BIOTECH DUE DILIGENCE SERVICES
”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.
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.
Our experts
Weatherden and Veramed bring together decades of experience in clinical development and biostatistics.
Emma is responsible for enabling the Veramed Biostatistics team to achieve the highest levels of quality from consultancy to reporting. Emma continues to provide statistical consultancy to clients to maintain her statistical acumen.
Emma has a wealth of experience in vendor oversight, statistical consultancy and of clinical statistical analysis gained from a variety of leading global pharmaceutical companies. She has knowledge in both technical and non-technical aspects of study design and statistical analysis across clinical studies from Phase I-III and multiple therapeutic areas, including oncology, respiratory and immunology.
Emma holds a PhD in Statistics and is an active member of Statisticians in Pharmaceutical Industry (PSI). Emma was the Conference Chair for the 2015 and 2016 annual conference in London and Berlin, respectively.
Duncan is a clinician scientist and early drug development specialist with over 20 years’ industry experience. He co-founded Weatherden and helps lead the strategic direction of the company, whilst also actively supporting clients with his clinical development expertise.
He is Chief Medical Officer at Evelo Biosciences, a company developing oral biologics targeting the small intestine, and a Venture Partner at SV Health Investors. With previous roles as Vice President and Head of Global Exploratory Development at UCB, Vice President for Personalized Healthcare and Biomarkers at AstraZeneca, and European Head of Translational and Molecular Medicine at Pfizer, he has over 20 years’ experience working across pharmacogenetics, early development and personalized medicine across multiple therapeutic areas.
Duncan completed his PhD in genetics at the University of Leeds and was Visiting Professor in Clinical and Molecular Pharmacology at the University of Liverpool. Previously Chairman of the EFPIA pharmacogenomics working group, Duncan has sat on multiple Medical Research Council panels and was the Innovative Medicine Initiative’s lead on Molecular Taxonomy of Human Disease.
Aaron is an expert in clinical drug development and Vice President of Clinical Development at Weatherden. He leads on the creation and delivery of innovative drug development solutions and pharmacovigilance practices, helping to deliver maximum value for clients and promote Weatherden as being the preferred consulting partner for biotechs.
Aaron has more than 20 years’ experience in clinical drug development, with previous roles at Takeda Pharmaceuticals and Ono Pharma Europe Limited in which he successfully brought a number of compounds to market. Aaron is an established leader of global and regional clinical development teams in a variety of therapeutic areas in both adult and pediatric indications, the management of strategic alliances and product portfolios, as well as major transformational programs restructuring global business functions.
Aaron completed his PhD in Clinical Pharmacology at The Royal College of Surgeons in Ireland and is a member of the British Pharmacological Association.
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
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