Biohealth Innovation
We have a few critical updates for you as well as news on many other issues. How about breaking the DoD SBIR program out from the others and making it permanent? How about breaking the DoD services (Army, Navy Air Force) out from under the OSD? We've got this and much more for you.
Johns Hopkins University is set to open a new branch of FastForward in East Baltimore. The incubator’s new location, called FastForward East, is located in a building just north of the university’s medical campus, at the corner of Wolfe and Ashland Streets. The original FastForward space, near JHU’s Homewood campus, is currently at capacity with 12 startups. FastForward also runs an accelerator program, which has helped 41 startups. University officials have openly acknowledged that JHU lags behind other universities of similar stature when it comes to tech transfer. The expanding physical space offers the university the chance to nurture companies that have grown directly out research at the university, and become a more visible player in the local startup scene.
M&A may seem hot in the life sciences, but that and IPO activity is starting to cool across all sectors, according to a new report from the National Venture Capital Association. The first quarter of 2015 saw less than 20 venture-backed IPOs since the first quarter of 2013. Independent of sector, when it comes to deal size, this quarter was the slowest in M&A since the first quarter of 2013. But the bulk of the IPOs completed were, of course, in the life sciences – 13 of the 17 exits were in the medical and biotech sectors.
Katie Kirsch did not expect a move to Baltimore. Wrapped in a pashmina scarf in Baltimore’s Harbor East, she sips her chai and shrugs her shoulders, “We were destination agnostic.” Kirsch is the chief marketing officer of Sisu Global Health, a startup that creates medical devices for emerging markets. Sisu got its start in Grand Rapids, Mich., but acceptance into DreamIt Ventures’ Baltimore Health IT accelerator had them pick up and move east.
The University of Maryland, Baltimore (UMB) has encouraged a culture of entrepreneurship, UMB President Jay A. Perman, MD, said in remarks at the 2015 Maryland Regional BioTech Forum. Perman appeared with three other university presidents on a panel, “How Academia Can Help Drive our Region’s Biotech Cluster.” The theme of the forum, “Growing Our Ecosystem,” referred to ways that corporate, governmental and academic partners can collectively make the region a leading hub of groundbreaking science and technology.
Cerner Corporation and Epic Systems have joined iPatientCare as CMS Designated Test EHR Program participants. The Office of the National Coordinator for Health Information Technology announced the two rival companies' participation April 6. The CMS program, designed to test electronic data exchange capabilities, is voluntary. Since the Test EHR Program was launched just over a year ago, more than 4,000 providers have registered to conduct tests, and more than 5,000 have successfully attested to the transition of care meaningful use core objective, ONC notes. In the past the program also included MEDITECH and McKesson.
Foundation Medicine Inc. (NASDAQ:FMI) today announced the closing of its strategic transaction with Roche. This transaction included the purchase by Roche of approximately 15.6 million shares of common stock by means of a tender offer from Foundation Medicine stockholders at a price of $50 per share. Concurrently Roche also purchased an additional 5 million newly issued shares directly from the company at the same price per share for gross proceeds to Foundation Medicine of $250 million. As a result of these two related transactions Roche is a majority shareholder in Foundation Medicine. Foundation Medicine will maintain its operational independence with Roche having minority representation on Foundation Medicine’s Board of Directors.
STONY BROOK, N.Y., April 8, 2015 – The National Institutes of Health (NIH) has granted Stony Brook University’s Center for Biotechnology a three-year $3 million award through the SUNY Research Foundation to establish the Long Island Bioscience Hub (LIBH). The award is part of the NIH’s Research Evaluation and Commercialization Hub (REACH) program and one of only three granted nationwide. The LIBH will be a collaboration between Stony Brook University, Cold Spring Harbor Laboratory and Brookhaven National Laboratory, and is designed to help accelerate the translation of biomedical discoveries into new drugs, devices, and diagnostics to improve patient care and enhance health.
MDHIMSS annually awards scholarships of $2,500 each to two deserving students in the healthcare information system field:
Gaithersburg-based MedImmune says it has received fast-track designation from the Food and Drug Administration for its MEDI8897, a drug being developed to prevent respiratory infections in infants and young children caused by respiratory syncytial virus. “We are working with a sense of urgency to develop a next-generation RSV [treatment] that we believe has the potential to benefit hundreds of thousands more infants, both in the U.S. and around the world,” said Steve Projan, senior vice president of research and development and infectious diseases and vaccines at MedImmune. “If successful, the fast-track designation will enable us to more quickly deliver a preventative solution.”
The stage has been set for a disruptive return of the “Small IPO” to the private equity marketplace (Seed, Series A, B etc.). This go-around, the liquidity boom will not be the exclusive provenance of the Four Horsemen (Alex Brown Inc., Hambrecht & Quist, Robertson Stephens & Co., and Montgomery Securities), the four boutique investment banks that drove liquidity for Silicon Valley during the boom. The new incarnation of the Four Horsemen will be in the form of crowdfunding marketplaces, not investment banks.
For University of Maryland researchers, the last year has marked a series of new discoveries and innovations: a revolutionary nanopore battery with high storage capabilities, a language aptitude measuring system, and a national food safety database to improve safety measures in retail establishments, just to name a few. UMD will honor nine nominees for the most promising new inventions at the Celebration of Innovation and Partnerships event on April 29, held as part of the University of Maryland’s ’30 Days of EnTERPreneurship,’ a month-long celebration and exhibition of innovation and entrepreneurship.
Establishes centralized vaccines research and development center in Rockville
GSK, one of the world’s leading research-based pharmaceutical and healthcare companies, announced today that they are expanding their operations in Rockville with the establishment of a centralized vaccines R&D facility.
The Maryland Department of Business and Economic Development (DBED) named today 12 finalists in the InvestMaryland Challenge (IMC), the State’s international business competition. The Challenge brings together startup companies from a variety of industries with investors, advisors, successful entrepreneurs and other established members of Maryland’s entrepreneurial community. There are three finalists in each of four categories — Life Sciences, IT, Defense & Security, and Sustainability & Exploration. The winner of each will win a $100,000 top prize from the State’s Maryland Venture Fund. InvestMaryland Challenge partners have contributed another $300,000 in prizes that will be awarded to others in the field of 214 applicants. Winners of all awards will be announced April 28 at an event at the Maryland Science Center in Baltimore.
Health and Human Services chief technology officer Bryan Sivak announced that he will step down from the job this month.
In so doing, Sivak is not just leaving the CTO position but also the entrepreneur-in-residence post he held simultaneously. Healthcare IT News Executive Editor Tom Sullivan spoke with Sivak in 2013 about disrupting government culture with both technology and modern business practices.
Sigma-Tau Pharmaceuticals, Inc., announced today that the U.S. Food and Drug Administration (FDA) has granted an orphan drug designation for the Company's investigational compound, STP-206 (lactobacillus acidophilus and Bifidobacterium animalis subsp. lactis), a live biotherapeutic being developed for the prevention of necrotizing enterocolitis (NEC) in premature infants with very low birth weight less than or equal to 1,500 grams. The Company is currently conducting a multi-center, double-blind, randomized, placebo-controlled Phase 1b/2a clinical trial for STP-206 at a number of different sites in the United States.
We're back in Baltimore thanks to The University of Maryland's Biotech Research and Education Program (BREP) who is sponsoring this BioBuzz networking event on April 9th at @HeavySeasAleHse. Join us to share an evening with BREP and Baltimore's growing Biotech community. Heavy Seas Alehouse is located in a very accessible part of the city and has plenty of free street parking or a $4 garage directly across the street.
Mtech's Biotechnology Research and Education Program (BREP) is the regions premier biotechnology, biopharmaceutical and biofuel research center, designed to bolster Maryland's burgeoning biotechnology industry. The program consists of two core facilities dedicated to providing supplemental research to academia, government and industry.
Start-up accelerators have become a prominent feature of the entrepreneurship landscape in recent years. New programs appear nearly every month, and in many ways, accelerator participation has become a rite of passage for budding entrepreneurs. Yet, with the proliferation of programs, the newness of the phenomena, and little to no publicly available data on outcomes for the programs and affiliated start-ups, it is hard for entrepreneurs to determine which programs are most effective and, more importantly, which specific program would be the best fit for their particular start-up’s goals. With this challenge in mind, we set out over the last few years to both foster conversation about the accelerator model, and help entrepreneurs gain visibility into the strengths of individual programs.
Strand Life Sciences today announced a partnership with MRI Global to open a reference laboratory in India and develop companion diagnostics.
The partners will conduct joint research to integrate Strand's SmartLab informatics software with MRI Global's mobile, rapid diagnostics laboratories. Strand will also act as a validation hub for new technologies that are developed, including point-of-care devices.
A Baltimore startup that's developing a medical device to treat migraine headaches is in talks to be acquired by a global medical device company.
Baltimore’s eNeura Inc. has entered into an agreement with Orthofix International N.V. that gives the Texas medical device firm 18 months to decide whether it wants to acquire eNeura for $65 million. As part of the deal, Orthofix is giving eNeura a $15 million loan to support commercialization of its migraine management device, Spring TMS.
Funding and Research Opportunities
The following funding opportunity announcements from the NHLBI or other components of the National Institutes of Health, might be of interest:
Notices:
Requests for Applications:
Immunomic Therapeutics, Inc. ("ITI"), a privately-held biotechnology company developing vaccines based on its proprietary LAMP technology, today announces that the National Institutes of Health has awarded ITI's Small Business Innovation Research (SBIR) grant application titled, "Development of Nanoplasmid LAMP-based Peanut Allergy Immunotherapy." The work in this award will help the pre-clinical development of new and advanced therapeutic platforms for peanut allergies.
"The receipt of this grant provides validation and financial support to evaluate the innovative combination of MHC-II targeting of important peanut allergens delivered in a minimal plasmid DNA backbone. With NIH's support, we look forward to designing and evaluating new plasmid-based constructs for their immunological activity and improved safety profile, which builds off of ITI's considerable expertise in plasmid-based therapeutics for food allergies. This research has the potential to help the more than one million Americans who suffer from peanut allergies," said Teri Heiland, Ph.D., Vice President of R&D, ITI.
Chief technology officer at Health and Human Services, Bryan Sivak, is leaving the agency and retiring from federal government at the end of April, according to a department memo.
During his four years at the agency, Sivak was an ardent proponent of using technology to innovate and provide better services, both for the civilians the agency serves and for the employees internally.
Could Greater Washington be one of the big three in biotech beside other market leaders like, say, Boston?
That was certainly the rallying cry Monday as CEOs and a few hundred entrepreneurs, academics and government types packed into MedImmune's auditorium in Gaithersburg. MedImmune, the research and development arm of AstraZeneca (NYSE: AZN), was hosting the first Maryland Regional Biotech Forum to chart a course for elevating the region's reputation into the top three by 2023. The event was also hosted by the Tech Council of Maryland and BioHealth Innovation Inc.
Biopharmaceutical venture capital investment climbed from $4.52 billion in 2013 to $5.29 billion in 2014, a 17% increase, according to Dow Jones VentureSource.
Joel Marcus, chief executive of Alexandria Real Estate Equities Inc., has been in biotech since its early days. From 1984 to 1994, he had a law career with expertise in the biopharmaceutical industry that included time as general counsel and secretary of Kirin-Amgen Inc., a joint venture between Kirin Brewery Co. and Amgen Inc.
Maryland is no stranger to USGBC’s Top 10 States for LEED list, and every year it has a strong list of impressive LEED projects certifying across the state. Maryland was the third state in the nation for LEED in 2014 (2.7 square-feet of LEED certified space per resident) based on the strength of its 132 newly certified projects.
One project that stands out this year is Qiagen’s new North America headquarters building, which is important not only because of its impressive architecture, but also because of the building’s purpose and what projects like this one symbolize about the growing impact of the green building movement across the country. Qiagen uses its 66,735 square foot headquarters for new research in the field biotechnology as well as its North American manufacturing operations. Skanska USA, a Platinum level member of USGBC, served as the contractor on the Qiagen project, ushering the building toward LEED certification.
Pieris Pharmaceuticals, Inc. (OTCQB: PIRS)and The University of Melbourne today announced the receipt by the University of a research grant to further develop Pieris' novel protein Anticalin®-brand therapeutic, PRS-060, in immunological diseases. The grant -- which will support Pieris' Australian subsidiary, Pieris Australia, and is disbursed by Australia's peak medical research funding body, the National Health and Medical Research Council (NHMRC) -- totals more than $AUS 500,000 and covers activities to advance PRS-060 for inhaled delivery to treat asthmatics.
WuXi PharmaTech (Cayman) Inc. (WX: Quote) announced that an Investigational New Drug or IND application for WuXi MedImmune's novel anti-IL6 monoclonal antibody for rheumatoid arthritis has been accepted for review by the China Food and Drug Administration or CFDA.
In September 2012, MedImmune, the global biologics research and development arm of AstraZeneca, and WuXi AppTec formed the joint venture WuXi MedImmune Biopharmaceutical Co. Limited to develop and commercialize MEDI5117, a novel, investigational, long-acting monoclonal antibody for autoimmune and inflammatory diseases, the first such collaboration in China between a global company and a Chinese company to develop novel biologics.
Swimtag and Brain Sentry were the winners at the 2015 Sports Technology Awards, at an event where wearable tech companies dominated the nominations.
The event, which is in its second year, is set up to recognise the technology that's playing an increased role across sport – be it tracking, broadcasting or participation.
The Maryland General Assembly recently honored University System of Maryland (USM) Chancellor William E. "Brit" Kirwan with a special tribute. In both chambers of the General Assembly, delegates and senators on March 20 recognized Chancellor Kirwan for his 50 years of service to Maryland higher education.
House Speaker Michael E. Busch and Senate President Thomas V. "Mike" Miller offered separate tributes to Kirwan, who has served as USM chancellor since 2002 and announced in May 2014 that he will step down from his leadership position. Kirwan will remain as chancellor through June 30, 2015. University of Massachusetts System President Robert L. Caret will succeed him.
The U.S. Food and Drug Administration approved the use of Anthrasil Tuesday for treating inhalational anthrax alongside antibacterial drugs, triggering a $7 million payment to Emergent BioSolutions under a Biomedical Advanced Research and Development Authority contract.
A rare disease, inhalational anthrax occurs after an individual is exposed to an infected animal or animal products that have been contaminated. Infection is also possible when anthrax spores are intentionally released, leading to the inhalation of Bacillus anthracis. After the bacterium enters the body, it replicates and produces toxins, causing massive, irreversible injury to tissues. Damage can also be so severe that an infection can be fatal.
AKT IP Ventures today announced the launch of a targeted $20 million incubation investment fund that will finance the creation and operation of IP-based businesses in the mobile, multi-touch, wearables, IoT, big data and medical technology sectors. As an incubator and operator of emerging IP-based businesses, AKT IP Ventures offers a unique, constructive and creative alternative to the litigation model of patent monetization. Employing a disciplined approach to bringing IP-based technologies to market, AKT IP Ventures turns patents into viable enterprises that create jobs, generate value and bring exciting new technologies and innovations into the marketplace.
Last night in Cambridge, LSN joined Women In Bio for a Shark Tank-style pitch event. The audience heard pitches from five life science entrepreneurs. Across the table from them were four experienced early stage life science investors playing the role of “sharks”.
So what did we learn from these life science innovators and from the sharks’ cutting responses to their pitches?
David Johnson was just one minute into making his pitch when the interruptions started.
“Why do I care?” barked a bespectacled man at the back of the seminar hall. Johnson, chief executive of the California biotechnology start-up GigaGen, blinked. He had condensed his company's story into a neat ten-minute presentation for I-Corps, a nine-week course designed to teach business skills to entrepreneurial scientists like him. Now his talk was derailed.
Emergent BioSolutions Inc said the U.S. Food and Drug Administration approved its treatment for inhaled anthrax, triggering a $7 million milestone payment from the Department of Health and Human Services (HHS).
The company developed the treatment, Anthrasil, as part of a $160 million contract it signed in 2005 with the Biomedical Advanced Research and Development Authority (BARDA), a part of the HHS.