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成功する提携のための戦略・戦術:製薬・バイオテクノロジープロジェクトの提携ガイド

Strategies and Tactics for Successful Partnering:An essential guide on how to partner your pharmaceutical or biotechnology opportunity

発行 IMS World Publications Ltd. 商品コード 253538
出版日 ページ情報 英文
納期: 即日から翌営業日
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成功する提携のための戦略・戦術:製薬・バイオテクノロジープロジェクトの提携ガイド Strategies and Tactics for Successful Partnering:An essential guide on how to partner your pharmaceutical or biotechnology opportunity
出版日: 2016年05月01日 ページ情報: 英文
概要

当レポートでは、製薬・バイオテクノロジー領域における提携を成功に導くためのガイドを提供しており、提携の詳細なイントロダクション、ドキュメンテーションを含む提携プロセスの詳細なレビュー、大手製薬企業・小規模バイオテクノロジー企業に対応する際に遭遇する課題についての議論、交渉・適正評価・アライアンス管理に関するアドバイスなどをまとめ、概略下記の内容でお届けいたします。

エグゼクティブサマリー

第1章 提携のイントロダクション

第2章 提携の時期・正しいパートナーを見つける方法

  • 提携の時期
  • 正しいパートナーを見つける方法
  • パートナーの特定

第3章 提携プロセス

  • 一連のコンタクト
  • 非機密情報
  • 秘密開示合意
  • 機密情報
  • 企業プレゼンテーション
  • 契約の管理

第4章 主要製薬企業への対応

  • 背景
  • 意思決定プロセス
  • タイミング
  • 文化

第5章 小規模バイオテクノロジー企業への対応

  • 背景
  • 意思決定プロセス
  • タイミング
  • 文化

第6章 企業を「選ばれるパートナー」にする

  • プロジェクトごとに選ばれるパートナーは異なる
  • 選ばれるパートナーの特徴
  • 戦略的一致
  • 内部非効率
  • アライアンス管理の重要性
  • 能力をアピールする

第7章 評価

  • 評価テクニックの組み合わせ
  • ベンチマーキング
  • 正味現価(NPV)の予測
  • 価値配分

第8章 契約構造

  • 提携の発展
  • R&D段階の合意
  • 製品ライセンシング合意
  • その他の契約構造

第9章 契約の保障

  • 適正評価プロセス
  • 適正評価のエレメント
  • 情報の提供
  • 交渉
  • プレゼンテーション段階
  • 交渉段階
  • 結果段階

第10章 契約のライフサイクル

  • アライアンス管理
  • プロセスリスク・業績リスク
  • アライアンスのライフサイクルモデル
  • アライアンス管理構造
  • アライアンス管理者の役割
  • 成功の主要因子
  • コラボレーションにおけるパフォーマンス管理
  • 訴訟管理
  • 仲裁・調停
  • 訴訟
  • 契約書の解除条項

図表

このページに掲載されている内容は最新版と異なる場合があります。詳細はお問い合わせください。

目次

Overview

The Strategies and Tactics for Successful Partnering Report: A Guide to Partnering Pharmaceutical and Biotechnology Projects a review of the partnering process which is outlined step by step to those unfamiliar to dealmaking.

Contents

  • The report discusses in detail all aspects of partnering including the steps that are involved from identifying the opportunity through to negotiating and signing the deal and beyond; the report provides hands-on advice on how to complete each of these activities
  • Detailed introduction to partnering, how and when to find the right partner and where you can get information about potential opportunities partners
  • In-depth review of the partnering process including the documentation - non confidential and confidential - which is required by each partner to complete the deal
  • A detailed discussion of unique issues encountered when dealing with large pharma and small biotechs
  • Guidance on how to value your products and what deal structure suits your product and your specific requirements
  • Advice on negotiation, due diligence and alliance management; the report also discusses what to do when things go wrong and therefore how to manage the process of deal termination

Key Benefits

  • Avoid the pitfalls in partnering with an in-depth understanding of all the components of partnering and dealmaking with pointers on how to complete each activity successfully
  • Answer key questions such as why and when should you partner; what issues you have to consider and what issues you need to anticipate in the partnering process
  • Know how best to present your company and your opportunity to potential partners; know how to value your product and how to negotiate the best deal

Table of Contents

EXECUTIVE SUMMARY

CHAPTER 1 AN INTRODUCTION TO PARTNERING

  • 1.1 What is Partnering?
  • 1.2 The Partnering Process
  • 1.3 Why Do Companies Partner?
  • 1.4 Types of Partnering Deal
  • 1.5 Who Partners with Whom?
  • 1.6 General Trends in Partnering

CHAPTER 2 WHEN TO PARTNER AND HOW TO FIND THE RIGHT PARTNER

  • 2.1 When to Partner
    • 2.1.1 Project Phase
    • 2.1.2 Project Exclusivity
    • 2.1.3 Internal Issues to be Considered
    • 2.1.4 The Final Decision
  • 2.2 How to Find the Right Partner
    • 2.2.1 Operational Capabilities
    • 2.2.2 Therapeutic Expertise
    • 2.2.3 Target Partner Profile
    • 2.2.4 Cultural Fit
    • 2.2.5 Ideal and Unsuitable Partners
  • 2.3 Partner Identification
    • 2.3.1 Databases
    • 2.3.2 Company Websites
    • 2.3.3 Academic Institutions
    • 2.3.4 General and Industry Press
    • 2.3.5 Regulatory Filings
    • 2.3.6 Personal Contacts
    • 2.3.7 Conferences
    • 2.3.8 Consultants
    • 2.3.9 Internal and External Experts
    • 2.3.10 Unsolicited Approaches
    • 2.3.11 Venture Capitalists
  • 2.4 Conclusion

CHAPTER 3 THE PARTNERING PROCESS

  • 3.1 Sequence of Contacts
    • 3.1.1 Initial Approach to Potential Partners
    • 3.1.2 Non-Confidential Information Sent
    • 3.1.3 Internal Review by Partner
    • 3.1.4 Confidential Disclosure Agreement Signed
    • 3.1.5 Confidential Information Supplied
    • 3.1.6 Due Diligence
    • 3.1.7 Deal Terms Agreed
    • 3.1.8 Contract Negotiated
    • 3.1.9 Alliance Management
  • 3.2 Non-Confidential Information
  • 3.3 Confidential Disclosure Agreement
    • 3.3.1 One-Way or Mutual
    • 3.3.2 Duration
    • 3.3.3 Project Coverage
    • 3.3.4 People Covered
    • 3.3.5 Information Covered
    • 3.3.6 Return of Confidential Information
    • 3.3.7 Public Disclosure
  • 3.4 Confidential Information
    • 3.4.1 Cover Sheet
    • 3.4.2 Summary Overview
    • 3.4.3 Scientific Rationale
    • 3.4.4 Therapeutic Rationale
    • 3.4.5 Chemistry, Manufacturing and Control
    • 3.4.6 Technologies and Drug Delivery Systems
    • 3.4.7 Preclinical Data
    • 3.4.8 Clinical Data
    • 3.4.9 Regulatory Status
    • 3.4.10 Pre-Marketing Activity
    • 3.4.11 Trade Marks
    • 3.4.12 Commercial Rationale
    • 3.4.13 Patents
    • 3.4.14 Future Plans
    • 3.4.15 Licensing/Partnership Opportunity
    • 3.4.16 Disputes
    • 3.4.17 References
    • 3.4.18 Marketed Products
  • 3.5 Corporate Presentation
    • 3.5.1 Company Background
    • 3.5.2 Major Product Summaries
    • 3.5.3 Sales Infrastructure
    • 3.5.4 R&D Overview
    • 3.5.5 Financials
    • 3.5.6 Licensing
    • 3.5.7 Current Agreements
    • 3.5.8 Partnering Strengths
  • 3.6 Managing Your Contacts

CHAPTER 4 DEALING WITH A MAJOR PHARMACEUTICAL COMPANY

  • 4.1 Background
    • 4.1.1 Initial Approach
    • 4.1.2 Making the Right Contact
  • 4.2 The Decision-making Process
    • 4.2.1 Initial Review
    • 4.2.2 Detailed Review
    • 4.2.3 Due Diligence
    • 4.2.4 Valuation
    • 4.2.5 Negotiation
    • 4.2.6 Approval Levels and Committees
  • 4.3 Timings
  • 4.4 Culture

CHAPTER 5 DEALING WITH A SMALL BIOTECHNOLOGY COMPANY

  • 5.1 Background
    • 5.1.1 Initial Approach
  • 5.2 The Decision-Making Process
    • 5.2.1 Initial Review
    • 5.2.2 Detailed Review
    • 5.2.3 Due Diligence
    • 5.2.4 Valuation
    • 5.2.5 Negotiation
    • 5.2.6 Approval Levels
  • 5.3 Timings
  • 5.4 Culture

CHAPTER 6 ESTABLISHING YOUR ORGANISATION AS THE PARTNER OF CHOICE

  • 6.1 Different Partners of Choice for Different Projects
  • 6.2 Characteristics of a Partner of Choice
  • 6.3 Strategic Fit
  • 6.4 Internal Inefficiencies
  • 6.5 The Importance of Alliance Management
  • 6.6 Promoting Your Capabilities

CHAPTER 7 VALUATION

  • 7.1 Combining Valuation Techniques
  • 7.2 Benchmarking
    • 7.2.1 Feasibility
    • 7.2.2 Data Gathering
    • 7.2.3 Refinement of the Valuation
  • 7.3 Expected Net Present Value
    • 7.3.1 Opportunity Cost/Time Value
    • 7.3.2 Risk
    • 7.3.3 Decision Tree Analysis
    • 7.3.4 Sensitivity Analysis
    • 7.3.5 Monte-Carlo Simulation
  • 7.4 Value Distribution
    • 7.4.1 Value of Deal Components
    • 7.4.2 Value Splits

CHAPTER 8 DEAL STRUCTURE

  • 8.1 Evolution of Partnerships
  • 8.2 Licensing Agreements
    • 8.2.1 Simple Licensing Agreements
  • 8.3 Collaborative R&D Agreements
  • 8.4 Evaluation Agreements
  • 8.5 Technology Access Agreements
  • 8.6 Co-marketing and Co-promotion Agreements
  • 8.7 Marketing Agreements
  • 8.8 Product Sale and Purchase Agreements
  • 8.9 Option Agreements
    • 8.9.1 Option to Purchase
    • 8.9.2 Option to License
  • 8.10 Equity Investments
  • 8.11 Alternative Deal Structures
    • 8.11.1 Drug Royalty Companies
    • 8.11.2 Risk Sharing Agreements with Contract Research Organis
    • 8.11.3 Quids
    • 8.11.4 Joint Ventures
  • 8.12 Conclusion

CHAPTER 9 SECURING THE DEAL

  • 9.1 The Due Diligence Process
  • 9.2 The Elements of Due Diligence
  • 9.3 Providing the Information
  • 9.4 Negotiation
  • 9.5 Preparation Phase
  • 9.6 Negotiation Phase
    • 9.6.1 Negotiating the Term Sheet and the Financial Terms
    • 9.6.2 Negotiation Behaviour
  • 9.7 Outcome Phase

CHAPTER 10 THE DEAL LIFE CYCLE

  • 10.1 Alliance Management
  • 10.2 Process Risk and Performance Risk
  • 10.3 Alliance Life Cycle Model
    • 10.3.1 Negotiation
    • 10.3.2 Formation
    • 10.3.3 Management
    • 10.3.4 Termination
  • 10.4 Alliance Management Structure
  • 10.5 The Role of the Alliance Manager
  • 10.6 Key Factors for Success
    • 10.6.1 Governance
    • 10.6.2 Communication
    • 10.6.3 Alliance Start-Up
    • 10.6.4 Process Integration
  • 10.7 Performance Management in Collaborations
  • 10.8 Conflict Management
    • 10.8.1 Anticipate and Prepare
    • 10.8.2 Intervene Early
    • 10.8.3 Take Appropriate Remedial Action
  • 10.9 Mediation and Arbitration
  • 10.10 Litigation
  • 10.11 Termination Clauses

FIGURES

  • Figure 1.1 The deal process chain.
  • Figure 1.2 Rate of development of new drugs
  • Figure 1.3 Capital raised by biotechnology companies in North America and Europe per year.
  • Figure 1.4 R&D stage agreements.
  • Figure 1.5 Product licensing agreements.
  • Figure 1.6 Joint venture activity, 2011 to 2015
  • Figure 1.7 Company type combinations involved in dealmaking, 2011 to 2015.
  • Figure 1.8 Biotech-biotech dealmaking activity, 2011 to 2015.
  • Figure 1.9 Global-global company dealmaking activity, 2011 to 2015.
  • Figure 1.10 Number of deals 2011 to 2015 (excluding funding awards).
  • Figure 2.1 Number of all deals by phase of development for deals from 2006 to 2015.
  • Figure 2.2 Average total deal values and average upfront payments for product deals by phase of development for deals from 2006 to 2015.
  • Figure 2.3 Capabilities across the R&D cycle.
  • Figure 2.4 Key areas for relationship fit.
  • Figure 2.5 The partner search.
  • Figure 3.1 Contact sequence.
  • Figure 7.1 Integrated valuation methods
  • Figure 7.2 Ideal benchmarking deal cluster.
  • Figure 7.3 Non-ideal benchmarking deal cluster.
  • Figure 7.4 Example pharmaceutical deal valuation force field.
  • Figure 7.5 Attrition by phase and therapeutic area.
  • Figure 7.6 Pharmaceutical product decision tree.
  • Figure 7.7 The effect of time and risk on the value of deal components.
  • Figure 9.1 The term of the working relationship
  • Figure 9.2 The negotiation team.
  • Figure 9.3 Negotiation styles.
  • Figure 10.1 Risks inherent in collaborations.
  • Figure 10.2 The four phases of the alliance management life cycle.
  • Figure 10.3 The roles of an alliance manager.
  • Figure 10.4 Relationship between substantive conflict and interest.

TABLES

  • Table 1.1 Selected biotech companies raising >US$100 M in 2015.
  • Table 2.1 Issues to consider when out-licensing and in-licensing a project.
  • Table 2.2 Checklist of questions to help evaluate in-licensing projects.
  • Table 2.3 Target Partner Profile.
  • Table 2.4 Corporate culture issues.
  • Table 3.1 Contents of a non-confidential document.
  • Table 6.1 Successful alliance fitness test.
  • Table 7.1 Overview of benchmarking methodology.
  • Table 8.1 Reasons a company would out-license or in-license a product.
  • Table 8.2 The positives and negatives to consider when entering into co-marketing agreements.
  • Table 8.3 The positives and negatives to consider when entering into co-promotion agreements.
  • Table 8.4 The positives and negatives to consider when entering into marketing agreements.
  • Table 8.5 The positives and negatives to consider in option to license deals.
  • Table 9.1 Key areas for consideration in a due diligence exercise.
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