Content of the Mentoring Program in Biostatistics - Statistical Solutions by Creascience

Empowering Biotech Innovation Through Biostatistical Mentoring

Basic Program Blocks

The ideal program covers all of the following elements, but depending on the needs, it can also focus on certain aspects :

Test Data Management & Presentation

Structure the results of each experiment: adequate formatting, informative dictionary, identification of the nature of each measure
Take advantage of descriptive statistics: error detection, anticipation of problems
Ensure the overall integrity of the data: continuity of research.

Planning Effective & Useful Tests

Define the scope of each experiment: target population, number of measurements, primary outcomes, etc.
Manage bias and variability: replicates vs. repetitions, operator, batch, day effects, etc.
Determine and justify the size of the trials: statistical significance versus practical/biological significance.

Preparation & Management of Laboratory Work

Write a precise and complete protocol: robustness, transparency and reproducibility
Manage the progress of experiments: identify anomalies, react to difficulties encountered
Establish a qualitative assessment: transmit and enrich knowledge of the processes

Rigorous Presentation of Results

Understand the structure of the experiment and perform a data analysis consistent with it
Adequately interpret the results: p-value, power, equivalence, superiority, non-inferiority
Write a comprehensive experimental report, a relevant summary, a quality scientific publication

Optional Satellite Blocks

Additional needs often arise during these interventions. In order to meet these needs, we offer several blocks that can be integrated into the program.

Scientific Paper Review

Althoughh this would be advantageous in several respects, this mentoring program rarely begins at the same time as the startup’s research activities. Typically, trials are already underway and several have already been completed. In this context, we offer an Adhoc service for reviewing documents presenting the progress of an experiment and/or the analysis of its results. This may be a report intended for external stakeholders (regulatory authority, investors) or an article intended for a scientific journal.

Planning & Interpretation of a Pilot Study

A common obstacle to implementing fully rigorous studies is their cost. In order to study the feasibility of large-scale experiments, identify potential logistical problems and more generally establish the necessary budget, we propose in this block our support to carry out a small-scale study. The results of this study can be used both internally to control costs and to obtain adequate funding for scaling up.

Seminar on the Integration of New Standards

The new practices induced by the introduction of standards sometimes represent significant changes, the integration of which may initially be perceived as counterproductive by some members of the research teams. In this context, the intervention of the mentor as an external expert during a seminar involving all the stakeholders concerned allows for mediation and a more general contextualization of the proposed changes.

Quantification of Sources of Variation

The research activities of biotech startups often involve series of experiments involving similar processes: same raw material, operators, types of measurements. A precise knowledge of the variability induced by each of the elements is crucial both for its scientific and economic implications. Indeed, it allows to appropriately choose the optimal experimental structure and to justify decisions that could seem counterintuitive to an external stakeholder. In this block, we offer you the necessary support to plan and analyze a study aimed at quantifying the main sources of variability present in your studies. The analysis includes recommendations on how to conduct future trials with respect to these sources of variability.

Tailored Training

Training has been at the heart of Creascience’s activities since its creation. In fact, it is largely our training activities and the feedback received from participants that led us to develop this mentoring program. Although this program primarily aims to empower startups by transmitting knowledge to a small group of resource people – who can then themselves transmit this knowledge to their colleagues – organizing sessions aimed at a wider audience remains a significant lever for increasing the acceptability of good statistical practices.

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Biostatistics Mentoring Program Overview

Mentoring Program Guidelines

Mentoring Program Content (This Page)

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