AGENDA

7:30am         Registration & Networking Breakfast | Sponsored by Jones Day

8:15am         Welcome & Opening Remarks

INDUSTRY LANDSCAPES & MARKET DRIVERS

8:30am         Cyber Security Start-up Landscape & Market Driver

Cyber intrusions have increased exponentially over the last decade, exposing sensitive personal, health and business information, disrupting critical business operations, and imposing high costs on the economy. With the increasing adoption of cloud computing, mobile devices and web-based applications, hackers have more opportunities than ever to infiltrate and crash network systems.

Sean Scott, CEO | Resilience

Adam Suri, Strategic Partnership | Community DNS

9:15am      Healthcare Technology Start-up Landscape & Market Drivers

Catherine Livingston, Partner | Jones Day

Jim Edwards, CEO | ELITE Strategic Services

Mark Leahey, President & CEO | Medical Device Manufacturers Assoc

NEXUS OF NEED AND OPPORTUNITY

10:15am    Cyber Security’s Impact From Financial Markets to Healthcare IT

Any product of system that travels over the Internet is susceptible to cyber attacks. Malicious attacks can stop or disrupt the workings of critical infrastructure, the financial backbone, communications, government, pacemakers, smartcars. What needs to be addressed and what solutions are available.

Keith Young Security Official | Enterprise Information Security Office DTS Montgomery County Govt.

Jeff Stratton, Manager | Cyber Security Services, Lockheed Martin

Bruce Mayhew, Director, Security R&D | Sonatype

11:00 am Safeguarding Patient Privacy/ Cyber Risks in Personal Healthcare Information

As new technologies evolve, the medical workforce becomes more mobile and efficient by moving away from paper processes and relying more heavily on the use of computers. The rise in the use of administrative and clinical technologies creates and increase in potential security risks. Health care organizations now account for one third of all security breaches reported across all industry segments worldwide. Cyber risks in Personal Healthcare Information (PHI) is strong and real and is amongst the industries area which have seen the greatest increase in incidents. Among the reasons are that covered entities, business associates and individual victims are far slower to identify data thefts than organizations in other sectors.

P. Tyson Kamikawa, Director of IT Effectiveness and Shared Platforms | Harvard Medical School

LUNCH

RISKS & HURDLES FOR COMPANY LEADERS AND INVESTORS

1:00 pm       Investment Capital Restrictions for Technology Start-ups and Pending Regulatory Risks

Export control and compliance knowledge is essential for any company dealing with technology that crosses borders. Getting issues of CFIUS and ITAR right can make or break a business. The Committee on Foreign Investment in the United States (CFIUS) review process has been the subject of significant reforms over the past several years given the state of national security. These include numerous improvements in internal CFIUS procedures and enactment of the Foreign Investment and National Security Act of 2007 (FINSA) and changes in International Traffice in Arms Regulations (ITAR). Other regulatory impacts could add either risk or opportunity for new start-ups and their investors, coming in the form of possible Congressional action and Executive orders.
 

Giovanna Cinelli, Partner | Jones Day

Thomas Goldberg, Co-Founder | Lineage Technologies, LLC

1:45pm        Healthcare Technology Approvals, Clearances and Commercialization

One of the FDA's most important roles in carrying out its public health mission is to monitor and evaluate the safety and effectiveness of medical devies. The changing business dynamics of the life sciences industry have also made it critical to have a clear understanding of the dynamics of the FDA. The clearance and approval process from pre-approval to post market controls or recalls and product withdrawals are critical aspects of the commercialization process for medical devies, which are governed by the FAC law and regulation. The organization, jurisdiction, functions, and operations of the FDA.An overview of medical device regulations, "risk-based" classification of devices, the 510(k) clearance process, premarket approval process (PMAs), drug labeling and promotion, general post-market controls and more.

Colleen Heisey, Partner | Jones Day

Anand Iyer, PhD, President & CEO | WellDoc. Inc.

BREAK

LEVERAGING THE OPPORTUNITIES

2:45pm        Future Technology Investment: mHealth Innovation and Implementation

Mobility in healthcare is a major component of the way healthcare solutions are delivered and consumed. Wireless technologies are enabling a shift in healthcare communications between physicians, hospital and patients. Issues discussed will be the state of the technology, implications for care, telemedicine and engaging patients in self-care.

Elliot Menschik, MD, PhD Founder Venture Forth/Managing Director | DreamIT Health

Leigh Ann Ruggles, Strategy & Development | Verizon Mobile Health Solutions

Alexis Gilroy, Partner | Jones Day

Robert Jarren, Senior Director, Government Affairs | Quallcomm

3:30pm       Building a Business: Strategic Partnerships & Exit Opportunities in Healthcare

Part of the art of attracting outside capital depends on what you do before you seek outside funding.  Building an early stage health care company in healthcare IT, medical devices or diagnostics requires timing, discipline and a full understanding of how to properly launch and build your company and well as how to build and manage the right strategic partnerships.   
                                   

Bob West, CEO | Pulmonary & Critical Care Associates

A. Craig Asher, Principal | Vital Venture Capital

Alex Castelli, CPA, Partner, National Technology & Life Sci Industry Practice Leader | Cohn Reznick, LLP

INVESTORS ON OPPORTUNITY: THE NEXUS OF HEALTHCARE AND CYBER SECURITY

4:15pm        Investor Roundtable