Formulation Development Options for Speed to Phase I Studies
Driven by pipeline productivity objectives and financial constraints, pharmaceutical companies of all sizes are under pressure to reach critical milestones faster in spite of challenging molecular properties associated with their candidate, and with limited active pharmaceutical ingredient (API).
The ability to work smarter has become a critical survival skill in order to move drug development candidates forward faster and to maximize the chance for success.
Though not all are relevant for commercial scale, there are a host of formulation development options to consider that enable speed to first-in-human studies while conserving API and other resources. API in bottle, powder in bottle, API into capsule, and traditional formulations are all approaches worthy of consideration as possible formulation options for clinical supplies for a Phase I clinical trial.
This webinar will address considerations for prototype formulation development, formulation options for phase I studies, a prototype formulation approach, strategies to overcome poorly soluble compounds, liquid in capsule, and controlled release formulations.
Paul F. Skultety, PhD, Director, Pharmaceutical Development Services, Xcelience, LLC
Paul Skultety has a unique background in Pharmaceutical development combining extensive experience with contract development and pharmaceutical companies. At Xcelience, his role is to provide leadership to Pharmaceutical Development Services. This includes analytical chemistry and formulation development.
Prior to Xcelience, he has held such positions as Vice President of Pharmaceutics at Quintiles, Director of Solids Formulation Development for Hoechst Marion Roussel and various management positions within Marion Merrell Dow and Marion Labs which were predecessors to HMR.
Dr Skultety has a successful track record of developing new chemical entities from pre-IND to commercialization. He has 9 US formulation and composition patents. He has written a number of publications and made numerous scientific presentations. He has been a member of AAPS since its inception.
Who Should Attend?
- VPs of R&D
- VPs of Product Development
- Senior Directors of Biochemistry
- Directors of Formulation Development
- Directors of Analytical Development
- Technical Section Managers
- Principal Analytical Chemists
- Team Leaders
- Formulation Development Scientists
Xcelience LLC, is a premier provider of formulation development and manufacturing solutions. We have been providing preformulation, analytical services, formulation development and clinical trial manufacturing since 1997. Xcelience has a solid reputation for accelerating early development activities to speed potential drugs to clinical trials while applying stage-specific scientific knowledge and experience. Xcelience’s unique corporate structure creates project teams that work intensively with each client, bringing an extension of their own organization into the Xcelience lab.
For information about the recorded archive for this event contact Xtalks at (416) 977-6555 ext 371, or email email@example.com