Our Organization

Our Administrative, Financial, HR, and IT teams are an essential component of Genvivo and support our mission. The HR team is committed to providing outstanding employee experiences and focuses on bringing top-tier talent to the organization. The Administrative, Finance, and IT teams provide the framework necessary to ensure the company's operational success.

Our BioManufacturing team is dedicated to producing Drug Substances and Drug Products to support our clinical trials, while upholding the utmost cGMP quality standards. With a vertically integrated department, we have control over the entire production process, from the creation of master cell banks to the packaging of finished vials for clinical use. This in-house capability gives us a significant advantage in managing our drug supply. Our relentless pursuit of excellence has driven our high success rate, consistency from lot to lot, and a safe working environment. Our highly skilled and trained team of BioManufacturing Scientists enables us to nimbly produce a diverse pipeline of gene therapy products at large scale.

Clinical Operations has a mission to support GenVivo’s company goals by designing and executing investigational drug clinical programs to achieve regulatory approval.  We are able to do this by understanding the challenges of cancer studies as well as the unique nature of gene therapy trials. Specifically, we work in the functional areas of project management, study monitoring, data management, biostatistics, pharmacovigilance/safety, trial supply management, and laboratory science.

Our Pre-Clinical team evaluates the safety and efficacy of our therapeutic interventions. During preclinical development, we support safety, toxicology, and pharmacological efficacy studies for drug candidates in future clinical trials.

Our Process Development & Engineering team is dedicated to designing, developing, and optimizing the manufacturing process for next-generation vector therapies. We utilize quality by design (QbD) to continuously identify, improve, and control critical process parameters (CPP) through a data-driven approach.

Our Process Science & Engineering (PS&E) team translates newly-developed vectors from R&D into preclinical products which can be administered in animals. PS&E assesses the developability and manufacturability of each novel vector candidate at the early stage of drug development.

GenVivo has sustainably implemented a quality culture with systems and processes in place to drive quality-focused behaviors and to ensure quality-conscious decision making based on what is best for product quality, patient safety, and protection of GenVivo’s reputation and business. 

GenVivo’s Quality System is backed by executive management and is central to our delivery of safe and effective products to our patients and to maintaining a culture of trust in our organization.

The quality control team employs cutting-edge technologies and applies integrated strategies in a stringent cGMP environment. This ensures control of the manufacturing process that enables the release of quality product to the clinic.

The team develops robust and reliable in-house assays to access our investigational products for safety, purity, and potency.

The Research & Development Department consists of a dedicated team of scientists. Our combined experience covers a diverse range of backgrounds including: gene therapy using adenoviral, retroviral and lentiviral vectors; stem cell biology; developmental biology; antibody development and screening; CRISPR technology; and automated protein screening platforms for drug discovery. Our research experience places GenVivo Inc. at the forefront of cancer gene therapy innovation and advancement.

Our current pursuits to treat cancer and other diseases include the development of: novel vector payloads; antigen-specific targeting systems; non-integrating vector systems; cutting edge delivery systems; and assay development.