Ronald Brashear

About Ronald Brashear

I currently serve as a Director of Strategic Product Quality supporting ViiV\'s early phase R&D portfolio. In this role, I help early phase programs (Discovery through Proof of Concept & Phase to develop appropriate processes, specifications, and Regulatory filing strategies that support ensuring critical quality attributes for the drug substance or final drug product are met. In addition to supporting the Quality Strategy for these assets, I am enjoying involvement and leadership opportunities in developing innovative clinical supply mechanisms and I am motivated by the opportunity to collaborate with colleagues across GSK\'s global network to develop more efficient mechanisms to supply innovative medicines to our patients. I have been involved in early phase development (both preclinical & clinical development) for almost my entire career. I have nearly 21 years of experience within GSK where I had various roles of responsibility throughout my career including serving as the Director of Exploratory Development Sciences in Research Triangle Park NC (RTP), which was accountable for early phase portfolio including drugs in the areas of enteroendocrine, infectious disease, and muscle/metabolism. Expertise in preclinical formulation development for support of biology and safety assessment, physical characterization of drug substance (thermal properties, crystallinity, chemical/physical stability, moisture adsorption/desorption, solubility, etc), salt selection, crystal form (polymorph selection), and formulation design and development to support First Time In Human (FTIH) and Phase IIA/IIB clinical studies. I also spent 3 years at Janssen (J&J Pharmaceuticals) where I served as a Senior Director and led the Small Molecule Developability function across 3 global sites. My specialities include: Understanding physical properties of drug substances, understanding key risks of molecules for development, understanding of limitations for absorption and strategies to resolve, Salt Selection, Polymorphism, Solubility, Formulation Development for both Animals and FTIH studies, Extemporaneous Compounding in both US & EU, Delivery of GMP-Compliant Drug Products in Accelerated Fashion

Experience

1. Product Quality Leader

   GSK

   Jul 2022 — Present · Collegeville, PA, US

Education

• North Carolina State University

  BS, Chemical Engineering

  1990 — 1995

• University of Iowa

  PhD, Pharmaceutics

  1995 — 2001

Skills

• Polymorphism
• Clinical Development
• Differential Scanning Calorimetry
• Biotechnology
• Drug Development
• Science
• Leadership
• Program Management
• Pharmaceutical Industry
• Fda
• Research
• Clinical Research
• R&D
• Solubility
• Glp
• Pharmaceutics
• Drug Discovery
• Hplc
• Drums
• Clinical Trials
• Formulation
• Product Development
• Gmp