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Food and Drug Administration Safety and Innovation Act highlighted

Members of Delaware's medical, pharma, and legislative communities gathered at the Helen F. Graham Cancer Center in Christiana Care Health System to discuss the U.S. Food and Drug Administration Safety and Innovation Act of 2012.

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The bill enables the FDA to collect fees from pharma companies to offset costs of regulatory reviews of biological products and drugs. The measure reauthorizes the Prescription Drug User Fee Act and Medical Device User Fee Act.

U.S. Senator Tom Carper issued the following statement:

"This bill helps ensure that Americans get access to the life-saving medications and medical devices that are developed in this country – including Delaware – as soon and as safely as possible," said Sen. Tom Carper. "It improves the Food and Drug Administration's ability to review and regulate drugs and medical devices for adults and children. This legislation also helps to protect patients' access to critical medicines by creating new programs to incentivize the development of new antibiotics and reduce drug shortages. Patients, health care providers, and the pharmaceutical and medical device industries will all benefit from a more responsive and effective Food and Drug Administration– a win-win for Delaware consumers and businesses."

and, our camera's were there to capture the conference:

 

 

 

Topics: Pharma, Senator Carper, FDA

We Work For Health honors Sen. Carper

U.S. Senator Tom Carper of Delaware was presented with this year’s Medical Innovation Champion award by the Dayton and EppesDelaware Chapter of We Work for Health (WWFH) at Junior Achievement of Delaware (JA) in Wilmington on August 27. The award was furnished in conjunction with a WWFH roundtable discussion on the future of medical innovation in Delaware.
 
Senator Carper’s work has been of tremendous importance to the robust medical innovation industry in Delaware, and the workforce and economic support it provides. He has been a strong supporter of the innovators, helping ensure they are able to recoup their investments with the protection of data exclusivity rights in health care reform. He is an advocate and supporter of the Delaware Health Information Network (DHIN) and Delaware becoming the first state to roll out electronic health records statewide.


“Senator Carper has gone to bat for innovators here in Delaware and around the country,” said Frank Howard, WWFH Campaign Manager. “His leadership in health care reform was critical in keeping important research alive.”
 
Medical innovation leaders in Delaware held a roundtable discussion following the award covering several issues of importance to the continued support of medical innovation in Delaware. Topics covered included narrowing gaps in translation research so more lab discoveries make it to market; navigating current limitations on private investment; reforming the Food and Drug Administration’s regulatory review process; and stimulating the cultivation of new innovators through Science, Technology, Engineering, and Mathematics (STEM) education and other programs.
 
“Today’s gathering allowed for important discussions on what steps we need to be taking to support future innovators,” said JA President and WWFH Delaware Chapter Co-Chair Rob Eppes. “Here at Junior Achievement, we are doing our part to prepare today’s students to be tomorrow’s leaders in medical innovation and research.”


Attendees were invited on a tour of JA’s Innovation Hub by Eppes. The Hub is a STEM career exploration zone within the JA World experiential learning center. Through virtual expeditions, students are able to explore local STEM career opportunities and the associated educational requirements. Preparations are underway for the Hub to host 2,700 students for the JA Innovation Hub Career and College Readiness Experience in late September.
 
Roundtable participants included representatives from: AIDS Delaware; Analtech, Inc.; Christiana Care Health System; Delaware AFL-CIO; Delaware Bioscience Association; Delaware Biotechnology Institute; Delaware Economic Development Office; Delaware Healthcare Commission; Delaware HIV Consortium; Delaware State University; Junior Achievement of Delaware; and Mid-Atlantic Association of Community Health Centers.
 
We Work for Health is a grassroots initiative that unites health consumers, biopharmaceutical company employees and retirees, vendors, suppliers and other business, academic and community partners to demonstrate how these diverse groups work together to improve America’s health care system and strengthen our economy.

Topics: Pharmaceutical Industry, BIO, Pharma, Pharma Industry

Connecting in Maryland

What happens when you mix Bio and Pharma professionals BioBuzzwith one of the most prestigious schools in the country and a great, relaxing setting on Baltimore's Inner Harbor? That was the question Chris Frew wanted to answer when he helped create "Bio on the Bay" a chance for many in the Bio and Pharma communities to come together and share ideas, network, and unwind together.

Chris Frew is Scientific Director at Tech USA. Here he explains the origins of these gatherings and the kinds of people who are attending on a regular basis.

Chris can be reached at cfrew@techusa.net if you would like to learn more.

Topics: BIO, Pharma, Maryland

A Call for Action for the Future of Bio/Pharma/Health

More than 100 leaders in the Bio, Pharma, and Health Industries gathered at Delaware Technical and Community College in Wilmington, Delaware on Friday, June 25 to hear from Governor Jack Markell, Former U.S. House Majority Leader Richard Gephardt, and Rich Fante, President of AstraZeneca US and Regional VP North America, as they announced the findings of a report from the Richard GephardtCouncil for American Medical Innovation about the future of Medical Innovation.

Click Here to download a copy of the full report.

Here's some excerpts from Media Coverage of the event:

The United States must invest more aggressively and stress development of more scientists if it is to retain its position as the worldwide leader in medical innovation, with the burden falling on government and community leaders to foster growth, former U.S. House Majority Leader Richard Gephardt said Friday.

...Gov. Jack Markell

"It is critical to our national and economic interests that we own medical innovation in the future as much as we owned mechanical innovation in the past," Markell said. "Big and serious companies are moving medical companies overseas. ... We want these companies to stay here and grow here."

...

Released at the conference was a 62-page report that focused on problems in the current U.S. Rich Fantemedical technology system and suggested improvements. The report was essentially a compendium of interviews with 72 experts in the biomedical and capital investment industry, as well as advocacy groups leaders.

Four major themes from the report emerged:

•More public/private partnerships are need to bring research to market.

•Government needs to provide better research and development tax credits and adopt favorable tax policies to keep manufacturing jobs stateside.

•The U.S. Food and Drug Administration regulatory process must be overhauled so new drugs and devices can be evaluated sooner.

•The bioscience curriculum in public schools must be significantly enhanced.


Click Here to read the article from the News Journal.

At the event, CAMI and We Work for Health unveiled a public policy agenda based on the recent Battelle study, "Gone Tomorrow? A Call to Promote Medical Innovation, Create Jobs, and Find Cures in America." The study, commissioned by CAMI, reflects direct feedback of leaders representing patients, academia, private industry, research, labor, venture capital, government, and economic development.


Medical innovation generates high-quality jobs, and if properly fostered, could generate many more across the state. Despite tough economic times, the biomedical industry grew 14.4 percent in the last jobs cycle, compared to 4.3 percent for all other industries. In Delaware, biopharmaceutical and related fields directly employ 11,500 workers in 247 companies according to a report published in July 2009 by the Center for Applied Demography and Survey Research at University of Delaware. Medical innovation holds the promise of finding more cures for more diseases at a faster rate and Delaware companies are leading the way in this important research and development.


Click Here to read the full article from the Business Ledger.

Despite tough economic times the Biomedical industry grew over 14-percent in the last jobs cycle. No state has been better at this than Delaware. Bio-pharmaceutical and related fields alone have directly employed nearly 12,000 workers in 247 companies.

Click Here for the full report from WILM NewsRadio

Click Here for Video of WDEL's Al Mascitti interviewing former U.S. House Majority Leader Dick Gephardt

The following are videos from the various speakers at the event:


 

 

Topics: Delaware BioScience Association, BIO, Pharma, Delaware Bio