Cover Image
Market Research Report

Early-Stage Product Development

Published by Cutting Edge Information Product code 486148
Published Content info 115 Pages
Delivery time: 1-2 business days
Price
Back to Top
Early-Stage Product Development
Published: February 28, 2017 Content info: 115 Pages
Description

EXECUTIVE SUMMARY

PRECLINICAL DEVELOPMENT TEAM STRUCTURES AND ACTIVITIES

As life sciences industry groups work to improve patients' quality of life, preclinical development presents a pivotal step. Multiple preclinical subgroups usher emerging products to the clinical stage. These groups' expertise provides a joint technology, medical, physics and engineering backbone for companies' initial research and development (R&D) operations.

Specific groups involved in preclinical work include toxicology, pharmacology and material biocompatibility. Other core teams that may support preclinical operations include quality assurance and information technology (IT) groups. Together, these groups collect invaluable information - from safety data to pharmacokinetic and pharmacodynamic insights - necessary to propel products from preclinical research to formal clinical studies.

From the R&D perspective, life science teams may have different pathways to improve existing medical treatment options. Pharma groups may formulate active ingredients which require extensive preclinical and clinical testing.

On the other hand, medical device companies may develop diagnostic tools and drug delivery systems. Medical device trials can be comparatively short - requiring between three and four months. They could also require fewer patients; compared with thousands of patients enrolled in pharma and biotech companies' Phase 3 studies, device trials may require at most 200 to 300 patients. Medical device company teams do not necessarily have formal Phase 3 studies. But these teams typically perform additional testing to validate safety and ensure that proposed treatments surpass existing standards of care.

USE OF THIS REPORT

This report's benchmarks address the preclinical landscape with a look at applicable regulations, team structures, staffing and budgetary resources and activity types. Among its many insights, this report also provides a look at the types of preclinical tests that dedicated teams perform. Surveyed preclinical groups may undertake different activities; this report explores the myriad resources to sustain these activities.

Table of Contents
Product Code: PH229

Table of Contents

  • 6. Preclinical Development Team Structures and Activities
  • 8. Study Methodology
  • 14. Preclinical Structures: Four Recommendations for Success
  • 20. Clients, Structures and Challenges in Today's Regulatory Landscape
  • 23. Factors Influencing Preclinical Structure Development
  • 54. Developing Effective, Reproducible Clinical Studies
  • 60. Preclinical Staffing, Budgets, Outsourcing and Activity Levels
  • 62. R&D Functions Prove a Substantial Preclinical Staffing Resource
  • 80. Preclinical Budgets Reflect Only a Small Portion of Overall R&D Expenditures
  • 85. Preclinical Outsourcing Strategy
  • 90. Quantifying General Preclinical Activities as a Percentage of Teams' Workloads
  • 96. Preclinical Test Resources and Timelines
  • 98. Quantifying Preclinical Study Types
  • 6. Preclinical Development Team Structures and Activities
  • 8. Study Methodology
  • 9. Figure E.1: Company Information (1)
  • 9. Figure E.2: Company Information (2)
  • 10. Figure E.3: Company Information (3)
  • 10. Figure E.4: Company Information (4)
  • 14. Preclinical Structures: Four Recommendations for Success
  • 15. Figure E.5: Factors Contributing to Teams' Decisions to Outsource Preclinical Workloads
  • 17. Figure E.6: Percentage of Preclinical Functions That Include the Following Subgroups
  • 20. Clients, Structures and Challenges in Today's Regulatory Landscape
  • 23. Factors Influencing Preclinical Structure Development
  • 23. Figure 1.1: Audience(s) That Preclinical Functions Serve: All Surveyed Teams
  • 24. Figure 1.2: Regulatory Agencies with Which Surveyed Teams Interact
  • 27. Figure 1.3: US FDA Hierarchy: Center for Drug Evaluation and Research (CDER)
  • 27. Figure 1.4: US FDA Hierarchy: Center for Devices and Radiological Health (CDRH)
  • 29. Figure 1.5: International Council for Harmonisation (ICH) Membership
  • 31. Figure 1.6: Percentage of Surveyed Teams Following Selected Key Guidelines
  • 32. Figure 1.7: Percentage of Surveyed Teams Following Additional Guidelines, by Company Type
  • 35. Figure 1.8: Average Breakdown of Preclinical Functions' Internal Customers
  • 36. Figure 1.9: Range of Preclinical Functions' Internal Customers, by Customer Type
  • 37. Figure 1.10: Current Interaction Method with Internal Customers: All Surveyed Teams
  • 38. Figure 1.11: Structure of Preclinical Function: All Surveyed Teams
  • 43. Figure 1.12: Percentage of Preclinical Functions that Include the Following Subgroups
  • 44. Figure 1.13: Number of Preclinical Groups: Toxicology
  • 45. Figure 1.14: Number of Preclinical Groups: Pharmacology
  • 46. Figure 1.15: Number of Preclinical Groups: Material Biocompatibility
  • 47. Figure 1.16: Number of Preclinical Groups: Analytical Chemistry
  • 48. Figure 1.17: Number of Preclinical Groups: Quality Assurance
  • 49. Figure 1.18: Number of Preclinical Groups: Lab Animal Science
  • 50. Figure 1.19: Number of Preclinical Groups: IT
  • 51. Figure 1.20: Preclinical Function as a Shared Service: All Surveyed Teams
  • 52. Figure 1.21: Percentage of Preclinical Subgroups That Operate as a Shared Service: Autonomous Teams
  • 53. Figure 1.22: Percentage of Preclinical Subgroups That Operate as a Shared Service: Non-Autonomous Teams
  • 54. Developing Effective, Reproducible Clinical Studies
  • 54. Figure 1.23: US FDA Hierarchy: Office of Device Evaluation (ODE)
  • 55. Figure 1.24: US FDA Hierarchy: Office of In Vitro Diagnostics and Radiological Health (OIR)
  • 60. Preclinical Staffing, Budgets, Outsourcing and Activity Levels
  • 62. R&D Functions Prove a Substantial Preclinical Staffing Resource
  • 64. Figure 2.1: Total Function Size: Quality Assurance
  • 65. Figure 2.2: Total Function Dedicated to Preclinical Activities: Quality Assurance
  • 66. Figure 2.3: Total Function Size: Regulatory Affairs
  • 67. Figure 2.4: Total Function Dedicated to Preclinical Activities: Regulatory Affairs
  • 68. Figure 2.5: Total Function Size: Medical Affairs
  • 69. Figure 2.6: Total Function Dedicated to Preclinical Activities: Medical Affairs
  • 70. Figure 2.7: Total Function Size: Research and Development
  • 71. Figure 2.8: Total Function Dedicated to Preclinical Activities: Research and Development
  • 75. Figure 2.9: Projected Staffing Changes from 2015 to 2017: Toxicology
  • 76. Figure 2.10: Projected Staffing Changes from 2015 to 2017: Pharmacology
  • 77. Figure 2.11: Projected Staffing Changes from 2015 to 2017: Material Biocompatibility
  • 78. Figure 2.12: Projected Staffing Changes from 2015 to 2017: Lab Animal Science
  • 79. Figure 2.13: Projected Staffing Changes from 2015 to 2017: Quality Assurance
  • 80. Preclinical Budgets Reflect Only a Small Portion of Overall R&D Expenditures
  • 80. Figure 2.14: 2015 Research and Development and Preclinical Budgets
  • 81. Figure 2.15: Preclinical Budgets: Percentage of 2015 R&D Budget
  • 82. Figure 2.16: 2015 Preclinical Budget v. Number of Products Managed
  • 85. Preclinical Outsourcing Strategy
  • 85. Figure 2.17: Factors Contributing to Teams' Decisions to Outsource Preclinical Workloads
  • 90. Figure 2.18: Percentage of Teams Performing Specific Preclinical Tasks
  • 90. Quantifying General Preclinical Activities as a Percentage of Teams' Workloads
  • 91. Figure 2.19: Average Percentage of Preclinical Workload, by Activity Type
  • 92. Figure 2.20: Percentage Range of Preclinical Workload, by Activity Type
  • 96. Preclinical Test Resources and Timelines
  • 98. Quantifying Preclinical Study Types
  • 100. Figure 3.1: Average Cost of One Study: Safety Pharmacology Studies
  • 101. Figure 3.2: Average Cost of One Study: Safety Toxicology Studies
  • 102. Figure 3.3: Average Cost of One Study: Pharmaceutical Qualification Testing Studies
  • 103. Figure 3.4: Average Cost of One Study: In Vivo Studies
  • 104. Figure 3.5: Average Cost of One Study: In Vitro/Ex Vivo Studies
  • 106. Figure 3.6: Average Percentage of Workload Outsourced: Safety Pharmacology Studies
  • 107. Figure 3.7: Average Percentage of Workload Outsourced: Safety Toxicology Studies
  • 108. Figure 3.8: Average Percentage of Workload Outsourced: Pharmaceutical Qualification Testing Studies
  • 109. Figure 3.9: Average Percentage of Workload Outsourced: In Vivo Studies
  • 110. Figure 3.10: Average Percentage of Workload Outsourced: In Vitro/Ex-Vivo Studies
  • 111. Figure 3.11: Comparison of Ideal and Actual Turnaround Times: Safety Pharmacology Studies
  • 112. Figure 3.12: Comparison of Ideal and Actual Turnaround Times: Safety Toxicology Studies
  • 113. Figure 3.13: Comparison of Ideal and Actual Turnaround Times: Pharmaceutical and Qualification Testing Studies
  • 113. Figure 3.14: Comparison of Ideal and Actual Turnaround Times: Device Biocompatibility Testing Studies
  • 114. Figure 3.15: Comparison of Ideal and Actual Turnaround Times: In Vivo Studies
  • 115. Figure 3.16: Comparison of Ideal and Actual Turnaround Times: In Vitro/Ex Vivo Studies
Back to Top