Partner or Perish: Forging effective alliances - MaRS Best Practices

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Moving from drug discovery to drug development requires a particular skillset usually not yet honed by start-ups. This phase of the development process is highly regulated and, critically, inexperienced start-ups often underestimate the duration and cost of delivering the dosage form into the clinic while meeting regulations.

This presentation will address the following:

* aspects of the Chemistry, Manufacturing and Control (CMC) portion of the drug development process
* bioavailability and the Biopharmaceutics Classification System (BCS)
* objectives of formulation
* cost-effective strategies to reach key milestones

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  • Buckingham Alliance Partners
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  • Buckingham Alliance Partners Some basic recommendations for dealing with imbalances are listed in each box on the slide.
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  • Partner or Perish: Forging effective alliances - MaRS Best Practices

    1. 1. Partner or Perish: Forging effective alliancesSeptember 9th, 2011 Buckingham Alliance Partners 1 Buckingham Alliance Partners
    2. 2. Partner or Perish:Forging Effective AlliancesMaRS Best Practices Series:Alliance ManagementJohn BuckinghamSeptember 9, 2011 2 Buckingham Alliance Partners
    3. 3. Partner or Perish: Forging Effective AlliancesSession Objectives Address key questions: u  Growing your business: Build or partner? u  What defines a competent partnering organization? u  How does one build and maintain an effective alliance? 3 Buckingham Alliance Partners
    4. 4. Partner or Perish: Forging Effective AlliancesContinuing Learning: The leading global professional association dedicated to the formation and practice of strategic alliances www.strategic-alliances.org ASAP - Toronto Chapter www.asaptoronto.com 4 Buckingham Alliance Partners
    5. 5. Partner or Perish: Forging Effective AlliancesProfessional Certification: Available through ASAP - Toronto Chapter 5 Buckingham Alliance Partners
    6. 6. What is an Alliance?•  An alliance is a collaboration•  Between independent organizations thatretain strategic autonomy•  While committing resources to jointactivity•  And run within an incomplete contract 6 Buckingham Alliance Partners
    7. 7. Major Alliance Types:Operational alliances •  One or more key functions of a company is performed solely or primarily by an alliance partnerProject alliances •  Alliance partners collaborate on a specific project, typically with defined progress milestones and a defined termination point 7 Buckingham Alliance Partners
    8. 8. Alliance Business Model Core Capabilities and Competencies Alliances for S CSupplementation/Load u o Balancing p m p p le le m m e n Core e n t t a a r r y y Alliances for Complementary Capabilities, Offerings and Skills 8 Buckingham Alliance Partners
    9. 9. Partner or Perish: Forging Effective AlliancesWhy would we want to do this?u  Alliances (collaborations) increasingly used to attain company goals: •  Access to expertise •  Flexible resources •  Increased speed (of development, to market, etc.) •  Reduced financial risk 9 Buckingham Alliance Partners
    10. 10. Partner or Perish: Forging Effective AlliancesWhy would we want to do this?u  Alliances (collaborations) increasingly used to attain company goals: •  Access to expertise •  Flexible resources •  Increased speed (of development, to market, etc.) •  Reduced financial risku  Less than 40% of alliances meet their stated objectives •  Misalignment of partner goals •  Miscommunications •  Poor execution •  Changed financial prospects •  Technical failure 10 Buckingham Alliance Partners
    11. 11. Partner or Perish: Forging Effective AlliancesWhy establish an alliance competency?u  Increase the proportion of alliances that meet or exceed their goals (and management expectations) 11 Buckingham Alliance Partners
    12. 12. Partner or Perish: Forging Effective AlliancesWhy establish an alliance competency?u  Increase the proportion of alliances that meet or exceed their goals (and management expectations)u  Accelerate `institutional learning of effective (and destructive) behaviors affecting collaborations: enhanced organizational awarenessu  Build consistency in effective alliance design, integration and maintenance processes 12 Buckingham Alliance Partners
    13. 13. Partner or Perish: Forging Effective AlliancesWhy establish an alliance competency?u  Increase the proportion of alliances that meet or exceed their goals (and management expectations)u  Accelerate `institutional learning of effective (and destructive) behaviors affecting collaborations: enhanced organizational awarenessu  Build consistency in effective alliance design, integration and maintenance processesu  Enhance company reputation as a skilled, successful partnering organization (to secure more, and more capable, partners) 13 Buckingham Alliance Partners
    14. 14. Partner or Perish: Forging Effective AlliancesKey Alliance Management Competencies:1. Communicating Effectively2. Leading by Influencing3. Gaining Value from Diversity4. Building and Maintaining Trust 14 Buckingham Alliance Partners
    15. 15. Alliance Management Principles* • Clear Responsibilities and Expectations • Robust Communication • Senior Management Commitment • Understanding one s Partner • Disciplined Improvement Approach • Effective, Efficient Processes • Broad-based Alliance Capability * Adopted by ASAP from `Endo Alliance Management Principles 15 Buckingham Alliance Partners
    16. 16. Internal Organization for Alliance ManagementKey Elements:Senior Management Sponsor u Alliance must serve sponsor s organizational goalsu  Dedicated Alliance Leader u `Mindshare or formal designation 16 Buckingham Alliance Partners
    17. 17. Effective Senior ManagementSponsorship of AlliancesWhy is Effective Sponsorship critical?u  Alliance failure rate – key factors: u Internal support for resourcing and decision-making u Ensuringalignment on key issues across partner organizations u Effective dispute resolution 17 Buckingham Alliance Partners
    18. 18. Alliance Leadership Alternatives Shared Leadership Integrated Leadership u  Internal/external u  Product Objectives/ Relationship Objectives 18 Buckingham Alliance Partners
    19. 19. Alliance Life Cycle Alliance Alliance Alliance Alliance Negotiation Integration Maintenance Transformation Agreement R&D Commercialization Signing Collaboration Alliance Integration Change or Termination AllianceManagement Problem Contract Resolution Negotiation Monitoring Prevention Diagnosis Treatment 19 Buckingham Alliance Partners
    20. 20. Establishing an Alliance Management CompetencyAlliance Management: Business Development InterfaceDeal-Making and Deal-Managing: An Integrated, Transparent Process Identify/ Negotiate Re-evaluate: Sign Launch/ Manage Recruit Revise or Integrate Opportunities Evaluate Terminate BD AM 20 Buckingham Alliance Partners
    21. 21. Alliance Management Perspective:Adding Value During Deal NegotiationsThree Main Considerations:•  Due diligence: partner candidate assessment•  Effective relationship development•  Designing the appropriate collaboration structure 21 Buckingham Alliance Partners
    22. 22. Integrating a New AllianceKey Considerations:•  Appointing a qualified alliance leader and a seniormanagement `sponsor•  Timely recruiting of alliance-facing staff 22 Buckingham Alliance Partners
    23. 23. Integrating a New AllianceKey Considerations:•  Appointing a qualified alliance leader and a seniormanagement `sponsor•  Timely recruiting of alliance-facing staff•  Joint communication of management expectationsand contractual requirements to the alliance teamand leader•  Joint alliance team formation and relationship-building•  Establish alliance team charter 23 Buckingham Alliance Partners
    24. 24. Alliance Team Charter TemplateGuidance Resource for Alliance Management Allied Companies: Your and XYZ Company Purpose: Provides focus, Alliance History and Background alignment and operational guidance to each alliance relationship. Serves as an Alliance Focus (Mission, Spirit of Alliance, High-Level Objectives/Milestones) operational reference and guide through the alliance lifecycle as a companion to contractual Roles and Responsibilities (Company Roles and Key Individual Roles) agreements and project plans. Key Sections: Alliance Working Guidelines •  Alliance mission, objectives (Addressing the Alliance Essentials) and spirit •  Roles and responsibilities •  Working guidelines Performance Measurement (Measuring and Monitoring Performance) •  Metrics and performance measurement 24 Buckingham Alliance Partners
    25. 25. Alliance Life Cycle Alliance Alliance Alliance Alliance Negotiation Integration Maintenance Transformation Agreement R&D Commercialization Signing Collaboration Alliance Integration Change or Termination AllianceManagement Problem Contract Resolution Negotiation Monitoring Prevention Diagnosis Treatment 25 Buckingham Alliance Partners
    26. 26. Alliance `Health Check SurveysAssessment Resources for Alliance Management Purpose: Primary measurement mechanism for Relationship Performance Alliance Health Check Strongly Strongly factors Disagree Disagree Neutral Agree Agree Key Features: 1. Alliance Focus (Goals and Objectives) §  Provides regular checkpoint a. Sensor Question b. Sensor Question on essential Alliance c. Sensor Question competencies 2. Roles and Responsibilities a. Sensor Question §  2-3 sensor questions per b. Sensor Question c. Sensor Question Relationship factor 3. Decision Making §  Results discussed with a. Sensor Question b. Sensor Question partner, to identify and 3. Relationship Trust understand areas for a. Sensor Question improvement and reasons b. Sensor Question for successful outcomes §  Action plans developed and implemented through Alliance Team 26 Buckingham Alliance Partners
    27. 27. Effective Senior ManagementSponsorship of Alliances Typical Alliance Governance Framework 27 Buckingham Alliance Partners
    28. 28. Establishing an Alliance Management CapabilityAlliance Structure and Management Considerations High Strategic Importance Imbalance Balance to Your Company Vulnerable Enthusiast Dynamic Duo Balance Imbalance Low Potential Bully Simple Pairing Strategic Importance to Low Alliance Partner High 28 Buckingham Alliance Partners
    29. 29. Partner or Perish: Forging Effective AlliancesSession Objectives Address key questions: u  Growing your business: Build or partner? u  What defines a competent partnering organization? u  How does one build and maintain an effective alliance? 29 Buckingham Alliance Partners
    30. 30. Partner or Perish: Forging Effective Alliances Questions? 30 Buckingham Alliance Partners

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