India SDE 2015 | 1

Statistics, Programming and Data Standardisation Considerations for Oncology

Lonavala, IndiaDecember 5th 2015

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WelcomeDear Single Day Event Attendee,

We, on behalf of the organizing committee, would like to welcome you all to this PhUSE Single Day Event (SDE) in Lonavala. Since its inception in 2005, PhUSE has been focused on organizing events of interest in the pharma industry; and, from 2013 onwards, the PhUSE India Working Group has focused on conducting events in India.

The theme for this SDE is “Oncology”. Drug development in oncology is witnessing a remarkable transformation fuelled by innovation, commitment to R&D and the advent of targeted therapies. The spectacular emergence of novel approaches to treatment and the control of cancer bring in their wake new challenges for the biometrics profession.

The first part of the day aims to impart an understanding of oncology and therapeutic-area-specific considerations in statistical designs, endpoints, programming challenges and data nuances. Following the lunch break we will talk about the SDTM and ADaM tips and tricks in oncology therapeutic areas. The day will come to an end with a discussion on how India can become the biostatistics and programming hub for oncology trials. The audience will have the opportunity to interact directly with our esteemed panel.

We would like to thank our sponsors Chiltern, Cytel, Navitas, PPD and Sciformix for their support. This event would not have been possible without the effort of the organizing committee, and we would like to thank them for all their contributions. A big thank you to all our presenters and panelists for dedicating time and effort for the success of this event.

We welcome all organizers, participants and sponsors of the event.

As usual, your feedback is important to us. We want to deliver the best events possible and we will review any comments or suggestions you make with great interest and will try to action them for future events.

Many thanks for your participation.

Best Regards,

Tushar Sakpal and Krishnendu BiswasPhUSE India Single Day Chair Organizers, Lonavala 2015

Drug development in oncology is witnessing a remarkable transformation fuelled by innovation, R&D and the advent of targeted therapies. The emergence of novel approaches to treatment and the control of cancer bring in new challenges

AgendaTime Title and Speaker08:30 - 09:00 Registration and Refreshments09:00 - 09:10 Welcome & Introduction

Sarvesh Singh, ICON & Ajay Sathe, Cytel09:10 - 10:30 Oncology as a Therapeutic Area in Clinical Trials

Digant Gupta, Independent Consultant10:30 - 10:45 Morning Break and Refreshments10:45 - 11:15 Endpoints and Other Considerations in Oncology

Amitava Mukhopadhyay, Cytel11:15 - 11:45 Optimizing the Utility of Evidence from Multiple Sources in Oncology Outcomes Research

Sameer Gokhale, Novartis 11:45 - 12:15 Clopper-Pearson Confidence Interval in SAS – Using Proc Freq

Anik Chatterjee, Novartis12:15 - 12:45 Statistical Analysis Considerations in Clinical Oncology Trials

Sunil Babu, Quintiles 12:45 - 13:15 Standards Update on Oncology from the CDISC Therapeutic Area User Groups

and ADaM Oncology Sub-teamTerek Peterson & Gaurab Chakraborty, Chiltern

13:15 - 14:00 Lunch14:00 - 15:25 SDTM – Tips and Tricks Oncology Domains

Abhijeet Sen, Cognizant & Godfrey Machado, TCS15:25 - 15:30 Relaunch of PhUSE Tube

Anik Chatterjee & Surendra Kandregula, Novartis15:30 - 15:45 Afternoon Break and Refreshments15:45 - 16:45 ADaM – Tips and Tricks Oncology Domains

Janki Chokshi, Cognizant & Shubhangi Majrekar, TCS16:45 - 17:45 Panel Discussion: India – B&SP Hub for Oncology Trials – Lets Make it Happen

Mandar Oak, Independent Consultant, Sameer Gokhale, Novartis, Arghya Chattopadhyay, TCS, & Kishore Kumar Balaji, Cognizant

17:45 - 18:00 Closing RemarksTushar Sakpal, TCS & Krishnendu Biswas, Cognizant

Tushar SakpalTCS

Krishnendu Biswas Cognizant

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Sponsors

Interested in sponsoring a PhUSE Single Day Event? Visit the PhUSE website for more information http://www.phuse.eu/SDESponsorship.aspx

Your clinical research program is different – because it’s yours. To make the most of it, you need a CRO who brings more to the table than a predetermined process. You need a partner who starts by understanding your situation and learning about your exact specifications – experienced professionals who customize engagements so the services you get are perfectly matched to your vision and goals. That’s our approach. Let’s talk about yours.

www.chiltern.com

US: +1 910 338 4760UK: +44 (0) 1753 512 000

Designed Around You

©2014 C

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hiltern is an Eq

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We provide strategy, execution and analytics for your data as its goes from discovery to patient with these services:

Consulting

Clinical Data Management

Biostatistics & Statistical Programming

Clinical Data Standardization

Regulatory Strategy & Submissions

Data Monitoring Committees (DMCs)

Endpoint Adjudication Committees (EACs)

• Timely access to quality data

• Improved analysis & reporting

capabilities

• Improved operational

effectiveness and cost savings

• More effective responsiveness to

potential drug safety issues

With Navitas you can expect:

We are domain experts in the areas of Clinical, Regulatory, Safety and Compliance. We pride ourselves on our

industry insight, our simplification approach and our pragmatic solutions. Our capabilities cover; industry leading

networks, strategic and change management consulting, technology and BPO. We are motivated by the success

of our clients; improving outcomes, ensuring compliance and enabling growth.

For more informationNavitas LLP, 2nd Floor, Block - A1, Shriram “The Gateway SEZ”, No.16, GST Road, Perungalathur, Chennai-600063, India

Phone +91 44 4590 9000 email contact@navitas.net or visit www.navitas.net

/company/navitas-life-sciences /NavitasLS

Improve Clinical Decision Making with Navitas’

Clinical Data Specialists

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About UsPPD is a leading global contract research organization providing drug discovery, development, lifecycle management and laboratory services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 46 countries and more than 13,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help clients and partners accelerate the delivery of safe and effective therapeutics and maximize the returns on their R&D investments.

Imagine being involved in cutting-edge drug development research that has the potential to improve the lives of people around the world. If you are passionate about your work, and want to apply and develop your skills, PPD provides rewarding career opportunities in a variety of fields. We’re looking for motivated and enthusiastic team players to help our clients accelerate delivery of safe and effective therapeutics for some of the world’s most urgent health needs.

PeopleAt PPD, we recognize our employees are the cornerstone of our success and will strive to provide a supportive and respectful environment that provides meaningful and challenging work and opportunity to acquire valuable skills. We recognize teams and individuals who make ownership, quality and a solution-focused, “can do” attitude hallmarks of their work.

ServicesPPD has been established in India for over ten years and has the following departments in India:• Biostatistics & Statistical Programming• Clinical Management • Data Management • Global quality and compliance • Pharmacovigilance • Process and learning services • Regulatory affairs • Site intelligence-activation • Strategic proposal development

Our statisticians and programmers support a wide range of services including:• Consulting services and collaboration on the

design of program development plans • Development of study protocols, including

power and sample size calculations • Randomization schedules that can be further

integrated into interactive response systems • Detailed statistical analysis plans consistent

with ICH guidelines • Statistical analyses and reporting of study results • Graphical and tabular patient profile presentations • Development and production of integrated safety

and efficacy summaries • Development and production of CDISC Study Data

Tabulation Model (SDTM), Analysis Data Model (ADaM) and Laboratory Data Model (LAB) data together with definition files

• Marketing application submissions with electronic capabilities and experience

• Support for interim analyses including safety and endpoint monitoring boards

• Phase I study support, including pharmacokinetic (PK) modeling and analysis

• Dedicated epidemiologists to support pharmacoeconomic, observational and patient reported outcomes research.

ppdi.com

USA | UK | India | Philippines

Safety and Risk Management | Clinical Research and Post-Approval Support | Regulatory A�airs and Operations

Contact us today at ask@sciformix.com

Learn more at www.sciformix.com

Sciformix Corporation is a leading global scientific process organization (SPO) that partners with life science companies to develop, launch and sustain medical products that aim to improve the quality of healthcare worldwide.

We collaborate with our clients through the entire product development lifecycle to provide a full range of Safety & Risk Management, Regulatory Affairs & Operations, and Clinical Development & Post-Approval Support services from study design to post-marketing surveillance and commercialization support.

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Notes

Fast Track to Approval: Speed and EfficiencyBarcelona 20169th–12th OctoberPrincesa Sofia Gran Hotel, Barcelona

Conference Chair Åsa Carlsheimer, TrialbeeConference Co-Chair Jules Van der Zalm, OCS ConsultingFor more information visit the PhUSE website phuse.eu/annual-conference.aspx

Annual Conference

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Computational Science SymposiumMarch 13th–15th 2016Silver Spring Civic Center, Silver Spring, Maryland, USA

Registration Opens November 2nd 2015Call for Posters Closes January 15th 2016Early Bird Registration Closes January 29th 2016

Smithsonian Institution Building

The 5th PhUSE and FDA Collaboration

phuse.eu/css