"Our clients
require a fusion of scientific, regulatory and business
expertise to help them develop products for worldwide
bio/pharmaceutical markets," said Alberto Grignolo, Ph.D.,
Corporate Vice President and General Manager of PAREXEL
Consulting. "Our expanding team of consultants in Washington,
D.C., many of whom have in-depth experience as former
regulators, will assist our clients in gaining regulatory
approval for important products."
PAREXEL Consulting Appointments
- Carolyn Finkle, Vice
President at PAREXEL Consulting, has more than 24 years of
experience in drug development, regulatory affairs, Good
Manufacturing Practice (GMP), pharmacology, drug product
safety evaluation, clinical development, post-approval
requirements, and scientific research. Ms. Finkle is
responsible for management of the product development and
regulatory consulting team in North America, focused on
helping clients optimize all aspects of the development
process for drugs, biologics, devices and combination
products. Prior to joining PAREXEL Consulting, Ms. Finkle was
Vice President of Regulatory Affairs at Celsion Corporation.
Her prior experience includes management of pre-clinical
development and drug development for TherImmune Research (now
Gene Logic), Gemin X Biotechnologies, and ConjuChem. Ms.
Finkle holds a Master of Science degree in chemistry from the
University of Toronto and a Bachelor's degree in chemistry
from the University of Ottawa. Ms. Finkle is currently on the
faculty of the Pharmaceutical Education and Research
Institute.
- Lawrence Grylack, M.D., is a
Principal Consultant at PAREXEL Consulting. Prior to joining
PAREXEL Consulting, Dr. Grylack served as Medical Officer in
the Division of Pediatric Drug Development in the Office of
Counterterrorism and Pediatric Drug Development, and the
Division of Pulmonary and Allergy Drug Products at the FDA
Center for Drug Evaluation and Research (CDER). In this role,
he handled reviews of adverse event reports, investigational
new drugs (INDs) and new drug applications (NDAs), and
performed consultations for other CDER Divisions and other FDA
Centers. His 40 years of medical experience include positions
as a neonatologist at Columbia Hospital for Women, Georgetown
University Hospital, and Fairfax Hospital. Previously, Dr.
Grylack taught in the Department of Pediatrics at the
Georgetown University School of Medicine, and conducted
clinical research. Dr. Grylack is Board Certified in
pediatrics and neonatal-perinatal medicine and holds an M.D.
from Tufts University School of Medicine, and a Bachelor's
degree from Brandeis University. He was granted fellowships in
neonatology from Washington Hospital Center and Georgetown
University.
- David Morse, Ph.D., is a
Principal Consultant at PAREXEL Consulting. Dr. Morse has more
than 20 years of experience in pharmacology and toxicology.
Before joining PAREXEL, he worked as a supervisory
pharmacologist for the FDA's CDER, where he provided strategic
regulatory oversight for all phases of product development and
safety testing for new therapeutics. Dr. Morse's experience
includes drug, biologic and combination products for the
treatment of a broad variety of indications, with a focus on
serious and life threatening disease indications, including
infectious diseases and oncology. In his most recent position,
Dr. Morse was responsible for the oversight of more than 150
pre-IND, IND, and NDA applications per year. He was awarded
his doctorate from the Uniformed Services University of the
Health Sciences, in Bethesda.
- Sally Hargus, Ph.D., is a
Senior Consultant at PAREXEL Consulting. Dr. Hargus has over
15 years of combined research, industry, and regulatory
experience in pharmacology and toxicology aspects of drug
development. Prior to joining PAREXEL Consulting she held
senior positions in toxicology, including with 3M
Pharmaceuticals and with the FDA's Center for Biologics
Evaluation and Research (CBER), where she reviewed
pharmacology and toxicology sections of IND, pre-IND, and
biologic license application (BLA) submissions for vaccines
and allergenic products. Dr. Hargus received the 2006 CBER
Director's Award for outstanding performance as a member of
RTSS Malaria Vaccine Working Group. Dr. Hargus holds a Ph.D.
and Master's degree in pharmacology degree in biology from
Augustana College, in South Dakota.
- Patrick Guinn is a Manager
at PAREXEL Consulting. Prior to joining PAREXEL Consulting Mr.
Guinn served as Consumer Safety Officer/Regulatory Health
Project Manager at the FDA's CDER. With more than 10 years of
FDA experience Mr. Guinn's expertise includes preparation and
facilitation of FDA regulatory meetings and negotiations,
coordination of activities for multi-disciplinary review
teams, management of the drug review process, and development
of several regulatory Guidances documents for the industry.
His career at the FDA includes serving in the Office of Drug
Safety and Division of Virginia Tech.
About PAREXEL International
PAREXEL International Corporation is a leading global
bio/pharmaceutical services organization, providing a broad
range of knowledge-based contract research, medical
communications and consulting services to the worldwide
pharmaceutical, biotechnology and medical device industries.
Committed to providing solutions that expedite time-to-market
and peak-market penetration, PAREXEL has developed significant
expertise across the development and commercialization
continuum, from drug development and regulatory consulting to
clinical pharmacology, clinical trials management, medical
education and reimbursement. Perceptive Informatics, Inc., a
subsidiary of PAREXEL, provides advanced technology solutions,
including medical imaging, to facilitate the clinical
development process. Headquartered near Boston, Massachusetts,
PAREXEL operates in 56 locations throughout 43 countries around
the world, and has over 6,215 employees. For more information
about PAREXEL International visit http://www.PAREXEL.com.
This release contains "forward-looking" statements regarding
future results and events. For this purpose, any statements
contained herein that are not statements of historical fact may
be deemed forward-looking statements. Without limiting the
foregoing, the words "believes," "anticipates," "plans,"
"expects," "intends," "appears," "estimates," "projects,"
"targets," and similar expressions are also intended to identify
forward-looking statements. The forward-looking statements in
this release involve a number of risks and uncertainties. The
Company's actual future results may differ significantly from
the results discussed in the forward-looking statements
contained in this release. Important factors that might cause
such a difference include, but are not limited to, risks
associated with: actual operating performance; actual expense
savings and other operating improvements resulting from recent
restructurings; the loss, modification, or delay of contracts
which would, among other things, adversely impact the Company's
recognition of revenue included in backlog; the Company's
dependence on certain industries and clients; the Company's
ability to win new business, manage growth and costs, and
attract and retain employees; the Company's ability to complete
additional acquisitions and to integrate newly acquired
businesses or enter into new lines of business; the impact on
the Company's business of government regulation of the drug,
medical device and biotechnology industry; consolidation within
the pharmaceutical industry and competition within the
biopharmaceutical services industry; the potential for
significant liability to clients and third parties; the
potential adverse impact of health care reform; and the effects
of exchange rate fluctuations and other international economic,
political, and other risks. Such factors and others are
discussed more fully in the section entitled "Risk Factors" of
the Company's Quarterly Report on Form 10-Q for the period ended
December 31, 2006 as filed with the SEC on February 9, 2007,
which "Risk Factors" discussion is incorporated by reference in
this press release. The forward-looking statements included in
this press release represent the Company's estimates as of the
date of this release. The Company specifically disclaims any
obligation to update these forward-looking statements in the
future. These forward-looking statements should not be relied
upon as representing the Company's estimates or views as of any
date subsequent to the date of this press release.
PAREXEL is a registered trademark of PAREXEL International
Corporation, and Perceptive Informatics is a trademark of
Perceptive Informatics, Inc. All other names or marks may be
registered trademarks or trademarks of their respective business
and are hereby acknowledged. |