Clinical Drug Development Expert

This clinical drug development expert has more than two decades of experience in pharmacology, pharmacokinetics and pharmacodynamics of products in numerous therapeutic areas. For more than 15 years, he specialized in the development of respiratory products for a global scientific healthcare company. During this time, he focused on clinical studies of drugs designed to treat chronic obstructive pulmonary disease (COPD), product label development and interacted with pharmaceutical regulatory agencies. Currently, this expert is president of a clinical drug development consulting firm, lending his expertise in the regulatory process and implementation of new drugs to the pharmaceutical industry.

• Aided in the development of more than 25 therapeutic drug products
• Extensive experience in the development and analysis of a variety of branded drugs, including those designed to treat COPD, chronic pain, gastroesophageal reflux disease (GERD), migraine headaches and human immunodeficiency virus (HIV)
• Developed clinical drug development applications including investigational new drug (IND), abbreviated new drug application (ANDA), supplemental new drug application (sNDA) and clinical investigator brochure (CIB) documents
• Author of numerous publications in scientific and medical research journals
• Provides educational courses in clinical and pediatric drug development and offers customized training to organizations

• Ph.D., Pharmaceutics
• B.S., Pharmacy

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