ConSPIC 2019 Agenda - IASCT · 2019-11-09 · 1 ConSPIC 2019 Agenda November 13, 2019 - Day 1 Time...

1

ConSPIC 2019 Agenda

November 13, 2019 - Day 1

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

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ConSPIC 2019 Agenda



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


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

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ConSPIC 2019 Agenda



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


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

4

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


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

Presenter’s Index Day-1

Programming:

Data Standards (1)


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

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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


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.

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Analysis of HMIS data with standard software tools to generate insightful empirical evidence of Ayurveda practice in a University hospital

Sadanand Deshmukh


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


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)


Can a Programmer be a Statistician??? Nirav Mistry Novartis Healthcare Pvt. Ltd.

Basket and Umbrella in Oncology Trials

Sugunesh Sivalingam

Agati Clinical Nishanth Nalachandrasekaran

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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


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


Programming:

Analysis Methods


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


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


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


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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


Basic Result Disclosure Report in one click Harish Kumar TATA Consultancy Services

BIMO- FDA’s Eye on Site compilance

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


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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



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

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Programming: Understanding the domain (2)


Significance of Early Development trials in Drug Development

Srikanth Neelakantham


Strategies and Challenges in PK/PD Programming

Saira Konar Novartis Healthcare Pvt. Ltd.

ECOG performance status Ram Reddy Kanthala


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


Clinical Data Security Augmentation – Steganography

Vinothkumar Subramani

Quartesian Radhika Mohan Madavilakam

Nuclear Medicine Rakesh Kumar


Nirupama Biswal

Programming: Data Standards (2)


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

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Statistics:

Trial Design


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:


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 L&Dscape 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

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Analytics:

Tools


Making workday easier through Technology Lucky Singh GenInvo

Email Dashboard Using SAS and HTML Dandothkar Sandeep


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



Study Level Codelist M Chanukya Samrat


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

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Student Poster Index Day-1

Poster Title Name Institute

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

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

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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

National Institute of Mental Health and Neurosciences

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

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Poster Index Day-2

Poster 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


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 TATA Consultancy Services

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

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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


Unboxing 3.3 Shweta Padmanaban

Zifo RnD Solutions

Poster Index Day-3

Poster 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.

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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


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


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

ConSPIC 2019 Agenda - IASCT · 2019-11-09 · 1 ConSPIC 2019 Agenda November 13, 2019 - Day 1 Time...

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Transcript of ConSPIC 2019 Agenda - IASCT · 2019-11-09 · 1 ConSPIC 2019 Agenda November 13, 2019 - Day 1 Time...