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VABIO E-News July 22, 2015
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VABIO E-News: July 22, 2015 Edition

Focus Around Virginia 
A Word from CEO Jeff Gallagher

Members and friends of Virginia Bio,

After several years of relative inactivity, federal lawmakers are in gear again. And so are we at Virginia Bio.

The 21st Century Cures Act (H.R.6) was passed in the House of Representatives on July 10 by an impressive vote of 344 to 77. This bill was bipartisan in its creation and authorizes several changes to the approval process for drugs and medical devices.

The bill also authorizes an increase of $8.7 billion for the NIH and a $550 million increase for the FDA over 5 years. The bill amends the Federal Food, Drug, and Cosmetic Act to revise the drug approval process by allowing patient experience data to be considered in the risk-benefit assessment of new drugs; requiring the FDA to qualify drug development tools; allowing the FDA to rely on data previously submitted for a different purpose to expedite the development of certain drugs; and establishing a streamlined data review program for approval of drugs for additional indications. The bill requires the FDA to establish a program for priority review of breakthrough medical devices, identify types of devices that do not require a report preceding introduction, and rely on a third party to determine the safety and effectiveness of changes to medical devices. The bill requires manufacturers and distributors of investigational drugs for serious conditions to publish their policies on compassionate requests; revises and extends the priority review voucher program for rare pediatric diseases; and requires a pharmaceutical and technology ombudsman within the CMS to respond to complaints from manufacturers of medical products. The bill allows Medicare prescription drug plan sponsors to limit certain beneficiaries’ access to frequently abused drugs and mandates interoperability and certification of electronic health records. The House overturned a last-minute amendment that threatened the bill’s passage by proposing to make the new NIH and FDA spending discretionary, rather than mandatory.

The Senate is working up and is expected to consider its own version of the bill in the Fall.

For complete article click here.


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In this issue
focus around Virginia
VABIO Articles
VABIO Community News
VABIO Anniversaries
VABIO Calendar

VABIO News

CIT INVESTS IN TYPEZERO
CERES DEVELOPS NOVEL TB TEST
VIRGINIA BIO WELCOMES AON 
INOVA HEALTH CENTER NAMES CEO
CIT HOSTING WEBINAR SERIES
SHEIKH ZAYED PRIZE PROPOSALS
IMMUNARRAY LAUNCH’S LUPUS TEST
K2M SELLS MORE STOCK
GOULD JOINS HEMOSHEAR BOARD 
HOUSE APPROVES 21ST CENTURY ACT
FDA CLEARS DEVICE BY RIVANNA
HDL WINS APPROVAL TO SALE
BTI LAUNCHES NEW CAMPAIGN
CHADD AND ATTENTION POINT ALIGN
CADENCE CELEBRATES 30 YEARS
WELCOME GEOFFREY KARNY 
WELCOME MID-ATLANTIC BROADBAND 
WELCOME TYPEZERO 
WELCOME WILLIAMS MULLEN 
VABIO Community News 
VABIO Member Anniversaries 

VABIO Events
Virginia Bio Calendar

 
 
 
 
 
 
 
 



 
 
 
 
 
 
 
 

VABIO Articles TO TOP

CIT GAP Funds Invests in TypeZero Technologies

The Center for Innovative Technology (CIT) has invested in TypeZero Technologies, LLC, an early-stage medical technology company with a proprietary intelligent control system that improves the safety, outcomes and quality of life for patients with Type 1 and Type 2 diabetes. These CIT GAP Funds led TypeZero’s seed round, which included several other investors.

For complete article click here.

Ceres Receives $746K From Gates Foundation To Use Novel Nanotrap® to Develop TB Urine Test

Ceres Nanosciences, Inc. (Ceres) began a development program, through $746K in funding by the Bill & Melinda Gates Foundation, to use Ceres’ Nanotrap® particle technology to develop a new method of diagnosing active pulmonary tuberculosis (TB) using urine samples from TB patients. During the 9 month performance of this program, Ceres will work in close collaboration with leading TB experts from George Mason University, Johns Hopkins University, Colorado University, and Colorado State University, to demonstrate the ability of the Nanotrap® to enable a highly sensitive rapid test for TB in urine.

For complete article click here.


Virginia Bio Welcomes Aon to BIO Business Solutions Member Discount Programs

Aon Risk Solutions, the global risk management business of Aon plc, has joined the BIO Business Solutions® program to offer comprehensive executive liability insurance coverage. BIO Business Solutions® is the largest cost savings purchasing program for the biotech industry.

Regardless of the organization’s size, location or status as a public or private company, the executive liabilities being faced are on the rise. Traditional risks such as directors and officers, employment practices, product liability and clinical trial risk have been joined by new threats such as privacy breach and cyber-crime. At the same time, increased regulation adds a new level of complexity and risk, especially for life sciences companies.

For complete article click here.

Inova Names Todd Stottlemyer as CEO, Inova Center for Personalized Health

Inova has named Todd Stottlemyer as Chief Executive Officer, Inova Center for Personalized Health (ICPH). In this role, Stottlemyer will be responsible for developing and growing all activities on the 117-acre ICPH campus (formerly the ExxonMobil site in Falls Church) which includes the Inova Dwight and Martha Schar Cancer Institute and the Inova Translational Medicine Institute (ITMI).

For complete article click here.

CIT Hosting NIH SBIR/STTR Webinar Series – BEGAN ON JULY 14

Center for Innovative Technology (CIT) is hosting NIH SBIR/STTR Webinar Series, beginning July 14, to help organizations prep for the September 2015 and January 2016 NIH SBIR/STTR deadlines.

For complete article
click here.

Sheikh Zayed Prize for Pediatric Device Innovation Seeking Proposals

 

 
In conjunction with the 3rd Annual Pediatric Surgical Innovation Symposium, The Sheikh Zayed Institute for Pediatric Surgical Innovation is seeking proposals from inventors who have medical device concepts for use with pediatric patients. Proposals should address a significant, yet unmet need within the pediatric population with a device idea that lends itself to commercialization.

For complete article click here.


ImmunArray to Launch SLE-Key Rule Out Test for Lupus in Select U.S. Markets

 
   
ImmunArray, maker of a breakthrough technology that provides unprecedented levels of accuracy in ruling out the presence of lupus through a simple blood test, launched its new SLE-key™ Rule Out test in selected U.S. markets on July 1, 2015.

SLE-key™ is based on results from more than 500 patients, whose blood was tested against 200 antigens each. The results were able to rule out a diagnosis of SLE (Systemic Lupus Erythematous) with a sensitivity of 94 percent and a specificity of 75 percent, levels of accuracy that far exceed any other test for lupus to date.

For complete article click here.


K2M Sells More Stock

K2M Inc., a Leesburg-based global medical device maker, has sold more stock to the public in a secondary offering that resulted in net proceeds of approximately $16.3 million.

The sale included 750,000 shares offered by the Company and 3,750,000 shares offered by the selling stockholders named in the registration statement (the "selling stockholders"), at a price to the public of $22.60 per share. In addition, the underwriter has a 30-day option to purchase up to 675,000 additional shares of common stock from the Company and the selling stockholders on a pro rata basis.

For complete article click here.


HemoShear Therapeutics Names Robert Gould to Board of Directors
HemoShear Therapeutics, a privately held discovery stage biotechnology company appointed Robert J. Gould, Ph.D., President and CEO of Epizyme, Inc., to the HemoShear Therapeutics Board of Directors. Dr. Gould brings more than 30 years of experience in the pharmaceutical and biotechnology industry.

For complete article click here.



BIO and Virginia BIO Praise 21st Century Cures Act House Approval
On July 10, 2015, the U.S. House of Representatives overwhelmingly approved the 21st Century Cures Act by a bipartisan vote of 344-77. The 21st Century Cures Act is designed to ensure the laws, regulations, and resources keep pace with scientific advances while maintaining the gold-standard level of safety for patients.

For complete article click here.


Rivanna Has Received FDA Clearance of Its Accuro™ Device
Rivanna Medical has received FDA 510(k) clearance to market Accuro™, a handheld and untethered smart phone-sized ultrasound device that is designed to guide spinal anesthesia with automated 3D navigation technology in addition to ultrasound imaging of abdominal, musculoskeletal, cardiac and peripheral vascular anatomies.

The Accuro™ platform is designed to provide automated navigation to an anatomical target so a clinician may avoid “guessing” where the target is. The initial commercial application of RIVANNA’s Accuro™ platform is designed for guiding clinicians to a first-attempt success in administering spinal anesthesia.

For complete article click here.


HDL Wins Approval to Put Itself Up for Sale
Health Diagnostics Laboratory, Inc. (HDL, Inc.) recently filed a motion with the United States Bankruptcy Court for the Eastern District of Virginia seeking the court’s authorization to conduct a sale of its business under Section 363 of the Bankruptcy Code. HDL Inc. intends to continue normal operations throughout the sale process, which is expected to maximize the value of the company and provide a platform for future growth.

For complete article click here.


Biotherapeutics Launches a New Fundraising Campaign
The Biotherapeutics (BTI) team traveled to BIO 2015 in Philadelphia June 16-19 to launch a new fundraising campaign that will allow the Company to complete IND-enabling TOX package, and initiate human clinical trials.

“BTI’s clinical candidate for Crohn’s disease (CD) is supported by data packages with strong animal pharmacology, validated MOA, promising safety profile, and impressive human translational data.” Said Dr. Carbo, Scientific Director.

For complete article click here.


CHADD and Attention Point Announce Strategic Alliance
Children and Adults with Attention-Deficit/Hyperactivity Disorder (CHADD), a national non-profit organization dedicated to helping individuals with ADHD and Attention Point, LLC, a leading health IT company committed to improving the diagnosis and management of neurobehavioral health disorders, today announced a strategic partnership aimed at increasing access to effective ADHD resources to help monitor and manage ongoing ADHD treatment.

For complete article click here.


Cadence, Inc. Celebrates 30 Years

Cadence, Inc., a leading contract manufacturer of advanced products, technologies, and services to the medical, life science, and industrial markets, celebrates 30 years in business. The company, originally founded as Specialty Blades in 1985 by engineer Martin Lightsey, was developed with the concept of combining Computer Numerical Control (CNC) and razor blade sharpening technologies to address the needs of companies who required high performance custom-made blades.

For complete article click here.


Welcome New Member: The Law Office of Geoffrey Karny
The Law Office of Geoffrey M. Karny provides clients with high quality, business-oriented legal services in a responsive manner and at a cost-effective price. Geoff Karny is an intellectual property attorney who brings over 25 years of experience from large law firms, corporations and government to his clients.

For more information please visit their website.


Welcome New Member: Mid-Atlantic Broadband Corporation
Mid-Atlantic Broadband Communities Corporation creates connections between technology and people to revitalize communities in Southern Virginia. By delivering high speed broadband access across underserved communities, MBC opens doors for businesses to locate operations across Southern Virginia with reliable broadband access at any capacity level. MBC operates an open-access network that enables businesses to work with the communication provider of their choice to secure diverse network access. As a non-profit entity, MBC reinvests in community programs that support the primary mission of creating jobs by attracting new businesses to the region.

For more information please visit their website.

Welcome New Member: TypeZero Technologies

TypeZero is leveraging more than 10 years of clinical trials, research, and innovation to develop the inControl Diabetes Management Platform to improve and simplify the lives of people with diabetes. inControl is a smartphone-based, artificial pancreas solution that automatically controls insulin delivery, virtually eliminates hypoglycemia and dramatically improves blood glucose levels. TypeZero has designed this product to reduce the significant device burden associated with diabetes and to create a unified solution that can be configured to personal preference and lifestyle.

For more information please visit their website.


Welcome New Member: Williams Mullen

Williams Mullen blends the law, government relations and economic development to help clients get where they want to go by focusing on finding solutions. Williams Mullen has 230 attorneys in offices across North Carolina, South Carolina, Virginia and Washington, D.C. Strategy, services and even the pricing structure can be customized to suit each client’s particular needs.

For more information please visit their website.

 
VABIO Community News TO TOP

Cloud Pharmaceuticals has added Dr. Harold “Skip” Garner, Director, Medical Information and Systems Division, Virginia Bioinformatics Institute at Virginia Tech, as a member of their new advisory board. Cloud Pharmaceuticals believes the advisors' insight into the drug development needs of the pharmaceutical industry will be of great value as the company embraces its role as pioeers in the digital disruption of drug design.

Two Institute for Advanced Learning and Research (IALR) scientists recently received confirmation of their adjunct professor status by Virginia Polytechnic Institute and State University

Dr. Satya Kadali is a Natural Products Scientist at IALR. Current projects Dr. Kadali is working on include: isolating, identifying, and characterizing the anti-cancer molecules from rosehip pods in collaboration with North Carolina A&T State University; developing anti-cancer, antifungal, and antibiotic drugs from plants; and identifying anti-anxiety products in Passiflora.

Dr. Scott Lowman is a scientist at IALR. Current projects Dr. Lowman is working on include: PCB remediation in partnership with the Town of Altavista; using precision robotics to record and track plant growth in a variety of conditions: studying and identifying beneficial bacteria to improve plant growth and stress tolerance; and researching the beneficial impacts of bacterial endophytes to improve grape vine growth and cold tolerance in partnership with the Virginia Department of Agriculture and Consumer Services.

Representatives from IALR including summer interns Emily MacLeish and Coleman Willis along with IALR scientist Dr. Kedong Da recently visited Deb’s Daylilies in Charlotte County, VA. MacLeish is a senior at James Madison University and Willis is a senior at Dan River High School participating in the Academy for Engineering and Technology program at IALR. Deb’s Daylilies is a small business founded by Debbie and Randall Parsons in 2008.

Currently they operate on 1.5 acres and have over 400 daylily varieties. Some are available for sale and others are in growing beds. IALR will provide the business with specific daylily breeding programs and will test five daylily varieties onsite this fall. Field research and establishing pathways to commercialization of IALR’s new daylily varieties is an essential part of IALR’s role in regional economic development.

Frank Gupton, Ph.D., with Virginia Commonwealth University’s School of Engineering, secured another multi-million dollar grant. In June, Gupton received $5 million from the Bill & Melinda Gates Foundation to develop cost-effective manufacturing for two important AIDS drugs.
VABIO Member Anniversaries TO TOP

Virginia Bio would like to thank our long term members who have recently celebrated their membership anniversaries:

ATTC  - 20 YEARS
GEORGE MASON UNIVERSITY COLLEGE OF SCIENCE - 20 YEARS
TECHLAB  - 20 YEARS
AFTON SCIENTIFIC - 16 YEARS
AMGEN - 13 YEARS
MEDIATECH - 11 YEARS
COOLEY - 10 YEARS
THIRD SECURITY - 10 YEARS

Virginia Bio would also like to thank our members renewing for the first time:

EMBODY
FINNEGAN

 
VABIO Calendar TO TOP

JULY 24
Event: Biotech and Beer
Where: LifeNet Health, Virginia Beach, VA
When: Friday, July 24
Details: Enjoy snacks and beverages with your colleagues from across the state while talking about the latest events in life science.
Registration: Click here for more information.

SEPTEMBER 9
Event: Governor’s Agriculture and Industrial Biotechnology Conference
Where: The Institute for Advanced Learning and Research (IALR), Danville, VA
When: Wednesday, September 9, 8am - 5pm
Details: Please join Governor Terry McAuliffe and Secretary of Agriculture and Forestry Todd Haymore to kick off the Virginia Ag Bio Initiative. Hosted by VirginiaBIO, this event will bring together public and private partners representing existing businesses engaged in the ag bio sector, research universities, and marketing and economic development professionals from across Virginia and the surrounding region to steer this effort for domestic and international business development. Attendees will discuss the current state of ag bio in the Commonwealth and identify opportunities for networking, collaboration and business development to support the future of this growing sector.
Registration: Click here for additional information.

SEPTEMBER 16
Event: RESI (Redefining Early Stage Investment) Boston
Where: The Westin Copley Place, Boston, MA
When: Wednesday, September 16, 7am - 5pm
Details: The RESI Conference is an ongoing conference series that will be establishing a global circuit for early stage life sciences companies to source investors, create relationships, and eventually, get funding. The RESI conference focuses on the diverse breadth of early stage investors that LSN tracks, including Family Offices, Venture Philanthropy Funds, VCs, Angel Groups, Corporate Venture Capital Funds, and more. The RESI Partnering Forum allows fundraising executives to identify and book up to 16 meetings with life science investors who fit their company's technology sector and stage of development. Additionally, through an expansive series of panels and workshops, attendees will have the chance to hear firsthand accounts from investors explaining their current investment mandates and process for identifying and qualifying candidates.
Registration: Virginia Bio Members receive discounted registration, please contact us for details and click here for additional information.

SEPTEMBER 25 - 26
Event: LifeNet Health Symposium 2015 - Regenerative Surgery: The Cutting Edge
Where: LifeNet Health, Virginia Beach, VA
When: Friday, September 25 - Saturday, September 26
Details: This specialized one and a half day symposium offers participants the opportunity to connect with highly respected providers and scientists from the fields of transformative therapies, technologies and tools in regenerative, reconstructive or restorative applications.
Registration: VIrginia Bio members receive Virginia Bio members receive a $200 discount on registration. Please contact us for the discount code. Click here to register.

SEPTEMBER 25
Event: MDMA's 8th Annual Medical Technology Executive Forum
Where: Crown Plaza Cabana, Palo Alto, CA
When: Friday, September 25
Details: This must-attend one day interactive forum will bring together more than 150 CEOs and senior executives to discuss the critical issues that affect product commercialization and the common challenges faced by med-tech companies today. Industry experts and government officials will address investment options, FDA reform, reimbursement challenges and much more.
Registration: Virginia Bio Members receive $100 off registration! Please contact us for discount details and click here for additional information.

OCTOBER 5 - 7
Event: AdvaMed 2015
Where: San Diego Convention Center, San Diego, CA
When: Monday, October 5 - Wednesday, October 7
Details: AdvaMed 2015 is the leading MedTech Conference in North America, bringing more than 1,000 companies together in a uniquely multifaceted environment for business development, capital formation, innovative technology showcasing, world-class educational opportunities and networking. An event rich in international flavor and featuring a deep, diverse attendee list that includes influential policy-makers, business executives and media, AdvaMed 2015 seeks to advance industry discussion from key perspectives.
Registration: Virginia Bio Members receive 20% off registration if you register by July 31! Please contact us for the discount code and click here for additional information.

NOVEMBER 18
Event: TEDMEDLive Streaming
Where: Live Streaming
When: Wednesday, November 18
Details: Due to an exciting partnership with TEDMED and Virginia Bio, TEDMED would like to invite you to join in on this year's event where we will Unlock Imagination in the service of Health and Medicine. We encourage you to convene and share in free online access to TEDMEDLive Streaming 2015, comprising of more than 70 talks from transformative thinkers in health and medicine.
Registration: Click here for additional information.

ABOUT VIRGINIA BIO
Virginia Bio, was formed in 1992 and incorporated in the Commonwealth of Virginia as a non-profit association. The purpose of the Association is to promote the biotechnology industry in Virginia, expand the knowledge and expertise of Virginia's businesses concerning biotechnology through seminars, educational publications and other means, to enhance public awareness of the biotechnology industry in Virginia and the scientific, economic and other benefits it provides, and to represent the interests of the biotechnology industry in Virginia before federal, state and local legislators and regulators.  We provide a forum for members and their guests to get to know each other and the many bioscience companies operating today in Virginia and serving our biotech community. We coordinate information among the many agencies and organizations interested in biotechnology.

To learn more about Virginia Bio and how you can get involved, Click Here
 
 
 
 
 
 
 
 




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