H. Stewart Nielsen, Jr., Ph.D. Vice Chairman and Founder
Prior to joining Nielsen, Dr. Nielsen founded Allermed Laboratories, Inc. and served as President of the company for over 40 years. His interest in the antigenic properties of plants and microorganisms provided the foundation for developing and licensing numerous products in the field of allergy and immunology. His current interests at Nielsen BioSciences, Inc. include the diagnostic and therapeutic use of antigenic materials of Candida albicans and Coccidioides immitis. Dr. Nielsen received his B.S. in Biology and M.S. in Botany from Brigham Young University. Dr. Nielsen received his Ph.D. in Botany and Microbiology from The Ohio State University. He was awarded a National Science Postdoctoral Fellowship in Medical Mycology, which he completed at Duke University. He was a member of the Department of Microbiology and Immunology at Duke University Medical Center where he taught microbiology, mycology, and parasitology.
David P. Burney, Ph.D, MBA President and COO
Dr. Burney has had over 20 years executive experience in the pharmaceutical industry with specific experience in manufacturing, quality and regulatory functions with extensive cGMP, FDA and compliance experience in biologics and sterile products. Most recently, he served as Vice President of Quality Operations at Biotest Pharmaceutical Corp. in Boca Raton, Florida, where he managed all aspects of quality for a manufacturer of plasma derived biological sterile drugs. Prior to Biotest, Dr. Burney was Vice President and Chief Operating Officer at Greer Laboratories, Inc. where he managed the Quality, Manufacturing and Regulatory Affairs Departments for the manufacture of allergenic extracts. Dr. Burney holds a Ph.D. in Chemistry from the University of Memphis and an MBA from Ashland University.
Scott Nielsen, MBA Vice President Operations
Mr. Nielsen has over 25 years of experience as a financial professional, with over 20 years within the biotech industry. He has executive responsibility for the general business operations of Nielsen BioSciences, Inc. Mr. Nielsen began his career in public accounting with Deloitte in San Diego, where he was a Senior Consultant. He transitioned to the private sector as Controller for Emerald Publications, a marketing company that services the financial industry. He moved to the biotech industry as Vice President of Business Operations at Allermed Laboratories, Inc., a pharmaceutical manufacturer. Mr. Nielsen is a Certified Public Accountant. He received his B.S. in Accounting from Brigham Young University and his MBA from Georgetown University.
Nelson Lugo, MBA Vice President Manufacturing
Nelson Lugo has over twenty five years’ of experience in the areas of biopharmaceutical process development and manufacturing. He most recently served as Sr. Director, Manufacturing and San Diego Site Lead for AstraZeneca PLC. Mr. Lugo has worked in process development and manufacturing of products derived from multiple sources. He has managed the technology transfer of products from R&D into Commercial and has overseen multiple contract CMOs for DS (API), fill/finish operations and secondary packaging sites. He has managed the technology transfer at XOMA (US) LLC, Scios, Inc., and Amylin Pharmaceuticals, Inc. He’s directed the manufacturing operations for Melville Biologics, Dendreon Corporation and ISTA Pharmaceuticals, Inc. He has been a guest lecturer at the University of California, Berkeley covering issues in Manufacturing. Mr. Lugo authored an article on the “Management Life Cycle Process” published in the Oct’09 issue of “Contract Pharma” magazine. Mr. Lugo received his Bachelor’s degree in Clinical Chemistry from York College, New York and holds an MBA from Adelphi University, New York.
Karen Adam, Head of Quality
Karen Adam serves as a consultant overseeing quality at Nielsen. Ms. Adam brings senior leadership experience in quality, compliance and operations for GMP, GCP, and GLP serving major biotechnology companies for over 20 years. Most recently she served as Sr. Director Quality Compliance at AstraZeneca, (formerly Amylin Pharmaceuticals) for 9 years overseeing manufacturing quality for global pharmaceutical products and drug development efforts. Ms. Adam previously served as Senior Director, Quality at Skye Pharma and as Director, Quality at Pfizer La Jolla. Ms. Adam has a BS in Chemistry from University of Wisconsin, Madison, WI.
Don Rindell, MBA Business Development
Don Rindell has more than 25 years of senior executive experience in the life sciences industry. He has held executive roles in global corporate development, business development and device/technology strategy for several US and European pharmaceutical and medical device companies. Don most recently served as Senior Director of Corporate Development at Amylin Pharmaceuticals, and has led a number of key global transactions with partners including Lilly, Shionogi Pharmaceuticals, BIOCON, and Takeda Pharmaceuticals. Don is a member of the Board of Directors of publicly traded TearLab (NASDAQ: TEAR), and advisor to two other medical device companies. He has previously held senior executivepositions at MDG, CardioNet, Advanced Tissues Sciences, Braun/Thermoscan, and Hybritech. Don received his B.A. degree in Economics from the College of Wooster and an M.B.A. from Pepperdine University Graduate School of Business.
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