Possesses over 35 years of combined academic, CRO, and pharmaceutical experience, with a focus on therapeutic areas such as anti-nausea, immunology, asthma, oncology, allergy, osteoarthritis, and gene therapy (AAV / lentiviral vectors). A proven record of success in leading drug development activities for gene therapies and abuse liability assessment of small molecules. Leverages exemplary leadership, organizational, and communication skills to drive innovation and achieve exceptional outcomes.
With experience developing gene therapy programs, nonclinical development programs and IND-enabling GLP toxicity studies we have worked extensively in AAV Gene Therapy. The U.S. Food and Drug Administration (FDA) granted the Regenerative Medicine Advanced Therapy (RMAT) designation to one of our programs based on positive 6-month efficacy data from the Phase I/II clinical trial.
We have over 35 years of experience in abuse liability assessment working for small biotech companies as well as large pharmaceutical companies. This has included an academic focus on drug abuse research and education, Safety Pharmacology, and serving as a subject matter expert (SME) on abuse liability assessment advising all company drug development programs advancing to the NDA or BLA stage from 2005 to 2020.
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