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Praduman Jain, known to colleagues as “PJ,” is CEO and Founder of Vibrent Health and the Principal Investigator of the Participant Technology Systems Center of the National Institutes of Health Precision Medicine Initiative, the All of Us Research Program, for which the PTSC received a $75 million grant in 2017 and an additional award in 2020 with initial first-year funding of $39 million to build a national platform for health research and health management insights for 1 million people across the U.S. for at least 10 years.  Jain is also the Chair of the Security Board of the Committee on Access, Privacy & Security for the NIH All of Us Research Program; a member of the Roundtable on Genomics and Precision Health at the National Academies of Sciences, Engineering, and Medicine; an invited external expert for eMERGE & Beyond, The Future of Electronic Medical Records and Genomics program of the Division of Genomic Medicine, National Human Genome Research Institute; and an external advisory board member for iTHRIVE – a Virginia Clinical and Translational Science Award.

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This year, more than ever before, we’ve seen just how important it is for us all to stay connected and work together to build a stronger biotech ecosystem. In the face of great adversity, the biotech community has risen to the challenge and formed new collaborations and partnerships to innovate and rapidly develop new medicines and tools to help us beat this pandemic. 

That’s why we decided that this year was the right time to launch the first annual BioBuzz Awards.  This is an opportunity for us all to revisit the accomplishments of the past year and recognize the leaders and companies in the region who are doing great things to build a stronger BioHealth Capital Region across Maryland, DC and Virginia, and are making an impact on human health.

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Exact Sciences said today it has agreed to a pair of acquisitions designed to create a diagnostics powerhouse across multiple cancers.

In the larger acquisition, Exact Sciences said it agreed to acquire blood-based diagnostics developer Thrive Earlier Detection for up to $2.15 billion in cash and stock. Exact Sciences also said it completed a $410 million cash acquisition of Base Genomics, adding Base’s DNA methylation analysis technology, designed to detect cancer at its earliest stages.

Image: Exact Sciences has announced a pair of acquisitions totaling up to $2.5+ billion intended to broaden its cancer diagnostics technology and test offerings. The company has agreed to acquire blood-based diagnostics developer Thrive Earlier Detection for up to $2.15 billion in cash and stock, and has completed its $410 million cash purchase of Base Genomics, adding Base’s DNA methylation analysis technology. (Exact Sciences) 

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Received coveted FDA Breakthrough Device designation for its NGS test for early detection of hepatocellular carcinoma

Rockville, Md. — Citing proximity to leading U.S. regulators and researchers, fast-growing precision oncology company, Genetron Health Inc. (Genetron), is moving its U.S. headquarters to Montgomery County, Maryland from North Carolina’s Research Triangle. The China-based company is relocating to a 6,000 SF hybrid space for Research & Development and a state-of-the-art lab in Gaithersburg, Maryland for its planned rapid growth.

Genetron’s blood-based next generation sequencing (NGS) test has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA), designed for early detection of hepatocellular carcinoma due to chronic HBV infection and/or liver cirrhosis. Genetron believes they are one of the first China-based, cancer molecular diagnostic companies to receive this critical FDA designation.

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The Small Business Innovative Research (SBIR) program provides grant or contract funding to small businesses seeking to commercialize innovative technologies. With $3.2 billion allotted to SBIR each year, there are twelve different agencies that have set aside SBIR funding. One agency is Health and Human Services which provides funding through the National Institutes of Health (NIH). NIH has three grant funding proposal deadlines a year. The next deadline is January 5, 2021. On the NIH/SBIR website, NIH states that the electronic submission process for grants can take from six to eight weeks, so this is a reminder to start now. Below are five key tips to help small businesses in their NIH SBIR electronic submission process.

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Novavax Inc. (NASDAQ: NVAX) said Monday it received a crucial status for its Covid-19 vaccine candidate as the pandemic drags on and coronavirus cases once again soar across the country.

The Gaithersburg company has earned fast-track designation from the Food and Drug Administration for NVX-CoV2373, a coronavirus vaccine candidate in late-stage development. It means the biotech can submit parts of its application on a rolling basis for a speedier review by the agency, and gives Novavax more direct and frequent access to the FDA.

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Novavax (NASDAQ:NVAX) announced on Wednesday that it has reached an agreement to provide the Australian government with 40 million doses of its COVID-19 vaccine candidate, NVX-CoV2373, if it earns approval from health regulators. Two early clinical trials of the vaccine candidate were run in Australia, and so far, the results have been positive.

The small biotech has had notable success at finding governmental buyers for its coronavirus vaccine: Novavax has signed direct supply deals with the United States, the United Kingdom, and Canada, and through its distribution partnerships has arranged to supply NVX-CoV2373 to Japan, India, and South Korea as well.

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The rapid availability of effective medical countermeasures against chemical exposures, from either accidents or chemical weapons attack, is critical in the treatment of their acute health effects following exposures.

The ReDIRECT Program is a new initiative from the Biomedical Advanced Research and Development Authority (BARDA) which aims to identify existing, commonly available therapeutics that can be used to save lives during a chemical emergency.

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Keeping kids safe at home is more important than ever – including safely storing medicines. Especially, as many families are living a new normal with children spending more time at home due to the pandemic.

Every hour in the United States, 5 children under age 6 are rushed to emergency departments for medication poisonings, many due to unsafe storage practices. There has been a 142% increase in prescribed medications over the past two decades. At the same time, an aging population and drastic increase in three-generation households, kids living with their parents and grandparents, are likely contributing to approximately 200,000 children visiting emergency departments each year due to adverse drug events.

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Biopharma and Life Science companies in the BioHealth Capital Region are known for their work with cutting edge technologies such as gene and cell therapies. Those strengths were on display at the 6th annual BioHealth Capital Region Forum.

The Strengths of our Region: Cutting Edge Therapies panel, which was moderated by Mark Cobbold, vice president of Discovery in Early Oncology at AstraZeneca, brought together leaders from three other companies to discuss their disruptive pipelines, the strength of the region and challenges brought by the COVID-19 pandemic. Cobbold touted the work performed by the three companies joining him on the panel, Cartesian Therapeutics, Adaptive Phage Therapeutics, and Ziel Bio. Pointing to the work being done by those three companies and AstraZeneca, Cobbold said they are representative of why the BioHealth Capital Region has become one of the most successful BioHubs in the United States.

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Johns Hopkins University launched its popular COVID-19 map on Jan. 22 — just 2 days after the first person in the United States was diagnosed with the novel coronavirus.

Exactly 8 months later, Healio and others cited the university’s COVID-19 dashboard on Sept. 22 when reporting that the U.S. had surpassed 200,000 deaths from COVID-19.

Image: https://www.healio.com

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“Somewhere past the pandemic” celebrates the 30-year partnership between The National Institutes of Health and The Children’s Inn in caring for the children and young adults who participate in clinical research to help make new treatments and cures possible. Thank you, NIH Director Dr. Francis Collins, for recognizing this milestone with an original song! #INNitfor30

Image: https://www.linkedin.com – From Video

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If you’ve ever kept track of your steps or the quality of your sleep, you’re familiar with wearable sensor technology apps. It’s a big deal in the fitness and wellness space, but did you know it could help older adults remain independent as they age?

In 2007, Ashkan Vaziri, Ph.D.and a few friends started a company called BioSensics to execute their vision for technology to help older adults age in place. More than a decade later, the company’s success — spurred in part by small business funding from the National Institute on Aging (NIA) at the National Institutes of Health — has led to a partial acquisition by electronics retailer Best Buy and to a continuing pipeline of innovative research projects.

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Over the past nine months, more than $7 billion in federal money has poured into the BioHealth Capital Region in support of therapies, diagnostics, and vaccines against COVID-19. In that short time, the region has shown its importance in halting the spread of the ongoing pandemic.

At the 6th Annual BioHealth Capital Region Forum, COVID-19 was a central focus of attendees and panelists. One panel, Strength of Our Region: Combating Infectious Diseases, included representatives from four companies in the region that provided an overview of the region’s role in combating the novel coronavirus as well as other infectious threats. Company representatives from Novavax, Emergent BioSolutions, BioFactura, and Aperiomics pointed to the work conducted by their organizations in COVID, as well as other infectious diseases, including Ebola, influenza, RSV, and SARS. The panel was moderated by Karen Smith, chief medical officer of Emergent BioSolutions, who said she was struck early on in the pandemic that companies in the BioHealth Capital region battling the pandemic are “all in the same storm, just in slightly different boats.” She said they are all trying to figure out a solution to this pandemic but in different manners due to their areas of expertise.

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The Glocal Innovation Life Sciences Meet-Up is run by the UK/Europe based #coffeebuddies online Thought-Leadership community. This is headed by Prof Tony Sedgwick and Graham Combe, and has an Agile Leaders Advisory Board of 18 life science innovation leaders and investors.

This Meet-Up has been inspired by huge advances in technology that allow us to connect, engage, inspire and entertain life science professionals from around the world. There are no boundaries for our abilities to connect and network with other global Thought-Leaders. We started with connecting our #coffeebuddies community with networks in Australia and NZ which is a phenomenal success. This event is the first in the series where we connect with the East Coast of the Americas.

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MADISON, Wis. and CAMBRIDGE, Mass., Oct. 27, 2020 /PRNewswire/ — Exact Sciences Corp. (Nasdaq: EXAS) and Thrive Earlier Detection Corp. (“Thrive”), a healthcare company dedicated to incorporating earlier cancer detection into routine medical care, today announced they have entered into a definitive agreement under which Exact Sciences will acquire Thrive for cash and stock consideration of up to $2.15 billion. The transaction was unanimously approved by both companies’ Boards of Directors and is anticipated to close during the first quarter of 2021, subject to regulatory approval and the satisfaction of other conditions.

Combining Thrive’s pioneering early-stage screening test, CancerSEEK, with Exact Sciences’ best-in-class scientific platform, clinical organization, and commercial infrastructure will establish Exact Sciences as a leading competitor in blood-based, multi-cancer screening. Thrive, with an early version of CancerSEEK, has conducted a first-of-its-kind 10,000-patient, prospective, interventional study in a real-world clinical setting. In this landmark study, using its mutation and protein biomarker approach, CancerSEEK achieved promising results detecting 10 different types of cancer, including seven with no recommended screening guidelines, with very few false positives. Bringing together highly complementary scientific approaches and the strengths of both organizations, Exact Sciences expects to develop a more accurate test and accelerate the widespread adoption of this potentially life-saving advancement.https://d-1827656436805240469.ampproject.net/2010132225002/frame.htmlAd

Image: https://biobuzz.io

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GAITHERSBURG, Md., Nov. 02, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. (Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the expansion of its Maryland campus to accommodate the company’s rapid growth as it works to develop its candidate vaccine against COVID-19 and advance its influenza vaccine for global markets. Novavax has secured two additional properties in Gaithersburg, Maryland to support the Company’s immediate need for additional laboratory and office space for manufacturing, R&D and business operations.

The Company currently has a large pivotal Phase 3 trial underway in the UK with another slated to begin in the United States and Mexico in November, as well as several Phase 2 trials ongoing and in the planning phases around the globe. Novavax has also created a global production network to enable manufacturing and rapid distribution across the U.S., Asia and Europe if and when its COVID-19 vaccine is approved for use. The Company also reported positive Phase 3 data for its influenza vaccine candidate, NanoFlu, earlier this year. Novavax has received $2 billion in funding for its COVID-19 vaccine efforts, including up to $1.6 billion from the U.S. government to help address the global pandemic and up to $388 million from the Coalition for Epidemic Preparedness Innovations (CEPI).

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ROCKVILLE, Md., Oct. 27, 2020 /PRNewswire/ — REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced that it will receive a milestone payment of $80.0 million from Novartis AG based upon the achievement of $1.0 billion in cumulative net sales of Zolgensma. REGENXBIO expects to recognize this revenue in the third quarter of 2020.

“Zolgensma is a transformative, one-time gene therapy for the treatment of pediatric patients with SMA, a debilitating and potentially deadly disease, and the first approved gene therapy based on REGENXBIO’s NAV Technology. We believe that this achievement provides further validation of the broad potential of NAV Technology to improve the lives of patients in need,” said Kenneth T. Mills, President and Chief Executive Officer of REGENXBIO. “We are pleased to have contributed to a therapy that has impacted the lives of over 700 patients with SMA and their families around the world.”

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GAITHERSBURG, Md.–(BUSINESS WIRE)–Neuraly, Inc., a clinical stage biotechnology company pioneering disease-modifying agents for neurodegenerative disorders, today announced it has received clearance of an investigational new drug application (IND) to initiate a Phase 2B trial of NLY01 in patients with Alzheimer’s disease. NLY01 is also being evaluated in patients with Parkinson’s disease in a Phase 2 trial initiated in February 2020.

“Initiation of this Phase 2 study in Alzheimer’s disease represents an important milestone in the ongoing advancement of NLY01,” said Seulki Lee, Ph.D., President and Chief Executive Officer of Neuraly. “Alzheimer’s has proven to be a particularly challenging disease to address therapeutically. We believe that targeting neuroinflammation via this novel mechanism of action represents a compelling pathway with the potential to be a disease-modifying agent for both Alzheimer’s and Parkinson’s disease.”

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ROCKVILLE, Md., Nov. 02, 2020 (GLOBE NEWSWIRE) — Rexahn Pharmaceuticals, Inc. (NASDAQ:REXN) (“Rexahn”) announced today that at its special meeting of stockholders held on November 2, 2020, Rexahn’s stockholders approved all of the proposals presented, including: (i) the issuance of shares of Rexahn common stock pursuant to the Agreement and Plan of Merger and Reorganization, dated June 17, 2020, as amended, by and among Rexahn, Razor Merger Sub, Inc. and Ocuphire Pharma, Inc. (“Ocuphire”) and the change of control of Rexahn resulting from the merger; (ii) a reverse stock split of Rexahn common stock, at a ratio of one new share for every 3 to 5 shares outstanding, with such final ratio to be approved by Rexahn’s board of directors; (iii) changing the name of Rexahn from “Rexahn Pharmaceuticals, Inc.” to “Ocuphire Pharma, Inc.”; (iv) the adoption of the Ocuphire Pharma, Inc. 2020 Equity Incentive Plan; and (v) the issuance of shares of Rexahn common stock upon the exercise of warrants to be issued in the pre-merger financing and the issuance of additional shares of Rexahn common stock that may be issued following the closing of the pre-merger financing.

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ROCKVILLE, Md., Oct. 29, 2020 /PRNewswire/ — Emmes today announced that the Montgomery County Chamber of Commerce has selected Emmes as the recipient of its 2020 Corporate Achievement Award. Dr. Anne Lindblad, who recently retired as the company’s president and chief executive officer, accepted the award at a virtual event hosted by the chamber on October 29.

According to Lowell Yoder, chairman of the Montgomery County Chamber of Commerce and M&T Bank’s group vice president for the Greater Washington Market, “Over the years, Emmes has set high standards for financial performance, sound management, and sustained growth – while contributing significantly to our community along the way.”

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Through a partnership with NIH, D.C. virtual reality startup Floreo is expanding from autism spectrum disorder to attention deficit hyperactivity disorder.

Image: Floreo’s platform allows kids to practice skills such as pointing or eye contact, with a linked tablet for parents to follow along. COURTESY FLOREO

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Greater Baltimore is one of few regions ideally suited to pioneer the future of digital health, an industry that will revolutionize healthcare as we know it. Companies in Greater Baltimore benefit from a rich ecosystem of healthcare assets that collectively provide every component necessary for digital health innovation: transformative research, specialized business incubation, access to funding, a talented workforce, and easily-accessible local and federal clients. The growing list of successes among Greater Baltimore’s digital health companies and groundbreaking partnerships showcase tremendous potential for this industry to play a defining role in the Region and influence healthcare throughout the nation for decades to come. The pandemic has accelerated the development of digital health technologies.

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The U.S. Army will spend a combined $599 million to procure two leading COVID-19 candidates—AstraZeneca’s vaccine AZD1222, co-developed with the University of Oxford and a spinout company; and Eli Lilly’s neutralizing antibody bamlanivimab (LY-CoV555).

The U.S. Department of Defense (DoD) disclosed yesterday that the Army this week awarded firm-fixed-price contracts of $312.5 million with Lilly (W911QY-21-C-0016) on Tuesday, and more than $286.9 million with AstraZeneca (W15QKN-21-C-0003) on Wednesday. The contracts, awarded by U.S. Army Contracting Command, cover an unspecified quantity of bamlanivimab to be made at a Lilly production site in Indianapolis; and 200 million doses of AZD1222 to be produced at AstraZeneca sites in West Chester Township, OH, and Albuquerque, NM.

Image: Spc. Selena M. Castillo prepares to administer a flu vaccination on Fort Sill, Okla., Nov. 15, 2019. Spc. Castillo is a medic for 3rd Battalion, 2nd Air Defense Artillery Regiment, 31st Air Defense Artillery Brigade. The U.S. Army will spend a combined $599 million to procure two leading COVID-19 candidates—AstraZenca’s vaccine AZD1222, co-developed with the University of Oxford and a spinout company; and Eli Lilly’s neutralizing antibody bamlanivimab (LY-CoV555). (Photo By: Army Sgt. Amanda Hunt, U.S. Department of Defense)

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Fina Biosolutions has been issued European patent No. 3099800, Expression and Purification of CRM Proteins and Related Proteins, and Protein Domains. The patent covers expression of the conjugate vaccine carrier protein CRM197 in our E. coli strain engineered to have an oxidative cytoplasm. FinaBio markets the E. coli expressed CRM197 under the name EcoCRM®.

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WAKEFIELD, Mass. and FAIRFAX, Va., Oct. 30, 2020 (GLOBE NEWSWIRE) — Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, and George Mason University’s (Mason’s) National Center for Biodefense and Infectious Diseases (NCBID), today jointly announce completion of extensive laboratory testing supporting anti-SARS-CoV-2 activity of Brilacidin, a defensin-mimetic drug candidate, which is being developed as a potential COVID-19 treatment.

Research findings are being submitted for peer-review publication. A preprint, available for download at the link below, is in the process of being posted to bioRxiv.org.

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Sep 05, 2020 (IssueWire via COMTEX) — San Diego, Sep 5, 2020 (Issuewire.com) – Jaan Biotherapeutics (“JBT”), announced that it has been awarded a Small Business Innovation Research (SBIR) grant from the National Heart, Lung, and Blood Institute, part of the National Institutes of Health under Award Number R43HL154884. Under the Phase I grant, JBT intends to advance its lead cardiac muscle regeneration viral delivered drug, JBT-miR2 through preclinical testing in large animals. The first indication of JBT-miR2 is for the treatment of Ischemic Heart Disease (IHD), the single largest cause of death of both men and women in the Western World.

JBT-miR2 is a first in class viral delivered microRNA inhibitor that reprograms cardiac muscle cells to divide within the damaged heart, and repair the heart muscle after permanent heart muscle injury, for example following a heart attack.

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When all the votes are cast and counted in this year’s momentous November 3 election, the results will have deep and potentially long-lasting impacts on numerous areas of society, including science. President Donald Trump and his challenger, former vice president Joe Biden, have presented vastly different visions for handling crucial issues—ranging from the deadly coronavirus pandemic to the damaging impacts of climate change and immigration policies.

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Have you heard of a little thing called Covid-19? So has Big Pharma, and the race to develop a vaccine is on. It’s high-stakes geopolitical chess and every country and company involved badly wants to win, including Anglo-Swedish drugmaker AstraZeneca.

When Oxford’s Jenner Institute partnered with AstraZeneca on its vaccine candidate, ChAdOx1 nCoV-19, analysts scratched their heads. AstraZeneca is not a leader in vaccines, unlike its major UK competitor GlaxoSmithKline. It’s relatively small and has a tumultuous history. But if you look, the signs are there that AstraZeneca is building a blueprint to thrive as a 21st century pharma company.

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Three Emmes employees were among the co-authors of the recent report, “Safety and Immunogenicity of SARS-CoV-2 mRNA-1273 Vaccine in Older Adults.” The employees are Jim Albert, lead project manager; Dr. Mat Makowski, senior biostatistician; and Kaitlyn Cross, senior biostatistician.

In its role as the statistical and data collection and coordination center, Emmes managed development of the statistical analysis plan and performed all data analysis.

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ANNAPOLIS (WJZ) — A NIH initiative will fund a new Johns Hopkins center to research COVID-19 immunity as the pandemic continues to affect people of all ages.

The five-year grant will fund more than $2 million a year to the new Johns Hopkins Excellence in Pathogen to support the studies, to start immediately, the immune elements that determine whether people get mild or severe coronavirus after being exposed.

Image: https://baltimore.cbslocal.com – From Video

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Leverage the only verified source of angel investment data to anticipate future trends with the Angel Funders Report 2020!

The Angel Funders Report 2020 is the only source of verified data provided directly by active angel investing groups. The report is based on information collected from a variety of ACA member groups, including some of the most active investing communities. It analyzes angel capital investments made during 2019, and features profiles and insights from leading angel investors and startup company executives. The Angel Funders Report 2020 also includes initial perspectives regarding the impact of the COVID-19 pandemic on the investing ecosystem.

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