The US Food and Drug Administration (FDA) DA has published draft guidance describing plans on how to handle serious drug safety issues with marketed drugs, which is now open for comment.

The guidance is intended to lay out a framework for the agency's response to post-marketing safety issues including serious adverse events, product quality issues and medication errors, with a ranking system to help prioritise each issue according to its level of risk.

The FDA has been criticised in a string medical journal articles in the last 18 months for not monitoring its own adverse event reporting (AER) database effectively enough and failing to communicate safety issues in a timely and effective way to healthcare professionals and the public.

Starting a company is always challenging, but for founders of life science startups, the regulations and funding hurdles make it dauntingly complex, overwhelming, and seemingly insurmountable.

This first-time conference will answer the critical questions that founders must address to start and grow viable life science companies. Industry experts and successful entrepreneurs will provide practical guidance on how to commercialize innovations in each of four sectors: medical device, therapeutics, diagnostics, and digital health. If you have a new startup in this space or are ready to start one, this two-day event may be for you.

OriGene Technologies, Inc. announces the acquisition of Beijing Zhongshan Golden Bridge Biotechnology Co., Ltd (ZsBio). The strategic acquisition establishes OriGene's leading position in the Chinese pathology testing market.

Headquartered in Beijing, China since 1993, ZsBio provides pathology testing products to the growing Chinese oncology diagnostic market. ZsBio has an industry leading position in the Chinese pathology testing market because of its innovative product portfolio, expertise, strong client relationships, and has established itself as a thought leader in the Chinese pathology diagnostic field. The Chinese pathology testing market has been experiencing double-digit growth annually and is one of the fast-growing segments of the Chinese diagnostic industry.

The Bill & Melinda Gates Foundation    has committed up to $220 million for the next five years to Rockville-based Aeras, a nonprofit dedicated to developing new vaccines for tuberculosis.

The grant extends the Gates Foundation’s longtime backing of Aeras, whose pipeline includes several mid- and early-stage TB vaccine candidates being developed through pharmaceutical and academic partnerships. The $220 million represents about half of what Aeras needs to meet its vaccine development targets through 2016, the nonprofit said in a news release Wednesday.

The University of Maryland School of Pharmacy has launched a Center for Translational Medicine (CTM) under the leadership of Joga Gobburu, PhD, FCD, MBA, to help improve medical product development efficiency.

“By establishing the Center for Translational Medicine, the School of Pharmacy is demonstrating its commitment to improving the drug development and regulation process,” says Natalie D. Eddington, PhD, FAAPS, FCP, professor and dean of the School of Pharmacy. “As a leader in the field of pharmacometrics, Dr. Gobburu’s expertise as director of the center will enhance our educational and research programs and will lead to substantial partnerships with the pharmaceutical industry and other collaborators.”

A Review of Medimmune Ventures Investment Portfolio.

Those looking to lose weight, quit smoking or keep tabs on a malady have a lot of choices in the smart-phone app stores. Choosing one that's beneficial is more of a problem.

Science is still trying to catch up to the market for mobile health applications, software that runs on mobile devices such as iPhones, Androids and tablets, which has produced tens of thousands of possible ways to achieve better health for free or a fee.

Joga Gobburu, PhD, MBA, FCP

The University of Maryland School of Pharmacy has launched a Center for Translational Medicine (CTM) under the leadership of Joga Gobburu, PhD, FCD, MBA, to help improve medical product development efficiency.

“By establishing the Center for Translational Medicine, the School of Pharmacy is demonstrating its commitment to improving the drug development and regulation process,” says Natalie D. Eddington, PhD, FAAPS, FCP, professor and dean of the School of Pharmacy. “As a leader in the field of pharmacometrics, Dr. Gobburu’s expertise as director of the center will enhance our educational and research programs and will lead to substantial partnerships with the pharmaceutical industry and other collaborators.”

In a November blog post, I mentioned the myriad of activities that are impacting our Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs, one of which was the congressional effort to reauthorize these programs. Well, Congress voted on the reauthorization, and it was signed into law last December 31. I’ve been waiting until the Small Business Administration (SBA) released their interim guidance so I could give you the details of how the reauthorization will impact NIH small business grants.

The SBA guidance can be found in this blog  by Sean Greene, Associate Administrator for Investment and Special Advisor for Innovation at the SBA. It discusses the timeline Congress gave the SBA for revising the existing regulations and policy directives. They are targeting the end of 2012.

Health and Human Services Department Chief Technology Officer Todd Park will be the next federal CTO, replacing Aneesh Chopra, the White House announced Friday.

Park made millions in healthcare technology before joining HHS in 2009. He initially was hired as the department's "entrepreneur in residence."

According to a June 2011 report in The Atlantic, Park, by age 24, had co-founded the health care technology company Athenahealth. "Nearly 10 years later he made a fortune when the company went public with a market capitalization exceeding $1 billion," the magazine reported. The Atlantic and Nextgov both are part of Atlantic Media.

Gaithersburg-based OpGen has closed on a third round of venture capital that could add as much as $17 million to the company’s coffers if it meets certain milestones, an executive said.

Chief Executive Douglas White declined to specify how much money the company has collected immediately, but said he anticipates the firm will eventually use the entire amount.

The Maryland Technology Development Corporation (TEDCO), in collaboration with The Abell Foundation, announced today the establishment of the $3.3 million Propel Baltimore Fund, an angel investment fund for entrepreneurs and start-up companies located in Baltimore City. TEDCO will administer the fund and will begin accepting applications on April 2, 2012. Through the fund, companies may receive maximum investments up to $220,000.

"The Propel Baltimore Fund was created to help support the establishment and development of promising businesses in Baltimore City," said Abell Foundation president Robert C. Embry, Jr. "The Abell Foundation wants to ensure that innovators recognize Baltimore as an attractive location to start, build and sustain their businesses. TEDCO has an excellent track record as a state-of-the-art resource for entrepreneurs, and we are confident that the organization will be a strong partner in managing the fund and in supporting economic development in the city."

University System of Maryland Chancellor Brit Kirwan

A new collaboration approved Thursday between the University of Maryland, College Park    and University of Maryland, Baltimore    could invest millions of dollars into the state’s tech community.

The University System of Maryland Board of Regents gave the OK to a long term plan for increased collaboration between College Park and UMB. The move comes almost a year after Senate President Thomas V. Mike Miller proposed a merger between the two schools, which was ultimately rejected by the regents.

Montgomery County's Department of Economic Development has tapped Sally Sternbach as deputy director. Sternbach, who was executive director of Rockville Economic Development Inc., will work directly with Steve Silverman, director of the department. Montgomery County Press Release

Sally Sternbach, Executive Director of Rockville Economic Development, Inc. (REDI), has been appointed to serve as Deputy Director of Montgomery County’s Department of Economic Development. Sternbach has served as executive director of REDI since 2003. Lynne Benzion, REDI’s associate director, has been appointed Acting Director while a formal search is conducted.

The US Food and Drug Administration (FDA) has approved MedImmune's, the global biologics arm for AstraZeneca PLC, FluMist Quadrivalent (Influenza Vaccine Live, Intranasal), a vaccine to prevent seasonal influenza in people ages 2 years through 49 years. The company submitted the sBLA early in the second quarter of last year.

FluMist Quadrivalent is the first influenza vaccine to contain four strains of the influenza virus, two influenza A strains and two influenza B strains. All other currently available licensed seasonal influenza vaccines are trivalent, containing three strains [two strains of type A influenza (A/H1N1 and A/H3N2) and one B lineage strain].

A proposal accepted Thursday by the University System of Maryland’s board of regents creates an alliance between its flagship institution in College Park and the professional school in Baltimore centered around combining research initiatives, blending public health programs and expanding course offerings in Montgomery County.

Chancellor William E. “Brit” Kirwan introduced the $45 million proposal, the result of an eight-month study ordered last year by the General Assembly, in Annapolis, calling it “a strategic alliance, a very significant set of initiatives and activities.”

Jim Hughes and Phil Robilotto see more than 100 ideas each year from scientists at the University of Maryland, Baltimore, potential innovations with a promise to better diagnose disease, alleviate pain, make medical care delivery more efficient, even save lives.

The biggest challenge is selling investors on the merits of research still in its infancy.

MedImmune today announced that the U.S. Food and Drug Administration (FDA) has approved FluMist® Quadrivalent (Influenza Vaccine Live, Intranasal) for prevention of influenza. The company submitted the sBLA early in the second quarter of last year.  FluMist Quadrivalent is the first quadrivalent influenza vaccine approved by the FDA.

All other currently available licensed seasonal influenza vaccines are trivalent, containing three strains [two strains of type A influenza (A/H1N1 and A/H3N2) and one B lineage strain].  FluMist Quadrivalent contains four strains (two type A strains and two type B lineages) to help provide broad protection against circulating influenza A and B.

In a town that's typically hungry for consumer Internet startups, health companies finally have a place to go.

The second class of health technology companies has had a month to settle into the Rock Health incubator in San Francisco.

Rock Health founder Halle Tecco is creating a community devoted to the healthcare space, the same way Paul Graham has seeded many successful companies through his Y Combinator program.

"Last year, no one knew what Rock Health was, but now it's a destination for healthcare entrepreneurs," Tecco said.

One prominent biotechnology venture capital researcher says the concept of the early stage funding valley of death is an “artifact” and actually a reflection of the classic supply and demand.

Many entrepreneurs, investors and life sciences industry veterans take the existence of the valley of death almost as an article of faith. The meme goes that young companies enter that valley, in which attracting investment capital becomes extremely difficult, at an early stage, typically between an initial round of angel funding and the company’s first institutional series A round.

State governments in 2011 continued to see regional economic growth in the life sciences industry and in 2012 will increasingly focus attention on technology transfer and venture funding as mechanisms to increase private sector innovation related activities within their jurisdictions. Realizing that entrepreneurship is a key ingredient in economic development, states and localities are undertaking the support of programs that assist high technology businesses, and that capitalize on state regional presence of universities and federal laboratories.

Once research yields a new discovery from a university or federal laboratory, there is still a great deal of work in creating a company and funding that research before the technology can be incorporated into the marketplace. The following are state legislative examples of ways industry, universities, and policymakers are creating essential building blocks for bioscience industry growth in company creation and capital for success.

From artificial floating wetlands designed to clean the Chesapeake Bay to electronic baseball plates, faculty members and graduate students across the state, including this university, are developing new technology projects with $4.1 million from the Maryland Industrial Partnerships.

The MIPS program — which was founded at this university 25 years ago to help companies fund research projects to develop new products — has approved 16 different projects teaming up companies with researchers from campuses across the University System of Maryland. This year's projects, seven of which involve faculty from this university, range from eco-friendly technology to food preservation to state-of-the-art running shoes and will receive funding from MIPS, the sponsoring companies and the Maryland Department of Natural Resources and the Environmental Protection Agency.

Starting a company is always challenging, but for founders of life science startups, the regulations and funding hurdles make it dauntingly complex, overwhelming, and seemingly insurmountable.

This first-time conference will answer the critical questions that founders must address to start and grow viable life science companies. Industry experts and successful entrepreneurs will provide practical guidance on how to commercialize innovations in each of four sectors: medical device, therapeutics, diagnostics, and digital health. If you have a new startup in this space or are ready to start one, this two-day event may be for you.

The Tech Council of Maryland (TCM), Maryland's largest technology and biotechnology association with more than 400 biotechnology and technology members employing more than 200,000 in the region, will honor Freeman Hrabowski, president of the University of Maryland, Baltimore County (UMBC), with its second annual Lifetime Achievement Award. Hrabowski will be presented the award at TCM's Lifetime Achievement Black Tie Gala, which is taking place February 29 at the Bethesda North Marriott Hotel and Conference Center.

The TCM Lifetime Achievement Award is presented to an individual who has gone above and beyond the excellence expected of a business executive over the course of a career by also serving the community at large. The recipient must have demonstrated generosity and compassion, along with business savvy -- ensuring that his or her lasting legacy encompasses both corporate success and community involvement.

BioHealth Innovation, Inc. (BHI), a new regional private-public partnership focusing on commercializing market-relevant biohealth innovations and increasing access to early-stage funding in the Central Maryland region, announced today the appointment of its Board of Directors, including Scott Carmer, MedImmune Executive Vice President of Commercial Operations, as Chairman.

"The State of Maryland is known as one of the most well-established biohealth research regions in the world," said Richard Bendis, BHI Interim CEO, "what we need is an integrated commercialization ecosystem to turn such research assets into economic success by fostering the next generation of 'MedImmunes' here. We are grateful for MedImmune's strong support and Scott's leadership to help us advance early-stage research from laboratories to market with the founding of new start-up companies."

Maryland and Montgomery County have signed a memorandum of understanding to create a National Cybersecurity Center of Excellence at the National Institute of Standards and Technology.

Lt. Gov. Anthony Brown, U.S. Sen. Barbara Mikulski and Montgomery County Executive Isiah Leggett took part in an event in Gaithersburg with Patrick Gallagher, director of the NIST on Tuesday.

University of Maryland Associate Vice President for Research and Economic Development Brian Darmody is adding to his portfolio the newly created position of University Director of Corporate Relations.

In the new role, Darmody will help coordinate corporate outreach and develop additional corporate partnerships in support of the Great Expectations capital campaign. He will report to both the University's Vice President for University Relations Brodie Remington and to Vice President for Research Pat O'Shea.

February 17, 2012 - Last night, nearly 300 of Maryland's business leaders and lawmakers gathered for Corridor Inc.'s Sixth Annual Person of the Year Awards, held at the brand new Hotel at Arundel Preserve. What began in December with 21 accomplished and worthy nominees was narrowed down by reader votes to one person: Aris Melissaratos, Senior Advisor to the President for Enterprise Development at Johns Hopkins University.

When Aris Melissaratos first arrived in Maryland, he was 13 years old and spoke not a word of English. His parents had brought him to the United States as they escaped communism and economic hardship. Now, Melissaratos is known throughout Maryland and the region for his entrepreneurship, work ethic, community involvement, and leadership.

The federal government has paid more than $3 billion to U.S. hospitals and doctors offices in the process of switching patient records from paper to computers.

U.S. Department of Health and Human Services    Secretary Kathleen Sebelius visited Kansas City Friday to report the progress of health care providers in adopting electronic health record technology.

According to the Centers for Medicare and Medicaid Services, it has paid out $3.12 billion in incentive payments to almost 2,000 hospitals and more than 41,000 physicians who have shown that they are using technology that federal and industry officials say can improve quality of care and lower costs.

Rockville's place as a hub for health care and bioscience makes it fertile ground for medical and scientific researchers from around the world to compete for jobs requiring specialized skills and experience—and often visas.

On Tuesday, at the Universities at Shady Grove, immigration law firm Taylor & Ryan, LLC will host a two-hour session on the immigration options available to workers seeking permanent resident status—aka green cards—for themselves and their families.

“These are people who may qualify for permanent residence for their significant contributions in the fields of science and medicine,” said Mary Ryan of Taylor & Ryan. “They’re already here and on Tuesday we’ll be talking to people who might want to consider these routes.”

Ken Malone and the board members of his startup biotech company gathered in a conference room at the University of Southern Mississippi last October to make a gut-wrenching decision.

Ablitech Inc.'s funding was slowly drying up, and it couldn't find new sources in Mississippi. If the company stayed, it would wither away.

The only option left for Ablitech, they decided, was for the fledgling company to move.

"We called our shareholders together and said, 'Look, if we stay here, we're going to die,'" Malone recalled recently.

For months, Malone and one of the firm's co-founders scoured the East Coast, from North Carolina to Boston, for a new home. They chose Baltimore.

Ablitech's choice this year was a modest win for the still-growing University of Maryland BioPark on the west side of downtown, where about 500 people work. The company brings only a handful of jobs, and its cancer-stopping technology is years — and millions of dollars — away from animal and human trials, let alone commercialization.

When it came time to generate a little “buzz” for its latest initiative – Deals on Wheels – the Johns Hopkins Technology Transfer office (JHTT) turned to the popular BioBuzz biotechnology industry happy hour series in Montgomery County. And they weren’t disappointed… January’s happy hour drew more than 100 biotech industry professionals who wanted to learn more about the Deals on Wheels program and have an opportunity to network with colleagues.

Deals on Wheels is an innovative program designed to bridge the geographical gap between Johns Hopkins University’s researchers in Baltimore and biotech companies and entrepreneurs in Montgomery County. Through Deals on Wheels, technology companies and entrepreneurs in Montgomery County will have the opportunity to connect one-on-one with Johns Hopkins representatives to discover potential partnership opportunities that include, licensing agreements, start-ups, core facilities, sponsored research, material transfer agreements, research collaborations, and clinical trials.