CRO and Sponsor Essentials in Animal Health Studies
Feb. 8, 2024
8:30 a.m. to 4:30 p.m.
This is an in-person event.
- Knowledge of Sponsor’s needs and CROs’ needs in research processes
- Vetting CROs for in-life process
- How do you improve your relationship between CRO and Sponsor
- Improved understanding of CVM's process with data submission
- Helpful hints for data quality and integrity from start to review processes
CE credits - 6.5 hours available
Those attending the entire seminar will be eligible to receive continuing education credits.
Selecting the right CRO for your organization is critical in the success of product development. Managing the relationship and ensuring regulatory compliance can be a challenge. Our experts and participants will discuss best practices to avoid GLP pitfalls, submission requirements and the CRO relationship.
*Rescheduled from Aug. 30, 2023
Meet the instructors
Rob Hunter, Ph.D.
Hunter is an internationally recognized subject matter expert on pharmacokinetics, antimicrobial PK/PD, interspecies allometry, drug metabolism, bioequivalence and tissue residues/human food safety, along with corresponding bioanalytical support.
Hunter has served on and chaired several AHI committees and represented the U.S. veterinary pharmaceutical industry on the VICH bioequivalence expert committee. He has represented various companies at CVM/FDA, EMA/CVMP, APVMA, VDD (Canada), NVQRS/QIA (South Korea), Thailand FDA, NVAL (Japan), Ministry of Agriculture (Vietnam), and IVDC (China) regarding specific products, issues, and/or policies. He is the current President of the American Academy of Veterinary Pharmacology and Therapeutics.
Deborah Eyer Garvin, MS, RQAP-GLP is currently the president of the newly reopened Pacific Rim GLP Consulting and Training, providing GLP consulting and training to the regulated community. She served as the GLP/GCP manager for Huvepharma, Inc., an international animal health company from June 2017 to May 2020.
Garvin has been involved in regulatory research since 1986 and was president of Pacific Rim Consulting and West Coast Quality Training Institute from 1992-2015, providing training and consulting in FDA, EPA and OECD GLPs and FDA CVM GCPs. In January 2015, Debi closed her 20+ year consulting business to take a job with CVM FDA establishing quality assurance study review policies and processes, now known as the QASR group. Garvin left this position in June 2017 to join Huvepharma, and is now an independent contractor.
This workshop features an all-star roster of experts.
John Byrd, Ph.D.
Southwest Bio-Labs Inc.
Since 1985, he has served as president of Southwest Bio-Labs Inc. (SBL). He has been directly involved in conducting GLP studies for FDA and EPA submissions for 38 years. These studies include metabolism, tissue residue, pharmacokinetic (bioavailability and bioequivalence) and target animal safety studies. Species used include companion animals (dogs, cats and horses), livestock (beef cattle, dairy cattle, swine, sheep, goats and poultry) and laboratory animals (rats, rabbits).
Debi Garvin, M.S., RQAP-GLP
Pacific Rim GLP Consulting and Training
Deborah Eyer Garvin, M.S., RQAP-GLP is currently the president of the newly reopened Pacific Rim GLP Consulting and Training, providing GLP consulting and training to the regulated community. She served as the GLP/GCP manager for Huvepharma Inc., an international animal health company from June 2017 to May 2020.
Garvin has been involved in regulatory research since 1986 and was president of Pacific Rim Consulting and West Coast Quality Training Institute from 1992-2015, providing training and consulting in FDA, EPA and OECD GLPs and FDA CVM GCPs. In January 2015, Debi closed her 20+ year consulting business to take a job with CVM FDA establishing quality assurance study review policies and processes, now known as the QASR group. Garvin left this position in June 2017 to join Huvepharma and is now an independent contractor.
Kyle V. Kappeler, Ph.D.
Before joining LBG, Dr. Kappeler held a senior management position (Director of Toxicology) at Charles River Laboratories and Attentive Science and also served as a Toxicology Study Director at Charles River Laboratories, Attentive Science and MRIGlobal. As the director of toxicology, Dr. Kappeler was responsible for managing study directors/study coordinators/group leaders and provided scientific oversight of key departments (analytical chemistry, formulations, clinical pathology, necropsy and histology), participated in business development activities (client introductions, program design and generation of proposals) and conducted program management of subcontracted vendors (resource availability, contract negotiations and tracking timelines/deliverables).
In addition, Dr. Kappeler has been responsible for the conduct of more than 500 preclinical/nonclinical studies in small and large animal models, which included early discovery (pharmacokinetic and formulation screening), non-GLP (maximum tolerated dose and repeat-dose range finder), GLP-compliant (subchronic/chronic/carcinogenicity), Highly Toxic Chemical Containment, and BSL-3 Containment efficacy studies. He is published in peer-reviewed journals and has presented posters/seminars at national/international conferences.
Dr. Kappeler received a Ph.D. in Basic Biomedical Sciences from the University of South Dakota and a B.S. in Biology from Mesa State College. He also completed a post-doctoral fellowship in the Department of Pharmacology and Toxicology at the University of Arizona.
Annette Kenser, B.Sc., RQAP-GLP
Global Director of Clinical Quality, Dechra
Kelly Lechtenberg, D.V.M., Ph.D.
Genetics and Research Expert
Thomas D. Overbay, Ph.D.
Business Development and Technical Consultant
health companies in the U.S. and internationally. In addition to business development, Dr. Overbay’s background of veterinary practice, technical services and sales management provides him with a unique perspective of the scientific, financial, and legal aspects of
innovative technologies. Dr. Overbay has successfully brought to market a number of products arising from universities, government agencies, human hospitals, start-up companies (both human and veterinary), and multinational pharmaceutical and chemical
Melinda Poole, D.V.M.
Over the course of her career, Dr. Poole has worked in a variety of roles for Kindred Biosciences, American Regent Animal Health, Dechra Veterinary Products, Elanco Animal Health, and Boehringer Ingelheim Vetmedica, and was responsible for the clinical development of several products that were successfully brought to market (global approval of five new animal drugs – equine and companion animal).
All times below are in Central Time (CT).
8:30 a.m. | Welcome/Introductions
9 a.m. | Essentials in Choosing a CRO (small, mid and large)
10:30 a.m. | Break
10:45 a.m. | Panel: What are CROs needing from a Sponsor? Best Practices in Building the Relationship and Communicating with Sponsors
- Significant audit findings
- Review of recent inspections
Noon | Lunch
12:45 p.m. | Panel: What are Sponsors looking for in a CRO? Best Practices in Selection and Building the Relationship
2 p.m. | How to Improve Quality of Submission and Recent Issues from CVM
3 p.m. | Break
3:15 p.m. | To EDC or Not?
3:45 p.m. | Panel Wrap-up: Practical discussion on today's topics
4:15 p.m. | Wrap-up
4:30 p.m. | Adjourn