The comprehensive care of cancer patients requires a full-time clinic with an on-site oncologist available Mon-Friday and 24/7 call availability. An experienced clinical staff with infusion services, ancillary laboratory services, and proximity to a hospital with diagnostic and surgical services are key to providing outstanding cancer care. All of these services will be provided through CBI in affiliation with Presbyterian Hospital at Huntersville.

CBI will continue to offer standard traditional oncology, professional, chemotherapy & clinical services with the unique advantage of research access to early phase biologics. Therefore it will strive to be a referral hub for general oncologists seeking research options for their patients.

The biopharmaceutical horizon is dramatically changing. Among the 400 new cancer drugs in development, only a few are chemotherapy drugs. The drug development industry has realized that the "one size fits all" chemotherapy approach will not cure cancer. Instead, the genomic revolution has focused on discovery of specific targets for each patient's unique tumor. This targeted drug approach is tailored to each individual patient's unique tumor genomic signature, knows as "Personalized Medicine." Where as conventional biopharmaceutical industry focuses on the block-buster drug product, the new personalized medicine approach focuses on tumor's genome with a process of research discovery for individual targeted, cellular and gene therapy (diagram attached). The new era of Personalized Medicine requires an entirely new research practice model with cellular/genomic capabilities and tumor access.

Personalized medicine modalities such as dendritic cell vaccines, tumor infiltrating lymphocytes (TIL), gene therapy and antibody conjugated radio-isotopes are shown in the attached diagrams. The flow diagram also shows an example of a personalized medicine protocol utilizing tumor harvesting, gene transfection, and the culture expansion of bio-engineered TIL cells.

These new research modalities require a specialized clinic with the infrastructure and equipment for leukopheresis, cellular processing and culture expansion, biosafety level 3 HEPA filtered clean rooms, and radio-isotope facilities. Collectively, these components are known as a Human Applications Laboratory (HAL). Furthermore, most targeted drug trials require access to a tumor bank for pharmacogenomics, proteomics and immunomics for safety/toxicity analysis(diagram attached).

CBI is developing HAL and genomic tumor banking capabilities. These modalities are outside the scope of a private practice or hospital, and require multiple PhD recruits, NC BioTech collaboration and public/private partnerships. CBI collaborations will include the newly formed UNCC BioMedical Research Institute of Charlotte and the NC BioInformatics Consortium to open the translational highway for research access to personalized medicine (diagram attached). The collection of clinical research trial data combined with a tumor bank will allow for the most modern bioinformatics analysis known as Systems Biology. Systems biology has the potential of discovering pharmacogenomic targets for an "in-silico personalized cure" by digitally predicting which cocktail of targeted drugs may eradicate a tumor, even before the patient has received the drugs (diagram attached).

These expanded research services will enable the broadest armamentarium of new cancer drugs for our community. CBI will continue to collaborate closely with Presbyterian Hospital , CMC Hospital and UNCC to raise awareness and access for patients and researchers.