Flexible approaches for drug product optimization
Biotech and pharma development teams are under pressure to rapidly advance molecules to the next development milestone and market as quickly as possible. However, progress is often constrained by challenges in drug development complexity, molecule chemistry, rising failure rates and increasing development costs. An example of this would be the prevalence of poorly soluble compounds within the development pipeline. Translational Pharmaceutics® accelerates the development and optimization of drug products by integrating key development functions into a single service provider to reduce “white space” and shorten clinical manufacturing and dosing times from months to days.
Drug products are manufactured in real-time during the clinical study, with arising human data used to inform the composition of the next formulation to be manufactured and dosed, removing the need to rely on preclinical or in- vitro data which is known to be poorly predictive for many drug molecules. A recent paper by Joseph DiMasi at Tufts CSDD in the Therapeutic Innovation & Regulatory Science (TIRS) Journal, quantified the financial benefits of Translational Pharmaceutics, demonstrating >12 months acceleration of development and multi-million-dollar reductions in R&D costs.
Translational Pharmaceutics has been used in over 400 drug programs by global pharmaceutical and biotech companies to develop all kinds of formulation, from simple capsules to complex formulations to address poor solubility or modify drug release.
This webinar will showcase examples of how Translational Pharmaceutics has been used across all phases of clinical development:
- Optimization of Phase I and II clinical formulations for poorly soluble NCE’s
- Life-cycle management and reformulation of late-stage molecules and marketed products
- 505(b)(2) product development and evaluation of novel drug delivery technologies to address poor bioavailability and suboptimal drug delivery