Resumes
Dou Huey (Lucy) Jean, Ph.D.
Expertise
- Over twenty years of pharmacology and toxicology review experience at the FDA.
- Four years as a Pharmacology Team Leader at the Division of Anesthetic, Critical Care and Addiction Drug Products.
- Over nine years as a consultant in regulatory pharmacology and toxicology to pharmaceutical industry.
Professional Experience
| Jan 2003 - Present | Regulatory Pharmacologist Salamandra, LLC, Bethesda, MD |
- Providing guidance to pharmaceutical companies on the non-clinical pharmacology and toxicology data needed for initiation of clinical trials and for approval of INDs, NDAs, and other regulatory submissions.
- Reviewing and evaluating non-clinical data on the efficacy and safety of the drug products submitted in INDs, NDAs, and other regulatory submissions. Reviewing nonclinical study protocols. Reviewed nonclinical study protocols..
- Writing nonclinical sections for pre-IND, End-of Phase 2 and pre-NDA packages as well as INDs, NDAs, Investigator’s Brochures, and non-US regulatory documents.
- Performing due diligence evaluation, reviewing nonclinical data, identifying issues and recommending solutions.
| 2002 - Present |
Consultant on Regulatory Pharmacology and Toxicology Issues Center for Drug Evaluation, Taipei, Taiwan |
- Provided reviews, opinions and recommendations on toxicological issues from pharmacologist's reviews of industry's IND and NDA submissions.
- Provided training courses on regulatory toxicology.
| 2000 - 2003 |
Consultant on Regulatory Pharmacology and Toxicology |
- Same as under Salamandra, LLC, above
- Participated in company's Expert Committee, advising on toxicological issues
- Provided cost estimate for nonclinical studies in clinical development plans and identified contract research organizations
| 1996 - 2000 | Team Leader Pharmacologist Division of Anesthetic, Critical Care and Addiction Drug Products |
- Assignment, secondary review, and sign-off of pharmacologists' reviews of INDs and NDAs.
- Met with sponsors (industry and individual investigators) to provide guidance on the non-clinical pharmacology and toxicology data needed for INDs and NDAs.
- Advised division director and interacted with medical, chemistry, pharmacokinetic and statistical teams on non-clinical data, issues and policy.
- Participated in recruitment, interviewing and hiring of pharmacologists.
- Interacted with CDER scientists and conducted consultation reviews for generic and OTC drugs, including anesthestics (general and local), analgesics (opioids, NSAIDs and others) for acute and chronic pain, for malignant and non-malignant pain, neuromuscular blocking agents, anticholinergic agents, sedatives, a benzodiazepine antagonist, a cardioprotective agent during bypass operation, and drugs for treating various addictions (nicotine, cocaine, heroin, alcoholism).
| 1989 - 1996 |
Reviewing Pharmacologist Center for Drug Evaluation and Research, FDA, Rockville, MD |
- Reviewed and evaluated non-clinical data on the efficacy and safety of the drug products submitted in INDs and NDAs.
- Assessed benefit/risk ratio and made recommendations, based upon pharmacology and toxicology data, regarding the initiation and continuation of clinical studies for INDs or approvability of NDAs.
- Interacted and communicated within division and the center on the non-clinical issues arising from review of INDs and NDAs and participated in consensus building.
- Reviewed anesthetics (general and local), neuromuscular blocking agents, sedatives, a benzodiazepine antagonist, anticholinergics, analgesics (opioids, NSAIDS), drugs for treating various addictions (nicotine, cocaine, heroin, alcoholism).
- Reviewed preparations, including parenteral, inhalation (oral and nasal), oral, topical, transmucosal, transdermal, epidural, intrathecal, instillation, intramuscular and subcutaneous depots, and liposomes.
- Communicated with industrial or individual research sponsors at the pre-IND, IND, End-of Phase 2, pre-NDA and/or NDA stages to discuss non-clinical issues, providing guidance on the non-clinical studies needed for assessing the safety and efficacy of drug products at different phases of clinical trials for INDs and/or phase 4 for NDAs.
- Served as peer reviewer (equivalent to a Supervisory Pharmacologist) for five tours.
- · Participated in reviews of draft ICH guidelines, various FDA guidelines and pregnancy category labeling and in drafting the guidance on pharmacology and toxicology for herbal products.
| 1977 - 1989 |
Review Pharmacologist, Division of Surgical and Dental Drug Products Bureau of Drugs, FDA, Rockville, MD |
- Duties and responsibilities were as listed above, but involved review of other classes of drugs, including bronchodilators, anti-asthmatic, anti-allergic agents: methyxanthines, beta-2 agonists, leucotriene antagonists, anticholinergics, antihistamines, and glucocorticoids.
- Designated and served as Acting Supervisory Pharmacologist when the Supervisory Pharmacologist was on leave.
- Served as a consulting reviewer 1979-1980, participated in reviewing the class labeling for local anesthetics and neuromuscular blocking agents.
- Drafted unofficial non-clinical guidance for neuromuscular blocking agents.
Education
-
Ph.D. Pharmacology, University of Mississippi Medical Center, Jackson, MS (1970) -
M.S. Pharmacology, University of Mississippi Medical Center, Jackson, MS (1967) -
B.S. Pharmacy, College of Medicine, National Taiwan University, Taipei, Taiwan (1962)
Professional Activities
- Member, American Association for the Advancement of Science (1971-1988)
- Member, National Institutes of Health Chinese American Association (1975-1990)
- Member, National Taiwan University School of Pharmacy Alumni Association (1981 – Present)
- President, National Taiwan University School of Pharmacy Alumni Association (1985-1989)
- Member and Treasurer, Chinese Medical and Health Association (1985-1988)
Honors, Awards, and Certifications
- Quality Step Increases for outstanding performance 1985, 1986, 1990, 1993
- FDA Commendable Service Award: CDER Botanical Working Group
- FDA Group Recognition Award: Carcinogenicity Assessment Committee
Publications
- Click here for a list of publications.
International Experience and Foreign Languages
- Fluent in Chinese and Taiwanese
- Ability to read and understand Japanese at a minimal level
- Prepared pre-IND meeting packages and attended pre-IND meetings at the FDA for Chinese pharmaceutical companies