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.
Lisa Fey - Associate Director Research & Development
Lisa Fey has over 30 years of experience in academia, pharmaceuticals, and contract research organizations with expertise in data integrity, in vivo and bioanalytical assays, regulated animal facility management and regulated laboratory operations. Lisa has a BS in Biology from San Diego State University and has studied in the graduate program at the SDSU School of Public Health. Lisa holds RQAP-GLP certification from the Society of Quality Assurance (SQA) and the LATg certification from the American Association of Laboratory Animal Sciences (AALAS). Most recently as part of Nielsen Biosciences, she has expanded her knowledge to cGCP and cGMP processes including clinical trial management and stability testing of commercial products.
Louise Firme, M.S., ASQ-CQA, RQAP-GLP - Associate Director Regulatory and Quality
Louise Firme has served as the Associate Director of Regulatory and Quality since February 2016. Ms. Firme has 15 years of experience in the pharmaceutical and biotech industries. She brings quality and compliance experience in GMP, GCP, and GLP. Prior to joining Nielsen BioSciences, Inc., she was responsible for oversight of the Quality programs at Therapeutics, Inc. and Ambrx, Inc. In addition to positions held in Quality, she also served in research and development positions at Amylin Pharmaceuticals, Inc., The Scripps Research Institute, and Weill Cornell Medical College. Ms. Firme received her bachelor’s degree in Chemistry from the University of California at Berkeley and M.S. degree in Regulatory Affairs from San Diego State University. She also holds certifications as a Certified Quality Auditor and Registered Quality Assurance Professional.
Masoud Ansari - Associate Director Pharmaceutical Development
Mr. Ansari has over 30 years of experience in the medical device and pharmaceutical industries with specific experience in microbiology, validation, manufacturing, and quality functions with extensive cGMP, FDA and compliance experience in biologics and sterile products. Most recently, he served as Site Quality Lead at Allermed facility of Stallergenes in San Diego, California, where he managed the quality system for a manufacturer of allergenic extracts. Prior to Allermed, Mr. Ansari was managing the microbiology laboratory at Medtronic (San Diego) where he managed the microbiology, sterilization and biocompatibility studies for the manufacture of cardiovascular devices. Mr. Ansari holds a B.S. in medical microbiology with minor in chemistry from the University of California Long Beach.
Vicki Clauson - Director Clinical Operations
Vicki Clauson has over 25 years of experience in Clinical Operations with in a variety pharmaceutical and medical device organizations ranging from Phase I through Phase III. Prior to joining Nielsen BioSciences, Inc., Vicki has held clinical research positions of increasing responsibility within Pharmaceutical companies, Medical Device companies and CROs including Ardea BioSciences, an Astra Zeneca subsidiary, Pfizer, Medtronics and PPD. Vicki has overall responsibility for the Project Management and operational delivery of multiple clinical studies at Nielsen. Vicki holds a BSc degree in Biology from Southeast Missouri State University.
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