Whether your product is a small molecule or biologic, Alacrita can provide tailored assistance to help you plan and advance your program. This includes expertise in the complex CMC, safety and toxicology, and translational medicine aspects of today's cutting-edge therapeutics.
Our preclinical drug development capabilities:
- Indication selection and definition of Target Product Profiles
- Drug discovery support, including target identification and validation, assay development, hit-to-lead, lead optimization and candidate selection criteria
- Development or review of preclinical development strategy plans
- Analysis of regulatory pathways for drugs and devices
- Design and management of in vitro and in vivo studies
- Chemistry, Manufacturing, and Controls (CMC) support through preclinical development
- CRO and CDMO selection, engagement and management
- Interpretation of preclinical study data and writing preclinical study reports
- Review of data in conjunction with market and regulatory frameworks to assist with go/no-go decision making
- Planning and execution of Pre-IND and IND meetings with regulatory agencies, including writing and submitting IND documents
The below list of recent projects can help illustrate the type of expertise we typically provide in this area:
- Preclinical due diligence of a novel live biotherapeutic: An early-stage venture fund asked Alacrita to review the opportunity for reinvestment in a biotech developing a novel live biotherapeutic for the treatment of inflammatory bowel disorders (IBD). Alacrita was asked to evaluate the strength of the data generated, as well as the target company's work plan for future preclinical data collection in order to evaluate its merits for more substantial fundraising from the investors. View full case study
- Managing preclinical programs into Phase I/II clinical trials: A leading cancer research charity needed project management and drug development expertise to shepherd two preclinical programs into Phase I/II clinical trials. Alacrita was engaged to oversee the formal preclinical development program, the submission of the IND and the execution of a Phase I/II clinical trial for two of the charity’s targeted therapy compounds. We were responsible for identifying and negotiating contracts with appropriate CROs, managing the CRO relationships, identifying and overcoming issues as they arose, ensuring regulatory compliance, liaising with ethics committees, monitoring and ensuring GMP compliance, and providing regular progress reports.
- IND-enabling studies plan for a small molecule in NASH: A biotech developing a novel drug for NASH asked Alacrita to create a project plan outlining costs and timelines for preclinical IND-enabling studies. We recommended the best animal models, such as DIAMOND and STAM, of NASH for evaluating the activity of the novel drug. We also identified the most suitable IND-enabling studies for this indication, specifically focusing on preclinical studies in module 2 of the IND which includes pharmacology (in vitro and in vivo pharmacodynamic test), ADME, toxicology, and pharmacokinetics. We also estimated the time and the cost for these preclinical studies.
- Preclinical strategy for IBD therapeutic: For a discovery-stage microbiome company, Alacrita developed a preclinical research strategy for its inflammatory bowel disease program. We then developed the high level strategy into a detailed workflow and subsequently assisted with implementation including putting in place the preclinical models required.
Valuation of drug discovery company with Monte Carlo simulation: A drug discovery company preparing for a forthcoming funding round wanted to update a valuation of the business based on a series of contract research projects and the proprietary value in its other research collaborations, and to understand which projects would maximize longer term value.We worked with our client to develop a current valuation for the company based on individual valuations for its portfolio of research assets. Each individual valuation was underpinned by realistic input assumptions (e.g. the addressable market, penetration, pricing and associated product revenues, costs, timelines, and probabilities of success at each go/no-go point, and deal structure). Given the uncertainty around many input assumptions, we used Monte Carlo simulation to capture a range of values for each assumption. We helped our client understand how the deals would affect the value accumulating over time. Our client used the results in negotiations for the funding round and in selecting between different strategic options for development of the business.