LEXINGTON, MA, July 27, 2000
- Genta Incorporated (Nasdaq:
GNTA
) announced the hiring of Paul F. Manley, formerly World Wide
Director of Regulatory Affairs at Johnson & Johnson, as its new
Vice-President for Regulatory Affairs.
Mr. Manley has more than 14 years of Regulatory Affairs
experience. Since 1990, he has held positions of increasing
responsibility within the J&J family of companies, both in the
U.S. and the U.K. He has directed a number of regulatory filings,
including multiple New Drug Applications (NDAs), Investigational
New Drug (IND) exemptions, supplemental NDAs, and European
Centralized and Multistate procedure applications. These
submissions have encompassed a variety of New Chemical Entities
across a broad range of therapeutic categories. His experience has
included negotiations with government agencies, safety monitoring,
and general management of Clinical and Research Quality Assurance.
Immediately prior to his current position, he was Director and
therapeutic area head within the R.W. Johnson Pharmaceutical
Research Institute of J&J, where he led U.S. and international
regulatory support for Hematology/Oncology, including Ortho
Biotechs largest product, PROCRITÒ(Epoetin alfa). Prior
to joining J&J, he was associated with Forest Laboratories,
Inc. and Medeva, Inc.
"Paul has exactly the broad range of knowledge and expertise
that we were looking for in this position," commented Dr. Raymond
P. Warrell Jr., Gentas President and CEO, who also noted: "He
enjoys excellent relations with FDA, and he has the depth of NDA
experience that we require as Genta prepares its own submission for
Genasense
TM
, pursuant to its Fast Track designation."
"This is an enormously exciting time for Genta," noted Mr.
Manley. "Genasense presents an extraordinary opportunity that will
fully utilize my experience across a range of disciplines. I am
very pleased to be joining senior management and look forward to
taking a key role in directing both the new applications as well as
the future direction of the Company."
