Andrea Paulson Email Address

Lab Group and Technical Project Lead

Saucony, Inc. (Saucony) designs, develops and markets performance-oriented athletic footwear, athletic apparel and casual leather footwear. The Company operates in two segments: the Saucony segment and the Other Products segment. The Saucony segment consists of Saucony technical and Originals footwear, and Saucony apparel. The Other Products segment consists of Hind athletic apparel and Spot-bilt shoes for coaches and officials, cleated football and multi-purpose footwear, and casual leather walking and workplace footwear, together with sales of Saucony's and other companies' products at its 21 factory outlet stores. Saucony's products include technical running, walking, cross training and outdoor trail shoes, and athletic apparel that are sold under the Saucony brand name, and technical running shoe models from the early 1980's, which Saucony reintroduced in 1998 as Saucony Originals, its classic footwear.

Prior to retirement, Andrea Paulson's most recent position was as Associate Research Fellow and lab group leader in Pfizer Biotherapeutics Pharmaceutical Sciences, Drug Product Design and Development in Andover, MA. Andrea has over 32 year's experience in the development of parenteral products, primarily focused on biologic NME’s. Responsibilities included drug product (DP) formulation and process development for the Pfizer biotherapeutic portfolio, from FIH dosage form development, technology transfer and validation of commercial DP processes, through licensure. Past efforts included DP Technical Project Lead for lyo-to-prefilled syringe manufacturing change, plus managing DP-CMC aspects of several manufacturing process and site changes for a commercially successful biologic. Another recent past project was FIH formulation and DP process development of immune-oncology medicines. Areas of research interests • Dosage form design of antisense oligonucleotide (ASO) • Delivery of DNA via viral vectors and other drug delivery systems • Mabs and fusion proteins from candidate selection through commercialization • Tech transfer of biotherapeutic DP to commercial sites, including QbD • Particularly experienced in commercial manufacture of prefilled syringes • Commercial-scale DS freeze-thaw systems • Authoring pharmaceutical development sections of regulatory dossiers for commercial BLA, MAA etc, applications Andrea received a B.S. in Pharmacy from Philadelphia College of Pharmacy (University of the Sciences in Philadelphia) and was a registered pharmacist with experience in community and hospital pharmacy. She holds M.S. and Ph.D. degrees in Pharmaceutics from the School of Pharmacy, University of Wisconsin – Madison (minor – Physical Chemistry). She is co-inventor with Jason Fernandez and Dan Dixon of patent 9,393,304 "Formulations of Single Domain Antigen Binding Molecules"