|
Ms. Wei has more than 20 years of biotechnology and pharmaceutical industry experience focused in regulatory affairs and quality assurance arenas before joining Favrille, Inc. in October 2002. Her involvement in the bio-pharmaceutical arena has included development of products in a variety of therapeutic areas (oncology, anti-inflammatory and immunologic disease, medical imaging/radiopharmaceuticals, anti-viral and anti-infective agents, dermatology, anesthetics/analgesics, and neuropharmacology) as well as managing a variety of product types (i.e., injectable, orals, and topicals), and developing the infrastructure for several regulatory affairs units. She was employed at IDEC Pharmaceuticals from 1993-2002, most recently as Department Head/Senior Director of Regulatory Affairs. While at IDEC, Ms. Wei led the company's successful efforts for FDA approval of Rituxan® and Zevalin®. Rituxan® was the first monoclonal antibody approved for oncology and Zevalin® is a "first in class product" - radioimmunotherapy. The Rituxan® clinical development program and registration strategy culminated in a BLA that was approved by FDA in only 9 months. In addition, she was instrumental in the company's receipt of FDA approval for a Rituxan® supplemental BLA that expanded the label for two additional patient populations and a new dosing schedule. She played a prominent and lead role in obtaining FDA licensing for IDEC's manufacturing facilities and the development of new FDA initiatives for oncology products and electronic filing standards. Zevalin® was the first radioimmunotherapy approved and today, remains the only therapy of its kind approved anywhere in the world. Ms. Wei also contributed to the organizational development of the clinical research and regulatory affairs division and participated in the company's growth from around 60 people in 1993 to a corporation of around 1000 staff in 2002. | 