Accelerating drug development with an integrated programme management approach
Drug development programmes are complex. The team at Boyds understands this complexity and can create an all-encompassing plan, pulling together all of the sometimes seemingly disparate activities, accelerating drug development.
Integrated programme management
We will work with you to plan your development journey bringing together input from seasoned industry programme directors, and experts from different disciplines to develop a streamlined, integrated product development plan. Through the integrated development plan, we can highlight critical dependencies across the programme, model potential scenarios for acceleration and track the impact of any unexpected data or delays.
Management of resources
Small companies may have a limited pool of resources, both people and financial. Deploying those resources in the most efficient manner to exert a significant impact on a programme is where an experienced programme director excels. Utilising our experience, we can help identify the most efficient use of your team and when to bring in an external resource.
Understanding the internal and external risks to your programme is key to being able to effectively manage and mitigate them. An experienced programme director recognises what can trip up even the best laid plans and will develop an informed risk register with your team to ensure all risks are identified, appropriate mitigations are in place and a contingency plan is prepared in case those risks become a reality.
Occasionally, questions arise within a drug development programme that none of the internal team can easily answer. The benefit of working with Boyds, is that alongside our expertise is our broad network of experts who we can draw on to add any additional specialised knowledge, making us an ideal partner for clients looking for support at any part of the process.
Target Product Profile
A programme director is key to the development of a Target Product Profile (TPP) who will work with the integrated team to collate input across the different disciplines. The TPP is reviewed periodically/when key data on the product has been generated and is used to drive key studies within the programme, re-assess the value of a programme based on what the product is likely to deliver and how long it will take to deliver, and to make Go/No-go decisions.
To manage and deliver an effective drug development programme, collaboration across multiple groups is key. The team at Boyds is experienced not only in working collaboratively with our internal clinical operations, medical and regulatory teams, but also with our clients’ R&D teams, CDMOs, CROs and our clients’ other consultants externally to deliver programmes and ensure that clients R&D milestones are met. Planning for regulatory submissions and upcoming clinical studies across multiple groups requires clear plans that are communicated well, with deadlines bought into by all relevant parties, and effective tracking by the programme director, to ensure that goals are achieved, and slippage minimised.
Management of the CMC and nonclinical programmes
An experienced programme director will be used to working with in-house R&D teams and CROs, to provide oversight of outsourced work, manage timelines and delivery, and ensure studies are delivered on time and on budget. This is especially crucial across multiple groups, where even a small delay in one group can have a huge impact on another task downstream in the plan.
The CMC programme will invariably require a variety of providers to develop and optimise the process for the manufacture of drug substance, formulation work and manufacture of drug product, analytical testing (release and stability). Likewise, the pivotal GLP safety and toxicology programme will also require the development and validation of the relevant bioanalytical methods, and therefore also often utilise more than one CRO, in different geographies.
The integration of these aspects of the programme is to ensure the delivery of sufficient material to supply nonclinical studies and to ensure that the correct package of data is generated to support investigational new drug and clinical trial applications via liaison with regulatory colleagues, is central to successful integrated programme management.