Genetron Health Inc. Relocates U.S. HQ to Montgomery County, Maryland

By | News | No Comments

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.

The company is planning for exponential growth following clinical trials, with the goal of hiring 30 to 50 people within two years and continued expansion thereafter. Genetron will be seeking workers at the crossroads of health and biotech, including professionals with expertise in bioinformatics. Learn more here about the FDA designation and the success of their study to date.

“Montgomery County is historically the first place for human genomics,” said Sizhen Wang, Genetron’s co-founder and CEO. “The county offers great advantages to us, including proximity to the U.S. evaluating authority, the FDA. We also have a perfect opportunity here for collegial interconnection with hospitals, pharma and tech companies, as well as a great talent pool to draw from as we grow.”

The company’s Chief Scientific Officer, Hai Yan, and Chief Technology Officer, Yuchen Jiao, have a Maryland connection as well, with both having been Post-Doctoral Fellows at Johns Hopkins University.

“On behalf of the State of Maryland, we are thrilled to serve as the new U.S. headquarters home for Genetron Health Inc.,” said Maryland Commerce Secretary Kelly M. Schulz. “With a bustling biohealth and life sciences sector, Genetron will fit perfectly in Montgomery County, surrounded by some of the state’s most innovative medical companies and the top researchers from across the nation.”

“We’re so pleased that Genetron has chosen to join the growing list of international companies making their home here. This innovative company’s choice of Montgomery County for its global expansion further highlights our county’s strengths in cell and gene therapy, bioinformatics and access to a highly-educated workforce,” said Montgomery County Executive Marc Elrich.

Montgomery County has approved Genetron for a MOVE grant of $46,848 to assist with their relocation, and the company is working to obtain additional State incentives for its relocation. The Montgomery County Economic Development Corporation (MCEDC) worked with the company to provide introductions to partners, incentives and available space.

“We welcome Genetron Health as yet another international company to have chosen Montgomery County. More global companies are making their home in our diverse community with the right set of assets that will help them be successful,” said Benjamin H. Wu, MCEDC President and CEO. “We congratulate Genetron on their exciting FDA Breakthrough Device designation, which is expected to be a catalyst for their rapid expansion.”

Genetron Health is committed to providing a one-stop, multi-scenario genomic profiling solutions in areas including early cancer screening, diagnosis and monitoring, as well as biopharmaceutical services.


ABOUT MCEDC

The Montgomery County Economic Development Corporation (MCEDC) is the official public-private economic development organization representing Montgomery County, Maryland. Created in 2016, MCEDC is led by a Board of Directors of business executives. Its mission is to help businesses start, grow and relocate in Montgomery County by helping them gain access to top talent, business and market intelligence and prime locations. For more information, visit our website. Follow us on TwitterFacebook and LinkedIn.

ABOUT GENETRON HOLDINGS LIMITED

Genetron Holdings Limited (“Genetron Health” or the “Company”) is a leading precision oncology platform company based in China that specializes in cancer molecular profiling and harnesses advanced technologies in molecular biology and data science to transform cancer treatment. The company has more than 700 employees in China with two manufacturing facilities and five clinical laboratories. For more information, please visit ir.genetronhealth.com.

BioBuzz: Seeking Funding During a Pandemic: Panel Discusses Recent Trends in Life Science Capital Investment

By | BioBuzz, News | No Comments

COVID-19 has created significant challenges for the Venture Capital (VC) market and life science companies seeking funding during the pandemic. While the pandemic has undoubtedly added a new layer of risk to an inherently risky field, the fundamentals for what makes a company attractive to a VC have remained steady. However, the way deals get done has changed.

At the recent BioHealth Capital Region (BHCR) Forum, which was held virtually, a panel of life science and VC experts came together to discuss what they want to see from a potential partner before pulling the trigger to invest and how companies seeking funding during a pandemic can better market and position themselves with VCs.

The world of VC funding has always been grounded in strong networks, “warm” introductions, and personal relationships developed over dinners, conference meetings, and boardroom table discussions.

All of this changed in the age of COVID-19. Life science companies seeking funding during a pandemic and VCs searching for the right organization to invest in have had to shift quickly to virtual interactions. Initially, this shift caused significant disruption for an industry rooted in trust built through face-to-face relationship building.

Arti Santhanam, the Executive Director of TEDCO’s Maryland Innovation Initiative (MII) moderated an all-star panel that explored seeking funding during a pandemic. The panel included Benjamin Britt, General Partner of Route 66 Ventures; David Hilbert, President and CEO of Arcellx, a clinical-stage cell therapy company; Sara Nayeem, Partner at New Enterprise Associates (NEA); and Bill Snider, Partner at BroadOak Capital Partners, LLC.

Click here to read more via BioBuzz

BioBuzz: Top Biopharma Talent Acquisition Experts Share Strategies for Hiring and Retaining Employees in 2020

By | BioBuzz, News | No Comments

The biotech industry continues to grow rapidly across the nation, especially in the BHCR. The region’s strategy for hiring and retaining employees is a key driver of the BHCR’s steady, sustained growth. The workforce development strategy and infrastructure that supplies the skilled and experienced workers needed for innovation and expansion is a key factor as well.

The region has always been known as a leading vaccine development hub, but in recent years personalized medicine, including cell and gene therapybacteriophage therapy, and a booming advanced biomanufacturing cluster has added to the region’s already strong and diverse biopharma portfolio. The BHCR is evolving and so are its talent needs, which begs the question, what strategic and tactical adjustments need to be made to ensure the BHCR talent pipeline can meet the region’s future workforce requirements?

A 2020 BHCR Forum virtual panel session, hosted by BioHealth Innovation’s (BHI) Managing Director of Economic Development Judy Costello, took a deep dive into the subject. The “Growing and Retaining Your Workforce” breakout session included panelists Diana Elias, Director of HR, ABL Inc.Ellen MacMahon, VP Human Resources Global Operations/IT at AstraZeneca; and Ed Radwinsky, Head of People Operations at RoosterBio, Inc.

Here some of the highlights from the lively and insightful panel discussion on hiring and retaining employees in 2020:

Click here to read more via BioBuzz

BioBuzz: BioHealth Capital Region Showcases Strengths of Cutting Edge Therapies

By | BioBuzz, News | No Comments

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.

“You’re really pushing the boundaries of what’s possible in treating patients,” Cobbold told the panelists.

Click here to read more via BioBuzz

Neuraly Receives FDA Clearance of Investigational New Drug Application to Initiate Phase 2B Trial of NLY01 for Patients with Alzheimer’s Disease

By | News | No Comments

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.”

NLY01 is a long-acting, glucagon-like peptide 1 receptor (GLP-1R) agonist. In a paper published in Nature Medicine, it was shown that NLY01 binds to upregulated GLP-1R, blocking pathological activation of microglia in animal models of neurodegenerative diseases. The study also showed that by inhibiting glial activation and subsequent pro-inflammatory cytokines, NLY01 prevented neuronal cell death and slowed the motor function decline that was observed in the absence of treatment.

“Our internal studies have confirmed the same mechanism of action underlies the neuroinflammation observed in animal models of Alzheimer’s and Parkinson’s disease,” added Viktor Roschke, Ph.D., Chief Scientific Officer of Neuraly. “These findings reinforce our belief in the potential of NLY01 in treating both of these diseases.”

The Phase 2B Alzheimer’s study is a multicenter, randomized, double-blinded, placebo-controlled trial that is expected to enroll more than 500 patients at more than 100 sites in the US, Canada and Europe. The study is designed to assess the safety, tolerability and efficacy of NLY01 in subjects with mild cognitive impairment due to Alzheimer’s disease. Topline results are expected by Q4, 2023.

About NLY01

NLY01 is a proprietary long-acting analogue of exendin-4, a glucagon-like peptide-1 receptor (GLP-1R) agonist. NLY01 penetrates the blood-brain barrier (BBB) in animal models and its receptor (GLP-1R) is highly expressed on reactive glial cells. NLY01 is being developed as a disease-modifying agent for neurodegenerative disorders including Parkinson’s and Alzheimer’s disease. In clinically relevant animal models, NLY01 was found to prevent neuronal cell death by inhibition of microglial activation and formation of A1 neurotoxic astroglial cells. Treatment with NLY01 slowed disease progression, improved motor and cognitive functions and extended the lifespan in mice with Parkinson’s and Alzheimer’s disease.

About Neuraly, Inc.

Neuraly is a clinical-stage biotechnology company whose mission is to translate scientific discoveries in neurology into new drugs that can radically improve and prolong the lives of people suffering from the devastating consequences of diseases such as Parkinson’s disease (PD), Alzheimer’s disease (AD) and other neurodegenerative disorders. The company is leveraging a deep understanding of the role of glia biology in neuroinflammation and neuroprotection in advancing a risk-diversified product portfolio for PD and AD. Neuraly is a subsidiary of D&D Pharmatech, a clinical stage global biotech company that funds the development of revolutionary medicines through disease-specific subsidiary companies founded and guided by top-tier medical research faculty and biotechnology veterans. Please visit http://www.ddpharmatech.com/

Contacts

Media Contact:
Christine Quern
CBQ Communications
cq@christinequern.com
617.650.8497

Novavax Announces Facility Expansion to Support Global Vaccine Development

By | News | No Comments
  • Expands campus with two properties to support vaccine research and development, manufacturing, business operations

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).

“The expansion of our physical footprint reflects Novavax’ significant growth as we work to both rapidly deliver a COVID-19 vaccine and progress NanoFlu, our influenza vaccine candidate, for regulatory submission and potential commercialization,” said Stanley C. Erck, President and CEO, Novavax. “We appreciate the support, partnership and speed of the Maryland Department of Commerce, Montgomery County, and the City of Gaithersburg, which have enabled the expansion of our operations, enhanced our ability to retain and attract highly skilled employees, and reinforced our longstanding commitment to the biotechnology sector in Maryland.”

Real Estate Transactions

Novavax entered into a 15-year lease for approximately 122,000 square feet located at 700 Quince Orchard Road, Gaithersburg, to be used for manufacturing, research and development, and offices. The Company will immediately invest in the buildout of the site to prepare for use beginning in early 2021

In addition, the Company’s affiliate, 14 Firstfield Holdings, LLC, purchased a 9.7-acre parcel of land at 14 Firstfield Road, Gaithersburg, that the Company plans to develop in the future to accommodate growth of the Company.

Novavax currently occupies approximately 79,000 square feet of office and laboratory space in Gaithersburg.

Government Support and Incentives

The Maryland Department of Commerce, Montgomery County, and the City of Gaithersburg are providing a combination of incentives, including conditional loans, grants and tax credits to enable the expansion. Additional terms were not disclosed.

About NVX-CoV2373
NVX-CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax’ patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and cannot replicate, nor can it cause COVID-19. In preclinical trials, NVX-CoV2373 demonstrated induction of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In the Phase 1 portion of its Phase 1/2 clinical trial, NVX-CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. NVX-CoV2373 is also being evaluated in a Phase 3 trial in the UK and two ongoing Phase 2 studies that began in August; a Phase 2b trial in South Africa, and a Phase 1/2 continuation in the U.S. and Australia. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $388 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI).

About NanoFlu™

NanoFlu is a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine produced by Novavax in its SF9 insect cell baculovirus system. NanoFlu uses HA amino acid protein sequences that are the same as the recommended wild-type circulating virus HA sequences. NanoFlu contains Novavax’ patented saponin-based MatrixM adjuvant.

About Novavax
Novavax, Inc. (Nasdaq: NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undertaking clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax’ proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

Novavax Forward-Looking Statements

Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading “Risk Factors” in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 10-Q for the period ended June 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

 

Contacts:
Investors
Erika Trahan ir@novavax.com
240-268-2022

Media
Brandzone/KOGS Communication
Edna Kaplan kaplan@kogspr.com
617-974-8659

BioBuzz: Strengths of Our Region: Combating Infectious Diseases Forum Roundup

By | BioBuzz, News | No Comments

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.

“Our organizations are different, and the places we started are different,” she said.

Click here to read more via BioBuzz

REGENXBIO TO RECEIVE $80.0 MILLION MILESTONE PAYMENT FROM NOVARTIS AG

By | News | No Comments

– Milestone payment based on achievement of $1.0 billion in cumulative net sales of Zolgensma® –
 

– Zolgensma is the first gene therapy based on REGENXBIO’s NAV® Technology Platform approved by the FDA and other regulatory authorities –

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.”

Zolgensma uses REGENXBIO’s proprietary NAV AAV9 vector and was designed and developed by AveXis, Inc., now known as Novartis Gene Therapies. In May 2019, Zolgensma was granted U.S. Food and Drug Administration (FDA) approval for the treatment of spinal muscular atrophy (SMA) in pediatric patients who are less than two years of age, and has since been approved in Europe, Japan and other countries. REGENXBIO continues to receive tiered royalties on sales of Zolgensma. Since FDA approval in 2019, REGENXBIO has earned more than $140.0 million in revenues from royalties and commercial milestone payments related to Zolgensma through the third quarter of 2020.

About REGENXBIO Inc.

REGENXBIO is a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy. REGENXBIO’s NAV Technology Platform, a proprietary adeno-associated virus (AAV) gene delivery platform, consists of exclusive rights to more than 100 novel AAV vectors, including AAV7, AAV8, AAV9 and AAVrh10. REGENXBIO and its third-party NAV Technology Platform Licensees are applying the NAV Technology Platform in the development of a broad pipeline of candidates in multiple therapeutic areas.

Forward-Looking Statements

This press release includes “forward-looking statements,” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements express a belief, expectation or intention and are generally accompanied by words that convey projected future events or outcomes such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “plan,” “potential,” “predict,” “seek,” “should,” “would” or by variations of such words or by similar expressions. The forward-looking statements include statements relating to, among other things, REGENXBIO’s cash flow. REGENXBIO has based these forward-looking statements on its current expectations and assumptions and analyses made by REGENXBIO in light of its experience and its perception of historical trends, current conditions and expected future developments, as well as other factors REGENXBIO believes are appropriate under the circumstances. However, whether actual results and developments will conform with REGENXBIO’s expectations and predictions is subject to a number of risks and uncertainties, including the timing of enrollment, commencement and completion and the success of clinical trials conducted by REGENXBIO, its licensees and its partners, the timing of commencement and completion and the success of preclinical studies conducted by REGENXBIO and its development partners, the timely development and launch of new products, the ability to obtain and maintain regulatory approval of product candidates, the ability to obtain and maintain intellectual property protection for product candidates and technology, trends and challenges in the business and markets in which REGENXBIO operates, the size and growth of potential markets for product candidates and the ability to serve those markets, the rate and degree of acceptance of product candidates, the impact of the COVID-19 pandemic or similar public health crises on REGENXBIO’s business, and other factors, many of which are beyond the control of REGENXBIO. Refer to the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of REGENXBIO’s Annual Report on Form 10-K for the year ended December 31, 2019, and comparable “risk factors” sections of REGENXBIO’s Quarterly Reports on Form 10-Q and other filings, which have been filed with the U.S. Securities and Exchange Commission (SEC) and are available on the SEC’s website at www.sec.gov. All of the forward-looking statements made in this press release are expressly qualified by the cautionary statements contained or referred to herein. The actual results or developments anticipated may not be realized or, even if substantially realized, they may not have the expected consequences to or effects on REGENXBIO or its businesses or operations. Such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking statements. Readers are cautioned not to rely too heavily on the forward-looking statements contained in this press release. These forward-looking statements speak only as of the date of this press release. REGENXBIO does not undertake any obligation, and specifically declines any obligation, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Zolgensma® is a registered trademark of Novartis Gene Therapies. All other trademarks referenced herein are registered trademarks of REGENXBIO.

Contacts:

Tricia Truehart
Investor Relations and Corporate Communications
347-926-7709
ttruehart@regenxbio.com

Investors:
Eleanor Barisser, 212-600-1902
eleanor@argotpartners.com

Media:
David Rosen, 212-600-1902
david.rosen@argotpartners.com

(PRNewsfoto/REGENXBIO Inc.)

Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/regenxbio-to-receive-80-0-million-milestone-payment-from-novartis-ag-301160023.html

SOURCE REGENXBIO Inc.

5 Questions with John Newby, CEO, Virginia Bio

By | BioTalk, News | No Comments

“5 Questions With…” is a weekly BioBuzz series where we reach out to interesting people in the BioHealth Capital Region to share a little about themselves, their work, and maybe something completely unrelated. This edition features 5 Questions John Newby, CEO, Virginia Bio.

John Newby is the CEO at Virginia Bio, the statewide non-profit trade association for the life science industry. Approximately 300 companies spanning biopharmaceuticals, medical devices, med tech, diagnostics, digital health, bioinformatics, agriculture, and industrial bio and related fields are based in Virginia, mainly clustered around research universities and medical institutions. Virginia Bio is the sole state affiliate and works closely with key national industry organizations BIO, AdvaMed, MDMA, PhRMA and We Work for Health.

Newby was formerly the Commissioner of the Virginia Department of Veterans Services (VDVS), where he led an 850-member Agency located across 50 Virginia locations, delivering employment, education, benefits, behavioral health, and long term health care services to Virginia’s Reservists, Guardsmen, transitioning service members and 725,000 veterans. Prior to leading VDVS Newby practiced corporate, intellectual property, and Hatch-Waxman biopharmaceutical law at international law firms in Richmond and Washington DC, and at a multinational company. Newby previously commanded an Air Force special operations unit supporting the U.S. Army’s 3rd and 7th Special Forces Groups (Airborne), and served in Iraq as an aviator aboard the Boeing B-1B Lancer strategic bomber. Newby received a B.S. from the United States Air Force Academy, with Military Distinction, and his J.D. from the University of Virginia School of Law.

1. You recently transitioned into the BioHealth world after various roles with the Commonwealth of Virginia. Share with us a little about your career path.

To be honest, I probably do not follow what most define as a “career path”; I probably more accurately adhere to a “career philosophy.”  Coming from a military family and being a veteran myself, I have always held a philosophy of and desire for public service, doing things that focus on a larger community and a mission worth supporting.  After leaving the military I went to law school with the same thought in mind: get some skills that would allow one to serve in innumerable capacities.  And glad I did!  It allowed me to practice in the biopharmaceutical space, do pro bono work for veterans filing claims for disability compensation, and led me to an opportunity to run Virginia’s Department of Veterans Services.  And, ultimately, brought me back to the life science community with a wonderful opportunity to lead the Virginia Biotechnology Association, our state’s premier organization supporting all aspects of life science.

2. You’ve been with Virginia Bio for a little over a year. Tell us about your role.

Our mission at Virginia Bio is to promote innovation and growth through strengthened networks, advocacy, capital investment, talent development, and retention, and advance the next generation of leaders. We are a member-driven organization comprising over 270 organizations representing all facets of biotechnology: MedTech, diagnostics, therapeutics and vaccines; research institutions; and investors. My role is simple: to support our Board and lead a team of professionals to execute that mission. I am primarily focused on network building within the BioHealth Capital Region, attracting capital to Virginia, and ensuring that our state policymakers appreciate and support our industry as we continue to innovate and save lives.

3. The industry in Virginia goes beyond just NoVa. What are some of your favorite stories from companies in the Commonwealth that most of the BioHealth Capital Region wouldn’t know about?

Yes, the industry goes well beyond one region!  For instance, the Richmond area is home to the 34-acre VA Bio+Tech Park, occupied by 70 companies, research institutes, and state/federal laboratories.  The Richmond region also has several major life science employers, such as Phlow Corporation (recent recipient of a $354 million BARDA grant to domestically produce certain API’s), Kaleo, FUJIFILM Wako Chemicals, and GlaxoSmithKlein Consumer Healthcare.

The Charlottesville area has an industry cluster of 179 firms and organizations in biotech and medical devices related industries that employ 3,033 workers, many with connection to the University of Virginia. Over the past 10 years, the region has seen nine major exits from companies within the biotech industry, including the 2018 acquisition of Type Zero by Dexcom and the Jazz Pharmaceutical’s 2019 $315m acquisition of Cavion.

Blacksburg is home to The Virginia Tech Corporate Research Center (VTCRC) situated on 230-acres with 180 resident research, technology, and support companies. Roanoke’ Fralin Biomedical Research Institute, adjacent to Carilion Clinic, has state-of-the-art facilities for molecular medicine, imaging, high-capacity data handling, and human performance analysis. In addition, the Virginia-Maryland School of Veterinary Medicine is located in Blacksburg, VA.

Hampton Roads, home to 510 life science companies that employ 8,787 workers, has experienced recent investments in a life science sector. Three research parks supporting expansion of the life sciences in the region include the Innovation Research Park @ Old Dominion University, the Tech Center Research Park in Newport News, and the future VABeachBio Research Park

And, of course, Northern Virginia itself, which has made significant investments to grow the life science sector to include the 9,000 sqft. Science accelerator and the 30,000 sq. ft. Northern Virginia BioScience Center expected to open in November 2021. The region is home to George Mason University, George Washington University Loudoun Campus, Northern Virginia Community College, HHMI Janelia Research Campus, and Inova, Sentara, Novant Health System, and several life sciences companies. Northern Virginia is home to 1,517 life science companies that employ 30,555 workers including Ceres Nanoscience, Serpin Pharma, Vibrent, ATCC, and Aperiomics.

4. What do you say to companies looking to startup or relocate to the BioHealth Capital Region about the benefits of Virginia?

Three things: quality of life, talent pool, and bioscience assets.  Regarding the quality of life: many biotechnology companies, responding to economic and employee pressures, are seeking opportunities in more economically viable and hospitable places.  Look no further than Virginia!  Our real estate and lab spaces are ½ or less the price found in Boston and California, and our cost of living and quality of life are immeasurably better!  Our talent pipeline is primed by our major research universities at Virginia Tech, University of Virginia, Virginia Commonwealth University, and others.  And regarding our assets: while other bioscience clusters are pricing new companies out of the market and are running out of lab space, Virginia is growing, with nearly 50,000 new sq. ft. of lab space coming online in the next two years.  And in addition to a robust and supportive bioscience ecosystem, another Virginia asset is the geographic proximity to our industry’s key federal agencies including the NIH, FDA, BARDA, DARPA, and NSF.  Come join us!

5. If you weren’t in this line of work, what career would you want to pursue?

Any “career” (such as it may be) that will enable me to lead a team, brought together to achieve a mission that benefits society.  Leadership is a largely underappreciated asset until tragedy strikes or major change needs to be accomplished in a short amount of time.  It is often the difference between a successful organization and one that is, at best, ineffectual and, at worst, detrimental to the community.  So, I would be attracted to anything that allows me to team with people who are working towards something greater than themselves, like what we have here at Virginia Bio.

Thank you to John Newby for participating in the ‘5 Questions with BioBuzz’ series and stay tuned for more interviews with others from across the BioHealth Capital Region and beyond.

BrainScope Wins BioHealth Capital Region 5th Annual Crab Trap Competition

By | News | No Comments

– Winning company has FDA cleared device to rapidly and objectively assess brain injury at point of care.

ROCKVILLE, MARYLAND, October 26, 2020 – BrainScope, a medical neurotechnology company that is a pioneer in the use of A.I. and machine learning in the creation of biomarkers of brain injuries and disease was selected from five finalists as the company with the most commercial potential at the 5th Annual BioHealth Capital Region Crab Trap Competition. The Bethesda, Maryland based company is helping hospital Emergency Departments (EDs) objectively triage the almost five million patients that present each year with suspected mild traumatic brain injuries. BrainScope’s FDA-cleared decision support tool provides a rapid and accurate assessment of the likelihood of a brain bleed and a concussion, at the point of care.

BrainScope’s outstanding 99% sensitivity to a head CT scan is performed without the use of radiation, in a fraction of the time, and can improve ED efficiency and increase patient satisfaction. Clinical studies have demonstrated that when BrainScope is used in triage, hospitals can reduce the number of patients being sent for head CT by about a third. According to BrainScope CEO Susan Hertzberg, “We are honored to have been chosen from this exceptional group of companies and are very excited by the early reception we are receiving from the emergency medical community.  Now more than ever in this COVID-19 world, emergency departments need to have fast, accurate, objective tools to rapidly assess patient status and needed care.”

In addition to BrainScope, four other finalists – CARRTECH (Frederick),  Creative Bio-Peptides (Rockville),  innara Health (MO recognized as NCC-PDI medtech innovator), and KaloCyte (Baltimore) presented their innovative technologies related to safe delivery of medications from glass ampules, neurodegenerative and chronic pain therapies, neonatal feeding technologies, and dried bio-inspired artificial red blood cells.

Judging this year’s virtual pitch competition were Sally Allain, Head, JLABS @ Washington, DC, Christian Barrow, Executive Director, Life Sciences Banking, JP Morgan, Conley Jones, Senior Associate, Science & Technology, Alexandria Venture Investments, and Charles Andres, PhD, RAC, Associate, Wilson Sonsini Goodrich,  Rosati Andrea Alms, MS, MBA, Fund Manager, BioHealth Capital Fund.  Rich Bendis, President & CEO, BioHealth Innovation, Inc. moderated the event and  stated “The judges made clear this was a particularly competitive group of finalists. We congratulate all the presenters on their progress to date and wish them great success in the future.”

BrainScope joins a group of prior winners all of whom have advanced their technologies and and raised funds since they presented at Crab Trap: Floreo (2019), Galen Robotics (2018), LifeSprout (2017) and Sonavex (2016).

2020 BioHealth Capital Region Pitch
A replay of the 5th Annual Crab Trap presentation can be viewed here.

Founded by BioHealth Innovation, Inc. (BHI) and MedImmune (now AstraZeneca) in 2016, the BioHealth Capital Region Crab Trap annual pitch competition focuses on highlighting the region’s innovative companies working in biohealth.

About the BioHealth Capital Region

The BioHealth Capital Region, comprised of Maryland, Virginia, and Washington, DC is the nation’s 4th largest biohealth cluster. The region encompasses more than 1800 life sciences companies, over 70 federal labs and world-class academic and research institutions. http://www.biohealthcapital.com/

About BrainScope

BrainScope is a medical neurotechnology company that is improving brain health by providing objective, diagnostic insights that enable better patient care. BrainScope is leading the way in the rapid and objective assessment of brain-related conditions, starting with mild traumatic brain injury (mTBI), utilizing multiple integrated assessment capabilities, artificial intelligence (AI), and digitization. The company’s technology supports the American College of Emergency Physicians (ACEP) Choosing Wisely® campaign to avoid CT scans of the head in emergency department patients with minor head injury. BrainScope’s innovative EEG-based, AI-driven platform empowers physicians to quickly make accurate head injury assessments, addressing the full spectrum of traumatic brain injuries from structural (brain bleed) to functional (concussion) injuries, providing for the first time a full picture of the injury, and doing so in less time and without radiation.

 

###

Media contacts:
Richard Bendis
Phone: 301-637-6439, e-mail: rbendis@biohealthinnovation.org

Join our Mailing List