Pharma and Biotech
Support for Virtual & Semi-Virtual Biotechs

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.

Challenge: For a discovery-stage microbiome company, Alacrita provided a senior preclinical immunologist to lead preclinical development and elaborate a preclinical research strategy for its inflammatory bowel disease program, as well an Interim VP CMC.

Solution: We developed the high-level strategy into a detailed workflow and subsequently assisted with implementation including putting in place the preclinical models required. Later, we also supplied a senior biologics manufacturing specialist to act as Interim VP CMC. Additionally, our manufacturing consultant assessed manufacturing options taking account of cost, quality control and regulatory considerations, devised a manufacturing strategy, and set up the initial CMC activities including processes for fermentation, harvesting and cryo-preservation for live biotherapeutic cultures. He also put in place quality systems and recruited the initial CMC team.

Challenge: An early-stage biotechnology startup company reached out to Alacrita for critical support of its two lead AAV-delivered gene therapy programs. As a virtual company, the client needed expert analysis of ongoing experimental research and development planning of future preclinical PoC studies conducted by CROs and academic collaborators. The client also requested support for planning CMC and regulatory activities needed to progress these programs to IND.

Solution: An Alacrita consultant worked closely with gene therapy, regulatory, and CMC consultants from Alacrita’s extensive expert network. We provided the client with ongoing technical data review, analysis, and preclinical development recommendations for both gene therapy programs including identification, timing, and design of preclinical animal model studies (mice, NHPs, etc); efficacy, biodistribution, safety, and toxicology studies; identification of risk factors and mitigation strategies; research timelines with go/no-go decision points; coordination of studies with CROs and academic collaborators to drive completion of translational studies; and presentations of scientific data to potential investors. Alacrita CMC and regulatory experts also assembled a CMC and regulatory roadmap for the client’s two gene therapy programs through preclinical development and into clinical development. The roadmaps highlighted exactly what needed to be done for each program, in what sequence, to allow success at key milestones.

Challenge: An early-stage biopharma company focused on immuno-oncology therapeutics, in collaboration with academic investigators and inventors, was developing small molecule and monoclonal antibody agents for three targets of high interest in the I/O field. The company had a sudden departure of their Chief Medical Officer and needed interim support while recruiting for a permanent replacement. Alacrita was engaged to provide that expertise.

Solution: Alacrita provided interim Chief Medical Officer support for the client. The consultant CMO provided clinical development input on the design of an FIH trial and clinical development plan for a differentiated small molecule that targeted a receptor of high interest in the I/O field. This study included dose-escalation for the novel agent as monotherapy and in combination with the anti-PD-1 antibody Keytruda (pembrolizumab). The agent was being developed in collaboration with a non-profit cancer research organization. The phase 1 trial was to be conducted at a prominent U.S. academic center.

Our CMO also contributed to joint team meetings regarding the FIH trial and IND preparation as well as meetings with the KOL-lead investigator and provided input on the clinical development plan and FIH study design for the next-most advanced agent in the company’s portfolio. He also joined the company’s executive team members for meetings with U.S. venture investors during due diligence, which led to a successful Series B financing. Lastly, our consultant assisted in evaluating and interviewing candidates for the permanent CMO position.