AstraZeneca: A Vision for a Collaborative Clinical Environment

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Slides from AstraZeneca's 2019 Veeva R&D Summit presentation. After receiving the 2018 Eagle Award for the best sponsor by the Society for Clinical Research Sites (SCRS), AstraZeneca is on an ongoing quest to remain a sponsor of choice for 2019 and beyond. Learn how they are leveraging technology, a unified clinical trial platform, and other strategies to simplify trial conduct at sites.

Health & Medicine

A Vision for a Collaborative Clinical Environment
Doug Schantz, Executive Director, Development Operations
Veeva R&D Summit 9 September 2019

More Trials Drive More Competition for Sites
2000 2004 20192008 2012 2016
# of Trials
0
300,000
250,000
200,000
150,000
100,000
50,000
# of Trials Linear (# of Trials)
Differentiation
is important

3
Opportunity to Become the Sponsor of Choice
`31%
CRA & sponsor
relationship
Scientific value
of research
24%
Quality of trial
documents
11%
Site training
9%
Important factors for study coordinators

2016 2017 2018 2019and beyond
AstraZeneca’s Road to Sponsor of Choice
4
OPERATING MODEL FOCUS
TECHNOLOGY TRANSFORMATION

Strategies to be the Sponsor of Choice:
Operating Model
5
In-sourced model leverages improved site relationships to be
“sponsor of choice” and decrease non-enrolling sites
Invest in site development, outreach, and collaboration
Build a site customer service model
Build an in-house function

6
CONGRATULATIONS TO THE 2018 EAGLE AWARD WINNERS

Strategies to be the Sponsor of Choice:
Technology Transformation
7
Shift IT strategy to
information sharing
Understand your
customer & provide
standardized
technology
Invest in unified
clinical platform

Strategies to be the Sponsor of Choice:
Technology Transformation
8
Shift IT strategy to
information sharing
Understand your
customer & provide
standardized
technology
Invest in unified
clinical platform

Drive Value with Unified Clinical Platform:
AstraZeneca Perspective
9
Manual MVR preparation Automation and speed $10M
Disparate site health data Unified and consistent $4M
Manual investigator & site
activation doc distribution
Repeatable user experience $3M
Value Metrics*Unified Clinical BenefitsChallenges
*These are projected cost reduction estimates

Strategies to be the Sponsor of Choice:
Technology Transformation
10
Understand your
customer & provide
standardized
technology
Invest in unified
clinical platform
Shift IT strategy to
information sharing

Technology Realities
11
SCRS Summit Survey 2016, CenterWatch 2016
CenterWatch
19%
25%
34%
37%
39%
46%
60%
74%
Too many usernames /
passwords
Repetitive training
Too many different
technologies
Too much training
Slow system response time
Incompatible tech
Lack of tech support
Tech too complex to use
SCRS
13%
16%
16%
17%
20%Too many systems
Repetitive training
Too many usernames /
passwords
Systems not aligned with
site workflow
Insufficient tech support

Technology Enabler: Site Business Processes
12
Site
Sponsor #1
Technology supports
site operations and
workflows
Sponsor
#1 Trial
Sponsor
#2 Trial
Sponsor
#3 Trial
CRO #1
Trial
CRO #2
Trial
Sites can standardize
on technology and use
across all studies
1
2

Drive Value with Unified Clinical Platform:
Site Perspective
13
Time to start a study Repeatable user experience Site activation cycle time
Budgets and payments Automation, consistency, speed Site satisfaction, engagement
Complexity of systems Simplified user experience Site satisfaction, training time
MetricsUnified Clinical BenefitsChallenges

Shift IT strategy to
information sharing
Strategies to be the Sponsor of Choice:
Technology Transformation
14
Invest in unified
clinical platform
Understand your
customer & provide
standardized
technology

Shift IT Strategy to Information Sharing
15
Site
Site
Site
Sponsor
CRO

16
Think Differently.
31%
CRA & sponsor
relationship
Scientific value
of research
24%
Quality of trial
documents
11%
Site training
9%
Important factors for study coordinators
Invest in unified
clinical platform
Understand your
customer & provide
standardized
technology
Shift IT strategy to
information sharing

Confidentiality Notice
This file is private and may contain confidential and proprietary information. If you have received this file in error, please notify us and remove
it from your system and note that you must not copy, distribute or take any action in reliance on it. Any unauthorized use or disclosure of the
contents of this file is not permitted and may be unlawful. AstraZeneca PLC, 1 Francis Crick Avenue, Cambridge Biomedical Campus,
Cambridge, CB2 0AA, UK, T: +44(0)203 749 5000, www.astrazeneca.com
17

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Watch the video here: https://bit.ly/3vrYslR The Parker Institute for Cancer Immunotherapy (PICI) runs complex clinical trials that depend on an electronic data capture (EDC) system that is adaptive, flexible and innovating at the same pace as their patient-centric mission. Learn why their legacy EDC system workarounds and custom functions no longer sustained their business, which motivated them to take a new approach. In this webinar, Toby Odenheim, the Director of Technology and Governance, will share how PICI decided to adopt a new EDC system that streamlines the build process for oncology trials and how they better equip their clinical programmers and data managers. PICI’s lead study builder, Gary Smith, will provide a hands-on perspective and share strategies to handle the key challenges that oncology teams face with EDC systems, including: * Umbrella trials that evaluate multiple therapies * Adaptive trial branching and routing * Having an unknown number of treatment cycles * Amendments and other unplanned changes Who Will Benefit: * Data managers * Database Programmers * Clinical Programmers * Clinical programmers in charge of building studies * Clinical leaders in charge of selecting EDC systems * EDC Programmers Meet Your Presenters: Toby Odenheim Director, Technology and Governance, Parker Institute for Cancer Immunotherapy In his current role as director of technology and governance at PICI, Toby Odenheim, MBA, leads an array of technology and process improvement initiatives aimed at accelerating the development of innovative cancer immunotherapy treatments. Core areas of oversight include management of clinical and pharmacovigilance systems, including CTMS, eTMF, IRT, EDC, ePRO, medical coding, safety, and business intelligence systems. Prior to joining PICI, Odenheim was the founder and principal at Odin Life Sciences Consulting, where he guided companies in the selection, implementation, and validation of best-of-breed clinical technologies. Toby Odenheim has held management positions at Gilead, Synteract, ClinicalSoft, and Pfizer. He holds an undergraduate degree in biology, an MBA, and professional certifications in finance, Oracle database administration, and relational database design. Gary Smith Senior EDC Programmer/Analyst, Parker Institute for Cancer Immunotherapy Gary has over twenty years of experience in clinical programming and is a subject matter expert on study design, configuration, and testing with off-the-shelf EDC systems including Veeva Vault CDMS, Medidata Rave, and Oracle Clinical. Gary has deep expertise in building oncology studies, specifically platform studies, and is currently responsible for all aspects of EDC design and study builds in immuno-oncology studies with the Parker Institute for Cancer Immunotherapy. Gary has developed global libraries for five different companies, spanning medical device and pharmaceutical industries.

Unify quality manufacturing to drive speed, compliance and collaboration

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Shorten Database Builds by 60% with Agile Design

Veeva Systems

Watch the video here: https://bit.ly/3f64wJZ See the Packed #SCDM2019 Session Radical time savings aren’t possible with incremental process improvements. An agile EDC enables process transformation that shortens database builds by 40-60%. Join a live webinar of the packed SCDM product showcase to hear the technologies and processes behind those savings, including real-time UAT, data-driven rules and dynamics, and easy amendments.

Best practices for implementing and maintaining successful standards

Veeva Systems

Watch the video here: https://bit.ly/3uvar1u This webinar provides best practices, check-lists and case studies for leveraging standards in clinical trials. From creation and implementation, to governance tools (both internal and with external partners), attendees walk away with actionable insights to leverage with their own organization. * Understand what to standardize * Learn several approaches to standards development and when they make sense * Ensure alignment with key stakeholders * Maintain and govern standards over time * Reduce overall configuration time Who Will Benefit: * Clinical Data (manager/director/head of) Clinical ops * Data management * Biostatistics * Data science * Clinical science * EDC * Biometrics * eClinical * Data standards * Quantitative sciences * Informatics * Data monitoring * Clinical leads * Study managers * Clinical study * Data manager * CRA * CDISC Meet Your Presenters: Carla Reis Director, Client Services, 4G Clinical Carla Reis, Director of Client Services at 4G Clinical, has over 18 years of experience as an operational leader in developing and implementing RTSM systems in a global pharmaceutical company. Carla was a leader in her organization in establishing vendor management standards and processes. She has helped lead major RTSM process improvement initiatives where she established new and innovated approaches to drug assignment verification and vendor integrations. Carla has presented at industry conferences as a subject matter expert on best practices using RTSM solutions for complex strategies in supply chain management. Carla holds a BS in Neurobiology and Physiology from the University of Connecticut and a certification as Lean Six Sigma Yellow Belt. Carla also holds a Masters in Science in Health Administration with a concentration in Health Informatics from Saint Joseph's University. Paul MacDonald Senior Director, Strategy Vault CDMS, Veeva Systems Paul is Senior Director Vault CDMS, responsible for strategy and direction in data management. With 25+ years experience working in life science at pharma, CRO and technology organisations, Paul brings a strong operational focus in relation to eClinical technology for data management and clinical operations that stretches from EDC, through CTMS to risk based monitoring.

Designing an EDC System to Work for a CRA

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Watch the video here: https://bit.ly/3h8gHIU Targeted source data verification (SDV) might be well established, but many clinical teams are still verifying 100% of their data, making monitoring costly and inefficient. By warching this on demand webinar, you will hear established RBM experts share the measures and metrics that organizations need to realize the true value of targeted SDV. Learn better ways to implement a risk-based strategy for SDV to ensure that CRAs focus on the most important data and how doing so can: * Improve data quality * Speed data collection and analysis * Result in higher confidence and user satisfaction Learn how Veeva is reinventing EDC to work for a CRA, creating significant speed and quality improvements. Who Will Benefit: Senior professionals working with clinical data/clinical documentation, including: * Clinical Development/ R&D * Clinical Data Management * eClinical Operations * Data Monitoring & Management * Development Strategic Operations * Information Strategy & Analytics, Clinical Informatics & Innovation * Information Technology, R&D IT * IT R&D Business Partner Meet Your Presenters: Drew Garty Chief Technology Officer, Veeva Vault CDMS, Veeva Drew Garty’s career in pharmaceutical technology spans over 20 years and includes significant expertise in EDC, clinical site monitoring, platform integrations and clinical trial management solutions. Drew’s innovative solutions in risk-based monitoring earned him a prestigious industry “Clinical Innovator of the Year” award in 2015. Drew joined Veeva in 2016 as Vice President of Product Management, and led the ground-up design of Veeva’s Vault EDC solution. In his current role of Chief Technology Officer at Vault CDMS, Drew shares and collaborates with customers, partners and the industry to set vision and direction of Veeva’s CDMS product. Dawn Anderson Managing Director, Life Sciences Strategy and Operations, Deloitte Dawn has more than 30 years of industry and consulting experience in pharmaceutical, biotechnology, CROs, and technology companies. Her practice is focused on clinical development and she works with clients to design and deploy global operating strategy, performance improvement and technology implementations across the development of new drugs, biologics and devices. Dawn has spoken frequently about clinical transformation and the future of clinical trials, including topics around adaptive design, protocol complexity, risk assessments and the use of technology including virtual trials, digital, mHealth and the use of clinical analytics platforms and cognitive automation in transforming clinical trial delivery.

Veeva Systems Webinar: Driving Continuous Quality Improvements

Veeva Systems

Watch the on-demand webinar here: https://go.veeva.com/driving-continuous-quality-improvements/on-demand Building a strong foundation to drive continuous quality improvements requires connecting people, processes, and technology. Life sciences companies transforming quality management with this holistic approach have increased quality management efficiency by up to 50% and reduced paperwork by 90%. Watch the webinar and learn how you can create such a foundation for your organization on an intelligent, data-driven, end-to-end digital platform. You will also hear real-world use cases of applying advanced technologies like AI to enable proactive quality management across all operational areas. You will hear: - Opportunities and recommendations to unify and streamline quality systems and processes - Areas where modern-era technologies like cloud and AI can increase efficiency, optimize cost, and bring products to patients faster - Real-world examples of how leading organizations are transforming quality management to drive continuous quality improvements.

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These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram. Learning objectives: 1. Define an electrocardiogram (ECG) and electrocardiography 2. Describe how dipoles generated by the heart produce the waveforms of the ECG 3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II) 4. Differentiate between intervals and segments 5. Enlist some common indications for obtaining an ECG 6. Describe the flow of current around the heart during the cardiac cycle 7. Discuss the placement and polarity of the leads of electrocardiograph 8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained 9. Define mean electrical vector (axis) of the heart and give the normal range 10. Define the mean QRS vector 11. Describe the axes of leads (hexagonal reference system) 12. Comprehend the vectorial analysis of the normal ECG 13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation 14. Explain the concepts of current of injury, J point, and their significance Study Resources: 1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition 2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition 3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition 4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/ 5. ECG in Medical Practice by ABM Abdullah, 4th edition 6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/ 7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics

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1. A Vision for a Collaborative Clinical Environment Doug Schantz, Executive Director, Development Operations Veeva R&D Summit 9 September 2019

2. More Trials Drive More Competition for Sites 2000 2004 20192008 2012 2016 # of Trials 0 300,000 250,000 200,000 150,000 100,000 50,000 # of Trials Linear (# of Trials) Differentiation is important

3. 3 Opportunity to Become the Sponsor of Choice `31% CRA & sponsor relationship Scientific value of research 24% Quality of trial documents 11% Site training 9% Important factors for study coordinators

4. 2016 2017 2018 2019and beyond AstraZeneca’s Road to Sponsor of Choice 4 OPERATING MODEL FOCUS TECHNOLOGY TRANSFORMATION

5. Strategies to be the Sponsor of Choice: Operating Model 5 In-sourced model leverages improved site relationships to be “sponsor of choice” and decrease non-enrolling sites Invest in site development, outreach, and collaboration Build a site customer service model Build an in-house function

6. 6 CONGRATULATIONS TO THE 2018 EAGLE AWARD WINNERS

7. Strategies to be the Sponsor of Choice: Technology Transformation 7 Shift IT strategy to information sharing Understand your customer & provide standardized technology Invest in unified clinical platform

8. Strategies to be the Sponsor of Choice: Technology Transformation 8 Shift IT strategy to information sharing Understand your customer & provide standardized technology Invest in unified clinical platform

9. Drive Value with Unified Clinical Platform: AstraZeneca Perspective 9 Manual MVR preparation Automation and speed $10M Disparate site health data Unified and consistent $4M Manual investigator & site activation doc distribution Repeatable user experience $3M Value Metrics*Unified Clinical BenefitsChallenges *These are projected cost reduction estimates

10. Strategies to be the Sponsor of Choice: Technology Transformation 10 Understand your customer & provide standardized technology Invest in unified clinical platform Shift IT strategy to information sharing

11. Technology Realities 11 SCRS Summit Survey 2016, CenterWatch 2016 CenterWatch 19% 25% 34% 37% 39% 46% 60% 74% Too many usernames / passwords Repetitive training Too many different technologies Too much training Slow system response time Incompatible tech Lack of tech support Tech too complex to use SCRS 13% 16% 16% 17% 20%Too many systems Repetitive training Too many usernames / passwords Systems not aligned with site workflow Insufficient tech support

12. Technology Enabler: Site Business Processes 12 Site Sponsor #1 Technology supports site operations and workflows Sponsor #1 Trial Sponsor #2 Trial Sponsor #3 Trial CRO #1 Trial CRO #2 Trial Sites can standardize on technology and use across all studies 1 2

13. Drive Value with Unified Clinical Platform: Site Perspective 13 Time to start a study Repeatable user experience Site activation cycle time Budgets and payments Automation, consistency, speed Site satisfaction, engagement Complexity of systems Simplified user experience Site satisfaction, training time MetricsUnified Clinical BenefitsChallenges

14. Shift IT strategy to information sharing Strategies to be the Sponsor of Choice: Technology Transformation 14 Invest in unified clinical platform Understand your customer & provide standardized technology

15. Shift IT Strategy to Information Sharing 15 Site Site Site Sponsor CRO

16. 16 Think Differently. 31% CRA & sponsor relationship Scientific value of research 24% Quality of trial documents 11% Site training 9% Important factors for study coordinators Invest in unified clinical platform Understand your customer & provide standardized technology Shift IT strategy to information sharing

17. Confidentiality Notice This file is private and may contain confidential and proprietary information. If you have received this file in error, please notify us and remove it from your system and note that you must not copy, distribute or take any action in reliance on it. Any unauthorized use or disclosure of the contents of this file is not permitted and may be unlawful. AstraZeneca PLC, 1 Francis Crick Avenue, Cambridge Biomedical Campus, Cambridge, CB2 0AA, UK, T: +44(0)203 749 5000, www.astrazeneca.com 17

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