Rho utilizes a “begin with the end in mind” approach to product development. When we are approached by a company early in the development process with pharmacodynamic data of an exceptional nature, the first step is to collaboratively define a projected marketed product label (e.g., target product profile) that the data would support. This helps us to rule out many interesting pharmacodynamic effects that have no potential benefit compared to current therapeutic treatments. The intellectual property is evaluated at this time and assurance is made that the product has an appropriate patent strategy for commercialization.
Once a target product profile is defined, the next step is preparing a clinical development plan (i.e., Phase 1, 2, & 3 studies) that provides the necessary safety and efficacy data to support marketing approval. After the scope of the clinical development plan is defined, the nonclinical studies required to generate the safety data to support the clinical development plan are outlined in the nonclinical development plan. After completing the design of the clinical and nonclinical studies, we create the chemistry, manufacturing, and controls data plan to ensure sufficient investigational product will be available for both sets of studies. Finally, the regulatory activities and timelines are defined and interwoven with these three respective disciplinary plans (clinical development plan, nonclinical development plan, and CMC data plan). The result is an integrated product development plan with an accompanying estimated budget and timeline.
The integrated product development plan should be managed by a Program Manager who has previously obtained marketing approval for a licensed product in all global markets of interest. There is no substitute for experience gained in bringing a product to market in collaboration with the relevant regulatory authorities.
The team that will execute the integrated product development plan consists of six primary individuals:
- Program Manager
- Medical Expert
- Clinical Lead
- Clinical Pharmacology Lead
- Nonclinical Lead
- CMC Lead
The Program Manager is responsible for the conduct of all the GCP-, GLP-, and GMP-compliant activities defined in the product development plan and for ensuring that these activities are performed on time and on budget. The Medical Expert is responsible for medical input across all the disciplines but is primarily responsible for ensuring the safety of the subjects exposed to the investigational product. The rest of the individuals on the team are responsible for direction of the activities within their respective disciplines required for the successful execution of the product development plan on time and on budget. With a well defined target product profile, a thoughtfully prepared integrated product development plan, and an experienced team of experts, you vastly increase your chances of success in navigating the path to marketing application approval.