Incyte: Best Practices for Driving Study Start-up Speed and Quality
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Incyte's development journey highlights significant milestones in drug discovery and commercialization, including FDA approvals for ruxolitinib and baricitinib, reflecting its commitment to innovative oncology treatments. The company has established a global presence with a robust pipeline of products while enhancing its clinical trial processes through in-house capabilities and technology. In 2018, Incyte continued to expand its operations and revenue with ongoing clinical programs in oncology and autoimmune diseases.
Incyte: Best Practices for Driving Study Start-up Speed and Quality
- 1. Incyte’s Study Start-up Journey Jen Heckman September 2018
- 2. WHERE SCIENCE DRIVES SUCCESS At Incyte, science and innovation drive our efforts to discover and deliver novel medicines in oncology and other diseases, creating value for patients and society
- 3. Pivotal Moments that Define Incyte’s History 2002 2004 2005 2011 2014 2015 2016 2017 • Drug discovery efforts founded • Ruxolitinib synthesized and filed first investigational new drug application (IND) • JAK2 mutation in myeloproliferative neoplasms (MPNs) discovered • FDA approved Jakafi® (ruxolitinib)1 as first treatment for myelofibrosis • Established first office outside of the U.S. • Incyte Europe expanded; European commercialization rights to Iclusig® (ponatinib)3 gained through acquisition of ARIAD Pharmaceuticals’ European operations • Surpassed $1B in revenue • Joined S&P 500 index • Opened operations in Tokyo • Expanded global headquarters and campus in Wilmington, DE • Olumiant® (baricitinib)2 marketing approvals received in Europe (Feb.), Japan (July) • FDA approved Jakafi as first treatment for polycythemia vera 3 1 In the U.S., Jakafi (ruxolitinib) is approved by the FDA for treatment of people with intermediate or high-risk myelofibrosis and for treatment of people with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea. 2 Olumiant (baricitinib) is approved for the treatment of mild to moderate rheumatoid arthritis in patients with inadequate response to standard-of-care therapies; Worldwide rights to baricitinib licensed to Eli Lilly. 3 Iclusig (ponatinib) is approved for use in chronic myeloid leukemia (CML) and Philadelphia-positive (Ph+) acute lymphoblastic leukemia (ALL) patients who are resistant to or intolerant of certain second generation BCR-ABL inhibitors and all patients who have the T315I mutation. Incyte has an exclusive license from ARIAD Pharmaceuticals, Inc. to commercialize Iclusig in the European Union and 28 other countries, including Switzerland, Norway, Turkey, Israel and Russia. 2018 • Olumiant marketing approval in U.S. (June)
- 4. Continually Building our Capabilities, Diversifying the Portfolio, and Growing Revenue 4 US 588 US 692 US Europe 980 US Europe Japan 1,208 Small molecules 7 compounds Figure represents Incyte total revenue for 2013 – 2017 (US$ millions) and 2018 includes current guidance for sales of Jakafi and Iclusig, consensus royalty revenues, and the $100m milestone from Lilly following the FDA approval of Olumiant. Jakavi (ruxolitinib) licensed to Novartis ex-US, Olumiant (baricitinib) licensed to Lilly worldwide; these brands are trademarks of Novartis (Jakavi) and Lilly (Olumiant) and are not trademarks of Incyte. Small molecules Large molecules 10 compounds Small molecules Large molecules 14 compounds Small molecules Large molecules Bispecifics 17 compounds US Europe Japan 1,308 Small molecules Large molecules Bispecifics 19 compounds 1,536 1,106 754 511 2014 2015 2016 2017 2018 Locations Team Discovery Development Sources of Revenue
- 5. Incyte Today: A Rapidly Growing Biotechnology Company • Established in the U.S., Europe, and Japan • World-class medicinal chemistry and biology expertise • Robust and diversified pipeline of oncology products, including targeted therapies and immuno-therapies, including small molecules, large molecules, and bispecific antibodies • Advancing portfolio beyond oncology, including clinical programs in inflammation and autoimmunity indications (IAI) • Publicly traded (NASDAQ:INCY) • Emerging large-cap biotech—part of S&P 500 index Incyte By the Numbers employees years of drug discovery and development clinical development employees offices worldwide 1,300+ 13 15+ ~600 of drug candidates discovered and developed in-house sources of revenue4 82% 5
- 6. The Evolution of Trial Delivery at Incyte • Enhance relationships with sites • Become sponsor of choice • Build consistency in site communication • Develop standard start-up processes • Ability to track and measure performance • Improved site selection timelines • Improved site activation timelines • Reduce external spend • Prior to 2015, all studies were delivered through CROs • Decision in 2015 to develop internal capabilities • Global Clinical Monitoring and Clinical Trial Logistics teams formed 6 Benefits of an In-house Study Start-up Model
- 7. Vendor Identification and Setup Technology Setup and Support Budget Development, Contract, and Budget Negotiation Essential Document Collection and TMF Setup Site Identification and Feasibility Clinical Trial Logistics Clinical Study Team Trial Informatics Setup and Support Site Identification and Feasibility Budget Development, Contract and Budget Negotiation Essential Document Collection and TMF Setup Vendor Identification and Setup Study Start Up
- 8. 8 Key Elements of Successful Study Start-up Ability to provide predictable estimates of time to greenlight (IP release) based on prior experience 1 2 3 54 Provide predictable estimates of time to greenlight Reduce burden to sites: • Customization of welcome packages Accountability for driving timelines/ reducing start-up timelines Ability to ensure accuracy/ consistency of documents Knowledge of evolving country-specific requirements
- 9. Rationale for Addition of Technology 9 Reduce manual entry Stop storing same information in multiple locations Seamless sharing and Visibility Share information more easily Store data in a validated, reliable source • Real-time information accessible in all locations • Workflow management system/alerts eliminate handoffs, errors, and downtime • Document version control
- 10. Technology to Support Innovation 10 Clinical Trial Management System Feasibility Tool • Support development of questionnaire, automate distribution, store data, searchable eTMF • Repository to store all essential documents (GCP)
- 11. Tools Needed to Support Growth 11 SSU Tracker and Analytics • Integrate data for investigator performance metrics • Automated workflows streamline internal processes Budget Development Tool • Support complex oncology budgets • Store site budget information, searchable database, repository with reporting capabilities Investigator Portal • Provide all materials for site-specific processes • Interface to send/receive/track site materials
- 12. Study Start-up Tool Requirements 12 • Accessibility for study start-up documentation in multiple countries • Built-in workflow for authoring, review, and approval of documents enabling real-time information for all team members • Built-in workflow for request, collection, review, and approval of site contracts and essential documents • Ability to integrate with existing systems – CTMS and eTMF
- 13. Study Start-up Tool Requirements (continued) 13 • Document version control • Site access to enable send/receipt of documentation from clinical sites • Ability to generate reports to document progress and metric reporting • Ability to leverage historical site information to expedite start-up timelines • Ability to repurpose same-site documents for multiple studies
- 14. Process for Selection Five Demonstrations: overview/demo/ implementation process Shortlisted Two Vendors and Accessed System Sandbox Final Decision using Proposal Review Evaluation Shortlisted Vendors Formed Cross- functional Team to Evaluate Vendors Requirements Shared in “Request for Proposal”
- 15. High Level Overview of Implementation 15 Jan Feb Mar Apr May Project Kick Off Solution Review and Configuration Refining Configuration Process Exercises Validation Training System Go Live Success Factor: Established Internal Processes for SSU Success Factor: Consideration of Process Change Required Success Factor: Training Material that Connects Process and System Success Factor: Time, Patience, Reinforcement of Purpose
- 16. Expected Value of Unified Clinical 16 Streamlined, Harmonized Processes Active Collaboration Visibility
- 17. Questions 17 For further queries, please contact: jen.heckman@incyte.com