RapidFACT® – Overcoming the Poor Predictability of Preclinical Models to Accelerate Formulation Optimization

In this presentation during AAPS 2024, learn how the Translational Pharmaceutics® platform and its applications can help integrate drug product formulation development, on-demand GMP manufacture and clinical testing to accelerate drug development programs. 

Conventional formulation development uses preclinical models to assess formulation performance to select prototypes to study in humans. It is well understood that there is often a disconnect between preclinical and human bioavailability, hence relying on animal data carries risk of selecting suboptimal formulations. 

Translational Pharmaceutics® enables clinical assessment with GMP manufacturing, release and dosing possible in less than seven days, allowing clinical assessment to proceed with only short term stability data, and significantly reduced batch sizes. 

Critical formulation attributes can be evaluated and assessed based on emerging clinical PK data. Additionally, we can use Translational Pharmaceutics® and its applications to support solubility enhancement for DCS class 2 compounds, modified release, and gastroretentive formulation optimization, among other cases, taking from our portfolio of expertise of over 300 customer programs completed over the last 16 years.

Here's what we'll cover:

• Why exposure in preclinical species doesn’t always predict human performance and how it could lead to misleading development activity
• What is Translational Pharmaceutics® and how it can accelerate drug development 
• How Translational Pharmaceutics® can be applied in different ways, including to facilitate formulation selection and optimization within a clinical study increasing chances of success and delivering better outcomes
• How Quotient Sciences have supported clients using Translational Pharmaceutics® and its applications
• Case studies covering integrated formulation development, compounding, first-in-human clinical testing with a novel synthetic peptide compound and other examples

Register now

*Please note that this is an in-person event that will not be recorded, and a virtual option to attend is not available. We reserve the right, at our sole discretion, to deny registration or remove any individual who is not a confirmed current or potential client/partner of Quotient Sciences.