Biohealth Innovation - 397th Edition

BioHealth Innovation

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March 17, 2020

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BioHealth Capital Region Forum Postponed Due to COVID-19 Outbreak - BioHealth Capital Region

The BioHealth Capital Region Forum Planning Committee has made the difficult decision to postpone our 6th annual BioHealth Capital Region Forum that was scheduled for April 14th and 15th at AstraZeneca. We believe the health and safety of all participants is of paramount importance. Following the most recent reports from the CDC, the WHO, and the state of Maryland’s ban on gatherings of 250 people or more, we have made this decision.

Stewart L. Edelstein, Ph.D., Executive Director of the Universities at Shady Grove, Joins Rich Bendis on BioTalk

Executive Director of the Universities at Shady Grove, Stewart L. Edelstein, Ph.D., joins BioTalk to discuss his career, USG, and its role in the BioHealth Capital Region

Dr. Stewart Edelstein joined the Universities at Shady Grove (USG) as Executive Director in 2002 and in 2007 was named to the dual title of Associate Vice Chancellor for Academic Affairs for the University System of Maryland (USM).

USG is a regional campus of USM that offers both undergraduate and graduate degree programs from nine partner universities. During Dr. Edelstein’s tenure, USG expanded its number of participating universities, as well as the breadth and depth of its academic programs, and enrollment has grown significantly, to more than 3,000 students. The campus’s capacity for future enrollment growth has doubled with the recent opening of a new Biomedical Sciences and Engineering Education Facility, which is expanding degree and certification offerings in healthcare, engineering, biosciences, computer science and other areas.

Entrepreneur- in-Residence Feedback Session (videoconference)

In accordance with state and federal recommendations to combat COVID19, BioHealth Innovation has modified the EIR Feedback Sessions for the near future to take place by videoconference only. There now are a couple openings tomorrow (3/18). To participate in this session, please register using this link www.tinyurl.com/EIR feedback and send your ppt presentation including the top 3 topics on which you would like feedback to This email address is being protected from spambots. You need JavaScript enabled to view it. by 2 p.m. 3/17/20. The next sessions are scheduled to take place by videoconference on 4/22 and 5/27.

(by videoconference)

BHI Recruiting a Senior Analyst, Immediate Opening.

OVERVIEW

BioHealth Innovation, Inc. (BHI), is a Montgomery County innovation intermediary which translates market-relevant research into commercial success by bringing together management, funding, and markets. BHI is seeking a life sciences professional with consulting, market research and/or portfolio management experience to join the BHI's team and serve as a Senior Analyst, Ph.D. to manage and support the Analyst team through training and front facing of potential start-up CEOs and Companies.

POSITION DESCRIPTION – Senior Analyst, Ph.D.

The Senior Analyst will manage the analysts and provide project support and guidance to the team as well as to new entrepreneurs on projects including SBIR Grants, corporate and private investments. This will entail market, technology, regulatory and other business intelligence research to support BHI consulting, coaching of companies and the Analyst team profit center. This is a hands-on leadership position.

Download the Full Job Description.

The life sciences industry has posted gains in the DMV. Here's what it will mean for jobs - Technical.ly DC

It’s at the center of some of the most groundbreaking work to advance human ingenuity in the region — and save lives. And, economically, it’s been home to some of the biggest news about M&A activity, venture capital and job growth. When it comes to growing industries, the life sciences sector is among the most impactful in the area. Spanning hospital research labs and manufacturing centers where production takes place, harnessing living cells to create new treatments and other biotech, biomedical and pharma work is happening in a footprint that knits together Baltimore, the Maryland suburbs, D.C. and Northern Virginia.

Emergent BioSolutions Signs Development and Manufacturing Agreement With Novavax for Experimental Vaccine Candidate for Coronavirus Disease | Emergent BioSolutions Inc.

GAITHERSBURG, Md., March 10, 2020 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has entered into an agreement with Novavax, Inc. (NASDAQ:NVAX) whereby Emergent will collaborate with Novavax, utilizing its molecule-to-market contract development and manufacturing (CDMO) services to support bringing into the clinic Novavax’s novel experimental vaccine candidate to protect against coronavirus disease (COVID-19). Under the terms of the agreement, Emergent will produce the COVID-19 experimental vaccine candidate, which is based on the proprietary recombinant protein nanoparticle technology platform of Novavax and utilizing their proprietary Matrix-M™ adjuvant to enhance immune responses. Emergent has initiated work for this program anticipating that the COVID-19 experimental vaccine candidate will be used in a Phase 1 clinical study within the next four months.

Emergent Biosolutions, Inc. (NYSE:EBS), Novavax, Inc. (NASDAQ:NVAX) - Emergent BioSolutions CEO Talks Coronavirus Vaccine Development | Benzinga

Global life sciences company Emergent Biosolutions Inc EBS 6.61% CEO Bob Kramer said Thursday that his company's partnership with Novavax, Inc. NVAX 6.3% could result in the creation of a therapy that poses a "fairly low risk."

Emergent Has Past Experience With Anthrax, Botulism Emergent is using its own platform to help Novavax with the creation of a coronavirus vaccine, Kramer said during a guest appearance on CNBC's "Squawk Box" segment Thursday morning.

FDA Clears First Clinical Study for a Polymicrobial Phage Library-Based Treatment for Antibiotic-Resistant Infections | Business Wire

GAITHERSBURG, Md.--(BUSINESS WIRE)--Adaptive Phage Therapeutics (APT), a clinical-stage biotechnology company founded to provide an effective therapeutic response to the global rise of multi-drug resistant (MDR) pathogenic bacteria, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for the clinical development of PhageBank™, a personalized bacteriophage therapeutic for the treatment of MDR and complicated bacterial infections. The Phase 1/2 trial represents the first study of an expanding phage library under FDA allowance for a multi-site study of intravenous administration and/or bladder instillation of phage therapy. Beginning in Q2, APT will enroll patients at up to three clinical sites for the evaluation of PhageBank for the treatment of complicated and chronic recurrent urinary tract infections (UTIs).

QIAGEN Gains BARDA Funding for Approval Process of QIAstat-Dx Test Kit for SARS-CoV-2 Coronavirus

QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced it will develop a new QIAstat-Dx test kit to differentiate the novel SARS-CoV-2 coronavirus from 21 other serious respiratory infections and will receive advanced development support from the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response (ASPR). Accelerated development of the QIAstat-Dx test kit further expands QIAGEN’s global mobilization for the emergency, which already includes a dramatic increase in production of components for a full range of U.S. and international testing protocols.

Roche gets special FDA nod for Covid-19 diagnostic test - MedCity News

The Food and Drug Administration has given an emergency approval to a test made by Swiss drug and diagnostics maker Roche for detecting the Covid-19 virus.

The company said Friday that the FDA had approved an emergency use authorization, or EUA, to its Cobas SARS-CoV-2 test. The test is designed to use nasopharyngeal and oropharyngeal swab samples to detect the coronavirus using Roche’s Cobas 6800 and 8800 lab-testing systems. The systems are designed to provide thousands of results over a 24-hour period, the company said.

Baltimore health tech startup b. well Connect Health raises $16M - Baltimore Business Journal

Baltimore health tech startup b. well Connected Health has raised a $16 million round as it looks to accelerate its growth.

The Series A round was led by UnityPoint Health Ventures, the venture capital arm of UnityPoint Health, an Iowa-based health system. Other investors include Wisconsin-based community health system ThedaCare and Well Ventures, a subsidiary of Walgreens Boots Alliance Inc., according to a release. The five-year-old company has previously raised $11.5 million in seed funding, bringing its total funding to over $27 million. In 2018, b. well also raised a total of $8.2 million in convertible debt funding from more than 60 investors.

NEA Closes On $3.6B for New Fund with Focus on Early-Stage Technology and Healthcare Investments

MENLO PARK, Calif. and NEW YORK, March 11, 2020 /PRNewswire/ -- New Enterprise Associates, Inc. (NEA) today announced that it has closed on $3.6 billion for its latest fund, bringing the firm's committed capital to nearly $24 billion over its 42-year history. In conjunction with the new fund, Liza Landsman has been named General Partner. Landsman, who joined the firm's New York office as a Venture Partner in 2018 after serving as president of NEA portfolio company Jet.com, focuses on software and services investments across the consumer landscape.

FDA Releases Final Guidance: Transition of Previously Approved Drugs to Being "Deemed Licensed" Biologics | Wilson Sonsini Goodrich & Rosati - JDSupra

U.S. prescription drugs can broadly be divided into two categories: 1) small molecule drugs and 2) biologics. Small molecule drugs tend to be chemically synthesized and often have molecular weights under 1,000 Daltons. Contrastingly, biologic drugs are larger and more complex molecules, for example proteins, viruses, and living cells such as CAR-T cells.

CEPI expands investment in COVID-19 vaccine development – CEPI

OSLO, NORWAY, March 10, 2020 – CEPI, the Coalition for Epidemic Preparedness Innovations, today announced the expansion of its COVID-19 vaccine portfolio. CEPI will be investing a further $4.4 million in partnering agreements with Novavax, Inc. and The University of Oxford to rapidly develop vaccine candidates against COVID-19. This brings CEPI’s total investment in COVID-19 vaccine R&D to $23.7 million.

Welldoc Announces Collaboration with Dexcom to Enhance the Value of BlueStar® with the Dexcom G6® CGM System | Welldoc Inc

Columbia, MD – March 11, 2020 – Welldoc, a leading digital health company, announced today a collaboration with Dexcom, the global leader in continuous glucose monitoring (CGM) systems for people with diabetes. Welldoc and Dexcom signed an initial data partnership in 2019. This new collaboration will allow Welldoc’s award-winning BlueStar®, a digital health product for individuals living with type 1 and type 2 diabetes, to deliver insights to Dexcom G6® CGM system users. These insights go beyond glucose trends to inform individuals how their glucose is being affected by other key parameters, including medication adherence, activity, nutrition, sleep and more. The parties will also explore additional opportunities with Welldoc customers to leverage a more integrated offering.

Johns Hopkins microbiologists develop coronavirus screening test

BALTIMORE — Two Johns Hopkins microbiologists have developed an in-house coronavirus screening test that may soon allow the health system to test as many as 1,000 people per day.

Karen Carroll, M.D., and Heba Mostafa, M.B.B.Ch., Ph.D are the microbiologists leading this.

“We will be able to diagnose more cases. This will allow the control of exposure,” said Mostafa, assistant professor of pathology and director of the molecular virology laboratory at The Johns Hopkins Hospital.

Image: Photo by: Johns Hopkins Medicine

Gates Foundation, Wellcome, Mastercard launch $125M COVID-19 Therapeutics Accelerator – GeekWire

The Bill & Melinda Gates Foundation is teaming up with Wellcome and Mastercard to form the COVID-19 Therapeutics Accelerator, a $125 million effort to help find potential treatments for the coronavirus epidemic and future threats.

The accelerator will bring together the World Health Organization, pharmaceutical companies, biotech firms, government, and other philanthropic groups to develop therapies for COVID-19.

Image: Mark Suzman. (Gates Foundation Photo)

FDA and FTC Send Joint Warning Letters to Seven Companies for "Selling Fraudulent COVID-19 Products" | Wilson Sonsini Goodrich & Rosati - JDSupra

The number of cases of SARS-CoV-2 coronavirus infection, and COVID-19, the disease caused by the virus, continue to increase in the United States—both in number and in location (real-time map). At the same time, the number and severity of symptoms post-infection can vary by age and other risk factors (CDC Report). High level officials and politicians have been reported to be infected by, or in contact with, the virus. And there is no U.S. Food and Drug Administration (FDA) approved or licensed cure for COVID-19 (other than time, supportive measures as necessary, and a healthy immune system). "Although there are investigational COVID-19 vaccines and treatments under development, these investigational products are in the early stages of product development and have not yet been fully tested for safety or effectiveness."

Top 15 Best-Selling Drugs of 2019

GEN publishes its updated annual A-List highlighting the top 15 best-selling drugs of 2019. Eleven of last year’s 15 top-selling drugs registered year-over-year sales gains, with seven of the 11 racking up double-digit increases . . .

All you need to know about TBS Osteo - Medimaps

All TBS Osteo features and main arguments. Included, in greater detail.

What is TBS Osteo powered by TBS iNsight and what is TBS (Trabecular Bone Score): the main arguments.
TBS Osteo compatibilities with different DXA systems.
Main evidence of TBS clinical validation.
How TBS can be a significant aid to better characterize your patient’s risk profile.
Short grid to understand the risk of fracture based on a combined model of TBS and BMD.

Updated for TBS Osteo 3.1

NIST Director Testifies Before House Science Subcommittee on Agency Reauthorization; Touts Success of the Manufacturing USA Program in Promoting Technology Transfer - ASME

Last Wednesday, the House Science Committee, Subcommittee on Research and Technology, invited Under Secretary of Commerce and Director of the National Institute of Standards and Technology (NIST) Dr. Walter Copan to testify before the Subcommittee on reauthorizing the agency. NIST was last authorized in 2016 as part of the American Innovation and Competitiveness Act. Director Copan’s testimony covered each of the technologies the Trump Administration is collectively referring to as “industries of the future,” including Quantum Information Science, Artificial Intelligence, 5G, Advanced Manufacturing, and Biotechnology. He specifically commented on how NIST catalyzes partnerships between industry, academia, government, and other organizations to promote U.S. innovation and economic competitiveness.

Uniform nanoparticle vaccines

Precise loading of diverse peptides for vaccination is enabled by a strategy for peptide–TLR7/8 conjugate self-assembly of uniform nanoparticles. The approach is compatible with the development of personalized strategies, such as cancer vaccines targeting patient-specific neoepitopes.

University of Maryland athletics announces spectator restrictions amid coronavirus outbreak - Baltimore Sun

University of Maryland athletics on Wednesday announced a series of safety measures for its home events amid concern over the coronavirus outbreak, now labeled a pandemic by the World Health Organization.

Among several changes announced in a release, "Effective immediately, only student-athletes, coaches, essential personnel, officials, credentialed media and a limited number of family members of the competing teams will be permitted to attend games, until at least April 10.”

New Enterprise Associates Amasses $3.6 Billion for 17th Fund - WSJ

New Enterprise Associates has raised $3.6 billion for its 17th venture fund, the largest in the more than 42-year history of the firm.

NEA set out in the second quarter of 2019 to raise New Enterprise Associates 17 LP and held a final closing in February at its target, said General Partner Mohamad Makhzoumi.