Early-Stage Product Development

$4,895.00

Early-Stage Product Development: Strengthen R&D Outcomes with Robust Preclinical Structures and Resources provides benchmarks, strategic recommendations and insights to help life science companies improve their existing preclinical strategiesThe report's best practices and insights are aimed at guiding industry leaders to develop and maintain right-sized preclinical teams. 

Download Now! speak-to-an-expert

REPORT DETAILS

Preclinical development marks one of the early-stage product development stages. Strategic alignment of preclinical teams can ease the burden of successful investigational products’ transition as they move into early clinical stages. More importantly, preclinical operations set the tone for the efficacy of companies’ broader R&D functions.

This study focuses on preclinical development: the stage of research before clinical trials (testing in humans) begins. This report contains benchmarks and best practices for preclinical team structures, staffing, budgets, study costs and trial turnaround times.

  • Publication Date: February 2017 
  • Pages: 115 
  • Chapters: 3 
  • Metrics: 500+ 
  • Charts/Graphics: 50+ 

Data have been split by launch region:

  • Global
  • US
  • Ex-US
  • Other

Data have also been split by company size and type:

  • Large Pharma
  • Small Pharma
  • Generic Pharma
  • Combination Product Manufacturer
  • Biotech
  • Medical Device

Data have also been split by activity:

  • Toxicology
  • Pharmacology
  • Material biocompatibility
  • Analytical chemistry
  • Lab animal science
  • Material science
  • Information Technology (IT)
  • Quality assurance

Top Reasons to Buy This Early-Stage Product Development Report

Review Preclinical Structural Alignments to Promote Balanced Workloads: Often, preclinical teams’ structural relationships with other internal teams shape the scope and extent of their workload. Although R&D structures may not “own” all preclinical groups, they are often a key presence — from providing much-needed budgetary and staffing resources to driving preclinical team objectives.  Unsurprisingly, planned R&D portfolio responsibilities account for a large percentage of many teams’ day-to-day activities.  Essentially, quantifying preclinical workloads starts with identifying where these teams sit within organizational structures — and how they interact with other, internal functions.

Use the Report’s Best Practices and Insights to Identify “Best-Fit Preclinical PartnershipsOnce life science teams identify the preclinical group’s scope of work, the next step is identifying the type of external organization most likely to complement existing preclinical workloads.  The study discusses how the benefits and drawbacks of working with contract research organizations (CROs).  Although CROs facilitate a more traditional working relationship, they tend to be very costly.  The report also analyzes academic partnerships, which are a cost-effective way to enable companies to pursue additional funding.

Learn from Industry Veterans when to Outsource Preclinical Activities: Life science teams outsource preclinical activities for several reasons, including limited bandwidth or the absence of sufficient in-house resources.  This report discusses how some companies may not need external assistance for preclinical resource support but prefer to work with third parties to complement existing R&D strategies.  Additionally, some teams that lack sufficient in-house expertise may have a harder time identifying external groups that can provide the desired return.

Chapters 2 and 3 provide extended discussions on the qualitative and quantitative aspects of outsourcing practices.  Chapter 2 focuses on the vendor selection aspect of outsourcing, including the merits of specific third-party types.  Look to Chapter 3 for a discussion of preclinical tests with an emphasis on the potential connection between average study cost and expected outsourced workload percentage.

Excerpt from Early Stage Product Development

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.

EARLY-STAGE PRODUCT DEVELOPMENT FACT SHEETS

Download the following fact sheets to see more of the data and metrics that this study has to offer:

Fact Sheet 1: Early-Stage Product Development

Preclinical teams’ strategic alignment can ease the burden of successful investigational products’ transition as they move into early clinical stage trials.

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

CHARTS AND GRAPHICS

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