MITRE Logo

A Bedford-based nonprofit, MITRE, is the powerhouse beyond a new initiative called Bridging Innovation, designed specifically to play matchmaker between startups and government agencies.

For the program, MITRE has partnered with essentially all of Massachusetts’ major players: MassRobotics, MassChallenge, Gov. Charlie Baker’s cybersecurity advisory panel, the Massachusetts Military Asset Task Force, Techstars’ Air Force Accelerator, Harvard Innovation Labs, MIT Engine and the UMass Lowell Innovation Hub.

 

China Virus Overwhelms Wuhan s Health System as City Rushes to Build New Hospital WSJ

China’s viral outbreak is straining the resources of front-line hospital staff in epidemic-stricken Wuhan, who have been forced to turn away patients because of a lack of beds and basic medical supplies.

Image: Chinese authorities are building a new hospital in the city of Wuhan following the outbreak of a virus that has infected more than 800 people and killed 26, aiming to complete it within six days. Photo: CCTV

74b2be40 c7fe 4fbd a22f 38ea2e40d783 pdf

Alexandria LaunchLabs™ in Maryland, will provide fully equipped, affordable laboratory/office space with flexible lease terms, supporting infrastructure, access to amenities, and supporting services and programming through the project’s consortium of world-class partners, including Alexandria Venture Investments, BioHealth Innovation, Montgomery County, and the City of Gaithersburg. This unique, startup environment will accelerate the growth of local early-stage life science companies.

Qiagen Logo

Hilden, Germany, and Germantown, Maryland, January 9, 2020 – QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the 2,500th placement of QIAsymphony, the leading Sample to Insight workflow automation solution for molecular laboratories worldwide, in Tübingen, Germany.

Cenata GmbH is a medically led genetic diagnostic laboratory offering prenatal testing, and repeat customer of the QIAsymphony, purchasing this milestone QIAsymphony SP as the third unit in their lab, expanding capabilities for circulating DNA purification and other applications.

 

emmes logo

Emmes today announced that the U.S. Food and Drug Administration (FDA) has approved a prescription-only medical device used to estimate the weight of infants who are up to 90 days of age.

The Mercy babyTAPE is a tape-measure-like device that permits health care professionals to estimate the body weight of preterm and full-term infants when a scale may not be available or practical to use. Accurately estimating pediatric patient weight is important for drug dosing, resuscitation interventions, and nutritional assessments. This easy-to-produce device could be especially useful in emergency or resource-constrained situations such as remote or rural areas, and in developing countries.

 

Emergent Logo

GAITHERSBURG, Md., Jan. 13, 2020 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) announced that it has received agreement from the European Medicines Agency (EMA) to pursue its proposed development plan for its chikungunya virus virus-like particle (CHIKV VLP) vaccine candidate. The company has proposed conducting a safety and immunogenicity Phase 3 trial using Serum Neutralizing Antibodies (SNA) as an immune correlate of protection to predict clinical benefit of the vaccine candidate.

“Emergent is encouraged by the concurrence we have received from EMA in paving the path for chikungunya vaccine development based on SNA as the surrogate endpoint,” said Abbey Jenkins, senior vice president and vaccines business unit head at Emergent BioSolutions. “As a leading provider of travel health vaccines, Emergent seeks to address the threat posed by this highly debilitating virus by defining a realistic and optimal path to bring to market a much-needed chikungunya vaccine that could potentially serve patients worldwide. We look forward to continuing to work with regulators, including the U.S. Food and Drug Administration (FDA) with whom we had our End-of-Phase 2 meeting last December, as we plan to initiate a pivotal Phase 3 trial this year and define the approach for a post-approval confirmatory efficacy trial.”

 

Intrexon Logo

GERMANTOWN, Md., Jan. 6, 2020 /PRNewswire/ — Precigen, Inc., a biopharmaceutical company specializing in the development of innovative gene and cellular therapies to improve the lives of patients, today announced that the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to PRGN-3006, a first-in-class investigational therapy using Precigen’s non-viral UltraCAR-T™ therapeutic platform for patients with relapsed or refractory acute myeloid leukemia (AML) (clinical trial identifier: NCT03927261). Precigen announced in Q3 2019 that it had completed enrollment for the first cohort of this clinical trial and expects an initial data readout in the second half of 2020.

 

IBT Logo

IBT Vaccines, a wholly owned subsidiary of Integrated Biotherapeutics Inc., announces it has received $3.9 million to advance the development of the IBT-V02 vaccine for Staphylococcus aureus induced recurrent skin and skin structure infections (SSSI). The funding is part of a $48 mil. investment in 8 companies by Novo Holding’s REPAIR Impact Fund, established in 1999 to support the discovery and early development of therapies targeting drug resistant microorganisms. IBT-V02, which is currently in late pre-clinical development, is a unique and potentially first-to-market multivalent toxoid vaccine with broad coverage. S. aureus produces a remarkably large number of toxins that modulate host immune response. The goal is to harness the growing knowledge about its complex relationship with the host to develop effective prophylaxis and immunotherapy for S. aureus/MRSA disease.

 

Hememics-Logo

Rockville, Maryland-based Hememics Biotechnologies Inc. has secured a $2.5 million investment from AMVI Partners, an international investment firm with offices in McLean, Virginia.

The startup is working on developing a handheld device equipped with a multiplex panel chip that is able to rapidly test a blood sample to detect bacteria or proteins in less than a minute. The initial device in development, named HEMEMICS, is a point-of-care panel to test for sexually transmitted diseases.

 

Protenus cofounder Robert Lord.

(Courtesy photo)

When Robert Lord cofounded Protenus with Nick Culbertson in 2014, it required choosing to put medical school on hold. After six years and plenty of growth at the Fells Point-based healthcare analytics company, Lord is returning to Johns Hopkins this month to complete training to become a physician. With that move, he will transition from a day-to-day leadership role to chairman of the board. The transition has been in the works for several months, and his responsibilities were apportioned across the company in that time.

Image: Protenus cofounder Robert Lord. (Courtesy photo)

Ampel Bio Solutions

SAN FRANCISCO, Jan. 17, 2020 /PRNewswire/ -- AMPEL BioSolutions' Co-Founder and COO/CSO Dr. Amrie Grammer today at the Biotech Showcase at JP Morgan Healthcare announces the kickoff of a Series A $12.5M raise to commercialize LuGENETM, a gene-based diagnostic.  AMPEL's initial focus is Lupus, but the test can be used for many autoimmune or inflammatory diseases.  AMPEL'S goal is to have its test available for routine use by physicians within the next few years.

 

Emerging Technology Centers Baltimore lands on top 10 incubators list Baltimore Business Journal

A Baltimore business incubator has been named among the best in the world.

Emerging Technology Centers in Baltimore has been recognized by UBI Global as one of the 10 best public business incubators in the world.

The ranking was created based on a world benchmark study that included a total of 1,580 programs worldwide assessed on 21 key performance indicators including economy enhancement, talent retention, access to funds, post-graduation performance of companies and more to create lists of the top university, public and private incubators.

Image: The ETC is located at the King Cork & Seal building in Highlandtown. CONTROL TEC INC, & METRO DEVELOPMENT LLC

JPM Roche Illumina unveil 15 year cancer diagnostic tie up FierceBiotech

SAN FRANCISCO—Roche has inked a 15-year partnership with Illumina in oncology, which will include collaborating on new companion diagnostic indications for the DNA sequencing giant’s pan-cancer assay.

Announced during the J.P. Morgan Healthcare Conference, the nonexclusive pact will also enable Roche to develop and distribute in vitro diagnostic tests for Illumina’s current and future hardware lines—such as the NextSeq 550Dx and the upcoming NovaSeqDx system. The deal’s financial terms were not disclosed. 

Image: Roche and Illumina, as well as Roche's Foundation Medicine division, will work to secure regulatory approvals for Illumina’s TruSight Oncology 500 assay as a pan-cancer companion diagnostic for different targeted therapies. (Illumina)

Idea Innovation Business Free photo on Pixabay

When Daria Mochly-Rosen discovered a compound in her lab that promised to lessen the effects of heart attacks, she set out to convince pharmaceutical companies to develop it.

She couldn’t.

So the professor of chemistry and systems biology at Stanford University’s School of Medicine took a leave of absence and started her own company to further test and potentially commercialize the drug.

It seemed the obvious next step. After all, universities often speak of their success in turning research into products that make life better, with the added bonus of contributing to the economy. There are seemingly countless examples, including Gatorade, invented at the University of Florida; Google, which began at Stanford; web browsers and plasma screens, both created at the University of Illinois; and the drug that became the allergy medicine Allegra, developed at Georgetown University.

 

NewImage

The big deal about the just-completed J.P. Morgan (JPM) 38th Healthcare Conference had little to do with big M&A deals, because there weren’t any. This time last year, the $74-billion Bristol-Myers Squibb acquisition of Celgene was announced, as was Eli Lilly’s takeover of Loxo Oncology for $8 billion.

There were no such blockbusters this year, though there was an interesting potentially up-to-$2 billion-plus collaboration: MorphoSys outlicensed ex-U.S. commercialization rights to its anti-CD19 Fc-engineered antibody tafasitamab to Incyte, with the companies agreeing to co-commercialize the B cell malignancy candidate Stateside.

Image: A dearth of deals, Illumina’s double launches, and the usual crowds marked the 38th J.P. Morgan 38th Conference. - https://www.genengnews.com

Scientist Drugstore Microscope Free photo on Pixabay

The BioHealth Capital Region (BHCR) experienced significant change in 2019 that has set the table for an intriguing 2020.

How 2020 plays out across the region is unknown.

However, if you’ve followed BioBuzz throughout the past year, it is abundantly clear that workforce development strategy, investment, and support will be a critical issue for the next decade in the BHCR. In addition to change and growth across more traditional life science sectors, the ascension of personalized medicine within the region, which includes a host of new and growing regenerative medicine, cell therapy, and gene therapy companies, has transformed the region’s workforce needs.

 

NewImage

Engineered Medical Systems, Longeviti Neuro Solutions and The LaunchPort™ announced today that they have entered into an agreement to place new, low temperature, low toxicity hydrogen peroxide sterilization capacity at The LaunchPort™/EMS facility in Port Covington. The systems are being procured by Longeviti to support the Maryland production of their Low-profile Intracranial Devices (L.I.D.) platform. The Longeviti L.I.D. Platform has led to several innovative FDA cleared products thus far, the ClearFit and InvisiShunt, and more are in development. The systems will be operated by Engineered Medical Systems within EMS’s regulated medical manufacturing facility at LaunchPort™. These new systems are expected to have completed initial validations by the end of Q1 2020.

Image: https://www.prweb.com

NewImage

Herndon, VA, Jan. 14, 2020 (GLOBE NEWSWIRE) -- The Center for Innovative Technology (CIT) today released the 2019 CIT GAP Funds Impact Report, detailing both return on investment and socio-economic impact made since the fund’s inception in 2005. A family of funds placing equity investments in Virginia’s high-growth based technology, life science, and cleantech companies at the earliest developmental stages, CIT GAP Funds has deployed $28.8 million in capital across 223 investments. CIT GAP Funds investment leadership has attracted national recognition and continues to demonstrate why CIT has been named Virginia’s Most Active Investor for the last five years by CB Insights.CIT GAP Funds has yielded four times their capital invested across Tech Fund “Roadmap” investments in cybersecurity, data analytics, enterprise software and deep tech sectors and helped position the fund for return of all capital deployed. The report highlights several other figures that capture the overall impact CIT GAP Funds has on the Commonwealth, including:

Image: https://www.streetinsider.com

NIST Logo

The National Institute of Standards and Technology is seeking public feedback on its plan to revamp the Interagency Edison (iEdison) System, an online portal where companies that receive federal government funding report their inventions.

The project is part of NIST’s increased focus on federal technology transfer as part of the Lab-to-Market Cross-Agency Priority Goal under the President’s Management Agenda. Every year the federal government invests more than $100 billion in research and development, and in return grantees report the inventions that come out of this funding to the government through iEdison.

 

Joanne S. Lawton

The Maryland Department of Commerce has created a new role focused on the state's startup ecosystem and tapped a former investment banker and angel investor to head up the effort.

Allyson Redpath, who previously worked at Citigroup and Goldman Sachs, started as the department's entrepreneurship director on Dec. 18, Secretary Kelly Schulz announced Thursday. In her new role, Redpath will work to attract and retain early-stage companies in Maryland. She will also help facilitate connections between these businesses and available resources, such as access to capital, company counseling and other small business workshops and events.

Image: Joanne S. Lawton

question

When was the last time you analyzed how much you should pay your board members? How do you know if you are paying too much or not enough? In this article we examine the results of our most recent research that highlights how much board members should receive in compensation.

Business size, industry, structure, complexity, the number of yearly meetings are just a number of variables you have to consider when setting your board remuneration programs. Private companies tend to struggle with board compensation because it is difficult to find accurate benchmarks for director pay.

 

NewImage

Why me?

I have spent the last 20 years as a serial CEO of multiple healthcare startups, as well as spending the last 3 years as a corporate/strategic venture capitalist. I have made many mistakes and gotten lucky on more than a few occasions. What I hope to accomplish in this blog is simple: educate and, on a good day, entertain. There are many that are much, much more successful than me (nearly everyone in Silicon Valley!). There are some that are worse (also in Silicon Valley...e.g. Elizabeth Holmes re: Theranos). I am not from Silicon Valley. If you have questions, comments, or suggestions (future topics), please feel free to reach out to me.

Image: https://www.linkedin.com

Register to the Largest Original Forum for Precision Medicine

The Precision Medicine World Conference (PMWC) is an independent and established conference series considered to be the preeminent precision medicine conference that attracts recognized leaders, top global researchers and medical professionals, and innovators across healthcare and biotechnology sectors to showcase practical content that helps close the knowledge gap between different sectors, thereby catalyzing cross-functional fertilization and collaboration. Since 2009, recognized as a vital cornerstone for all constituents of the health care and biotechnology community, PMWC provides an exceptional forum for the exchange of information about the latest advances in technology (e.g. DNA sequencing technology), in clinical implementation (e.g. cancer and beyond), research, and in all aspects related to the regulatory and reimbursement sectors.

 

Success Curve Hand Free image on Pixabay

LOS ANGELES, Jan. 15, 2020 /PRNewswire/ -- USA News Group – A new study published in the journal Molecular Therapy reports that researchers found a drug used in the treatment of HIV that may also suppress Zika virus infection. Zika virus disease is caused by a virus transmitted primarily by Aedes mosquitoes, which bite during the day.

Research and developments with multidisciplinary approaches are proving vital to the treatment and defense against viral and infection diseases as they become more aggressive and deadly. Companies preparing to offer new treatments to deal with the onslaught may become some of valuable over the next decade. Leaders in this space are anticipating strong revenue from collaborations including NGM Biopharmaceuticals Inc. (NASDAQ: NGM), Emergent BioSolutions Inc. (NYSE: EBS), and SIGA Technologies, Inc. (NASDAQ: SIGA)

 

Bacteria Medical Biology Free image on Pixabay

A company developing treatments for drug-resistant bacterial infections is getting a boost from the Department of Defense.

Gaithersburg, Maryland-based Adaptive Phage Therapeutics, also known as APT, said Tuesday that it the DoD had awarded it $10.2 million to fund a clinical trial to develop its personalized bacteriophage therapeutic, PhageBank.

 

NewImage

BioMarker Strategies, LLC, today announced that the National Cancer Institute (NCI) has awarded the Company a Phase II Small Business Innovation Research (SBIR) contract to continue development of its PathMAP® Immunotherapy test to predict clinical response to PD-1/PD-L1 targeted immune checkpoint inhibitors, both alone and in combination with chemotherapies, for individual patients with non-small cell lung cancer (NSCLC). The contract totals $1.5 million over two years.

Image: https://finance.yahoo.com

CIT Gap Funds

The Center for Innovative Technology (CIT) today announced that CIT GAP Funds has invested in Herndon, Va.-based Jeeva Informatics Solutions Inc. (Jeeva), a precision medicine data science company focused on significantly accelerating clinical trial operations by taking trials to patients’ homes. Using AI and digital health technologies, Jeeva fast tracks patient recruitment, improves adherence to trial protocols, and reduces patient burden and dropout rates, solving some of the pressing challenges in bringing innovative medicines to market effectively. Jeeva plans to use the GAP Funds investment to advance customer pilot projects and use cases for further validation.

 

AstraZeneca Logo

AstraZeneca today announced the US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) and granted Priority Review for FARXIGA® (dapagliflozin) to reduce the risk of cardiovascular (CV) death or the worsening of heart failure (HF) in adults with heart failure with reduced ejection fraction (HFrEF) with and without type 2 diabetes (T2D).

The Prescription Drug User Fee Act date, the FDA action date for this supplemental application, is scheduled for the second quarter of 2020.

 

apply

WASHINGTON – The National Capital Consortium for Pediatric Device Innovation (NCC-PDI), in collaboration with MedTech Innovator, is now accepting applications for its showcase pitch event on March 23, 2020, in College Park, Maryland. The competition is focused on pediatric devices in three areas of critical need: cardiovascular, orthopedic and spine, and neonatal intensive care unit (NICU).

Up to ten companies selected from this event will move on to the “Make Your Medical Device Pitch for Kids!” on Oct. 4, 2020 in Toronto, Canada, to compete for up to $250,000 in grant awards. These companies also receive a spot in the MedTech Innovator 2020 Accelerator – Pediatric Track, which provides a customized curriculum and in-depth mentorship.

 

NewImage

NexImmune, a clinical-stage biopharmaceutical company developing novel immune-therapeutics based on a proprietary Artificial Immune Modulation (AIM) nanotechnology platform, announced that industry veteran John Trainer, MBA has been appointed as the Company’s Financial Officer. Additionally, Han Myint, MD has been appointed as the Chief Medical Officer.

 

NewImage

NexImmune, a clinical-stage biopharmaceutical company developing novel immune-therapeutics based on a proprietary Artificial Immune Modulation (AIM) nanotechnology platform, announced that industry veterans Han Myint, MD has been appointed as the Company’s Chief Medical Officer. Additionally, John Trainer, MBA has been appointed as the Chief Financial Officer.

Image: https://biobuzz.io

NewImage

SANTA CLARA, Calif., Jan. 7, 2020 /PRNewswire/ -- Based on its recent analysis of the global single-cell analysis market, Frost & Sullivan recognizes LumaCyte, LLC (LumaCyte) with the 2019 Global New Product Innovation Award for its groundbreaking Laser Force Cytology™ (LFC™) technology. The solution accelerates therapies and analytical insights by enabling new cell discovery, characterization and phenotyping across broad applications. LumaCyte's recently launched flagship platform, Radiance®, is an automated, high-content, label-free single-cell analysis and sorting platform. LFC™ helps labs and biopharmaceutical organizations cost-effectively optimize viral quantification for example, which are critical assays for vaccine and cell and gene therapy development and production, leading to easier sample preparation, shortened detection time, and high-quality, objective data.

 

Digital Health Expert Robert Lord Joins LionBird as New Partner

CHICAGO/TEL AVIV-YAFO (January 7, 2020) – LionBird has a new partner: Robert Lord. Lord is the co-founder of Protenus, a healthcare compliance analytics company from LionBird’s second fund. Lord joins LionBird to provide strategic insight as the company prepares to hone its digital health focus for its upcoming fund, LionBird III. In addition to his role at LionBird, Lord is the Chairman of the Board of Protenus, providing support to the Protenus team while also completing his medical degree at Johns Hopkins University School of Medicine.

 

Human Skeleton Body Anatomy Free image on Pixabay

A new initiative spearheaded by Johns Hopkins is setting out to organize and grow the digital health community in the region, with an aim of fueling successful startups.

The Chesapeake Digital Health Exchange (Chesapeake DHX) wants to create more connectivity between the stakeholders in digital health, such as companies, investors and healthcare providers. The regional effort aims to include Maryland, D.C. and Northern Virginia.