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

By News Archive

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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.

 

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

By News Archive

Qiagen Logo

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.

 

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Scientist Drugstore Microscope Free photo on Pixabay

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

By News Archive

Scientist Drugstore Microscope Free photo on Pixabay

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.

 

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BHI Recruiting a Senior Analyst, Immediate Opening. (2)

By News Archive

BHI LogoOVERVIEW

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.

 
BHI Logo

BHI Recruiting a Senior Analyst, Immediate Opening.

By News Archive

BHI LogoOVERVIEW

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.

 

397th Edition – March 17, 2020

By BHI Weekly Newsletter Archives




BioHealth Innovation


If you are having trouble viewing this email, please click here


March 17, 2020












FOUNDING MEMBER OF



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.

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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.

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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 BHI@BioHealthInnovation.org 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)

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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.

 

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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.

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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.

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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.

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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).

 

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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.

Read More




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.

Read More




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.

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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.

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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.

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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.

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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.

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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

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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)

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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.”

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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 . . .

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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

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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.

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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.

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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.”

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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.

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396th Edition – March 10, 2020

By BHI Weekly Newsletter Archives




BioHealth Innovation


If you are having trouble viewing this email, please click here


March 10, 2020












FOUNDING MEMBER OF



Chris Frew, Founder of BioBuzz and Workforce Genetics, Joins Rich Bendis on BioTalk

BioBuzz and Workforce Genetics Founder, Chris Frew, Joins BioTalk to discuss building two organizations, talent acquisition, and his role in the BioHealth Capital Region ←Sub title

Chris is the Founder and CEO of Workforce Genetics, LLC (WGx), and BioBuzz Media to foster highly engaging experiences that connect people and companies across biohealth ecosystems. His insights into talent attraction, employer branding, and marketing have helped top companies to tackle their most pressing challenges in the new talent economy. Previously as Vice President at Breezio, a leading innovator in cloud-based online communities, he lead the development of the new Internship Network of Maryland (inMD) platform that was approved by Gov. Hogan in 2017. As Vice President of Tech USA’s Scientific Division Chris founded and ran a national staffing division operating at $23M annually when he left in 2015. Chris is passionate about impacting others, especially his family and his team, and helping to foster a strong community within the BioHealth Capital Region. He is a Maryland native and a graduate of Towson University. Learn more at https://www.workforcegenetics.com/ and http://biobuzz.io/

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BioHealth Capital Region Forum 2020 (April 14-15) – Register Now

Register Now for the 6th Annual BioHealth Capital Region (BHCR) Forum held on April 14-15 at AstraZeneca in Gaithersburg, MD. Join your peers biotech and life science executives and expert speakers from industry, academia, healthcare, government, finance and real estate development, among others, converged to discuss the BHCR’s path forward to becoming a top three U.S. biotech cluster by 2023.

Register Now

 

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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.

 

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Deals News: Thermo Fisher Scientific to Buy Qiagen for $12 Bln – Bloomberg

U.S. laboratory equipment maker Thermo Fisher Scientific Inc. agreed to buy Qiagen NV, a Dutch maker of tests for diseases including cancer and the new coronavirus, for about 9 billion euros ($10 billion) in the biggest health-care acquisition so far this year.

Investors will get 39 euros in cash for every Qiagen share, Thermo Fisher said Tuesday. That’s 23% higher than Monday’s closing price. Qiagen also sells products for food and forensic testing. Bloomberg earlier reported the companies were nearing a deal after reviving discussions that broke off late last year.

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Coronavirus vaccine news boosting Gaithersburg’s Novavax – Washington Business Journal

Novavax Inc. is already cashing in on its stock spike after announcing plans to develop a vaccine for the COVID-19 coronavirus.

The Gaithersburg biotech has raked in $98.7 million in net proceeds this quarter from selling 10.5 million shares of common stock at $9.55 per share, the company reported Monday in Securities and Exchange Commission filings. And it could sell up to $150 million more in common stock shares, the company said.

Novavax’s (NASDAQ: NVAX) stock was trading at $12.09 per share Monday early afternoon — which, though down about 24% from Friday’s close (as stocks see general volatility amid the coronavirus outbreak), is still notably high for the Maryland biotech.

Image: Novavax is developing a vaccine candidate for the COVID-19 coronavirus. This Centers for Disease Control and Prevention illustration shows the structure of coronaviruses. CENTERS FOR DISEASE CONTROL AND PREVENTION

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CEL-SCI Initiates Development of Immunotherapy to Treat COVID-19 Coronavirus Infection | Benzinga

CEL-SCI Corporation (NYSE:CVM) announces that it is developing an immunotherapy with the potential to treat the COVID-19 coronavirus using its patented LEAPS peptide technology. The LEAPS peptides will utilize conserved regions of coronavirus proteins to stimulate protective cell mediated T cell responses and reduce viral load. The LEAPS peptide technology can be used to construct immunotherapeutic peptides that exhibit both antiviral and anti-inflammatory properties. Consequently, these products not only target the virus infection against which they are directed, but also elicit the appropriate protective response(s) against it.

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Amazon Web Services, Montgomery College, George Mason University Announce the College’s First Bachelor’s Degree for Cloud Computing – MC News

Montgomery College and George Mason University (Mason), in collaboration with AWS Educate, will partner to create a Bachelor of Applied Science (BAS) pathway in cloud computing. This degree offers students a seamless transfer pathway from a two-year associate’s degree to a four-year bachelor’s degree in cloud technology, providing a clear path to high-demand careers in cloud computing with AWS (Amazon Web Services) partners and customers.

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BioHealth CXO/Consulting Database

Are you an experienced biohealth industry executive seeking full time or part time employment as a consultant or start-up C suite executive? BioHealth Innovation is updating its database of experienced industry executives who may be able to share their expertise with early stage/growing companies. To be considered by companies or technology transfer organizations seeking leaders for their spin-out companies and/or advisors to support their business growth, please this form and upload a copy of your resume. (For questions/more information, please email: BHI@BioHealthInnovation.org.)

 

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Innate Pharma

Tomorrow and every day, we recognize the hashtag#RareDisease community on behalf of the Innate Pharma team. We do what we do because of you. hashtag#RareDiseaseDay hashtag#WRDD hashtag#HairyCellLeukemia hashtag#cutaneouslymphoma hashtag#SézarySyndrome hashtag#MycosisFungoides

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Immunomic Therapeutics Announces Completion of Pre-IND Meeting with US FDA for ITI-1001, a Vaccine for the Treatment of GBM – Bloomberg

Immunomic Therapeutics, Inc., a privately held clinical stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, announced today that it successfully completed a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) regarding its First-In-Human (FIH) Phase I trial and development plans for ITI-1001. The FDA addressed the Company’s questions and provided feedback on key components of the planned IND application for the candidate, ITI-1001, for the treatment of newly diagnosed Glioblastoma Multiforme (GBM).

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CORRECTING and REPLACING Neuraly Announces First Patient Dosed in Phase 2 Clinical Trial of NLY01 for Patients with Parkinson’s Disease | Business Wire

NEURALY ANNOUNCES FIRST PATIENT DOSED IN PHASE 2 CLINICAL TRIAL OF NLY01 FOR PATIENTS WITH PARKINSON’S DISEASE

Novel Mechanism of Action Inhibits Pathological Activation of Microglial Cells and Prevents Neuronal Cell Death

Neuraly, a clinical stage biotechnology company pioneering disease-modifying agents for neurodegenerative disorders, today announced the dosing of the first patient in its Phase 2 clinical trial of NLY01 for Parkinson’s disease.

“Current therapies for Parkinson’s disease provide only temporary symptomatic improvement and fail to slow or halt the relentless progression of the disease,” said Seulki Lee, Ph.D., President and Chief Executive Officer of Neuraly. “The initiation of this Phase 2 study is an important milestone in the ongoing advancement of NLY01 which we believe has the potential to be a ground-breaking therapy for Parkinson’s patients based on results we have seen to date in preclinical trials.”

 

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Mason to unveil a new Cyber Living Innovation Lab as part of the CCI | George Mason

A Cyber Living Innovation Lab with robotic platforms to evaluate 5G performance and a fleet of driverless cars will provide experiential learning opportunities to students from universities across the region as the anchor of George Mason University’s cybersecurity research expansion, thanks to $2.5 million in funding as part of a statewide initiative.

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HHS Solicits Proposals for Development of Medical Products for Novel Coronavirus | HHS.gov

As part of the government-wide effort to mitigate the spread of COVID-19 in U.S. communities, the U.S. Department of Health and Human Services (HHS) has updated a broad agency announcement (BAA) to focus specifically on products to diagnose, prevent or treat coronavirus infections.

The Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), issued the BAA, BAA-18-100-SOL-00003-Amendment 13, to solicit proposals for advanced development and licensure of COVID-19 diagnostics, vaccines, or medicines such as therapeutics or antivirals.

“Amid the expanding global outbreak of COVID-19, Americans need diagnostics, vaccines, and medicines to mitigate the potential impact of this virus”, said BARDA Director Rick Bright, Ph.D. “To accelerate the availability of these lifesaving tools, BARDA took an important step today to request proposals for development of COVID-19 diagnostics, vaccines, or therapeutics, many of which will be developed using existing platform technologies to permit rapid development.”

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Alexandria Real Estate Equities, Inc. and Executive Chairman and Founder Joel S. Marcus Honored With the 2020 Navy SEAL Foundation Patriot Award

PASADENA, Calif. and NEW YORK, March 6, 2020 /PRNewswire/ — Alexandria Real Estate Equities, Inc. (NYSE: ARE), an urban office REIT and the first, longest-tenured and pioneering owner, operator and developer uniquely focused on collaborative life science, technology and agtech campuses in AAA innovation cluster locations, and its executive chairman and founder, Joel S. Marcus, were honored to receive the 2020 Navy SEAL Foundation Patriot Award. This recognition highlights Alexandria’s contributions to our nation and unwavering support for the Naval Special Warfare community, as well as its embodiment of the values that epitomize the SEAL community. Congressional Medal of Honor recipient and retired U.S. Navy Master Chief Special Warfare Operator Britt Slabinski presented the prestigious award to Mr. Marcus yesterday evening during the Navy SEAL Foundation’s 12th annual New York City Benefit Dinner celebrating the Foundation’s 20th anniversary.

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The best, and the worst, of the coronavirus dashboards – MIT Technology Review

If you’ve been on the web to learn more about the latest pandemic, chances are you’ve stumbled upon at least one or two coronavirus dashboards. These are the landing pages for interactive maps and visuals that show where the virus has spread, as well as numbers on the latest in infection rates and deaths, breakdowns of what countries are suffering from new cases and what regions are likely seeing new outbreaks, and much more.

Image: UPCODE ACADEMY

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Maryland Economic Development Association Announces 2020 Award Winners

The Maryland Economic Development Association (MEDA) is proud to announce the winners of the 2020 MEDA Awards. The 2020 awards, sponsored by Miles & Stockbridge P.C., recognize the exceptional people, programs and projects that bring economic prosperity to Maryland.

“We’d like to thank all who submitted a nomination for recognizing such deserving programs, projects and individuals, and our awards judges for their hard work determining the winners,” says Pamela Ruff, MEDA executive director. “The 2020 winners exemplify the Maryland communities that are going above and beyond when it comes to economic expansion and prosperity.”

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Northern UK Trade Mission to the BioHealth Capital Region with British Department of Trade and Industry of the UK Embassy at AstraZeneca

Northern UK Trade Mission to the BioHealth Capital Region with British Department of Trade and Industry of the UK Embassy at AstraZeneca

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Baltimore: poised for a revolution in health business | COMMENTARY – Baltimore Sun

The region’s politicians and business leaders are mourning the fact Baltimore stands to lose another headquarters of a prestigious, publicly traded company with the news that Legg Mason Inc. was acquired by Franklin Resources Inc. But investors should remain bullish about the city’s business future. The acquisition of Legg Mason was part of a natural cycle of industry consolidation and not a measure of Baltimore’s business climate. In fact, Baltimore and the surrounding region are poised to lead a business revolution in health.

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How to Conquer Coronavirus: Top 35 Treatments in Development

As the world scrambles to monitor and contain the COVID-19 outbreak, drug companies are racing to develop or repurpose treatments to combat the potential pandemic. The death toll continues to climb. The first U.S. death associated with the SARS-CoV-2 virus was reported in Washington state February 29. As of March 2, according to the Center for Systems Science and Engineering (CSSE) at Johns Hopkins University, 3,048 people in 11 countries had died worldwide, nearly all of them (96% or 2,914) in China.

Image: Credit: NASA/Johns Hopkins University Applied Physics Laboratory/Southwest Research Institute/Roman Tkachenko

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Southern Maryland’s 6th Annual Crab Pot Pitch Competition – Speed Rounds Tickets, Thu, Apr 9, 2020 at 6:00 PM | Eventbrite

What is Crab Pot?

The Crab Pot Pitch Competition is Southern Maryland’s premier pitch competition for entrepreneurs with cutting edge, disruptive and innovative technologies. Made popular by television shows like ABC’s “Shark Tank,” pitch contests provide an opportunity for entrepreneurs to present their ideas to a panel of judges or investors in front of an audience.

Crab Pot provides an opportunity for the community to celebrate the efforts of local entrepreneurs and innovators. Audience members get to see what entrepreneurs in Southern Maryland are up to. Crab Pot provides an opportunity for the community to celebrate the efforts of local entrepreneurs and innovators. Audience members get to see what entrepreneurs in Southern Maryland are up to. Entrepreneurs get to practice their pitches and win cash prizes. This year will be the 6th annual competition!

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U.S. IPO Week Ahead: One Biotech Takes On A Turbulent IPO Market | Seeking Alpha

Facing record-high volatility and market uncertainty, one biotech is scheduled for the week ahead.

Formed by New Enterprise Associate’s orphan drug accelerator Cydan, genetic disorder biotech Imara (IMRA) plans to raise $76 million at a $301 million market cap. The Boston-based company’s sole candidate IMR-687 is a once-a-day therapy targeting sickle cell disease and beta-thalassemia by inhibiting PDE9. It is expected to begin a Phase 2b trial in the 1H20. While there is significant unmet medical need for both disorders, it is a crowded space, with three products approved in 2019.

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How to self-quarantine during coronavirus outbreak | Live Science

With more than 378 confirmed coronavirus cases in the U.S. and more than 15 associated deaths, the Centers for Disease Control and Prevention (CDC) is actively monitoring, and trying to contain, the transmission of the disease, called COVID-19.

In some cases, depending on risk level, the CDC may ask individuals or families to self-quarantine or remain in isolation. Here’s a look at what that means and tips for implementing such measures.

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Innovationeering: What’s your (innovation) number?

In this age of near-exclusive reliance on electronic communication, practically nobody asks for your number any longer — we just text, email or AirDrop critical identifiers.

However, some of us still must record our activities numerically, and innovators are certainly not immune from exchanging numbers — usually with interested leaders or colleagues, for the purpose of benchmarking.

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STAT Madness has begun. Vote for the best innovations in biomedicine – STAT

This is our fourth annual STAT Madness, a bracket-style tournament to find the best innovations in science and medicine.

The second round of voting begins Monday, March 9 at 12 a.m. EDT and is open until Sunday, March 15 at 11:59 p.m. EDT.

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What’s Behind Novavax’s Coronavirus/COVID-19 Vaccine Development Program · BioBuzz

The BioHealth Capital Region (BHCR) has a long history of leading the fight against new, frightening diseases, like Ebola and the novel Coronavirus (COVID-19) which is quickly spreading across the globe. Leading public health agencies such as the World Health Organization (WHO) and others believe the COVID-19 virus has the potential to reach pandemic levels as infection numbers rise beyond China’s borders.

Image: https://www.arcgis.com/apps/opsdashboard/index.html#/bda7594740fd40299423467b48e9ecf6

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Thermo Fisher Acquiring Qiagen For €9 Billion: Details About The Deal You Should Know

As one of the largest healthcare tech deals in 2020, Thermo Fisher is buying coronavirus diagnostics company Qiagen NV for €9 billion. QIAGEN is considered a leading global provider of molecular diagnostics and sample preparation technologies. The deal has been approved by the boards of directors at both companies as well as the managing board of QIAGEN.

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395th Edition – March 3, 2020

By BHI Weekly Newsletter Archives




BioHealth Innovation


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March 9, 2020












FOUNDING MEMBER OF



BioHealth Capital Region Forum 2020 (April 14-15) – Register Now

Register Now for the 6th Annual BioHealth Capital Region (BHCR) Forum held on April 14-15 at AstraZeneca in Gaithersburg, MD. Join your peers biotech and life science executives and expert speakers from industry, academia, healthcare, government, finance and real estate development, among others, converged to discuss the BHCR’s path forward to becoming a top three U.S. biotech cluster by 2023.

Register Now

 

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Northern Powerhouse Life Sciences and Healthcare Showcase Event (Tuesday, March 3, 2020)

We would like to invite you to join leading companies from the Northern Powerhouse region of England for a morning of presentations and networking. The delegation is visiting the Capital Region to help build relationships with key decision makers and build close trade and collaboration ties.

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Novavax Advances Development of Novel COVID-19 Vaccine | Novavax Inc. – IR Site

GAITHERSBURG, Md., Feb. 26, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced progress in its efforts to develop a novel vaccine to protect against coronavirus disease COVID-19. Novavax has produced and is currently assessing multiple nanoparticle vaccine candidates in animal models prior to identifying an optimal candidate for human testing, which is expected to begin by the end of spring 2020.

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Arcellx Announces First Patient Treated with T Cell Therapy Utilizing the Company’s Novel Binding Domain

GAITHERSBURG, Md., Feb. 28, 2020 (GLOBE NEWSWIRE) — Arcellx today announced that the first patient has been dosed with its engineered T cell therapy utilizing a novel deimmunized synthetic binding domain in the treatment of patients with relapsed and refractory multiple myeloma. This first-in-human Phase 1 trial is the first in a series of clinical trials planned for efficient, stepwise development of the Arcellx ARC-T + sparX cell therapy platform, with BCMA as an initial target.

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Pink Equity: The Power Of The Female Dollar (March 12, 2020)

Who runs the healthcare world? Women make 80% of all buying decisions and make up over 70% of the healthcare workforce—yet in 2020 we still do not have an equal voice in the ranks of leadership.

Diversity is also an issue when it comes to venture capital. Female entrepreneurs continue to struggle to raise as much capital as their male counterparts. Although capital investment in all-female founding teams hit an all time high of $3.3 billion in 2019, it represented only 2.8% of capital invested across the entire U.S. startup ecosystem.

Join JLABS for an evening panel discussion as we tackle these issues, and discuss avenues for capital, while forging a path forward for two of the most prohibitive factors at play: a lack of a robust network of female mentors and lack of investment dollars in female-led startups. 

 

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Interactive map from Johns Hopkins shows coronavirus spread in real-time

The map allows you to see which parts of the world are impacted the most by it.

A chart is placed to the left of the map showing the number of confirmed cases for specific countries, states, and cities.

Two charts are placed to the right of the map.

Image: https://www.arcgis.com/

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IBBR Researchers Awarded $850K from NSF to Study How Plants Defend Against Fungal Invasion | Institute for Bioscience and Biotechnology Research

(Rockville, MD, February 25, 2020) Researchers at the Institute for Bioscience and Biotechnology Research (IBBR) recently received $850K from the National Science Foundation (NSF) to advance our understanding of how fungi like powdery mildew infect plants including food source crops, and how plants fight back. IBBR Fellow Dr. Shunyuan Xiao (Professor, Department of Plant Sciences and Landscape Architecture, University of Maryland College of Agriculture & Natural Resources) is the principal investigator on the award.

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United Therapeutics and DEKA Announce Additional FDA Clearance Related to the Unity Subcutaneous Delivery System for Remodulin® | BioSpace

RESEARCH TRIANGLE PARK, N.C. and MANCHESTER, N.H., Feb. 24, 2020 /PRNewswire/ — United Therapeutics Corporation (Nasdaq: UTHR) and DEKA Research & Development Corp. today announced receipt of an additional 510(k) clearance by the U.S. Food and Drug Administration (FDA) related to the Unity Subcutaneous Delivery System for Remodulin® (treprostinil) Injection, also referred to as the Remunity™ pump, enabling United Therapeutics to launch the system using drug reservoirs that have been prefilled by specialty pharmacies.

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Capsulomics establishes $3.7 million NIH-funded research collaboration with Johns Hopkins University

BALTIMORE, Feb. 25, 2020 /PRNewswire/ — Capsulomics, Inc., a Baltimore-based molecular diagnostics company whose mission is to detect and prevent cancer through earlier detection, today announced a research partnership with Johns Hopkins University, funded by a 5-year, $3.7 Million NIH Academic-Industrial Partnership grant, to conduct an important clinical research study to detect esophageal cancer and its precancerous precursor condition, Barrett’s esophagus (BE).

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Poets&Quants | $25 Million To Accelerate Johns Hopkins’ MBA Makeover

Alex Triantis, dean of the Carey Business School at Johns Hopkins University in Baltimore, Maryland, says a new $25 million gift from the school’s namesake foundation will go toward accelerating the transformation of the MBA curriculum into a much more healthcare-oriented experience, among other uses. Carey photo

At Johns Hopkins University, nearly a quarter of the Carey Business School’s full-time faculty study or teach in health-related fields. About 38% of current full-time MBA students and 35% of part-time MBA students focus on health-related areas of study.

Image: https://poetsandquants.com

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Congratulations to Sonavex, Inc. CEO David Narrow on being selected as an Innovation Leader at Emerging Medtech Summit 2020.

Congratulations to Sonavex, Inc. CEO David Narrow on being selected as an Innovation Leader at Emerging Medtech Summit 2020.

More: https://lnkd.in/e3Z8fUv

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Maryland Commerce releases FY19 annual report | Maryland Business News

Over the past year, the Maryland Department of Commerce has continued to foster business growth throughout the state, by simplifying the process of starting a business, prioritizing customer service, and investing in our innovative companies.

During fiscal year 2019, the department provided financial assistance to 167 different economic development projects statewide, from Kite Pharma in Frederick to Smithfield Foods in Cecil County, bringing in a total capital expenditure of $630.5 million. More than 70 of these projects fell under the small, minority, and women-owned business category, according to the recently released annual report.

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NIH Is Supporting Entrepreneurs To Address The Looming Public Health Crisis: Life Science Nation Interview with Todd Haim, Ph.D., Chief, Office of Small Business Research, National Institute on Aging, National Institutes of Health | Next Phase Newsletter

Todd Haim(TH): I began working on small business grant programs at the National Institutes of Health (NIH) more than 10 years ago when I joined the National Cancer Institute (NCI) as an AAAS Science and Technology Policy Fellow. After 9 years at NCI, I was asked to lead the launch of a new Office of Small Business Research (OSBR) at the National Institute on Aging (NIA). NIA’s OSBR was created just over 1 year ago. It serves as the main coordinating office for Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) grants that are awarded to companies working on solutions to address aging and aging-related diseases.

Image: https://blog.lifesciencenation.com

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This Philly lawyer is building three new venture capital funds to invest millions in start-ups

“Philadelphia was an innovation and investment backwater,” but Ajay Raju says it’s headed for venture capital’s mainstream, and he’s personally setting up the partnerships to make it happen, pledges the real estate finance lawyer and chairman of the law firm Dilworth Paxson.

Image: ANDREW THAYER / FILE PHOTOGRAPH

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Changes Recommended for Keystone Innovation Zone Tax Credit – Smart Incentives

Pennsylvania’s Independent Fiscal Office has suggested making the Keystone Innovation Zone (KIZ) tax credit refundable, which would eliminate the portion of the tax credit going to tax brokers and increase the funding available to target businesses. Other proposed changes would strengthen the applicant review process and expand data collection to improve program accountability.

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Copyright © BioHealth Innovation 2017
All Rights Reserved.



Biotalk Skyscraper Rich And Chris Frew

Chris Frew, Founder of BioBuzz and Workforce Genetics, Joins Rich Bendis on BioTalk

By BioTalk with Rich Bendis Podcast, News

Biotalk Skyscraper Rich And Chris Frew

BioBuzz and Workforce Genetics Founder, Chris Frew, Joins BioTalk to discuss building two organizations, talent acquisition, and his role in the BioHealth Capital Region ←Sub title

Chris is the Founder and CEO of Workforce Genetics, LLC (WGx), and BioBuzz Media to foster highly engaging experiences that connect people and companies across biohealth ecosystems. His insights into talent attraction, employer branding, and marketing have helped top companies to tackle their most pressing challenges in the new talent economy. Previously as Vice President at Breezio, a leading innovator in cloud-based online communities, he lead the development of the new Internship Network of Maryland (inMD) platform that was approved by Gov. Hogan in 2017. As Vice President of Tech USA’s Scientific Division Chris founded and ran a national staffing division operating at $23M annually when he left in 2015. Chris is passionate about impacting others, especially his family and his team, and helping to foster a strong community within the BioHealth Capital Region. He is a Maryland native and a graduate of Towson University. Learn more at https://www.workforcegenetics.com/ and http://biobuzz.io/

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