In this presentation, Jennifer Heckman, Sr. Director of Clinical Trial Logistics, shared Incyte's plan to leverage Vault Study Startup - a modern, purpose-built solution - to tackle the complex site activation process and increase 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