Organ-on-a-Chip & New Approach Methodolgies

Turn Advanced In Vitro Technologies into Credible, Fit-for-Purpose Solutions

Organ-on-a-chip technologies, microphysiological systems (MPS), organoids, and other complex in vitro models are opening doors to new ways of investigating human biology, disease, efficacy, and toxicity, but full adoption of new methods has yet to occur. Roper Toxicology Consulting Limited (Roper TCL) helps organisations determine where advanced approaches can add real value to studies, building the evidence, strategy, and partnerships needed to increase the use of these advanced in vitro technologies.

From Scientific Potential to Practical Application

Advanced or complex in vitro models can generate mechanistically informative and human-relevant data while supporting efforts to reduce reliance on animal studies. Their value, however, depends on whether they are biologically relevant, reliable, reproducible, and appropriate for the specific question they are intended to answer.

Led by Clive Roper, Roper TCL combines specialist knowledge of in vitro toxicology and NAMs with practical experience in product development, safety assessment, regulatory science, technology evaluation, and adoption.

The aim is not to promote a technology simply because it is new, but to select the right method for the question and establish a credible path to its use.

Where Roper TCL Adds Value

Independent scientific and technical evaluation of organ-on-a-chip, MPS, organoid, and other complex in vitro platforms
Definition and refinement of the model’s intended application and context of use
Review of biological relevance, performance, reproducibility, controls, limitations, and evidence gaps
Study strategy, experimental design, protocol review, and data interpretation
Planning for method development, validation, qualification, and regulatory readiness
Comparison with established in vitro and in vivo approaches and integration into broader testing strategies
Identification of scientific, laboratory, commercial, and industry partners
Translation of technical capabilities into a clear value proposition for pharmaceutical and other end users

Scientific Communication, Training, Workshops, and Stakeholder Engagement

Defining the Right Context of Use

For any NAM, we don’t simply want to know “Does the technology work?” but instead we want to understand “What specific regulatory relevant decision can this technology support?”

A clear context of use defines the model’s purpose, the endpoint or biological question it addresses, the setting in which it will be applied, and the confidence required from the resulting data. Roper TCL helps clients define a realistic context of use and align model development, performance criteria, study design, and evidence generation around it. This creates a stronger foundation for scientific adoption, commercial engagement, and regulatory discussion.

Support Multiple Audiences
Roper TCL helps identify the problems a platform is best positioned to solve, clarify how it differs from existing methods, and shape the evidence that pharmaceutical, biotechnology, chemical, consumer-product, laboratory, and regulatory audiences will expect.

Technology Developers & Research Groups
Academic teams and early-stage developers often have deep knowledge of the biology or engineering behind a platform but less experience translating that capability into an application that addresses an industry or regulatory need. Support may include reviewing development plans, refining technical and commercial messaging, preparing for discussions with prospective partners or customers, identifying collaborators, and communicating both the strengths and current limitations of the technology.

Pharmaceutical, Biotechnology and Laboratory End Users
Organisations evaluating an advanced model face a different set of questions: Is the platform suitable for the intended test article, biological pathway, endpoint, or decision? Is the available evidence sufficient? What further work is needed before it can be incorporated into an internal program or used to support a regulatory position?
Roper TCL provides an independent perspective to help clients compare technologies, assess readiness, select suitable providers, design pilot or comparative studies, and interpret the resulting data. This helps organisations invest in approaches that are relevant to their needs.

A Practical Pathway from Evaluation to Implementation

Roper TCL provides a structured, evidence-led pathway to help clients assess a technology’s readiness, identify critical gaps and move confidently towards practical application. Some technologies will be ready for immediate application while others will require further development. Independent advice helps clients understand the difference and direct resources accordingly.

Define the question. Clarify the scientific, regulatory, or business decision the model must support
Evaluate the platform. Review biological relevance, performance, reproducibility, controls, limitations, and existing evidence
Identify the gaps. Determine which additional studies, comparisons, documentation, or partnerships may be needed
Build the strategy. Align the context of use, evidence plan, development priorities, and stakeholder communication
Support implementation. Assist with study design, partner engagement, data interpretation, and refinement as the program progresses

Scientific Leadership with an International Perspective

Clive is actively involved in international scientific committees, conferences, publications, and collaborative initiatives focused on in vitro toxicology, MPS, organ-on-a-chip technologies, NAMs, and their responsible application. Clients benefit from direct access to his experience and, where needed, an international network of trusted scientific, technology, laboratory, and regulatory specialists.

Where Could Your Technology add the Greatest Value?

Whether you are developing an advanced in vitro platform, evaluating a technology for internal use, defining a context of use, or planning the next stage of implementation, Roper TCL can help clarify the scientific and strategic path forward.

Discuss Your Technology or Application →