|
March 3:
|
Short Course
|
|
March 4 - 6:
|
Conference Workshops
- Regulated Bioanalysis
- Biotransformation
- Discovery
|
|
Biotransformation Short Course
Case studies, Transporters LC-MS/MS, recent regulatory updates, new technologies in transporter assay, clinical DDI, reactive metabolites and technologies discussion. Issues encoutered in Discovery/Biotransformation and how to resolve them
|
Bioanalysis Short Course
Case studies, ADME Assays & Bioanalytical challenges, Ligand binding assays, Readiness for regulatory audits, case studies on bioanlaytical challenges, current updates on regulatory guidelines, DBS & its application in Discovery,Utility of HRMS in Quantitation, Utility of Biostatistics in Bioanalysis and Regulatory guidelines etc.
|
|
Instructors: Jasminder Sahi,Jonathan Josephs,Mike Sinz, Girish Gudi, Kunal Taskar,Szilagyi and Berend Osterhuis confirmed.
|
Instructors: Tim Olah,Jonathan Josephs, Carol Gleason, Vinay Shedbalkar & Prashant Kole confirmed.
|
Regulated Bioanalysis Workshop - Monday, 4 March
|
**Tentative Time, topics and speakers are subject to change
|
|
SESSION
|
TOPIC
|
SPEAKER
|
COMPANY
|
TIME
|
|
REGISTRATION & Breakfast
|
|
|
07:45 - 08:45
|
|
Conference Opening
|
Sandhya Mandlekar
|
BMS, India
|
08:45 - 08:50
|
|
Conference Welcome
|
Deepak Barot
|
Boston Society MicroTherapeutics, India
|
08:50 - 08:55
|
|
Opening Remarks
|
Girish Gudi
|
Glenmark, India
|
08:55 - 09:00
|
|
PLENARY SESSION
|
|
KEYNOTE
|
“International Regulations and Quality Standards of Bioanalysis”
|
Surendra Bansal
|
Roche, USA
|
09:00- 09:45
|
|
Session I:
|
|
Session I Introduction
|
Vinay Shedbalkar
|
Pharmaedge, India
|
09:45- 09:50
|
|
Deviations and Investigations in Regulated Bioanalysis : Standard practices versus science
|
Ravi Sankar
|
GVK Bio, India
|
09:50- 10:20
|
|
|
Are deuterated Internal standards always safe to use
|
Vinay Shedbalkar
|
Pharmaedge, India
|
10:20 - 10:50
|
|
|
Panel Discussion
|
|
|
10:50 - 11:05
|
|
BREAK
|
|
|
|
11:05 - 11:20
|
|
Session II:
|
|
Session II Introduction |
|
|
11:20 -
11:25
|
|
|
LBA and LC-MS assays for bioanalysis of biotherapeutics
|
Tim Olah
|
BMS, US
|
11:25 - 11:55
|
|
Quantification of Endogenous Molecules
|
Vijaya Bharathi
|
Dr. Reddys, India
|
11:55 - 12:25
|
|
HR/AM Mass Spectrometry For Large Molecule Quantitation: Why HR/AM? why Intact Level? Why Peptide Level or Everything IN-Between?
|
Patrick Bennett
|
Thermo Fisher
|
12:25 - 12:55
|
| LUNCH |
|
|
|
12:55 - 13:55
|
| |
Challenges of GLP/GCLP-Bioanalysis for Biosimilars
|
Aparna Kasinath
|
Clinigene, India
|
13:55 - 14:25
|
| |
Panel Discussion
|
|
|
14:25 - 14:40
|
|
Session III:
|
|
Session III Introduction |
|
|
14:40 - 14:45 |
|
|
QbD in analytics
|
Varma Rudraraju
|
Aizant, India
|
14:45 - 15:15
|
|
Role of bioanalytical science in formulation development
|
Manish Yadav
|
Alkem, India
|
15:15 - 15:45
|
|
|
Emerging and novel technologies supporting pharmacokintics and pharmacodynamics in drug development
|
Anirudh Gautam
|
DRL, India
|
15:45 - 16:15
|
|
Panel Discussion
|
|
|
16:15 - 16:30
|
|
BREAK
|
|
|
|
16:30 - 16:45
|
|
Session IV:
|
|
Session IV Introduction |
|
|
16:45 - 16:50 |
| |
Regulatory policies
|
Dr. Sam Haidar (Invited)
|
FDA
|
16:50 - 17:20
|
|
Regulatory challenges to Indian Scientists
|
C T Viswanathan
|
C T Viswanathan and Associates
|
17:20 - 17:50
|
|
Panel Discussion: CROs, Where to move and how to move - Indian CRO industry - new vision and mission is to be created to cope up with global quality, cost and business pressures.
|
Tim Olah et al
|
BMS, US
|
17:50 - 18:20
|
|
|
|
|
|
|
EVENING RECEPTION
|
Discovery Bioanalysis Workshop - Tuesday, 5 March
| SESSION |
TOPIC
|
SPEAKER
|
COMPANY
|
TIME
|
|
Breakfast
|
|
|
07.00 - 08.00
|
|
Session Introduction
|
Vijay Raina
|
Nektar, India |
08:25 - 08:30
|
 |
Chemical Intelligence in UNIFI, enhancing in silico decision making to provide confident and accurate results for metabolite identification experiments
|
V Umasankar
|
Waters, India
|
08:30 - 09.00
|
|
Keynote
|
Discovery of small molecule/biologics, regulatory perspectives
|
Ramesh Panchagnula
|
Nektar, India
|
09:00 - 09:45
|
| Session I - Drug Discovery & Bioanalysis |
| |
Development of Taranabant, a CB-1 agonist for the treatment of obesity: a DMPK perspective / CASE STUDIES
|
Bindhu Karanam
|
Merck, US
|
09:45 - 10:15
|
| |
A Current View and Future Vision for the Role of Bioanalysis in Drug Discovery,
Development, and Patient Care
|
Timothy Olah
|
BMS, US
|
10:15 - 10:45
|
| BREAK |
|
|
|
10:45 - 11:00
|
| Session II - HRMS : Emerging bioanalytical tool |
| |
Session II Introduction |
Jignesh Kotecha |
Torrent, India |
11:00 - 11:05 |
| |
Integrated Qual/Quan Metabolism profiling using uHPLC/HRMS
|
Jonathan Josephs |
BMS, US |
11:05 - 11:35
|
|
MIST guidelines: Metabolites in preclinical and met ID in discovery scenario/case study
|
Subrahmanyam Vangala
|
Ridgeview Clinical Consulting, US
|
11:35 - 12:05
|
| |
Applied High Resolution Mass Spectrometry: Advantages in Pharmaceutical Quantification Workflows
|
Axel Besa
|
A B Sciex |
12:05 - 12:35
|
| |
Panel Discussion
|
|
|
12:35 - 12:50
|
LUNCH |
|
|
|
12:50 - 13:50 |
| Session III - Characterization of Large Molecules |
|
Session III Introduction |
Ravi Trivedi |
BBRC, India |
13:50- 13:55 |
|
Characterization of large proteins and peptides
|
Alok Sharma
|
Lupin, India
|
13:55 - 14:25
|
|
|
Strategies for implementing a tiered approach for immunogenicity testing of Biologics
|
Arumugam Muruganandam |
Affigenix Biosolutions, India
|
14:25 - 14:55
|
|
Challenges with DBS and microsampling in preclinical and clinical research & development
|
Philip Timmerman
|
Jannsen R & D, NV
|
14:55 - 15:25
|
|
BREAK
|
|
|
|
15:25 - 15:40
|
| Session IV - Tissue Distribution: An Insight |
|
Session IV Introduction |
Ravi Shankar |
SunPharma, India |
15:40 - 15:45 |
|
If its Bound, set it Free:Relevance of Protein Binding in Drug Discovery and Development
|
Rahul Deshmukh |
Rosalind Franklin University
|
15:45 - 16:15
|
| |
Insight into unbound Tissue Concentrations-Utility in Drug discovery and Development Bioanalysis of Tissue distribution studies
|
Punit Marathe ( Webinar)
|
BMS, US |
16:15 - 16:45
|
|
Bioanalysis of tissue distribution studies |
Yongjun Xue (Webinar) |
Celgene, US |
16:45 - 17:15
|
|
Panel Discussion: Challenges in Discovery, Preclinical CROs
(Panelist from different National & international Pharmaceutical Industry) Bioanalysis
|
Jonathan Josephs, Tim Olah, Bindhu Karanam Philip, Mani,Rahul, Alok et al
Deepak Barot (Moderator)
|
BMS, Merck, Jannsen,Lupin
Microtherapeutics, India
|
17:15 - 17:45
|
| POSTER SESSION + EVENING RECEPTION (In the Exhibitor Hall): 18:00 - 20:00 |
Biotransformation Workshop - Wednesday, 6 March
|
SESSION
|
TOPIC
|
SPEAKER
|
COMPANY
|
TIME
|
|
Breakfast
|
|
|
07:00-08:00
|
|
Session Introduction |
Sandhya Mandlekar |
BMS, India |
08:00 - 08:05
|
|
PLENARY
|
Evolution and trends in drug metabolism. Perspectives from the pharmaceutical industry and an international scientific society
|
Bill Smith(President, ISSX)
|
Pfizer, US
|
08:05 - 08:50
|
|
Session I: Advanced technologies in BTx studies
|
|
Session I Introduction |
Sanjeev Giri |
Jubiliant, India |
08:50 - 09:00 |
|
|
Applications of High-Resolution Mass Spectrometry in PKDM
|
Raju Subramanian
|
Amgen US
|
09:00 - 09:30
|
|
|
Creating an integrated drug metabolism process using a laboratory notebook
|
Jonathan Josephs
|
BMS, US
|
09:30 - 10:00
|
|
Break
|
|
|
|
10:00 - 10:15
|
|
Hepatic transporter expression and interindividual variability data for better in vitro-in vivo extrapolation of transporter-mediated clearance in the liver
|
Bhagwat Prasad
|
University of Washington (webinar) |
10:15- 10:45
|
|
PANEL DISCUSSION
|
|
|
10:45 - 11:00
|
|
Session II: Transporters
|
|
|
M V S Rao |
Advinus, India |
11:00 - 11:05 |
|
|
Blood Brain Barrier: interplay between Pgp and BCRP
|
Jasminder Sahi
|
GSK, US
|
11:05 - 11:35
|
|
|
Intestinal transporters: A Gateway to the Body but Also a First Line of Defense
|
Dhiren Thakker
|
University of North Carolina
|
11:35 - 12:05
|
|
|
Enabling Pharmaceutical R&D via Advancing Technological Solutions
|
Dr. Nalini Sadagopan
|
Agilent Technologies, US
|
12:05 - 12:35
|
| LUNCH |
|
|
|
12:35 - 13:35
|
|
Session III: Drug-Drug Interaction/Metabolism mediated toxicity
|
|
Session III Introduction |
Ravi Talluri |
Glenmark, india |
13:35 - 13:40 |
|
|
siRNA approaches to modulate cyp2C11 activity in rats
|
Michael Sinz
|
BMS, US
|
13:40 - 14:10
|
|
|
Multi-dose Pharmacokinetics of Rifampin in BALB/c mice
|
Vinayak Hosagrahara
|
AstraZeneca, India
|
14:10 - 14:40
|
| |
Novel applications of human hepatocytes in the evaluation of DDI and adverse drug properties
|
Albert Li
|
In Vitro ADMET Labs, US
|
14:40 - 15:10
|
|
BREAK
|
|
|
|
15:10 - 15:25
|
|
Session IV: Mechanism of Biotransformation
|
|
Session IV Introduction |
Murali Subramanian |
BBRC, India |
15:25 - 15:30 |
|
Identification of a disproportionate metabolite of 5HT4 partial agonist PF-04995274: adherance to the MIST strategy by application of old tools but using new approaches
|
Aarti Sawant Basak
|
Pfizer, US
|
15:30 - 16:00
|
|
|
Biotransformation in Discovery: Improving Drug Properties Early in Design
|
Alfin Vaz
|
Pfizer, US
|
16:00 - 16:30
|
|
Aldehyde oxidase role in drug metabolism
|
Krishna Iyer
|
|
16:30 - 17:00
|
|
Panel Discussion
|
|
|
|
17:00 - 17:30
|
Deepak Dalvie, Pfizer,
US Raju Subramanian, Amgen, US
Narendra Kishnani, Bristol-Myers Squibb, US
Ravi Rahavendran, Pfizer, US
Murali Subramanian, Biocon-Bristol-Myers Squibb Research Centre, India
Sanjeev Giri, Jubilantbiosys, India
M Venkata Rao, Advinus, India Ravi T, Glenmark Pharma, India
|
