The biopharmaceutical horizon is dramatically changing.  Among the 400 investigational 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.”    Modern personalized medicine approaches focus on each tumor’s genome with a process of research discovery for individual targeted, cellular and gene silencing protocols  (personalizedmedicine.png).   The new era of Personalized Medicine requires an entirely new research clinic model with cellular/genomic capabilities and tumor biopsy access. 

These new research modalities require a specialized clinic with the infrastructure and equipment for leukapheresis, 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 (View Diagram).  

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 (transhighway.png). 

The collection of clinical research trial data combined with a tumor bank will allow for the most modern bioinformatics analysis known as systems biology.  Although this experimental field is still in its infancy, systems biology has the theoretical potential of discovering pharmacogenomic targets based on computer analysis.   Future tumor banks and bioinformatics may allow ‘in-silico personalized medicine’ by digitally predicting which cocktail of targeted drugs may inhibit a tumor, even before the patient has received the drugs
(View Diagram).   

These expanded research services will enable the broadest armamentarium of investigational 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.