A leader in Personalized Therapy Decision Support and Precision Drug Development, Cellworks, has announced the opening of a CLIA-certified computational laboratory in Franklin, Tennessee. Administered by the Centers for Medicare and Medicaid Services, CLIA (Clinical Laboratory Improvement Amendments) ensures high standards for clinical lab testing in the U.S. Dr. Michael Donovan, a distinguished academic and biotech leader, has joined Cellworks as Laboratory Director to lead computational biosimulation efforts, delivering Personalized Therapy Decision Support reports from this newly certified lab.
This new facility marks a significant advancement in Cellworks’ mission to innovate Personalized Therapy Decision Support, initially focusing on personalized therapy predictions for non-small cell lung cancer (NSCLC) patients. The Cellworks Platform, along with its in silico Computational Biology Model (CBM), analyzes genomic aberrations in a patient’s tumor to predict therapy responses. Comprehensive Genomic Profiling (CGP) and clinical data provided by clinicians will be processed in the lab using mechanistic biology modeling, statistical analysis, and machine learning to predict patient-specific therapeutic outcomes.
“We are excited about our new lab’s potential to advance NSCLC treatment and thrilled to welcome Dr. Michael Donovan to Cellworks,” said Yatin Mundkur, CEO and Board Director of Cellworks. “Dr. Donovan’s extensive contributions to medical science and innovation make him a valuable addition. His leadership enhances our commitment to excellence and strengthens our position as a leader in Personalized Medicine.”
Dr. Donovan brings over two decades of experience, having held significant roles in academia and the biotechnology industry. He is currently an adjunct professor at the Icahn School of Medicine at Mount Sinai and the University of Miami. Dr. Donovan’s impressive academic background includes institutions like Harvard Medical School and Boston Children’s Hospital, and senior management roles at Millennium Pharmaceuticals and Incyte Pharmaceuticals.
Dr. Donovan earned a Ph.D. in Cell and Developmental Biology from Rutgers University, followed by a postdoctoral fellowship at Harvard Medical School. He received his medical degree from Rutgers New Jersey Medical School, with a residency at New York Hospital and a fellowship at Boston Children’s Hospital.
“I am delighted to join the Cellworks team and look forward to collaborating with such talented individuals,” said Dr. Donovan. “We have a tremendous opportunity to advance Personalized Therapy Biosimulation, starting with key breakthroughs for NSCLC patients. I am eager to contribute my expertise and work closely with the team to drive innovation and improve patient outcomes.”
Cellworks Platform and Therapy Response Index (TRI)
The Cellworks Platform simulates the effects of specific drug compounds on patients using their genomic profiles. Multi-omic data from patients or cohorts is inputted into the in silico Cellworks Computational Biology Model (CBM) to generate personalized disease models. The CBM, a detailed mechanistic network of over 6,000 human genes, 30,000 molecular species, and 600,000 molecular interactions, along with drug models, simulates the impact of drugs on patients, producing therapy response predictions. These predictions are statistically modeled to produce a qualitative Therapy Response Index (TRI) score, ranging from 0 (unfavorable outcome) to 100 (favorable outcome). The Cellworks CBM has been validated across various clinical datasets and reported in over 125 presentations and publications with global collaborators.