Corporate Advisory Team...
Icilio Cavero, Ph.D.
Dr. Cavero is presently a freelance consultant in the cardiac electrophysiological safety of drugs. He also holds an adjunct appointment as Professor, Department of Neurobiology, Pharmacology and Biotechnology, Pharmacy School, at the University of Pisa, Pisa, Italy.
Dr. Cavero received a Pharmacy degree, magna cum laude, at the University of Pisa, School of Pharmacy. Then, he continued his education at the School of Pharmacy at the University of Pittsburgh where he obtained a Ph.D. in cardiovascular pharmacology.
After a 2-year postdoctoral fellowship at Hoffman-La Roche in Basel, Switzerland, he was called to direct the Synthélabo Cardiovascular Group in Paris where he participated in the development of the calcium antagonist diltiazem, the b-adrenoceptor antagonist betaxolol, and the a-adrenoceptor antagonist alfuzosin which recently received FDA approval for treating prostate hypertrophy under the trade name of Uroxatral.
From 1985 to 1992, Dr. Cavero directed the Cardiovascular Pharmacology Department of the former Rhône Poulenc Santé. From 1993 to 1999, he was Director of the Safety Pharmacology Unit of the former Rhône-Poulenc Rorer where he established the first worldwide research group working under GLP, a truly innovative way of performing Safety Pharmacology experiments for the middle 90’s.
Since 2000, when he retired from the newly formed pharmaceutical group Aventis Pharma, Dr. Cavero enjoys freelance consulting worldwide in Safety Pharmacology.
Dr. Cavero published 187 papers and in recent years his research interests have been entirely addressed to cardiac electrophysiological safety of pharmaceuticals.
Benedict R. Lucchesi, Ph.D., M.D.
Dr. Lucchesi has been a faculty member in the Department of Pharmacology at the University of Michigan for over 43 years. During this time, he has made significant contributions to both basic pharmacology and drug development research by publishing more than 370 manuscripts. He is recognized internationally in the field of pharmacology and has received the Gustav Nylin Award (Karolinska Institute, Stockholm, Sweden, 1985), the ASPET Award for Experimental Therapeutics (1989), and the Torald Sollmann Award (2001). In addition, he has been supported by the longest, uninterrupted NIH-HLBI award, including 10 years of funding as a Merit Award.
Dr. Lucchesi serves as an Editor for the British Journal of Pharmacology and is an editorial board member of many cardiovascular journals including; Circulation, Journal of Pharmacology and Experimental Therapeutics, American Journal of Physiology (Heart and Circulatory Physiology), Journal of Cardiovascular Pharmacology, and the European Journal of Pharmacology.
Dr. Lucchesi was elected as a Fellow of the American Heart Association, a Fellow of the International Society for Heart Research and a Fellow of the International Academy of Cardiovascular Sciences.
Robyn L. Phelps, Ph.D.
Dr. Phelps has 25 years of scientific and drug development experience in the commercial, contract research and pharmaceutical industries with special emphasis in cardiopulmonary safety pharmacology. Dr. Phelps has authored publications in cardiovascular toxicity, inhalation toxicology, animal imaging and remote monitoring technologies, ocular pharmacology, and in animal modeling techniques.
Currently, Dr. Phelps is CEO of a nonclinical consulting firm established in 2006 which provides comprehensive services to small and mid-sized pharmaceutical companies supporting all stages of drug development. She is experienced in small molecule, anti-neoplastic and botanically derived compound development, and has specialized experience in dermal and ocular administration.
Previously, Dr. Phelps was Scientific Director of Safety Pharmacology at Allergan, Inc. (1999–2006) where she directed the evaluation of drug side effects in multiple therapeutic areas. Additionally, she served as the lead toxicologist in the FDA approval of Lumigan for the treatment of glaucoma, for a dermal anti-neoplastic agent currently completing clinical trials, and for multiple BOTOX therapeutic programs. Prior to her position with Allergan, Dr. Phelps led pharmaceutical, industrial and chemical product toxicity testing programs and was the discipline leader and technical director for a dual campus pulmonary therapeutics/anti-neoplastic program at Battelle Memorial Institute.
Dr. Phelps received her B.S. in physiology from Michigan State University (1979) and her MSc in cardiovascular physiology at the University of North Carolina (1990). She obtained her PhD in cardiovascular physiology from the University of British Columbia (1995) where she was a Research Fellow of the Canadian Heart and Stroke Foundation of British Columbia and the Yukon. Additionally, Dr. Phelps received specialized training in microsurgery from the Bowman Gray School of Medicine, Wake Forest University, North Carolina (1985).
Ronald J. Shebuski, Ph.D.
Dr. Shebuski has over 20 years experience in the pharmaceutical industry and served as the Director of Cardiovascular Therapeutics at Pharmacia & Upjohn from 1990–1998. He established a cardiovascular research consulting firm in 1998 and has served small, mid and large pharma in many aspects of drug discovery and development.
Additionally, Dr. Shebuski co-manages start-up companies through his association with the Apjohn Group (www.apjohngroup.com). He served as the Vice President of Pre-Clinical Research for Afmedica, Inc., a Kalamazoo, Michigan-based biotech start-up that developed a drug-eluting (sirolimus) polymer product which was placed around surgical graft sites to prevent hemodialysis access and peripheral vascular graft failure. Afmedica was acquired by Angiotech Pharmaceuticals (Vancouver, B.C.) in late 2005.
Currently, Dr. Shebuski is CSO and Vice President of Research for MedElute, Inc., also based in Kalamazoo, which is developing a polymer-based product from which anti-fibrin drugs are eluted locally to prevent post-surgical adhesions. He is also the President and CEO of MuciMed which is developing novel mucin-based protein therapeutics for treatment of Inflammatory Bowel Disease (IBD) and mucositis.
Previous to directing the cardiovascular group at Pharmacia & Upjohn, where he managed the team responsible for FDA approval in 1995 of the Class III anti-arrhythmic agent, Corvert®, Dr. Shebuski was a Senior Scientist responsible for leading cardiovascular drug discovery teams at Merck Research Laboratories and Smith Kline & French. His primary field of research has focused on platelet and coagulation activation in thrombosis and the development of effective new therapies. At Merck, Dr. Shebuski led the in vivo discovery and development effort which culminated in the identification and eventual FDA approval of the anti-platelet GPIIb/IIIa antagonist, Aggrastat®. He also led development teams in identification of novel factor Xa- and P-selectin antagonists at Merck and Pharmacia & Upjohn, respectively.
Dr. Shebuski is an Adjunct Associate Professor of Pharmacology and Full Professor of Integrative Biology and Physiology at the University of Minnesota Medical School. He received his B.S. Degree in Microbiology from the University of Wisconsin-Madison (1976) and Ph.D. in Pharmacology from the University of Minnesota Medical School in Minneapolis (1985).
Richard W. Shubart
Mr. Shubart is a well-respected decision-maker in the pharmaceutical industry’s Quality Assurance arena. He has a broad depth of knowledge and experience in GMP, GLP, GCP, Computer Validation and Compliance Audits.
Working for multiple pharmaceutical companies for more than 35 years, Mr. Shubart rose to Senior Director of Global R&D Quality Assurance where he managed several Foreign Regulatory and U.S. FDA Pre-approval Inspections resulting in on-time product approvals. With a reputation for a thorough and comprehensive approach to problem solving, his team reduced the potential for negative regulatory impacts. He also created and developed an R&D Computer Validation QA group and, in cooperation with IT colleagues, an engineered approach to software validation.
Mr. Shubart is a member of the American Chemical Society and the American Society for Quality where he has been a certified Quality Engineer since 1982. After earning his BS in chemistry from the University of Michigan in 1962, he went on to graduate from Roosevelt University with an MS in Chemistry in 1970 and from Northwestern University with an MBA in 1975.