This workstream builds best practice guidance, normalizing the use of modelling and increasing agency acceptance of using modelling data in submissions.
Poor industry and regulatory recognition of the potential benefits
In-silico is a relatively new strategy for most biopharmaceutical companies and is still quite a niche tool and as such is not typically used by every company, or even for every project. Where it is used, it has been shown to be massively beneficial in terms of reduction in costs and timelines. The limited use in the industry and lack of recognition of it’s value, has led to challenges including difficulty in matching technology to business needs, difficulty in demonstrating business value to management and general acceptance by the industry and regulators.
There are other issues in this area including costly and time-impacting lessons learned, diminished credibility of tools; difficult scaling modelling activities and missed opportunities to build strong modelling capabilities and accelerate the development process.
Delivering industry valued fit-for-purpose models as standard practice
This workstream enables a greater understanding of best practice approaches through learning from others. Members collaborate to ensure models are fit-for-purpose, predictive trusted models are delivered and used as standard practice. This ensures business value, saves time and cost during development and paves the way for full digital transformation.
In-Silico Strategies deliverables
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Our workstreams focus on the areas with the greatest impact across the industry. Led by science, our members are problem-solving today’s sustainability issues. By working with the regulatory governance community, they are also creating future-ready outcomes for the industry.
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