Non-clinical program plans
Taking early experimental data and validating it to ensure it can be repeated is essential. With this in hand, the development of your product through to regulatory approval needs planning with a focus on finding the most appropriate disease models for safety testing.
Boyds can lead the planning of these studies, identifying appropriate GLP-compliant centers to carry out pivotal toxicology studies and support the submission of the regulatory dossier.
IND/CTA gap analysis
Before starting human studies, an Investigational New Drug (IND) for the EU or Clinical Trial Application (CTA) for the US is required. Often clients will have developed their own plan on how to develop their drug based on their specialist knowledge of the disease and the molecule in question. We can critically analyse our client’s plan to ensure current regulatory required studies are incorporated and the scheduling of the studies are optimised to reduce time. We then work with clients to advance and finalise their plan to deliver a package of work to the regulators ensuring all requirements are fulfilled.
Estimation of timelines and costs
Our experience of developing multiple drugs utilising different modalities gives us a deep insight into how long activities can take and ballpark estimates of the costs involved. We can use this experience to help companies develop their investment proposals (see our page on Biotech Start-up Support and Investment Readiness) as well as support the negotiations with CDMOs for the outsourcing of drug manufacturing.
Management of outsourcing partners
Both Clinical Research Organisations (CROs) and Contract Development and Manufacturing Organisations (CDMOs) are required to support the development of novel medicines by small companies. These organisations often have considerable experience in their speciality, whether this is toxicological testing of drugs in different animals or the scale-up for the manufacture of a GLP batch. Choosing the right outsourcing partner is essential to the rapid development of cutting-edge medicines. The team at Boyds are experienced in collaborating with multiple outsourcing partners to obtain the best results for our clients.
