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.
Using case studies on modified release, poor solubility, and pediatrics, Quotient Sciences’ featured speaker will demonstrate how integrating GMP manufacturing and clinical testing can rapidly accelerate development timelines for even the most challenging of molecules.
Join this webinar to understand how an integrated program design can simplify drug development processes for complex molecules, reduce overall costs, and improve the likelihood of clinical & commercial success.
Speaker
John McDermott, Executive Drug Development Consultant, Quotient Sciences
John has over 20 years industry experience in roles in pharmaceutical sciences with Rhone Poulenc Rorer, Covance and Quotient Sciences, which he joined in 2001. He has been central to the development of Quotient’s Translational Pharmaceutics approach, which integrates formulation development with clinical manufacturing, regulatory support and clinical testing, to help achieve flexible and efficient first-in-human studies and fast development. In addition, John has a significant body of experience in scintigraphy imaging studies for oral and inhaled dosage forms, including the development and validation of radiolabeling methods.
Message PresenterWho Should Attend?
- Chief Scientific Officers
- Formulations Scientists
- Drug Product Development/CMC Management
- Technical Operations
- Outsourcing Managers
- Drug Product Process Development Engineers
- Scale-Up Specialists
- Clinical Supplies & Tech Transfer Specialists
- Clinical Operations
- Project Managers
- Manufacturing Director
- Drug Product Development/CMC Consultants
What You Will Learn
Attendees will learn:
- How it is possible to screen and evaluate multiple formulation technologies for poorly soluble molecules in a single clinical protocol
- The use of design space concepts in evaluating and optimizing formulation modified release performance in “real-time” using clinical data
- Product considerations when designing acceptable, palatable pediatric products including formulation, clinical assessment and manufacturing
Xtalks Partner
Quotient Sciences
Quotient Sciences is a drug development and manufacturing accelerator providing integrated services across the entire development pathway for small molecules & peptide drug programs. We cut through silos across a range of drug development capabilities, saving precious time and money in getting drugs to patients.
We work with customers in a flexible way by either designing and delivering fully integrated programs at each stage of the development lifecycle, or by providing them support through tailored individual services in Drug Substance Synthesis & Manufacturing, Formulation Development, Clinical Trial Manufacturing, Commercial Manufacturing, Clinical Pharmacology, Data Sciences, Bioanalysis and Drug Development Consulting.
Quotient Sciences has over 30 years of experience developing a breadth of formulations across a range of indications and across an array of drug product formats including oral, inhaled, parenteral & topical. We also have a depth of expertise in modified release, oral peptides, ADME studies, Radiolabelling, Scintigraphy, Pediatrics, and we have the ability to handle highly potent compounds. Our innovative approach to formulation development is based on our proven track record in early clinical evaluation delivering phase-appropriate formulations across the product development pathway from candidate selection thru commercial product launch.
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