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

2. Buckingham Alliance Partners
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 Growing your business: Build or partner?
Partner or Perish: Forging Effective Alliances
Session Objectives
Address key questions:
 How does one build and maintain an effective
alliance?
 What defines a competent partnering
organization?

3. Buckingham Alliance Partners
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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

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

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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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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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Alliance Business Model
S
u
p
pl
e
m
e
nt
a
ry
Alliances for
Supplementation/Load
Balancing
C
o
m
pl
e
m
e
nt
a
ry
Alliances for
Complementary
Capabilities,
Offerings and Skills
Core
Core Capabilities
and Competencies

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Partner or Perish: Forging Effective Alliances
Why would we want to do this?
 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
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Partner or Perish: Forging Effective Alliances
Why would we want to do this?
 Alliances (collaborations) increasingly used to attain
company goals:
• Access to expertise
• Flexible resources
• Increased speed (of development, to market, etc.)
• Reduced financial risk
 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
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Partner or Perish: Forging Effective Alliances
Why establish an alliance competency?
 Increase the proportion of alliances that meet or exceed their
goals (and management expectations)

11. Buckingham Alliance Partners
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Partner or Perish: Forging Effective Alliances
Why establish an alliance competency?
 Increase the proportion of alliances that meet or exceed their
goals (and management expectations)
 Accelerate `institutional learning’ of effective (and destructive)
behaviors affecting collaborations: enhanced organizational
awareness
 Build consistency in effective alliance design, integration and
maintenance processes

12. Buckingham Alliance Partners
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Partner or Perish: Forging Effective Alliances
Why establish an alliance competency?
 Increase the proportion of alliances that meet or exceed their
goals (and management expectations)
 Accelerate `institutional learning’ of effective (and destructive)
behaviors affecting collaborations: enhanced organizational
awareness
 Build consistency in effective alliance design, integration and
maintenance processes
 Enhance company reputation as a skilled, successful
partnering organization (to secure more, and more capable,
partners)

13. Buckingham Alliance Partners
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Partner or Perish: Forging Effective Alliances
Key Alliance Management Competencies:
4.Communicating Effectively
5.Leading by Influencing
6.Gaining Value from Diversity
7.Building and Maintaining Trust

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

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Effective Senior Management
Sponsorship of Alliances
Why is Effective Sponsorship critical?
 Alliance failure rate – key factors:
Internal support for resourcing and decision-making
Ensuring alignment on key issues across partner
organizations
Effective dispute resolution

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Alliance Leadership Alternatives
Integrated LeadershipShared Leadership
 Internal/external
 Product Objectives/
Relationship Objectives

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

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

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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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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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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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Alliance Team Charter Template
Guidance Resource for Alliance Management
Purpose: Provides focus,
alignment and operational
guidance to each alliance
relationship. Serves as an
operational reference and guide
through the alliance lifecycle as
a companion to contractual
agreements and project plans.
Allied Companies: Your and XYZ Company
Alliance History and Background
Alliance Focus
(Mission, Spirit of Alliance, High-Level Objectives/Milestones)
Alliance Working Guidelines
(Addressing the Alliance Essentials)
Performance Measurement
(Measuring and Monitoring Performance)
Roles and Responsibilities
(Company Roles and Key Individual Roles)
Key Sections:
• Alliance mission, objectives
and spirit
• Roles and responsibilities
• Working guidelines
• Metrics and performance
measurement

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

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Alliance `Health Check’ Surveys
Assessment Resources for Alliance Management
Alliance Health Check
Purpose: Primary
measurement mechanism for
Relationship Performance
factorsStrongly
Disagree Disagree Neutral Agree
Strongly
Agree
1. Alliance Focus (Goals and Objectives)
a. Sensor Question
b. Sensor Question
c. Sensor Question
2. Roles and Responsibilities
a. Sensor Question
b. Sensor Question
c. Sensor Question
3. Decision Making
a. Sensor Question
b. Sensor Question
Key Features:
 Provides regular checkpoint
on essential Alliance
competencies
 2-3 “sensor” questions per
Relationship factor
 Results discussed with
partner, to identify and
understand areas for
improvement and reasons
for successful outcomes
 Action plans developed and
implemented through
Alliance Team
3. Relationship Trust
a. Sensor Question
b. Sensor Question

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Effective Senior Management
Sponsorship of Alliances
Typical Alliance Governance Framework

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Strategic Importance to
Alliance Partner
StrategicImportanceto
YourCompany
Low High
Low
High Imbalance Balance
Balance Imbalance
Establishing an Alliance Management Capability
Alliance Structure and Management Considerations
Vulnerable Enthusiast
Potential Bully
Dynamic Duo
Simple Pairing

28. Buckingham Alliance Partners
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 Growing your business: Build or partner?
Partner or Perish: Forging Effective Alliances
Session Objectives
Address key questions:
 How does one build and maintain an effective
alliance?
 What defines a competent partnering
organization?

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