An early-stage biotech company developing a targeted cancer therapy engaged Alacrita to provide expertise to help them navigate an upcoming IND submission. An Alacrita partner and medical oncologist with over 25 years of industry experience in drug development was integrated virtually into their team as interim CMO. The initial project scope was to help the client review data and FDA correspondence from an ongoing investigator-initiated phase 1 clinical trial being conducted under an academic IND, with the objective being to map the path for the client’s own commercial IND submission. The project scope also included preparing the team for upcoming scientific advisory board meetings with KOLs and to develop a Clinical Development Plan with additional phase 1 and phase 2 clinical trial protocol synopses.
Upon review of the scientific data and the ongoing trials, our consultant was able to diagnose several fundamental issues that needed attention before the program could progress to commercial IND submission. By providing strategic clinical development expertise to the team, the consultant was able to map out a new path forward to IND, which included working with the IIT investigator to expand the ongoing study, as well as incorporating an Alacrita toxicologist to manage the collection of required safety data. As a trusted member of the team, our consulting medical oncologist provided strong scientific grounding that aided in the project’s trajectory both in clinical development and fundraising. The client leadership team was also coached on the context of generated data and how to position it accurately to investors.
Additionally, to ensure an adequate regulatory-affairs perspective was incorporated, an Alacrita senior regulatory consultant with significant previous industry experience was added to the team and began preparations for the pre-IND meeting as well as the preparation of the IND submission itself.
To further assist leadership with gaining a sharper picture of the potential therapeutic’s value, Alacrita was also engaged to perform a valuation of the clinical candidate, producing projections for addressable market, penetration, pricing and the associated product revenues for major markets for the various target indications. This included projections for development costs, timelines and probabilities of success at each go/no-go point. Considering the uncertainty in many of the valuation’s input assumptions, a Monte Carlo simulation was used to capture ranges of such values (Min, Mode, Max). This information was also used directly in the next round of investor interactions by the client management team.
Throughout the engagement, Alacrita team members worked closely together while being integrated seamlessly into the client. It allowed the biotech to bring in professionals with deep industry experience across various domains who did not need to be located in the same geographic area nor be formally contracted as full-time staff, at a time when financial resources did not support high overheads. This virtual team approach provided the early-stage enterprise with the flexibility and cost-savings that it needed at that stage in its development, without compromising the quality of guidance it was getting. Working within these restraints, engaging Alacrita allowed them to find and engage highly-experienced professionals with precisely the right expertise and effectively and efficiently progress their project.