Expert Details

Expert in Large Animal pharmacology/pharmacokinetics, Sterile products,GMP,Product Development, Safety and ID

Expert ID: 731238 Alabama, USA

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Expert has training is antimicrobial monitoring and reporting to Blue Cross/Blue Shield of hospital infectious diseases. She is an occupational safety officer for laboratory animal programs and a pharmacy safety instructor. She has completed GMP training to include auditing in biologicals, pharmaceuticals and medical devices. Expert has many years of hospital pharmacy experience to include USP 797 Compounding Sterile Products under ISO 9000 training. She has expertise in drug pharmacology, identification and information to include current Good Manufacturing Practice training for drugs, biologicals, vaccines and medical devices. Expert has worked in drug withdrawal pharmacokinetics and drug residue prevention in food animals for 25 years. She has developed a standard quality control program for sterile products rooms and have taught numerous courses in rabies safety, pharmaceutical information, pharmacy law, pharmacology and drug dispensation in human and veterinary medicine. Experience also in developing Unit dose drug distribution programs to include development and implementation of automated dispensor system ( PYXIS) and medical safety program to include bar coding safety. She also develop and do Phase I testing on transdermal drugs and sustained release ophthalmics as well as pharmacokinetic studies in animals.

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.

Expert may consult nationally and internationally, and is also local to the following cities: Atlanta, Georgia - Columbus, Georgia - Macon, Georgia - Roswell, Georgia - Albany, Georgia - Marietta, Georgia - Montgomery, Alabama - Dothan, Alabama

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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 Responsibilities
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.
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 Shield
Experience in Risk Assessment and pedigree of drugs.
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.
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.
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.

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

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