Past EventDealing with FDA Regulations and Other Issues in Developing Companion Diagnostic Programs

Glen Paul Freiberg, vice president, regulatory affairs and quality assurance, Epic Sciences

Glen Paul Freiberg, vice president, regulatory affairs and quality assurance, Epic Sciences

Glen Freiberg will be presenting an innovative small company’s perspective on diagnostic product development. Epic Sciences’ “one-highway” program covers liquid biopsy assay development for academic and pharma investigational therapy and research partnerships, observational clinical trials and the evolution to CLIA/CAP, interventional studies, companion diagnostics and independent diagnostics.

The one-highway program has been developed with consideration of:

  1. FDA thinking, including the draft lab developed test guidance
  2. Joint ventures with other organizations
  3. Funding options/opportunities

For background on the “no cell left behind” liquid biopsy technology, please visit 

Glen Paul Freiberg, RAC is the vice president, regulatory affairs and quality assurance at Epic Sciences. Mr. Freiberg’s career began as an FDA investigator in New England, where he specialized in clinical trials, drug, medical device and diagnostic regulations. He has held positions of increasing responsibility at The Upjohn Company, The Coulter Corporation, Curtin Matheson Scientific, and Boehringer Mannheim. As vice president of clinical and regulatory affairs at Oncor, he most notably completed PMA work on DNA probes for cancer and introduced a successful FDA submission strategy using cytogenetic stains as the predicate device for DNA probes (e.g., trisomy detection).

After Oncor, Mr. Freiberg was vice president at Bard Diagnostic Sciences, where he completed a PMA and two 510(k) submissions, including the first home use cancer-monitoring test, which achieved CLIA waiver. Then as vice president of regulatory, quality and government affairs at Gen-Probe, he helped in the completion of the first amplified nucleic acid tests for HIV, hepatitis and West Nile blood screening as well as for other infectious agents. He has also served as vice president of clinical, regulatory and quality at SpectraScience, and vice president of regulatory affairs and quality assurance at Eveia Medical and Alphatec Spine.