Welcome back to the YourCareerEdge Blog. Here’s another contribution from Rob Hunter, Animal Health Lead Instructor and Advisor on the topic of animal health regulatory affairs. Rob and his partners Stephanie Batliner and Dr. Karen Fuller share their perspectives on the K-State’s upcoming pharmaceuticals workshop. The Advanced Pharmaceutics Regulatory workshop was first held at K-State Olathe in November of 2020. This 2-day workshop covers FDA/CVM (Food and Drug Administration/Center for Veterinary Medicine) in a detailed manner focused on the 4 major technical sections in NADA/ANADA applications. The workshop was well received by attendees and is being planned to be offered again on June 16-17, 2021.
This workshop discusses real-world examples of data and studies needed to complete all 4 major technical sections (CMC, Target Animal Safety, Effectiveness, and Human Food Safety) for NADA applications to CVM/FDA. Instructors also cover biowaivers/bioequivalence to support companies working on ANADA applications. The target audience/attendees for this workshop are people tasked with developing and maintaining an animal health company’s product portfolio and involved with a company’s regulatory strategies, but have some experience in the industry. The information covered in the Regulatory 101 workshop also offered by K-State is considered a “pre-requisite” to this workshop, but not absolutely essential.
The Chemistry, Manufacturing and Controls (CMC) section of the Advanced Pharmaceuticals Workshop takes a deep dive into the elements necessary for a successful CMC technical section. Highlighting available resources, connection points between CMC and other technical sections, and presenting case studies of different dosage forms and their associated requirements. Attendees will gain a clear understanding of the elements necessary to construct a robust submission demonstrating control of the drug substance, drug product and manufacturing parameters.
The Clinical Effectiveness section of the Advanced Pharma Workshop is designed to walk the attendee through the seven stages of clinical effectiveness – from the pre-submission conference to the technical section complete letter. Included within this section is a discussion on the interrelatedness between Target Animal Safety and Efficacy, highlighting the regulatory guidelines required for these two technical sections as well as an overview of the latest draft Guidances for Industry and a discussion on how to apply them. This then sets the stage for the attendee to journey through a GCP-level study. Included throughout this section are several opportunities for attendees to collaborate on mock scenarios related to various aspects of running clinical trials. With the knowledge gained from this section, attendees may gain a new perspective on merging the art and the science of creating expert level clinical investigations.
Discussions and strategies regarding Target Animal Safety Studies (TASS) and human food safety/residues (HFS) will be presented and discussed. Direct relationships will be demonstrated between TASS, HFS, CMC and Clinical Effectiveness with be explained and discussed to allow for a deep understanding of the relationships and big picture of animal health drug development and project planning. Human Food Safety will address not just residues, but the determination of NOEL, ADI, slaughter authorization, tolerances and safe tissue concentrations in addition to the method trial.
For those attending with an interest in generic animal health product interest, an overview of biowaiver applications and strategy will be discussed. When biowaivers are not an option, the design and implementation of a bioequivalence study is needed and will be discussed in detail.
We hope that you will attend or refer your colleagues to this workshop as it has been both fun and educational for all involved. Please don’t hesitate to contact Rob Hunter rphunter@1medicineconsulting.com or Angela Buzard abuzard@ksu.edu if you have questions, comments, or interest in attending. We look forward to working with you!