We work with our collaborators to
  • Characterize and assess the risk profile of drugs
  • Optimize the design of clinical trials
  • Define inclusion/exclusion criteria 
  • Identify patient subpopulations
  • Perform due diligence when assessing in-licensing opportunities

Drug developers are under increasing pressure to better assess the risk profile of drugs and take appropriate action pro-actively rather than reactively. Serious adverse events of a marketed drug can have significant implications in terms of human suffering, cost to the sponsor and potential loss of good will from regulators, and are ill tolerated.

Drug developers are therefore looking to understand this risk early and more holistically, and then use this understanding in trial design optimization, drug/treatment differentiation and drug label definition.

How we can help

Biovista’s B2B Drug De-risking service can help you:

  • Create a more complete understanding of the risk profile of a drug including non-obvious risks that may impact the development program
  • Assess the level of risk both in isolation and in comparison to alternative therapies
  • Optimize clinical trial design and target population definition
  • Perform due-diligence on in-licensing opportunities

How we work

Biovista’s systematic discovery COSS™ platform supports our teams of biologists, medical doctors and epidemiologists in generating robust Mechanism-of-Action rationale to identify or characterize suspected side effects.

We work with your team, using where appropriate your in-house data to fully characterize the risk profile of your drug. We:

  • Create a multi-dimensional representation of each possible adverse reaction
  • Create a multi-dimensional profile of your drug
  • Enrich the profile by cheminformatics analysis which helps identify additional off-targets and associate them to known or predicted adverse reactions
  • Match and rank the profile of your drug against all possible adverse reactions using mechanism-of-action and other associations
  • Cross-validate potential risks against outcomes data and

Why Biovista

  • Proven track record – successful prediction of side effects for large biotech/pharma collaborators
  • Significant advance notice capability (2 years in advance of adverse reaction being observed)
  • A “no stone left unturned” approach covering multiple non-obvious eventualities
  • We help you translate the outcomes of the profiling analysis into actionable points in the context of your drug development program

For more information

To find out more information on our B2B Drug De-risking service and how we can help you get more from your portfolio, contact us or send an email directly to ps{at}biovista.com.