Executive Management Team
Arthur J. Tipton, PhD, Vice President, SurModics and President, Brookwood Pharmaceuticals joined Southern Research in 2004 to lead the formation of a new company based on Southern’s pharmaceutical formulations business. Brookwood Pharmaceuticals was launched in January 2005 with Dr. Tipton as President and CEO. He also directed the acquisition of Alkermes’ external polymer business which was completed in November 2004. The new company, Lakeshore Biomaterials, was established as a wholly-owned subsidiary of Brookwood. Immediately prior to joining Southern, Dr. Tipton served as Executive Vice President at Durect Corporation, a California-based, publicly traded drug delivery company. Dr. Tipton held a variety of positions in Southern BioSystems, including Vice President and Chief Scientific Officer where he led all efforts on biodegradable technology from 1993-2001. At Southern BioSystems he invented the SABER Delivery System and led its development into multiple clinical campaigns. He was a part of the negotiating team for acquisition of Southern BioSystems by Durect. Prior to joining Southern BioSystems, Dr. Tipton was with Atrix Laboratories (now part of QLT) from 1988-1993.
During his career, his development efforts have led to the launch of four commercial products. He holds 22 US patents with numerous foreign equivalents, and has more than 60 publications, presentations and invited lectures to his credit. Dr. Tipton earned his PhD in Polymer Science and Engineering from the University of Massachusetts, Amherst. He has previously served on the Boards of the Society for Biomaterials and Southern BioSystems, and currently serves on the Boards of Brookwood Pharmaceuticals, the Biotechnology Association of Alabama, and the Controlled Release Society.
Thomas R. Tice, PhD, Vice President, Brookwood Pharmaceuticals - Research, is internationally recognized for research in drug delivery and has lectured on the topic throughout the world. His specialties include microencapsulation, controlled release, and medical applications of biodegradable polymers. In particular he is known for his accomplishments involving injectable, long-acting microparticles made with resorbable polymers designed to release pharmaceuticals and vaccines at precise rates for days, weeks or months. He was a part of the team that developed the first commercial, injectable microparticle product, which was a one-month LHRH formulation indicated for the treatment of prostate cancer (Decapeptyl® SR). His efforts in LHRH microparticle development also led to the patent that was licensed to TAP for Lupron Depot®. Several other drug-delivery products based on his patents and pending patents are being evaluated in the clinic today.
Dr. Tice earned his PhD in Biophysics from Syracuse University, New York. Prior to joining Brookwood Pharmaceuticals, he held a variety of positions at Southern Research Institute (1979-2005), including Director of the Pharmaceutical Formulations Department. He holds 29 US patents with numerous foreign equivalents and has more than 180 publications, presentations and invited lectures to his credit. He has previously served on the Board of the Controlled Release Society, and currently serves on the Boards of McWhorter School of Pharmacy at Samford University, Drug Delivery and Sciences Journal, Drug Delivery Technology, Journal of Microencapsulation, and Expert Opinion on Drug Delivery. Additionally, Dr. Tice currently serves on two expert committees of the US Pharmacopia, the Ad Hoc Committee on Microspheres and the Pharmaceutical Dosage Forms Expert Committee.
John Middleton, PhD, Vice President, Brookwood Pharmaceuticals - Operations, brings a wealth of experience in leading technical teams on programs at both the bench and clinical level. He has been synthesizing biodegradable polymers since the early 1980s. As the Vice President and Technical Director of Birmingham Polymers (BPI), he directed the day-to-day operations of BPI from 1996-2001. During that time he was involved in the synthesis of over 600 batches of polymer and the commercialization of five products. As a Director of Product Development at Durect from 2001-2003, Dr. Middleton lead technical teams on programs at the both bench and clinical level. Previous to his roles in Birmingham Polymers and Durect, Dr. Middleton worked in the industrial fiber business for Monsanto (now Solutia). Dr. Middleton has published 18 articles in scientific and trade journals and holds two patents. He received his doctorate in Polymer Science from the University of Southern Mississippi.
F. Reese Frazer, Senior Director, Brookwood Pharmaceuticals - Licensing and Strategic Affairs, has more than 13 years of experience managing intellectual properties and contracts. He previously assisted with the management of the intellectual property portfolio of Southern Research Institute, and prior to that, spent seven years in the drug delivery industry at Southern BioSystems, Inc. (currently Durect Corporation.) There Mr. Frazer was responsible for directing the licensing and patenting of intellectual property and oversight of the company’s contract portfolio. He has additional experience in a variety of areas of corporate management. As a microbiologist, he conducted R&D projects in a range of scientific disciplines leading to 15 publications. Mr. Frazer earned his MBA from the University of Alabama at Birmingham, and his BS in Microbiology from Auburn University in Alabama.
Jay K. Staas, Senior Director, Brookwood Pharmaceuticals - Product Development leads all of Brookwood’s external research and development programs. In his 20+ year career at Southern Research Institute, Mr. Staas managed research and development programs in the field of pharmaceutical formulations for various government agencies as well as commercial clients around the world. These programs involved the controlled-release or targeted-delivery of a wide range of biologically active materials including: small molecules, peptides, proteins, antigens, including DNA and chemotherapeutic agents. He has led teams that have been the first to advance several products into the clinic, including a melanotan-containing implant, a microsphere-based, anti-cancer formulation, as well as a controlled-release allergy treatment formulation. He holds 11 patents and has contributed to more than 60 presentations and publications. He earned his BS in Chemistry from University of Alabama at Huntsville.
Linda L. Moran, CPA, Senior Director, Brookwood Pharmaceuticals - Finance, has more than 15 years of experience, including employment with the Internal Revenue Service, and corporate accounting in the government contracting, manufacturing, and biotech industries. Mrs. Moran has been involved in all aspects of financial accounting, including financial reporting, budgeting, cost management, business projections and strategic planning.
Robert J. Brady, Director, Brookwood Pharmaceuticals - Quality, is a quality professional with 34 years experience in the areas of Quality Assurance and cGMP, cGCP, and cGLP compliance. Prior to joining Brookwood he worked as an independent consultant to the pharmaceutical industry in the areas of compliance auditing, equipment and facility qualification, and clinical manufacturing. Mr. Brady gained his extensive quality management experience in positions of increasing responsibility with Boehringer Ingelheim Pharmaceuticals and Schering-Plough Corporation. He has presented at several professional meetings, most recently hosting a Webcast presentation on the current U.S. and E.U. cGMP requirements for the Regulatory Affairs Professionals Society (RAPS). Mr. Brady was a field Investigator for the U.S. Food and Drug Administration for thirteen years with experience in drug manufacturing primarily. In the FDA role, he worked in the Philadelphia, Boston and New Jersey District Offices on a variety of pharmaceutical facility inspections. He also has experience in inspections of biologics, medical devices and bioresearch monitoring activities. Bob is a graduate of Temple University in Philadelphia, PA with a B.A. degree in Anthropology.
Kevin W. Burton, PhD, Director, Brookwood Pharmaceuticals - Research, has an extensive background in the research and development of a variety of products utilizing novel drug delivery systems with an emphasis on preclinical and early human proof of concept efforts. These products include those used for controlled and sustained delivery of therapeutic agents such as biodegradable microparticulates, organogels, hydrogels and polymer conjugates for the delivery of analgesics, antibiotics, opioids, opioid agonists, antineoplastics, steroids, and several peptides/proteins. Through his career at Purdue Pharma, DURECT, Nektar Therapeutics and now Brookwood Pharmaceuticals, Dr. Burton has led efforts from early discovery through late phase clinical trials holding key leadership positions in Technical and Scientific Writing, Program Management and Product Development departments. In these positions, Dr. Burton has provided oversight of the CMC aspects of Drug Substance and Drug Product development of parenteral and oral products including Pre-formulation and Formulation Development, Analytical Development, Scale up and Tech Transfer operations. Dr. Burton holds two patents and has contributed to more than 20 publications and presentations. Dr. Burton earned his degree in Pharmaceutical Sciences from the University of Kentucky.
Renata Hawthorne, PhD, Director, Brookwood Pharmaceuticals - Quality Control and Analytical Laboratory, has over 15 years of experience in Analytical Chemistry and instrumentation. She recently completed 1-1/2 years of teaching Chemistry at the University of Alabama in Birmingham. Dr. Hawthorne previously managed the Quality Control Analytical Laboratory at Southern BioSystems, Inc. She also managed the Analytical Development laboratory at BioCryst for 10 years, where she was involved with the set up of the laboratory, instrument purchasing, establishment of procedures for compliance with cGMPs, method development and validation. She began her analytical career working for the Alabama State Forensic Department conducting analyses in the toxicology laboratory. Dr. Hawthorne has contributed to more than 10 publications and presentations. She earned her doctorate in Physical Organic Chemistry from Auburn University in Alabama.
Michael E. Hudson, Senior Director, Brookwood Pharmaceuticals - Manufacturing, brings a broad experience basis in the scale up and clinical trial manufacturing of human parenteral products. He has led teams on multiple efforts for more than 90 lots of a variety of products and at a scale of up to 75 kilograms. He was recently invited to lecture on this experience at the 2005 Annual meeting of the Controlled Release Society. Mr. Hudson also brings 20 years of experience at research and development in the controlled-release field including the encapsulation of steroids, antibiotics, analgesics, peptides, proteins, immunomodulators, and vaccines. He oversees the operation of GMP facilities, including clean room design, construction, testing and monitoring, regulatory interactions and compliance, and GMP requirements for production of clinical trial material. Mr. Hudson holds one patent and has contributed to nine publications and presentations. He earned his BS in Chemistry from Birmingham-Southern College in Alabama.
Peter Markland, PhD, Director, Brookwood Pharmaceuticals - New Technologies, has managed numerous research and development programs involving a wide range of controlled release technologies and drug-delivery applications. In these efforts, Dr. Markland has managed programs ranging from initial feasibility evaluations to formulation identification and optimization through to process scale up and the manufacture of clinical trial supplies. In particular, Dr. Markland has extensive experience in the development of microsphere and implant products and technologies for applications including parenteral, nasal, pulmonary, intrathecal, and ocular/intravitreal routes of administration. He earned his PhD degree in Pharmaceutics at the University of Michigan where he developed and investigated novel polypeptide-based hydrogels. Previously, he worked at Alza Corporation and the Upjohn Company. Dr. Markland holds one patent and has contributed to more than 15 publications and presentations.
Matt Padgett, Director, Brookwood Pharmaceuticals - Facilities Operations, is a Chemical Engineer with over 27 years of diverse experience in the pharmaceutical drug and device industries. His background includes responsibilities for process engineering design, process and facility capital project management as well as leading large commercial manufacturing operations. He specializes in grassroots facility design and construction as well as existing plant upgrades. His engineering and construction management experience includes ranges of projects from small upgrades to $300 million new construction. This has been across a broad range of the industry including API bulk manufacturing, aseptic processing, beta lactams, potent compounds and research. Padgett’s pharmaceutical manufacturing experience gives him a unique perspective in building state of the art facilities that meet the most stringent guidelines. Padgett is formerly from Monsanto, Hoffman-LaRoche, IRIX Pharmaceuticals, Holopack International and most recently Nektar Therapeutics. His role at Roche included leading the engineering effort for a $300 million bulk API manufacturing facility as well as managing the Maintenance/Engineering effort upon facility completion. He held roles at both IRIX and Nektar, where he was responsible for facility master planning, construction and operations management of these emerging companies. He received his BS in Chemical Engineering from the University of South Carolina.
Paul Spencer, Vice President, Brookwood Pharmaceuticals and General Manager, Lakeshore Biomaterials brings more than 20 years of leadership experience including over 14 years in the drug delivery and medical device industries. Prior to joining Lakeshore Biomaterials, he worked in the Business Development Group at Alkermes. His primary responsibility was the Alkermes’ Medisorb® bioabsorbable polymer business unit, which included worldwide sales and marketing, business strategy, product development, and customer service. Mr. Spencer’s experience includes being a top sales consultant and distributor at Biomet’s Subsidiary, W’Lorenz Surgical, where he was involved in the launch and commercialization of the world’s first Craniomaxillofacial absorbable plating system. He also served over six years as a U.S. Army Aviation Officer in the U.S. and abroad. Mr. Spencer holds a BS in Quantitative Business Analysis from Indiana University.