OCT 01, 2015 07:30 AM PDT

Latest clinical results in oncology drug management

  • Founder and Chief Scientific Officer, Saladax Biomedical, Inc.
      Dr. Salamone is the founder of Saladax Biomedical which is a company dedicated to the development of TDM in the field of oncology and companion diagnostics. Saladax has supported numerous clinical studies supporting the use of TDM in oncology and has become the leading force in oncology TDM. Dr. Salamone has more than 25 years' experience in the health care and medical device industries. Prior to founding Saladax, he was Vice President of Research and Development, Roche Diagnostics, where he was responsible for North American research and development efforts for the Laboratory Systems Division. Dr. Salamone's efforts during his 17-year tenure at Roche resulted in the launch of seven major reagent product lines, comprised of more than 70 FDA-approved products and more than 200 instrument applications. Dr. Salamone is well published in the field with more than 70 peer reviewed publications, numerous book chapters and is also the holder of 42 issued US patents. He serves on the boards of several companies, is a reviewer for several scientific journals, participates on a NIH study section for SBIR-STTR grants and often is an invited speaker at major conferences. Dr. Salamone received two bachelor's degrees from Villanova University, a master's and a PhD degree from Rutgers University and was a SERC Post-Doctoral Fellow at Oxford University.


    While TDM is routinely used in a number of medical fields, it has not gained wide utilization in oncology. There is a growing body of evidence demonstrating that current dosing methods based upon body surface area (BSA) are inadequate in delivering the proper drug exposure for optimal treatment effectiveness. BSA-based dosing is associated with drug plasma level variability as high as 30-fold and evidence exists that such inter- and intrapatient pharmacokinetic variability is a major contributor to toxicity and treatment failure. The use of therapeutic drug management (TDM) in oncology will not only serve to lower toxicity and improve efficacy but also help to control the escalating cost of cancer care. A recent randomized study with paclitaxel and carboplatin in NSCLC demonstrated that TDM led to lower dose intensity and significantly lower neuropathy without affecting efficacy. In another study with 5-fluorouricil (5-FU) in colorectal cancer the use TDM resulted in a majority of patients receiving higher exposure without increasing severe toxicities.

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