Expert Details
Large Animal pharmacology/pharmacokinetics, Sterile products,GMP,Product Development, Safety and ID
ID: 731238
Alabama, USA
Taught staff USP 797 Parenteral Compounding GuidelinesDiscuss how to design a compounding pharmacy with a quality control program to include Good Manufacturing Practices for 503A and 503BDevelop quality control programs for cGMP intravenous plastic bags made for long term use.Design an animal pharmacokinetic study.She has worked with pharmaceutical companies to get medical devices on the approval process with the FDA. She has also worked with topical products for analysis of efficacy and safety.
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 2003 | Degree: PhD | Subject: Pharmacal Science | Institution: Auburn University |
| Year: 1978 | Degree: MS | Subject: Pharmacology/Veterinary Pharmacology | Institution: Auburn University |
| Year: 1970 | Degree: BS | Subject: Pharmacy | Institution: Auburn University |
| Year: 2000 | Degree: Diplomate and Chair | Subject: Veterinary Pharmacy, | Institution: International College of Veterinary Pharmcy |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 1975 to 2013 | Employer: Auburn University | Title: Director of Pharmcy/Professor and Adjunct Professor, Clinical Dept. | Department: College of Veterinary Medicine and Harrison School of Pharmacy |
Responsibilities:She advanced from Instructor to Professor. She is responsible for the Supervison of a Large Animal Veterinary Teaching Hospital Pharmacy which includes training clinicians, residents, interns and students in human and veterinary pharmacy as well as a GMP pharmacist for a equine source plasma facility. |
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| Years | Employer | Title | Department |
| Years: 1989 to 2009 | Employer: Lake Martin Community Hospital | Title: Consultant | Department: Pharmacy |
Responsibilities:She worked to organize and structure the pharmacy, hire Director's of Pharmacy, Teach clinicians and nurses in the area of medication dispensation, drug safety and infectious disease.She is also an infectious disease pharmacist for submitting reports to the Health Department and Blue Cross/Blue ShieldExperience in Risk Assessment and pedigree of drugs. |
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| Years | Employer | Title | Department |
| Years: 1970 to 1973 | Employer: Johns Hopkins Hospital | Title: Intern, Clinical Pharmacists and Supervisor of IV Admixture | Department: Pharmacy |
Responsibilities:Clinical Pharmacy rotation in all areas of medicine and surgery. |
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| Years | Employer | Title | Department |
| Years: 2003 to Present | Employer: Undisclosed | Title: GMP Pharmacist | Department: Administrative/ Clinical |
Responsibilities:She is responsible for screening all medications used on horses that will be used to manufacture vaccines and anti-seras for human use. She works in the clean room, assisted in design, grant writing, review of documents for grants and coming up with innovative ideas for new grants in the area of humans and domestic animals. A GMP Pharmacist, reviews Risk Assessments and Pedigree of all products used in the manufacture of equine plasma for human sources. |
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| Years | Employer | Title | Department |
| Years: 2019 to Present | Employer: Undisclosed | Title: Professor Emeritus Clinical Pharmacist, GMP Pharmacist, Drug Development of Extended Release Animal Drugs | Department: Clinical Science Veterinary College |
Responsibilities:I work with graduate students to develop drug studies, write grants, pharmacokinetics and pharmacodynamic studies in animals. Work on clinical trails in animals.My doctoral degree is in Pharmaceutical Science to include Drug Discovery and Development. |
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Government Experience
| Years | Agency | Role | Description |
|---|---|---|---|
| Years: 2003 to Present | Agency: CDC, BARDA, HHS | Role: GMP Pharmacist | Description: She has worked with an equine source plasma project in implamentation of SOP's in the area of aseptic techniques and drug deferral list for donors. |
| Years: 1993 to 1997 | Agency: FDA | Role: Member of Committee for VMAC | Description: Served as the consumer affairs reprsentative for the VMAC program, a division of the center of Veterinary Medicine FDA |
| Years: 1990 to 1993 | Agency: USP | Role: Writing and reviewing monographs | Description: She worked to develop several monographs in veterinary pharmacy |
International Experience
| Years | Country / Region | Summary |
|---|---|---|
| Years: 2003 to Present | Country / Region: Canada | Summary: She has worked with a vaccine company as part of the equine source plasma project. |
Career Accomplishments
| Associations / Societies |
|---|
| Society of Veterinary Hospital Pharmacist, International College of Veterinary Pharmacy, Society of American Hospital Pharmacist Memberships: Professional Society Membership American Society of Hospital Pharmacists International Society of Veterinary Hospital Pharmacists Member at Large President-Elect Board Certification- Chair University Committees: Wellness and Health Committee EPA subcommittee Safety Committee Auburn University Pharmacy School Alumni Board of Directors College of Veterinary Medicine Committees: Occupational Safety Officer for Clinical Sciences Clinical Hospital Board Infectious Disease Committee Computer Committee Pharmacy and Therapeutics Committee Laboratory Safety Committee Good Laboratory Practice Committee Oversight Committee Curriculum Committee School of Pharmacy Library Committee-Veterinary Medicine Laboratory Safety Committee Mentor Committee |
| Licenses / Certifications |
|---|
| Parenteral Pharmacist, GMP Pharmacist, Compounding Pharmacist, Preceptor Pharmacist and Training by Joint Commission in the area of Infectious Disease monitoring. Alabama Board of Pharmacy License |
| Professional Appointments |
|---|
| International College of Pharmacy Pharmacist, Contract, GMP Production Auburn Equine Source Plasma Project Professor, Department of Clinical Sciences Auburn University College of Veterinary Medicine Teaching Hospital and Adjunct Associate Professor at the School of Pharmacy, Clinical Department Medical Monitoring Program- Auburn University- sub-committee member University Safety Committee College Safety Committee-Chair University Wellness and Health Committee Safety Officer and Safety Training- College of Veterinary Medicine Webinar Instructor Pertinent Information Relative to FDA pharmaceutical and biological drug approvals: GMP Pharmacist that contributed as a team member to the development of an HBAT heptavalent antidote an FDA approval for Emergency Use over the last 15 years. Development of a Drug Deferral List for Horses used for Equine Source Plasma. Worked on studies with Baxter Pharmaceutical on Stability and Development of the Viaflex Plastic IV Bag in 1972 and 73. Total Parenteral Nutrition Protocols for Adults and Pediatric Patients at Johns Hopkins Hospital Phase I and Phase II Clinical Trials on End-stage renal disease medications with Dr. William Ravis GMP training in pharmaceutical, biological, medical devices and food at Auburn University, FDA seminars, USDA seminars, Baxter and Cangene Pharmaceutical Company. Contact Reference: Dr. Scott- Hancock. Hancock, Scott (HHS/ASPR/BARDA) Consumer Affairs Representative and Pharmacists for the Center of Veterinary Medicine Advisory Committee to review animal medications and sterile product guidelines. Work on the development of new products for veterinary medicine and phase my testing. Speaker: American College of Veterinary Pharmacists invited speaker on numerous animal pharmacology topics. Over 1200 post-education classes and lectures over the past 30 years in Veterinary Pharmacy Law, Compounding of Sterile Products, GMP for drugs and nutraceuticals, Occupational Safety in Human and Veterinary Medicine. Classes in large animal equine pharmacology, alpaca’s pharmacokinetics, GI drugs, NSAIDS, and antimicrobial drugs. Invited speaker to China on sustained release medication development, antimicrobial resistance, One Health approaches to antimicrobial stewardship and quality control of veterinary products. Previous Professional Experience: Supervisor of Intravenous Admixture Service, Johns Hopkins Hospital Clinical Pharmacist- Oncology, Pediatrics, Medicine, Johns Hopkins Hospital Pharmacy Department Northside Hospital Pharmacist, Atlanta, GA. Instructor and Associate Professor and Director of Pharmacy, Department of Large Animal Surgery and Medicine, Auburn College of Veterinary Medicine, Auburn, AL. Tripler Army Hospital Pharmacist, Honolulu, HA. Director of Pharmacy, Department of Large Animal Surgery and Medicine, Auburn College of Veterinary Medicine, Auburn, AL. Clinical Pharmacist Infectious Disease pharmacist, joint accreditation training, Blue Cross/Blue Shield training Consultant Pharmacist and served as Interim Director of Pharmacy on 3 occasions- Lake Martin Community Hospital Was responsible for AAHA Veterinary Officer- responsible for standards of Clinical Science inspections. American Association for Laboratory Accreditation (AALAC) and Occupational Safety training and coordinator of the program for the college of veterinary medicine and other animals units on campus and in the agriculture college to include dairy cattle, fisheries, beef cattle, horses, alpacas, dogs, and cats. First response pharmacist in Alabama. |
| Awards / Recognition |
|---|
| Honors: Thinking Out of the Box Award -presented by the International Society of Veterinary Hospital Pharmacists for Residency Program and Board Certification Specialty. Phi Zeta Research - Non-DVM member, for outstanding contributions to veterinary medicine and research Auburn University Food Systems Institute (core faculty) Phi Lambda Sigma- Charter member and Co-Founder Outstanding Woman in Pharmacy Auburn University School of Pharmacy Alabama Student Pharmaceutical Association Award |
| Medical / Professional |
|---|
| Johns Hospitals Hospital- Clinical Pharmacy TEACHING RESPONSIBILITIES: Graduate Teaching BLOL 7970 Good Manufacturing Practice – Sorokulova, Guest lecture, 2016, 2017. GMP in Nutraceuticals VMED 9000- Orientation to Veterinary Medicine. - Guest Lecturer 1 hr. - 12 students 2014, 2015, 2017. Designing a Drug Delivery System. Advanced Equine Surgery- Hanson 1 hr 8 students- NSAIDS and Antimicrobials in Horses. 2017 Advance Equine GI - Schumacher 1hr 9 students- Gastrointestinal Drugs in Horses 2016 Undergraduate Teaching and Clinical Service Teaching: Veterinary College 1975- present VM 5601, 5602, 5603, 5604- Clinical Science, 6 hrs. Lab, 24 students per section, Clinical Pharmacology Rounds. VM 5020 Pharmacy Law and Ethics, 2hrs, 100 students VM5260 Pharmacology, 4 hours, 100 students VM 444,445,446,447- Large Animal Clinic, 7 credit hours each. VTMED 5502-40 Equine Elective 2 lectures- 40 students The teaching of clinical pharmacy and pharmacology to senior Veterinary students. 6 students every 2-3 weeks. Clinical Pharmacology Rounds 4 hour twice monthly (44 students) VM 430-, then VM 5020 2 lectures 1997 present Pharmacy Law and Ethics (87 students) Visiting Guest Lecture- Tuskegee University- College of Veterinary Medicine, Pharmacology Department, 3 hours lecture, SP 2004-2008. Visiting Professor. St. George University, Grenada, West Indies Pharmacy School: PC 453 Professional Practices- PC 401 Pharmaceutics III -87 students Fall 1998 PC 495 Special Problems- 1 student 1997 Pharmacy Externs 400 hours/quarter, 2 students per quarter, 1997-present. Two pharmacy students train under my supervision to compound and dispense prescriptions. PC 469 Pharmacy Clerkship- 10 students- 1997-present, 5-week elective clinical rotation PYPPD 5670 Clinical Elective 1999 -present Doctorate of Clinical Pharmacy Candidate- 1 student- 40 hrs/wk 4 Wks 2-4 students per year. PYPS 5900- Special Problem 3 hours 2000- University of Missouri School of Pharmacy 1 student, Ginger Ertel- Internship 2012- University of South Carolina School of Pharmacy Erika Rost- 1 student, Internship 2000- University of Florida Extern program- 1 student. 1995- University of Florida Intern- Sally Wilson- 1 student 6 months Pharmacy Students_PharmD program- 4-5 week clinical rotations (92 total) 2016, 2017, 2018. PYDI 9970-001. Developed a 2 hours Veterinary Pharmacy Elective for 25 pharmacy students per year. |
| Publications and Patents Summary |
|---|
| She has had 51 publications, 80 abstracts and poster presentations and over 400 lecturers at scientific and technical programs to include international, national, local and regional. |
Additional Experience
| Expert Witness Experience |
|---|
| She has had experience in the area of drug assay validation and cross- reactions of medications for cases of residuals found in horses as an expert witness for development of depositions. She has assisted veterinarians in research of drug information, toxicities and residues for depositions. She is also a member of Auburn University Food Systems Institute. |
| Training / Seminars |
|---|
| USP 797 Sterile Compounding for Pharmaceuticals Veterinary Pharmacy Law approved in Florida and Alabama Pharmacology Seminars Food animal drug withdrawal and residue safety seminars Drug interaction seminars Quality assurance and requirements by DOD and the USDA for purchasing of drugs. Development of a drug deferral list for equine source plasma horses Develop of Veterinary Pharmacy Modules for pharmacists and veterinarians Lectured at more than 400 program in all areas of pharmacology, drug dispensation, pharmaceutical safety, medical waste, occupational safety and infectious diseases. |
| Vendor Selection |
|---|
| 35 years of experience in contract reviews with Amerinet and other group purchasing associations. She has located numerous human and veterinary drugs for private practices and hospitals. |
| Marketing Experience |
|---|
| She has experience in GMP pharmaceutical and biological production. She has experience in pharmacokinetics and pharmacology in both human and veterinary medicine |
| Other Relevant Experience |
|---|
| Served at a Project Director in writing numerous grants for food safety, pharmaceuitcal phase one testing and clinical trials of products in animals and humans. |
Fields of Expertise
anti-infective agent, chemical safety training, Current Good Manufacturing Practice, Current Good Manufacturing Practice auditing, drug, drug identification, Drug Information Association, drug labeling requirement, drug regulation, Good Clinical Practice, Good Laboratory Practice, Good Manufacturing Practice training, ISO 9000 training, pharmaceutical drug, standard quality program development, technical training, antibiotic, drug formulation, drug stability, eye drop solution, FDA medical device regulation, Federal Food, Drug, and Cosmetic Act, Food and Drug Administration drug registration, Food and Drug Administration regulation, medical device manufacturing quality control, pharmaceutical quality assurance, pharmaceutical quality control, 21 CFR Part 11, pharmaceutical manufacturing facility auditing, over-the-counter drug regulation, pharmaceutical industry, drug testing statute