Cell & Gene Therapy Support
Alacrita supports clients developing a broad range of cell therapies & gene therapies. By combining our core team with functional specialists from our consulting network, we're able to field project teams with extensive industry experience. This allows us to provide clients with support that is both of considerable depth and that can be precisely tailored to the specific needs of each program. Additionally, we have consultants with the required backgrounds in regulatory affairs and CMC for advanced therapy medicinal products, to ensure our support can help you keep pace with and adapt your program as necessary to changes in development - a critical aspect when the process is the product and the product is the process.
We have experience with a range of technologies in the field including CAR-T, viral vectors such as adeno-associated virus and lentiviruses, as well as both autologous and allogeneic cells, and have supported programs across a range of indications including oncology, immuno-oncology, autoimmune diseases, cardiovascular disease, ophthalmology, CNS and rare disease.
Additional details, by technology type:
The support we provide ranges from opportunity mapping and business strategy to regulatory affairs and preclinical and clinical support to due diligence, valuations and in- and out-licensing. We're able to provide a comprehensive level of support by combining the capabilities of the firms's partners with those of our extended consulting network, which contains over 80 biotech and pharmaceutical consultants with expertise in cell and gene therapies.
The below list of recent projects can help illustrate the type of support we typically provide to clients in the cell and gene therapy space:
- Competitive and market landscape for CAR T-cell therapy: A biotech company developing a platform technology to improve the safety of CAR T-cell therapies asked Alacrita to conduct a comprehensive competitive landscape to better understand the current CAR T-cell therapy space.
- FDA Regulatory affairs support for first-in-class allogeneic Natural Killer (NK) cell therapy: A company developing a first in class allogeneic Natural Killer (NK) cell therapy needed regulatory support for its FDA interactions. The product was in early clinical trials in an ex-US territory and had shown preliminary evidence of efficacy. The company was looking at establishing an IND to enable further clinical development in the United States. Alacrita was engaged to help with this process.
- Manufacturing license negotiations for gene therapies for orphan diseases: A private biotech company developing gene therapy products for several orphan diseases was in the process of initiating CMC development for their pipeline products. In order to move forward, they needed to acquire commercial manufacturing licenses for several technologies that would be required for the production of their therapeutic products, including cell lines and patented processes for AAV manufacturing. The company sought interim support from Alacrita to secure the manufacturing licenses in order to move forward, while they built out their BD team. View full case study.
- Due diligence on a novel T cell therapy and discovery platform: A VC investor wished to make an investment in a California-based preclinical biotechnology company with a discovery platform and novel T cell therapies for cancer and other diseases. Alacrita was commissioned to use its experience in cell therapeutics to perform a technical due diligence on the company to highlight any key risks and to propose mitigation strategies.
- R&D pipeline planning for gene therapy company: A biotechnology company developing proprietary synthetic biology technology in gene therapy expression for several clients was looking to evolve its business model. The company engaged Alacrita to find a way to build their own internal cell and gene therapy (including gene editing) pipeline and to put together a plan in order to establish medical indications the technology could be applied to.
- Regulatory support for CMC and pharmacology & toxicology: Our client is an innovative, publicly-traded, lean biotechnology company focused on developing potential cures for infectious diseases and cancer utilizing cell and gene therapies and proprietary platform technologies. Alacrita was engaged to provide cell and gene therapy regulatory affairs consultant support for Chemistry, Manufacturing & Controls (CMC), and Pharmacology & Toxicology to help support and accelerate client Research & Development (R&D) activities.
- Virtual Stewardship of a Targeted Cancer Therapy to an IND Submission: 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.