What's on Tap this week in Medtech

This is a particularly busy week with great networking opportunities available for those in the Medtech and/or Entrepreneurial space.

The week kicks off tomorrow, Tuesday, with the annual Medtech Conference hosted by ibiliti. The event will include some outstanding speakers and breakout sessions including Diabetes, Oncology, and Orthopedics. The event begins at 9:30 at the Washington Duke Inn and concludes at 5:15 with a Medtech Celebration.

On Wednesday, the NCSU Biomedical Engineering Senior Design students will be hosting a design review. These design reviews are stepping stones to the annual Research+Design Symposium (save the date for Tuesday, May 3, 2011). The Design Review will take place on NCSU's Centennial Campus in the BTEC room 135 starting at 1:30.

On Thursday, you don't want to miss the Carolina Innovations Seminar. The topic is, "A Primer for University Entrepreneurs." Speakers include Merrill Mason and David Pierson. The event gets going with presentations at 5:30 at UNC's Sitterson Hall room 014 and the moves to Top of the Hill for a networking reception.

Undergrad team develops lens to treat eyelid paralysis - Technician - News

Undergrad team develops lens to treat eyelid paralysis - Technician - News

Free RTP Conference on Personalized Medicine

Check out this free RTP conference on personalized medicine. Act fast if you want to attend.

Personalized Medicine in the 21st Century

Presented by

RTI International and

The North Carolina Biotechnology Center

June 15, 2010

8:30 a.m. to 4:30 p.m.

The personalized medicine field presents a new paradigm in healthcare

and the treatment of disease. North Carolina has a number of leaders in

this emerging field - represented by researchers and scientists at its preeminent universities, laboratories and research institutes, as well as its

biotechnology and pharmaceutical companies. Among the subjects to be explored by a field of local, national and international experts will be a concept gaining momentum called "P4," which uses treatment tools that are

"Predictive, Preventive, Personalized, and Participatory."

View Agenda

http://www.rti.org/page.cfm?obj=921E3F1A-9D0A-D2B7-848AFD67B0046C2D

Register to Attend (Registration is free.) Lunch is included

http://www.rti.org/events.cfm?register=personalmed

Location:

Sheraton Imperial Hotel

4700 Emperor Blvd.

Research Triangle Park, NC

For more information, contact Alison Mendys, amendys@rti.org.

Battelle report affirms Research Triangle Region as life sciences industry leader

FOR IMMEDIATE RELEASE
May 3, 2010

New study affirms North Carolina’s Research Triangle Region
as national life sciences leader in jobs, salaries, growth potential

Chicago, IL – The Research Triangle Region of North Carolina remains among the nation’s leaders in life sciences industry jobs and salaries, according to a report issued today (May 3) at the Biotechnology Industry Organization (BIO) annual international convention in Chicago.

The study by Battelle Memorial Institute, “State Bioscience Initiatives 2010,” benchmarks how U.S. states and regions are faring in their efforts to attract companies and quality jobs in an increasingly competitive national and international environment during a challenging economic downturn. Battelle, the world’s largest, independent research-and-development organization, has conducted the national industry review every two years since 2004.

“This study again demonstrates the steady growth and diversity of the Research Triangle Region’s life sciences cluster and the high rate of return for investments made by the region and the state of North Carolina over the past 25 years,” said Peter M. Pellerito of PMP Public Affairs Consulting in Chapel Hill, a contributing editor/author for the Battelle report.

“Dozens of U.S. states and foreign nations would love to have this diverse industry cluster,” Pellerito said. “What is especially noteworthy is the diversity of the industry in healthcare, agriculture and industrial applications in biology-based research, development and manufacturing. North Carolina’s state and regional lawmakers and economic developers can use this information as evidence of strong public/private partnerships as well as a reminder of what it will take to continue to compete in today’s global marketplace.”

Among the Battelle report’s key findings:

• Raleigh-Cary and Durham-Chapel Hill metropolitan statistical areas (MSAs) accounted for 10,816 of the state’s 18,789 drug and pharmaceutical jobs in 2008. Those jobs paid an average annual wage of $74,829 and each job generated an additional 4.6 jobs for the state and regional economy.
• Raleigh-Cary and Durham-Chapel Hill 2008 MSAs accounted for 12,988 research-and-testing company jobs at an average $75,829 annual wage in 2008. Those jobs generated an additional 2.6 jobs each for the state and region.
• Durham-Chapel Hill ranked first among mid-sized 2008 MSAs (those with employment of 75,000-250,000) for jobs in two core employment concentration sub-sectors of the nation’s life sciences industry: research, testing and medical laboratories jobs (8,270) and drugs and pharmaceuticals jobs (6,755).
• Raleigh-Cary ranked 4th in drugs and pharmaceuticals jobs (3,331) and 11th in research, testing and medical laboratories jobs (3,718) among large MSAs with total private employment of greater than 250,000.

“The report shows that the Research Triangle Region continues to be well positioned to compete,” said Charles A. Hayes, president and CEO of the Research Triangle Regional Partnership (RTRP), which coordinates economic development for the 13-county Research Triangle Region.

“Novozymes has been part of the Research Triangle Region’s biotech community for more than 30 years,” said Adam Monroe, president of Novozymes North America, which operates major research-and-development and manufacturing operations in the region. “It is the partnership of North Carolina’s state and regional leaders, the economic development community, private companies and the world-class university and community college system that has allowed our company to thrive.”

Among the state and region’s competitive assets for life sciences investment cited in the report were:

• National Institutes of Health awards of $6.49 billion to North Carolina biomedical research centers during 2004-2009.
• 579 U.S. Food and Drug Administration clinical trials for the 10 largest disease categories conducted in the state during 2009.
• 2,308 bioscience-related patents issued in North Carolina during 2004-2009.

“Life sciences is a key driver of our region’s economy,” Hayes said. “We remain focused on taking the steps necessary to help our existing life sciences companies remain competitive and to attract new investment and jobs.”

The Battelle study may be downloaded at http://www.bio.org/news.

For more information on the Research Triangle Region’s life sciences cluster, contact the Research Triangle Regional Partnership, (919) 840-7372, rtrp@researchtriangle.org.

The Research Triangle Regional Partnership (RTRP) is a public/private partnership that promotes economic development for the 13-county Research Triangle Region of North Carolina. The region comprises the north-central N.C. counties of Chatham, Durham, Franklin, Granville, Harnett, Johnston, Lee, Moore, Orange, Person, Vance, Wake and Warren counties. RTRP coordinates the regional competitiveness plan, called The Shape of Things to Come. For more information, visit www.researchtriangle.org.

# # #

Contact:
Charles A. Hayes, (919) 840-7372
Peter M. Pellerito, (919) 215-1490

Med Tech Gets New 'Ibiliti'

See the complete story at the following:
www.ncbiotech.org/news_and_events/med_tech_gets_new_ibiliti.html

New Websites

North Carolina’s life science community is debuting two new websites – a new portal for the State’s NCBioImpact workforce training partnership, and a new site hosted by the North Carolina Biotechnology Center to emphasize the job-creating dimension of North Carolina’s life sciences sector.

The workforce training partnership NCBioImpact will unveil a new Internet presence in time for BIO 2010. The website will serve as a resource for worker training and related information for visitors to the North Carolina Pavilion at the BIO 2010 International Convention. “One of the goals of the training initiative is to be more visible to industry, current and future employees and government officials,” said Bruce Kaylos, who manages NCBIO Biotech Manufacturers Forum. “The NCBioImpact will start by offering top-level information on North Carolina’s biomanufacturing and related work force training capabilities. Later, the site will provide students, employees and employers tools to get the most out of our training assets.”

NCBioImpact includes the North Carolina Community College System BioNetwork program, the North Carolina State University Golden LEAF Biomanufacturing Training and Education Center, and the North Carolina Central University Biomanufacturing Research Institute and Technology Enterprise.

Jobsfornc.com is a new website of the North Carolina Biotechnology Center featuring five video segments that highlight personal stories of a dozen people across the state. The site is designed to grow in the coming months, according to Robin Deacle, Senior Director of Corporate Communications at the Biotechnology Center. "We invite people whose lives have been improved by biotechnology - a summer training program, a better job or a life-saving medicine - to add their stories to the collection," Deacle said. "Biotechnology has made a huge impact on North Carolinians and together we can get the word out."

Reference for this post: The North Carolina Biosciences Organization

Duke receives $10 million gift for stem cell research

See the complete story at:
www.newsobserver.com/2010/03/18/395409/duke-receives-10-million-gift.html

Carolina Innovations Seminar - NC BioStart

Thursday, March 4, 2010 5:30-6:30pm

014 Sitterson Hall UNC-Chapel Hill

NC BioStart – Accelerating Technology Development at UNC Chapel Hill and Beyond

Speakers: Dr. Richard Boucher – Executive Director of NC BioStart & NC BioStart Entrepreneurs in Residence, Drs. Perry Genova, Joel Shaffer, and Tom Mercolino

UNC’s new NC BioStart program was established to increase the commercialization of intellectual property developed by our public universities in North Carolina, beginning in the first year at UNC and eventually including all UNC system schools. The program was started by the School of Medicine to meet the goals of its Clinical Translational Science Award, in partnership with the Office of Technology Development and the Kenan-Flagler Business School.

Dr. Richard Boucher, Executive Director of NC BioStart, Director of the UNC Cystic Fibrosis Center, and UNC entrepreneur, will be discussing the goals of the program and the resources that will be available through NC BioStart to our faculty, staff, and students which include a range of services from connecting faculty with industry experts to assisting with writing of business plans. Faculty can also be matched with an Entrepreneur in Residence (ER) to receive further consultation to explore their ideas. ERs Drs. Genova, Shaffer, and Mercolino (who have more than 75 years combined industry product development experience) will also discuss some of the exciting work that is currently ongoing at UNC through this program.

For more information on NC BioStart please visit their website at: http://tracs.unc.edu/index.php?option=com_content&view=article&id=448&Itemid=427

For more detailed information please visit - http://research.unc.edu/otd/carolina_innovations_seminar.php

NC Biomedical Innovation Network Symposium RESCHEDULE

The North Carolina Biomedical Innovation Network, due to the greater-than-anticipated response to tomorrow's symposium, has decided to reschedule the program to be held at a later date in a larger local venue. This will enable everyone to attend the symposium who has expressed interest in it and will also lead to a more interactive program. Additionally, they are going to evaluate conducting an industry-wide symposium at a major scientific conference that will further showcase the extensive preclinical resources in North Carolina.

Registration information for the NC Biomedical Innovation Network Symposium

Registration for the N.C. Biomedical Innovation Network Symposium is open until Feb. 17 (seating is limited): http://bit.ly/bnAnae (PDF)

N.C. Biomedical Innovation Network Launches With February 26 Symposium

FDA Unveils Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging

Initiative to focus on 3 types of procedures with high radiation doses

SILVER SPRING, Md., Feb. 9 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today announced an initiative to reduce unnecessary radiation exposure from three types of medical imaging procedures: computed tomography (CT), nuclear medicine studies, and fluoroscopy. These procedures are the greatest contributors to total radiation exposure within the U.S. population and use much higher radiation doses than other radiographic procedures, such as standard X-rays, dental X-rays, and mammography.

CT, nuclear medicine, and fluoroscopic imaging have led to early diagnosis of disease, improved treatment planning, and image-guided therapies that help save lives every day. The FDA continues to support a strong dialogue between patients and physicians over the medical necessity and risk associated with these types of imaging studies.

However, like all medical procedures, CT, nuclear medicine, and fluoroscopy pose risks. These types of imaging exams expose patients to ionizing radiation, a type of radiation that can increase a person's lifetime cancer risk. Accidental exposure to very high amounts of radiation also can cause injuries, such as skin burns, hair loss and cataracts. Health care decisions made by patients and their physicians should include discussions of the medical need and associated risks for each procedure.

"The amount of radiation Americans are exposed to from medical imaging has dramatically increased over the past 20 years," said Jeffrey Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health. "The goal of FDA's initiative is to support the benefits associated with medical imaging while minimizing the risks."

While there is some disagreement over the extent of the cancer risk associated with exposure to radiation from medical imaging, there is broad agreement that steps can and should be taken to reduce unnecessary radiation exposure.

For example, the radiation dose associated with a CT abdomen scan is the same as the dose from approximately 400 chest X-rays. In comparison, a dental X-ray calls for approximately one-half the radiation dose of a chest X-ray. Both diagnostics serve important, sometimes critical, public health needs.

Through the FDA's regulatory oversight of medical imaging devices, such as CT scanners, and through collaboration with other federal agencies and health care professional groups, the FDA is advocating the adoption of two principles of radiation protection: appropriate justification of the radiation procedure and optimization of the radiation dose used during each procedure.

"Working together," said Shuren, "the FDA and other organizations hope to help patients get the right imaging exam, at the right time, with the right radiation dose."

The three-pronged initiative the FDA is announcing will promote the safe use of medical imaging devices, support informed clinical decision-making, and increase patient awareness of their own exposure.

The FDA intends to issue targeted requirements for manufacturers of CT and fluoroscopic devices to incorporate important safeguards into the design of their machines to develop safer technologies and to provide appropriate training to support safe use by practitioners. The agency intends to hold a public meeting on March 30-31, 2010, to solicit input on what requirements to establish.

Examples could include a requirement that these devices display, record, and report equipment settings and radiation dose, an alert for users when the dose exceeds a diagnostic reference level (the optimal dose for most patients), training for users, and a requirement that devices be able to capture and transmit radiation dose information to a patient's electronic medical record and to national dose registries.

In addition, the FDA and the Centers for Medicare and Medicaid Services are collaborating to incorporate key quality assurance practices into the mandatory accreditation and conditions of participation survey processes for imaging facilities and hospitals. These quality assurance practices will improve the quality of oversight and promote the safe use of advanced imaging technologies in those facilities.

The FDA recommends that health care professional organizations continue to develop, in collaboration with the agency, diagnostic radiation reference levels for medical imaging procedures, and increase efforts to develop one or more national registries for radiation doses.

A dose registry would pool data from many imaging facilities nationwide, capturing dose information from a variety of imaging studies. This registry will help define diagnostic reference levels where they do not yet exist, validate levels that do exist, and provide benchmarks for health care facilities to use in individual imaging studies.

In a bid to empower patients and increase awareness, the FDA is collaborating with other organizations to develop and disseminate a patient medical imaging history card. This tool, which will be available on the FDA's Web site, will allow patients to track their own medical imaging history and share it with their physicians, especially when it may not be included in their medical records.

FDA Web site on Radiation Initiative:

http://www.fda.gov/Radiation-EmittingProducts/RadiationSafety/RadiationDoseReduction/UCM199904

Media Inquiries: Peper Long, 301-796-4671, 240-429-9205, mary.long@fda.hhs.gov,

Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration

Medtronic Receives FDA Approval for First Replacement Heart Valve Implanted without Surgery

1/26/2010 1:36:02 AM -- Business Wire

Medtronic Receives FDA Approval for First Replacement Heart Valve Implanted without Surgery

Melody® Transcatheter Pulmonary Valve Offers Non-Surgical Valve Replacement Option for Congenital Heart Disease Patients

MINNEAPOLIS--(BUSINESS WIRE)-- In a significant development for congenital heart disease patients, Medtronic, Inc. (NYSE: MDT), announced today that its Melody® Transcatheter Pulmonary Valve has received U.S. Food and Drug Administration (FDA) approval under a Humanitarian Device Exemption (HDE). This innovative medical device is the first transcatheter heart valve to receive FDA approval.

Delivered through a catheter requiring only a small incision, the Melody valve will benefit children and adults who are born with a malformation of their pulmonary valve, which is the valve between the heart and lungs. These patients often require open-heart surgery to restore effective blood flow to their lungs. Previously, the only way to repair or replace a failed pulmonary valve conduit was through additional surgeries. To date, more than 1,100 patients worldwide have received a Melody valve.

"The Melody Transcatheter Pulmonary Valve is a significant technological breakthrough and offers a reprieve for many patients with congenital heart disease - many of whom are young and will require several heart surgeries over their lifetime," said pediatric cardiologist Dr. William E. Hellenbrand of the NewYork-Presbyterian Morgan Stanley Children's Hospital and Columbia University Medical Center.

"The Melody valve gives patients with congenital heart disease a new, non-surgical approach to managing their disease."

"This novel technology will improve the lives of thousands of patients in the United States," said Dr. John Liddicoat, vice president and general manager of the Structural Heart division, part of the CardioVascular business, at Medtronic. "Medtronic is leading the development of transcatheter therapies for heart valve disease. FDA approval of the Melody Transcatheter Pulmonary Valve is evidence of that leadership."

In October 2006, the Melody valve became the first transcatheter valve to receive regulatory approval anywhere in the world when it received the CE (Conformité Européenne) mark. It is now approved by the FDA for use in the United States under an HDE, a special regulatory approval for treatments intended for fewer than 4,000 U.S. patients per year. HDEs are granted for medical devices that have demonstrated reasonable safety and probable benefit, but not clinical effectiveness.

Medtronic CardioVascular is committed to advancing the treatment of coronary, peripheral, aortic and structural heart disease through collaboration with leading clinicians, researchers and scientists worldwide.

ABOUT MEDTRONIC Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology - alleviating pain, restoring health and extending life for millions of people around the world.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's Annual Report on Form 10-K for the year ended April 24, 2009. Actual results may differ materially from anticipated results.

Medtronic, Inc. Public Relations: Joe McGrath, 612-819-6421 or Investor Relations: Jeff Warren, 763-505-2696

Source: Medtronic, Inc.

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Copyright © 2010 Business Wire

Global Health Links Added

A new section has been added to Medtech Central in the link list on the right side of the blog that is focused on World Health. Please post responses if you are aware of specific global health resources that should be included in the list.

Hear the Story of Oriel Therapeutics tonight at the Carolina Innovations Seminar

Carolina Innovations Seminar
"The Story of Oriel Therapeutics"
Thursday, January 7, 2010
5:30-6:30 p.m.
Sitterson Hall, Room 014
University of North Carolina at Chapel Hill

Dr. Paul Atkins co-founded the UNC spin-out company Oriel Therapeutics in 2002. Dr. Atkins is currently the President and Chief Operating Officer of Oriel, which was based on technology developed for dry powder inhaler devices in the lab of Dr. Anthony Hickey of the UNC School of Pharmacy. Prior to founding Oriel, Atkins spent more than ten years with GlaxoSmithKline where he established the Inhaled Product Development group and was responsible for a number of global technical development programs, including the development of HFA metered dose inhalers and novel dry powder inhalers. Oriel Therapeutics is now actively developing a portfolio of respiratory products targeted primarily at asthma and COPD. Dr. Atkins will share the journey of Oriel and their progression from the academic lab to the initiation of clinical trials.

For more information about the OTD seminars, go to:
http://research.unc.edu/otd/carolina_innovations_seminar.php