Empowering Biotech Innovation Through Biostatistical Mentoring
Tailoring Mentorship to Your Development Stage
Tailoring a mentoring program in biostatistics to the development stage of biotech companies is important for several reasons. Development stage biotech companies have specific needs and challenges that differ from more established companies, and customizing mentorship can better address these needs.
Discovery Phase
Focus on exploratory data analysis, hypothesis generation, and early experimental design. Statistical mentoring emphasizes efficiency in screening approaches and identifying promising candidates while maintaining scientific rigor despite small sample sizes.
Preclinical Development
Statistical guidance shifts to robust study design, appropriate animal model selection, and developing analysis plans that will satisfy regulatory requirements. Mentors help establish quality control procedures and data management practices essential for IND submissions.
Target Audience
Program Objectives
Direct Knowledge Transfer
Long-Term Tooting
Biostatistics Mentoring Program Process
As this program represents a long-term commitment, we propose a progressive involvement with the possibility of interrupting the sequence at any time while still deriving notable benefits from the steps already completed.
1. Masterclass: Best Statistical Practices in Life Sciences
First, we offer a 3-hour masterclass presenting the various aspects of good scientific practices in relation to statistical methods.
This masterclass (see attached detailed program) presents examples of both good and bad practices, particularly in relation to regulatory requirements. We recommend that all scientific and managerial staff attend.
Finally, participation in the seminar is a prerequisite for the mentoring program, but it can be offered independently.
2. Practical workshops: 3 serious games to understand the role of statistics in Ru0026amp;D
To raise awareness among research teams about the importance of mastering statistical practices, we offer, after the masterclass, three workshops in the form of cooperative games during which participants are confronted in a playful way with practical situations in which simple statistical tools allow them to solve real-life problems. The topics covered during each session concern, respectively, the management of experiments and collected data, the scientific and financial setup of trials, and finally the interpretation and proper communication of the results obtained.
3. Program Set Up
The program is customized in close collaboration with company management, paying particular attention to the following aspects:
- Selection of the Resources
One or two people are selected to lead the program internally. Their choice and number remain at the client’s discretion. However, we ideally recommend combining one person directly involved in the lab work with another in a position of authority.
- 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 following the initial masterclass, and the budget and time available, it is possible to focus on certain aspects.
To determine the exact objectives, the mentor assigned to the startup meets with representatives of the management team and the selected resource persons and ensures a realistic curriculum and timeline are established, while meeting the expressed needs.
- Determining the Program Duration
The exact duration of the program depends primarily on the objectives set and the anticipated availability of the key stakeholders.
The minimum duration is six months, and ideally one year. However, at the end of the first six-month period, a re-evaluation of the entire process is proposed, and the startup is asked for further involvement on a quarterly basis only.
It is also possible to organize the program over a longer period, either to accommodate limited resource availability or to integrate additional concepts and tools.
4. Program Implementation
Intervention Principle
For each theme:
- Initial meeting – presentation of concepts
- Submission of an analysis grid to transpose the concepts to the company’s reality
- The resources establish a proposed standard
- Second meeting to discuss the proposal
- Adjustments if necessary and final touch to the standard
Mentor Involvement
The mentor is an experienced biostatistician. They share their expertise in two ways:
- Regular meetings with the company’s resource persons, either in person or remotely
- Always available for specific questions by email or telephone
In addition, we have planned several optional components that can be added at any time when the implementation process generates additional unanticipated requests.
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