Former FDA, Industry Experts Have More Than 115 Years of Experience
RESEARCH TRIANGLE PARK, N.C., May 8 /Xinhua-PRNewswire/ -- Quintiles Transnational Corp. today announced the formation of a global biologics regulatory team to advise customers about development plans and optimal strategy for regulatory submissions for vaccines, monoclonal antibodies, stem-cell based therapies and other biological products.
The team has been created in response to increasing requests for regulatory expertise in the expanding field of biologics. The expansion has been fueled by recent breakthroughs in the use of monoclonal antibodies for the treatment of cancer, new developments in blood substitutes, stem-cell based therapies, and the development of promising future vaccines for emerging infectious diseases.
The team is led by Ed Tabor, head of Regulatory Affairs, Americas, and by Beatrice Deprez, head of Regulatory Affairs, Europe and International.
"Over the past several years, biologics have acquired an increasing share of new product development in the pharmaceutical and biotechnology industries," said Tabor. "The experts in this new Quintiles Regulatory unit understand the major and minor differences between what regulatory authorities expect for the successful development of drugs and what is expected for biologics. Successful biologics development begins with good planning, and that starts with a clear understanding of the regulatory landscape."
The team members are:
-- Ed Tabor, Executive Director, a former FDA division director in both
the Center for Biologics Evaluation and Research (CBER) and the Center
for Drug Evaluation and Research (CDER), and formerly Associate
Director for Biological Carcinogenesis at the National Cancer
Institute, National Institutes of Health.
-- Lou Mocca, Senior Director, who had 20 years of experience in CBER as
well as 10 years in Regulatory Affairs in industry, working
extensively with vaccines.
-- Judith Hoglind, Senior Director, who has 17 years of Regulatory
Affairs experience with extensive experience in biologics, most
recently with cancer vaccines.
-- Paul Aebersold, Senior Director, who joined Quintiles April 16 after
16 years in the FDA, the last 13 in the Clinical Review Branch,
Division of Hematology, Office of Blood Research and Review, CBER.
-- Beatrice Deprez, Executive Director, who has more than 25 years of
European Regulatory Affairs experience in various therapeutic areas.
-- Linda Lebon, Director, who has more than 10 years of Regulatory
Affairs experience in biologics, including all aspects of vaccine
development.
-- Angelique Winzenrieth, Director, who has more than 10 years of
Regulatory Affairs experience in biologics, including cell therapy
products.
-- Philippa Whiteside, Associate Director, who has more than 10 years of
Regulatory Affairs experience, including recombinant proteins,
monoclonal antibodies, vaccines, DNA products and cell therapy
products.
The addition of Paul Aebersold provides an important expansion of the team's scope, based on his years at FDA and his familiarity with a broad range of regulatory issues, Tabor said. "We're very pleased that Paul is joining our team," he said. "He's well known for his leadership and expertise in biologics through his extensive experience in the FDA, particularly in plasma derivatives. We began receiving calls from industry people who wanted to work with him as soon as word got around that he would be joining us."
About Quintiles
Quintiles Transnational Corp. is powering the next generation of healthcare by providing a broad range of professional services in drug development, financial partnering and commercialization for the biotechnology and healthcare industries. With 17,000 employees and offices in more than 50 countries, it is focused on providing customer-centric solutions that are the gold standard of the industry. For more information, please visit the company's Web site at http://www.quintiles.com .