The costs of developing a new medication can amount to over $1 billion, depending on the complexity of the drug and expenses associated with unsuccessful studies. With these costs in mind, an optimized regulatory process is required to ensure that the procedures behind drug development are secure, safety-oriented, and reliable. One way of managing drug development is through Chemistry, Manufacturing, and Controls (CMC). CMC is critical for establishing high quality products and effective manufacturing processes to ensure that drugs are consistently reproduced to the standards established in the clinical setting. This ensures the developed drug can remain unchanged as it moves from a clinical trial to market availability, meeting the expectations of regulatory authorities such as EMA and FDA.
Regulatory strategies and procedures for CMC drug development differ significantly when developing a drug product for veterinary medicine compared to human medicine. Veterinary medicine has its own CMC drug development requirements, given the varied species in veterinary medicine and that animals cannot assist in patient compliance. Below, we will consider regulations and CMC drug development nuances and what they mean for veterinary medicine.
Accelerated Pathways in Veterinary Medicine
In veterinary medicine, the drug development process is expedited compared to human medicine, essentially beginning at what would be considered Phase III in human health. This expedited pathway necessitates a highly confident and robust manufacturing process from the outset. Manufacturers must determine the best methods for granulation or direct compression to produce dosage forms, or for making liquids, granules, and feed. Any changes to the manufacturing process once the drug enters clinical trials could necessitate restarting clinical trials or running bridging pharmacokinetic (PK) studies, making initial decisions critical. Of course, preclinical safety data is still required before pivotal veterinary studies despite this streamlined pathway.
Smaller Market Size and its Implications
The veterinary drug market is generally smaller than that of human pharmaceuticals. This discrepancy directly impacts the resources and investment allocated to CMC drug development within the veterinary sector. Companies involved in veterinary drug development often operate with leaner budgets and fewer resources, constraining the extent and depth of CMC studies they can feasibly conduct.
In human drug development, extensive resources are often available to address the complex demands of CMC studies. However, veterinary drug firms must navigate these waters with greater fiscal prudence and strategic planning.
Regulatory Landscape
While the overarching regulatory framework governing CMC drug development is consistent between human and veterinary drugs, nuanced differences in requirements and review processes exist. In the United States, the Food and Drug Administration's Center for Veterinary Medicine (CVM) oversees veterinary drugs, while the Center for Drug Evaluation and Research (CDER) focuses on human medicines.
These specialized centers cater to the distinct needs of their respective domains. The CVM, for instance, might prioritize certain aspects of drug safety and efficacy that are unique to animal health and in the case of food producing animals, human health also. This influences the CMC drug development strategy for veterinary products.
Formulation Challenges
One of the more pronounced differences in veterinary drug development lies in product formulation. Veterinary medicines must be designed to be palatable and easy to administer to different animal species, each with their own set of characteristics and requirements. This necessity adds layers of complexity to the CMC drug development process. Formulations must meet stringent quality and efficacy standards while accommodating the practicalities of administering drugs to animals.
Such considerations may involve creating formulations that can:
– Be easily mixed with feed
– Withstand various environmental conditions
– Be palatable to different species
This extends beyond the typical challenges faced in human drug formulation. For instance, dogs may reject unpalatable medications, impacting patient compliance. Human health deals with one species, whereas veterinary health encompasses numerous species, each requiring specific testing.
Preclinical and Clinical Trials
Veterinary drug development diverges from human medicine in the scale and scope of clinical trials. Veterinary trials tend to be smaller, influenced by market size and the practicalities of conducting studies across various animal populations. This difference can impact the volume and depth of CMC data required to support a drug application.
Veterinary trials start directly with in-patient clinical trials, reflecting a Phase III approach in human terms. Preclinical safety data generated for one species can sometimes be translated to another, but a margin of safety study with the formulated product is necessary before pivotal studies.
Specific Considerations in Veterinary Medicine
Genotoxic impurities, a significant concern in human medicine, are less relevant in veterinary medicine due to the shorter lifespans of animals. Excipient selection is another critical factor; some excipients safe for humans can be toxic to animals, necessitating careful selection and validation for each species.
The journey of CMC drug development in veterinary medicine is marked by distinct challenges and considerations, shaped by the market's smaller size, specific regulatory demands, and formulation complexities. As the pharmaceutical industry evolves, understanding and adapting to these differences will be crucial for companies aiming to innovate and succeed in the veterinary drug market.
Ultimately, the future of veterinary medication relies on an enhanced CMC drug development process. Optimizing this process involves handling complex medications, ensuring efficient CMC development timelines, and leveraging new technologies such as data analytics and automation. These strategies will ensure that veterinary drugs are safe, effective, and meet high-quality standards.
If you need specialist advice on CMC drug development, DS Inpharmatics is here to help. Our expertise extends to veterinary medicine, providing guidance on specific regulations in this area. Learn more about CMC drug development in our blog, where we discuss various related topics, ensuring you follow the correct procedures with confidence.
Contact us today to support you with the CMC drug development process.
