BIOTECH DUE DILIGENCE SERVICES
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.
DOWNLOAD THE BROCHURE NOW
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.
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?
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?
- 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?
Presents the key ‘takeaways’ and our recommendations.
Detailed technical report
Sets out the work undertaken, key data, analyses and results, and our recommendations.
Summarises the risk/benefit profile with suggested mitigation steps for key risks.
DOWNLOAD THE BROCHURE NOW
Weatherden and Veramed bring together decades of experience in clinical development and biostatistics.
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.
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 Personalised 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 personalised 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.
His expertise includes clinical biostatistics; clinical study design, reporting and logistics; imaging informatics and medical image analysis, with applications in multiple therapeutic areas including neuroscience, cardiovascular, oncology and respiratory.
He also has detailed understanding of computing infrastructures, having been involved in software development, training and support.
Formally trained in pure mathematics (BSc, University of Durham, 1990) and statistics (MSc, University of Sheffield, 1991), Andrew gained a PhD from the University of Glasgow in 1994 for research into statistical methods for functional neuroimaging. He has co-authored numerous publications, book chapters and software packages.
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 paediatric 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 to discuss how we can help.