Brian Keesee, Catalent's Senior Manager, Clinical Supplies Services Project Management, and Matt Blume, Catalent's General Manager, Clinical Supply Services, Kansas City, will present, “There is More Project at the End of the Money: Building and Managing a Clinical Supply Budget” at the 5th Annual Conference of the Bio Supply Management Alliance (BSMA) on October 9th in Foster City, CA.
Ms. Sadler-Williams' presentation focuses on therapidly changing clinical supply business - specifically, cost containment coupled with a strong demand for rapid recruitment into larger global studies with limited or expensive clinical material. The presentation discusses thechanges in strategy as well as the models that support a fuller “outsourced service” of clinical supply management. The types of processes and structures that can be invoked to optimize precision during the clinical supply process will also be covered. The presentation concludes with a Catalent case study.
The 10th Annual Clinical Trial Supply East Coast conference allows industry professionals to learn about efficient ways of delivering quality drugs while working with restrained budgets and facing global regulatory complexity. The conference helps to establish innovative ways of using currently accessible technologies and strategies when challenging new landscapes of the pharmaceutical industry.
Messrs. Keesee's and Blume's presentation discusses the demanding task of building and managing a clinical supply study budget. Strategies for working with vendors, managing internal expectations, and dealing with sponsor CRO/CMO relationships will be outlined. The presentation also mentions real-life examples of studies that ran over estimated budgets as well as provides strategies to identify and mitigate this risk early in the trial.
The BSMA conference allows business and academic leaders to address strategic and tactical management of global sourcing, entry into the emerging markets, information transfer from R&D to clinical trials to commercialization, manufacturing excellence, environmentally controlled distribution, risk mitigation, sustainability and SCM talent and career development. All of these issues are addressed while ensuring compliance with expanding government regulations.
Esther Sadler-Williams is currently Senior Director, Strategic Development and Innovation for Catalent Pharma Solutions and is EU chair of the ISPE Investigational Products Community of Practice. As a pharmacist, Ms. Sadler-Williams has had nearly 30 years experience in various pharmaceutical fields most latterly in clinical supply environments. Her experience also includes five years with Sanofi Winthrop where she was Head of Research Services during which time she managed groups of CRA's medical writers and information/adverse event surveillance specialists. Previous roles include Principal Pharmacist with the Regional Drug Information Service at St. Mary's Hospital in Manchester, and Pharmacy Manager with Boots the Chemist.
Brian Keesee, Senior Manager, Clinical Supplies Services Project Management for Catalent Pharma Solutions, has spent his entire career in the Pharmaceutical industry. He has held leadership positions in Project Management, Operations Management, and Compliance. Mr. Keesee has managed large global clinical studies and offers extensive experience and expertise in clinical packaging and label design, project management, supply chain management, logistics, and IVRS. He brings a unique perspective to his presentations based on his Compliance and Operations roles at AmerisourceBergen Drug Corporation, and his involvement in the Lean Six Sigma Black Belt Program. Mr. Keesee holds a Bachelor of Science degree in Business Administration from MissouriWesternStateUniversity.
Matt Blume is the General Manager for Catalent Pharma Solutions' Kansas City Clinical Supply Services site. Mr. Blume has worked in the clinical supplies field since 1999. He has held variousroles in the clinical supplies arena. These roles have included packaging floor operations, project management, and site management. He holds a Bachelor of Pharmacy degree from the University of Kansas.