Inflammatory Bowel Disease

Transcription

1 Inflammatory Bowel Disease ICONplc.com

2 Inflammatory bowel disease (IBD) is a chronic, relapsing, inflammatory disorder of the gastrointestinal tract and includes Ulcerative Colitis (UC) and Crohn s Disease (CD). IBD affects over 5 million people worldwide, and the incidence has been growing steadily over the past 10 years. While the exact cause of IBD is unknown, the inflammation results from the immune system s response to environmental triggers. Today, the goal of treatment is to bring about and maintain remission, and a range of advanced treatment options are available to reduce inflammation and manage symptoms. The area is one of the most active in biopharmaceutical development and clinical research with hundreds of active trials in progress. Full-Service Support for IBD Programs ICON offers end-to-end services to support the development of your product to treat Inflammatory Bowel Disease (IBD). In the past seven years, we ve conducted 12 studies in Crohn s disease and 34 in Ulcerative Colitis, giving us a profound understanding of the clinical and operational challenges in this therapeutic area. Such immersion translates into strong development plans, efficient study management, defensible data packages, and careful preparation for commercial success. Because we offer a broad range of services from initial strategy development all the way through to pricing and market access recommendations your product will be ushered to market in the most expedient way possible. Experience 46 Studies Number of studies: 12 in Crohn s, 34 in Ulcerative Colitis 4,500 Patients Number of patients: 1,200 in Crohn s, 3,300 in Ulcerative Colitis Nearly 4,000 Sites Number of sites: 930 in Crohn s, 3,000 in Ulcerative Colitis An Integrated Approach to Development

3 Our full range of clinical development services for delivering your IBD trial includes: Early Phase Services ICON maintains a staff dedicated exclusively to conducting early-phase clinical research, spanning First-in-Human (FIH) through Proof of Concept (POC) studies. We provide: PK/PD Modeling and Simulation Data Management SAS Programming Medical Monitoring Project Management and Site-Monitoring Services Medical Writing We also operate a customized, Clinical Research Unit in San Antonio, Texas complete with 180 beds, an on-site pharmacy, a PK laboratory, and a clinical laboratory. We maintain an extensive database of volunteers for studies in gastrointestinal disorders. We are the only organization to support your earlyphase decision-making with: NONMEM, a nonlinear mixed-effects modeling tool used in PK/PD analysis. With a license to NONMEM you can determine the appropriate dosing strategy for your product and increase your understanding of its mechanisms and interactions. Data visualization to help you identify outliers at a glance. Drug Development Services Our professionals are available to work in partnership with you as you evaluate your options and choose a clear path ahead. We can support you with: Devising the overall development strategy Drafting the clinical development plan Defining the regulatory development strategy Analyzing licensing opportunities Adaptive Study Design Adaptive trial designs are particularly attractive in IBD programs given the intense competition for patients and the desire to limit the burden on them. Our experts have perfected adaptive trial designs through: Market leading software, ADDPLAN, for designing, simulating, and analyzing fixed and adaptive clinical studies in all phases of development. ADDPLAN combines comprehensive tools with state-of-the-art methodology. ADDPLAN is the first commercial software with implemented MCP-Mod dose-finding approach, which has been endorsed by the US Food and Drug Administration and the European Medicines Agency. Providing diverse options of adaptation which include multi-armed multi-stage confirmatory adaptive studies; group sequential critical boundaries for an exhaustive range of design types; seamless phase II/III designs; control of family-wise error rate, comparing various multiple testing procedures and selection rules.

4 Site Relationships ICON has alliances with site networks and maintains relationships with, and a database of, a vast pool of Key Opinion Leaders (KOLs) and Principal Investigators in gastroenterology who have demonstrated their ability to enroll IBD patients and provide quality data. Patient Recruitment and Engagement The intense competition for patients in IBD makes patient recruitment and engagement a very specialized activity. To best support your enrolment needs, we: Monitor the treatment and access landscape Develop site-specific patient engagement plans Educate patients using our learning management system, FIRECREST Support econsent with interactive, multimedia presentations FIRECREST digital solutions increase efficiency in clinical trials by driving site performance and enhancing patient engagement. It is deployed across 1,400 studies in 100+ indications, with over 500,000 registered users, including the top 10 global pharmaceutical companies. Solutions include; - Site Portaz - Training Site & Study Staff - Visit by Visit Guide - edocument distribution and - Pre-Screen - econsent FIRECREST econsent employs easy-to-understand videos and visual aids to explain the complex scientific concepts and medical terms that are found in initial protocols. Multimedia materials are designed with evidence-based research from Carnegie Mellon University, which greatly enhances patient knowledge, recruitment and retention particularly for children. Despite intensive and costly monitoring, 5% of all FDA findings are due to errors in the consenting process. FIRECREST s econsent virtually eliminates these errors while providing a real-time view of your trial compliance. Medical Imaging ICON s team of 200 medical imaging specialists: Have participated in GI studies involving over 7,000 patients and 1,200 sites. Collaborate with GI Reviewers, a network of independent gastroenterologists who serve as central readers of IBD images Central Laboratory Services Our global network of wholly owned laboratories can receive samples from investigator sites within hours. Analyses are performed using a range of key biomarkers for IBD and are reported in a single Laboratory Information Management System. Commercialisation and Outcomes To help deliver commercial success for your IBD compound, we infuse development decisions with foreknowledge of what evidence will eventually be required by regulators, payers, prescribers, and patients. To establish and communicate your product s unique clinical outcomes and economic impact, we offer: Peri-approval & Observational Research Global Pricing & Market Access Health Economics & Epidemiology Clinical Outcomes Assessment Healthcare Communications Language Services Our Clinical Assessments Technology group is team of industry experts to support implementation of Outcome Assessments on modern electronic platforms such as Tablets, ediaries or BYOD Apps. They work with technology vendors and manage the implementation not only within industry standards but exceeding them. The team has extensive experience in IBD studies and usage of disease specific assessments such as Bristol Stool Scale. ICONplc.com/ FIRECREST

5 Data Analytics Our ICONIK decision-support platform provides a single view of study data to: Manage data quality Support a risk-based approach via analysis and visualization of trends Ensure compliance with assessment schedules Assess site performance Analyze and manage quality of rating scales and scoring tools Using ICONIK, we can tap into a library of data analytics assessing key clinical and operational risk indicators. From this we can chose standard or develop custom analytics and KPI s tailored to your project. Our IBD Experts Dr. Jolanta Wichary, MD VP, Therapeutic Lead Gastroenterology/Immunology, Drug Development Services Board-certified gastroenterologist with 24 years of clinical research experience Expertise in inflammation/mucosal healing in IBD Padraic Conway, MSc, M Biol, C Biol Senior Director, Project Management Over 22 years of industry experience in clinical research, including 18 years within project management Leads ICON s Gastroenterology team and provides senior oversight and therapeutic strategic development to all ICON IBD programs Shellie George, MS (Biology) Senior Director, Project Management Over 20 years of industry experience in clinical research, including 17 years within project management Instrumental in providing operational oversight for many large global programs in UC and CD Le Quan Su, MBA Director, Project Management Over 8 years of experience working on IBD trials Provides operational oversight to large complex global UC and CD trials

6 ICON plc Corporate Headquarters South County Business Park Leopardstown, Dublin 18 Ireland T: (IRL) T: (US) F: ICONplc.com About ICON ICON plc is a global provider of outsourced development solutions and services to the pharmaceutical, biotechnology and medical device industries. The company specialises in the strategic development, management and analysis of programmes that support clinical development. With headquarters in Dublin, Ireland, ICON currently operates from 97 locations in 38 countries and has approximately 13,250 employees. Further information is available at ICONplc.com ICON plc. All rights reserved.