2nd Edition – March 26, 2012

BioHealth Innovation, Inc. Names Todd Chappell Its First Entrepreneur-in-Residence at National Institutes of Health Office of Technology Transfer

Chappell will help start-ups based on innovative discoveries 

from NIH and FDA research programs

ROCKVILLE, 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.

back to top

County, Business Execs, Tout Biotech Tax Credit – Gaithersburg, MD Patch

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.

back to top

GOVERNOR MARTIN O’MALLEY ANNOUNCES $84 MILLION IN INVESTMENT FOR MARYLAND’S INNOVATION ECONOMY

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).

back to top

Gazette.Net: Montgomery biotechs get $6M boost from first local tax program

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.

back to top

Group to draft rules of the road for Maryland tech transfer efforts – Baltimore Business Journal

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.

back to top

Johns Hopkins University Launches JHU Research Accelerator

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.

back to top

Rockville Based OriGene Technologies Announces the Acquisition of Beijing Zhongshan Golden Bridge Biotechnology Co., Ltd, a Leading Chinese Pathology Reagent Company – MarketWatch

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.

back to top

Analyzing MedImmune Ventures Portfolio Startups | SeedTable

A Review of Medimmune Ventures Investment Portfolio.

back to top

New University of Maryland Center for Translational Medicine Aims to Improve Ways Medical Products are Developed

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.”

back to top

When is the April 5 NIH SBIR/STTR Deadline? | BBC’s Blog

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.

back to top

Johns Hopkins to test mobile medical apps – FierceMobileHealthcare

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.

back to top

Kauffman Life Science Ventures Summit: Call for Applications

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.

back to top

Maryland startup initiative will address varied needs of IT, biotechs – Baltimore Business Journal

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.

back to top

Growing popularity of virtual biotechs promises boon to outsourcers – FierceCRO

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.

back to top

Pharma Execs Admit: ‘Our Model Is Broken’ // Pharmalot

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.

back to top

GSK, J&J back Index’s new $200M fund for early-stage deals – FierceBiotech

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.

back to top

Springboard 2012: A Forum Program for Women-Led Companies.

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.

back to top

FDA mulls the role of screening apps, devices | mobihealthnews

This week the US Food and Drug Administration (FDA) is holding a hearing about using innovative technologies and other mechanisms to expand the number of medications that can administered over the counter. A report in the San Diego Union Tribune recognizes that some of the innovations that the FDA has in mind are mobile health apps and devices.

“FDA is aware that industry is developing new technologies that consumers could use to self-screen for a particular disease or condition and determine whether a particular medication is appropriate for them,” the agency wrote in the Federal Register last month. “For example, kiosks or other technological aids in pharmacies or on the Internet could lead consumers through an algorithm for a particular drug product. Such an algorithm could consist of a series of questions that help consumers properly self-diagnose certain medical conditions, or determine whether specific medication warnings contraindicate their use of a drug product.”

back to top

For Biotech Firms, Gravy Days Are Over – WSJ.com

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.

back to top

FDA seeks comment on post-market drug safety plans – NEWS – General articles – Pharmaceutical Industry – PMLiVE

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.

back to top

University of Maryland School of Pharmacy: News

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.”

back to top