Clinical Research, and Drug and Biologics Development, Specializing in Individual Trial Design, Execution

Expertise

• More than 35 years of both academic clinical research and drug and biologics development experience.
• Directing overall program development, and individual trial design, execution and reporting.
• Primary direction of complete drug development programs from IND to NDA that resulted in FDA approval.
• Complete management and oversight of Chemistry, Manufacturing and Controls (CMC) activities, and nonclinical trials.
• Complete clinical development activities including clinical trial design protocols, informed consents, case report forms and statistical analysis planning, data management and statistics, and medical writing.
• Worked in academia as a faculty member and clinical investigator.
• Worked in the drug and biologics industry and at contract research organizations.
• Primary faculty for graduate courses in Drug and Biologics Development, Clinical Trial, and Clinical Trial Operations for the Johns Hopkins University.
• FDA interactions and submissions.

Experience

Undisclosed Company, Founder, President and Chief Executive Officer, Present

• A clinical research organization (CRO) providing support to pharmaceutical companies that require product development services in support of future FDA approvals and wish to expedite that process with the most efficient and cost-effective development possible.
• Services provided, pre-IND planning to NDA submissions.
• Insure proper planning and overall project management is employed throughout the development process.
• Clinical trial planning and operations to deliver key first results within days of the last patient visit and careful attention to the critical path for all development activities.
• Strategic partnerships that assure the customer of getting the finest quality possible, yet maintaining a degree of overall project integration that will be indistinguishable from a single provider.

Airway Therapeutics, LLC,2011 - 2012

• Filling the positions of Founder, President and Chief Executive Officer.

Chiesi Pharmaceuticals Inc., 2002 - 2010

• Filling the positions of Managing Director, Vice President, and Treasurer.

Cato Research Limited, 1996 - 2002

• Filling the positions of Senior Vice President, Drug Development, Managing Director, Clinical Development and General Manager.

Collaborative Clinical Research, Inc., 1995 - 1996

• Vice President, Clinical Development

Undisclosed Research Company,President, 1992 - 1995

Univax Biologics, Inc., Director, Clinical Research, 1992

Boehringer Mannheim Pharmaceuticals, 1986 - 1992

• Filling the positions of: Associate Director, Clinical Research and Project Leader.

Burroughs Wellcome Co., 1985 - 1986

• Project Leader and Clinical Research Scientist Medical Division.

University of Maryland, School of Medicine, 1980 - 1984

• Assistant Professor of Pathology Graduate Faculty.

University of Maryland, Shock Trauma, 1978 - 1984

• Clinical Physiology Research Associate for the Maryland Institute for Emergency Medical Services Systems.

Honors & Publications

Credentials

Fellowships and Scholarships

• NIH Predoctoral Fellowship, Pennsylvania State University-NIA/NIH
• Pyle Scholarship, University of Delaware

Academic and Professional Affiliations

• Graduate Faculty, John Hopkins University (Member)
• The American Physiological Society
• Drug Information Association

Publications

• Author and Co-Author of two text books, numerous abstracts, journals and peered reviewed medical articles.

Education

• Ph.D. Physiology, Pennsylvania State University, University City, PA
• M.S. Physiology, Pennsylvania State University, University City, PA
• B.A. Biology, University of Delaware, Newark, DE