In this interview, News Med talks to Tammy Newbold about Global Harmonization of Regulatory CMC within Veterinary Medicine.
Sponsored Content by DSI, a PLG CompanyReviewed by Maria OsipovaJul 26 2024 insights from industryTammy NewboldCMC regulatory strategistDS InPharmatics In this interview, News-Med talks to Tammy Newbold about the Global Harmonization of Regulatory CMC within Veterinary Medicine .
How does the regulatory CMC framework influence the development and approval of new veterinary medicines? The regulatory CMC framework sets the foundation for developing new veterinary medicines. Development of veterinary medicines moves much faster than human drug development because we go directly into our target species, bypassing the initial animal testing required for human drugs to check for the safety profile and other concerns.
What are some key challenges faced when aligning CMC regulatory practices internationally in the veterinary sector? We do not have phases in veterinary medicine. We only talk about “phase three” for animal health because human drug developers understand this terminology, and most facilities the Veterinary Industry use to develop drugs are specific to human drugs.
We develop analytical methods and may run pilot studies, similar to phases one and two in human medicine, to test animal efficacy. While not submitted to the FDA as pivotal studies proving efficacy, these studies provide valuable learning about the drug's effects, potential adverse events, and trial glitches.
If these estimates were wrong, it risked supply shortages or overproduction. Accurate estimates are vital to avoid additional development studies, scaling up batch sizes, and obtaining further FDA approvals, all of which can cause market delays and increased costs. Once approved, the product undergoes the same regulatory oversight as human drugs. Annual reports detailing marketing, manufacturing volumes, and adverse events must be filed with regulatory agencies, and any significant manufacturing changes must be pre-approved by the agencies.
In the veterinary world, the Veterinary International Conference on Harmonization allowed us to standardize the product development process globally. This global harmonization means that if you consider the requirements of all regions from the start, there are a few differences worldwide. What role do analytical and quality assurance processes play in maintaining the integrity of veterinary drugs throughout the manufacturing cycle? Analytical processes are crucial in maintaining the integrity of veterinary drugs throughout the manufacturing cycle. Early in development, analytical methods must first provide valid information, even if the accuracy is not what we want. These methods must be fit for purpose, giving us the necessary information to begin generating data.
Quality assurance is critical in the drug development program. Quality assurance also ensures that protocols and reports supporting the development of a drug substance or drug product are accurate and valid. Additionally, QA ensures that accurate data is entered into the dossiers of which the development protocols and reports are the foundation. Errors in data transcription can lead to significant scrutiny and delays.
With harmonization the number of stability studies are limited and sponsors will often establish those studies during development streamlining efficiency and reducing costs, and expediting the time-to-market for veterinary drugs. However, small startups in veterinary medicine often work with CDMOs specializing in human health and may not be aware of these differences. These smaller startups may not have a CMC regulatory person, relying on the CDMO's regulatory person can lead to the conduct of unnecessary studies. This results in wasted resources and the obligation to submit all generated data to the FDA, even if it’s not required, incurring additional costs.
Drugs for food-producing animals have a different regulatory pathway compared to those for companion animals. While companion animals require prescription drugs from a vet, the large scale of food-producing animals means that drugs fall under the veterinary feed directive. This directive allows veterinarians to prescribe these drugs without overwhelming pharmacies, reflecting the vast market volume.
Many sponsors streamline development by initially releasing a basic product version, such as a tablet taken once or twice a day, to understand market reception. We know that people do not want to give their cat or dog a tablet every single day, but that is what is available on the market. It fills a need.
For instance, if a company develops a daily injectable and later realizes a monthly formulation is needed, it can cause significant delays. Therefore, starting with a robust CMC framework and strategy ensures alignment with market demands from the outset, streamlining development and approval processes.
On the food-production side, humane treatment practices are gaining attention. Even though animals are going to be slaughtered, it does not mean that they should suffer. It reflects on us as a human population to treat animals humanely. This shift is encouraging the development of products aimed at humane treatment.
Throughout her career, Tammy has contributed significantly to the development of, and gained FDA approval for, numerous pharmaceutical products tailored for food and companion animal products, including the ivermectin line of products, omeprazole for horses, Eprinomectin for dairy cattle, to more recently Entcye, Nocita and Galliprant.
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