Case Study: DPP4 Development Program
PPD entered into a partnership agreement to jointly develop and commercialize a DPP4 inhibitor that represented a new class of drugs for the oral treatment of Type 2 diabetes.
The primary end point of the DPP-4 program was to demonstrate efficacy and safety of the investigational product in patients with Type 2 diabetes. PPD took the product from lead optimization to NDA and was the sole provider of all clinical development services in the United States and Europe.
The DPP-4 partnering program was set up to optimize the development timeline and market position of the compound and to demonstrate PPD’s ability to accelerate the drug development process. The study involved six concurrent studies with over 2,200 patients and very aggressive timelines.
Partnership approach and careful contingency-based planning throughout the program were necessary in meeting the aggressive timelines.
- PPD applies proven solutions leveraged from extensive global experience to reduce development timelines
- Scenario-based contingency planning techniques, parallel processing and focused project management efforts to speed up decision-making
- Small core partnering team is empowered to make decisions quickly
- Real-time technology tools facilitate rapid data review and decision-making '
- Clinical development programs are designed to optimize market position of the compound
- Development team focuses on science/must have studies and drives timelines and vendors accordingly
We partnered and took the compound from lead optimization to NDA submission in a total of 49 months, trouncing traditional development timelines and demonstrating our ability to accelerate the drug development process.
IND submitted: 2004
FPI: 3 March 2006
LPO: 30 July 2007
Final TLFs: 12 September 2007
NDA filed: December 2007
By applying our extensive global drug development experience to the discovery efforts of our partner, we shortened timelines in bridging steps in clinical research with effective planning across multiple phases of drug development and commercialization.