Early-Stage Product Development

Strengthen Research and Development Outcomes with Robust Structures and Resources

Early-Stage Product Development

$4,895.00

Learn how to evaluate the types of internal audiences that early-stage product development groups serve — and the average percentage of workload generated by each of these audiences.

  • Determine the types of subgroups to include in preclinical structures (ex. toxicology, pharmacology, etc.).
  • Develop and maintain right-sized preclinical teams.
  • Compare current outsourcing and budgeting practices during early-stage product development against those of global, US and ex-US preclinical groups.

 

  • Description
  • Additional information

REPORT HIGHLIGHTS

Preclinical development marks one of the early-stage product development stages. Strategic alignment of early-stage product development 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.

Early-Stage Product Development: Strengthen R&D Outcomes with Robust Preclinical Structures and Resources

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

Data have been split by company size and type:

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

Data splits also include the following launch regions:

  • Global
  • US
  • ex-US
  • Unspecified

Data have also been split by functions such as:

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

Average preclinical workloads, including a quantitative breakdown of average preclinical workloads dedicated to:

  • Planned and unplanned R&D portfolio work
  • Providing pre- and post-market support
  • Navigating regulatory updates
  • Fulfilling customer requirements
  • Resolving field issues and more

Data on preclinical tests, including:

  • Percentage outsourced
  • Average cost
  • A comparison of ideal and actual turnaround times

Metrics on preclinical outsourcing, including insights on working with contract research organizations (CROs), research organizations and similarly-sized, non-CRO life science organizations.

Report Features

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 the benefits and drawbacks of working with contract research organizations (CROs). Although CROs facilitate a more traditional working relationship, they tend to be costly. The report also analyzes academic partnerships, which are a cost-effective way to enable companies to pursue additional funding.

Reason To Buy

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.

Target Audience

Biopharmaceutical executives with similar titles to the ones below will be able to use this early-stage development study:
– Chief Operating Officer
– Vice President Preclinical Development
– Senior Director Preclinical and Toxicology
– Clinical Research Associate
– Managing Director of Early Stage Development
– Global Head of Toxicology
– Senior R&D Executive

Chapter Example

Pharmaceutical, biotech and device companies structure their preclinical teams differently. Some develop completely centralized structures. Others incorporate a mixture of decentralized and centralized structural characteristics. Often, these structures depend on regulatory guidelines and the clients they serve. For example, teams may follow globally implemented standards such as Good Laboratory Practice (GLP). However, depending on their geography, they may not adhere to regional-specific guidelines such as FDA requirements. Additionally, life science teams may support a mixture of internal and external client bases. Yet some may dedicate the bulk of their workload toward R&D interests. Chapter 1 provides an overview of how surveyed global and country-level life science team align their preclinical groups.