February 25 - February 27, 2018

Sunday Monday Tuesday Tuesday
Short Courses
Short Courses run concurrently

Regulated Bioanalysis/Discovery Biotransformation/Chemistry, Manufacturing and Control

Discovery/Biotransformation

 Regulated Bioanalysis/Chemistry, Manufacturing and Control
SESSION LIST OF TOPICS SPEAKER COMPANY TIME
  REGISTRATION & Breakfast    

7:00AM- 8:35AM

  Boston Society: Opening Remarks & Conference Introduction Deepak Barot Boston Intl  8:35AM- 8:50AM
  Conference: Opening Remarks Prashant Kole Chair- APA INDIA 2018 8:50AM- 8:55AM
  Chemistry, Manufacturing and Control: Introductory Remarks Pankaj Shah Chair-APA INDIA 2018 CMC 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- 2:05PM
  Metabolomics by NMR spectroscopy and its implications to Human health Research Prof. Raja Roy  CBMR, India 2:05PM - 2:35PM
  Large Molecule Metabolite Identification- Sciex Solution for Comprehensive Coverage using Novel Workflows Anoop Kumar   Sciex, India  2:35PM- 3:05PM

Panel Discussion

      3:05PM- 3:15PM

BREAK

      3:15PM- 3:30PM

COMBINED SESSION DISCOVERY & REGULATED BIOANALYSIS WORKSHOP

Session III: Challenges with Bioanalysis of Different Matrices
Session Chairs: Jignesh (Torrent Pharma) & Deepak Barot (Boston Intl)
  Session Introduction     3:30PM- 3:35PM
  An Integrative Paradigm for Drug Resistance: A Metabolic Systems Biology Approach Anu Raghunathan           NCL, India 3:35PM- 4:05PM
  " 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     Peter van Amsterdam          Abbott,Netherlands 4:05AM-4:25PM
  Sudipta Basu Abbott,Singapore 4:25AM-4:45PM
Panel Discussion       4:45PM- 5:00PM

COMBINED SESSION: DISCOVERY, BIOTRANSFORMATION, REGULATED BIOANALYSIS & CMC

PANEL DISCUSSION Contract Research Organizations (Preclinical/Clinical) in India: Challenges and Opportunities Panelist: Cliantha, Accutest,  Vimta        Moderator:       Deepak Barot 5:00PM- 5:30PM

PARALLEL SESSION (26 Feb, 2017): REGULATED BIOANALYSIS

Session II: Bioanalysis and Characterization of Large Molecules

Session Chairs: Ravisankar (Dr. Reddys)

  Session Introduction  
 
1:30PM - 1:35PM 
 

Tool for Bioseparations

Rashi Kochar

Shimadzu 1:35PM- 2:05PM
 

Bioassay Development: Regulatory Requirement

Jennifer Bharucha

Lupin, India 2:05PM- 2:35PM
  Cutting Edge Instrumentation for the Characterization and Quantitation of Biotherapeutics Jonathan Josephs ThermoFisher, US 2:35PM- 3:05PM

Break

      3:05PM- 3:20PM
  Opportunites and Challenges While Addressing Residual Uncertainty During the Development of Biosimilars Anita Krishnan Lupin, India 3:20PM- 3:40PM

 

Biomarker bioanalysis : Case studies Shaifali Gupta Cliantha, India 3:40PM- 4:10PM
  Risk of Immunogenicity and Risk Assesment of Biosimilar products Devnia Bharadwaj

InterVein, India

4:10PM- 4:40PM
Panel Discussion       4:40PM- 5:00PM

COMBINED SESSION: DISCOVERY, BIOTRANSFORMATION, REGULATED BIOANALYSIS & CMC

PANEL DISCUSSION Contract Research Organizations (Preclinical/Clinical) in India: Challenges and Opportunities Panelist:  Moderator  5:00PM- 5:30PM
Cliantha, Bioneeds, Accutest, Vimta   Deepak Barot 

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

Session II: Drug Delivery/ Early Phase Development

Session Chairs:

  Session Introduction     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 

 

5:30PM - 7:30PM

EVENING DINNER RECEPTION 

7:30PM- 8.30PM
SESSION TENTATIVE LIST TOPICS SPEAKER COMPANY TIME

Breakfast

                              

8:00AM-9:00AM

Session III: Emerging technologies and tools for Biotransformation  

Session Chairs:  Jakir Pinjari (Sai Lifesciences) 

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

9:00AM-9:30AM

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

9:30AM- 10:00AM

COMBINED DISCOVERY & BIOTRANSFORMATION WORKSHOP

Session IV: Drug discovery application and Drug Drug Interaction

 

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

  Session Intro    

10:00AM-10:05AM

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

10:05AM- 10:35AM

Break      

10:35AM- 10:45AM

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

10:45AM- 11:15PM

  Reversible metabolism and Pharmacokinetic modelling in new drug discovery: A case study Rabi Bhatta    CDRI, India 11:15PM- 11:45PM
Panel Discussion       11:45PM- 12:00PM
Lunch       12:00PM- 1:00PM
 

COMBINED DISCOVERY & BIOTRANSFORMATION WORKSHOP

Session V: Bioanalysis and Characterization of Large Molecules 

 

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

  Session Intro    

1:00PM-1:05PM

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

1:05PM- 1:35PM

  Managing the Lifecycle of a Bioanalytical Method Binodh Desilva BMS, US

1:35PM- 2:05PM

  Opportunities and Challenges while addressing residual uncertainty during the development of biosimilars  Anita Krishnan Lupin, India 

2:05PM- 2:35PM

  Assay Strategies for the Detection of Neutralizing Antibodies (NAbs)  Renuka Pillutla BMS, US 

2:35PM- 3:05PM

  TBD  Shalini Sharma (Invited) USV, India 

3:05PM- 3:35PM

PANEL DISCUSSION      

3:35PM- 4:00PM

Conference Conclusion   

4:00PM- 4:15PM

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)
  Regulatory challenges in bioanalysis and CSV remediation approach Amarnath Jaiswal Mylan, India 10:45AM- 11:45AM
  Sense and Nonsense of geometric mean medium QCs and analysis batch sequences Peter van Amsterdam  Abbott, Netherlands 11:45AM-12:30AM
  Trends in Bioanalytical methods for Large Molecules Jayachandran Ramalingam Serum Institute, India 12:30PM- 1:15PM
Lunch       1:15PM- 2:15PM
Tea Break  Ask the Regulator Panelist: Peter,    Amarnath,  Jayachandran Moderator: M. N. Dixit 2:15PM-3:00PM
 

Session IV: Data Integrity

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

   Session Intro     3:00PM-3:05PM
  Data Integrity:Expectations and Implementation of Compliant laboratory system  Srinivas Savale    India  3:05PM-3:35PM
  Data Integrity:Human Mindset Mitesh Pillai  Zydus, India  3:35PM- 4:05PM
Panel Discussion       4:05PM-4:30PM
BREAK        
CONFERENCE CONCLUDING SESSION
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
  The Strategy of Smooth Tech Transfers, from Lab to Commercial scale          Vinod Kansal  Amroli, 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 Solid 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-   1:55PM
  Dealing with Organic Impurities for effective life cycle management of chemical products K K Bhagchandani ACD/Labs Inc, Canada 1:55PM-   2:20PM
  Control Strategies for Genotoxic Impurities and Elemental Impurities during Pharmaceutical Development Gopal Vaidyanathan Natco Pharma, India  2:20PM-   3:00PM
PANEL DISCUSSION       3:00PM-    3:10PM

Session V: REGULATORY/ TECHNOLOGY TRANSFER

Session Chairs: 

  Session Intro     3:10PM-   3:15PM
 

The Challenges with Technology Transfers and Validations of Analyical Methods     

Joel Young 

Bristol Myers Squibb, US

3:15PM-   3:55PM
 

Best Practices for CMO Selection and Successful Technology Transfer

 Shoban Sabnis 

Vetoquinol, US

3:55PM-   4:35PM
BREAK            4:35PM-   4:40PM
  NCE API development: Case Study Steven Mennen and Narendra Ambhaikar Amgen, USA and Syngene, India 4:40PM-  5:40PM 
Panel Discussion      

5:40PM-   5:45PM

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

 

Workshops

Discovery

Regulated Bioanalysis

CMC

Biotransformation

Registration

Click here to register for the APA-India 2019 conference online.

APA-India 2019 will take place 24-26 February 2019

Novotel Goa Resort and Spa - Goa, India

 

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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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