CRO Governance Model for Emerging & Virtual Biopharma
Clinovo 1208 E. Arques Avenue, Suite 114 Sunnyvale, CA 94085 contact@clinovo.com +1 800 987 6007 www.clinovo.com
Today’s Speaker
Matthew Smith, VP of Business Operations at Clinovo Matt has over 20 years experience in executive leadership, clinical trial management, business development, proposal development and contracts administration within the contract research industry. Prior to Clinovo, Matt was CEO and Chief Business Officer of Clinimetrics, a full-service public contract research organization (CRO). www.clinovo.com/management http://www.linkedin.com/in/matthewpsmith1
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Agenda Industry overview Virtual company model Collective goals Governance model framework Tools for success Conclusion
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Industry Overview
Rising cost and length to bring a drug to market
Strategic and integrated CRO/sponsor partnerships
• $2 billion development cost per drug
• The CRO market in 2008: $20 billion — almost 30 % of U.S. drug development budget
• x2.5 development cost increase per in 10 years • 11% annual rise in clinical testing expenses • +21% length of clinical trials from 2000 to date • 2 to 3 times as many participants vs. end 1990’s
• 13.4% annual growth of total spending on contract clinical services between 2001 and 2009 • In the San Diego area, more than 50% of the biotech startups created since 2005 are virtual companies
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Virtual Company Model Definition of a “Virtual Organization”
Own the intellectual property or product
Collaborative network
Outsource non-core competencies
Information technology
Contractual arrangements
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Pros and Cons of Going Virtual PROS
CONS
Access to specialized knowledge and resources, worldwide
Potential for reduced interest in sponsor’s success
Increased flexibility and speed
Potential loss of confidentiality
Less investment in fixed assets
Increased dependence on information technologies
Ability to scale operations Huge cost savings Transitioning the risks Investor interest
Dependence on suppliers and their stability Potential loss of hands-on control
Effective communication between CRO and Sponsor is essential
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Collective Goals for Governance Monitor the CRO-Sponsor relationship
Project team communication
Program timelines
Budget adherence
Expectations per scope of work
“Relationship satisfaction”
Mechanism for regular communication and feedback
Adapt to project change
Improve service level
Build long term working relationships
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Governance Model Framework “Basics” Establish Relationship Steering Team Create framework with agreed-upon tools for project feedback
Budgeted vs. actual
Operational dashboard
Partnership Charter document
Regular Relationship Steering Team meetings
Key to success
Senior management buy-in
Trusting relationship
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Relationship Steering Team Identify team participants Lead regular Steering Team meetings with senior-level representatives Ongoing dialogue across management staff to ensure satisfaction Formalized issue escalation process
GOAL: Develop and maintain strategies for program success and budget performance 9 Š 2011 Clinovo. All Rights Reserved. The contents of this document are confidential and proprietary to Clinovo
Relationship Steering Team Meeting Agenda SAMPLE RELATIONSHIP STEERING TEAM MEETING AGENDA Mission Statement Define Steering Committee Members Company Member Names CRO Member Names Meeting Agenda 1. Evaluate overall program performance to date 2. Review adherence to key metrics (dashboard) •Project timeline(s) •Project budget(s) •Quality and performance metrics (per SOW and/or Charter) 3. Opportunities for improvement 4. Review upcoming projects 5. Confirm action plan and parties responsible 10 © 2011 Clinovo. All Rights Reserved. The contents of this document are confidential and proprietary to Clinovo
Partnership Charter Summary of joint agreement on how you work together Mission statement Critical elements for successful studies
Teamwork
Communication
Quality
Commitment
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Conclusion Effective Sponsor-CRO communication strategy Creation of mechanism for successful projects Up-front buy-in, effort, and tools “Relationship satisfaction” Smart partners
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Q&A
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Contact
Matthew Smith VP of Business Operations matt.smith@clinovo.com
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