A New Model for Collaborative Partnerships William H. Carson, M.D. Sr Vice President, Global Clinical Development Otsuka Pharmaceutical Development & Commercialization, Inc. [email protected]David Zuckerman President Customized Improvement Strategies LLC [email protected]
This presentation describes a state-of-the-art partnership alliance between Otsuka and Covance. It also describes a staffing forecasting model that will be used in the partnership.
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Transcript
A New Model for Collaborative Partnerships
William H. Carson, M.D.Sr Vice President, Global Clinical Development
Otsuka Pharmaceutical Development & Commercialization, [email protected]
2. Otsuka has based our CRO selection on cultural fit rather than capability
3. We are using long-term, systematic staffing planning to assure continuity & staff availability
Apr 2009 2
The Otsuka Pharmaceutical GroupGlobally
106 Companies
18 Nations
33,000+ Employees
77 Factories/Plants
18 Research Facilities
Healthcare 38%
Consumer Products 62%
Apr 2009 3
Tufts & CIS Analyses: Key Results
• Industry– Most Pharma’s using tactical, capacity-driven outsourcing– Key characteristics of strategic partnerships
• Formal needs and core capabilities assessment• Internal governance structures• Small number of carefully selected, partner-providers• Operating procedures focused on collaboration
• Otsuka– Outsourcing approach is tactical, capacity-driven – Too many CROs, providers– Multiple CRO governance structures– Too many required Otsuka competencies– Limited outsource management staffing and training
Apr 2009 4
Otsuka 2020 Future StateImplies a Substantial Leap
– Time to anticipate and engage the ‘best’ available team
• Joint requirements– Complementary responsibilities without redundancy– Core competency alignment– Ability to collaborate at all management & team levels
Apr 2009 6
1
2008 2009 2010 2011 2012
One-Now, More-LaterProof of Concept Approach
Num
ber o
f CRO
s
Tactical Providers
StrategicPartners
Work transfers gradually from tactical providers to strategic partner (e.g., end of study, phase or contract period), not all at once
Proof of concept (POC) period
Add additional Strategic Partners after POC
Apr 2009 7
OtsukaProof of Concept Objectives
Successfully identify, select and negotiate an agreement with a core strategic partner that will:– Develop systematic approach to outsourcing – Leverage internal and external expertise– Build integrated project teams– Define strategies to maximize efficiency, quality, and
innovation – Evaluate organizational requirements for successful
implementation– Establish an effective, long-term relationship
Apr 2009 8
Partnerships fail due to communication & alignment problems, not technical capabilities
Partnerships fail due to communication & alignment problems, not technical capabilities
Compatible CROsSelect BestOverall FitSelect BestOverall Fit
• Size• Experience• TA coverage• Global reach• etc
• Size• Experience• TA coverage• Global reach• etc
• Application, not RFP• Malcolm Baldrige National
Quality Award based• 50 pages, 3 weeks
• Application, not RFP• Malcolm Baldrige National
Quality Award based• 50 pages, 3 weeks
• Rank ordered• Top 10 selected• Rank ordered• Top 10 selected
• 100 pt objective scoring• Top 4 selected• Scoring & feedback provide
to all applicants
• 100 pt objective scoring• Top 4 selected• Scoring & feedback provide
to all applicants
• Review of all functions & approaches
• Mock kickoff meeting• 8 hrs, 35-50 people from
Otsuka & each CRO
• Review of all functions & approaches
• Mock kickoff meeting• 8 hrs, 35-50 people from
Otsuka & each CRO
• 100 pt objective scoring• Top CRO selected• 100 pt objective scoring• Top CRO selected
Apr 2009 10
CRO Comments on Otsuka’s Approach
• We appreciate Otsuka’s efforts and transparency in this process – its not usual to get this level of constructive feedback during one of these partnership processes.
• The level of professionalism and knowledge your team exudes is amazing.
• We will use the information as a benchmark of how we can continuously improve our operations and approach to partnership.
• Otsuka’s thoughts regarding the strength of our application are appreciated.
• Thanks so much for the feedback – there is SO much great information here that we truly appreciate and will use in our process of continuous improvement.
Apr 2009 11
Alliance Development Status - Mar 2009
• Executive & Operations Governance Teams formed– Current state health check– Vision of the future
• Alliance operating norms being developed– Pipeline forecasting– Work sharing & management– IT & process integration– Issue escalation process eliminated?– Novel pricing strategies?
• Alliance now in kickoff process– Near-term actions required to commence the alliance– Long-term actions to optimize the alliance during POC
Apr 2009 12
Future Views
If We Fail….
…And If We Succeed
Apr 2009 13
The Global Business Partnership AlliancePartnership Crab