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 John
J. Puisis
Co-Founder, President and Chief Executive Officer
John is a senior executive with over 25 years experience at
transforming technology-based companies into value creating
organizations. He combines a unique set of strategic,
financial, talent management, and operating skills to
identify growth and value opportunities, while optimizing an
organization’s technology and talent. He was President
and CEO of Third Wave Technologies (NASDAQ: TWTI), a biotechnology company, where he led the
transition from a non-sustainable research tools business to
a robust growth driven molecular diagnostics company.
Third Wave was eventually sold for $600 million. John
also served as a strategic consultant to DEKALB Genetics
Corporation which was ultimately sold for $2.8 billion. John
was with the Spencer Stuart and Egon Zehnder life sciences
practice groups where he consulted with biotech and
pharmaceutical firms. John
received his BS - Accounting from Northern Illinois
University and his MBA at Northwestern University.
 James
J. Herrmann
Co-Founder, Chief Operating Officer
James (Jim) is a senior financial and operations executive
with over 20 years experience experience in product
development, manufacturing, sales and marketing. Jim served
as vice president of finance and operations for Third Wave
Technologies (NASDAQ: TWTI), where his responsibilities
included long-range and annual planning, company-wide
systems and infrastructure development, financial and
operational management as well as quality system oversight.
Jim is a graduate of the University of Notre Dame (BBA:
Accounting and English) and the University of Chicago (MBA).
He is a certified public accountant.
 Leslie
O'Toole
Director, Clinical Operations
Leslie is a registered nurse with over 20 years clinical
experience. She started her clinical research career as a
Clinical Research Associate (CRA) in 1994 with Clinimetrics
Research, a full service CRO. She received advanced
training in Regulatory Compliance Auditing and performed
Investigator Site audits. In 1999, Leslie joined the
Project Management department where she managed large, Phase
II-IV multi-service clinical trials for leading
Pharmaceutical and Biotech companies (Fujisawa Healthcare;
now Astellas Pharma, Inc.), Solvay Pharmaceuticals, Genzyme,
Insys Therapeutics, Javelin Pharmaceuticals, Inc.). In 2005
Leslie joined the senior management team at Clinimetrics
where in the role of Director, Project Management, she
played an integral part in developing Clinical Project
Management SOPs and implementing standardized work
instructions and training. Leslie received her BS-Nursing
from the University of Pittsburgh.
 Frank
J. Fokta, PhD
Molecular Biology / Analytics / Quality
Frank is a molecular biologist with biotech experience in
quality systems, quality testing and analytics. He has
served as a quality control manager in a GMP manufacturing
environment and is a Six Sigma green belt. He received
his BS in biology from Loyola University and a PhD from
Marquette University, Milwaukee, Wisconsin.
 Melissa
J. Vrba
Administration
Prior to joining Tolera, Melissa spent 13 years as a
consulting project administrator to Pfizer Corporation across a
wide range of projects including R&D, quality and lean
manufacturing. Melissa has trained in lean manufacturing,
quality systems and project management and has an AB in business
administration.
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 Maria
Siemionow, MD, PhD, DSc
Co-Founder,
Chief Science Technology Officer; Cleveland Clinic Foundation
Dr. Siemionow is Director of Plastic Surgery Research, and
Head of Microsurgery Training in the Plastic Surgery
Department of Cleveland Clinic. She has a faculty
appointment as Professor of Surgery in the Department of
Surgery at the Cleveland Clinic Lerner College of Medicine
of Case Western Reserve University, Cleveland, Ohio. She
was awarded her medical degree by the Poznan Medical
Academy, completed her residency in orthopedics, and then
earned a PhD in microsurgery. She completed a hand surgery
fellowship at the Christine Kleinert Institute for Hand and
Microsurgery in Louisville, Kentucky. In 2008, Dr.
Siemionow led the medical team that performed the first U.S.
facial transplantation surgery. Her research interests
include microsurgery, nerve regeneration, regenerative
medicine, and induction of tolerance in composite tissue
transplant models. She has been awarded a research grant by
the Armed Forces Institute of Regenerative Medicine to study
minimal immune suppression protocols in composite tissue
transplantation.
 Ellen
C. Cooper, MD, MPH
Clinical and Regulatory Affairs Consultant
Dr. Cooper brings extensive clinical development and
regulatory expertise from her roles at the Food and Drug
Administration and in the life science industry. Dr. Cooper
served as the first Director of the Antiviral Drugs Division
and later as Deputy Director of the Office of Biologics
Review at FDA, in addition to other key appointments and
duties within the agency. She served as Director of the
Department of Clinical Research and Information at the
American Foundation for AIDS Research (AmFAR), the largest
privately funded AIDS research organization in the country.
Dr. Cooper also served at the senior management level in the
pharmaceutical and biotech industries, including Syntex
Research and ViroPharma, Inc. Dr. Cooper received her
medical degree from Case Western Reserve University in
Cleveland, Ohio and her Masters in Public Health from Johns
Hopkins in Baltimore, Maryland.
 Patricia
Williams, PhD
Pharmacology and Toxicology Consultant
Dr. Williams is a drug development executive with over 25
years experience in the biotechnology and contract service
industries. Dr. Williams is a pharmacologist skilled in all
aspects of preclinical development and has held various
management positions in the pharmaceutical (Bristol-Myers,
Eli Lilly, American Cyanamid), biotech (Glycomed, Ligand,
Biochem Pharma) and the contract services (SRA Life
Sciences, Therimmune, GeneLogic) industries. Dr. Williams
received her MS in Physiology from Arizona State University,
Tempe, Arizona and her PhD in Pharmacology from the Upstate
Medical Center (SUNY), Syracuse, New York.
Steven
A. Brown, PhD
Technology and Antibody Research
Stephen Brown, PhD, is a Researcher and Principal
Investigator in the Department of Internal Medicine at the
University of Kentucky and co-inventor of
the company’s underlying anti-ab TCR antibody technology. He
earned his MS degree from Iowa State University and his PhD from
the University of Kentucky. Steve has extensive research
experience with monoclonal antibodies and is co-inventor of
numerous immune targeting antibodies. His current research
interests include the induction of transplantation tolerance,
graft versus host disease, and the immunological effects of
radiation.
 Daniel
Getts, PhD Immunology/Technology Development
Daniel is an immunologist / pathologist with research
expertise in T-cell mediated disease and tolerance induction.
Most recently he was a post doctorate fellow in the Department
of Microbiology and Immunology at Northwestern University,
Chicago. He earned a Bachelor of Medical Science and a PhD from
the University of Sydney, Sydney, Australia.
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