Brian McMillan
Vice President - Formulation Development
Brian has twenty-three years of relevant experience in the pharmaceutical development arena beginning his professional career at Roxane Laboratories in Formulation Development. Brian worked on nearly every marketed dosage at Roxane concentrating on solid and semi-solid ANDA and NDA product development, in addition to various novel dosage forms including buccal tablets, lozenges, immediate and modified release tablets, as well as numerous oral solution products. Brian also played a lead role in the conversion of dozens of existing formulations and processes into newer technology, including Zanchetta granulators and Fette “high speed” tablet presses.
Following Roxane Labs, Brian joined Bausch and Lomb Pharmaceuticals, in Tampa Florida as a leader on the formulation team. There he worked on a wide range of ANDA and NDA ophthalmic and nasal medications. Brian was the lead formulator and process development scientist for the development of Retisert™, which was approved in April 2005. Retisert™ (fluocinolone acetonide intravitreal implant 0.59mg), is a sterile implant (micro-tablet), designed to release fluocinolone acetonide locally to the posterior segment of the eye. Retisert™ is the world's first intravitreal drug implant for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye.
Brian joined MDS Pharma services following B&L Pharmaceuticals, where he was a Sr. Manager of Formulation Development. In this capacity he worked closely with clients to design and execute formulation and process development studies as well as technical transfer and scale up of prototype formulations to client facilities. These prototype formulations included IND (investigative new drugs), NDA (new drug applications), and ANDA (abbreviated new drug applications) development of various dosage forms including but not limited to tablets (IR, MR, SR, micro-tablets), capsules, topical (creams, suspensions, ointments, gels, lotions), ophthalmics, and parenterals (IV and IM). Having this contract development expertise at MDS proved to be an important factor for the lead in founding CoreRx in 2006.
Since joining CoreRx, Inc. Brian has developed formulations for injectable products applicable for potential pandemic influenzas in solution, suspension and lyophilized forms. He has also developed over a dozen analgesic oral solution products, as well as numerous formulations for both IR and MR mono and multi layer tablet systems containing multiple active pharmaceutical ingredients. In addition to his position at CoreRx, Inc. Brian is an Assistant professor of Pharmacy at the University of South Florida’s College of Pharmacy. Brian has been a keynote speaker on JRS PHARMA’s (The World leader in tablet excipient technology) annual advisory board numerous times and has worked in conjunction with JRS on cutting edge tablet excipient technology development. With this relationship Brian has worked closely with JRS Pharma development scientists whereby CoreRx, Inc. conducts formulation and development work for drugs that have been co-processed using JRS PHARMA’s proprietary PROSOLV® Technology. Brian holds a B.A. in Biochemistry from The Ohio State University where he also majored in the College of Pharmacy . Brian is scheduled to graduate with his M.S. in Pharmacy and Pharmaceutical Chemistry from the University of Florida in Spring 2013.
