Case study:
Boyds supports fledgling biotech company to help build investable plan for venture capital firms and investors
Background
When trying to secure investment for your biotech from investors or a Venture Capital (VC) company it is essential to have a well-developed, integrated development plan describing how monies invested and entrusted to the development of the product will be spent and what the key milestones are e.g., demonstrating preclinical proof-of-concept in a relevant animal model, successful tech transfer of manufacture to a CDMO, the manufacture of GMP material, development of a suitable formulation for pivotal toxicology studies/the clinic, confirmation of an acceptable safety profile in pivotal tox studies, submission of a CTA/IND application for a first-in-human clinical study, regulatory approval for the study, confirmation of a good safety profile and/or a suitable pharmacokinetic profile in an initial clinical study.
Boyds is frequently approached by biotech companies to help them with their development plans. Recently, one such approach was made concerning an exciting new Advanced Therapy Medicinal Product (ATMP), for which the client needed to work up the strategy for developing the product to support a Series A investment round. Prior to approaching VCs, the company wanted to prepare a detailed operational plan for the development of their product through to a first-in-human (FIH) clinical study including cost and timeline estimates.
Boyds approach
Boyds quickly assembled a team of consultants with the relevant expertise in ATMP manufacture, non-clinical development, regulatory strategy, clinical operations and medical expertise in the specific therapeutic area. A Boyds programme director was the point of contact for the team, to ensure that the team was aligned in its recommendations and delivery of the work for the client according to the scope and brief provided in a timely fashion. Boyds successfully provided the client with:
- A shortlist of potential preferred contract development and manufacturing organisations (CDMOs) to complete the required analytical method development and validation work and move product manufacturing forward from lab scale to development of a clinic-ready GMP process including outline costs and timelines. We also provided a recommendation as to which CDMO was Boyds’ preferred vendor and the reasons why.
- A proposal to develop the strategy for the non-clinical work to ensure a support CTA application, including a breakdown of the required pharmacology and toxicology studies.
- A proposal for the regulatory strategy concerning early engagement and interactions with different regulatory agencies, including timings and topics/potential questions to be asked to ensure a productive outcome.
- A study outline and synopsis for a FIH clinical study, employing a novel trial design to optimise dose selection while minimising the number of subjects required and a high-level budget estimate.
Impact and Outcomes
The overall output gave the client a clear picture of the costs required and the timelines to complete the pre-clinical development of their product, and critical input to planning for the FIH clinical study. The output from Boyds provided our client with a level of detail they were unable to create themselves to share with prospective investors. Also, the client was able to show they had engaged with credible external experts to work up their plans to develop this new medicine, providing investors with confidence and thereby increasing the probability of securing investment.
