Early-stage biotech; drug discovery and development
Investigating an unexpected result — biotech sponsor
The challenge, in operational terms
A small biotech had hit a data reproducibility problem. The scientific team was struggling to investigate it, plan the next experiments, and do both in a way that would stand up to regulatory expectations. The project was slipping and investor confidence was going with it.
What I did, including the assessment method
I ran a tailored training and brainstorming session on handling unexpected events during drug development: the drug approval process, what regulators look for, and the quality tools that apply to an investigation like this one. The session then used those tools on their actual problem to draft an investigation and remediation plan.
The result
The team came away understanding how regulatory expectations applied to their own discovery and development work, and with a draft plan they could act on. Using their own challenge as the worked example is what made the concepts stick.
Related services
Customised Training
Training built around your organisational needs, for the roles that need it, with reinforcement afterwards to check it landed.
For: companies whose training records are complete and whose practice isn't consistent.
Who you'd be working with.
I'm Antiksha Joshi. I've spent 28 years in pharmaceutical and life sciences quality across three continents. I am Chair of Women in Pharma, ISPE Australasia Affiliate.
I also write and speak on quality systems for various knowledge sharing organisations and online publications.
My background is in microbiology, and I hold a diploma in counselling, which sounds like an odd combination until you've watched a technically sound quality system fail because nobody could be persuaded to use it.
Whoever you speak to on the call is the person who does the work.
