Katherine M. Bennett, Pharm.D.

Expertise

Extensive experience in a wide variety of therapeutic areas.
Extensive experience in clinical drug information evaluation.
Medical writing experience in all aspects of the drug development process in accordance with U.S. and European regulations and ICH guidelines, including INDs, clinical study reports, NDAs and sNDAs (in standard and electronic format), and CTDs.
Experienced in IND and postmarketing safety surveillance, including adverse event data gathering, coding, and reporting.

Professional Experience

Aug. 2000- Present

Senior Consultant - Medical Writer
Salamandra, LLC, Bethesda, MD

Assist with the data analysis and writing of clinical study reports for New Drug Application (NDA) submissions to the U.S. Food and Drug Administration. Collaborate as needed with biostatistical programmers to ensure appropriateness of data tables and listings and to find solutions to data issues, with medical experts for clarification or expansion of medical issues, and with project managers to coordinate the timely delivery of projects
Assist with the data analysis and writing of sections of NDA Integrated Summary of Safety documents, including Adverse Experiences, Clinical Laboratory Evaluation, Vital Sign Measurements, and Other Examinations.
Responsible for the review and preparation of postmarketing adverse event reports submitted to the FDA on behalf of clients. This includes the initial assessment of the adverse event, patient and/or reporter contact, and completion of the appropriate documentation within a specified timeframe.
Responsible for coding adverse event and medication data obtained in clinical trials using a variety of dictionaries, including COSTART, MedDRA, and WHO drugs for the purpose of standardizing terminology for use in a clinical study database.

Nov. 1999 -
Aug. 2000

Medical Writer
Independent Contractor

Prepared manuscripts of clinical study results for publication.
Wrote clinically oriented articles for a national pharmacy organization’s monthly newsletter.
Developed medical information documents that targeted healthcare professionals for a pharmaceutical communications agency.
Developed concise monographs for drugs used to treat HIV/AIDS in clinical trials for a health communications company. Also provided consultation on standardization of the information development process for this project.

Dec.1997 -
Dec. 1999

Pharmacist
Food and Drug Administration, Rockville, MD

Solely responsible for the monthly review and analysis of 500 to 1000 MedWatch reports of adverse drug events for antidepressants, antipsychotics, miscellaneous sedative/hypnotic, and antiplatelet medications
Identified safety signals by reviewing MedWatch reports and by actively monitoring the medical literature and international drug regulatory activity.
Monitored the Adverse Event Reporting System (AERS) database for related cases, search and evaluate the relevant Agency background material and the medical literature, and actively participated in the development, implementation, and enhancement of the Agency’s AERS.
Communicated findings in writing, including 22 full-length safety documents of a confidential nature.
Communicated findings orally to the Office of Postmarking Drug Risk Assessment and to the appropriate drug review divisions.
Acted as primary liaison for antidepressant and antipsychotic drug safety to the Division of Neuropharmalogical Drug Products.
Served as FDA reviewer of case reports of adverse drug events submitted for publication in the Annals of Pharmacotherapy.
Contributed globally by sharing safety findings with Canadian Health Protection Branch (HPB) and the European Agency for the Evaluation of Medicinal Products (EMEA)
Chosen as team leader accountable for the scientific content of the work of other safety evaluators and their productivity

July 1994 -
Dec. 1997

Drug Information Specialist
U.S. Pharmacopeial Convention, INC, Rockville, MD

Responsible for the development of new drug monographs and for the revision of 45 existing drug monographs related to the practice of respiratory medicine. .
Performed liaison duties for the Pulmonary Disease and the Geriatric Advisory Panels.
Preceptor for pharmacy students completing externship rotations in drug information.

Jan. 1990-
Aug 1990

Staff Pharmacist
Clinical Care Pharmacy, INC

Sept. 1990 -
Sept. 1991

Staff Pharmacist, Part-time
Coronado Hospital Pharmacy, Coronado, CA

Provided inpatient and outpatient pharmacy services in a 40-bed, private community hospital .
Provided pharmacy consultation for the 100-bed skilled nursing facility .

Oct. 1989 -
Jan. 1990

Staff Pharmacist
UCSD Medical Center, San Diego, CA

Provided pharmacy services for large teaching hospital.
Handled inpatient unit-dose and intravenous admixture services, clinical services and outpatient services as needed .

Professional Activities

Education

Honors, Awards, and Certifications

Publications

International Experience and Foreign Languages

Collaborate on an ongoing basis with multidisciplinary teams from a European pharmaceutical company to prepare the clinical sections of multiple sNDAs and CTDs (in electronic format) for submission in accordance with European regulations and ICH guidelines.