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.

  • 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?
  • 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?
  • 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.

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.
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Get in touch

CONTACT

Have you found what you are looking for? Learn more about our other services below or get in touch.

Statistical Consultancy

We provide a comprehensive statistical service, from study design through to submission and beyond.

Data Monitoring Committees (DMC)

We provide a wide variety of DMC offerings, from one-off consultation to full end-to-end Statistical Data Analysis Centre with administrative and logistical support.

Functional Service Provider

Our bespoke FSP relationships allow us to partner with you to understand your requirements, build trust, enhance quality and develop long-term, collaborative relationships.

Launch & Commercialisation

We will support you with a range of strategically-focused, collaborative services that help maximise launch impact and ensure commercial success.

Study Reporting & Analysis

We offer a range of outsourced and insourced Study Reporting & Analysis services.

Automation

Our Automation, Efficiency and Standards group helps you to assess, evaluate and implement enhancements to your clinical trial workflows.

The team are competent statisticians and programmers, but also personable and friendly and very easy to work with. We have full and frank communication, we work as closely with them as if they were internal staff.

FSP client since 2017

Many thanks to all of you for your hard work on these outputs. I don’t think I’ve ever done QC with so few comments. It's been a pleasure to work with your excellent team.

Client since 2015

I am very impressed at your professionalism and very grateful for your careful and effective management of this significant project issue. Many thanks for your hard work.

FSP client since 2018

I knew you guys were good. That’s perfect. Not every vendor is. The SAP and shells were in very good shape if those are my only 3 comments about those two documents. You did a wonderful job.

FSP client since 2018

Functional Service Provider

Statistical Consultancy

Study Reporting & Analysis

Data Monitoring Committees (DMC)

Launch & Commercialisation

Automation