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| Name and Educational Degree: |
Ph.D., Pharmacology, University of Missouri-Columbia, 1988 Fellowship in Clinical Chemistry with emphasis in Molecular Pathology, Department of Pathology and Laboratory Medicine, School of Medicine University of North Carolina at Chapel Hill, 1994-1996 |
5420 Hideaway Dr.
Chapel Hill, NC 27516
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| Telephone: |
919-968-7963 |
| Mobile Number: |
919-537-1879 |
| Email Address: |
mcowlen@nc.rr.com |
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- Nonclinical drug safety assessment and regulatory strategy.
- Toxicology study design and program management.
- Inhalation, ocular, oral, intranasal, and intravenous routes of administration.
- Data interpretation and presentations for internal and external communication.
- Preparation of pre-INDs, INDs, EOP2s, NDAs and other regulatory documents.
- Direct interaction with FDA, EMA, and other international regulatory agencies.
- Safety qualification of impurities, degradation products, leachables and residual solvents.
- Due diligence for corporate development and licensing.
- Nonclinical outsourcing, study monitoring, and CRO management.
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| Dr. Cowlen is a drug development professional with over 15 years of pharmaceutical industry experience. Formerly the Director of Toxicology at Inspire Pharmaceuticals in Raleigh, NC, he now provides nonclinical drug safety assessment services to the pharmaceutical industry at Cowlen Consulting, LLC. At Inspire, Dr. Cowlen was responsible for nonclinical safety assessment at all stages of drug development for the respiratory, ophthalmic, and cardiovascular therapeutic areas. He developed and implemented nonclinical safety assessment strategies to successfully advance multiple drug development programs in compliance with international regulatory requirements. Dr. Cowlen designed, executed, interpreted, and reported outsourced toxicology, pharmacokinetic, and safety pharmacology studies using inhalation, ocular, intranasal, oral, and intravenous routes of administration for in-house development programs, and provided nonclinical safety assessments for corporate development and licensing opportunities. He authored the nonclinical pharmacology, pharmacokinetics and/or toxicology sections of numerous applications to US and international regulatory agencies, including INDs, NDAs, pre-INDs, End-of-Phase 2 packages, Protocol Assistance briefing packages, Investigator Brochures, and Orphan Drug Applications. Dr. Cowlen has met directly with international regulatory agencies, including the FDA, European Medicines Agency, and Health Canada in support of multiple clinical development programs. Dr. Cowlen is a co-inventor on three pharmaceutical patents and a past Chairperson of the Genetic Toxicology Association. At Cowlen Consulting, LLC, Dr. Cowlen has provided nonclinical drug development expertise to small biotechnology and large pharmaceutical companies, including pre-IND strategy, toxicology study protocol development, monitoring, and reporting, and nonclinical authorship of multiple NDAs in Common Technical Document format. |
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