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Published by: PJB Publications USA Inc.
Published: May. 1, 2003 - 143 Pages
Table of Contents
1 Executive Summary
- 1.1 Introduction
- 1.2 Scope and Objectives of Report
- 1.3 Report Organization
2 Process of Drug Development
- 2.1 Preclinical Testin
- 2.2 Phase I Clinical Trials
- 2.3 Phase II Clinical Trials
- 2.4 Phase III Clinical Trials
- 2.5 Treatment Investigational New Drug (IND) Status
- 2.6 New Drug Application (NDA)
- 2.7 Time to FDA Approval
- 2.8 Key Points
3 Industry Overview
- 3.1 Pharmaceutical Industry
- 3.1.1 Overview
- 3.1.2 External Forces Impacting Pharma
- 3.1.3 Internal Forces Impacting Pharma
- 3.2 Biotechnology Industry
- 3.2.1 Overview
- 3.2.2 Genomics
- 3.2.3 Proteomics
- 3.2.4 Pharmacogenomics
- 3.2.5 Information Technology
- 3.2.6 Forces Impacting Biotech
- 3.3 Key Points
- 3.3.1 Pharma
- 3.3.2 Biotech
4 Intellectual Property Protection
- 4.1 Patents
- 4.2 Copyright
- 4.3 Trade Secrets/Know-How
- 4.4 Licensing
- 4.5 Background and Foreground Rights
- 4.6 Federal Ownership of Intellectual Property
- 4.7 Intellectual Property Insurance
- 4.8 Key Points
5 Partnering Models
- 5.1 Outsourcing
- 5.2 Cooperative Relationships
- 5.2.1 Co-marketing
- 5.2.2 Co-promotion
- 5.2.3 Co-development
- 5.3 Licensing
- 5.3.1 Out-Licensing
- 5.3.2 In-Licensing
- 5.3.3 Reach-through Licensing
- 5.3.4 Product Acquisition
- 5.3.5 Product Fostering
- 5.3.6 Early Versus Late Stage Licensing
- 5.4 Collaborations
- 5.4.1 Research and Development Agreements
- 5.4.2 Contract Research Agreements
- 5.4.3 Evaluation and Option Agreements
- 5.5 Joint Ventures
- 5.6 Consortia
- 5.7 Key Points
6 Partnering Process
- 6.1 Self-Evaluation
- 6.1.1 Inventory of Intellectual Property
- 6.1.2 Initial Financial Analysis
- 6.1.3 Evaluation of Intellectual Property Versus Strategy
- 6.2 Project Management Teams
- 6.3 Partner Profile Development
- 6.4 Candidate Identification
- 6.5 Confidentiality Agreements
- 6.6 Due Diligence: Organizational
- 6.6.1 Intellectual Property
- 6.6.2 Infringement of Third Party Rights
- 6.6.3 Agreements
- 6.7 Due Diligence: Market and Product
- 6.7.1 Data Ga
- 6.7.2 Valuation
- 6.8 Negotiations
- 6.9 Working With Public Funds
- 6.9.1 Overview
- 6.9.2 Current Concerns
- 6.9.3 NIH Working Group Recommendations
- 6.9.4 Recommendations for Contracting With NIH-Funded Recipients
- 6.10 Key Points
- 6.10.1 Of the Partnering Process
- 6.10.2 Of Working With Public Funds
7 Key License Agreement Terms
- 7.1 Scope of Agreement
- 7.1.1 Subject
- 7.1.2 Field of U
- 7.1.3 Territory
- 7.2 Intellectual Property Management
- 7.2.1 Exclusivity
- 7.2.2 Special Provisions for Collaboration Agreements
- 7.2.3 Maintenance and Enforcement of Patents
- 7.2.4 Special Provisions for Agreements With IT Providers
- 7.3 Rights in I
- 7.4 Authorized Users of Licensed Rights
- 7.5 Warranties, Indemnities, Limitation of Liability
- 7.6 Payment Arrangements
- 7.6.1 Upfront Payment
- 7.6.2 Milestone Payments
- 7.6.3 Equity Investment
- 7.6.4 Royalties
- 7.7 Enforceability
- 7.8 Term and Termination Provisions
- 7.8.1 Rights on Termination
- 7.9 Novel Terms From 2002 Activity
- 7.10 Key Points
8 Partnership Implementation and Success
- 8.1 Report of Partnering Experience
- 8.2 Reasons for Suboptimal Performance
- 8.2.1 Partner Selection
- 8.2.2 Management of Change
- 8.2.3 Management of the Deal-Making Process
- 8.2.4 Planning and Implementation
- 8.2.5 Commu
- 8.3 Key Points
9 World Market Impact of Licensing
- 9.1 Global Pharma/Biotech Market Factors
- 9.1.1 Harmoni
- 9.1.2 Patent Expiry and Blockbuster Drug Exposure
- 9.1.3 U.S. as Drug Development Leader
- 9.1.4 Information Technology and Drug Delivery
- 9.1.5 Changes in Japanese Regulation
- 9.2 Major Therapeutic Categories
- 9.2.1 Cardiovascular Drug Market
- 9.2.2 Central Nervous System (CNS) Drug Market
- 9.2.3 Gastrointestinal/Metabolic Drug Market
- 9.2.4 Anti-Infectives Market
- 9.2.5 Respiratory Drug Market
- 9.3 Key Points
10 Future of Licensing and Partnerships
- 10.1 Reasons for Permanency of Licensing
- 10.2 Changes in the Partnership Process
- 10.2.1 Alliance Management
- 10.2.2 Financial Structure
- 10.2.3 Matching Supply and Demand
- 10.3 Compulsory Licensing
- 10.4 Integrated Licensing
- 10.5 Drug Cost Justification and HTAs
- 10.6 Key Points
11 Partnership Activity Survey 2002
- 11.1 Survey Criteria
- 11.2 Volume of Activity Types
- 11.3 Geographic Regions
- 11.4 Major Partner Companies
- 11.5 Partnership Areas of Interest
- 11.6 Partnership Types by Industry
- 11.6.1 Pharma Biotech Partnerships
- 11.6.2 Biotech Biotech Partnerships
- 11.6.3 Pharma Pharma Partnerships
- 11.7 Key Points
12 Company Alliance/Partnership Lists
- 12.1 Abbott Lab
- 12.2 Amersham PLC
- 12.3 Amgen
- 12.4 Aventis
- 12.5 Bristol-Myers Squibb
- 12.6 Cambridge Antibody Technology
- 12.7 Eli Lilly
- 12.8 Genentech
- 12.9 Genmab
- 12.10 Genzyme
- 12.11 GlaxoSmi
- 12.12 Johnson & Johnson
- 12.13 Merck & Co.
- 12.14 Millennium Pharmaceuticals
- 12.15 Novartis
- 12.16 Pharmacia/Pfizer
- 12.17 Roche
- 12.18 Schering-Plough
- 12.19 Wyeth
AbstractTheta Reports has developed this practical guide report on
pharmaceutical and biotechnology licensing as a resource
for licensing professionals who are interested in the latest
information on deal making; pharmaceutical and biotechnology
professional staff who want an introduction to licensing; and
all others who want to understand the mechanisms of the licensing
process and the issues and trends affecting these arrangements.
This report focuses on and explains the mechanics and reasoning
that produce strong and productive licensing agreements within the
larger context of the pharma/biotech partnering phenomenon.
Key issues addressed:
- The current pharmaceutical and biotechnology industries
- The drug discovery process
- Forms of partnerships
- How-to information for partnering
- Recommendations for optimizing partnerships
- A review of licensing impact by therapeutic category
- Future of pharma partnering and licensing
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