NEW YORK (January 18, 2005) — Callisto Pharmaceuticals, Inc., a biopharmaceutical company primarily focused on the development of drugs to treat cancer and osteolytic bone disease, has announced the appointment of Paula Craft to the newly-created position of Vice President, Regulatory Affairs.
Craft brings to Callisto more than 18 years of regulatory, quality and compliance experience in biologics and pharmaceuticals.
“Callisto has two drugs that will be in clinical trials in 2005,” said Dr. Donald Picker, executive vice president, research and development. “To drive these programs, it is imperative we have an executive of Paula’s caliber to manage regulatory affairs and product direction throughout the entire product lifecycle, from strategy, government regulation, quality assurance and testing, through distribution partnerships and product launch. We look forward to having Paula join our team.”
Craft most recently held the position of president, regulatory compliance, quality systems and strategic planning for Biopharmaceutical Consulting. In this role, she led the company’s efforts in drug safety, internal audits and testing, supply chain management, software program selection, product testing and compliance, budget planning, and quality control.
Prior to her role at Biopharmaceutical Consulting, she held vice president and senior director level product support, quality assurance and compliance positions with Alexion Pharmaceuticals, Johnson & Johnson, and American Home Products. She received her bachelor’s degree from the University of Rhode Island and continued her graduate studies at Eastern Connecticut State University and Rutgers (University of Medicine and Dentistry of New Jersey).