan Lupin, India

9:55AM- 10:35AM

  Challenges in Developing and Validating Immunogenicity Assay for Safety and Efficacy Assessment  Deepa Reddy  SPMVV, India

10:35AM- 11:05AM

Break      

11:05AM- 11:20AM

  Neutralizing Antibodies Analysis  Renuka Pillutla BMS, US

11:20AM- 12:05PM

  TBD Deepa Joshi (Invited) Torrent Pharma, India 12:05PM- 12:45PM
Panel Discussion       12:45PM- 1:00PM
Lunch       1:00PM- 2:00PM

COMBINED DISCOVERY & BIOTRANSFORMATION WORKSHOP

Session IV: Drug discovery application and Drug Drug Interaction

Session Chair: Zainuddin (Jubilant Biosys) & Selvum Ravindran (Symbiosis)

  Session Intro    

2:00PM-2:05PM

  Drug-drug interactions: A discovery and lead optimization perspective Punit Marathe BMS, US

2:05PM- 2:45PM

  Andecaliximab pharmacokinetics after repeated IV administration in pregnant and lactating rats Nevena Mollova   Gilead, US

2:45PM- 3:25PM

  Reversible metabolism and Pharmacokinetic modelling in new drug discovery: A case study Rabi Bhatta  CDRI, India 

3:25PM- 4:05PM

PANEL DISCUSSION      

4:05PM- 4:20PM

Break      

4:20PM- 4:30PM

BIOTRANSFORMATION WORKSHOP

Session III: Emerging technologies and tools for Biotransformation 

Session Chairs: Jakir Pinjari (Sai Lifesciences) 

  Session Intro    

4:30PM- 4:35PM

  Hepatocytes, Spheroids and Enterocytes: Invitro Tools Albert Li IVAL,USA  

4:35PM- 5:05PM

  Effects of solvents during in vitro drug metabolism studies with reference to CYPs and nonCYP enzymes. Krishna Iyer  Bombay University, India 

5:05PM- 5:35PM

Panel Discussion      

5:35PM- 5:45PM

Conference Conclusion   

5:45PM- 6:00PM

PARALLEL SESSION (27 Feb, 2017): REGULATED BIOANALYSIS WORKSHOP

Tuesday, 27 February, 2018

 
Session IV:  Regulatory Guidelines, audits and discussion forum
Session Chairs: M.N. Dixit (Accutest)
  TBD  DCGI India (To be Invited) 9:00AM- 9:45AM
  Regulatory Challenges in Bioanalysis and good ANDA practices Amarnath Jaiswal Mylan, India 9:45AM- 10:30AM
  Which (Relative Concentration should the medium level QC have? and Best common practices in setting up an analysis batch: Sequence of cals, qcs and samples PeterVan Amsterdam  Abott, US 10:30AM-11:15AM
Break       11:15PM- 11:30PM
  Trends in Bioanalytical methods for Large Molecules Jayachandran Serum Institute, India 11:30PM- 12:15PM
  TBD Atul Solankar Accutest, India 12:15PM- 1:00PM
Lunch       1:00PM- 2:00PM
Tea Break  Ask the Regulator  Panelist: Peter,     Amarnath,  Jayachandran Moderator: M. N. Dixit 2:00PM-2:30PM
 

Session IV: Data Integrity

Session Chairs: Deepak Barot (Boston Intl) & Ravisankar (SunPharma)

   Session Intro     2:30PM-2:35PM
  Dealing with Organic Impurities for effective life cycle management of chemical products K K Bhagchandani ACD/labs Inc, Canada 2:35PM-3:05PM
  Computer System Validation/Software validation/Data integrity  Rajiv Batra (Invited)  Intas, India   3:05PM-3:45PM
  Expectations and Implementation of Compliant laboratory system  Srinivas Savale  India  3:45PM-4:20PM
Panel Discussion       4:20PM-4:35PM
BREAK        
CONFERENCE CONCLUDING SESSION

Tuesday, 27 February, 2018

SESSION TENTATIVE LIST TOPICS SPEAKER COMPANY TIME

Session III: Quality by Design (QbD)/continuous manufacturing

Session Chairs: 

  Session Introduction     9:00AM - 9:05AM
  Strategy towards Process Development utilizing QbD Concepts – Saving Time and Cost Sushil Sriviastava  Ex-Bristol Myers Squibb, USA  9:05AM-  9:50AM
  Quality by Design Approaches to Drug Product Development  Chris Balducci   Novartis, USA 9:50AM - 10:35AM
  Continuous Manufacturing-New Trends          Vinod Kansal  Ex-Teva, India  10:35AM-11.20AM
Panel Discussion       11:20AM- 11.30AM
Break       11:30AM - 11:45AM

Session IV:  MANUFACTURING

Session Chairs: 

  Session Intro   
 
11:45AM-11:50AM
  Managing Physical Forms in Drug Development  Michael Mutz Novartis, Switzerland 11:50AM-12:30PM
  Experience with Real Time Analytics: Challenges and Way-forward

 

Pankaj Shah  Ex-Bristol Myers Squibb, US 12:30PM-1:10PM
LUNCH  

 

    1:10PM-2:10PM
  Control Strategies for Genotoxic Impurities and Elemental Impurities during Pharmaceutical Development Gopal Vaidyanathan Natco Pharma, India  2:10PM-2:55PM
PANEL DISCUSSION       2:55PM-3:05PM

Session V: REGULATORY/ TECHNOLOGY TRANSFER

Session Chairs: 

  Session Intro     3:05PM-3:10PM
 

The Challenges with Technology Transfers and Validations of Analyical Methods     

Joel Young 

Bristol Myers Squibb, US

3:10PM-3:50PM
 

Best Practices for CMO Selection and Successful Technology Transfer

 Shoban Sabnis 

Vetoquinol, US

3:50PM-4:30PM
BREAK            4:30PM-4:35PM
  NCE API development: Case Study Steven Mennen and Narendra Ambhikar Amgen, USA and Syngene, India 4:35PM-5:35PM 
Panel Discussion      

5:35PM-5:45PM

 Conference concluding session 5:45PM-6:00PM

 

Workshops

Discovery

Regulated Bioanalysis

CMC

Biotransformation

Registration

Click here to register for the APA-India 2018 conference online.

APA-India 2018 will take place 25-27 February 2018

The Westin Pune Koregaon Park

 

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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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