PK-PD Concepts and Programming Bangalore, India. 6th December India SDE

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1 PK-PD Concepts and Programming Bangalore, India 6th December 2014 India SDE

Welcome Dear Single Day Event Attendee, We, on behalf of the organising committee would like to welcome you all to this PhUSE Single Day Event in Bangalore.

The theme of this event is PK-PD Concepts and programming. We have choosen this theme because we realised that there is a need for data scientists to understand PK-PD Concepts at length.

2 Welcome Dear Single Day Event Attendee, We, on behalf of the organising committee would like to welcome you all to this PhUSE Single Day Event in Bangalore. Since its inception in 2005, PhUSE has been focussed on organising events of interest in the Pharma industry and since 2013 the PhUSE India working group has focussed on organising events in India. The theme of this event is PK-PD Concepts and programming. We have choosen this theme because we realised that there is a need for data scientists to understand PK-PD Concepts at length. Today s presentations will help them to understand PK-PD Concepts in details and eventually help them in programming PK-PD data. We would like to thank our sponsors Quanticate, Quintiles and Theorem for their support of this PhUSE Single Day Event in India. This event would not have been possible without the effort of the organising committee and we would like to thank them as well for all their contributions. Looking at today s remarkable response, we hope for many more events in India and Asia in the future. We wish to extend our gratitude and welcome to all organisors, participants and sponsors of the event. We hope all of you will enjoy this event and will learn a lot about the Pharma industry in general and about graphs and visualisation in particular. This event will provide you a great networking opportunity as you will get chance to meet many people from different companies. Shashi Konanur Event Chair Nand Kishore Rawat Events Coordinator 2 India SDE 2014

3 Agenda Time Title and speaker 08:30-09:00 Registration and Light Refreshments 09:00-09:15 Welcome and Overview of PhUSE Shashi Konanur (Quintiles) & Ajay Sathe (Cytel) 09:15-09:45 Plenary Session Jaya Pisupati (Quintiles) 09:45-13:00 PK-PD Concepts in Clinical Research (with tea break) Dr. Dhanashri Gudi (Founder, EduCater) 13:00-14:00 Lunch 14:00-15:00 NONMEM PK-PD Dataset Programming, Making it Simpler Ravichandra Hugar, Sandeep Lakkol (Theorem Clinical Research) 15:00-15:45 Whats and Whys of Combining Clinical and Pharmacokinetic Database Vijayalakshmi Gajulapalli (Novartis) 15:45-16:15 Afternoon Break 16:15-17:15 Demystify Analysis Dataset of Pharmacokinetic Concentration and Analysis Datasets of Pharmacokinetic Parameters Hema Krishnamoorthy (Quanticate) 17:15-17:30 Wrap-up and Closing Remarks Shashi Konanur (Quintiles) India SDE

4 Speakers and Abstracts 09:15 09:45 Plenary Session Dr. Jaya Pisupati Quintiles Biography Dr. Jaya Pisupati is a Research Pharmacokineticist/Director in the Clinical Pharmacology Department at Quintiles Inc., Overland Park, Kansas, USA. Dr. Pisupati has over 10 years of research experience which encompasses all areas of pharmacokinetics and clinical pharmacology from first-inhuman to late phase clinical trials. Her job responsibilities include design, conduct analysis and reporting of clinical pharmacology studies (including safety/tolerability, proof of concept, biopharmaceutics, drug-drug interaction, special population, and QT/QTc studies), PK/PD and population PK/ PD modeling and providing pharmacokinetics consultation on Phase I to III programs. Dr. Pisupati obtained a bachelors and masters degree in pharmacy at Andhra University (India), a masters in pharmacology at the University of Strathclyde in Scotland (UK) and a PhD. in pharmaceutical sciences (in-vivo pharmacokinetics and clinical pharmacokinetcs of Cellcept in liver transplant patients) at the University of Pittsburgh, Pittsburgh, PA, USA. Dr. Pisupati is the author of six peerreviewed publications/abstracts. 4 India SDE 2014

5 09:45 13:00 PK-PD Concepts in Clinical Research Dr. Dhanashri Gudi Founder, EduCater Abstract Today s fast-paced drug development environment is characterized by the generation of voluminous amounts of data. Indeed, one needs to have the ability to efficiently extract pertinent knowledge from new data and have proper tools to analyse it. Understanding the basics of Pharmacokinetics (PK) and Pharmacodynamics (PD) are stepping stones for further in depth understanding of PK/PD concepts and PK/PD modeling. The aim of this introductory workshop is to present fundamental pharmacokinetic concepts in a manner that will allow participants without a specific pharmacokinetic background to subsequently apply these principles to their work. Topics covered will include: understanding physiological aspects of drug absorption, distribution, metabolism and elimination. Definition, derivation and significance of pharmacokinetic parameters will be discussed at length and participants will gain insights in non-compartmental and compartmental analysis. They will also be introduced to PK/PD concepts, different models and analysis. At the end of workshop there will be a demonstration of using Phoenix WinNonlin for PK analysis. At the conclusion of this workshop, participants will be able to calculate essential pharmacokinetic parameters, such as the rate and extent of absorption, clearance, volume of distribution and half-life from simple concentration-time data. Biography Dr. Dhanashri Gudi obtained her bachelors and masters in pharmaceutical sciences from Mumbai University. She got her PhD. in pharmaceutical sciences at the School of Pharmacy, West Virginia University, Morgantown WV followed by a post-doctoral fellowship in clinical pharmacology at the School of Medicine Indiana University. She then worked in the area of drug discovery and development at Abbott Laboratories, IL for two and a half years before returning to India. She has eight publications to her credit. Currently she serves as a Technical Director in Grindlays Pharmaceuticals which is involved in manufacturing of drug intermediates as well as finished formulations. She started and is a partner in Q-Source, which is involved in import and export of fine chemicals. In 2011, she founded EduCater which offers training to pharmaceutical scientists in industry as well as academia. She has coordinated several workshops in the areas of pharmacokinetics, statistics, drug metabolism and PK/PD modeling across the country. Overall she has more than ten years of experience in the pharmaceutical sector in diverse roles ranging from drug discovery, clinical pharmacology, pharmaceutical intermediate synthesis, formulation development, marketing and pharmaceutical education. India SDE

Speakers and Abstracts 14:00 15:00 NONMEM PK-PD Dataset Programming, Making it Simpler Ravichandra Hugar, Sandeep Lakkol Theorem Clinical Research Abstract Pharmacokinetics is the study of what the

PK/PD analysis guides in taking critical decision for the drug development such as optimizing the dose, frequency and duration of exposure.

6 Speakers and Abstracts 14:00 15:00 NONMEM PK-PD Dataset Programming, Making it Simpler Ravichandra Hugar, Sandeep Lakkol Theorem Clinical Research Abstract Pharmacokinetics is the study of what the body does to a drug whereas Pharmacodynamics is often summarized as the study of what a drug does to the body which helps explain the relationship between the dose and response, i.e. the drug s effects. PK/PD analysis guides in taking critical decision for the drug development such as optimizing the dose, frequency and duration of exposure. Selecting the tools for making such decisions is equally important. Fortunately, PK/PD analysis software has evolved greatly in recent years. The effect of the drug on the target population of patients is predicted using nonlinear mixed effects modeling software called NONMEM Analysis (a powerful software tool for population pharmacokinetic/ pharmacodynamics (PK/PD) modeling), which is becoming more and more common in clinical trials. Here the SAS Programmer s role is to create a standard dataset structure ready to be compatible for NONMEM software model. This is often the nightmare part of the process because it involves collecting multiple domains of datasets together along with the time dependent / independent covariate variables that are needed for the analysis, which includes imputation rules for covariates. Thereby getting the desired NONMEM data structure comprising of dosing and concentration records. This presentation provides the simplest way for the programming group to clearly understand the characteristics and programming methods in achieving the required model structure. It also overcomes the problems that may arise and finally minimize the time taken for creating the final NONMEM dataset. Biography Ravichandra Hugar is working as a Senior Statistical Programmer Analyst for Theorem Clinical Research, India. He started his career with Theorem and has around five years of experience in statistical programming. Ravi holds a bachelor degree in engineering (electronics and communication) from Basaveshwara Engineering College, Bagalkot which is affiliated to Visvesvaraya Technological University, Belgaum, Karnataka. In his role at Theorem, Ravi has been working on analysis and reporting of all phases of clinical trial data. He has experience in many therapeutic areas like oncology, immunology, gastroenterology, dermatology, musculoskeletal and infectious disease. Ravi also possess substantial experience in analysis of PK/PD data for Phase I trials. Sandeep Lakkol is working as Senior Statistical Programmer Analyst for Theorem Clinical Research, India. He started his career with Theorem as an intern and has approximately five years experience in statistical programming. Sandeep holds a bachelor degree in engineering (electronics and communication) from Don Bosco Institute of Technology, Bangalore which is affiliated to Visvesvaraya Technological University, Belgaum, Karnataka. 6 India SDE 2014 In his role at Theorem, Sandeep has been working on analysis and reporting of all phases of clinical trial data. He has experience in many therapeutic areas like dermatology, gastroenterology, neurology, oncology, pediatrics, musculoskeletal, infectious disease and vaccine. Sandeep also possess substantial experience in analysis of PK/PD data for Phase I trials.

15:00 15:45 Whats and Whys of Combining Clinical and Pharmacokinetic Database Vijayalakshmi Gajulapalli Novartis Abstract According to Regulatory Guidelines it is vital for sponsors to investigate

7 15:00 15:45 Whats and Whys of Combining Clinical and Pharmacokinetic Database Vijayalakshmi Gajulapalli Novartis Abstract According to Regulatory Guidelines it is vital for sponsors to investigate the extent and rate of A-D-M-E of drugs under development. Demographic, dose exposure and other related data from the clinical database, Pharmacokinetic data are collected and stored at different sites. All this data needs to be combined to draw the inference. Combining of the data among the sites need to be consistent and organized to ensure that the clinical data is correctly related to associate PK data. Biography Vijayalakshmi Gajulapalli is currently working as a Senior Statistical Programmer at Novartis Healthcare Pvt. Ltd., India. She has a batchelor s degree in CS and statistics and a masters degree in business administration (MBA). She has over seven years experience in analysis and reporting of clinical studies as statistical programmer with a good understanding of CDISC standards and comprehensive programming experience in SDTM and ADaM creation. India SDE

Speakers and Abstracts 16:15 17:15 Demystify Analysis Dataset of Pharmacokinetic Concentration and Analysis Datasets of Pharmacokinetic Parameters Hema Krishnamoorthy Quanticate Abstract Knowledge

8 Speakers and Abstracts 16:15 17:15 Demystify Analysis Dataset of Pharmacokinetic Concentration and Analysis Datasets of Pharmacokinetic Parameters Hema Krishnamoorthy Quanticate Abstract Knowledge brings light to any discussion and I hope to bring a ray of light through this presentation Demystify ADPC and ADPP that can help clear our minds and the path before us in creating ADaM PC and PP datasets. With the fact that the Pharmacokinetic (PK) data is produced from different sources with different data formats: sample collection on CRF, concentration results from lab findings and parameters calculated by pharmacokineticist, this brings a lot challenge for the programmers in preparing ADaM PC and PP datasets for regulatory submission. This presentation aims to provide an insight into the PK analysis process flow and implementation of CDISC standards in creation of ADPC and ADPP datasets. Biography A Computer Science Engineer by education, Hema is currently working with Quanticate International Ltd., based in Bangalore. Prior to this Hema has worked with GSK as a lead programmer. She has worked on Pharma and CRO for almost six years. Hema has a good understanding and working knowledge of CDISC and has worked on many early phase trials and in the reporting of Pharmacokinetic analysis for regulatory submission in different standards. She was one of the early adopters in implementation of CDISC standards in PK submission, including creation of SDTM and ADaM PC and PP domains. 8 India SDE 2014

9 Enter our SAS Programming Competition - WIN Rupees 10 Lakh! The Challenge: The challenge will consist of creating a generic set of SAS macros to convert SDTM data to ADaM standards based on the latest available CDISC specifications and implementation guides. The competition is now open and will end on February 28th If you have any questions please do not hesitate to ask by ing programming.competition@quanticate.com India SDE

Rosario, PhD Director, Office of Computational Science, FDA Steve E.

10 Computational Science Symposium March 14th 17th 2015 Silver Spring Civic Center I Silver Spring, Maryland, USA Program Co-Chairpersons Lilliam Rosario, PhD Director, Office of Computational Science, FDA Steve E. Wilson, DrPH, CAPT. USPHS Director of Biometrics III, CDER, FDA 10 India SDE 2014 phuse.eu/css

Vienna 2015 Clinical Data Science From Data to Knowledge Annual Conference Intercontinental Wien Hotel, Vienna October 11th 14th Conference Chair: Chris Price

11 Vienna 2015 Clinical Data Science From Data to Knowledge Annual Conference Intercontinental Wien Hotel, Vienna October 11th 14th Conference Chair: Chris Price (Roche) Conference Co-Chair: Åsa Carlsheimer (Ferring Pharmaceuticals) For more information visit the PhUSE website: phuse.eu/annual-conference.aspx India SDE

PhUSE India Working Group Ajay Sathe Cytel Ajay s 27 years experience spans managing businesses in software development, information services and outsourced analytics services.

Ajay is currently CEO of Cytel s Indian operation and is responsible for Cytel s software development and analytics services delivered out of the Indian offices.

12 PhUSE India Working Group Ajay Sathe Cytel Ajay s 27 years experience spans managing businesses in software development, information services and outsourced analytics services. After studying Engineering and Business Management, Ajay worked in quantitative software development and co-founded and ran Spectrum Business Support Ltd. prior to joining Cytel. Ajay is currently CEO of Cytel s Indian operation and is responsible for Cytel s software development and analytics services delivered out of the Indian offices. Lovita N Fernandes Accenture Lovita has extensive experience in the field of statistical programming in the life science industry. She has an overall experience of nearly ten years, which includes working on therapeutic areas like CV, oncology, immunology, etc. across various phases of the clinical trial, for which she has used SAS. She also has good experience of working with CDISC standards like SDTM and ADaM. Lovita is the Group Lead at Accenture Operations Life Science Vertical, handling various roles like recruitment, branding and resourcing, in addition to, her core responsibilities of project and people management. Lovita holds a masters degree in computer science from the University of Mumbai. Krishnendu Biswas Cognizant Krishnendu is currently working as a Deputy General Manager at Cognizant Technology Solutions, Mumbai. Prior to joining Cognizant, he has worked with Tata Consultancy Service and Pfizer in Mumbai. He has over nine years of experience in clinical trial domain as a Statistician. Nand Kishore Rawat Cytel Nand is working as Lead Biostatistician in Cytel Statistical Software and Services Pvt. Ltd., Pune. He did his Ph.D. in Statistics from Rajasthan University. He has more than ten years of experience in the clinical domain. He worked with Ranbaxy, Novartis and Bristol Myers Squibb prior to joining Cytel. 12 India SDE 2014

Sarvesh Singh ICON Sarvesh Singh is Director, SAS Programming at ICON Clinical Research. He completed his MBA from Rotterdam School of Management and MSc. in statistics from the University of Delhi.

He has also spearheaded global transition for a top Japanese pharmaceutical customer and led a virtual global team spread across India and Netherlands.

Senthil Kumar K TAKE Solutions Senthil has more than seven years of experience and expertise in statistical programming, data standardisation and building clinical information systems.

13 Sarvesh Singh ICON Sarvesh Singh is Director, SAS Programming at ICON Clinical Research. He completed his MBA from Rotterdam School of Management and MSc. in statistics from the University of Delhi. Prior to joining ICON; he worked with TATA Consultancy Services (TCS) for close to ten years. He has also spearheaded global transition for a top Japanese pharmaceutical customer and led a virtual global team spread across India and Netherlands. Currently he is a member of PhUSE India working group and also of scientific committee of CONSPIC for Senthil Kumar K TAKE Solutions Senthil has more than seven years of experience and expertise in statistical programming, data standardisation and building clinical information systems. He is responsible for the development and implementation of the SAS based reporting systems for analysis and reporting of clinical trial data for submission activities. After his academics in Engineering Senthil worked with KINSHIP Technologies as Senior System Analyst prior to joining TAKE Solutions. Shashi Konanur Quintiles Shashi Konanur works for Quintiles as an Associate Director. Shashi has 16 years of programming experience working across the life science and finance sectors, of which, 12 years has been within the life sciences organisations, working with companies such as TCS, Ephicacy, SIRO Clinpharm, Biogen-Idec and Biogen. He is a management graduate from Alliance Business School, majored in lean operations strongly backed by a computer science and engineering degree. Tushar Vijay Sakpal TCS Tushar works as a Domain Consultant in the Biostatistics and Statistical Programming group of TCS in India. Prior to joining TCS, he worked with PharmaNet-I3, SIRO Clinpharm, Reliance, Pfizer and GE Capital. He has more than 12 years experience and has expertise in biostatistics, statistical programming and data management. He is also Six-sigma Green Belt certified. India SDE

14 Thanks to our Sponsors 14 India SDE 2014

15 India SDE

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