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Cytel Software Development Shaping the Future of Drug Development Cytel Software Development EUGM November 2019 Agenda ❖ Company Update ❖ Software Update ❖ East On-Demand and the Future of East Cytel Inc. 2 The Data Revolution is Here Increased complexity, volume and the proliferation of data sources requires advanced analytics and insights to harness its power Increased Complexity, Volume And We are purpose built to The Proliferation Of Data Sources address this challenge as the pioneering experts in analytical solutions for clinical development Advanced Analytics And Insights 30+ year track record of exponential growth underpinned by quality Power To Transform Healthcare 20+ 100% Our People Are Recognized More Adaptive> Trial Acceptance Leaders With Instrumental Scrip Award Designs Than Any Other Data Sets By FDA Roles In Industry Think-tanks Best Specialist CRO And Associations Organization Consulting Services Real World Define the Execute against Analytics Authored The Seminal Piece on Adaptive Years Of Leadership problem the problem Bring novel data Of Advanced Designs Featured In New Analytics assets to bear England Journal of Medicine Software Leverage Technology FDA 600+ Software Used By Publications The FDA To Review Industry Designs Top 30 900+ <10% Of The Best And Top 30 Pharma Low Employee Brightest Talent In Companies Use Our Turnover Our Sector Services And Technology 11/12/2019 Cytel Inc. 4 Driving the New Paradigm Leverage Historical Apply Fast Flexible Optimize Go/No-go Centralize Efficient And Real-world Trial Designs Decision Making Data Collection & Evidence Analysis 20%-30% REDUCTION IN DEVELOPMENT COSTS 11/12/2019 Cytel Inc. 5 We Help Solve The Toughest Problems Strategic Consulting GENERICS & BIOSIMILARS PARTNERSHIPS DEVELOPMENT DEVICES & BIOLOGICS DIGITAL HEALTH DEVELOPMENT DEVELOPMENT DRUG FMCG TRAINING DEVELOPMENT Regulatory, clinical, medical & health policy DEVELOPMENT experts, & quantitative strategists empower better decisions REGULATORY, CLINICAL DEVELOPMENT STRATEGIES MARKET ACCESS & THOUGHT LEADERSHIP & PRODUCT QUALITY COMMERCIALIZATION QUANTITATIVE STRATEGIES Expert Data Focused Services Innovative Approaches To Advanced Analytics And Data Complexities Offshore Project Based Services (PBS) Highly skilled people across the globe Onshore All of our employees are of We deploy our model of the highest caliber, onshore/ offshore, based regardless of the size of the on the customer needs, customer or project Functional Services supporting them with the highest quality talent Provider (FSP) across the globe. Transformative Technologies Innovative Approaches To Advanced Analytics And Data Complexities Industry Standard Comprehensive Trial Design Solution Our Clients Include All Top We Promote Accelerated Pharma Companies And Timelines, Reduced Costs & The FDA Increased Of Success Rates Real World Analytics Applying Advanced Analytics to Real World Data Tailored Solutions for your Data Asset Identification & RWA expertise from specific challenges Navigation Discovery, Research to Reimbursement 11/12/2019 Cytel Inc. 9 Cytel History and Key Milestones Barcelona and Paris Training engine is established offices are opened Cytel India wins first European contract is founded by India Cytel receives Second Hyderabad Cyrus Mehta India investment adopt East and Xact office is opened & Nitin Patel subsidiary is from Merck established Capital Geneva office and two new in Pune Ventures offices in India are opened NMC invests In Cytel Cytel India becomes ISO certified and Business Milestones Business opens new office in Mumbai 1987 1989 1995 1996 2001 2005 2007 2008 2010 2011 2012 2014 2015 2016 2017 2018 2019 2020 LogXact EOD Software is Project-based software is released Services released Business is Data OKGO Software launched management is released operations are Pharmacometrics established and Data Sciences StatXact Functional Product Launches Product operations are software is East software Services established released is released Business is launched Marvin Zelen, a highly respected statistician and Strategic widely regarded as the Father of Clinical Trials, Consulting EnForeSys played a pivotal role in the founding of Cytel. Business is ACES & Compass software is Professor Marvin Zelen, 1927 – 2014 launched are released released 11/12/2019 Cytel Inc. 11 Key services 1 Highly efficient clinical 2 Synthetic and external trial (HECT) design control data Bespoke clinical trial solutions Flexible and agile synthetic control based on the latest advances in data for hard-to-reach patient Bayesian statistics, machine populations, supported by learning, precision medicine and comprehensive data acquisition. simulation research. 3 Disease modeling and 4 Evidence synthesis and microsimulation regulatory support Comprehensive disease modeling Holistic evidence review, backed by and microsimulation covering both practical solutions to regulatory individual and system-wide requirements. requirements and roadblocks. 12 Clinical Development Software Construct the optimal dose finding Design fixed and adaptive Phase 1 - 4 study using Frequentist or Bayesian trials with the industry leading trial adaptive methods design platform “StatXact is clearly the leader in the field and continually enhances its nonparametric exact statistics offerings. SAS and SPSS capabilities in this respect can be considered FDA / Preclinical asPhase a subset 1 of StatXact” Phase 2 Phase 3 Post- Reference: Robert A Oster & Joseph M Hilbe (2008) An Examination of Statistical Software Packages for Parametric and Nonparametric Data Analyses Using Exact Methods, The American Statistician, 62:1, 74-84, DOI: Approval 10.1198/000313008X268955 Decision Making Planning Analysis and Meta-analysis Implementation A quantitative go/no-go decision- Forecast clinical trial Conduct efficient Facilitate secure DMC making framework in clinical trials. enrollment with confidence. centralized interim analysis Giving the best opportunity to bring Reduce uncertainty to randomization in real- communications and effective new medical products to maximize trial success rates time: improve balance data access in market faster. while reducing bias compliance with The world's most popular statistical regulatory guidance software package for exact non- parametric inference 13 East Overview East is the industry standard software for designing clinical trials, specifically addressing adaptive design requirements as per FDA and EMA guidance “ Helpful illustration tool Sample Size & Power for talking to clinicians ” Adaptive Design Features “ Reliable, comprehensive, Trial Monitoring Dashboard easy and fast ” Advanced Simulations “ Usability, quick simulations, clear results ” Documentation & Support “ World class responsiveness and technical expertise ” • Comprehensive trial design solution • Extensively tested and documented • Continuously developed since 1995 • Highly intuitive work flow 14 East 6.5 Contains three new modules for MCPMod, Population Enrichment, Program-level simulations Enhancements to existing modules including SEQUENTIAL - Group sequential approach for Equivalence trials SURVIVAL - Simulate with surrogate endpoints ADAPT/SURVADAPT - SSR for Non-Inferiority design MAMS - now available for all three endpoints – normal, binomial and survival PREDICT - event prediction with Weibull distribution ESCALATE - mTPI-2 BUSINESS CONFIDENTIAL 15 New East Modules MCPMod An efficient statistical methodology for design and analysis of phase 2 dose-finding studies under model uncertainty. ENRICH Clinical trial designs with adaptation options for population enrichment, while strongly controlling type-1 error rate. PROGRAM Model and simulate a sequence of clinical trials within an oncology program using flexible go/no-go rules to support decision-making. BUSINESS CONFIDENTIAL 16 ESCALATE East 6.5 (three new modules) (Ph1) ENDPOINTS EXACT BASE MAMS (Pow, SS, FSD) MULTIARM (Ph 3) SEQUENTIAL SURVIVAL SURVADAPT ENRICH (Ph 3-GSD) (Ph 3-GSD) (Ph 3-SSR) (Ph 3) ADAPT MCPMod (Ph 3-SSR) PROGRAM PREDICT (Ph1-2-3) (Ph 3) BUSINESS CONFIDENTIAL 17 East On Demand Cytel Inc. 18 East 6.6… 11/12/2019 Cytel Inc. 19 East 6.5 (three new modules) MCPMod MAMS MULTIARM (Ph2-3) ESCALATE (Ph1) BASE (Pow, SS, SEQUENTIAL ADAPT SURVADAPT ENRICH FSD) (Ph 3-GSD) (Ph 3-SSR) (Ph 3-SSR) (Ph 3) PROGRAM EXACT (Ph1-2-3) SURVIVAL (Ph 3-GSD) PREDICT (Ph 3) ENDPOINTS Shaping the Future of Drug Development Q&A Session Shaping the future of Drug Development ©2019 Cytel Inc. 22.
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