News Archive

CDER’s mission is to protect and promote public health by helping to ensure that human drugs are safe and effective for their intended use, that they meet established quality standards, and that they are available to patients. The range and complexity of the human drug supply and development pipeline, and the global nature of regulated industry operations present unprecedented challenges to effective regulatory oversight. Effective and sustainable regulatory operations also require explicit recognition of agency resource limitations.

A new health information technology accelerator has caught the eye of one of Baltimore’s technology leaders.

Jason Hardebeck, executive director of the gb.tc, formerly the Greater Baltimore Technology Council, has been named managing director for DreamIt Health Baltimore. The accelerator is scheduled to launch in January.

Once a month, Growlers Brew Pub in Gaithersburg is packed with people talking about the latest trends in the biotechnology and life sciences industries.

The people who gather at Growlers are biotechnology students, lab workers, human resources managers, job seekers, educators, scientists, entrepreneurs and vendors. They come for the camaraderie and the opportunity to connect with people in the bioscience industry.

In 1837, entrepreneur and philanthropist Johns Hopkins bought a Federal-style mansion located on 300 acres in northeast Baltimore. Henry Thompson, a businessman and War of 1812 cavalry captain, had built the estate in 1803 and named it Clifton after his ancestral home in England. It became Hopkins’ summer home, where he liked to entertain family and friends, until his death in 1873. It’s where he welcomed the Prince of Wales, who became King Edward VII. It’s where he held a clandestine meeting that included Salmon Chase, secretary of the Treasury under President Abraham Lincoln; his friend John Work Garrett, the B&O Railroad president; and other B&O officials, who offered to use the rail for Union Army troop movements. And it’s where he hoped the university that would bear his name would be located

The fiasco with the $600 million federal health insurance website wasn’t all bureaucratic. Forcing slow and disparate databases run by government and insurance companies to work together in real time—and then launching the service all at once—would have challenged even technology wunderkinds.

In particular, the project was doomed by a relatively late decision that required applicants to open an account and let the site verify their identity, residence, and income before they could browse for insurance. That meant the site would have to interface in real-time with databases maintained by the Internal Revenue Service and other agencies.

The Evan Burfield of June 2000 was the archetypal startup wunderkind, the kind of overachiever who naturally invites unfavorable comparisons to yourself at the same age.

There was his skinny, almost teenaged face on The Washington Post’s website, accompanying a reader Q&A on how he built a financial software company, netDecide, instead of rowing at Dartmouth.

Peter DeComo raised $20 million from investors for Renal Solutions Inc. in 2002, when the Pittsburgh medical device company had only a working prototype for an artificial kidney and no money.

During the next five years, he brought in $20 million more in capital before selling Renal Solutions to a German outfit in 2007 for nearly $200 million.

“That company couldn’t even get funded today,” lamented DeComo, the CEO of South Side-based ALung Technologies Inc., because venture capital investors have pulled back from startup companies in his industry.

You’ve cracked open the crate of cranberries, stuck the turkey in the oven and are well into filling your second muffin tin with cornbread batter. And just in time for dinner, MedCity is here to talk about innovative obesity treatments, both pharmaceutical options and medical devices.