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Cylex
Incorporated® (Cylex) is
a global life science company that develops and manufactures research
and in vitro diagnostic
products that are intended to illuminate immunity. ImmuKnow® is
an in
vitro diagnostic utilized to detect cell mediated immunity in an
immunosuppressed population, and is increasingly being adopted at organ
transplant centers throughout the country. The Company’s patented
technology provides an innovative platform allowing clinical researchers
to simply and reproducibly measure immune cell function for the development
of new diagnostics, biomarkers and companion assays.
Commercialization
In 2002, Cylex began marketing ImmuKnow, the immune cell function assay,
as an in vitro diagnostic. The assay is
used for the detection of cell-mediated immunity in an immunosuppressed
population.
Method
Patent Issued in 1998
An SBIR contract with the Department of Defense involved developing methods
for monitoring immune response to a vaccine for Q-fever. From this preliminary
work, the Company's method patent for the measurement of T cell activation
arose. The growing company portfolio has patents in the U.S. and Australia
and pending patents in Europe, Canada, and Japan.
Management
Team
The management team at Cylex has
extensive experience in developing, manufacturing, marketing and distributing
medical diagnostic products. Their collective experience spans start-up
companies to multi-billion dollar corporations.
 Brad
L. Stewart, President
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Cylex
President
Brad L. Stewart is responsible for global commercial operations,
corporate strategy and business development. An experienced senior
executive, Mr. Stewart maintains a record of success in many specialty-areas
of the life sciences industry including: biotech; pharmaceuticals;
orphan drugs; and diagnostics.
His accomplishments include the establishment and leadership of
a successful U.S. business for a European pharmaceutical company;
growth and diversification of an orphan drug company; strategic
restructuring of the North American business unit of a global pharmaceutical
company; development and management of joint ventures, including
a multi-million dollar global pharmaceutical venture; creating
an operational improvement business within a major global diagnostics
company; and extensive management consulting and corporate strategy
assignments.
Mr. Stewart is a graduate of the University
of Florida.
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Norman
Paradis, M.D., Chief Medical Officer and Vice President, Clinical
Affairs
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Dr. Norman Paradis is vice president of clinical affairs and chief
medical officer for Cylex. He is responsible for Clinical Affairs,
a department that oversees execution of clinical trials, and Medical
Affairs, which is the interface between the company and the clinical,
academic and research communities. The company's research and development
group also reports to Dr. Paradis.
Dr. Paradis, author of more than 60 scientific articles and texts,
is a biomarker development authority: in university, public and
private sector settings, Dr. Paradis distinguishes himself with
more than 20 years of research and administrative experience.
As vice president for clinical and medical affairs at Biosite
Inc. (now Inverness), Dr. Paradis managed research and development
initiatives to seek molecular diagnostics in more than a dozen
clinical areas including sepsis, stroke and cardiac. He served
as professor of surgery and medicine at the University of Colorado;
senior medical director at University of Colorado Hospital, where
he headed a research group with active programs in real-time diagnostic
technology, hemodynamics, hypothermia, stroke biomarkers and emergency
cardiopulmonary bypass; and led research groups to investigate
ischemia-reperfusion in various clinical, academic and administrative
positions at Columbia University, New York University and the Medical
College of Virginia.
Dr. Paradis earned his M.D. degree from Northwestern University,
trained in emergency medicine at the University of Southern California
(USC) and completed a research fellowship at Henry Ford Hospital.
He is adjunct faculty at USC and the University of Colorado, and
a fellow of the American Board of Emergency Medicine.
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Michael
Petruny, Vice President, Sales
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Michael Petruny, M.S., is vice president of sales at Cylex.
Guided by over 25 years of sales and marketing experience, he
manages the field activities of a growing national sales team,
and is responsible for revenue and profitability budgets. He
was instrumental in redefining the sales model used to promote
ImmuKnow to health care providers.
Mr.
Petruny’s initial health care experiences led to senior
director and vice president positions at two consulting firms
specializing in peer-to-peer selling, and market research and
consulting. Then, at Fujisawa Healthcare, he rose to the position
of senior director of immunology sales, ultimately developing
a team of 45 sales and management professionals responsible for
the Tacrolimus™ product line, an anti rejection transplant
product. Mr. Petruny served as regional manager for Enzon
Pharmaceuticals, where he managed sales of anti-fungals in the
bone marrow transplant market, along with an oncology product.
Mr.
Petruny holds an undergraduate degree in economics and a master’s degree in marketing from Louisiana State University
(LSU). While at LSU, Mr. Petruny authored 10 peer-reviewed articles
in the field of marketing. He provided research for a sales
management textbook that became widely used across the country.
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Richard
J. Kowalski, Ph.D., Director, New Market Development and Clinical
Studies
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Dr.
Richard Kowalski, an experienced senior
executive, is acting director of medical and clinical affairs at
Cylex. He is responsible for the use of Cylex platform technology
with immunosuppressed populations, as well as design and implementation
of multi-center studies required to generate data for ImmuKnow
in all of its various applications. These studies support market
expansion into new areas including allogeneic hematopoietic stem
cell transplantation, Hepatitis C, HIV and cancer.
As senior manager of preclinical development for Osiris Therapeutics,
Dr. Kowalski assisted in the development of cell-based therapeutics
for gene therapy and tissue regeneration using Mesenchymal stem
cells. He spent several years as a research and development scientist
at Cambridge Biotech, a subsidiary of BioMerieux-Vitek.
Dr. Kowalski
earned a bachelor’s degree in biochemistry/molecular
biology from the University of Maryland, and a doctorate in molecular
biology from Vanderbilt University. He completed postdoctoral training
at the University of Florida and the National Cancer Institute.
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Lucy
Carruth, Ph.D., Director, Product Development
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Dr.
Lucy Carruth is director of research and development and new
product development for Cylex. Drawing on more than 15 years
of experience in immune monitoring research and assay development,
she pioneers new developments in the company’s successful
ImmuKnow immune cell assay and related products.
Dr. Carruth worked with collaborative national and international
organizations to develop assays to measure T lymphocyte function
in candidate AIDS vaccine trials and for clinical studies using
a non-human primate model of AIDS dementia. She served as director
of the Immunology Core Laboratory of the HIV Prevention Trial
Network and managed the cellular immunology testing of candidate
vaccines for the AIDS Vaccine Evaluation Group at the Center
for Immunization Research, Johns Hopkins School of Medicine.
Dr.
Carruth holds a bachelor’s degree in zoology from
Duke University and a doctorate in immunology and microbiology
from the Wake Forest University School of Medicine. She served
on the faculty at the Johns Hopkins University School of Medicine
(Infectious Disease and Comparative and Molecular Pathobiology),
where she maintains an adjunct appointment.
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Stacey
Wills Yager, M.P.H., Ph.D., Director, Marketing
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Dr. Stacey
Wills Yager, marketing director, develops and manages national
and international marketing programs at Cylex. She brings nearly
20 years of bio-pharmaceutical industry experience and a strong
record of global success to her role.
During her director-level positions at Pfizer and
Pharmacia, she built medical-marketing programs that elevated
the most profitable global bio-pharmaceutical brands in these
companies’ portfolios. As global director at Wyeth,
Dr. Yager built ex-US medical-marketing programs for its flagship
autoimmune disease product.
A former faculty member at the Johns Hopkins
Medical Institutions, Division of Internal Medicine, Dr. Yager
earned a doctorate in health outcomes research techniques while
serving as consultant to the Covance Health Economics and Outcomes
Research group. She earned a master’s degree in public
health from the School of Medicine at Yale University,
with a focus on health economics.
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Tracy
Hall, Director, Manufacturing
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Tracy
Hall, director of manufacturing at Cylex, is responsible for
production of the company’s successful ImmuKnow immune
cell assay and related products. An expert in his field, Mr.
Hall brings more than 13 years of experience producing in
vitro diagnostic devices.
As
manager of manufacturing (including filling operations
and kit assembly) for Digene Corp., Mr. Hall directed the
development of processes consistent with GMP and
International Organization for Standardization (ISO) requirements,
positively impacting rapid corporate growth. Prior to that, he
held senior manufacturing and laboratory positions at Igen
Inc. and Oncor, Inc.
Mr.
Hall earned a bachelor’s degree in biology from Virginia
Polytechnic Institute and State University.
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Teri
Toth, Director, Quality Systems
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Teri
Toth, director of quality systems at Cylex, is responsible
for maintaining standards of excellence for the company’s
successful ImmuKnow immune cell assay and related products. With
a distinguished career spanning more than 25 years, Ms. Toth
provides expertise in microbiology, quality control and quality
assurance.
At KPL Inc., Ms. Toth implemented a c-GMP/ISO 9001 Quality System
and coordinated the USDA licensing of 21 veterinary diagnostic
kits. She moved into human diagnostic kits at Dexall Biomedical
Labs Inc., where she managed FDA-licensed human diagnostic kits
for allergy testing and obtained CE marking and EU IVD approval
for their products. She implemented global quality assurance
systems, global change control systems and integrated new DNA
and RNA purification products at QIAGEN Inc.; and, as director
of quality at MaxCyte Inc., an instrument manufacturer for cell
therapeutics, successfully implemented a GMP Quality System and
obtained ISO 9001:2000 certification in a 14-month period.
Ms.
Toth earned a bachelor’s degree in general science
from Bridgewater College in Bridgewater, Virginia.
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