conspic 2019 agenda - iasct · 2019-11-09 · 1 conspic 2019 agenda november 13, 2019 - day 1 time...
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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
2
ConSPIC 2019 Agenda
November 14, 2019 - Day 2
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
3
ConSPIC 2019 Agenda
November 15, 2019 - Day 3
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
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
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
Presenter’s Index Day-1
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
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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
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.
6
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
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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
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.
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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
Presenter’s Index Day-2
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 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
Novartis Healthcare Pvt. Ltd.
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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
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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
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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.
Presenter’s Index Day-3
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 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
12
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
13
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
14
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
15
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
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 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
16
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
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.
17
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