ConSPIC 2019 Agenda

  • November 13th, 2019 - Day 1
  • November 14th, 2019 - Day 2
  • November 15th, 2019 - Day 3
Time LISBOA 1 LISBOA 2 PORTO
09:00 - 11:00 Registration ( Pre- function area)
11.00 - 11:30 Welcome Note
11:30 - 12:30 Plenary - 1
Pioneering Disruptive Transformation in Statistical Programming - Past, Present and Future - James Gallagher
12:30 - 13:30 Lunch Break
13:30 - 15:00 Programming
Data Standards (1)
Programming
Beyond SAS
Statistics
Analysis Methods (1)
15:00 - 15.30 Tea Break
15:30 - 17:00 Programming
Understanding the domain (1)
Programming
Analysis Methods
Analytics
Models and Algorithms
17:00 - 18:30 Student Posters Session (PATIO)- SPS
Time LISBOA 1 LISBOA 2 PORTO
08:30 - 10:00 STR-1
KPIs and metrics for SAS and Stat output
STR-2
Building talent at grass root level
Poster Session 2 (PATIO) – PS1
10:00 - 11:00 Plenary - 2
Virtual Trials and Synthetic Arm Trials – Rakhi Kilaru
11:00 - 11:30 Tea Break
11:30 - 13:00 Programming
Regulatory Reports
Programming
SAS Tips and Tricks (1)
Statistics
Invited Talks
13:00 - 14:00 Lunch Break
14:00 - 15:30 Panel Discussion – 1:
Future of Outsourcing to India
Statistics
Analysis Methods (2)
15:30 - 16:00 Tea Break
16:00 - 17:30 Programming
Understanding the domain (2)
Programming
Data Standards (2)
Statistics
Trial Design
17:45 - 19:00 IASCT AGM
19:00 - 22:30 Gala Dinner
Time LISBOA 1 LISBOA 2 PORTO
08:00 - 09:30 STR-3
AI/ML, digitization and automation in TFLs
STR-4
A view from the junior side: What are junior associate’s expectations?
Poster Session 3 (PATIO) – PS2
09:30 - 10:30 Plenary - 3
Tell me something that I don’t know- Shobhit Shrotriya
10:30 - 11:00 Tea Break
11:00 - 12:30 Management and soft skills Analytics
Tools
Programming
Invited Talks
12:30 - 13:30 Lunch Break
13:30 - 15:00 Panel Discussion – 2:
Future of Clinical Trials
Programming
SAS Tips and Tricks (2)
15:00 - 15:30 Tea Break
15:30 - 16:30 Plenary - 4
Moving Faster through Innovative Trial Designs- Prof. Diana Gibb
16:30 - 17:00 Closing

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Programming : Data Standards (1)

Presentation Title Name Organization
Clinical Trials for Medical Devices - How do they play in SDTM? Neelima Sama Ephicacy Lifescience Analytics
Overview of standardization and analysis of medical devices data into CDISC standards Naveen Pal Navitas Life sciences
Findings About Custom "Findings About" Raghava Regulla Bayer Pharmaceuticals
The Future of SDTM Mapping Vasanthakumar Lakshmanan Symbiance Pvt. Ltd.
Jey Arunachalam
Pinnacle21 - Make it more robust and effective Ranjan Routray Novartis Healthcare Pvt. Ltd.
Ajay Sinha
Chanukya Samrat M
Domain Analysis Model Obulpathi Naidu Navitas Life sciences

Programming : Beyond SAS

Presentation Title Name Organization
Discrepancy Analysis of clinical data sets using python Aslam Basha Shaik Ancla
Dr Krishna Asvalayan
Do you contemplate Visual Programming; A Python Library will rescue Sudharsan Dhanavel Cognizant Technology Solutions
Subject level data using Python - Building the ADSL.Py N Mouli Pfizer
P Karthik
V Jayashree
Archiving our deliverables - when there is no version-controlled system Baskaran Dharmalingam Pfizer
NONMEM PK - Programmers Bird View Kiran H GSK Pharmaceuticals
K P S BharathKumar
Graphical Presentation of Data/ Results using R, for Oncology Trials Dhananjay Srivastava Cognizant Technology Solutions
Dheeraj Rane
Operational excellence using R Shiny Deepthi Novartis Healthcare Pvt. Ltd.

Statistics : Analysis Methods (1)

Presentation Title Name Organization
Analysis of HMIS data with standard software tools to generate insightful empirical evidence of Ayurveda practice in a University hospital Sadanand Deshmukh Novartis Healthcare Pvt. Ltd.
Ashwini Mathur
Girish Tillu
Poornima Devkur
Prasan Shankar
Darshan Shankar
Satish Rao
Vinay Mahajan
Impact and Risk assessment of modification in ULN of ALT on Liver Safety Monitoring to inform National Health Authorities. Ashwini Shenoy GSK Pharmaceuticals
A story about how a trial starts (for a statistician) Rishav Mukherjee Novartis Healthcare Pvt. Ltd.
Competing risks in survival analysis: An Oncology case study Ashwin Adrian Kallor GSK Pharmaceuticals
Meta-Analysis of Individual Placebo Response in Peripheral Neuropathic Pain Baishakhi Chakraborty Quartesian
Shivam Sharma
RMST: an alternative way for the estimation of treatment effect Anubrata Kundu Novartis Healthcare Pvt. Ltd.
Immunogenicity Cut-point Evaluations Ramkumar Marudhai Rajendiran Cognizant Technology Solutions

Programming : Understanding the domain (1)

Presentation Title Name Organization
Can a Programmer be a Statistician??? Nirav Mistry Novartis Healthcare Pvt. Ltd.
Basket and Umbrella in Oncology Trials Sugunesh Sivalingam Agati Clinical
Nishanth Nalachandrasekaran
Programmer’s perspective: LEANing TFL shells Jitendra Singh Novartis Healthcare Pvt. Ltd.
Personalized medicine at the age of Real-World Evidence and AI Arnab Goswami DOCS Global
Master protocols Chandrakanth Kamlekar Novartis Healthcare Pvt. Ltd.
Electronic Diary (E-Diary) - A SAS®sy advent to optimize Questionnaires Harish Gopalarathnam DOCS Global
Vital Role of Exposure Response Analysis in Drug Development Aleti Praveen Reddy Novartis Healthcare Pvt. Ltd.

Programming : Analysis Methods

Presentation Title Name Organization
Implementation of Data Cut Off in Interim Analysis of Clinical Trials Rajitha Penchala Ephicacy Lifescience Analytics
Legacy studies & MedDRA version update Prerana Jain Novartis Healthcare Pvt. Ltd.
SAS solution to analyze competing risk in time to event data Abhramoy Mandal Novartis Healthcare Pvt. Ltd.
Adverse Events Summary by Exposure Adjusted Incidence Rate (EAIR) Aditya Movva PPD
Multiple Imputation Dayasagar Chaudhary Accenture Services Pvt. Ltd.
Rahul Sinde
SOFA Score as Primary Endpoint in Sepsis Study Purnendu Chakraborty Quartesian
Amrita Nandy
Plots in Oncology Studies Sumit Pratap Pradhan Syneos
Nimit Agrawal

Analytics : Models and Algorithms

Presentation Title Name Organization
Simplifying Clinical Trial Disclosure Through Automation Jeny R GSK Pharmaceuticals
Swathi S S
Chandrima Pal
Priya Pavithran
Cancer Prediction: Random Forest Vs Logistic Classifier Debadrita Banerjee Novartis Healthcare Pvt. Ltd.
Information Value – A way to select good predictors in Big Data Modelling Himanshu Pradhan Novartis Healthcare Pvt. Ltd.
Abheenava Kumar
Information Value – A way to select good predictors in Big Data Modelling Himanshu Pradhan Novartis Healthcare Pvt. Ltd.
Abheenava Kumar
Association Patterns within Adverse Events and other domains in Clinical Trials using Data Mining Techniques Jasmine Khurana Novartis Healthcare Pvt. Ltd.
Naeem Shaikh
Learning Eligibility in Cancer Clinical Trials using Deep Neural Networks Shantanu Nagpal Novartis Healthcare Pvt. Ltd.
Anmol Gureja
Diagnosing Diabetes using Support vector machine Soumitra Kar Novo Nordisk

Programming : Regulatory Reports

Presentation Title Name Organization
Basic Result Disclosure Report in one click Harish Kumar TATA Consultancy Services
BIMO- FDA’s Eye on Site Inspection Jasmin Jobanputra Covance
Shreetam Sheregar
Different Approaches - BIMO Site level listings Maneesha Unnikrishnan CROS NT India
Umayal Annamalai
Multiple Studies BIMO Submission Package – A Programmer’s Perspective Harsha Handigodu Dyavappa Accenture Services Pvt. Ltd.
Suspect in Anticipated Aspect Neha Gahalot Cognizant Technology Solutions
Kanchan Gund
Data Anonymization – Need & Challenges Sridhar Punniamurthi CROS NT India
Priya Govindaswamy
RTOR - FasTRack Approval Srinivas Kolamuri Novartis Healthcare Pvt. Ltd.

Programming : SAS Tips and Tricks (1)

Presentation Title Name Organization
What functions are in your future? Johnson Dsouza DOCS Global
Encoding, Transcoding with UTF-8 Shikha Sreshtha Covance
One Macro to Produce Descriptive Statistic Summary Tables with P-Values Rajaram Cognizant Technology Solutions
How sysinfo can save your time, it’s all about automation, quality!! Kiranmai Byrichetti DOCS Global
Macros Trio in SAS: Dataset Comparison and Reporting Nagaraju Mancha Ephicacy Lifescience Analytics
Traceability Marshal Chettiar IQVIA

Statistics : Analysis Methods (2)

Presentation Title Name Organization
Exploratory Analysis & Data Visualization of Clinical Trial Outcomes using R Padma Ahilaveni Cytel
Archana Patil
Prem Sagar K
Prakash P
Weighting in survey data, introduction to why and how Usha K Thamattoor Novo Nordisk
Shared Frailty Model under the Bayesian Mechanism Rajneesh Singh Covance
Sensitivity analyses of time-to-event data using Pattern Mixture Model Approaches Chaithra Shetty GSK Pharmaceuticals
Supriya K
An application of joint frailty-logistic model to investigate the association between rate and severity of exacerbations in COPD Pritam Gupta Novartis Healthcare Pvt. Ltd.
Handling multiple inter-current events in Estimands Bharath Kumar Novo Nordisk

Programming : Understanding the domain (2)

Presentation Title Name Organization
Significance of Early Development trials in Drug Development Srikanth Neelakantham Novartis Healthcare Pvt. Ltd.
Strategies and Challenges in PK/PD Programming Saira Konar Novartis Healthcare Pvt. Ltd.
ECOG performance status Ram Reddy Kanthala Novartis Healthcare Pvt. Ltd.
Leverage Process Maps- Raising the bar of automation to its highest possible extent Nikhil Upadhyay Pfizer
Immunogenicity in Oncology Studies – A Programmer’s View Vijay Raghavendra Novartis Healthcare Pvt. Ltd.
Clinical Data Security Augmentation – Steganography Vinothkumar Subramani Quartesian
Radhika Mohan Madavilakam
Nuclear Medicine Rakesh Kumar Novartis Healthcare Pvt. Ltd.
Nirupama Biswal

Programming : Data Standards (2)

Presentation Title Name Organization
Overview Of CDISC-SEND Piraisoodan Navitas Life sciences
Standardization of Biomarker to CDISC Standards Suresh Annabathina Navitas Life sciences
DONT BE REL-wRECked Haritha Varanasi Quartesian
Data Standards and Observational Studies Payal Shah Sciformix
Pinnacle 21 report - Why GUI when you can automate!! Kiruthika Bala-subramanian Pfizer
Sailing with LOINC & iRECIST Priyesh Sura Ephicacy Lifescience Analytics
Sync to Link’ ..Towards Adoption of Automation in Statistical Programming! Dr. Sangram K. Parbhane Syneos

Statistics : Trial Design

Presentation Title Name Organization
Estimation of Sample Size in Immunogenicity Trial Shirsendu Sarkar Sciformix
Sample Size Estimation with Covariate Adjustment Meenakshi Mahanta Cytel Inc
Sample Size Determination with Multiple Co-Primary Endpoints in Clinical Trials Tushar Nikumbh IQVIA
Rajendra Desai
Population Enrichment Kiran Wadje Cytel Inc
Janhavi Kale
Correlate of Protection – Introduction and challenge (Prentice Criteria) Jyoti Soni GSK Pharmaceuticals
Futility Analysis using the concept of Predictive Probability of Success (PPoS) Prateek Garg Novartis Healthcare Pvt. Ltd.
Mrigank Jain
Usefulness of Predictive Probability assessment in a Phase 2 clinical trial set up Preenan Sarkar Novartis Healthcare Pvt. Ltd.

Management and soft skills

Presentation Title Name Organization
4 things I wish I knew when I was starting out as a Statistical Programmer Jeffy Sarto Pfizer
The Great Bounce Back Devi Gopalakrishnan PPD
The Changing landscape of Skill Building Shiksha Pathak Cytel Inc
The Risky RASCI of SMEs in the programming world Charumathy Sreeraman Ephicacy Lifescience Analytics
Divya Cetlur
PAINS and GAINS in Software Development–from POC To Market Charan Kumar KJ Ephicacy Lifescience Analytics
Reshma Rajput
Visualization for Project management to Trial Management Ravi Prakash Gupta Eli Lilly

Analytics : Tools

Presentation Title Name Organization
Making workday easier through Technology Lucky Singh GenInvo
Email Dashboard Using SAS and HTML Dandothkar Sandeep Novartis Healthcare Pvt. Ltd.
R-Shiny Dashboards John Thomas Johnson Pfizer
Automation of Analysis Data Reviewer’s Guide (ADRG) through R language Vinodhkumar Katikala GSK Pharmaceuticals
Clinical SAS Programming by Auto mapper Vignesh Kumar Bala-subramanian Zifo RnD Solutions

Programming : SAS Tips and Tricks (2)

Presentation Title Name Organization
Study Level Codelist M Chanukya Samrat Novartis Healthcare Pvt. Ltd.
No Mess!!! No Fuss!!! Hassle free Deliverable with “SWIGGY” !! Saisuraj Srinivasan Symbiance Pvt. Ltd.
Tricky sorting in SAS Neha Saxena PPD
Re-screened Subject? We are ready for you Kalpesh Valaki Covance
Utility of parallel processing in clinical SAS Vinayamani Menneni PAREXEL Pvt. Ltd.
Vikramaditya Yandapalli
ERROR: A lock is not available for YYYXX.DATA - No Worries!! You can still update and continue your Job Vijay Dharmaraj Azhagurajan Symbiance Pvt. Ltd.
Tips to improve TLFs SAS Programming Sangeetha Sathaiah Zifo RnD Solutions

Statistics : Invited Talks

Presentation Title Name Organization
Statistical Inputs in deciding Go / No-go for Generics and Biosimilars in Early Development Christian Russel Reyes, Associate Director Pfizer
Safety data in clinical trials: The Past, Present and future Genevieve Wills, Medical statistician Medical Research Council at University College, London
Instantaneous Risk Ratio function and its use in disease-disease mapping for Real World Evidence studies Ashwini Mathur, Head - Data Science & AI Novartis

Programming : Invited Talks

Presentation Title Name Organization
Real World Data & Analysis -book your place in the battlefront! Ajay Sathe, Head - India Operations Cytel
Metadata Management & Related Automations – The good, The bad & The ugly… Tushar Sakpal, AVP, Biostatistics & Programming Tata Consultancy Services

Student Poster Index Day-1

Presentation Title Name Organization
A comparative study of efficacy and acceptability of pharmacological drugs for the treatment of acute bipolar mania: a Bayesian network meta-analysis for binary outcome data Palash Kumar Malo NIMHANS Bengaluru
B. Binukumar
Muralidharan K.
K. Thennarasu
A Statistical Test: To Test the Impact of Increasing Level of Dose Manish Goyal Panjab University, Chandigarh
Narinder Kumar
Application of non-linear and non-parametric regression on medical data Shivshankar S Christian Medical College
Mahasampath Gowri
Application of Path Analysis Gowtham Hegade Manipal Academy of Higher Education
Dr. Shreemathi S Mayya
Comparative efficacy of Paroxetine, an antidepressant drug - A Meta-analysis Anoop Joseph NIMHANS Bengaluru
Palash Kumar Malo
Dr. B. Binukumar
Comparison of Cox Regression Analysis (CRA) and Ensemble Machine Learning Methods for Analysing Survival Data Aratrika Ghosh Christian Medical College
Comparison of Least Absolute Shrinkage and Selection Operator (LASSO) with a Combination of Stepwise Tuning in Maximum C-Index & Forward Nested Subset Selection (STMC & FNSS) in Survival model Mini Jayan NIMHANS Bengaluru
Dr.P. Marimuthu
Covariate Adaptive Randomization-An approach to balance continuous co-variates using Non-parametric methods Nivetha S Christian Medical College
Arunangshu Biswas
Diagnostic Classification of Scrub Typhus Based on Laboratory Investigations: Using Mixture Modelling Approach G. Kiruthika ICMR-National Institute of Epidemiology
Manoj V. Murhekar
Jeromie Wesley Vivian Thangaraj
Velusamy Saravanakumar
From Medical Image to Disease Diagnosis: A Multivariate Analysis Perspective Josmin Rose Joseph Manipal Academy of Higher Education
Dr. Vani Lakshmi R
Impact of Environmental Factors on Cardiac Arrest Mortality Sreerag T N Manipal Academy of Higher Education
Dr. Vipin N
Intermediate event model using Nelson-Aalen and Aalen-Johnsen estimator Sivakami Sundari S Christian Medical College
Grace Rebekah
Joint modelling of Binary outcome and Survival data in Clinical research Amrutha Jose NIMHANS Bengaluru
Dr. Bingshu Chen
Dr. Mariyamma Philip
Dr. M. Manjula
Latent Class Growth Trajectories in patients with Severe and Resistant Obsessive-Compulsive Disorder Aakash Bajaj NIMHANS Bengaluru
Srinivas Balachander
Thennarasu Kandavel
Janardhan Reddy YC
Machine Learning – The Emerging Underdog in Health Care Shardul Deshmukh GITAM Deemed To Be University
Amresh Singh
Mixed Data Types in Medical Data: Challenges and Opportunities Najma Ashraf Manipal Academy of Higher Education
Dr Vani Lakshmi R
Multicollinearity and Variable Selection Methods in Multiple Linear Regression Dilshad Naseem Ara Christian Medical College
Reka
Optimization of Clinical Trials using Bandit Algorithm Shubham Jain IIT-BHU, Varanasi
Dr. M. S. Muthu
Vikash Kumar
Shubham Patel
Population Biodiversity study of rubella virus using a statistical approach Anjali Nehul Department of Statistics, SPPU
Mrudula Belgal
Keerti Athalye
Population Genomics Study of Rabies Virus using Statistical approaches Ananya Pandurang Pisal Savitribai Phule Pune University
Hemlata Uttamrao Rathod
Vaishnavee Digambar Charpee

Poster Index Day-2

Presentation Title Name Organization
Abecedario about PMDA Durai Gopal ICON Clinical Research India Pvt. Ltd.
Sujay Doss
Act before rejection: Optimizing the study data submission Shelendra Pawar GSK Pharmaceuticals
An Effective way of handling missing data Praveenraj Mathivanan Quartesian
Prakash Subramaniam
Can we really rely on an IVD? Taniya Chatterjee Novartis Healthcare Pvt. Ltd.
CDISC Checks, a private detective Sangeetha Sathaiah Zifo RnD Solutions
Digital transformation in Clinical trials Prabhakar Munkampalli PAREXEL Pvt. Ltd.
EC and EX Domains in CDISC SDTM Submissions Kavya Tirupathi Clinipace Clinical Research
Evolution of Statistical Programmer role and Developing Staff Skill Set Sathish Kumar Thota PAREXEL Pvt. Ltd.
Fraud Detection using Mahalanobis Distance in Risk Based Monitoring Abhyuday Chanda Quartesian
Have you addressed ICE? Mohd Tariq Novo Nordisk
Hierarchical Data in Clinical Trials - The Need for Visualization Kishore Kumar Sundaram Agati Clinical
HIV eliminated from the genomes of living animals for the first time Lavanya Sundaram Bayer Pharmaceuticals
Immuno-Oncology The 4th Pillar of Cancer Therapy: How does it challenge the ground rules of conventional statistical methodologies Jomy Jose GSK Pharmaceuticals
Interpretation of Commonly Used Graphs in Oncology Trials Janki Chokshi Cognizant Technology Solutions
Item response models for the longitudinal analysis of health-related quality of life in cancer clinical trials Anmol Gureja Novartis Healthcare Pvt. Ltd.
Shantanu Nagpal
Kit Randomization - Methods for labeling drug kits Navneet Jha IQVIA
Rajendra Desai
Multiple Imputation in ADaM Sudeepto Roy Quartesian
Silvia Biswas
New frontiers in immuno-oncology (Post PD-1/PD-L1 wave) Thejas M S GSK Pharmaceuticals
Udaykumar
Re-Screened Subjects Ambiguities, Approaches and Standards Vignesh Kumar Bala-subramanian Zifo RnD Solutions
RWE in clinical trials – still a far fetched dream? Radhika Chawda GSK Pharmaceuticals
The Journey of a Companion Diagnostic Purbayan Chatterjee Novartis Healthcare Pvt. Ltd.
Unboxing 3.3 Shweta Padmanaban Zifo RnD Solutions

Poster Index Day-3

Presentation Title Name Organization
A Brief Insight on COPD Questionnaires Priyanka Thumganti GSK Pharmaceuticals
Adapting to new technologies in clinical trials with Adaptive trial design – a programmer’s view Bhakti Gadekar Quartesian
AI in clinical trials and disease prediction Nitesh Kumar Dubey Covance
Puja Jaiswal
An Overview of Bayesian Generalized Linear Mixed Model Shaheen Islam Novartis Healthcare Pvt. Ltd.
Balancing Benefit and Risk in Medical Device Regulation Shivaram Nagabhushana Sharma DOCS Global
E2E analysis of Bioequivalence Using R P Karthik Pfizer
N Mouli
Effective analysis and better insights by implementing Bigdata and Blockchain data Venkateswarlu Layam Pfizer
Efficiency of the Zero-Inflated Possion Model and Hurdle Model to handle Responses with excess zero counts Amila Poddar PAREXEL Pvt. Ltd.
Hassle-free Integration Sreelekha Pasupuleti Zifo RnD Solutions
Mental health data analysis: perspective from a clustered randomization trial to assess community(public) health data comparing GLIMMIX vs. GENMOD Sitaram Sahoo The George Institute for global health, New Delhi
Meta-Analysis and Forest Plotting in Clinical Trials Senthilnathan Ramanathan Agati Clinical
Prasanth Palanisamy
Necessity is mother of i[az]+tion Ninan M Luke Pfizer
Network Meta-Analysis Sohan Dey Novo Nordisk
Patient Narratives using SAS Nisha Amin Sciformix
Rescreening and Data mapping in SDTM Vidya Sagar Siripurapu Novartis Healthcare Pvt. Ltd.
Significance of Concordance Check Priyanka Sarode GSK Pharmaceuticals
Standardized MedDRA Queries in AE safety Analysis Shoba GS Cognizant Technology Solutions
Tests for “the tests” Satya Swati Kapuganti Novartis Healthcare Pvt. Ltd.
The one click solution for convert and combine the TFL’s using SAS and java - Stay Relaxed !!! Gunasekaran Panchamoorthy Symbiance Pvt. Ltd.
T-QT Waiver: Concentration-Response (CR) Analysis - Programming Aspect Harshit Yadav Novartis Healthcare Pvt. Ltd.
Janardhana Vemula
Unconventional Designs in Clinical Trials Prasannakannan A Quartesian
Using Dictionary Tables in Your SAS Code Nakul Kamath GSK Pharmaceuticals