Product Development and Regulatory Affairs
The PDRA team develops and licenses Dechra's own branded veterinary product portfolio of novel and generic pharmaceuticals. Additionally, the team manages post-approval adverse event reporting, periodic product renewals and other activities required to maintain the product approvals.
The team of 52 people are split into European Regulatory Affairs, US Regulatory Affairs, Pharmaceutical Development and Product Development. They work at four locations: Overland Park, USA, Sansaw, England, Skipton, England, and Bladel, the Netherlands. The team includes veterinarians, formulation chemists, pharmacists, analysts, clinical trial managers and product development managers.
Product development process
Although some products may have a slightly different path, most novel and generic products follow a fairly standard process which contains five phases which Dechra defines as: Exploratory, Pre-Clinical, Clinical, File/Submission and Launch.
Dechra employs a structured process in its development pipeline however retains an opportunistic and entrepreneurial approach. Focus is given to the Group's therapeutic specialisations: endocrinology, equine medicine, analgesia and critical care, cardiovascular, ophthalmology, and antimicrobials for food producing animals. New development opportunities and in-license opportunities are evaluated for strategic fit within these categories; therapeutics outside of the key areas are considered for inclusion in the pipeline if they are novel and address unmet needs in the veterinary market.
A product's return on investment can vary: novel developments tend to have a mid to long term realisation with attractive high value returns; generic developments generally have shorter development timescales with returns dependent upon the number of generic entrants and speed to market relative to competition. Dechra's current development pipeline is a mix of short, medium and long term opportunities.
The Exploratory phase begins with identifying a novel molecule, an opportunity to develop a new formulation for an existing molecule, or an in-license opportunity. Before initiating a development programme, each opportunity is assessed by market need, market value, therapeutic indications, strategic fit and the likely complexity of the regulatory pathway.
The second phase of the process is Pre-Clinical, which involves the collection of a range of preliminary data. When initiating development of a novel product, the correct dose has to be titrated and a stable formulation, that can be reliably and consistently manufactured, must be developed. For a generic product, the pioneer formulation may not meet the current regulatory requirements and may need to be reformulated. This phase is vital prior to initiating the clinical phase which involves expensive clinical trials or bio equivalency studies.
The Clinical phase is the longest part of the process, potentially taking two or three years. After the formulation has been demonstrated to be stable, two to three pilot batches are manufactured for use in safety studies, efficacy studies and stability testing. For generic products, the batches are used in one or more bio equivalency studies to demonstrate that activity will replicate the pioneer product. If the studies conducted during the Clinical phase demonstrate the required safety, efficacy and chemical stability of the product, regulatory dossiers are prepared for submission.
From beginning to end, this process takes on average between three and five years.
The PDRA team includes skilled people with expertise in spotting niche opportunities, and the experience to navigate the hurdles of the development process. Across the four locations, project teams operate to tackle the wide range of projects. Investment in state-of-the-art laboratories in Bladel and Skipton, each with their respective dosage form expertise, provides the resources required to develop novel and generic formulations cost effectively.
We believe our integrated and entrepreneurial approach to product development successfully delivers new products effectively and efficiently in the shortest possible time frame.
Dechra Development Laboratory at DPM, Skipton