Jeff Goddard, CEO
The therapeutic landscape is changing quite rapidly in terms of measuring small molecule drugs to macromolecules, along with advancements in gene therapy and personalized medicine. These developments have paved the way for organizations such as AIT Bioscience to overhaul the bioanalytical space through their technological proficiencies.
Headquartered in Indianapolis, AIT Bioscience is an integrated contract research laboratory that delivers expert bioanalytical assay services for small molecule and biotherapeutic drug programs, encompassing early discovery to IND enabling toxicology through clinical studies to NDA/ANDA/BLA filing stages. The integration of these services with an ultra-modern and futuristic smart electronic laboratory environment enables AIT Bioscience to develop the best-of-breed solution for its clients across all bioanalytical regimes. AIT Bioscience provides robust analytical methods, efficient sample logistics, highly knowledgeable client consultation, and quick sample analysis from pre-IND through investigational new drug (IND) and new drug application (NDA). “Our multimodal set of services that can address all molecule types effectively has uniquely positioned us in this bioanalytics space,” begins Jeff Goddard, CEO of AIT Bioscience.
What started as a two-person entrepreneurially-minded company with a pioneering goal to utilize cutting edge electronic technology to improve efficiency and quality has matured into an established CRO with over fifty employees who have gained expertise in preclinical and clinical small and large molecule bioanalysis. “We are still the only fully electronic bioanalytical lab on the planet, which translates to a paperless experience from beginning to end,” adds Goddard. AIT Bioscience designed a new lab from scratch as it created the very first fully electronic bioanalytical CRO to support error prevention and correction in real-time. The company implemented a highly configurable, Oracle-based Electronic Laboratory Notebook (ELN) called E-WorkBook Suite (EWBS) from IDBS.
By providing real-time quality control in the lab as well as streamlined scientific data analysis and reports using Watson LIMS data links, ELN serves as a powerful tool for high quality, audit-ready bioanalytical data. As a single, convenient, one-stop-shop, AIT Bioscience offers several service lines to meet clients’ needs. “We have traditional triple quad liquid chromatography-mass spectrometry (LC-MS) instrumentation, high-resolution mass spectrometry (HRMS), an expanding fleet of ligand binding assay platforms (LBA), and are ramping up nucleic acid technologies (HELISA/PCR) to handle small and large molecule and gene therapy development,” states Goddard.
Our multimodal set of services that can address all molecule types effectively has uniquely positioned us in this bioanalytics space
AIT Bioscience offers quality analysis throughout the drug development process, no matter the development stage, molecule size, or therapeutic target. “We will get you from where you are currently to where you want to be in the future,” states Goddard. AIT Bioscience collaborates with its clients at all stages of their discovery, development, and commercialization trajectory. For instance, a client can approach AIT Bioscience at the very beginning of the discovery stage when they are figuring out the characteristics of their molecules, when they are headed into preclinical GLP studies, or as they are entering clinical testing. “Some stay with us through the whole journey, from preclinical testing to Phase III support to enable their NDAs or BLAs and get their drugs and biologics to market,” adds Goddard.
AIT Bioscience has collaborated with multiple clients from the R&D cycle to commercialization. “It is a wonderful accomplishment for us, and it proves how client-oriented we are, and the amount of scalability we possess,” states Goddard. For instance, AIT Bioscience engaged with a customer who had a specific need to find a CRO that could perform branched DNA testing to support gene therapy work. The company performed a feasibility assessment on its own to launch this particular service and sent its scientists to work side by side with the client. This particular engagement showcases the flexibility that AIT Bioscience possesses to pivot and grow with its customer base.
“We envision a very bright future, and we have played a vital role in improving the lives of people everywhere. Our mission is to help great minds do great things to enrich lives,” concludes Goddard.