At CoreRx, the real asset is our people. Our senior scientists are personally involved in every aspect of your project. Not only does CoreRx have the expertise to handle your most complex formulations, we pride ourselves on unsurpassed communication, innovative problem solving, and overall dedication to meet your timelines & project expectations.
Todd R. Daviau, Ph.D.
Chief Executive Officer | Read Bio
Brian McMillan
Director - Formulation Development | Read Bio
Saurabh (Rob) Trivedi
Sr. Director - Quality Operations | Read Bio |
Mark J. Licarde
Director of Manufacturing | Read Bio
Jim Davis, M.S.
Director - Analytical | Read Bio |
Todd R. Daviau, Ph.D.
Chief Executive Officer
Todd Daviau, an accomplished scientific leader brings 25+ years of pharmaceutical experience and knowledge to CoreRx, as well as being one of principal founders. Prior to founding CoreRx, he served as Director of the Analytical & Pre-formulation Laboratory for MDS Pharma Services in Tampa, FL. In this role, he directed the analytical group of over 20 scientists responsible for all the analytical, stability, and pre-formulation activities in support of over 75 stability, formulation and/or manufacturing projects.
Dr. Daviau was also a strategic analytical team member with Guilford Pharmaceuticals, and involved in a number of NDA programs, including development of Gliadel® . Todd is acknowledged as a creative leader focused on advancing projects with experience in multiple therapeutic areas. He is an expert in optimizing the drug discovery process through optimal resource allocation, process improvements and using scientific acumen to resolve complex project related issues.
Todd brings a breadth of pharmaceutical experience, from drug discovery through research & development, analytical (R&D and QC.) and management experience in top-tier multinational pharmaceutical organizations. He is recognized as global, strategic thinker, with demonstrated ability to deliver pre-clinical and clinical candidates, within stringent timelines
Dr. Daviau is also the founder and Chairman of the Board of Magellan Bioscience Group, an innovative discovery company focused on identifying lead candidates derived from microorganisms for the development of new chemical entities. Magellan has numerous proprietary compounds advancing through commercial development.
Dr. Daviau holds a bachelor's degree in Marine Biology and Chemistry and a PhD in Natural Product Chemistry.
Brian McMillan
Director - Formulation Development
Brian has twenty one 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 Roxanne concentrating on solid and semi-solid ANDA and NDA product development, is 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 Roxanne 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.
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 closely 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 currently a Ph.D candidate in Pharmaceutical Chemistry at The University of Florida.
Saurabh (Rob) Trivedi
Sr. Director - Quality Operations
Rob Trivedi brings 16+ years of pharmaceutical expertise, both within big Pharma, as well as the pharmaceutical CRO industry. He started his career as a building automation/operations engineer at Schering-Plough and was involved with all aspects of operations, facilities, clean rooms, production, utilities, automated systems, and engineering.
Moving over to the manufacturing world at Schering-Plough, Mr. Trivedi impacted the tablet coating department, utilizing his knowledge from his previous position as an operations engineer. His knowledge of the manufacturing processes combined with the engineering background led to his leadership role as the manufacturing representative for a new $80MM+ manufacturing facility in Kenilworth, NJ, the site headquarters for Schering-Plough. He was involved in designing, specifying, and selecting coating and HSG manufacturing equipment, CIP and USP systems, process automation systems, and all other associated systems and supporting equipment. Mr. Trivedi played a key role in the validation of the aforementioned items, including documentation development and execution of IQ/OQ/PQ protocols, SOPs, implementation plans, SFATs, FATs, SATs, regression testing, gap analysis, computer system validation plans, and test summary reports.
Mr. Trivedi also held senior level management positions at MDS Pharma Services (CRO) as the Manufacturing Manager and is knowledgeable in manufacturing various dosage forms with a vast working knowledge of FDA, GMP, and CFR guidelines, Rob provided guidance and support for the daily operations of the manufacturing department. Currently, he serves as Sr. Director of Quality Operations at CoreRx, Inc., overseeing manufacturing and the daily activities that govern compliance with cGMP, CFR, and FDA guidelines, as well as corporate finances oversight. Mr. Trivedi holds a BS in Engineering from NJIT (NCE).
Mark J. Licarde
Director of Manufacturing
Mark Licarde has an extensive pharmaceutical manufacturing background with more than 28 years in the industry. Mark started his pharmaceutical career with Bristol Myers Squibb. His mechanical abilities and in depth knowledge of equipment afforded an opportunity to assume the newly created position of PM Specialist which included managing the PM schedule for all manufacturing equipment, technical procurement, and parts inventory management for the manufacturing department. In this role, he was responsible for overseeing a budget of $3.6 m and in the first year saved the department an estimated $725 k. His innovativeness, resourcefulness, and leadership abilities earned him the Employee Excellence Award.
Mark also worked at Mylan Pharmaceuticals as a senior manufacturing manager and was responsible for the day-to-day operations in the manufacturing facility. Mark was responsible for floor supervisors, as well as department personnel across 3 shifts in the manufacture and packaging of liquid products (bottled and form, fill, seal). Marks leadership skills directly impacted Mylan through positive retention of employees and ultimately corporate profitability.
Mark served in an entrepreneurial and leadership role at MDS Pharma Services (Tampa). Through his 8 year tenure with MDSPS, he held various leadership positions within the company. As one of the original 12 employees of this company, he played a key role in the successful start up of this GMP CRO facility. He assisted in the design and layout of the facility, sourced and recommended equipment and systems for purchase, wrote SOPs for equipment and systems, and designed and implemented the preventative maintenance and calibration programs for manufacturing equipment, packaging equipment and the facility operation and support systems. Upon completion of the start up exercises, he assumed the management duties for the manufacturing department. Mark’s ability to clearly communicate with clients resulted in receiving several client service awards.
Mark’s manufacturing and technical background lead to his new role at CoreRx as the Director of Manufacturing. Being a part of a startup company was not new to Mark. The knowledge and experience he acquired in his previous role made for a smoother startup of the GMP manufacturing area at CoreRx. Due to his years of CRO experience, Mark has extensive experience on nearly every dosage form. As the Director of Manufacturing, Mark is responsible for all manufacturing personnel, equipment, systems, and processes. Mark is a part of a project from the initial discussions to the completion of the project and is always available to interact with clients.
Jim Davis, M.S.
Director - Analytical
Jim Davis brings 15+ years of analytical experience to CoreRx. Mr. Davis has held several positions as an analytical chemist and consultant to the pharmaceutical industry. Prior to forming CoreRx, Mr. Davis served as both a section head and as a senior scientist within the analytical laboratory of MDS Pharma Services in Tampa, FL. Prior to MDS he was a lead scientist in the R&D Nasal Division of Bausch and Lomb in Tampa.
He formerly served as a scientist in analytical services for contract research organizations (CROs) Proceutics and Oread in Atlanta. He has extensive experience in the separation, isolation and analysis of emerging and classical pharmaceutical compounds. Mr. Davis has an in-depth understanding of the drug development process from molecule to market.
Currently, Jim serves as the Director of Analytical Laboratory where he oversees the daily activities of the Chemistry department in addition to generating and verifying all data prior to client delivery. In addition to his M.S. in analytical chemistry from Georgia State University, Jim Davis holds a B.S.A. degree in biological sciences from the University of Georgia in Athens.
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