CRO and Sponsor Essentials in Animal Health Studies

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

Rob Hunter, Ph.D.

Seminar instructor Rob Hunter has 20 years of veterinary and human drug development experience with NASA, Pfizer, Elanco, Parnell and Provetica. He has contributed to the approvals for Revolution®, Dectomax®, Aviax®, Doxidyl™, A180®, tylosin, Micotil®, Ovugel®, Kexxtone®, ractopamine, Experior™, Posilac® and Pulmotil®, with others currently in development or under regulatory review.

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.

This workshop features an all-star roster of experts.  

John Byrd, Ph.D. 
Southwest Bio-Labs Inc.

John Byrd has a B.S. in Biochemistry from the University of Arizona and a M.S. and Ph.D. in Chemistry from New Mexico State University.

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.  
Senior Consultant

 

Kyle Kappeler has more than 10 years of subject matter expertise in preclinical toxicology and safety support for IND/NDA, Global Registration, Food Safety Assessment, Companion Animal and Animal Rule submissions in accordance with FDA, OECD, U.S. EPA, ICH and/or EFSA guidelines. He possesses an expert understanding of non-GLP and GLP-compliant (21 CRF Part 58) preclinical program design and costing, protocol development, program management, study monitoring/execution, report generation and SEND management. 

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 

Annette obtained her B.S. in Biology from Rockhurst University. During college, Annette volunteered at local veterinary hospitals and after graduation worked as a microbiologist in animal vaccine development and testing for several years before transitioning her career to Quality Assurance (QA). She became a Registered Quality Assurance Professional-with Good Laboratory Practices (RQAP-GLP) certification in 2008. As a scientific QA auditor, she developed an in-depth understanding of the global regulations, laws and guidelines supporting veterinary and human scientific research. As an auditor, she acquired skills such as critical thinking and management of ambiguity as the requirements and interpretations of these regulations, laws and guidelines are ever changing. Throughout her career, she has worked for a wide variety of CMOs, CROs, CRLs and sponsors.  

 

Kelly Lechtenberg, D.V.M., Ph.D.
Genetics and Research Expert 

Kelly Lechtenberg’s professional passion is animal feedlot medicine where he is an internationally recognized expert in respiratory diseases of cattle and swine.

 

Dr. Lechtenberg is the founder and president of Midwest Veterinary Services, Central States Research Centre and Logan Valley Feeders of Oakland, Nebraska. In 2013, he founded the Veterinary and Biomedical Research Center of Manhattan, Kansas. In addition to providing data to support the FDA and USDA approval of animal health products, a significant amount of his time and energy is focused on translational medicine. His companies assist the animal health industry ensure that vaccines and pharmaceuticals are safe and effective.

 

Dr. Lechtenberg has served as president and two terms on the Board of Directors for the Academy of Veterinary Consultants as well as active membership in the American Veterinary Medical Association and the American Association of Bovine Practitioners. In addition to having presented academic papers at over 20 international industry meetings, including a discussion of the role of veterinary medicine in antimicrobial resistance to the World Health Organization in Geneva, Switzerland, Dr. Lechtenberg also is an agriculture producer, with operations including a commercial feedlot and grazing unit, a swine production unit, and a corn/soybean farm.

 

Dr. Kelly Lechtenberg received his Doctor of Veterinary Medicine degree in 1987 (College of Veterinary Medicine) and his Ph.D. degree in ruminant nutrition/microbiology in 1988 (College of Agriculture), both from Kansas State University. He serves on the Kansas State University Foundation Board of Directors, the Kansas State University Board of Trustees and a variety of local community and health care organizations.

 

 

 

 

Thomas D. Overbay, Ph.D.
Business Development and Technical Consultant

 

Thomas D. Overbay serves as a business development and technical consultant to the international animal health industry. He founded Expedite Animal Health which is a company formed to discern opportunities in animal health then assist with product development across pharmaceuticals, biologicals, devices, and diagnostics. Expedite’s clients span the globe and include the largest multinational animal health companies, the smallest of startup companies, and the financial community including venture capital and private equity.

 

Following five years in veterinary practice, Dr. Overbay brings nearly 35 years of experience in the veterinary pharmaceutical industry. He led global business development and was an executive committee member for a top-5 animal health company and has served in similar roles with a contract services provider and start-up animal 
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 
companies.

 

Dr. Overbay holds his veterinary degree from the Virginia-Maryland Regional College of Veterinary Medicine and resides in Louisburg, Kansas.

 

 

 

Melinda Poole, D.V.M.
Argenta Global

 

Melinda Poole is head of Clinical Research and Development (U.S.) for Argenta Global. She has 20 years of global animal health industry experience in pre-approval pharmaceutical and biological regulatory affairs and clinical development across multiple companion animal and equine therapeutic areas. She has worked on numerous small molecules and biologics for dogs, cats and horses in early and late-stage development. Dr. Poole has additional clinical practice and academic veterinary experience (6 years clinical and academic equine practice at Mississippi State University College of Veterinary Medicine). Additionally, she has further experience in veterinary medical affairs (technical services), pharmacovigilance, business development and acquisition, and possesses expertise in recruiting, team building and group management. 

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)

• In-life
• Laboratory

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
• Pre-submission
• Post-submission

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