Join us for a complimentary happy hour seminar and reception on March 2^nd to learn how an integrated program design can simplify development processes for complex molecules & reduce overall costs.

Title: Overcoming Complex Formulation Challenges: Integrated Strategies for Poor Solubility, Modified Release & Pediatrics

Seminar overview
Drug development for any molecule type is challenging, however complex molecules requiring solubility enhancement or specialized formulation expertise like modified release or pediatrics, have even greater challenges achieving clinical and commercial success. These types of molecules require a development program that advances these challenging molecules rapidly to the next milestone while keeping an eye on downstream process development and commercialization.

With the ultimate goal being to get treatments to patients faster, drug developers can leverage an integrated approach to rapidly screen formulation technologies and dosage forms in as early as the preclinical stage. Using biorelevant in-vitro screening tools and physiologically based in-silico models they can flag developability problems that could impact the downstream success of the program. This approach is essential before quickly transitioning drug candidates into first-in-human (FIH) clinical studies to understand a molecule’s full potential.

There are also many benefits of employing an integrated approach when expediting complex molecules from FIH into proof-of-concept (POC) trials. The seamless integration of formulation development, drug product manufacturing and clinical testing capabilities enables real-time clinical data to help guide dosage form design, ensuring better decision making; and supporting a more streamlined approach to outsourcing.

Key topics covered:

• How it’s possible to screen and evaluate multiple formulation technologies for poorly soluble molecules in a single clinical protocol
• How an integrated manufacturing and clinical program can expedite the transition from an IV to sub-cutaneous formulation to improve patient delivery
• The use of design space concepts in evaluating and optimizing modified release formulation performance in “real-time” using clinical data
• Product considerations when designing acceptable, palatable pediatric products including formulation, clinical assessment, and manufacturing

About Speaker

Dr Aruna Railkar, Sr. Drug Development Consultant at Quotient Sciences
Aruna has over 25 years of experience in the pharmaceutical industry working at the discovery–development interface, providing critical input for progressing compounds into clinical development, prodrug evaluation, understanding challenges in absorption/exposure of lead molecules, and development of formulation strategies (conventional or enabling) based on compound properties.

During her career at Hoffmann-La Roche, she led the group characterizing compounds' physicochemical and biopharmaceutic properties to inform NCE selection and provided stage-appropriate formulation development for preclinical and clinical studies collaborating with discovery and development teams in multiple therapeutic areas. Her area of interest is the development of novel dosage forms for existing drugs (as an alternate route of administration or improved delivery, which can use the 505(b)(2) development pathway). She joined Quotient Sciences as a Senior Research Fellow in the Scientific consulting group.