Ron Schultheis, MS, MBA, has 18 years of project management experience
encompassing multiple facets of the clinical commercialization process from
early stage regulatory planning, business and market plan development an the
execution of a full range of clinical operations capabilities. Mr. Schultheis has
led numerous teams that successfully developed a wide array of clinical
products and applications. While at UroCor, Inc., a successful start-up
company subsequently purchased by Laboratory Corporation of America, Mr.
Schultheis led product development teams to launch several diagnostic
products for the management of bladder cancer, prostate cancer, and kidney
disease. Mr. Schultheis also interfaced with the regulatory and manufacturing
arms of a major therapeutic manufacturer for the launch of a biotherapeutic
for the treatment of bladder cancer. In addition, while at UroCor he led the
development team for a radiation therapy product for the treatment of
prostate cancer. Mr. Schultheis has proven experience in development of
product specifications, technology, and market evaluation. He was the leader
of teams responsible for evaluating new product opportunities in the clinical
pathology market while at UroCor, Inc and in the infectious disease market
while at Meridian BioSciences. Mr. Schultheis started his career in clinical trials
management with Kendle International and has consulted for several major
pharmaceutical companies on Phase II-IV development. Most recently, Mr.
Schultheis has served as Sr. Director, Clinical Operations for a medical device
development firm conducting PMA enabling research for its medical device
clients; and providing regulatory and development strategy planning for early
stage diagnostic and biotherapeutic companies. Mr. Schultheis holds a Masters
degree in the field of immunology and infectious disease. His product
management and development experience includes oncology and infectious
disease diagnostics, molecular diagnostics, cardiology, diabetes, and
biotherapeutic and medical device applications for the treatment of urologic
cancer.
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