Expert Details

Expert in wound healing, burns, clinical research, FDA regulations, drugs, devices, medical writing

Expert ID: 729915 Texas, USA

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Expert provides scientific knowledge and regulatory background to assist companies in the research and development of clinical, animal and laboratory studies designed to promote pharmaceutical drugs and medical device products specializing in wound healing and burn care.

Additional Services:
•Development of study protocols and reporting forms.
•Preparation of position papers based on current literature.
•Communication of scientific information to a variety of recipients including the FDA, study investigators, other expert consultants, professional societies and company departments such as clinical research, regulatory affairs, sales and marketing.
•Interpretation of raw data and determining additional research testing.
•Working knowledge of industrial and clinical standards.
•Facilitation of product strategy discussions between company departments.
•Attendance and representation at professional meetings.
•Preparation of clients and sites for meetings, inspections, and audits.
•Inter-company networking.
•Management and coordination of clinical trials.
•Monitoring and auditing clinical trials.

Resource Services:
•Maintenance of current knowledge in wound healing ranging from cutaneous to membranous repair to gastric and cardiac repair.
•Maintenance of current knowledge in burn and wound care.
•Maintenance of current knowledge in immunology and pathobiology.
•Maintenance of current knowledge in microbiology and infectious disease.
•Familiarity of current knowledge in oncology.
•Maintenance of current knowledge of FDA regulations for drugs, devices and biologics.
•Familiarity with ISO and CE regulations.

Testing Models
•Development of in vivo models for skin care and biotechnology companies:
Microbial assessment
Antimicrobial testing
Inflammatory testing
•Development of in vitro models for skin care and biotechnology companies:
Microbial assessment
Antimicrobial testing
Inflammatory testing
•Development of ex vivo model for biotechnology company:
Antimicrobial testing
•Development of animal models for skin, wound care, and biotechnology companies and government institutions:
Infectious disease
Burn wound sepsis
Wound healing
Inflammation

Technical/Medical Writing
•Protocol development for:
Drug and device wound healing clinical trials
Chronic ulcers include pressure, venous insufficiency, diabetic etiology
Acute wounds
Long-term care and hospitalized elderly and average adult populations
OTC drug wound healing clinical trials in the elderly
Antipruritic drug clinical trial in burn patients
Preventative skin protection clinical trial in photodynamic therapy patients
Immunological therapeutic biologic clinical trial for a biotechnology company
Quantitative surface measurement of microbial flora
Trocar herniation clinical trial in gynecological patients
Trocar hemorrhage clinical trial in gynecological patients
Trocar fascial healing clinical trial in gynecological patients
Gastric and digestive clinical trial in bariatric patients
Immunological therapeutic biologics for allergy, asthma and autoimmune diseases
Immunological therapeutic biologic product oncology patients
Cardiac adhesion clinical trial in CABG patients
•Technical writing for skin care, wound care, biotechnology, and surgical companies
Clinical research result summary project status
Manuscript submissions
Professional meeting presentations
FDA scientific meeting presentations
Sales and Marketing literature brochures
Literature reviews
Executive summaries
•Technical writing topics include:
Acute and chronic healing
Dermatology
Contact dermatitis, pruritus, cellulitis, inflammation, acne, dermabrasion
Mucosal healing such as tonsillar, esophageal, gastric, intestinal, hemorrhoidal
Photodynamic Therapy and phototoxicity
Surgical techniques
Laparoscopic entry, digestive surgery procedures, anastomosis
•Technical writing of translated and non-translated data for manuscript submissions and professional presentations.
•Develop score scales and definitions for skin care companies.
•Develop reference tool for skin care and professional equipment companies.
•Develop case report forms and data collection sheets, scales and instruments.
•Develop non-English case report forms, data collection sheets, scales and instruments.

Monitoring
•Monitoring of device wound healing clinical trials.
•Monitoring of antiinfective drug wound healing clinical trials.
•Monitoring of herniations and adhesions clinical trials.
•Auditing of oncology (leukemia) clinical trials case report forms, adverse events, data sheets, laboratory sheets and other clinical records for preparation of NDA submission and FDA inspection.
•Monitoring of oncology (leukemia) clinical trials.
•Monitoring of allergic rhinitis clinical trials.

Expert may consult nationally and internationally, and is also local to the following cities: Houston, Texas - Pasadena, Texas - Beaumont, Texas - College Station, Texas - Baytown, Texas - Bryan, Texas - Sugar Land, Texas - Port Arthur, Texas - Galveston, Texas - Missouri City, Texas

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Education

Year Degree Subject Institution
Year: 1999 Degree: Certificate Subject: Wound Specialist Institution: American Academy of Wound Management
Year: 1992 Degree: Master of Science Subject: Veterinary Microbiology and Immunology Institution: College of Vererinary Medicine, Texas A & M University
Year: 1990 Degree: Bachelor of Science Subject: Biomedical Science Institution: College of Vererinary Medicine, Texas A & M University

Work History

Years Employer Title Department Responsibilities
Years: 1998 to Present Employer: Undisclosed Title: Founder and President Department: Responsibilities: Drugs, Devices, Biotechnology
•Prescription drug regulatory and product development strategy for drug and skin care companies.
•Over the Counter (OTC) drug regulatory and product development strategy for drug and skin care companies.
•Device regulatory and product development strategy for skin care and surgical companies.
•Design and develop antimicrobial products for licensing and marketing.
•Design and develop immunomodulatory products for licensing and marketing.
•Elucidate mechanism(s) of action of skin and wound care products.
•Clinical trial strategy on principle investigators, site coordination, and FDA.
•Arrange and/or facilitate confidential scientific meetings between potential business partners.
•Perform scientific due diligence.
•Project management of drug and device wound healing clinical trials.
Years: 1996 to 1998 Employer: Dow Hickam Pharmaceuticals / Bertek Pharmaceuticals Inc. Title: Project Manager Department: Department of Clinical Research and Professional Services Responsibilities: Available upon request.
Years: 1994 to 1996 Employer: Dow Hickam Pharmaceuticals Inc. Title: Research Associate Department: Department of Clinical Research and Professional Services Responsibilities: Developed, organized and monitored clinical, animal and laboratory studies for pharmaceutical drugs and medical device products. Developed and managed a literary database to provide technical support for all departments. Managed an information service to answer product inquiries and handle product complaints.
•Developed and prepared study protocols and reporting forms.
•Managed clinical, animal and laboratory studies. Ensured availability of supplies, compliance of investigational and financial agreements, and documentation of findings. Performed all close out visits and prepared all final reports and executive summaries.
•Acted as liaison between the Director of Clinical Research and Professional Services and the investigators when required to ensure that any details regarding the studies were understood and any questions were resolved.
•Reviewed investigator reports for completeness and accuracy. Assisted in the details of publications and presentations.
•Communicated scientific information to a variety of recipients including the FDA, study investigators, expert consultants, sales, marketing and regulatory personnel as well as customers and professional societies.
•Developed and managed continually growing literary database to provide support for company and parent operation. This included an ongoing review of the literature relevant to medical drugs and devices.
•Maintained an up-to-date working knowledge of FDA guidelines for clinical, animal and laboratory studies for drugs and devices.
•Maintained an information service which formulated numerous written responses to product inquiries from sales representatives, physicians and hospitals throughout the country.
•Answered product inquiries and complaints from a variety of callers including patients, clinicians and purchasing agents.
•Handled communications related to adverse drug and device experiences and prepared appropriate reports for QC/QA department and the regulatory file.
•Provided backup to Sales Training and Marketing when requested to ensure understanding and completeness of information in the promotion of products.
•Prepared “English” mock-ups for translation for package labels and package inserts in accordance with FDA, CE and ISO regulations
•Managed communication and software compatibility issues between translator and printer within a validated system.
•Served on DHP President’s Advisory Board. Acted as liaison between company employees and the president.
Years: 1992 to 1994 Employer: University of Texas Health Science Center Title: Research Assistant Department: Department of Allergy and Immunology Responsibilities: Supervised up to six technicians in the laboratory and assisted them in problem solving when necessary while continuing research on other projects.
•Informed the Director of Allergy and Immunology of research progress and other events occurring in the laboratory.
•Mapped cytokine pathways in response to various stimuli.
•Developed sandwich ELISAs for various inflammatory cytokines.
•Maintained cell lines and cultured human PBMCs in vitro.
•Isolated specific cell populations by utilizing columns, monoclonal antibodies and facscan separation techniques.
•Performed laboratory assays such as ELISA, radial immunodiffusion, NK/LAK chromium release to provide data for use by corporate sponsors and for publication purposes.
•Ensured all laboratory personnel performed laboratory studies in accordance with study protocols and SOPs.
•Ensured performance of laboratory tests met GLP standards and all SOPs were updated on a regular basis.
•Responsible for training of new laboratory employees.
Years: 1990 to 1992 Employer: Texas A&M University Title: Research Assistant and Lead Teaching Assistant Department: College of Veterinary Medicine Responsibilities: Compiled data relevant to the process of wound healing that was reported in a thesis and defended before a committee. Taught a junior/senior level microbiology laboratory course each semester that correlated with the professor’s syllabus.
•Responsible for preparation of study protocols for thesis.
•Organized personnel, supplies and facilities as needed for each study.
•Performed animal surgeries utilizing various models available.
•Performed in vitro cell culture studies.
•Prepared specimens and performed histologic staining and immunocytochemistry.
•Responsible for training new teaching assistants.
•Taught undergraduate students basic microbiologic stains, identification methods and relevant clinical tests.
Years: 1989 to 1991 Employer: Texas A&M University Title: Laboratory Technician Department: College of Veterinary Medicine Responsibilities: Performed animal and laboratory experiments to assist a full time veterinarian in development of data for her Ph.D. dissertation and defense.
•Purified canine protein α-1-antitrypsin using various techniques.
•Assisted in development of a detection assay for canine α-1-antitrypsin.
•Raised polyclonal antibodies to α-1-antitrypsin in rabbits and goats.
•Performed molecular techniques such as SDS PAGE, immunoelectrophoresis, isoelectrofocusing, column chromatography and photo spectroscopy to purify antibodies and verify proteins collected.

Career Accomplishments

Associations / Societies
Inducted into The Honor Society of Agriculture Gamma Sigma Delta
Inducted into Honorary Agriculture Fraternity Alpha Zeta

PROFESSIONAL SOCIETIES:
American Academy of Wound Management (AAWM)
American Burn Association (ABA)
American Society of Microbiology (ASM)
Association of Women in Science (national AWIS)
Gulf Coast-Houston AWIS Chapter
Board Member
President
Drug Information Association (DIA)
Food and Drug Law Institute (FDLI)
Science-By-Mail volunteer when program ended
Society for Leukocyte Biology (SLB)
Wound Healing Society (WHS)
Appointed to membership committee
Appointed chair of membership committee
Appointed to scientific liaison committee ex officio
Appointed to industrial advisory committee
Appointed to the Board of Directors ex officio
Elected to the Board of Directors
Professional Appointments
Has spoke at over 10 conferences. Information available upon request.
Publications and Patents Summary
Currently holds 10 patents and 55 publications. Information available upon request.

Fields of Expertise

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