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:
Data have also been split by company size and type:
- Large Pharma
- Small Pharma
- Generic Pharma
- Combination Product Manufacturer
- Medical Device
Data have also been split by activity:
- 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 Partnerships: Once 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.