September 11, 2013 7:30 a.m. to 5 p.m.
Jones Day Terrace & Conference Center | 51 Louisiana
Ave. NW | Washington, DC
Speaker Biographies
A. Craig Asher
Principal | Vital Venture Capital
Craig Asher has had a successful track record of developing software companies. Over the past ten years he
has been a key team member in three successful software startups: Commerce One;
Trigo Technologies;
and the internal IBM startup
for InfoSphere Traceability Server. He has guided major software
implementations at over 50 customers in markets including retail, medical products, pharmaceuticals, and
general distribution. At Trigo Technologies Craig’s position was director
of product management. He
played a broad role as
company strategist for marketing, sales, product development, and professional
services, and he also drove implementation of much of the strategy. During Craig’s tenure at Trigo,
annual
revenue grew from under $1 million to nearly
$40 million and the firm attained profitability. Trigo was
successfully sold to IBM for over $140 million in April, 2004, thereby generating significant profits for
venture capital and individual investors.
Following Trigo’s
sale to IBM, Craig formed a new startup group within IBM to build a new product for
information management software for sensor data. Craig’s role in the new venture was
the product
strategist, product manager, and implementation
manager. In 2005 the venture signed its first customer,
Glaxo
Smith Kline, and Craig led the delivery to that customer in 2006. He Co-chaired the international
EPCglobal EPCIS standard which was the core for the broad adoption of similar
information management
software, and attained ratification
of the standard in 2007. Craig significantly helped sign and implement 7
additional customers until his departure from IBM to join Vital Venture Capital. In 2008 the IBM product’s
customer base grew to 15 customers, annual sales were approximately $9 million
and gross margin was
approximately $6 million. Craig
has enjoyed co-chairing several working groups in international standards
bodies. He has one issued US patent - 7,866,543. He also has extensive experience in marketing strategy,
product management, product development, services delivery, business development,
and technical sales
for growing software companies.
Before
moving into software startups, Craig was a consultant with Andersen Consulting (now Accenture)
in the supply chain strategy practice, and helped drive the turnaround of a distressed
packaging
manufacturer. Craig did his undergraduate
work at Stanford University, and completed his MBA and
Masters
in Industrial Engineering at Northwestern University.
R. Christian Bartley
Managing Director | Faleiro
Christian
Bartley’s specialty is global strategy and marketing. Through his work at
Faleiro, he holds leadership positions within Faleiro’s affiliated companies, Varthema,
focused on Global Digital Strategy for Fortune 1000 companies; and the World
Trade
Center (WTC) office in Wisconsin, a business
association that is part of the New Yorkbased World Trade Centers Association, with over 300 WTCs in 90+ countries around
the globe.Fluent in English, Spanish, and French, he has traveled the globe from
Iceland to Singapore, and has lived
in such places
as San Juan, Warsaw, Sofia, and Paris. Advanced studies include a Bachelor of Science in
Mechanical Engineering and a minor in French from Marquette University; Intensive studies
at the
University of Paris-Sorbonne; MS in Engineering
Management and an MBA, also from Marquette.
Bartley’s
career has been focused on international marketing and strategy, and he has worked with, led
projects for, and consulted companies from start-ups to Fortune 500s on multiple
continents. He sits on a
number of executive and
advisory boards for both private companies and economic development
organizations. His experience at building boards ranges from small advisory groups to a board consisting of
senior executives from global corporations representing over US$375 Billion in
annual revenue.
As a result of his work in the international
arena, Bartley received a Royal Appointment to be an Adviser
for Foreign Trade to the Kingdom of Belgium. Other honors include being a judge in Ernst & Young’s
Entrepreneur of the Year Award program, Hong Kong’s International Institute
for Business Development
(IIBD) New Business Venture
Competition, and MIT’s Global Challenge / IDEAS Competition.
Outside of work, Christian has a passion for education and has guest lectured in the graduate programs at
the European University College Brussels, the Washington, DC based Les Aspin
Center for Government,
Thunderbird School for Global
Management, and Marquette University Law School and College of
Business.
Alex Castelli, CPA
Partner and National Technology & Life Sciences
Industry Practice Leader | CohnReznick LLP
Alex Castelli is an Audit Partner and the Tysons Corner Office Managing Partner. With
more than 23 years of experience managing audit, accounting, and reporting issues
of
both public and development stage entities, he
is actively involved in providing audit,
accounting,
and advisory services to his entrepreneurial client base. Alex also serves as
the CohnReznick national practice leader for Technology and Life Sciences, which
include middle market clients ranging from early stage, emerging growth to venture
and private equity
backed to later stage public
and private companies. Alex helps clients form accounting policies and
procedures, identify and resolve technical accounting and financial reporting issues, and assists in
the
coordination of financing and capital infusion
transactions. He has experience providing services to SEC
clients including guidance on reporting and filing requirements, as well as, Sarbanes-Oxley compliance
efforts. Alex began his career in public accounting with the Big Four and also
served as a controller for a
national retail clothing
chain, which provided him with a pragmatic perspective to better understand and
advise his clients. He holds a bachelor of science degree in accounting from Washington and
Lee
University and holds professional affiliations
with the American Institute of Certified Public Accountants;
the Maryland Association of Certified Public Accountants; and the Virginia Society of Certified Public
Accountants.
Giovanna M. Cinelli
Partner | Jones Day
Giovanna
M. Cinelli is a partner at Jones Day in their Washington, DC office and a
member of the Firm’s Government Regulations practice group. With over 25 years of
experience in the export and national security arena, Ms. Cinelli has advised
defense and
high technology companies on export
and government regulatory issues affecting the
satellite,
space, missile, computer, submarine, and defense services industries. She
conducts export transactional due diligence, handles civil and criminal export investigations, negotiates
and
settles disclosures involving violations of
US export laws and analyzes national and economic security
issues under a variety of statutes, related to CFIUS and the Defense Production Act. Ms. Cinelli serves as
an expert witness on export issues affecting litigations and arbitrations involving
controlled goods,
technologies, data and services.
She also advises clients and tribunals overseeing or adjudicating cases on compliance, licensing, and constitutional issues
relevant to US export laws and regulations. Ms. Cinelli
was
listed in Chambers Lawyers Research as a specialist in export compliance as well as a 2012
Washington, DC “Super Lawyer.”
She has worked extensively
with the Departments of State, Commerce, Defense, and Treasury, as well as
Energy and the military services. She was a member of the Defense Trade Advisory Group (DTAG) from
1992 through 2008 and advised the Department of State on matters associated with
defense trade. She held
the position of Vice Chair
from 2006 through 2008. In addition, she served on the Regulations and
Procedures Technical Advisory Committee (RPTAC) at the Department of Commerce for 8 years, ending
her tenure as Vice Chair. She advised the Department of Commerce on issues related
to the export of dualuse commodities, data and technology.
Ms.
Cinelli has lectured and written extensively on international arms, technology transfer and export
issues and has appeared on CNN’s Burden of Proof and MSNBC’s Hardball
with Chris Matthews as an
expert in international
technology transfer, arms exports, and related issues. She currently serves on the
National District Export Council’s Export Modernization Subcommittee and is a member
of the
Virginia/DC District Export Council. As a
Naval Reserve Intelligence Officer, Ms. Cinelli specialized in
former-Soviet submarine platforms and national security and intelligence issues. She is fluent in French
and Italian and lives with her family in Virginia.
Doug Doan
Angel Investor
Doug is an active Angel Investor and helps entrepreneurs start and run successful businesses. Two of the
companies launched over the past four years are now growing rapidly and have
achieved revenues in
excess of $100 million. Doug’s
primary focus is to help graduates of the U.S. Military Academies (West
Point, Annapolis, Coast Guard and Air Force) by providing the seed and early stage, start-up capital
to
launch their own businesses.
Doug
has worked at all levels of the federal government, to include service at the White House on the
National Security Council Staff during the Reagan Administration. As a Presidential
Appointee, Doug
joined the newly-created Department
of Homeland Security (DHS) and provided America’s private sector
with a direct line of communication to the Department. Doug worked directly with individual business,
trade associations and other non-governmental organizations to improve security,
while promoting crossborder trade and travel.
Doug
has also designed and implemented complex technology and business process solutions. He also
gained experience in how to manage change in large organizations while serving
in one of the leading
manufacturing mergers and
acquisitions (M&A) firms in the U.S.
He received his bachelor of science degree from the United States Military Academy,
West Point; a masters
of science degree from the
Defense Intelligence College in Washington, D.C. and a subsequent masters
degree in public administration from the John F. Kennedy School of Government at Harvard University in
Cambridge, MA. In addition, he has been published in Cigar Aficionado magazine
and The Washington
Post.
James
Edwards
CEO | ELITE Strategic Services
James Edwards, Ph.D., is founder and CEO of ELITE Strategic Services. He is also
Senior Advisor with Sovereign Global Solutions. Edwards has consulted for over
a
decade to corporate, association, and nonprofit
clients, with emphasis in health care.
Edwards has established
a reputation for long-term client relationships, superior customer
service, and strategic insight. His counsel has brought clients new business alliances, new
market opportunities, and key advancements. His background in business and politics
has made Dr. Edwards a thought leader and trusted advisor, interpreting how government and political actions
will affect the economic and social environment in which businesses operate.
His analysis of policy trends
has provided Fortune
500, small, and midsized companies, as well as Wall Street analysts, reliable outlooks
on policy directions and the implications for their business or investment strategies. He
has contributed to
several books, testified before Congress
as an expert witness, and addressed audiences across the country.
Edwards’s talents include entrepreneur and communicator. He co-founded a start-up public affairs firm, a
health care organization, and ELITE Strategic Services. He has appeared on CNN,
CBS News, Fox News
Channel, National Public Radio,
and other media. He is Contributing Editor to ALineofSight.com. Dr.
Edwards has served as an Officer or a Director of more than 10 corporations and nonprofits. He has
handled strategic planning, resolving sensitive personnel matters, budgeting
and financial management, due
diligence, marketing,
property searches, and dispute resolution, as well as fundraising and negotiation.
Edwards holds a doctorate in communications from the University of Tennessee. His bachelor’s and
master’s degrees were earned at the University of Georgia.
Christopher
J. Ferlow
Chief Operating Officer | Ridge
Global
Chris Furlow is Chief Operating
Officer at Ridge Global, the international security and
risk
management consulting firm founded by Tom Ridge, the first U.S. Secretary of
Homeland Security and 43rd Governor of Pennsylvania. Mr. Furlow manages Ridge
Global’s business operations and leads the company’s strategic consulting
practice,
helping clients strengthen business-to-government
and business-to-business
relationships, with a particular
emphasis on emergency preparedness, response and
public-private
partnerships. He also manages operations of Ridge-Schmidt Cyber, the cyber security firm
founded by Gov. Ridge and former White House Cyber Security Coordinator Howard Schmidt.
Immediately following the 9/11 attacks, Mr. Furlow was named Director for State
Affairs in the White
House Office of Homeland Security
where he led development of the network of state homeland security
advisors, supported new threat/warning protocols, and served as homeland security liaison to U.S.
governors and state officials. In this role, he was part of the Incident Support
Group (ISG) providing
coordination on “incidents
of national significance.”
During the historic stand-up of the Department of Homeland Security, he was appointed
Executive Director
of the Homeland Security Advisory
Council (HSAC), the department’s principal advisory board composed
of committees for state & local government officials, first responders, the private sector and academia.
While leading HSAC operations, the group addressed issues from operational information
sharing, lexicon
and training gaps to grant funding
challenges. Mr. Furlow is a former Deputy Assistant Secretary at the
U.S. Department of Commerce, where he worked with states on issues surrounding international trade. In
the 1990’s he was a member of the senior staff of U.S. Rep. Jim McCrery
(R-La.), a member of the House
Ways & Means
Committee. He holds a B.A. from Louisiana State University and is a former Senior Fellow
of the Homeland Security Policy Institute of The George Washington University.
Mr. Furlow is currently a member of the U.S. Chamber of Commerce National Security
Task Force and its
Cyber Security Working Group,
promoting policies to support more robust public- private collaboration on
cyber security. He serves as Vice Chair of the Private Sector Committee of the National Emergency
Management Association (NEMA) and is a member of the Royal Institute of International
Affairs
(Chatham House, London).
Valerie
Gaydos
Founder | Angel Venture Forum
President and CEO | Capital Growth, Inc.
Valerie Gaydos is an angel investor and business development expert. She has
been involved with many start-up companies as a founder, investor, and advisor
particularly in the areas of operational development, strategic planning and
governance
for more than 20 years. She is the founder
and president of Capital Growth, Inc. (CGI) which was founded
in 1994 as a venture capital data and information publishing company and was the first entrepreneur
affordable searchable online database of venture news and information. CGI continued
to acquire, build
then sell several small business
and publishing entities over the years. CGI currently specializes in angel
investing and business building and actively invests in early stage companies in various industries and
various stages of development.
She is the Founder of the
Angel Venture Forum which is an ad hoc group of active angel investors in the
Mid-Atlantic region, is a member of the Lancaster Angel Network, serves on the Policy Committee of the
Angel Capital Association (ACA), is a board member of the Pennsylvania Business
Council Political
Action Committee (PEGPAC), and
is president and owner of Fifty-First Associates, LLC, an association
management and government relations firm in Pennsylvania. From 2004-2007 Valerie served as President
of the Pennsylvania Angel Network. From 2004-2010 she was director of the Private
Investors Forum
(Philadelphia). Valerie earned a
BA in Russian Language and Economics from Dickinson College in
Carlisle, Pennsylvania. In her spare time she races sailboats on the Chesapeake Bay (and wherever else the
opportunity presents itself).
Alexis Gilroy
Partner | Jones Day
Alexis Gilroy advises health care and technology companies on health care and
corporate matters with an emphasis on e-health topics (telemedicine, telehealth, and
mobile health). She counsels and directs transactions involving venture capital,
private
equity, debt financing, joint ventures,
mergers, acquisitions, management
arrangements,
physician engagement, hospital affiliation, and other general and
complex contractual needs. Alexis has broad experience with the practical and legal
needs of health care companies, especially the unique legal issues faced by e-health
companies. Prior to
joining Jones Day, she managed
more than 20 strategic M&A transactions for a publicly traded health care
company that involved cyberknife, imaging centers, teleradiology companies, and radiation oncology
centers. In addition, she advised on business strategy and implementation matters
specific to e-health
programs, business models,
devices, and products; counseled on regulations regarding e-consults, online
prescribing, patient consents, credentialing by proxy, corporate practice of medicine, physician supervision,
reimbursement, anti-kickback, and licensure matters specific to e-health providers
and businesses;
developed and negotiated e-health
specific customer, vendor, and affiliation contracts and documentation;
structured research arrangements involving HIT (health information technology); and led strategy and
communications with medical boards and other regulators and policy makers on
e-health matters.
Alexis has spoken extensively on matters
involving e-health, including testimony before legislative and
regulatory bodies. She serves as chair of the Business & Finance Group of the American Telemedicine
Association, appointee to the Maryland Governor's Telemedicine Taskforce, member
of the Federation of
State Medical Boards' workgroup
on telehealth, board member of the Maryland Tech Council Foundation,
and leader of the American Health Lawyer Association's E- Health and Telemedicine Affinity Group.
Thomas
R. Goldberg
Co-Founder | Lineage Technologies,
LLC.
Mr. Goldberg is the co-founder of Lineage
Technologies, LLC, a secure IT hardware manufacturing
enterprise.
Prior to founding Lineage Technologies, Mr. Goldberg served as an advisor to the Co-Chair of
House Committee on Armed Services (Rep. Bartlett, R-MD) on matters concerning
cyber security. While
in that capacity he helped
to draft sections 806, 808 and 818 of the 2012 National Defense Authorization
Act, and section 933 of the 2013 National Defense Authorization Act that govern DOD acquisition policy
regarding secure IT products.
In 2007 he founded ATS, LLC,
a government-marketing firm. ATS, LLC is the successor to GHL
Incorporated a government relations and marketing firm he sold to Fabiani and Company in 2005. In 1996
he co-founded Perrault Structural Products, Inc. a government contracting enterprise
focused on blast and
ballistics engineering. There
he developed and produced the Blast Information System (BLIS) that is still
used today by The Department of Defense, the Department of State and other federal departments and
agencies as the definitive resource for secure facility design and construction.
From 1987-1989 Mr.
Goldberg served in the Reagan
and the first Bush Administrations as an adjunct staffer to the Office of the
National Security Advisor. There he provided analyses on certain advanced materials technologies that
were under consideration for transfer to Japan under a Memorandum of Understanding
concerning the
Fighter Support Experimental Program
(F-2). Prior to his work there, he ran a private consultancy focused
on materials science and engineering, and ran several trade associations, including the Aspirin Foundation
of America, Inc., the Coalition for Responsible Waste Incineration, Inc., and
served on the staff of others,
including the National
Association of Manufacturers, Society for the Plastics Industry, Inc., Synthetic
Organic Chemical Manufacturers Association, and the National Solid Waste Management Association.
Mr.
Goldberg also served as the Washington Liaison
Officer for the Radian Corporation of Austin, Texas, and
as a Principal with Technology Management Services, Inc. of Gaithersburg, Maryland.
Karen Griffith
Gryga
Managing Partner | DreamIt Ventures
Karen Griffith Gryga is an experienced venture capitalist, investor and entrepreneur
with close to 20 years of startup and emerging growth company experience. Karen
is a
Managing Partner for DreamIt Ventures. DreamIt
is a leading technology accelerator
for entrepreneurs
which has worked with and launched 127 companies since 2008
including SCVNGR (Level Up), SeatGeek, Notehall (acquired by Chegg), Adaptly,
Yevvo, SnipSnap, Parsely, Trendkite, Betterific, ShowMe, Take the Interview, Winston, CloudMine,
and
MindSnacks.. DreamIt runs accelerators in Philadelphia,
New York City, Austin and Israel and attracts
entrepreneurs
from all over the world in to those programs. DreamIt has also launched specific initiatives
in educational technology (with Startl), healthcare IT (with Penn Medicine and
IBC) and minority
entrepreneur access (with Comcast).
Karen is a lead for the Philadelphia based accelerators and is also the
lead on raising a $30 million fund for DreamIt.
Karen is also Co-Founder and Chairman
of FashInvest, an initiative focused on emerging growth
entrepreneurs
within Branded Goods, Fashion, Fashion Tech and Retail. The goal of FashInvest is to create
a business platform focused on bringing together entrepreneurs, investors and industry executives
to foster
the growth and development of emerging
growth enterprises within Branded Goods, Fashion and Retail.
FashInvest is a media, events and advisory entity. Karen was previously Executive Director of MAG, The
Mid-Atlantic Angel Group, which has two angel funds under management. The Mid-Atlantic
Angel Group
Funds I & II, LP (MAG I & II)
were created to bridge the gap between angel funding and institutional
venture capital funding serving the Greater Philadelphia Region.
Previously, Karen
was a Founder and Partner of Liberty Venture Partners, a Philadelphia based venture
fund established in 1997 with $150 million under management. Previous to Liberty Venture Partners,
Karen was a Managing Director of Philadelphia Ventures Inc., a privately held
venture capital management
firm with a family of
corporate and institutional limited partnerships exceeding $100 million of committed
capital. Notable transactions included Synchronoss (Nasdaq: SNCR), InSoft, (acquired by ape),
Liveprint.com (acquired by Kinkos), Cadis (acquired by Aspect Development) and WiseBear (acquired by
Michael Milken). Subsequent to Liberty Venture Partners, Karen was brought into
Context Capital
Partners to help with the development
of next generation private equity funds. During that time she was in
charge of Context’s intellectual property and licensing businesses and was instrumental in the
formation of
several funds. In addition, Karen worked
on an initiative called Lipstick Wisdom whose focus was on
practical, actionable video-based day-to-day advice for moms with children with neurological challenges.
Ms. Gryga is well known throughout the entrepreneurial community and was previously
on the board of the
Greater Philadelphia Venture
Group for seven years and was Chairman of the group for the 1999-2000
term. Ms. Gryga also serves on the board of the Ben Franklin Technology Partners of Southeastern
Pennsylvania.
Ms. Gryga began her career at TRW Inc., a multi-billion dollar conglomerate,
in their Federal Systems
Division as a software
developer. Ms. Gryga is a frequent speaker on the subject of venture capital and
entrepreneurialism in both professional and academic communities. Karen holds a MBA in decision
analysis from the Wharton School of Business at the University of Pennsylvania
(with Distinction). At the
same time as Wharton,
Karen obtained a Masters in Computer Science from the Moore School of
Engineering at the University of Pennsylvania. Karen earned her Bachelor of Science degree in computer
science (Phi Beta Kappa) from the College of William and Mary in Williamsburg,
Virginia.
Jeffrey N. Hausfeld
M.D., M.B.A., F.A.C.S.
Chairman
of the Board and Founder - Society of Physician Entrepreneurs (SoPE)
Jeffrey N. Hausfeld M.D., M.B.A., F.A.C.S., led the field in otolaryngology/facial plastic
surgery for many years and is now a business operator and entrepreneur. He invests,
manages and consults to a variety of healthcare businesses, including assisted
living
facilities for Alzheimer’s and dementia
patients, medical device companies, healthcare
information
technology firms, and debt collection services for physicians. He is an
Advisor to Nex Gen Medical Systems, a medical device company with products for
endovascular thrombectomy as well as a neurosurgical device platform for multiple
neurologic disorders,
including the visualization
of implanted stem cells. He is the Chairman and Founder of the Society of
Physician Entrepreneurs (www.sopenet.org ), a global network focused on educating healthcare and life
science professionals in Bioentrepreneurship and Innovation.
Dr. Hausfeld invites healthcare professionals to use financial information and
the “science of business” as
valuable
tools to nurture medical innovation at their institutions and private practice, as well as to enhance
the ability to promote quality patient care and improve decision-making. Dr.
Hausfeld will demonstrate that
power, pleasure and
improved performance can result from the ability to mesh the cultures of medicine and
business in a comprehensive and strategic manner. “The exciting thing about life after
the practice of
medicine is that now I am able to
draw upon the diversified fields of medicine, business, and organizational
psychology, and implement novel solutions that have an immediate impact on the client’s bottom
line.”
Jim
Hawkins, MBA, Ph.D.
Managing Director
| Focus Bankers
James (Jim) W. Hawkins, MBA,
PhD, a FOCUS Managing Director, has been President
and
CEO of five early stage biotechnology companies. Dr. Hawkins has experience in all
major areas of the biopharmaceutical industry including: drug discovery, diagnostics,
analytical instrumentation, and specialty reagents and chemicals. Through the
process of
building early stage companies, Dr. Hawkins
has been involved in the strategic and
operational
aspects of founding, growing, and exiting emerging businesses. In this regard, he has been
involved in a variety of business development and financial transactions including the acquisition
and sale
of companies and the solicitation of equity
and debt financing. Formerly, Dr. Hawkins was the President
and CEO of Synthecell Corporation, a company providing the specialty design and manufacture of nucleic
acids and peptides to major international research institutions and pharmaceutical
houses for research and clinical diagnostics applications. In conjunction with this company, Dr. Hawkins served as President
and
CEO of Genetic MediSyn Corporation, a biotechnology
company specializing in the discovery of
genetically
targeted therapeutics based on antisense technology.
Over the past fifteen years, Dr. Hawkins has also served as CEO of three additional
companies: Bio-Tech
Imaging, Inc., a company focused
on cell-based diagnostics and the treatment of HIV infection; Dynamic
Biosciences Corp., a scientific instrument company developing a platform technology for the
characterization of intermolecular interactions; and Neurotrophic Bioscience,
Inc., a drug discovery
company involved in the advancement
of therapies for neurodegenerative disorders including Parkinson’s
disease. Over the past 15 years Dr. Hawkins has also co-founded and served as the Editor-in-Chief of
the
peer-reviewed scientific journal Antisense Research
and Development. He has organized numerous
scientific
and business conferences and has authored several major industry reports on gene therapy and
genomics as well as numerous scientific and industry articles on a variety of
life science subjects. Dr.
Hawkins has also consulted
for companies ranging in size from startup to Fortune 500 and on projects
involving business development, technical analysis, and due diligence.
Dr. Hawkins received
his baccalaureate degree in biology from the University of Western Ontario, London,
Ontario, Canada, his MBA degree from George Mason University, Fairfax, Virginia, and his doctorate
in
molecular biology from Baylor College of Medicine
in Houston, Texas. He conducted post-doctoral studies
at
the National Institutes of Health in Bethesda, Maryland, and subsequently served as an Assistant
Professor at the Hébèrt School of Medicine, Uniformed Services
University of the Health Sciences, also in
Bethesda,
Maryland. Dr. Hawkins currently serves as an Adjunct Professor at Georgetown University in the
Department of Biochemistry and Molecular & Cellular Biology.
Colleen
M. Heisey
Partner | Jones Day
Colleen Heisey's practice focuses on food and drug law with a particular emphasis
on
product promotion and advertising, compliance
counseling, good manufacturing practice
requirements,
product recalls, FDA inspection, competitor issues, and enforcement
actions. She has advised on issues surrounding the regulation of drug, biological, food,
dietary supplement, medical device, and cosmetic products by the FDA, USDA, and
other federal and state
agencies. Colleen has substantial
experience with regulatory oversight and compliance assessment for due
diligence audits of drug, medical device, and food companies, including those related to product safety,
product labeling, product marketing and advertising, and consumer complaints.
She regularly provides
legal support for pharmaceutical
and device advertising and promotional activities, sales and marketing,
and development of practitioner-oriented and direct-to-consumer print and broadcast advertising.
Colleen has conducted audits and inspections of pharmaceutical and medical device
company policies,
procedures, and programs, including
drug sampling, adverse event reporting, medical information
management, and unsolicited requests. She has advised clients regarding matters related to the False Claims
Act and Anti-Kickback Statute, reviewed and commented on strength of clinical
trial designs in drug and
device development and
as potential support of product marketing, and has assessed proposed brand names
for drug products in development for potential claims and product confusion, including appraisal
of drug
name similarity reports by third-party vendors.
She has worked with regulated industry to develop and
implement
comprehensive regulatory compliance programs. Colleen has written extensively on the food
and drug industry.
James Hunt
Adjunct Professor | Georgetown University McDonough School of Business
Investor | J. Hunt Holdings
James (Jim) Hunt is a seasoned technology and investment professional with a principle focus on
companies with technologies that can have a positive impact on the public sector
markets. Hunt began his
career in Washington in
the mid 70’s as a U.S. Government scientist. After eight years with the
government, Hunt founded “BDS, Incorporated” where he served as CEO for ten years and was
subsequently taken public in a successful offering. Hunt co-founded “Ernst
& Young Technologies”
(EYT), where he
was CEO for eight years. EYT was subsequently sold to Cap Gemini and Hunt served as
President of Cap Gemini Technologies for two years. Next, Hunt founded “The MITA Group”
a
Washington-based consultancy focused on public
affairs and business strategy. Mr. Hunt began his angel
investing
activities in the mid 1990’s with five investments in area companies. After several successful
exits, Hunt expanded his portfolio in early 2000’s to include roughly twenty
five companies. Hunt sits on
five corporate boards.
Anand
K. Iyer, Ph.D.
President and Chief
Operating Officer | WellDoc, Inc.
Anand K. Iyer,
Ph.D., serves as president and chief operating officer of WellDoc, Inc.,
where he oversees the deployment of the company’s cell phone- and web- based diabetes
management platform, and leads efforts to integrate WellDoc’s solution
internationally
into mainstream chronic disease
management programs. Iyer has more than 20 years of
consulting
experience. Previously, he served as a director (partner) at PRTM
Management Consultants in the firm’s communications industry group and led its wireless solutions
practice. During his 14-year tenure with PRTM, Iyer helped companies in commercial
and government
sectors capitalize on the convergence
of three trends – internet ubiquity, emerging wireless technologies
and innovation business models – to unlock new business and customer value. Iyer is also the founder
and
president of the In-Building Wireless Alliance,
a global, cross-industry, not-for-profit focused on
accelerating
the adoption of in-building wireless technologies to improve public safety response, energy
consumption and real estate value for buildings. Prior to PRTM, Iyer was a member of the scientific
staff at
Bell Northern Research, which is now part
of Nortel Networks, based in Ottawa.
Iyer received a bachelor’s degree in electrical and computer engineering
from Carleton University in
Ottawa. He earned a
master’s and doctorate degrees in electrical and computer engineering, as well as a
master of business administration degree from Carnegie Mellon University in Pittsburgh. Iyer
is a frequent
speaker on wireless technology and
its ongoing integration into the healthcare industry. Most recently, he
was a keynote speaker at the Fifth Annual Healthcare Unbound Conference 2008 discussing “Leveraging
Emerging Wireless Technologies in Healthcare”. In addition, he will be
a keynote speaker at the 2008
Institute for Defense
and Business on the topic, “Wireless Disruptions in the Military Health Care Supply
Chain.” Iyer is a member of IEEE, Society for Photo-Optic Instrumentation Engineers
(SPIE) and Sigma
Xi. In 2007, he was voted by Jim
Young, CEO of Realcomm, as one of the “Top 35” to watch in the realm
of wireless technology.
Robert Jarrin
Sr. Director, Government Affairs | Qualcomm
Robert Jarrin is a Senior Director of Government Affairs for Qualcomm Incorporated. He is based in
Washington, D.C., and represents Qualcomm on U.S. regulatory matters relating
to wireless health and life
sciences. Jarrin’s
areas of responsibility include federal wireless health policy, healthcare legislative affairs,
Food and Drug Administration (FDA) regulation of converged medical devices, Federal
Communications
Commission (FCC) healthcare efforts,
Centers for Medicare and Medicaid Services (CMS) telehealth
reimbursement, and Office of the National Coordinator (ONC) regulation of health information technology.Externally,
Jarrin Chairs the Advisory Council to the Healthcare Information and Management Systems
Society Mobile Initiative (mHIMSS), leads the American Telemedicine Association (ATA) Policy
A-Team
on Telehealth and Meaningful Use, is the
U.S. Chair for the Trans-Atlantic Business Council (TBC)
eHealth Policy Sub-Working Group, Co-Chairs the Telecommunications Industry Association (TIA) Health
IT Working Group, co-leads the FCC mHealth Task Force (MTF) and serves on the
Scientific Advisory
Board of Medical Automation.
He also served for three years as Co-Chair of the U.S. Policy Working
Group for the Continua Health Alliance, and is on the Board of Directors for Vida Senior Centers, the
oldest Latino non-profit organization in the District of Columbia.
Recently,
Jarrin testified before the U.S. House of Representatives Committee on Energy and Commerce,
Subcommittee on Communications and Technology. The hearing titled, “Health Information
Technologies:
Harnessing Wireless Innovation”
focused on the implementation of the Health Information Technology for
Economic and Clinical Health Act (HITECH), the Affordable Care Act (ACA), and FDA draft guidance of
mobile medical applications.
In March 2013, FCC Chairman Julius Genachowski
formally invited Jarrin to join the FCC’s Consumer
Advisory Committee (CAC). The CAC has since created a Healthcare Working Group to gather
information on consumer and patient issues related to the proliferation of mHealth
technologies. In April
2013, Jarrin was invited
by the ONC to serve on the Food and Drug Administration Safety Innovation Act
(FDASIA) Section 618 Workgroup of the ONC Health IT Policy Committee (HITPC). The FDASIA
Workgroup is charged with providing expert input on issues and concepts identified
by the FDA, ONC, and
the FCC, to inform the development
of a report on an appropriate, risk-based regulatory framework
pertaining to health IT including mobile medical applications.
Prior to joining Qualcomm, Jarrin worked
as a Manager of Strategic Partnerships for Ericsson Wireless
Communications, served as a Law Clerk in the White House Office of Counsel to President Clinton and
also served as a Law Clerk and subsequent Consultant in the U.S. Department of
Justice to Attorney
General Janet Reno.
Jarrin
frequently speaks at public conferences, federal workshops and hearings. He is on the faculty of the
George Washington University School of Medicine and Health Sciences as an Adjunct
Assistant Professor
of Emergency Medicine, and provides
lectures on mHealth and medical device regulations for Case
Western Reserve University, Case School of Engineering. Jarrin holds a Bachelor of Arts degree in
Government and Politics from the University of Maryland at College Park and a
Juris Doctor degree from
Northeastern University
School of Law.
P. Tyson Kamikawa
Director of IT Effectiveness and Shared Platforms | Harvard Medical School
P. Tyson Kamikawa is the current Director of IT Effectiveness and Shared Platforms at
Harvard Medical School responsible for the integrity, performance and reliability
of
central technology functions for HMS. He brings
with him deep experience in bringing to
bear technology
solutions supporting pharmaceuticals and was the enterprise architect
responsible for the IT capabilities supporting the commercial launch of the drug Linzess,
which has market potential upwards of $6billion. Prior to pharma, he was Deputy
CIO at MIT’s Lincoln
Laboratory where he supported
Dept of Defense research efforts and gained front line experience in cyber
security and defense. He also spent ten years as a Disaster Recovery consultant for IBM specializing
in
rapid recovery efforts for corporations as well
as spending time as the Emergency Response lead for IBM’s
relationship with the City of New York’s Office of Emergency Management.
Mark Leahey
President and CEO | Medical Device Manufacturers Association (MDMA)
Mark Leahey is the President & CEO for the Medical Device Manufacturers Association
(MDMA), a national trade association in Washington, DC that represents hundreds
of
research-driven medical technology companies.
His responsibilities include advocating
on behalf
of the entrepreneurial sector of the medical device industry to Congress, the
Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services
(CMS), and other federal and state agencies. He has lobbied for a more reasonable
user fee for smaller
companies, worked to open access
to the hospital marketplace by challenging the exclusionary and anticompetitive nature of certain large group purchasing organizations
(GPOs), as well as ensure that medical
device technologies
are reimbursed adequately. Mr. Leahey was named one of the medical device
industry’s top lobbyists. He is a member of the Massachusetts Bar and a graduate of Georgetown
University, the Georgetown Law Center and Georgetown’s McDonough School
of Business.
Catherine
E. Livingston
Partner | Jones Day
Cathy Livingston is a leading authority on the Affordable Care Act. She has in-depth
knowledge of the multitude of tax provisions contained in the act, including
the
employer coverage requirement, the individual
coverage requirement, the premium tax
credit, insurance
reforms, insurer fees, the medical device excise tax, and new
requirements for tax-exempt hospitals.
Prior to joining Jones Day in 2013, Cathy was Health Care Counsel in the IRS
Office of Chief Counsel
where she served as principal
legal advisor to IRS senior leadership on all aspects of the Affordable Care
Act and its implementation. She was instrumental in advising the IRS team building the systems and
operational protocols needed to integrate tax subsidies and tax information with
the new system of health
insurance exchanges and
to incorporate the individual coverage requirement in the tax filing system. She
worked closely with the White House and the Department of Health and Human Services in all
aspects of
Affordable Care Act implementation. She
also worked closely with the Department of Justice on the cases
challenging the constitutionality of the Affordable Care Act from the district courts through the Supreme
Court. Prior to working on the Affordable Care Act, Cathy supervised all IRS
legal work with respect to
tax-exempt organizations,
employment taxes, and government entities. Cathy also served at the Office of
Tax Policy at the Treasury Department where she handled matters affecting tax-exempt organizations and
charitable giving. Cathy is a Fellow of the American College of Tax Counsel.
Bruce
Mayhew
Director | Security R&D, Sonatype
Bruce Mayhew is the Director of Security Research and Development at Sonatype
with over 20 years of
software development experience,
13 years of which have been focused on application security. He has
performed code-level security assessments for hundreds of applications, created application security
programs and training curriculums for large institutions, and has been a Web
Application Security Course
instructor for the SANS
Institute. Bruce is the primary author and project lead of OWASP WebGoat, a
deliberately insecure JavaEE educational application. He is an author of the SANS GSSP Secure
Programming Assessment and a frequent speaker on application
security
topics.
Elliot Menschik, M.D. Ph.D.
Managing Partner | DreamIt Health – Philadelphia
Elliot is a physician/engineer/hacker turned serial entrepreneur and investor. He is a
managing director of DreamIt Health, a program that invests in and accelerates
the
development of pre-seed healthtech ideas/teams/companies.
He is co-founder of
Venturef0rth, a campus in Philadelphia
for tech startups and an entity dedicated to doing
whatever
it takes to make it easier for early-stage companies to succeed. He also serves
on the Penn faculty where he teaches a crash course in entrepreneurship for engineers
and scientists aspiring to create companies that take their tech to market.
Elliot
was previously the founder and CEO of HxTechnologies, a pioneer in health information exchange
which he sold to MEDecision in May 2009. Following the acquisition, he served
as General Manager at
MEDecision with responsibility
for building new lines of business around health information exchange
(HIE), electronic health record (EHR), personal health record (PHR) and telehealth products and services.
On the academic side, Elliot is the author and inventor of multiple patents and
patents pending. He’s been
an oft-invited
speaker on the subject of imaging and health information exchange and is the author of
numerous peer-reviewed papers ranging from medical informatics to computational neuroscience.
He’s
been the principal investigator for a
number of grants from the National Institutes of Health that funded
HxTechnologies in its earliest days and has also led research on the economics of fragmented healthcare
delivery nationwide.
An NIH Fellow in the Medical Scientist
Training Program, Elliot received an MD and PhD in
Neuroscience
from the University of Pennsylvania School of Medicine following his work on memory
function and Alzheimer’s disease developing and exploring massively-parallel computer
models of the
brain. He holds MSE and BSEE degrees
in Electrical and Computer Engineering from the Johns Hopkins
University following work on microchip design.
John Reppas, M.D. Ph.D.
Director of Public Policy | Neurotechnology Industry Organization (NIO)
John Reppas MD-PhD is a technology expert who operates at the intersection of
academic, government, and private-sector innovation. Currently he is the Washington
DC based Director of Public Policy for the Neurotechnology Industry Organization
(NIO), where he is responsible for government engagement, advocacy, international
initiatives, and public-private collaboration to advance commercial neuroscience.
He spent fifteen years in academic medicine, at Harvard Medical School and the
Stanford University
School of Medicine, focused
on translational neuroscience. He is an expert in brain-machine interfaces,
therapeutic neuromodulation, the biological basis of choice behavior, and brain imaging. His current
entrepreneurial focus is on using mobile devices and cloud-based analytics to
predict real-world behaviors
in the consumer, healthcare,
and national-security setting.
Dr. Reppas is an angel investor in early-stage life science, gaming, and healthcare
information-technology
companies. He collaborates
with emerging companies on developing and commercializing new
therapeutics, medical devices, and diagnostics to best address unmet medical need. John also advises
private-equity and public-market investors, as well as family offices, on healthcare
investment strategy.
John graduated from Oxford University
with a Bachelors of Medicine, received his MD from the HarvardMIT Division of Health Sciences and Technology, and a
PhD from the Department of Neurobiology at
Harvard
Medical School. He received further fellowship and postgraduate training at the Howard Hughes
Medical Institute, Stanford University School of Medicine and at the Wharton
School.Leigh Ann Ruggles
Strategy & Development |
Verizon Mobile Health Solutions
Leigh Ann leads the Go-to-Market Strategy for Verizon Mobile Health Solutions
Product
Team. Verizon Mobile Health Solutions leverages
Verizon’s expertise in mobility, data
security,
scalability and consumer engagement to connect patients, providers and payers
in innovative ways with the mission to transform how these stakeholders engage to help
solve some of healthcare’s biggest challenges. In her role, Leigh Ann is
responsible for new business
development, driving
new mobile health products into the market via both direct and channel sales. Her
responsibilities include marketing, business development, strategy and salesforce mobilization.
Leigh Ann joined Verizon from Healthways (Nasdaq: HWAY), a wellness and disease
management
company, where she served as Director
of Business Development. During her tenure at Healthways, she
held strategic business development roles across multiple distribution channels, including health plans,
large self-insured employers, and health system clients. Across all channels,
Leigh Ann developed and
executed on strategy to
drive revenue directly and through distribution channels via clients such as: Cigna,
CareFirst and WellMark.
Prior to joining Healthways, Leigh Ann served as Senior Director of Business
Development for the
Economic Alliance of Greater
Baltimore, working with business, government and university leaders to
promote business and economic development in the Greater Baltimore region. Her responsibilities
included strategic business development in the health care industry, with a focus
on companies supporting
the Centers for Medicare
and Medicaid Services (CMS) Chronic Care Improvement Program.
Leigh
Ann also served as Director of Marketing for the first business service management software
company, Managed Objects, which is now part of Novell. In this role, she founded and grew
the marketing
department, leading a cross-functional
marketing team for the US and Europe. Her responsibilities
included all aspects of marketing to launch products and drive sales, including: analyst relations, internal
and external communications, public relations, sales support, lead generation,
marketing collateral and web
presence. Leigh Ann
has a Bachelor of Science degree in Biology from Wake Forest University in
Winston-Salem, N.C. She has served in numerous volunteer roles, including two terms as President of the
Healthcare Businesswomen’s Association Mid-Atlantic Chapter, Advisory Board
member, and Founding
Board Member of the Esophageal
Cancer Action Network.
David I. Safferman, M.D., FACR
President and CEO | Advanced Radiology, P.A.
Dr. David Safferman serves as President and Senior Partner of Advanced Radiology, P.A.
- the largest radiology provider in Maryland. He received his medical degree
from West
Virginia University School of Medicine
in Morgantown, VA, and completed his residency
in
diagnostic radiology from the George Washington University Medical Center in DC. In
addition, he received his Fellowship in Cross Sectional Imaging (MR/CT/US) from the Pennsylvania
State
University Hospital in Hershey as well as
completed specialty training in nuclear medicine and
radioisotope
techniques from the Naval Medical Command. He currently serves as MedChi Board of
Trustees Co-Chair of Operations Council and holds a position with the American College of
Radiology
Council.
Sean
M. Scott
CEO | Resilience
Mr. Scott joined Resilience shortly after its founding in 1995, when he began
as a manager
and senior engineer. Since then he
has served several key roles in engineering, product
development
and customer support, eventually ascending to Vice President for Global
Systems Engineering. In 2009, he was elevated to CEO and is now a member of the Board
of Directors of Resilience Technology Corporation.In addition to world-class
credentials in the field of cyber security, Mr. Scott’s leadership skills proved
pivotal as he steered the company through its recent acquisition and subsequent management
take-over.
Through this period, he charted a course
for continued growth, sustained production quality and technology
advances, while maintaining excellence in customer service and support. Mr. Scott has also retained and
recruited a cohesive and committed management team, while continuing to build
a skilled network of sales
professionals, strategic
resellers and best-of-breed technology partners. Mr. Scott is served in the United
States Air Force, where he served as an electronic warfare systems specialist 1987-1991. He
is a veteran of
Operation Desert Storm where he
served as a communication, navigation, and radar systems specialist. He
now works out of the Resilience Corporate Headquarters in Hanover, Maryland.
Jeff Stratton
Manager | Comprehensive Cyber Security Services (CS)2, Lockheed Martin
Since 1996, Jeff Stratton has been working in the IT field and specifically doing
work in IT Security since
2000. Jeff is a thought
leader in the design, testing, and implementation of IT security. With several years
of experience in all areas of security including penetration testing (network and application)
Incident
Response, Intrusion Detection, Malware,
and Forensics. At Lockheed Martin, Jeff is currently the manager
of the Comprehensive Cyber Security Services (CS)2 organization within the IS&GS Civil product line.
The organization's focus is to perform comprehensive security testing that goes
above and beyond the
common penetration test for
its customers. By doing architecture, code reviews, and developer training
combined with penetration testing, the team brings a product to its customers that is far more
comprehensive, taking information assurance to a much higher level. Specialties,
include: Unix, Windows,
Penetration Testing, Web
Application Testing, Wireless Security, Network Infrastructure.
Adam Suri
Strategic Partnerships, Community DNS
Adam Suri is currently managing the North American expansion for CommunityDNS,
the global Internet’s second largest resolver of DNS, and one of the largest
provider of
cloud based DDoS mitigation. Prior to
this role, Suri was senior vice president of
Cyber
Operations at Secure Technologies Group, a provider of Cybersecurity services,
and was with the State of Maryland's Department of Business and Economic
Development, as the director of Cybersecurity and the Office of Innovative
Technologies, charged with implementing the recommendations of Gov. Martin
O'Malley's CyberMaryland Initiative. Before that, he was a serial entrepreneur:
co-founder of Beny Bigalos
and managing sales and
marketing at Yafo Networks. His cyber background includes roles in leading sales,
marketing and engineering at Yafo Networks, Cisco Systems, Honeywell and Charles Industries.
Suri has a
Bachelor of Science degree in Industrial
Engineering from Bradley University and an MBA from the
University
of Illinois at Urbana-Champaign. He also holds patents in network management and optical
encryption.
Tom Weithman
Managing Director | CIT GAP Funds
Mach37
Tom Weithman serves as Managing
Director of CIT GAP Funds -- a family of seedstage venture funds focused on making equity investments in the Commonwealth
of
Virginia’s most promising tech, energy
and life science companies -- and is a core
member
of the CIT Team forming the MACH37 Cyber Accelerator. Under Weithman’s
leadership, CIT GAP Funds, has placed more than 80 seed-stage equity investments,
attracted more than $75M of private equity investment into CIT GAP Funds portfolio
companies, driven 15
portfolio companies to Series-A
investment or beyond, and propelled several companies to exit. CIT GAP
Funds has been recognized by Entrepreneur Magazine as a Top 100 venture fund for several successive years.Weithman
brings to CIT GAP Funds a strong prior executive experience in sales, business
development, and operations with both IBM and Hughes Electronics and has raised over $90M in funding
for numerous early stage technology companies. Weithman is active in numerous
angel investment, venture
capital, and entrepreneurial
support organizations, speaking frequently on the subjects of seed stage
investing, federal R&D funding and technology transfer and has been recognized as among the “25
Most
Influential People in the Southeast Technology
Community” by TechJournal South.
Weithman currently
serves on the Board of Directors of the Alzheimer’s Association National Capital
Chapter and serves as an advisor to American University’s Masters Program in Entrepreneurial
Journalism.
Weithman holds a Bachelor’s degree
from the University of Notre Dame, an MBA from Michigan State
University and a Master's degree in Public Administration from Harvard's John F. Kennedy School of
Government. He resides in Vienna, Virginia with his wife, Elizabeth and their
two children.
Robert
S. West, MS, FACHE
CEO | Pulmonary
and Critical Care Associates of Baltimore, PA
Managing Partner | C3 Healthcare Solutions, LLC
President | Proximal, LLC
Mr. West is
a seasoned healthcare executive with over 22 years of progressive
leadership experience in both the hospital and physician practice settings. He is Board
Certified in Healthcare Management and is a Fellow of the American College of
Healthcare Executives. Mr. West holds his Master Degree in Management from the
University of Maryland with a concentration in Healthcare Administration. His
expertise is in health care
financial management,
strategic planning, service line and program development as well as
physician/hospital relations. Currently Mr. West is the Chief Executive Officer of Pulmonary and Critical
Care Associates of Baltimore (PCCAB), where 45 private practice physicians direct
top rated intensive care
units across Maryland.
He is the Managing Partner of C3 Healthcare Solutions, LLC, a small healthcare
consulting company dedicated to helping physicians and hospitals collaborate to provide quality care
to
patients and maximize business opportunities.
Mr. West also created, and is President of Proximal, LLC, a
physician billing and management services company. He serves as the Board Audit Chairman of a publicly
traded company and a Board Director of a medical device start-up company.
Keith
Young
Security Official | Enterprise
Information Security Office, DTS Montgomery County
Government
Keith Young, CISSP, Security
Official for the Montgomery County Government,
Maryland,
is responsible for providing support to security/technology initiatives for the
Department of Technology Services. Mr. Young has over 17 years of Information
Technology experience with 15 of those years focused primarily on IT Security.
He
joined the County in 2002. As the Security Official,
he is responsible for all aspects of
the County
IT Security management, including regulatory compliance, computer forensics, vulnerability
and threat management, and enterprise architecture review and recommendation. His IT Security
initiatives
have won several awards and recognitions
including the National Association of Counties (NACo)
Achievement
Awards for two consecutive years and a finalist in the Information Security Executive North
America Government Project Award.
Prior to joining the County, Mr. Young
was the Director of Customer Care/Support and a Senior Security
Sales Engineer for V-ONE Corporation providing IT security support, solutions, and incident response for
Federal, Commercial, DoD, and Educational customers. He also held security engineering
and research
positions at Acterna/TTC and Salve
Regina. Mr. Young is an information security enthusiast and has
spoken/presented at many information security conferences. Mr. Young holds a Bachelor’s Degree in
Information Systems from Salve Regina University.
