Lab to Lives
A simple question started this show: How do we medicine from the lab to making a difference in people's lives as quickly as possible?
The answers are complex. Actual solutions are hard to come by. We want to distill ideas until we see actual impact in the industry.
Our three hosts all have backgrounds in life sciences and in improv comedy. Together, with their guests, they're on a mission to have conversations that can have an impact. And have some fun along the way.
Lab to Lives
Jakob Juul Rasmussen: Zero cost technology - transforming how smaller companies oversee their assets
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Sam and Ivanna speak to Jakob Juul Rasmussen about the stubborn prevalence of paper in clinical trials, especially in small pharmaceutical and biotech companies. Paying money up front, covering the implementation and license costs and building up internal IT functions can be prohibitive for small pharmaceutical and biotech companies. This leads many companies to outsource their entire IT landscape to CROs. As a result, control over assets becomes complicated and cumbersome, as your clinical data risks being stored in different applications with multiple data models applied. Standard configuration is helping bridge the gap, but compliance requirements from authorities for both internal and CRO-maintained software are unchanged. Jakob suggests a radical third way of getting the set of applications needed to run the business of any biotech or pharmaceutical company, without resorting to paper or complete outsourcing, transforming both how technology companies deliver IT solutions and how IT is anchored with the sponsor companies.
“Small companies really want to focus on science and just have the necessary tools to provide the best science”
- Jakob Juul Rasmussen
Notes
- Guest Jakob Juul Rasmussen : https://www.linkedin.com/in/jakobjuulrasmussen/
- PharmaIT: https://pharmait.dk/
- ISPE GAMP 5 https://ispe.org/publications/guidance-documents/gamp-5
- ALCOA ++ https://www.gmp-compliance.org/gmp-news/alcoa-what-does-it-mean
- Pharmacovigilance Signal Detection: https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/signal-management
- EMA Notice to Sponsors on Validation and Qualification of Computerized Systems used for Clinical Trials: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/notice-sponsors-validation-qualification-computerised-systems-used-clinical-trials_en.pdfhttps://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/notice-sponsors-validation-qualification
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Hosts
Alexander Booth aka the MedTech Guy
Dimitri Borisevich aka the start-up Guy
Ivanna Rosendal aka the R&D pharma Gal
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