Early Phase Drug Product Strategies
June 15 @ 6:00 pm – 7:00 pm
What formulation strategy is best for your goals? With fewer Phase I candidates making it to proof of concept, it’s important to have the appropriate strategy in place for your early phase development. Brent will discuss how reaching first-in-human clinical studies quickly is often critical, especially for companies with limited budgets or investor milestones tied to this step.
A phase-appropriate approach to development will get you from the bench to the clinic quickly. Of equal importance is the creation of a formulation that will give your candidate the best chance at success. From bioavailability enhancement technologies for insoluble compounds to API-in-a-capsule, this seminar covers multiple development strategies.
What you’ll learn
• Why understanding different formulation strategies is important to the long-term success of your compound
• Strategies for oral and injectable drugs
• Strategies for poorly soluble compounds
Seminar Speaker: Brent Moody, Field Engineer, Pharmatek
A pharmaceutical scientist with over 16 years of experience, Brent’s background includes drug product development, formulation for oral and injectable dosage forms, method development/validation, project strategy, project management, and laboratory supervision. He is experienced in the application of FDA/EP regulations and ICH guidelines for drug product development studies and CTM supply operations. Brent’s career began as a pharmaceutical chemist at Magellan Laboratories and then Cardinal Health where he was responsible for analytical projects ranging from pre-clinical product and method development to Phase 3 stability studies. Brent then joined Pharmatek in 2003 as a pharmaceutical scientist as a scientific group leader and project manager, responsible for guiding client candidates from discovery through early-phase CTM manufacturing campaigns. He then joined Banner Pharmacaps as a group leader for clinical supplies where he managed the day-to-day operations of a cGMP pilot plant. Brent returned to Pharmatek in 2009 as a technical sales representative where he assists clients with their early phase development strategies. Brent received his Bachelors from East Carolina University in Chemistry.
Leave a reply →