February 22 Short Course
February 23-25 Conference Workshops
Registration 07:45- 08:30
Welcome address 08:45-08:50
Conference: Introduction 08:50-08:55
Conference: Opening Remarks 08:55-09:00
Plenary Speaker I Bioanalysis: Paradigm shift from small molecule to large molecules Uptal Tatu IISc, India 9:00 - 9:45
Plenary Speaker II Method transfer for Ligand-binding assays (LBA): learning the skills for a successful method transfer Bruce Stouffer BMS, USA 9:45-10:15
Session I: Bioanalysis : Large & Small Molecules

Session Introduction

Robust and High-Throughput Cholesterol Efflux Biomarker Assay for Evaluating Lipid Lowering Drugs: A case study M N Dixit Clinigene, India 10:20 -10:40
Panel Discussion 10:40-10:55
10:55 -11:10
Suitability of 'One Assay' for Immunogenicity Assessment of Both Innovator and Proposed Biosimilar Drug Products Vikas Kumar Dr. Reddys, India 11:10 - 11:40
A window to the making of Adcetris and Kadcyla Anita Krishnan Lupin, India 11:40 -12:10
Applications of novel acquisition modes and instrument geometries in Time-of-Flight Mass Spectrometer for Targeted Quantitation Stephen McDonald Waters 12:10 - 12:40
Panel Discussion 12:40-1:00
Lunch Break 1:00 -2:00
ADA Assays when and where you need and optimizing cell based assays for immunogenicity assessment Aparna Kasinath Clinigene, India 2:00 -2:30
Method Development (Calibration curve and Qcs) Gopalkrishna Dasika Hospira, India 2:30-3:00
Bioanalytical challenges with metabolites and internal standrards Manoj Bob Lupin Bio 3:00-3:30
Panel Discussion 3:30- 3:45
Break 3:45-4:00
Session II: Bioanalysis: Regulatory Aspects
Recent regulatory issues on bioanalysis and impact of GDUFA (Generic drug user fee act) on Regulated Bioanalysis Amarnath Jaiswal Mylan, India 4:00 - 4:30
Perceptions about Regulatory Agency Inspections and Reflections on Current Guidances: Industry and Regulators (e.g. ANVISA, US FDA draft, EMEA guidelines) Bruce Stouffer, Rustom Mody, M. N. Dixit, Amarnath Jaiswal   :30 - 5:00
Panel Discussion 5:00 - 5:15
Poster Session 5:15 - 6:15

Evening snacks/mocktail 6:15 - 7:15

Session Introduction 8:55 - 9:00
Plenary-I The Continuing Development of Quantitative Bioanalytical Methods to Support Drug Discovery and Development Tim Olah BMS, USA 9:00 - 9:45
Session I: Sample Preparation
Session I Introduction 9:45- 10:15
Why is Small Such a Big Deal? Timothy Sangster CRL, USA 10:15 -10:45
Dried Blood Spot Analysis Work: Stabilization for Hydrolyzable Compunds Vijay Raina Nektar, India 10:45 -11:15
Panel Discussion 11:15 -11:30
Break 11:30 - 11:40
Session II: Large Molecule Bioanalysis
Session Introduction 11:40 -11:45
Quantitation of Endogenous Protein Biomarkers and Challenges: Case Studies Himanshu Gadgil Intas, India 11:45 -12:15
  Quantitation of Therapeutic Proteins (mAb/ Fc-fustion proteins and ADCs etc.) Anand Khedekar Biocon, India 12:15 -12:45
  NKTR-214: A Long-Acting, Engineered Immunotherapy Shows Excellent Therapeutic Efficacy in Multiple Syngenic Mouse Tumor Models both Alone and in Combination with Checkpoint Inhibition Murali Adipali Nektar, India 12:45 - 1:15
Vendor Talk 1:15 - 1:45
Lunch 1:45 - 2:45
Session III:Newer Technologies/Tissue Bioanalysis
Session III Introduction 2:40- 2:45

Identification and Characterization of Proteins

Jonathan Josephs Thermo, USA 2:45 - 3:15

Nanomaterials for Ultra-Sensitive Biodiagnostics

Raman Suri Inst. of Microbial tech, India 3:15- 3:45
Surface Plasma Resonance Technology for Determination of Biointeractions Like Protein Receptor Binding Along with Case Studies Dhanashree Jagtap National AIDS Res.Inst.India 3:45 - 4:15
Panel Discussion 4:15 - 4:30
Break 4:30 - 4:45
Session IV Drug Discovery-Preclinical Phase
Sessions IV Introduction ÂÂ ÂÂ ÂÂ ÂÂ
ÂÂ ÂÂ Punit Marathe BMS, USA 4:45- 5:15
  Role of Biotransformation in Drug Discovery and Development Krishna Iyer Bombay Uni. 5:15 - 5:45
Panel Discussion "Outsourcing in India: Preclinical Drug Discovery and Development" Tim Olah, Jonathan Josephs, Punit, Krishna Iyer,   5:45 - 6:15
Poster Presentation & Evening snacks 6:30 - 8:00
Session Introduction 08:25-08:30
Plenary Talk Monoclonal Antibodies for Cancer Immunotherapy Nils Lonberg BMS, USA 08:30- 9:15
Session I: Recent Advances : BTX pathaways
Session I Introduction Murali Subramanian BBRC, India n
Discovery and pre-clinical development of vismodegib
Harvey Wong

Genentech, USA

09:15 -09:45
Panel Discussion 09:45- 10:00
Break 10:00 -10:15
Session II-Metabolite coverage in Safety evaluation
Session II Introduction Ravi Talluri Glenmark, India
Prediction of the magnitude of induction response (AUC change) using calibrated human hepatocytes. Charles Crespi BD Corning 10:15 -10:45
  Induction-based Drug Drug Interaction Studies in Preclinical & Clinical Development Jasminder Sahi GSK, Shanghai 10:45-11:15
  Mechanistic static and dynamic population
models for prospective predictions of drug-drug interaction
Sheila Peters AstraZeneca, Sweden 11:15 -11:45
Vendor Presentation Use of very high resolution and fine isotope patterns for structural elucidation and creation and use of very rich and deep MS/MS libraries (m/z Cloud). Tim Stratton ThermoFisher 11:45 -12:15
Lunch 12:15- 1:15
Session III-
Session III Introduction Sandhya Mandlekar BBRC, India n
Organic anion transporters: Gateways for drugs
and tools to study transporter genetics
Bruno Steiger University Hospital, Zurich 1:15- 1:45
Role of four transporters in the intestinal absorption of metformin Dhiren Thakker UNC 1:45 -2:15
Panel Discussion 2:15- 2:30
Break 2:30- 2:45
Session IV Transporters
Session IV Introduction M V S Rao Advinus
Metabolites in safety testing: six year after
the guidance
ChandraPrakash Biogen, USA 2:45- 3:15
  Mitigation of Reactive Metabolites in Drug Discovery Vinayak Hosagraha Astrazeneca, USA 3:15- 3:45
Non-P450 (MAO) metabolism Arti Basak Sawant

Pfizer, USA

3:45- 4:15
Panel Discussion 4:15- 4:30
APA India 2015 Concluding remarks 4:30