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

1. Partner or Perish: Forging effective alliances
September 9th, 2011
Buckingham Alliance Partners
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Buckingham Alliance Partners

2. Partner or Perish:
Forging Effective Alliances
MaRS Best Practices Series:
Alliance Management
John Buckingham
September 9, 2011
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Buckingham Alliance Partners

3. Partner or Perish: Forging Effective Alliances
Session 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?
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Buckingham Alliance Partners

4. Partner or Perish: Forging Effective Alliances
Continuing 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
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Buckingham Alliance Partners

5. Partner or Perish: Forging Effective Alliances
Professional Certification:
Available through ASAP - Toronto Chapter
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Buckingham Alliance Partners

6. What is an Alliance?
• An alliance is a collaboration
• Between independent organizations that
retain strategic autonomy
• While committing resources to joint
activity
• And run within an incomplete contract
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Buckingham Alliance Partners

7. Major Alliance Types:
Operational alliances
• One or more key functions of a company is
performed solely or primarily by an alliance
partner
Project alliances
• Alliance partners collaborate on a specific
project, typically with defined progress
milestones and a defined termination point
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Buckingham Alliance Partners

8. Alliance Business Model
Core Capabilities
and Competencies
Alliances for
S C
Supplementation/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
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Buckingham Alliance Partners

9. Partner or Perish: Forging Effective Alliances
Why 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
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Buckingham Alliance Partners

10. Partner or Perish: Forging Effective Alliances
Why 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
u Less than 40% of alliances meet their stated objectives
• Misalignment of partner goals
• Miscommunications
• Poor execution
• Changed financial prospects
• Technical failure
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Buckingham Alliance Partners

11. Partner or Perish: Forging Effective Alliances
Why establish an alliance competency?
u Increase the proportion of alliances that meet or exceed their
goals (and management expectations)
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Buckingham Alliance Partners

12. Partner or Perish: Forging Effective Alliances
Why 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
awareness
u Build consistency in effective alliance design, integration and
maintenance processes
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Buckingham Alliance Partners

13. Partner or Perish: Forging Effective Alliances
Why 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
awareness
u Build consistency in effective alliance design, integration and
maintenance processes
u Enhance company reputation as a skilled, successful
partnering organization (to secure more, and more capable,
partners)
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Buckingham Alliance Partners

14. Partner or Perish: Forging Effective Alliances
Key Alliance Management Competencies:
1. Communicating Effectively
2. Leading by Influencing
3. Gaining Value from Diversity
4. Building and Maintaining Trust
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Buckingham Alliance Partners

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
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Buckingham Alliance Partners

16. Internal Organization for Alliance Management
Key Elements:
Senior Management Sponsor
u Alliance must serve sponsor s organizational goals
u Dedicated Alliance Leader
u `Mindshare or formal designation
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Buckingham Alliance Partners

17. Effective Senior Management
Sponsorship of Alliances
Why 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
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Buckingham Alliance Partners

18. Alliance Leadership Alternatives
Shared Leadership Integrated Leadership
u Internal/external
u Product Objectives/
Relationship Objectives
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Buckingham Alliance Partners

19. Alliance Life Cycle
Alliance Alliance Alliance Alliance
Negotiation Integration Maintenance Transformation
Agreement R&D Commercialization
Signing
Collaboration Alliance
Integration Change or
Termination
Alliance
Management
Problem
Contract Resolution
Negotiation
Monitoring
Prevention Diagnosis Treatment
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Buckingham Alliance Partners

20. Establishing an Alliance Management Competency
Alliance Management: Business Development Interface
Deal-Making and Deal-Managing:
An Integrated, Transparent Process
Identify/ Negotiate Re-evaluate:
Sign Launch/ Manage
Recruit Revise or
Integrate
Opportunities Evaluate Terminate
BD
AM
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Buckingham Alliance Partners

21. Alliance Management Perspective:
Adding Value During Deal Negotiations
Three Main Considerations:
• Due diligence: partner candidate assessment
• Effective relationship development
• Designing the appropriate collaboration structure
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Buckingham Alliance Partners

22. Integrating a New Alliance
Key Considerations:
• Appointing a qualified alliance leader and a senior
management `sponsor
• Timely recruiting of alliance-facing staff
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Buckingham Alliance Partners

23. Integrating a New Alliance
Key Considerations:
• Appointing a qualified alliance leader and a senior
management `sponsor
• Timely recruiting of alliance-facing staff
• Joint communication of management expectations
and contractual requirements to the alliance team
and leader
• Joint alliance team formation and relationship-
building
• Establish alliance team charter
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Buckingham Alliance Partners

24. Alliance Team Charter Template
Guidance 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
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Buckingham Alliance Partners

25. Alliance Life Cycle
Alliance Alliance Alliance Alliance
Negotiation Integration Maintenance Transformation
Agreement R&D Commercialization
Signing
Collaboration Alliance
Integration Change or
Termination
Alliance
Management
Problem
Contract Resolution
Negotiation
Monitoring
Prevention Diagnosis Treatment
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Buckingham Alliance Partners

26. Alliance `Health Check Surveys
Assessment 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
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Buckingham Alliance Partners

27. Effective Senior Management
Sponsorship of Alliances
Typical Alliance Governance Framework
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Buckingham Alliance Partners

28. Establishing an Alliance Management Capability
Alliance 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
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Buckingham Alliance Partners

29. Partner or Perish: Forging Effective Alliances
Session 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. Partner or Perish: Forging Effective Alliances
Questions?
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Buckingham Alliance Partners