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