Mentoring for biotech/medtech companies - Statistical Solutions by Creascience

A program to optimize

research activities

on the long term

Context

For over 25 years, Creascience’s biostatisticians have been collaborating with both young startups and established pharmaceutical and biotechnology companies to train their scientific staff and assist them in setting up, analyzing and interpreting and reporting scientific studies. Building on this experience, we are proud to present a new mentoring program aimed at increasing the autonomy of research teams within biotechnology startups with regard to good statistical and scientific practices.

Scientific research is an essential and critical activity for any startup in the field of life sciences, regardless of its stage of development. What is more, the sustainability of startups in this field depends directly on the quality of this research, whether directly to ensure the validity of the results obtained or to convince potential investors. Finally, the outcome and ultimate success inevitably involve confronting regulatory authorities at one point or another.

All these aspects make the use of good scientific practices and the ability to convince external stakeholders of them essential. In this context, statistical methods – which go well beyond the analysis of experimental data – constitute essential tools, as demonstrated in particular by their omnipresence in the standards of institutions in the health field.

For example…

USA : The FDA requires that nonclinical trials follow a formal, detailed experimental design that includes steps taken to reduce bias.
UK : The MHRA produces a specific guide for medical devices in particular to supervise the statistical aspects of R&D.
Europe: EMA produces specific guidance to support the management of missing data: from trial planning to data analysis

Program Objectives

Direct Knowledge Transfer

Train one or two people in the short term in good statistical practices in experimental research

Long-Term Tooting

Establish standards (SOPs) to generalize the application of good practices to all scientific staff

Bénéfices attendus

Reduce R&D Costs

Statistical tools allow us to build more efficient trials whose scale is directly in line with to the intended research objective.

Speed Up the Research Process

Rigorous interpretation of results limits the need for validation studies.

Boost Scientific Credibility

Investors and government agencies are sensitive to good experimental practices as they translate to robust and reproducible findings.

Target Audience

Biotechnology Startups in the Medical Field (Therapy Area)

Reassuring investors

Biotechs & Pharmas in Preclinical Stage

Respect regulatory constraints

Life Sciences Research Centers

Optimize R&D

Program Implementation

Seminar/Workshop on Good Statistical Practices

First, we offer a 3-hour seminar presenting the different aspects of good scientific practices in relation to statistical methods. This seminar (see attached detailed program) presents examples of both good and bad practices, particularly in relation to regulatory obligations. We recommend that all scientific and managerial staff attend. Finally, participation in the seminar is a prerequisite to the mentoring program, but it can be offered as a standalone product.

Selection of Contact Persons

At the end of the workshop, the company that decides to invest in the mentoring program chooses the person(s) who will be responsible for implementing the program within the company. We usually recommend that two people be involved, one active in the research laboratories and the other also concerned with research and in a position of authority in order to facilitate the adoption of the standards that will be established. These people must each be able to free up the equivalent of 10 to 15 hours per month.

Determining Program Objectives

The action plan described in the following section serves as a basis for discussion. Ideally, all suggested points should be covered, but depending on the company’s priorities, the weaknesses identified at the end of the initial seminar, the budget and time available, it is possible to focus on certain aspects.

In order to determine the exact objectives, the mentor assigned to the startup meets with representatives of the management team as well as the chosen resource persons and ensures to establish a curriculum and schedule that is both realistic and in accordance with the needs expressed.

Fixing the Program Duration

The exact duration of the program depends primarily on the objectives set and the anticipated availability of the resource persons. In all cases, its minimum duration is 6 months and ideally one year. However, at the end of the first 6-month block, a re-evaluation of the entire process is proposed and the startup is asked for subsequent involvement on a quarterly basis only.

It is also possible to organize the program over a longer period, either to accommodate limited availability of resource persons or to integrate additional concepts and tools.

How the Program Works

Principle of Intervention

For each theme:

Initial meeting – presentation of concepts
Submission of an analysis grid to transpose the concepts to the reality of the company
Resource persons establish a standard proposal
Second meeting to discuss the proposal
Adjustments if necessary and finalization of the standard

Mentor Involvement

The mentor is an experienced biostatistician. He shares his expertise in two ways:

Regular meetings with the company’s resource people either in person or remotely
Permanently accessible for specific questions (email, telephone)

In addition, we have planned a certain number of optional blocks/bricks that can be added at any time when the implementation process generates new services.

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 Article Review

Although 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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