The Evolution of an NCE’s Suspension Formulation, from pre-GLP Studies to the Pharmacy Shelf

Register free: https://www.pharmtech.com/pt/Pre-GLP

Event Overview:

This presentation focuses on the development of suspension formulations of an NCE for oral administration.

Starting with the simple formulations used in safety studies, moving through the multi-dose product used for clinical programs and onto the advanced, long shelf-life product that is commercialized. Both formulation and analytical aspects will be covered.

Suspensions for other routes of administration, e.g., IM or SC injections and eye drops, are outside of the remit of this presentation.

Key Learning Objectives:

• Attendees will gain an understanding that:
  • The formulation complexity increases during development of a compound
  • Analytical testing requirements also increase during development
  • Multiple aspects of API characterization need to be considered

Who Should Attend:

• Formulation scientist
• Chief Scientific Officer
• VP Research and Development

Speakers

David Barnes PhD
Vice President of Scientific Affairs
Pace® Life Sciences

Dave graduated with a degree in pharmacy from The School of Pharmacy, U. of London (“The Square”). After completing a year’s pharmacy internship, he returned to The School of Pharmacy to undertake a Ph.D. in Pharmaceutical Sciences.

Dave then joined Pfizer’s R&D division in Sandwich, England and for the next 13 years worked on developing drug products of locally discovered molecules, from early pre-formulation through scale-up and transfer into production sites in Europe and the US.

In 2001, with the acquisition of Parke-Davis, Dave moved to Ann Arbor to complete the construction and commissioning of the new Pharmaceutical Sciences building (550/TDF). Upon the successful start-up of the facility, he moved to the Clinical Trial Materials department managing activities across the Ann Arbor, Kalamazoo and Groton, CT sites.

In 2008, with the closure of the Ann Arbor facility, Dave teamed up with Gerry Cox to set up Velesco Pharmaceutical Services which provides formulation and analytical development services for small to medium sized pharma companies as well as the provision of small scale, non-sterile cGMP supplies for early stage clinical studies.

In 2021 Velesco became a part of the Pace® Life Sciences laboratory network. Dave is now Vice President of Scientific Affairs at Pace® Life Sciences in Wixom, MI.

Register free: https://www.pharmtech.com/pt/Pre-GLP