BIOTECH DUE DILIGENCE SERVICES

Veramed & Weatherden in partnership: A unique collaboration between industry leaders in clinical development and biostatistics

"With our unique combination of deep translational, clinical and biostatistical expertise we conduct data driven due diligence to thoroughly interrogate the scientific hypothesis. We ensure we leave no stone unturned and highlight additional opportunities for assets.”

Emma TinsleyChief Executive Officer, Weatherden

External collaboration in the pharmaceutical industry presents game-changing opportunities. The ability to seek out potential acquirees or partners with the most promising assets under development can bring huge rewards but getting it wrong can lead to severe financial and reputational implications.

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What is needed?

The key to your decision making is thorough technical due diligence on the assets.

That is, a review of the entire data package and hypothesis, from target, through mechanism of action, scientific rationale, clinical relevance and the evolving risk/benefit balance in the context of the available preclinical and clinical data.

This is where we come in.

Our process

We focus on establishing the risk/benefit hypothesis and ensuring that the scientific data is robust and supports the investment. To do this, we have created a bespoke due diligence framework which adapts our work to suit the clinical stage of the asset in question.

Early pre-clinical

  • Can the relationship between the target/phenotypic assay and disease be established?
  • How tractable is the target and likely to produce hits for an exposure/response relationship?
  • How does target expression vary across tissues?
  • Have the target-related and off-target safety margins been established?

Late pre-clinical/ early clinical

  • Can an exposure/response relationship be generated in vivo to demonstrate proof-of-concept?
  • Can biomarkers of each stage of the exposure/response relationship be generated to measure this both in preclinical and early clinical?
  • Is the indication chosen appropriate and does it offer the fastest path to data efficacy?
  • Does the trial design answer the key question and give a basis to continue development if successful?

Late clinical

  • Does the therapeutic hypothesis work with meaningful clinical benefit?
  • Are any safety concerns sufficiently understood and able to be managed to an appropriate risk level?

Our deliverables

Headline report

Presents the key ‘takeaways’ and our recommendations.

Detailed technical report

Sets out the work undertaken, key data, analyses and results, and our recommendations.

Risk/benefit matrix

Summarises the risk/benefit profile with suggested mitigation steps for key risks.

 

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Why choose us?
  • We provide a team of expert drug development clinicians and statisticians, supported by a network of international key opinion leaders.
  • We test each link in the translational chain to evaluate the overall scientific and clinical merits of the complete data package.
  • We deliver outputs which give you a complete view of the overall risk/benefit profile and set out our recommendations.
  • We ensure your stakeholders are kept engaged throughout and give them the knowledge to make the right decisions.

Get in touch to discuss how we can help.

Email: stuart.mcguire@veramed.co.uk

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