BiotechTuesday @ Microsoft NERD (Boston, MA)

Innovation Workshop - Early Stage Formulation Strategies

For most biotech/pharmaceutical companies today, reaching first-in-man clinical studies quickly is critical. Investor payments are often tied to this important milestone. Of equal importance is the company’s choice of formulation strategy. Choosing the best formulation is essential for clinical success.  A poorly formulated drug can lead to bad clinical data, severely tripping up your development plans. Undesirable results could mean costly delays, reformulation requirements or tragically, project termination. However, “over-development” at this phase can be just as detrimental when timelines and resources are tight.

Formulation projects should start with a thoughtful formulation plan. A small investment now can save you millions down the road.  The formulation strategy is the result of a thorough analysis of the drug substance structure and stability, pre-formulation data, the intended manufacturing process, any patient compliance issues and the strategic goals of the company.

Join presenter, Brent Moody of Pharmatek, where he will review several formulation approaches in the early phase. His discussion will include methods for developing a sound, phase-appropriate formulation with scientifically supportable data to help progress development to the next phase in a timely and cost-efficient manner while still meeting regulatory requirements. Brent’s presentation focuses on strategies for oral and injectable drugs and includes strategies for poorly soluble drug candidates.

About the speaker

Brent Moody is Technical Sales Representative for Pharmatek, a contract dosage form development and GMP manufacturing organization. A pharmaceutical scientist with over 16 years of experience, his 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 III 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.