Former FDA, industry experts have more than 115 years of experience
RESEARCH TRIANGLE PARK, N.C., May 7 /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.
SOURCE Quintiles Transnational Corp.
 back to top
Related links:
http://www.quintiles.com
CONTACT:
Dick Jones, Media Relations,
media.info@quintiles.com, or +1-919-998-2091, or Greg Connors,
Investor Relations, invest@quintiles.com, or +1-919-998-2000
|
