Preclinical Services
BioAcceleration™ includes progressing your antibody candidates seamlessly into Preclinical Development, which saves time and unnecessary cost. We do this by becoming an integral part of your program. We work with your internal team and provide guidance, leadership, and focus. Our expertise in development strategy, scientific design, implementation, and management of your company’s programs ensure that you meet all regulatory requirements throughout the drug development process. In addition to our own internal team, we have partnered and managed third party experts who will conduct high quality studies in support of your preclinical development program. BioAtla has prequalified several service providers based on quality, cost, and historical performance. In addition, we have negotiated preferred pricing and priority for our clients within our Asian preclinical network.
Preclinical Program Planning Strategy
Defining and designing in vitro and in vivo studies to support your IND ensures that your objectives demonstrating efficacy and safety are met in a timely and cost effective manner. This program comprehensively evaluates the Pharmacology, Toxicology and Pharmacokinetics of your antibody and includes both timelines and budgets. This could include potential regulatory interfaces such as a pre-IND meeting with the FDA.
Preclinical Activities
Design study protocols, initiate and monitor study, analyze data and issue progress and final reports. We work with clients on the evaluation and interpretation of the preclinical data such that all objectives have been met or addressed: 1) Pharmacology: in vitro such as affinity and functional binding, in vivo pharmacology studies to demonstrate that the reported mechanism of action results in the desired pharmacology, 2) Toxicology and Safety Studies: in vivo studies conducted in the appropriate species that are intended to characterize the safety and toxicity of your antibody. Animals are dosed with multiples of the expected therapeutic dose via the intended clinical route of administration. These studies include dose range finding studies and GLP IND-enabling studies which support the regulatory requirements, 3) Pharmacokinetics: These studies are designed to evaluate exposure and elimination of your antibody and are required for an IND.
IND Documentation
BioAtla will oversee the production of individual study reports and author the required IND summary documentation.
