Medical Lights

Crowdsourcing and the world of medicine are already proving strong bedfellows with pharmaceutical giants Eli Lilly and AstraZeneca, who are using open innovation to fund academic research for new treatments and medicines.  However, such ventures are only beneficial as the resources and funding are being made readily available to them, leaving many other research and development projects without the means to get started.

Crowdfunding has already provided a lifeline to charitable, creative and entrepreneurial projects and looks set to offer the same support to medical research, development and provision.

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That’s not quite a trick question. If you have been preparing a National Institutes of Health (NIH) SBIR/STTR grant submission, you are obviously aware that the deadline is 5 p.m. your local time on Thursday, April 5. However, since January 2011 there have been some important changes in the electronic submission process, so please read the rest of this email closely.

BBC has always advised that you submit your proposals well in advance of the deadline, and we highly encourage you to submit your SBIR/STTR to Grants.gov by April 1. This has always been a good strategy, but now it is essential. The Error Correction Window, which was implemented in December 2005 to facilitate the transition from paper to electronic submission of grant applications, has now been removed. The window had allowed applicants an opportunity after the deadline to correct missing or incorrect aspects of their applications, identified by NIH system-generated errors and warnings displayed to the applicant after submission.

chappell-todd

Chappell will help start-ups based on innovative discoveries 

from NIH and FDA research programs

Todd ChappellROCKVILLE, MARYLAND, March 26, 2012 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 Central Maryland, announced today its selection of Todd Chappell as the first Entrepreneur-in-Residence (EIR) for BHI at the National Institutes of Health (NIH) Office of Technology Transfer (OTT). Mr. Chappell, a venture capital-backed entrepreneurial leader and inventor with more than ten years of experience in molecular biology research, drug development and life sciences business strategy, will help support the development of new start-up companies based upon OTT technology license agreements.

Sequencing the human genome will lead to many diagnostic breakthroughs.

Science and entrepreneurship are both acts of experimentation. Both involve taking risks to reach a positive end, changing course when needed, and attempting the never-been-done. While many start-ups now are focused on creating the next Facebook or some genius e-commerce play, there are also scientists tinkering in labs.

Biotechnology is sometimes forgotten about, but the field leads to real products — new drugs and medical devices that aid human health. Want to cure cancer? These people will be the ones to do it.

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The recent news that tiny FerroKin BioSciences earned a big buyout deal with Shire ($SHPGY) has helped spotlight the growing popularity of the virtual biotech model. And that has big implications for everyone in the outsourcing industry.

Like other virtuals--such as Stromedix, recently acquired by Biogen Idec ($BIIB)--FerroKin had only a handful of employees working full-time for the company. CROs, CMOs and other outsourcers created a network of support vendors that carried out much of the heavy lifting in drug research. And with some proof of concept data in hand, FerroKin made a tantalizing morsel for an acquirer looking to build up its pipeline without having to acquire a sizable research infrastructure it didn't need.

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As if we didn’t already know this, yes? Still, a new survey finds that 68 percent of pharma execs agree that Humpty Dumpty has fallen off the wall. To be specific, 44 percent agree that the pharma industry model is broken and 24 percent strongly agree with this statement. Another 22 percent are neutral and 6 percent disagree. We wonder where this 28 percent is working right now…

And over the next two years, 76 percent believe the healthcare system pricing and budget pressures will be the biggest challenge; followed by 70 percent who believe they will have to demonstrate cost effectiveness; 69 percent who cite more restrictive market access; 60 percent who fear generic competition; 53 percent who worry about less access to docs and 50 percent who are concerned about the ability of patients to pay for their meds.

Leggett BHI

A county and state tax credit program leveraged nearly $6 million in investments last year in 10 biotechnology companies in Gaithersburg, Potomac and Rockville, officials said Monday.

Elected officials, including Montgomery County Executive Isiah Leggett (D), Sen. Jennie M. Forehand and Del. Brian J. Feldman joined biotech company executives and representatives of the county’s Department of Economic Development to tout the program at Sequella, Inc. in Rockville.

funding

GlaxoSmithKline and Johnson & Johnson are teaming up with Index Ventures to launch a $200 million fund devoted exclusively to backing early-stage biotechs. And while its primary focus will be in Europe, the venture group intends to invest in biotechs throughout the U.S. as well.

Index takes what it calls an "asset centric" approach to investing, looking for developers with just one or two products--a classic feature of most start-ups. And some heavy hitters from GSK ($GSK) and J&J ($JNJ) will sit on the scientific advisory board of the new fund, giving a few early-stage companies a chance to mix with some top execs from companies they'll be hoping to partner with at some point. From GSK, R&D chief Moncef Slaoui (photo) and Paul-Peter Tak, head of GSK's immunoinflammation therapy area unit, will join Janssen's Paul Stoffels and Bill Hait, global head of R&D. They'll confer with Index Ventures' Francesco De Rubertis, Kevin Johnson, Michele Ollier, Roman Fleck, and Remy Luthringer.

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In an age of information overload where getting in front of the right investors and potential strategic partners is harder than ever, where do you go to find the support you need to build the next iRobot, Zipcar, Constant Contact, or Achillion?

We know how to help investment-ready women-led companies raise capital to scale BIG. Springboard's forum programs are designed to support, promote and showcase investment-ready, high-growth companies led by women.  And after 11 years of presenting over 480 businesses that have raised over $5.5B in capital, we've figured out the secret to overcoming the hurdles startups face when trying to scale. It's about building relationships, not just about raising capital.  Click here to learn more about our how our forum programs work.

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March 20 (Bloomberg) -- Patrick Fung, a partner at New Enterprise Associates Inc., talks about the venture capital firm's New Experiment Fund, a seed-stage fund for financing student startups and investing in the U.S. East Coast. He speaks with Emily Chang on Bloomberg Television's "Bloomberg West."

Johns Hopkins University

JHU Research Accelerator is a platform that facilitates an easy and secure collaboration and sharing of resources across the JHU scientific community as well as other insitutions within the Sharing Partnership for Innovative Research in Translation (SPIRiT) Consortium of the NIH Clinical and Translational Science Award program. Yale University, University of Pennsylvania, Washington University and the the University of Chicago are institutions currently members of the SPIRiT Consortium.

Johns Hopkins University

Last week we told you about some ambitious app development going on at Johns Hopkins Medical School. Well this week, Hopkins did themselves one better: They're diving in to not only create apps, but also to evaluate the 10,000-plus universe of health apps for efficacy and safety, according to a recent article in the Baltimore Sun.

Hopkins also will judge whether the apps are more or less effective than traditional care, such as in-person visits.

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Biotechnology firms are coming around to a harsh reality: The gravy days are over.

These small, innovative drug companies were once an investment darling, able to secure millions of dollars from venture capitalists and even more later through public offerings. But in recent years, venture financing for biotech has been in decline, due to the tough economic environment and poor returns from stock offerings.

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Ten biotechnology companies in Montgomery County last year received almost $6 million from investors who were spurred by the state and county’s biotech investment tax credit programs, officials said Monday.

The county’s program, which received its initial funding this fiscal year after being approved by the County Council in 2010, is the first such local one for biotechs in the nation, said Montgomery County Executive Isiah Leggett (D) during a news conference at the Rockville headquarters of biotech Sequella. Officials approved $500,000 in fiscal 2012 and another $500,000 for fiscal ’13, which starts July 1.

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Program Spurs Nearly $6 Million in Investments

Among Ten Local Biotech Companies

March 19, 2012

10:00 am

Sequella, Inc.

9610 Medical Center Drive, Suite 200

Rockville, Maryland 20850

Montgomery County Executive Isiah LeggettMontgomery County Executive Isiah Leggett will announce the first 10 biotech companies to receive significant investments through the County’s biotech investment tax credit program. The program allows investors receiving tax credits from the State of Maryland to also receive a supplemental payment from the County based on their investments in local biotech companies. The County’s program is modeled after Maryland’s Biotech Investment Tax Credit Program and works in conjunction with it.

Leggett will join other local and state elected officials, local biotech company executives and representatives from the Montgomery County Department of Economic Development.  

Group to draft rules of the road for

University of Maryland Ventures, a new joint effort between the University of Maryland’s two biggest campuses, will soon create groups to help standardize the schools’ product licensing and technology transfer initiatives. The program calls for the two schools — the University of Maryland, Baltimore and University of Maryland, College Park — to create teams of individuals to help both schools increase the commercialization of their research programs. The teams will focus on developing and refining ideas for boosting intellectual property, patent submission, tech transfer and community outreach efforts for university researchers.

Startup maryland

When Startup Maryland kicks off March 30, it will be confronted with a challenge unique to this region’s three Startup America subgroups: How to bring life sciences and information technology — the state’s two major tech industries — under one banner. The pro-entrepreneurship effort introduced by President Obama in January is the last of the region’s trio to launch. Startup Virginia got under way Jan. 31 in Arlington, Va., with Startup D.C. following later that day. Nationwide, there are 17 Startup America regions.

Gov. Martin O'Malley

Maryland first state in the nation to use online auction to raise funds for venture capital program

InvestMaryland will deploy first round of funds to seed early stage companies this summer

ANNAPOLIS, MD (March 15, 2012) – Governor Martin O’Malley and Peter Greenleaf, chairman of the Maryland Venture Fund Authority, today announced that $84 million has been raised for Maryland’s Innovation Economy through InvestMaryland – an historic initiative created by the Governor and passed by the General Assembly last year to invest in the State’s promising start-up and early stage companies. The $84 million raised far exceeds a goal of $70 million and was generated through an online auction of premium tax credits to insurance companies with operations in Maryland. While other states have sold tax credits to fund similar venture capital initiatives, Maryland is the first state to use an online auction to raise the capital for such a program. The inaugural round of investments will be made in innovative companies this summer through several private venture capital firms and the State’s successful Maryland Venture Fund (MVF).

FDA

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.

Kauffman Life Science Ventures Summit

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

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 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.

University of Maryland

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.”

Hopkins mobile

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.

Gobburu

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.”

rbendis

Welcome to BioHealth Innovation News, a new Central Maryland e-newsletter focused on bringing to you the latest news and developments in the vibrant biohealth industry. This newsletter is produced and distributed by BioHealth Innovation Inc. (BHI), a new private public partnership whose mission is "to connect market relevant biohealth assets to appropriate funding, management and markets that will result in commercially viable products and companies."

As the interim CEO of BHI, I have the privilege of working with a committed team and an esteemed board of directors. I would like to give special thanks to one of our key partners, the Montgomery County (Maryland) Department of Economic Development, for providing its extensive database as part of our initial distribution list. We are also working with other stakeholders to grow our database of interested parties in biohealth news.

This newsletter will cover regional, national and global news and trends related to biohealth. We welcome your contributions of breaking news and original content. Please send any news, suggestions or inquiries to Lily Qi at This email address is being protected from spambots. You need JavaScript enabled to view it..

We are excited about the growth opportunities in the Central Maryland region and hope that we can be an effective intermediary in this biohealth ecosystem.

Best regards,

Richard A. Bendis
Interim CEO BioHealth Innovation Inc.
e-mail:This email address is being protected from spambots. You need JavaScript enabled to view it.
www.biohealthinnovation.org

 

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BHIOTT

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 Central Maryland, announced today it has entered into a Partnership Intermediary Agreement (PIA) with the National Institutes of Health’s (NIH) Office of Technology Transfer (OTT). As a partnership intermediary for NIH OTT, BHI will assist, counsel, advise, evaluate and cooperate with small businesses or educational institutions to make productive use of technologies from a federal laboratory.

“We are thrilled to partner with NIH to accelerate technology transfer and the commercialization of early-stage research,” said Richard Bendis, BHI Interim CEO. “This Agreement will allow health care industry experts to proactively identify market-relevant technologies being conducted at one of the finest research institutes in the world to better capture the commercial value of those technologies. Ultimately, the goal is to advance human health care while growing jobs in Central Maryland.”

Dr. Sally Rockey is NIH's Deputy Director for Extramural Research, serving as the principal scientific leader and advisor to the NIH Director on the NIH extramural research program.

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.

ToddPark

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.

OpGen

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.

TEDCO

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 says University of Maryland, College Park and the University of Maryland, Baltimore have 'very complimentary strengths.'

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.