Alkermes: Improving TMF Quality and Oversight with Effective Collaboration

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Kate Santoro from Alkermes presented on their experience improving TMF quality and oversight through effective collaboration with CROs on their Veeva eTMF system. Key aspects of their process included getting CRO input during system configuration, training CRO and sponsor users together, aligning processes during implementation, and holding periodic check-ins and TMF summits with internal and CRO stakeholders to review metrics and identify areas for improvement. The goal was to drive better sponsor oversight through collaborative working relationships with CROs.

Health & Medicine

Improving TMF Quality and Oversight
with Effective Collaboration
Kate Santoro
Clinical Trial Manager

2019 Veeva R&D Summit
1. About Alkermes
2. System Configuration
− Why CRO input is important
− Partnering with CROs
3. System (and Process) Implementation
4. Maintenance
− New upgrades/enhancements
− Periodic check-ins
Agenda

About Alkermes
Company:
• Mid-size biopharmaceutical company
• ~2,400 employees globally
• 4 locations
eTMF History:
• Implemented: June 2015
• Two strategic CRO partners
• Multiple smaller CRO contributors
2019 Veeva R&D Summit

2019 Veeva R&D Summit
System Configuration and CRO Collaboration
CRO Experience Process Sandbox
• Electronic system
• TMF Reference Model
• System understanding
• Team training
• Both CRO and sponsor
• Beneficial workflows

System Configuration Model
2019 Veeva R&D Summit
•Workshops
•Decisions
•CRO feedback
•Participation
•CRO users (2)
•Alkermes
•Veeva
•System/process
Change
•Participation
CRO
Buy-in
Build
Team
MeetingsProcess

2019 Veeva R&D Summit
System Implementation (Go-Live)
Sponsor and CRO Alignment
System Training Process

System Implementation (Go-Live) – Alkermes Experience
2019 Veeva R&D Summit
Pilot Study
Assess Change (if needed)
Process Documents
TMF plan Content list
Training
CRO and Alkermes Onsite session

2019 Veeva R&D Summit
event 4
Periodic
check-ins
Metrics
System
enhancements
Notification
Options
Working teams
Stakeholders
Measure
Share
Improve
The Maintenance Phase
Metrics

2019 Veeva R&D Summit
The Maintenance Phase – Alkermes’ Experience
Internal CombinedStakeholders
• Compare
• Discuss
• Alkermes
• CRO 1 and 2
• Working teams
• TMF Summit

2019 Veeva R&D Summit
Goals
Alkermes TMF Summit
BenefitsEvents Meeting
Agenda
Attendees

Driving Sponsor Oversight
Interim TMF
Reviews
Metrics
Reviews
Lessons
Learned
2019 Veeva R&D Summit

3
Days in advance Trends
Issues
Collaborative working
Notice ResolveInform
Interim Reviews
30
2019 Veeva R&D Summit

Reviewing Metrics
QC Rejections
Cycle Times
Submissions
2019 Veeva R&D Summit

Naming
Conventions Flexibility
System/Process
Changes
Communication
CRO Differences Turnover
Lessons Learned
Security
2019 Veeva R&D Summit

2019 Veeva R&D Summit
Veeva Clinical Network
Expected Document
Lists
Future Endeavors

Alkermes eTMF Timeline
June 2015 Sep 2019
Jul 2019
May 2016 May 2018 Feb 2019
Oct 2015
Feb 2017
Feb 2018
2019 Veeva R&D Summit

Questions?
For further queries, contact:
Kate.Santoro@alkermes.com
2019 Veeva R&D Summit

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Watch the video here: https://bit.ly/3oUi6Vg The clinical data team at Vertex asked themselves, how can we reduce our development timelines and costs—make things go faster, for less? Answering those questions set Vertex on a path to challenge themselves and their vendors to improve speed without sacrificing quality. As a result, they’re reducing database build times by as much as 50% and reliably lock data in 15-18 days. This webinar covers: * How Vertex reaches 80-90% compliance with sites entering data within 2 days of the event * Their #1 goal for transforming the UAT process * Their novel recommendation for when to go live * The technology strategy supporting their process improvements Who Will Benefit: * Clinical data executives * Heads of clinical * Heads of clinical research Meet Your Presenters: Vikas Gulati Senior Director of Clinical Data Management and Metrics, Vertex Pharmaceuticals Vikas Gulati has over 20 years’ experience focused on clinical data management, data standards and governance. He has led several global cross-functional teams to successful outcomes in Biotech/Pharma and CROs. He is currently the Global Head of Clinical Data Management at Vertex Pharmaceuticals, Inc. Richard Young Vice President, Vault EDC, Veeva Systems Richard Young has nearly 25 years of expertise in data management, clinical solutions, and advanced clinical strategies. At Veeva, Young is establishing Vault EDC as the leading solution for clinical data management. Michelle Harrison Associate Director of Clinical Data Management and Metrics, Vertex Michelle Harrison is currently working at Vertex Pharmaceutical in Boston Massachusetts as an Associate Director of Data Management. Prior to joining Vertex, she worked as a consultant for BioBridges. For 2 years there she consulted for a number of small Biotechs assisting with Vendor oversight and start up activities.

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Veeva Systems

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.

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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.

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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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Watch the webinar here: https://go.veeva.com/Driving-Operational-Agility_webinar This presentation is from a Veeva Systems Quality Team webinar series hosted by Contract Pharma. Is the disconnected technology landscape slowing down operations and draining resources? New-market demands, increasingly complex supply chains, and changing regulations will continue as the norm. Modern technologies can help manufacturers manage these external forces effectively, enabling them to be more agile, data-driven, and future-ready. Today many manufacturers are digitizing quality management to increase operational agility and supply chain collaboration, meeting continually-changing market and customer demands. Join Veeva experts in this webinar to learn how digitalizing quality management bridges gaps between manufacturing and quality management, improving cycle times and agility. In this webinar, you will learn: - About the opportunities to transform quality management - How the right technology streamlines global quality processes, increasing automation and operational agility - The industry best practices for driving successful digital transformation

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1. Improving TMF Quality and Oversight with Effective Collaboration Kate Santoro Clinical Trial Manager

2. 2019 Veeva R&D Summit 1. About Alkermes 2. System Configuration − Why CRO input is important − Partnering with CROs 3. System (and Process) Implementation 4. Maintenance − New upgrades/enhancements − Periodic check-ins Agenda

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4. A Show of Hands 2019 Veeva R&D Summit

5. 2019 Veeva R&D Summit System Configuration and CRO Collaboration CRO Experience Process Sandbox • Electronic system • TMF Reference Model • System understanding • Team training • Both CRO and sponsor • Beneficial workflows

6. System Configuration Model 2019 Veeva R&D Summit •Workshops •Decisions •CRO feedback •Participation •CRO users (2) •Alkermes •Veeva •System/process Change •Participation CRO Buy-in Build Team MeetingsProcess

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9. 2019 Veeva R&D Summit event 4 Periodic check-ins Metrics System enhancements Notification Options Working teams Stakeholders Measure Share Improve The Maintenance Phase Metrics

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15. Naming Conventions Flexibility System/Process Changes Communication CRO Differences Turnover Lessons Learned Security 2019 Veeva R&D Summit

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17. Alkermes eTMF Timeline June 2015 Sep 2019 Jul 2019 May 2016 May 2018 Feb 2019 Oct 2015 Feb 2017 Feb 2018 2019 Veeva R&D Summit

18. Questions? For further queries, contact: Kate.Santoro@alkermes.com 2019 Veeva R&D Summit

19. Thank you

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