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CTTG’s attorneys have extensive experience in technology
transfer. As technology transfer professionals at the National Institutes
of Health, they assisted government scientists and researchers to establish
partnerships with industry for the development of a wide range of technology.
In private practice they have represented pharmaceutical companies, medical
device and dietary supplement manufacturers, law firms, and academic medical
centers on technology transfer matters and regulatory issues concerning
the clinical research and development of drugs, medical devices, natural
products, and dietary supplements.
Kate Duffy Mazan brings a unique blend of experience
in law and health care to CTTG’s legal team. Kate has expertise
in technology transfer and clinical research compliance in both the
public and private sector.
For the past 7 years Kate has practiced exclusively
in the area of food
and drug law with an emphasis on the regulation of clinical research.
In private practice she has assisted a variety of companies and institutions
in complying with federal and state laws and regulations governing the
conduct
of clinical trials. Kate has extensive experience in the negotiation
of clinical trial agreements and the regulatory review of clinical research
practices. Prior to entering private practice, Kate worked for nine
years
at the National Cancer Institute (NCI) within the National Institutes
of Health. As a technology transfer professional at NIH she managed
the intellectual
property portfolio of NCI’s Natural Products Branch, negotiating
CRADAs and international agreements with countries in Africa, Central
and South
America, and the Pacific rim. Kate also worked with scientists from several
other institutes within NIH to develop a wide range of technology. She
began her career at NIH as Chief of NCI’s Cancer Information Service
(CIS), a nationwide network of cancer information and education programs
located
at major cancer centers across the country. In that capacity she was responsible
for developing a training program on the conduct of clinical trials to
assist information specialists explain clinical research to patients and
the public.
Kate holds a law degree from the Columbus School of Law
at the Catholic
University of America, Washington, D.C., a Master of Science in Public
Health Administration from the University of Massachusetts Amherst,
and an A.B.
from Stonehill College, North Easton, Massachusetts. Kate is admitted
to practice law in Virginia, Maryland, and the District of Columbia.
Kathleen Sybert has over twenty years of experience in the
life sciences, including as a researcher and inventor in the biotechnology
industry,
and as a technology transfer professional at the National Cancer Institute
(NCI) of the National Institutes of Health (NIH).
At NCI, Kathleen served
as Chief of the Technology Transfer Branch, supervising a staff of professionals
with backgrounds in law, science,
medicine and
business management, who served the technology transfer needs of M.D.
and Ph.D. scientists at twelve of NIH’s Institutes and Centers.
Kathleen advised pharmaceutical and other commercial organizations as
well as universities and other non-profit institutions about the compatibility
of their proposed projects with the research and development goals of
NCI, especially those of the Developmental Therapeutics and Cancer Therapy
Evaluation Programs of the Division of Cancer Treatment and Diagnosis.
Kathleen also advised commercial and non-profit recipients of federal
funding about the government’s rights and interests in inventions
made under grants and contracts, including Small Business Innovation
Research awards (SBIRs), and cooperative agreements. She worked closely
with industrial,
academic and federal scientists, attorneys and business managers in
drafting and negotiating Cooperative Research and Development Agreements
(CRADAs),
clinical trial agreements, material transfer agreements and confidential
disclosure agreements. Kathleen also participated in revising model
agreements for NCI and NIH, including license agreements. While at NCI,
Kathleen
team taught the technology transfer course at the Foundation for Advanced
Education in the Sciences graduate school at NIH, and served a term
as Chair of the NIH Technology Development Coordinators, which included
sitting
with the Public Health Service Technology Transfer Policy Board.
Before
joining NCI, Kathleen was a research scientist at three Maryland biotechnology
corporations, including the Viral Science Laboratory of
Electronucleonics Laboratories, where she helped established their first
Institutional Biosafety Committee; Igene Biotechnology, where she participated
in the company’s start-up phase; and Advanced Biotechnologies, where
she worked in a Biosafety–Level 3 laboratory environment.
Kathleen
is co-author of an Association of University Technology Managers (AUTM)
Technology Transfer Practice Manual chapter on CRADAs, and a Practicing
Law Institute Biotechnology Patents and Business Strategies program
paper entitled Government Funding and Research and Development Collaborations
with Biotechnology Companies.
Kathleen holds a law degree from the Washington
College of Law at American University, Washington, D.C., and a Ph.D.
in Biology from the University
of Maryland. She is admitted to practice law in Maryland, Pennsylvania, and before
the United States Patent and Trademark Office.
 Of Counsel
 nsiegel@cttg-law.com
Nancy brings a uniquely diverse background in regulatory practice in regulated industry. For over ten years Nancy was a legislative and regulatory counsel for the American Insurance Association. She had responsibility for a diverse portfolio of regulatory practice areas, including rate making, regulatory compliance, automobile insurance, anti-trust, surplus lines and surety. Nancy regularly advised representatives of large nationwide property/casualty insurance companies, lobbyists, and regulators on a full array of regulatory issues in these areas. She had responsibility for testifying before state legislatures and regulatory agencies on legislative and regulatory initiatives affecting member companies, and developed and communicated policy positions to industry lobbyists and regulators. She coordinated policy with industry organizations, specialty boards, trade associations, and major insurance companies. Nancy also published a comprehensive 50-state survey and analysis of property/casualty insurance rate laws as well as a similar guide for workplace drug testing laws.
Holly J. Bayne contributes extensive knowledge and experience
in the dietary supplement industry to CTTG’s legal team. Since 1997,
Ms. Bayne has engaged in the practice of food and drug law, with a distinct
focus on matters pertaining to the regulation of dietary supplement and
botanical products by the U.S. Food and Drug Administration, the Federal
Trade Commission and other regulatory agencies.
Ms. Bayne routinely advises
companies on a wide range of issues pertaining to the composition, positioning,
marketing and distributing of dietary
supplement, botanical and "functional food" products, including
in-house quality control/manufacturing procedures, safety, and the substantiation
of claims regarding efficacy in product labeling and advertising. In
addition, Ms. Bayne brings unique experience to CTTG in matters relating
to the
development of botanical monograph and pharmacopoeial standards for
validation of the identity, purity and composition of botanical ingredients
and supplements.
Ms. Bayne serves on the Government Relations Committee of the American
Herbal Products Association and consults with the American Botanical
Council (ABC) on informational, educational and legislative issues affecting
the
dietary supplement and herbal products industry. She has spoken nationally
and internationally on issues concerning the regulation of food, dietary
supplement and botanical products, and has written numerous papers and
articles pertaining to these issues.
Before entering law school in 1993,
Ms. Bayne worked within the dietary supplement industry, where she
served as botanical products marketing
manager for a California-based manufacturer of nutritional and herbal
supplements. In that capacity, she developed product labeling and
other promotional materials and managed consumer and professional educational
health seminars nationwide. Ms. Bayne also participated in grass-roots
and Congressional lobbying efforts in support of industry legislation
that was enacted into law as the Dietary Supplement Health and Education
Act of 1994.
Ms. Bayne earned her law degree in 1996 from the University
of San Francisco, where she was awarded Best Oral Argument in Moot Court
Competition.
During law school, Ms. Bayne served as an independent research consultant
to
ABC and co-authored a white paper concerning the international regulation
of phytomedicines, which formed the basis for comments submitted
to the Presidential Commission on Dietary Supplement Labels.
Ms. Bayne
received her undergraduate degree from the University of California
at Berkeley (1980), summa cum laude, where she was
elected
to Phi Beta
Kappa.
Ms. Bayne is admitted to practice law in the District of
Columbia and California and is also a member of the American Bar Association.
Kathleen has a broad range of experience in corporate law and litigation. She litigated national health care cases with Camot, Zapor & Klassen, P.C. in Rockville, MD and provided litigation support for Carr, Goodson, Lee & Warner, P.C. in Washington, D.C.
Kathleen clerked for Chief Judge the Honorable Allen M. Wilner of the Court of Special Appeals of Maryland and for the Honorable Eugene M. Lerner of the Circuit Court of Anne Arundel County, MD.
Kathleen has a B.A. from Goucher College and a J.D. from The Dickinson School of Law. Kathleen is admitted in Maryland and the District of Columbia.
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Kate
Duffy Mazan, Esq.
Kathleen Sybert, Ph.D., Esq.
Holly
J. Bayne, Esq.
