Insights On Drug Development

1. Tumor-Infiltrating Lymphocytes: What, Why, And How 7/1/2020

   As we’ve begun to understand the complexities of immune mechanisms through technology, we’ve found better ways to fight disease. Here, we focus on an important player in such targeted, highly personalized cancer therapies called tumor-infiltrating lymphocytes (TILs).

2. Technology Selection For Bioavailability Enhancement 6/3/2020

   Due to the growing incidence of low drug solubility in the pharmaceutical discovery and development pipeline, the number of enabling technologies that are employed to improve oral drug absorption and bioavailability (BA) are growing. Rational selection methodologies across this array of technologies can improve chances of clinical success, reduce program complexity, and accelerate development timelines.

3. In Vitro Test Methodologies For Characterizing Bioavailability Enhancing Formulations 6/2/2020

   Improved methods are needed to evaluate the effectiveness of bioavailability-enhancement approaches.  This presentation covers the development of in vitro tools for characterizing bioavailability-enhancing formulations, criteria for selecting the optimal in vitro methods based on compound properties and dose, and case studies for multiple low solubility compounds.

4. High-Loaded Dosage Forms: Novel Platform Expands Dispersion Utility 6/1/2020

   Spray-dried amorphous solid dispersions (ASDs) show enormous promise in the delivery of drug compounds with low solubility. A novel platform expands the utility of this approach to meet patient needs.

5. Lipid-Based Formulations For Early-Stage Clinical Trials 6/1/2020

   For certain molecules, the most appropriate technology for bioavailability enhancement and accelerated development will be lipid-based formulations (LBF), supported by in silico development tools. Senior Formulation and Product Development Scientists analyze the potential benefits and applications of lipid/liquid-based formulations and how they may reduce timelines to clinical trials.

6. An Engineered Platform For High-Loaded Dosage Forms Of Amorphous Solid Dispersions 5/11/2020

   This poster outlines a novel engineered platform for the formulation of high-active-loading oral solid dosage forms containing amorphous solid dispersions (ASDs) of a rapidly crystallizing drug with a low glass-transition temperature (Tg).

7. Combination Product Overview: Fixed Dosage 5/7/2020

   With dwindling pipelines, limited resources, & expiring patents, now, more that ever, combination products are being considered in drug development portfolios. However, regulatory hurdles, physician acceptance, and market strategy, are just a few considerations that one should address. This brief overview will cover specifics regarding fixed dosage combinations (FDC’s), and will hopefully give your company a better understanding to the challenges ahead.

8. Formulation Selection And In Vitro Screening For Oral Bioavailability Enhancement 5/7/2020

   Oral administration of small molecules is an ongoing challenge because most new drug candidates have poor aqueous solubility. This presentation describes use of a proven model-based technology-selection method for low-solubility molecules and in vitro evaluation strategies for three challenging classes of compounds, including one with high-dose requirements.

9. Bioavailability Enhancement: The Key To Unlocking The Potential Of Drug Development Pipelines 5/5/2020

   In this paper we look at the process CoreRx goes through when given an active ingredient with low bioavailability and four approaches that may be applied to increase the amount of the therapeutic that enters systemic circulation.

10. uFlux In Vitro-In Vivo Correlation (IVIVC) Testing Trans-Membrane Permeation And BSC Class II Formulation Challenges 5/5/2020

    This poster focuses on methods that could discriminate against formulation differences which may not present using traditional in-vitro dissolution techniques.