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Advisory
Board
Dick Coyne
Dick Coyne advises Edical May on all matters related to medical
device reimbursement. Dick recently completed a career of more than 34 years
with the Federal Government. Twenty-four of those years were with the
Centers for Medicare and Medicaid Services (CMS), serving in
increasingly responsible positions. From 1998 until July of
2004, Dick was the Deputy Director of the Coverage and Analysis
Group of CMS. In that capacity, he played a major role in
designing, implementing and operating an evidence-based process
to make decisions on which new and controversial medical
technologies Medicare would cover on a nationwide basis. These
decisions impacted millions of lives and hundreds of millions of
dollars.
Immediately preceding the Coverage assignment, Dick was the
Acting Deputy Director of the Office of Clinical Standards and
Quality, CMS. That office has oversight of the CMS Quality
Improvement Organizations; the standard setting function for
providers such as home health agencies; many of the agency
clinical quality measurement and health assessment programs; the
End Stage Renal Disease Programs, and the Coverage function.
Other assignments included Acting Director of the Office of
Intergovernmental Affairs, Director of the Office of Beneficiary
Education and Assessment, and Agency lead for developing and
implementing the breakthrough Vaccines for Children Program.
The experience, judgment and reputation as a trusted partner
that Dick developed during his career equips him well to offer
key strategic and tactical advice to parties looking to navigate
the often tricky processes of Medicare and Medicaid, FDA review
and approval and looking to build alliances to further business
interests.
William Morton
Bill Morton advises Edical May on all matters
pertaining to FDA approval. Bill has over thirty years of experience
in the field of medical device research, development, and
regulatory compliance. Prior to founding MDCI in 1980, he was
Director of Regulatory Affairs and Clinical Studies for AVCO
Medical Products Division of AVCO Corporation. Bill has
contributed numerous publications to the scientific literature,
is a member of the Regulatory Affairs Professionals Society
(RAPS) and the American Society of Artificial Internal Organs (ASAIO).
He is on the Editorial Advisory Board for the journal Medical
Product Outsourcing and serves as Chairman of the Regulatory
Affairs Certification Board for RAPS. He holds a B.S. degree in
Materials Science from San Jose State College and is Regulatory
Affairs Certified (RAC).
Steve Richter,
Ph.D.
Steve Richter
advises Edical May on matters requiring FDA approval or clinical
trials, as well as biotechnology issues. Steve is a former FDA scientist
who started
Microtest Laboratories, the
first biotech company in Western Massachusetts in 1984 and grew it
to a 95-member team. Under Steve's leadership,
Microtest became a premier testing and manufacturing support
provider for the pharmaceutical and biotechnology industries.
Steve's knowledge and capabilities have earned him recognition
throughout Massachusetts and beyond, as well as a seat on the
board of the globally-known Mass Biotech Council (MBC).
Throughout the course of his career, Steve led two medical
devices companies and has extensive
experience and knowledge of the FDA approval requirements for
medical devices, particularly with 510Ks, clinical studies and
in-vivo materials testing.
Greg Endress
Greg Endress advises
Edical May on biotech and health science matters. Greg is the CEO
of the second biotech company in Western Massachusetts, Origin Antimicrobials, a company
developing therapeutic solutions for the treatment and
prevention of bacterial infections. Most recently, Greg
held the position of Chief Scientific Officer
for Protedyne Corporation where he helped attain venture capital
investment and establish the company's product, the Biocubeä,
in the drug discovery, biotech, diagnostics and pharmaceutical
industries. Before Protedyne, Greg was with Maryland-based Avalon
Pharmaceuticals, a genomics-based drug discovery company.
He has also held senior scientific positions at Life
Technologies and Human Genome Sciences. He holds over 15
patents in his name and is known globally in biotech and
pharmaceutical circles. He has a B.A. from Kenyon College
and a Masters in Science from the University of Illinois at
Urbana-Champaign.
Joseph Steig
Joseph advises Edical May on deal structure and financing and
has a background in finance and strategic planning. He has
worked in a diverse range of industries, including agriculture,
environmental technologies, outdoor recreation products and
software. For much of his career he has raised equity capital,
especially at the early stage with individuals and venture
capitalists, and also at a mezzanine stage through investment
banks and corporate acquisitions. Joseph has extensive
technology economic development experience, working with
non-profits and universities to identify technology development
opportunities and develop regional economic development
strategies. His current projects are outlined at his website
www.innovationpath.com and include
River Valley Investors, a regional angel investor
group that he co-manages with a partner.
Jeff
Ciuffreda
Jeff Ciuffreda advises
Edical May on local, state-wide and national legislative affairs
issues. Presently
wearing two hats, Jeff is the VP of Legislative
Affairs for the
Affiliated Chambers of Commerce of Greater
Springfield as well as the VP of Legislative Affairs
for the
Western Massachusetts Economic Development
Council. He joined the organization in 1991
after serving as Aide to late Massachusetts
Congressman Silvio Conte. Jeff began his career in the
Peace Corps, rising up
through the ranks from Volunteer to
Associate Director of Programs and Training, serving in the West
and South of Africa from 1972 to 1978. Jeff graduated Cum
Laude from Boston College with a B.A. in Accounting.
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