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 .
For more information, please contact:
Dick Jones, Media Relations
Tel: +1-919-998-2091
Email: media.info@quintiles.com
Greg Connors, Investor Relations
Tel: +1-919-998-2000
Email: invest@quintiles.com
