To improve R&D productivity and bring new molecules to market as quickly as possible, drug companies are continuously seeking new ways of streamlining drug development using alternative outsourcing models. One such approach is to focus on smarter R&D by adopting a highly integrated model, like Quotient Sciences’ Translational Pharmaceutics® platform, in which a single outsourcing partner coordinates and adapts the drug product manufacturing requirements (“make”) with the specific needs of the clinical development plan (“test”), creating significant time efficiencies and cost savings.
This webinar will cover a real-world case study with Druggability Technologies, a specialty pharmaceutical company, which utilized Quotient’s integrated approach to advance the development of DRGT-46, a novel, fast-acting formulation of celecoxib, using proprietary super-API compositions developed by DRGT. The case study will give examples of how clinical data can be used to drive formulation selection in “real-time” and demonstrate how Quotient’s tight integration of formulation, manufacturing and clinical research activities has enabled DRGT to execute an efficient development plan with a single outsourcing partner and, most importantly, reduce the time from early development to confirming the commercial formulation.
In this webinar, we will explore:
- An understanding of how an integrated “make-test” model can generate clinical data to drive formulation selection
- Assessing the benefits of phase-appropriate development of solubility challenged molecules and learn how manufacturing processes can be effectively scaled up for late stage development and commercialisation
- Evaluating the advantages to a small biotech/pharma of working with a fully integrated drug development outsourcing partner
|Wednesday, April 24, 2019||04:00 PM GMT / 11:00 AM EST|