R&D Strategies

Content

• Chapter 1 Executive Summary
  • Scope Of The Report
  • Methodology For Primary And Secondary Research
  • Key Findings
• Chapter 2 Concerns Over R&D Productivity Have Increased The Focus On R&D Strategies
  • The Fall In Innovative Drug Approvals, Coupled With Soaring R&S Costs, Indicates That Big Pharma Is Suffering From An R&D Productivity Crisis
  • The Number Of Innovative Drug Approvals Is Falling
  • The Cost Of Developing Each Successfully Launched Drug Has Soared
  • But Is The Drug Development Industry Really Facing A Fall In R&D Productivity?
  • A Range Of Challenges Faces Drug Developers, Increasing The Importance Of Prioritizing Enhanced R&D Productivity
  • Factors Making It More Profitable For Drug Developers To Become More Focused On R&D Investment And Switch Away From Biasing Spending Towards Sales And Marketing
  • Factors Creating Less Stability Or Threatening Profitability, Which Are Making Companies More Risk-Averse
• Chapter 3 Analysis Of Medtrack Clinical Pipeline Deals And Drug Databases
  • Partner Mix In Deals: Earlier-Stage Companies Are The Most Active Deal Makers
  • Primary Deal Goal: Co-Development And Licensing Deals Remain The Most Popular Deal Types
  • Therapeutic Focus Of The Pipeline: Oncology Remains The Dominant Target
  • Approval Times Are Quickest For Infectious Disease And Oncology/Idi Drugs
  • Both Probability Of Progression Through Development And Development Speed Are Optimal For Oncology, Idi And Infectious Disease Drugs
  • Specific Characteristics Of Therapy Areas Make Them Attractive To Different Drug Developers
  • Cost Of Development Is Also Vital In Deciding Which Therapy Area To Target
  • Deal Product Type Focus: Biologics Are Popular, Although Small Molecules Remain Dominant
• Chapter 4 A Wide Range Of R&D Strategy Recommendations Can Be Implemented To Improve R&D Productivity
  • An Introduction To R&D: The History Of Drug Development
  • Many Different Strategies Have Been Held Up As The Panacea Of The Drug Development Industry
  • Companies Such As Bayer Schering Pharma Are Leading The Pack In Development Time
  • Case-Study Examples Of How Big Pharma Is Changing R&D To Enhance Productivity
  • A Number Of Companies Are Making Small Refinements To Drive Incremental Improvement; However Companies Will Need To Ally These With Seismic Changes To Yield Dramatic Access To Innovation In The Future
  • Merck's Model
  • Lilly's Model
  • Novartis's Business Model Strategy
  • Wyeth's Business Model Strategy
  • Some Big Pharma Companies Have Thrown Out The Old Models And Have Started Again: These Are Likely To Be The Big Winners In The Future From An Innovation Capture Perspective
  • Gsk's Model
  • Roche's Model
  • Which Model Is Best?
  • Datamonitor Has Identified Two Groups Of Strategies To Optimize R&D: Those That Improve The R&D Model, And Those That Optimize R&D Pathway Progression
• Chapter 5 Recommendations To Optimize The R&D Model
  • Optimize Outsourcing Strategies
  • Drug Developers Should Implement Strategies To Optimize The Way That Cmos Are Used
  • Across The Drug Development Industry, There Is Increased Strategic USAge Of Outsourcing And Globalization Of Functions
  • Introduction To Contract Research Outsourcing
  • A Range Of Factors Are Driving The Use Of Cros
  • Despite The Significant Number Of Benefits, There Are Some Downsides To Using Cros
  • There Are A Wide Variety Of Cros
  • The Cro Market Is Becoming Increasingly Globalized
  • Outsourcing R&D: Advantages And Disadvantages Of Emerging Countries
  • There Are A Range Of Advantages And Disadvantages With Outsourcing To Emerging Markets
  • How Can Western Cros Survive? The UK Situation As A Case Study For How Cros Can Be Used In Western Markets
  • India And China Are The Most Popular Emerging Countries For Outsourcing Cro Activity
  • Indian Cros-Advantages And Disadvantages
  • Chinese Cros-Advantages And Disadvantages
  • Strategies That Can Be Used To Optimize The Cro Experience
  • Make Significant Commitments In The Relationship With The Cro
  • Ensure That Communication Between The Cro And The Drug Developer Is Strong, And That The Right Information Is Communicated
  • Ensure That The Way That Staff Are Used Is Optimal
  • Drug Developers Should Try To Remain Appropriately Cautious And Not Take Unnecessary Risks With The Cro Relationship
  • There Are Also Some Recommendations That Are Specific To The Chinese Market
  • Major Drug Developers Need To Improve Their Access To Early-Stage Research
  • Private Equity Arms Of Big Pharma Companies Are Particularly Useful In Capturing European Early-Stage Innovation
  • Incubators Are A Relatively New Strategy Designed To Improve Earlier-Stage Innovation Capture
  • Despite Significant Potential In Providing Access To Early-Stage Pre-Commercial Data, Open-Source Research Remains Under-Utilized
  • Drug Developers Should Use Licensing And M&A To Support In-House R&D
  • There Are A Range Of Advantages And Disadvantages With Licensing
  • A Range Of Factors Are Influencing The Licensing Environment
  • There Are A Range Of Recommendations That Drug Developers Can Use To Optimize Their Licensing Strategy
  • Big Is Not Always Best For Drug Discovery And Development: Why Mega-Mergers Are Not Always The Solution For Improved R&D Productivity
  • Optimize Macro Drug Development Strategy
  • Companies Must Determine The Strategic Balance Between Me-Too Incremental Improvement And First-In-Class Targeting
  • Even Large Multinational Drug Developers Should Look To Tighten Therapeutic Focus
  • Implementing Infrastructure Improvement-Focused Strategies Including Optimizing Portfolio Management Is Integral To Improving R&D
  • Broaden The Range Of Targets But Maintain The Therapeutic Focus Is Another Option
  • Improving Specific R&D Tools Will Help Improve The R&D Model
  • Biomarkers Use Patient Stratification And Market Segmentation To Drive Future Market Growth
  • Introduction: The Evolution Of Patient Treatment Into Personalized Therapies
  • The Current State Of The Biomarkers Market
  • Biomarkers Are Used In A Range Of Functions
  • Factors Driving The Evolution Of Biomarkers
  • Factors Restricting The Biomarkers Market
  • Better Implementation Of It Can Also Significantly Help R&D
• Chapter 6 Optimizing R&D Processes Will Help To Boost R&D Productivity
  • Optimize Safety Assessment In Preclinical Tests
  • The Problem: The Evolution Of Effective Safety Assessment Is Lagging
  • The Solution: Improved Safety Assessment Tools Plus The Implementation Of A Rigorous Assessment Program
  • Drug Developers Should Look To Improve The Way That Clinical Trials Are Being Run In-House
  • Better Use Of Academic Medical Centers Helps To Improve Clinical Trial Progression
  • Introduce Innovative Clinical Trial Designs To Get Rid Of Redundancy And Identify Where Parallel Operations Can Be Carried Out
  • Develop Robust Strategies To Reduce Attrition
  • What Causes Attrition?
  • Why Reduce Attrition?
  • How Can Attrition And Risk Be Reduced?
  • Taking Attrition Early Helps Reduce The Financial Impact
  • Optimize Use Of, And Interaction With, Regulators
  • Use Regulatory Bodies To Gain Access To Huge Amounts Of Data
  • Use Increased Interaction To Reduce The Cost And Time-Delays Associated With Regulatory Procedures
  • Build A Strong Understanding Of The Global Regulatory Environment
  • Focus On Developing Innovative Drugs To Capitalize On Regulatory Rewards
  • Capitalize On Regulatory Programs To Help Develop Drugs For Niche Or Serious Indications
  • The Launch Of The Accelerated Development Program In Europe Brought It More In Line With The Many Acceleration Programs In The Us
  • Drug Developers Should Make Use Of The Fda's Fast-Track Program
  • Orphan Drug Regulations Aid Innovative Drug Development
  • Introduce Greater P&R Involvement In Clinical Trial Design
  • Improving Patient Enrollment And Retention In Clinical Trials Helps To Speed Up Clinical Trials
  • Close Relationships With Key Opinion Leaders Bring A Number Of Advantages
• Chapter 7 Bibliography
  • Publications And Online Articles
  • Conference Resources
  • Chi Conference, San Francisco, February-March 2007
  • Biobusiness Network, 2006
  • Economist: 12th Annual Pharmaceutical Conference, February 2006
  • Datamonitor Resources
  • Appendices
• Appendix A: The Drug Discovery Process
• Appendix B: Categorization Of Deals In The Medtrack Deal Database
• Appendix C: Categorization Of Therapeutic Areas
• Appendix D: Glossary Of Terms
• List Of Tables
  • Table 1: Emerging Market Cros Offer A Range Of Services
  • Table 2: Advantages And Disadvantages Of Cros In Emerging Markets
  • Table 3: Costs Are Considerably Cheaper In India And China Than In The Us
• List Of Figures
  • Figure 1: Nme And Bla Approvals Are Falling, 1990-2004
  • Figure 2: Fda Drug Approvals From 1989-2000 Were Primarily For Low-Innovation Drugs
  • Figure 3: A Variety Of Different Studies Have Shown That The Cost Of R&D Has Increased Over Time
  • Figure 4: The Number Of Priority Approvals Has Risen Consistently Over The Last 40 Years
  • Figure 5: The Greatest Number Of Deals In 2005-06 Involved Phase Ii Drugs, And The Greatest Number Of Clinical Drugs In Development Are Also In Phase Ii
  • Figure 6: Deal Activity Is Relatively Constant, But Spikes Slightly At The End Of Each Year
  • Figure 7: Earlier-Stage Companies Dominate As Both Source And Partner In Deals
  • Figure 8: Collaborations Between Earlier-Stage Companies Are The Leading Deal Type
  • Figure 9: Some Partner Deal Mixes Are More Prevalent In Certain Phases Of Development Than Others
  • Figure 10: Co-Development And Licensing Agreements Are The Most Common Deal Goals, Accounting For More Than Two-Thirds Of All Deals
  • Figure 11: Single-Product Deals Were The Primary Focus
  • Figure 12: Different Deal Objectives Are More Common At Different Stages Of Development
  • Figure 13: The Deal Database Indicates Cancer Is Also The Dominant Therapeutic Focus Among 2005-2006 R&D Deals
  • Figure 14: The Pipeline Database Snapshot Indicates That Cancer Is The Dominant Pipeline Therapy Class
  • Figure 15: Oncology/Immunologic And Cns Therapies Have Dominated The Clinical Pipeline From 1993-2005
  • Figure 16: Immune Disorders And Inflammation Dominate R&D Focus, Based On A Snapshot Of The Current Patent Situation
  • Figure 17: Systemic Anti-Infectives Are The Most Likely Drug Class To Move From Entering Clinical Testing To Being Approved By The Fda
  • Figure 18: Antiparasitic Drugs Have The Highest Probability Of Approval And Transitioning Through From Phase Ii To Approval
  • Figure 19: Hiv Drugs Are Among The Quickest Therapies To Develop
  • Figure 20: Respiratory Drugs Are Among The Most Expensive To Develop
  • Figure 21: Antibodies And Vaccines Dominate The Deal Focus
  • Figure 22: Merck Redesigned Its Business Model To Focus On Capturing Innovation And Carrying Out Effective Lifecycle Management
  • Figure 23: Lilly's Business Model Aims To Improve Productivity And Reduce Waste
  • Figure 24: Novartis's Model For Better Integration
  • Figure 25: Wyeth Has Revolutionized Its Approach To R&D
  • Figure 26: Gsk's Cedd Model Is Designed To Mimic Smaller-Scale Biotech Companies
  • Figure 27: Roche's Networked Pharma Model Provided Significant Innovation
  • Figure 28: Optimizing The R&D Process And The R&D Model Are Central To Improving R&D Productivity
  • Figure 29: High Cro USAge Projects Have Faster Development Times Than Low Cro USAge Projects
  • Figure 30: Bric Countries Compare Favorably With European Countries In Terms Of Places To Perform Clinical Trials Outside The Us
  • Figure 31: Astrazeneca's Licensing Opportunity Evaluation Strategy
  • Figure 32: Factors That Restrict Licensing Deals
  • Figure 33: There Is An Inverse Correlation Between Company Size (Defined By Sales) And R&D Productivity
  • Figure 34: A Range Of Safety-Focused Activities Should Be Carried Out To Optimize Safety Assessment
  • Figure 35: Oncology Trials Shows Multiple Opportunities To Change Clinical Trial Design
  • Figure 36: The Greatest Amount Of Drug Development Spending Is In Phase Iii, 2005
  • Figure 37: Poor Pharmacokinetics/Adme And Lack Of Efficacy Top The Reasons For Attrition
  • Figure 38: Clinical Development Is Still The Most Expensive And Lengthiest Section Of Drug Development
  • Figure 39: Regulatory Initiatives Designed To Help Accelerate The Development For Niche Or Serious Indications