Twenty-five years of experience in infectious disease including food microbiology, chemical/ biological defense and regulatory science. Provide guidance on microbiology and regulatory affairs for clients developing antimicrobials and biologics allowing clients to navigate through the FDA regulatory process. Provide advice for developing protocols and strategies; review and advise on IND, NDA and ANDA submissions and meeting minutes; advise on regulations, guidelines and guidance documents; assist in dispute resolution; advise on labeling; support clients in strategic meetings; accompany clients in face-to-face FDA meetings; and prepare clients for Advisory Committee meetings. Serve as an expert witness in litigation and provide assessment of scientific and data integrity of biotech companies and assess causation in food poisoning.

Education: 

• Clark University, MBA, 1996
• University of Texas, PhD, Microbiology, 1990
• University of Montana, MS, 1981
• University of Vermont, BS, 1979

Additional Information: 

Antimicrobial Regulatory Consulting LLC
Owner and sole member, September 2016 to present
Microbiology and Regulatory Consultant
• Provide regulatory and scientific guidance for clients developing antibiotics, topical antiseptics, medical devices, botanicals, biologics, bacteriophage therapy, generic drugs and dietary supplements to navigate through the FDA regulatory process;
• Provide advice for developing protocols and strategies; review and advise on IND, NDA and ANDA submissions and meeting minutes;
• Advise on regulations, guidelines and guidance documents;
• Assist in dispute resolution;
• Advise on labeling;
• support clients in strategic meetings and accompany them in face-to-face FDA meetings; Assist in preparation for FDA Advisory Committee meetings;
• Serve as an expert witness in litigations and provide assessment scientific and data integrity for the biotech and financial industries;
• Perform operational, financial and marketing functions of this consultancy as needed.

CARB-X
Scientific Advisory Board, March 2017-January 2020
• Review scientific merit of short form and long form submissions for companies developing antimicrobial products. These products are at either the hit-to-lead, lead optimization or preclinical stage.
• Meet with board members to discuss and decide whether to fund submissions from Sponsors.

National Institutes of Health
Biodefense Contract Reviewer, December 2019 to present
• Evaluate scientific merits of biodefense contracts for applicants developing antimicrobials at the lead optimization, pre-clinical and clinical studies stages.

BioScience Laboratories, Inc.
Director of Regulatory Affairs, February 2015-August 2016
• Provided regulatory guidance to staff for various FDA and EPA regulatory issues (topical antiseptics and disinfectants);
• Provided contractual consultation and regulatory advice for various clients including meeting for strategy sessions and support during face-to-face FDA meetings;
• Provided regulatory guidance to study directors for study protocols;
• Trained laboratory and administrative personnel in FDA regulations including INDs and Bioequivalence/Bioavailability.

Food and Drug Administration
Microbiologist, October 2002-February 2015
• Reviewed and evaluate all microbiological data submitted as part of New Drug Applications (NDAs), Investigational New Drug Applications (INDs), including supplements, special protocol assessments and amendments for a broad range of antimicrobial agents which include antibiotic and non antibiotic drug products;
• Preclinical evaluation reviews of the antimicrobial agents for preclinical efficacy by in vitro methods which assess the mechanism of action, antimicrobial spectrum of activity, mechanism(s) of resistance, and epidemiological studies and by in vivo methods which include pharmacokinetics and pharmacodynamics, animal prophylactic and therapeutic studies;
• Reviewed clinical efficacy by examining effectiveness in clinical trials and establish in vitro clinical interpretation criteria;
• Reviewed manufacturing and control processes including package inserts;
• Conducted special studies and consultations including participation in ad hoc task forces and professional meetings.
• Completed dozens of pre-IND and IND reviews and/or special protocols;
• eight NDA review.
• Completed thirteen training courses and attended 13 Scientific Rounds.
• Co-chair Healthcare Antiseptic Committee and writing guidance document for Topical Healthcare Antiseptics;
• Consulted with independent laboratories on protocols for these antiseptics.
• Attended four national professional meetings;
• Presented at three Anti-Infective Advisory Committee Meetings;
• Presented at two Anti-Infective Workshops;
• Involved in professional development focus group;
• Participated in interviews for candidates for open Microbiology Reviewer positions; Mentored new reviewer;
• Consultations performed for other centers including: Center for Devices and Radiological Health (CDRH), Center for Veterinary Medicine (CVM), Center for Biologicals Evaluation and Research (CBER) and Center for Food Safety and Nutrition (CFSAN).

Microbiology Team Leader (detail performed July-October, 2004)
• Served as principal advisor to the Division Director and team leader in Microbiology; Planned coordinated, and evaluated programs and activities of the Division for Microbiology;
• Maintained personal contact with “state of the science”;
• Assigned and reviewed work of team members;
• Assured requirements for production and accuracy are met;
• Planned work to be performed by team members, set and adjusted short-term priorities, and prepared schedules for the completion of work;
• Assigned work to team members based upon priorities, selective consideration of difficulty and requirements of assignments, and capabilities of team members;
• Gave advice, counsel, and instruction to team members on work matters;
• Found ways to improve production and increase quality of work of team;
• Team completed six consultations, five pre-INDs, 15 INDs, and six NDAs.

Naval Surface Warfare Center, Dahlgren Division
Interdisciplinary Microbiologist, October 2000-October 2002
• Acquired funding for, directed and implemented independent, basic and applied research on:
1. Enzyme kinetics of synthesis of 2-dimethyl-2-dinitrobutane by peroxidases (sponsor: Office of Naval Research);
2. Expression of heterologous markers in Bacillus sp. for bioremediation (confidential sponsor);
3. Bacteriocins for a decontamination solution against anthrax (sponsor: Office of Naval Research);
• Served as technical agent for DARPA
• Advised naval base public works department and developed protocols for pathogen detection in water supply
• Served as naval representative to biological warfare treaty
• Wrote research proposals
• Presented data at national meetings
• Supervised two laboratory technicians.

US Department of Agriculture, Agricultural Research Service-ERRC

Research Chemist/Research Molecular Biologist, January 1998-October 2000
• Directed and implemented independent, basic and applied research projects on:
1. heterologous expression of antimicrobials in lactic acid bacteria;
2. expression of food-grade markers in lactic acid bacteria;
3. construction of secretion cassettes for use as vehicles for vaccine delivery by lactic acid bacteria;
• Supervised one laboratory technician;
• Mentored college student
• Served as judge for county science fairs
• Managed laboratory
• Wrote and edited scholarly research publications
• Presented data to colleagues at national meetings
• Served on the microbiology safety committee
• Served as institution coordinator for U.S. Savings Bonds drive

Arcadia University (Beaver College)
Adjunct Faculty, Biology Department, February 2000-May 2000
Molecular Biology lecture and laboratory to upper classmen.
• Devised and delivered lectures
• Prepared and graded examinations
• Devised laboratory experiments
• Graded laboratory notebooks and reports
• Assigned grades.