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BHI Weekly News Archives

506th Edition, May 3rd, 2022

By May 12, 2022No Comments





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May 3, 2022

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Maryland Commerce Secretary Mike Gill Guests on BioTalk with Rich Bendis Podcast

Mike Gill, Maryland Commerce Secretary, visits BioTalk to discuss Life Sciences in the State, growing the economy, and how we can continue building on our successes.

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Secretary Mike Gill is a business leader with four decades of experience as an entrepreneur, technology executive, investment banker, and public servant. He was tapped by Governor Larry Hogan in 2014 to lead the Maryland Department of Commerce as its first-ever Secretary and was asked by the Governor to again lead the Department in December 2021.

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Vita Therapeutics relocates to University of Maryland Biopark

From its new headquarters and lab space, the biotech company aims to generate state-of-the-art cellular therapeutics for the treatment of debilitating neuromuscular diseases and cancers

BALTIMORE, May 2, 2022 /PRNewswire/ — The University of Maryland (UM) BioPark announced today that Vita Therapeutics, a cell engineering company harnessing the power of genetics to develop cellular therapies to treat muscular dystrophies and solid tumors, has established offices and laboratory space within approximately 10,000 square feet of leased space in the BioPark. Vita Therapeutics will leverage the new space to bring together its 25+-person team under one roof for the first time with the goal of progressing its co-lead programs, VTA-100 and VTA-300. The company uses induced pluripotent stem cell (iPSC) technology to engineer specific cell types designed to replace those that are defective in patients.

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Rockville's Supernus Announces FDA Approval of Qelbree® for the Treatment of ADHD in Adults
  • First novel, nonstimulant option for adults with ADHD in 20 years
  • ADHD affects an estimated 10 million adults in the U.S.

ROCKVILLE, Md., April 29, 2022 (GLOBE NEWSWIRE) — Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, announced today that the U.S. Food and Drug Administration (FDA) approved an expanded indication for Qelbree (viloxazine extended-release capsules) for the treatment of attention deficit hyperactivity disorder (ADHD) in adult patients aged 18 and older. The FDA has now approved Qelbree for the treatment of ADHD in children (starting at age 6), adolescents and adults.

Approximately 16 million children, adolescents, and adults have ADHD in the U.S. While many children with ADHD outgrow it, up to 90% of those diagnosed with ADHD in childhood continue to have ADHD as adults.

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Kite’s Maryland CAR T-cell therapy site gets FDA go-ahead

Kite, a Gilead company, says the US Food and Drug Administration (FDA) has approved commercial production at the company's new CAR T-cell therapy manufacturing facility in Frederick, Maryland.

Image: https://www.biopharma-reporter.com

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How can your BioHealth business benefit from a review by BHI industry experts? Please register for our next Entrepreneur-In-Residence (EIR) day on May 18th and find out. To sign-up for any of the EIR dates in 2022, please follow this link.

These free 1:1 virtual sessions are an opportunity to discuss your company with experts in diagnostics, therapeutics, digital health and medical devices. If you’re a growth-stage biohealth company looking for unbiased advice on your pitch deck, commercialization strategy, evidence development or entrepreneurial challenges, our EIRs can help.

To sign-up for any of the EIR dates in 2022, please follow this link.

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6 life sciences leaders see Montgomery County as partner in success – Washington Business Journal

Home to nearly 18 federal agency headquarters, 36 federal labs, and more than 300 life science companies, it’s no surprise Maryland’s Montgomery County is a leader in the life sciences industry.

The six life sciences companies highlighted here consider Montgomery County critical to their success.

MaxCyte, Inc.

“The Montgomery County community has an expansive amount of experience and a perpetual abundance of innovative ideas based on excellent science,” says Doug Doerfler, CEO of MaxCyte, Inc. MaxCyte provides technologies to advance innovative cell-based research and next-generation cell therapeutics. The company’s Flow Electroporation® platform facilitates complex engineering of a wide variety of cells, currently focusing on immuno-oncology and gene editing.

Image: https://www.bizjournals.com

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Emmes and Casimir Announce Research About a Novel, Home-Based Assessment for Duchenne Muscular Dystrophy | Emmes

Emmes, a global, full-service Clinical Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced that Casimir’s research on the development of the Duchenne Video Assessment (DVA) scorecards was published in PLOS ONE.  Emmes acquired Casimir in March 2022, and the group is now part of Emmes’ Rare Disease Center, Orphan Reach™.

The DVA is a novel, home-based clinical outcome assessment that measures ease of movement among those with Duchenne muscular dystrophy (DMD) through identification of compensatory movement patterns.  Caregivers video record patients performing specific movement tasks at home using a secure mobile application.  The paper describes the development of the scorecards that DVA-trained physical therapists use to score the videos.

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Medcura Expands its Senior Leadership Team and Appoints Leading Neurosurgeon Dr. Kenneth Renkens as Chief Medical Officer

RIVERDALE, Md., April 26, 2022 /PRNewswire/ — Medcura, Inc., a commercial-stage medical device company, today announced the expansion of its senior management team to include Dr. Kenneth Renkens as its Chief Medical Officer. Dr. Renkens is a thought-leading neurosurgeon who co-founded the Indiana Spine Group and has been involved in the development and commercial success of numerous innovative products now widely used in operating rooms around the world.

Chosen for his deep expertise in neurosurgery and past involvement with numerous implantable surgical innovations, Dr. Renkens joins an experienced team with a demonstrated track record of execution in delivering groundbreaking hemostat innovations. The Medcura team is now narrowly focusing its attention on bringing more disruptive technology to the Operating Room (OR).

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Washington D.C. Mayor Bowser Announces $92 Million Initiative to Catalyze Health Innovation and Address Disparities

Thursday, April 28, 2022

The HOPE Initiative will utilize federal funds to create new lab space, technology advancement & new services

(Washington, DC) Today, Mayor Muriel Bowser and the Office of the Deputy Mayor for Planning and Economic Development (DMPED), announced the Helping Our People Endure (HOPE) initiative, which intends to invest $92 million in the life sciences, to catalyze health innovation and address disparities in the District of Columbia. The participants will be part of the District of Columbia's application to the U.S. Department of Treasury's Capital Project Fund.

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Virginia Based AMPEL BioSolutions' Machine Learning Breakthrough Predicts Drug Options for Inflammatory Skin Diseases

CHARLOTTESVILLE, Va., May 3, 2022 — AMPEL BioSolutions today announces a breakthrough in precision and personalized medicine that could revolutionize the way doctors treat inflammatory skin diseases, such as Lupus, Psoriasis, Atopic Dermatitis and Scleroderma. Revealed in the peer-reviewed journal Science Advances, the paper details AMPEL’s breakthrough machine learning approach to characterize disease activity from gene expression data obtained from patient skin biopsies. The lab test, only a concept for the last few years, is now ready for development for practical use. AMPEL's initial focus was Lupus, but the test can be used for many autoimmune or inflammatory skin diseases that affect more than 35 million Americans.

AMPEL's innovative machine learning approach, which is now ready to be developed as a decision support biomarker test, could greatly impact health care by allowing physicians to identify the cause of patient disease symptoms and select appropriate treatment more precisely.  AMPEL’s approach is sufficiently sensitive to detect changes in clinically uninvolved skin so that early intervention may prevent systemic flares and skin damage apparent in lesions.  The application of AMPEL’s machine learning approach could also assist pharmaceutical companies in drug development and clinical trials.

Patients with chronic skin diseases often suffer from unpredictable disease activity that impacts daily activities like work and family life. Since unpredictable symptoms often result in trips to the Emergency Room, the ability to predict worsening disease and systemic involvement with routine skin biopsies has important health care and health economics implications. 

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Life sciences partnerships key to fast-track products in Montgomery County, Maryland – Washington Business Journal

Biotechnology innovation is a team sport.

While we often credit the discovery of a promising new therapy to a single scientist or research team, turning that discovery into a viable product patients can access requires a vast network of players. There are manufacturing platforms capable of producing new cell and gene therapies, teams to support preclinical and clinical trials, real estate developers that offer cutting-edge laboratory space and experts across a wide range of fields who all contribute to bringing a product to market.

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How is Montgomery County built for bio? Get the answers from these life sciences execs (video) – Washington Business Journal

Montgomery County is well known for many transformative firsts in life sciences. First to sequence the human genome; first gene therapy for sickle cell, first cell therapy for COVID-19 — and that’s just the start.* Montgomery County is an epicenter for translating knowledge into life-changing treatment and cures, with gene and cell therapies representing some of the most promising advancements in human health.

Image: Being part of the industry that delivers building solutions to help scientists do their work is what drives Pat Larrabee, CEO of Facility Logix. – https://www.bizjournals.com

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Bringing biotech to market faster in Montgomery County, Maryland – Washington Business Journal

In biotechnology, speed matters.

Emerging technology has opened a new world of possibilities for treating — and potentially curing — diseases. Scientists are developing cell and gene therapies designed to help patients with cancer, heart disease, liver disease, Parkinson’s disease, Alzheimer’s and many other conditions. The faster they can get these therapies from the laboratory through clinical trials and into production, the sooner people will be able to benefit.

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Life Sciences | Virginia Economic Development Partnership

Top companies in the life sciences industry choose to locate in Virginia – and flourish here – because of the state’s top talent, advanced culture of innovation, outstanding logistical advantages, competitive costs, and top-ranked business climate. Virginia’s life sciences sector has gained significant momentum in recent years, with 20 life sciences industry projects announced in just the past three years, representing over 1,400 jobs and $1.2 billion in investment. Recent announcements include U.S. Pharmacopeia, AMPAC, Civica, Merck, GlaxoSmithKline (GSK), Bausch + Lomb, and Virginia-grown biotech firm Grenova.

Image: https://www.linkedin.com/

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The ARPA-H (Health) Headquarters: Where Will It Be, and Should I Care?

The medical science publication Stat just published an article about Congressional interest in the location of ARPA-H headquarters, the new $6 billion effort to fund high, risk-high reward health research and cures. We are about to witness a biotech version of the Amazon HQ2 competition, with states and jurisdictions across the country angling to land this headquarters facility.

It is great to see the national interest in housing ARPA-Headquarters, but this project should not distract jurisdictions from planning for the far more important and
numerous other opportunities emerging as Congress and the White House put the finishing touches on current and new programs and projects to fund applied science and health research programs. Both the science community and commercial real estate (CRE) industry should take notice.

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