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Speakers at ConSPIC 2018

Topic : The contemporary relevance of Ayurveda- biology an emerging trans disciplinary field that will shape key needs of 21st century healthcare

Darshan Shankar is currently the Vice Chancellor of University of Trans Disciplinary Health Sciences and Technology (TDU). He has coordinated at a national level programs in several fields in order to demonstrate the contemporary relevance of India’s Medical Heritage. The core fields include national policy formulations for traditional medicine, in-situ conservation of medicinal plants, development of traditional knowledge data bases on medicinal botanicals, theoretical foundations of Ayurveda, scientific validation of traditional health practices and promotion of ethno-medicine. He has written one book, chapters in several books and peer reviewed articles. He has won several national and international awards including the ‘Norman Borlaug’ Award, the Columbia University’s Centre for Complementary & Alternative Medicines International Award for cultural stewardship and the Govt. of India conferred civilian award, Padma Shri.

Darshan Shankar

Topic : Through the Looking Glass and What We Find There

Chitra Lele’s career of 28 years across USA and India, includes 20 years in the pharmaceutical industry (both on the sponsor and the CRO side), a few years as an academician in Universities and Institutes, and a few years in cancer epidemiology. Chitra has a PhD in Statistics from Stanford University, USA and she also completed her Associateship from the Society of Actuaries, USA. She is a founding member of Sciformix and is its Chief Scientific Officer. Her prior industry experience includes 10 years with Pfizer Global R&D, establishing India’s first Development Operations group to support global clinical trials of a pharmaceutical company. Her experience ranges across all aspects of drug development and lifecycle maintenance. Chitra is also a founding member of the IASCT.

Dr. Chitra Lele

Topic : Integrating Phase 2 Go/No-go Criteria and Phase 3 Probability of Success: A Bayesian Case Study

Adam is Head of Infectious Disease Statistics at GSK with 20+ years’ industry experience across all phases of drug development and multiple therapeutic areas. Educated and based in the UK, Adam has extensive experience in the design and conduct of cardiovascular outcomes trials and in working with the associated external groups (Academic Research Organisations, Steering Committees, IDMCs). Adam is a member of GSK’s “Global Safety Board” and is a GSK Senior Fellow. Adam also serves on the Scientific Committee for the PSI organisation and recently contributed to the PSI/EFSPI Expert Working Group on Confidentiality of Interim Results. Adam has a range of statistical interests, with recent publications on topics such as use of assurance to support decision making in drug development, and a wide-ranging overview of blinding in clinical trials; recent external presentations have included contributions as a panellist at the 2017 ISBS Conference session “Data Monitoring Committees – Scope, Expectations and Challenges” and as speaker at the 2016 ASA Biopharmaceutical Workshop on the subject “Futility assessments in late-phase drug development: a novel two-stage outcomes trial in Acute Coronary Syndrome”. Adam received his PhD in Statistics from University College London and has a Diploma in Mathematical Statistics from Cambridge University.

Adam Crisp

Topic : Modelling and forecasting of count time series consisting large number of zeros and ones

Atanu Biswas is a Professor at the Indian Statistical Institute, Kolkata. He did his his PhD from the Calcutta University in 1998, and is a faculty member of the Indian Statistical Institute, Kolkata, from 1998 as well. He works in Sequential Clinical Trials, Response-Adaptive Designs, Categorical Data, Survival Analysis, Directional Data Analysis, among other topics. He has published about 175 research papers and coauthor of a book on Response-Adaptive Designs. Prof. Biswas is Associate Editors of the journals like Statistics and Probability Letters and Communications in Statistics.

Prof. Atanu Biswas

ConSPIC 2018 Agenda

  • November 22, 2018 - Day 1
  • November 23, 2018 - Day 2
  • November 24, 2018 - Day 3
Time Track 1
( GBR 1 )
Track 2
( GBR 2 )
Track 3
Programming and Management
Track 4
08.00 - 9.30 Registration ( Pre- function area)
09.30 - 10.00 Welcome Address (Grand Ball Room)
10.00 - 11.00 Inaugral Address (Grand Ball Room)
11.00 - 11.40 Registration (Pre- function area) and Tea
11.40 - 12.05 P01 - "The Untold Story of Drug Discovery – Real World Evidence"
Manasi Srinivaan
P03 - SDSP: All you need to know
Vikas Dhongde
A01 - Real-World Evidence is equivalent to truth?
Prasanthi Sanjeevi
S01 - Sensitivity Analysis in Multiple Imputation with Tipping-Point Approach: A case-study
Jairaj R
12.05 - 12.30 P02 - Is 8 a good number? – Let’s know its significance in drug development
Ninan M Luke
P04 - Legacy data conversion to CDISC standards and its Challenges
Manjira Bandyopadhyay
A02 - Understanding Pragmatic and Explanatory Trial
Pavithra Venugopal
and Meena Raghuraman
S02 - RE-randomization tests under covariate-adaptive randomization
Shree Harsha B
12.30 - 13.30 Lunch Break
13.30 - 13.55 P05 - Don’t be Chaotic with TEAE Transitions
Harish Mavatoor
P09 - Overview of implementing pharma genomics data into Cdisc
Naveen pal Arumugam
P13 - Dose Proportionality: Power Model and Confidence Interval Approach
Preeti Kumari
S03 - Recent Advancements in Statistical Analysis of Missing Data: Broader Range of Sensitivity Analyses for MNAR & MAR mechanisms
David Raj
13.55 - 14.20 P06 - Serious Adverse Events Data Reconciliation Using SAS
Harathi Vidiyala
P10 - Effective Management of Core and Extension studies in CDISC Standards
Neethu Babu
P14 - Tricky Designs - Let’s clear the air
Sudarvizhi Rajaram
S04 - An Advanced Statistical Approach for Recurrent Adverse Events Data Analysis in Randomized Clinical Trials
Debasis Dey
14.20 - 14.45 P07 - How Studies with Medical Devices Differ from those with Drugs?
Pragnya Mishra
P11 - RTOR (Real-Time Oncology Review) – Insights from the Statistical programmer
Kishore Kumar Paramkusham
P15 - Reimagining Statistical Reports with R Shiny
Sudharsan Dhanavel
S05 - Today’s posterior distributions become tomorrow’s prior distributions: A Bayesian Concept in Clinical Trials
Arjun C
14.45 - 15.10 P08 - Homogenizing Breast Cancer data into Standard SDTM Domains applying TAUG-BrCa
Srinivasa and
P12 - PostScript - a boon to develop eCTD compliant aCRF
Silvia Biswas
P16 - Comparison of Logistic Regression in R and SAS
Athira Sudhakaran
S06 - Comparison of Objective Bayesian Priors for administrative interim analysis: futility and predictive probability
Rajendra Prasad Sarkar
15.10 - 15.45 Tea Break
15.45 - 16.10 P17 - Data and Documentation – Programmer’s View
Aditi Pradip Marathe
P19 - Implementation of CDISC for non-clinical data
Obulpathi Naidu
A03-Evaluating AUC - A different approach
Grace Martina
S07-Covariate-Adjusted Response-Adaptive Designs for Semi-Parametric Survival Responses
Ayon Mukherjee
16.10 - 16.35 P18 - Proc DS2-An Overview
Sruthi Selvaraj
P20 - Data Cloak
Shweta Padmanaban
A04 - Forecasting Database Lock window for better project management
Srikanth Garre
S08 - Statistical models for analysis of multilevel survival data
Priti Kadu
16.35 - 17.00 A05 - Validation is merely not matching the counts? Think beyond!!!
Sibi Mani
S09 - Cure Fraction Model - An underused but useful Statistical Tool for Estimating Survival
Harshit Yadav
17.15 - 18.15 IASCT Annual General Body Meeting
Time Track 1
( GBR 1 )
Track 2
( GBR 2 )
Track 3
Programming and Management
Track 4
09.30 - 09.55 P21 - Streamline and improve the acceptability of the clinical trial results - An Adjudication Process , Guidelines for Assessing Drug Safety Management
Pravinkumar Doss and
Reshma Radhakrishnan
P24 - Preparing a Submission Ready Clinical Study Data Reviewer’s Guide - The “Dashboard” of a Clinical Study
Hanumanta Rao Karedla and
Murali Mareedu
P26 - Solution lies within the QUERIES!
Sanjyot Bakshi
S10 - Are we analyzing Percent change from baseline as an endpoint in a right way? And what is the behaviour when we have Non-response too?
Sarfaraz Sayyed
09.55 - 10.20 P22 - Uncovering the complementary component of precision medicine clinical trials
Thejas MS
P25 - Can an S and a D wreck a future Blockbuster
Shanmugavel S
P27 - Qurie – Our own SDTM Bot
Shweta Padmanaban
S11 - Shift from statistical power to statistical assurance to support decision making in drug development
Jomy Jose
10.20 - 10.45 P23 - Immuno-oncology: An emerging branch in the field of immunotherapies
Sudeshna Porwal
P28 - Hey!! Do You know Proc LUA?
Dr.Sangram Parbhane
10.45 - 11.10 Tea
11.10 - 11.35 P29 - SAS-R-Python: To Clash or Clasp?
P33 - Common Issues in P21
Rohith Chennamaneni
A06 - A Neural Network classifier for adverse event forecasting during immuno-oncology clinical trials
Ashwin Adrian Kallor
Invited Speaker :
Adam Crisp
11.35 - 12.00 P30 - SAS is still a winner – with a little help from JAVA
Praveen Kumar J
P34 - Implementation of CDISC ADaM in the Pharmacokinetics
Suresh A
A07 - Interactive Clinical Report Review - Make your life easy!!-
Ashwini Kumthekar
S12 - Machine Learning for Clinical Trial Data
Sree Venkatesh Yanamadala
12.00 - 12.25 P31 - Bringing the “R” Flavor in Clinical Report Generation
Mouli Nagarajan and
John Thomas Johnson
P35 - Therapeutic Area User’s Guide and its relation with the Medical Devices SDTM domains
Sumeet Subhedar
A08 - Rare Diseases... not that rare!
Kalpesh Valaki
S13 - Companion Diagnostics (CDx) - “A game changer”: Overview of Statistical analyses
Srijani Das and
Purbayan C
12.25 - 12.50 P32 - "SASPy" - Execution of SAS code through Python
Yajurvanan Chinnasamy
P36 - SDTM Coronation – with my way!!!
Sadanand Deshmukh
A09-Exploratory Data Analysis: A step beyond
Nimisha Jain
12.50 - 14.00 Lunch Break
14.00 - 14.25 P37 - A drugs life in the body
Baskaran Dharmalingam
P40 - Bioresearch Monitoring (BIMO) Reports Creation Using AGILE Approach, OSI - BIMO: Is Your Clinical Study Inspection Ready?
Harish Kumar and
Sathish Saravanan
A10 - An Overview of efficacy Endpoints in Epilepsy diseases
Muthukumaran Murugan
S14-Tipping point analysis for Time to Event data under Estimands framework
Bharath Kumar
14.25 - 14.50 P38 - Surrogate endpoints and their evaluation in HIV trials
Vikas Dhongde
P41 - Producing Volcano Plots using SAS ODS Graphics to Interpret Incidence of Adverse Events
Balaniharika Pillalamarri
A11 - Role Of Big Data Analysis for Cancer Care
Saira Konar
S15 - Achieving Optimal Patient Exposure and Efficient Outcome in Clinical Trial using Group Sequential Design – An Illustration
R Arul Gandhi
14.50 - 15.15 P39 - Challenges and Solutions in analysing Genotyping amino acid sequence changes in HIV studies
Sugunesh Sivalingam
P42 - Graphs and Gyaan
Sandeep Kumar Maneni
A12 - Standardization of Real World Data(RWD) for Real World Evidence(RWE)
Vinodhkumar Katikala
S16 - Estimands and Sensitivity Analysis in Clinical Trials
Swati Neve
15.15 - 15.30 Tea Break
15.30 - 17.30 Students Poster Session

**** DJ Party and Dinner - 19.00 – 23.00 ****

Time Track 1
( GBR 1 )
Track 2
( GBR 2 )
Track 3
Programming and Management
Track 4
08.00 - 11.00 Poster Session
11.00 - 11.15 Tea Break
11.15 - 11.40 P43 - "Children are not little adults"- A foresight for safe and effective pediatric NDAs
Bindu Sekar
P46 - Create Customized Clinical SAS Graphs Without learning Graph Programming!!
SivaNagaraju Vajja
M01 - Be an all-rounder if you wanna be a complete Project Statistical Programmer!
Sandeep Kambhampati
Invited Speaker :
Dr. Atanu Biswas
11.40 - 12.05 P44 - Keeping up with clinical trends – Abuse Deterrent Opioids
Bhakti Gadekar
P47 - Calculation of confidence interval and Patient Year(s) at Risk using PROC GENMOD
Muthulakshmi Muthusamy
M02 - Workflows and Seamless Study Management
Charumathy Sreeraman
S17-Adjusting Complete & Quasi-complete separations in logistic regression.
Dipayan Maity
12.05 - 12.30 P45-Personalized medicines: the powerful friendship between targeted therapy and companion diagnostics
Jeffy Sarto
P48 - A Day in the life of Clinical Programmer’s
Swarnalatha Shivanna
M03 - Real Talent will get through Whatever the Obstacles
Rosina Jose
S18-Models and Methods for analysis of Recurrent data in Clinical trials
Arati Nair
12.30 - 13.30 Lunch Break
13.30 - 13.55 P49 - Meaningful Imputation for Enhancing Clinical Trial Validity
Aishwaria Manek
P51 - SAS Macro Validation
Shweta Padmanaban
M04 - How to develop TOP Clinical SAS programmers?
Anantha Jyoti Sankaran
S19 - Quantify treatment effects in clinical trials - ESTIMANDS
Rudrani Banerjee
13.55 - 14.20 P50 - Clinical Trial Safety Disclosure Process
Rupesh Dwivedi
P52 - Beyond the Basics of PROC MIXED in Clinical Data
Amala Peter
M05 - Retention after Resignation - What TO and NOT TO do!
Divya Cetlur
S20 - Determination of optimum portfolio structure in Pharmaceutical Industry
Debadrita Banerjee
14.20 - 14.45 M06 - Emotional intelligence: A way towards ergonomics
Sudeshna Porwal
S21 - Leveraging Simulation Techniques in reducing turnaround time in Fast Paced Clinical Trials Analysis and Reporting
R Arul Gandhi
14:45 - 15.15 Tea Break
15:15 - 16.15 Valedictory Session
16:15 - 17.00 Awards and Closing

Please download the ConSPIC 2018 Agenda pdf document here