Strategy and TPP
A detailed roadmap allows for seamless advances from the lab through each stage of development
A well-thought-out strategic plan is essential for improving efficiency, reducing costs, shortening timelines, and increasing the probability of success. The creation of a target product profile (TPP) early in development complements the strategic plan. TPPs facilitate communication among the sponsor, FDA, and stakeholders in and outside the industry.
Our experts provide a clinical plan that reduces clinical trial time and risk. The success of the regulatory process depends on clearly defined end goals.
The BBCR team knows how to develop the product TPP in early development along with clinical plan strategy to gain the most benefit from FDA input on the design of phase II and III studies
Strategies that move products to market faster
- A biology-targeted approach
- Program gap analyses
- Indications selection and prioritization
- A clinical plan that saves time and resources
- Pre-IND, Orphan Petition and IND strategies and submissions
- Trial Design and Protocol
- Study Remediation and Rescue
Case Study
Strategy to Avoid Market “Me Too drug” in Gaucher Disease type 1
Challenge: To develop the new product avoiding a “me too” treatment in the orphan population when a similar product had a market monopoly for over 15 years.
Solution: The clinical plan included clinical strategy and avoided a head-to-head design, which would have required an unfeasible number of patients and had a high risk of proving efficacy and safety in the rare disease population. The FDA at the IND approved the clinical plan with no modification. The proposed clinical plan was successful, and the product was approved in many countries.
Carla Epps, M.D., MPH, FAAP, Medical Officer FDA/CDER/OND, on May 2011, summarized the clinical strategy stating:
- Well planned
- Clinically meaningful endpoints
- Each trial had a distinct purpose