RICHMOND, Va., Nov. 14, 2022 /PRNewswire/ -- BRAINBox Solutions today announced that the company has enrolled the 1,000th patient in the pivotal, HeadSMART II study of its concussion diagnostic and prognostic test, BRAINBox TBI. The multi-national, multi-site, trial is designed to support an application for regulatory clearance by the U.S. FDA.

"We are developing the BRAINBox TBI (Traumatic Brain Injury) test as the first objective test to aid in the diagnosis of concussion and to provide an assessment of the risk of post-concussive symptoms," said Donna Edmonds, BRAINBox Solutions' CEO. "We are now in the home stretch of this very important study for the field. We believe the test has great potential to change clinical practice in the diagnosis and management of concussion and will define for the first time, objective diagnostic criteria for this condition, termed Acute Traumatic Encephalopathy (ATE). As such, the trial has been rigorously designed in collaboration with leading experts in traumatic brain injury and emergency medicine. The study evaluates patients in multiple settings and includes state of the art expert adjudication panels."

GAITHERSBURG, Md., Nov. 14, 2022 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) announced today a research award by the U.S. Department of Defense (DoD) Congressionally Directed Medical Research Programs (CDMRP) to evaluate efficacy of the company’s single-dose chikungunya virus virus-like particle (CHIKV VLP) vaccine candidate. Emergent will begin the planning phase, the first of two phases, in collaboration with the Armed Forces Research Institute of Medical Sciences (AFRIMS) and academic partners, to enable a post-approval field efficacy study in areas with active chikungunya virus (CHIKV) transmission.

The University of Maryland Strategic Partnership: MPowering the State (MPower) has announced that it is establishing an Institute for Health Computing that will focus on artificial intelligence and advanced computing to further develop the field of precision medicine and improve health care for patients across the state.

The University of Maryland Strategic Partnership: MPowering the State (MPower) today announced a transformative partnership to establish the University of Maryland 3 - Institute for Health Computing (UM-3-IHC), which is being led by the University of Maryland, Baltimore (UMB) and the University of Maryland, College Park (UMCP), in collaboration with the University of Maryland Medical System (UMMS) and Montgomery County, Md. This new Institute will leverage recent advances in artificial intelligence (AI) and computing to create a premier learning health care system that evaluates both de-identified and secure digitized medical health data to diagnose, prevent and treat diseases in patients across the state of Maryland.

Image: Bruce Jarrell, MD, FACS

Montgomery County Executive Marc Elrich signed Thursday a multiagency agreement to launch a new higher education institute in North Bethesda dedicated to artificial intelligence in health care, with the goal of establishing a magnetic academic-industrial complex akin to what's envisioned for Northern Virginia's National Landing.

The budding collaboration — dubbed The University of Maryland 3 - Institute for Health Computing, or UM-3-IHC — involves Montgomery County, the University of Maryland campuses in Baltimore and College Park and the University of Maryland Medical System Corporation (UMMS), a hospital network. 

Image: https://www.bizjournals.com/

November 9, 2022 — Johnson & Johnson Innovation, together with Johnson & Johnson Office of Military and Veterans Affairs, announced that AmacaThera, Hawkeye Bio, Inc., Garwood Medical Devices, LLC, Immunophotonics, Limax Biosciences, and Nanochon have been selected as the awardees in the Innovations for Vets QuickFire Challenge: Lung Cancer & Physical Trauma.

The challenge invited innovators to submit potentially groundbreaking ideas that aim to directly address the unique healthcare needs of the military community.

When London-based artificial-intelligence (AI) company DeepMind unveiled predicted structures for some 220 million proteins earlier this year, the trove covered nearly every protein from known organisms in DNA databases. Now, another tech giant is filling in the ‘dark matter’ of the protein universe.

Researchers at Meta (formerly Facebook, headquartered in Menlo Park, California) have used AI to predict the structures of some 600 million proteins from bacteria, viruses and other microorganisms that haven’t been characterized.

Image: The ESM Metagenomic Atlas contains structural predictions for 617 million proteins.Credit: ESM Metagenomic Atlas (CC BY 4.0)

November 08, 2022 08:30 AM Eastern Standard Time

ROCKVILLE, Md.–(BUSINESS WIRE)–Immunomic Therapeutics, Inc. (ITI), a privately-held clinical-stage biotechnology company pioneering the development of LAMP-mediated nucleic acid-based immunotherapy, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to the ITI-3000 program for the treatment of patients with Merkel cell carcinoma. The company is currently enrolling a phase 1 study evaluating ITI-3000, a plasmid DNA (pDNA) vaccine targeting patients with Merkel cell carcinoma (MCC), a rare but aggressive form of skin cancer that is typically caused by the Merkel cell polyomavirus (MCPyV).

“The FDA’s decision to grant FTD underscores the potential for the ITI-3000 program to address a serious unmet need and serve as a meaningful therapeutic option for patients with Merkel cell carcinoma,” stated Dr. William Hearl, Chief Executive Officer of ITI. “We are committed to unlocking the full potential of ITI-3000 in patients with this aggressive form of skin cancer. We expect to report top-line data from our ongoing phase 1 trial of ITI-3000 in MCC patients next year and look forward to working closely with the FDA on a potential next phase clinical study design, while simultaneously continuing dialogue with possible partners.”

Catalio Capital Management, an investment firm with offices in Baltimore and New York City, this week announced the close of a new fund that already counts a Johns Hopkins University-borne cancer detection company and patient-monitoring software system in its portfolio.

According to Catalio executives, the $85 million Catalio Credit Opportunities Fund I partners with what a statement called “39 world-renowned serial scientist-entrepreneurs at top-tier academic institutions in the US and Europe in order to vet opportunities to fund founders.” The fund, also described as a “special situations fund,” targets small and mid-sized private companies.

Image: (L to R) Catalio Capital Management cofounders R. Jacob Vogelstein and George Petrocheilos. (Courtesy photo)

BALTIMORE, MARYLAND, UNITED STATES, November 8, 2022 /EINPresswire.com/ -- Linshom Medical was awarded a $2.4 Million Fasttrack SBIR grant from the National Institutes of Health (NIH), National Heart Lung and Blood Institute (NHLBI).

“This award further validates our technology for critical bedside respiratory monitoring and adds to the list of Linshom Medical’s achievements,” said Richard Hughen, CEO. “This award funds a clinical study to prove Linshom’s early detection capability of patient respiratory decline. It also funds the further miniaturization of our technology to reach more patients in more settings such as a nasal cannula and a wearable sensor for home monitoring.”

Lawrence A. Tabak, D.D.S., Ph.D., who is performing the duties of the National Institutes of Health director, has selected Joni L. Rutter, Ph.D., as director of NIH’s National Center for Advancing Translational Sciences (NCATS). Dr. Rutter has served as NCATS acting director since April 2021. She officially began her role as NCATS director on Nov. 6, 2022.

Image: NCATS Director Joni L. Rutter, Ph.D.

Researchers have identified shared genetic risk factors for systemic lupus erythematosus and coronary artery disease, according to data published in Cell Reports Medicine.

The findings may open the door for early testing for coronary artery disease risk in patients with lupus, the researchers wrote.

Under the SBIR and STTR Extension Act of 2022 (the Act), signed into law last month, the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs were extended through fiscal year 2025. These programs provide grants or contracts to small businesses to fund early-stage research and development. Over a dozen agencies participate in the SBIR or STTR programs, including the U.S. Department of Defense, the U.S. Department of Energy, and NASA. According to the Small Business Administration, more than 5,000 new awards, amounting to over $3 billion, are made each year under these programs. The complete list and link to each agency's website (including current opportunities) can be found here.

An Orange County-based startup, Innovation Lab, announced that it was awarded $30,000 in grant funding to help bring its “Move-D” mechanical elbow brace to market to help improve Activities of Daily Living (ADL) for pediatric ataxic cerebral palsy patients. The grant was awarded during the “Make Your Medical Device Pitch for Kids!” competition held during the 10th Annual Pediatric Device Innovation Symposium hosted by Children’s National Hospital on October 23, 2022.

Join this collaborative webinar between MedTech Color and the National Institutes of Health on November 8th 2022 at 2:30 PM ET. Attendees will learn about the NIH programs and initiatives relevant to diverse founders and entrepreneurs in the Medtech space including SBIR/STTR funding and related NIH programs for entrepreneurs. Hear from specific institutes and departments, such as the NIH Small business Education and Entrepreneurial Development (SEED), National Heart, Lung, and Blood Institute (NHLBI), and more, further describe their specific programs, have an open dialogue, and ask questions regarding best fit programs, resources and more!

MedTech Color aims to advance diversity, equity, inclusion, and belonging (DEIB) measures in the medical device industry for underrepresented ethnic minority groups. Their core objectives are: to increase the number of leaders of color who enter and stay in Medtech, add tangible value to the industry's ecosystem via thought-leadership and actionable initiatives, and build a strong, diverse network of mentors and sponsors who champion thought leadership and innovative clinical advancement.

To register for the event, visit https://bit.ly/3Fgrvk0.

HOUSTON – (Nov. 2, 2022) – The largest crowd in the history of the Global Consortium of Entrepreneurship Centers (GCEC) Conference gathered last week in Las Vegas to celebrate creativity and innovation in university-based entrepreneurship education.

The GCEC is made up of more than 250 leading university entrepreneurship programs working together not only to share best practices and develop programs and initiatives, but also to collaborate and help each other advance, strengthen and celebrate the role universities fulfill in educating the entrepreneurs of tomorrow. The Rice Alliance for Technology and Entrepreneurship at Rice University’s Jones Graduate School of Business in Houston is the global headquarters for the GCEC.

LEIDEN, The Netherlands, November 02, 2022 / B3C newswire / -- MIMETAS is the winner of the Dutch Innovation Award 2022. This award recognizes the company's considerable focus on innovation, contribution to the reduction of animal experimentation, leadership, organization, cooperation with partners, and market position.

Henk Volberda, chairman of the jury and professor of Strategy & Innovation at the University of Amsterdam: “MIMETAS is world-leading. Since its foundation in 2013, the company has grown considerably, with branches in Europe, the USA, and Asia. It can now count the largest pharmaceutical companies worldwide among its partners. With its miniaturized organs-on-a-chip, MIMETAS has found a promising approach to enable major advancements in the pharmaceutical industry.”

Stephen Squinto, Ph.D., Gaurav Gupta, M.D. and Anya Schiess join J.P. Morgan as Managing Partners

Industry luminaries to act as Strategic Advisors to support new team

NEW YORK, Nov. 1, 2022 /PRNewswire/ -- J.P. Morgan Asset Management today announced the launch of a new life sciences private equity team, Life Sciences Private Capital. The new team will invest in both early and growth stage healthcare companies across multiple strategies aligned to specific market opportunities, with a focus on novel therapeutics and technologies in several target areas including Genetic Medicine, Oncology, Neurodegenerative Disease, Rare Diseases, Autoimmunity, AI/ML platforms, Metabolic Diseases and Neuropsychology.

GAITHERSBURG, Md., Nov. 01, 2022 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) announced results from a Phase 2 study evaluating the safety and immunogenicity of the company’s adjuvanted single dose chikungunya virus virus-like particle (CHIKV VLP) vaccine candidate in prior recipients of other investigational alphavirus vaccines. The study demonstrated that the CHIKV VLP vaccine candidate was well-tolerated and immunogenic in both alphavirus vaccine-naïve participants and participants previously vaccinated against the Venezuelan equine encephalitis virus. The findings were presented at the American Society of Tropical Medicine and Hygiene (ASTMH) annual meeting.

“We are pleased with these positive Phase 2 study results that support the potential utility and continued development of a chikungunya vaccine candidate to help prevent chikungunya disease, including in those who have previously received another alphavirus vaccine,” said Chris Cabell, M.D., chief medical officer and SVP clinical development at Emergent BioSolutions. “There are currently no approved vaccines or treatments for chikungunya disease, and we are committed to advancing our program to help address this unmet medical need.”

United Therapeutics Corp. (NASDAQ: UTHR) continues to snap up properties near its Silver Spring headquarters — but has largely remained quiet about its long-term plans for the additional space.

The local drugmaker most recently bought a building at 8905 Fairview Road for $11.85 million, according to Montgomery County property records. The transaction, which closed Oct. 5, also includes a parking lot across the street.

Ambix Healthcare Partners Leads Funding Round Bringing New Surgical Robot To Market

BALTIMORE, Nov. 1, 2022 /PRNewswire/ -- Galen Robotics, the Digital-Surgery-as-a-Service ™ pioneer, today announced it has completed the 1st close for an oversubscribed Series A round with $15 million in funding, including investment from Ambix Healthcare Partners, from Menlo Park, CA.

Galen Robotics has submitted a new collaborative soft tissue surgical robot, intended to address unmet needs in the market, to FDA for consideration.  Galen plans to level the surgical playing field by erasing large capital expenditures associated with today's surgical robots. Galen Robotics will be the first surgical robotics company to launch as  "as-a-service" using the per-usage disposable model. Termed Digital-Surgery-as-a-Service, is a new approach to surgical robotics, clearing the way to capture surgical data and promote continuous improvements of surgical techniques, outcomes, and the training of residents. The Series A helped complete the final robot prototype, and submission to FDA. Funds will also be used to develop a clinical sales team, expand engineering, grow product development, and develop surgeon training programs.

Galen Robotics, which is commercializing a surgical robot developed at a Johns Hopkins research lab, has announced the first close of a Series A round, after raising $15 million from investors led by California’s Ambix Healthcare Partners. It simultaneously announced a second close for its Series A worth an additional $5 million.

“We will be the first robotic company to launch using an on-demand business model,” said Galen Robotics CEO Bruce Lichorowic, after the Baltimore startup swiftly pivoted from trying to sell its robots to a so-called “digital-surgery-as-a-service” model. The switch makes Galen’s robotic services more affordable for hospitals that have financially struggled since the coronavirus pandemic amid a sharp drop in elective surgeries.

United Therapeutics is continuing to buy properties near its downtown Silver Spring corporate headquarters at 1040 Spring St.

Dewey Steadman, director of investor relations for the drug manufacturer, confirmed a report in the Washington Business Journal of the purchase of 8905 Fairview Rd. for $11.85 million, including a parking lot across the street.

Image: https://www.sourceofthespring.com

Great entrepreneurs can come from anywhere, but some universities have a truly exceptional track record of producing future entrepreneurs.

PitchBook's annual university rankings compare schools by tallying up the number of alumni entrepreneurs who have founded venture capital-backed companies. The undergraduate and graduate rankings are powered by PitchBook data and are based on an analysis of more than 144,000 VC-backed founders.

Maryland life sciences and biotechnology companies have been at the forefront of the state’s public health response and economic recovery from the COVID-19 pandemic. However, lawmakers are considering policies that weaken the very backbone of Maryland’s robust innovation economy at a time where protecting this industry had never been more critical. Without the necessary policies and protections in place, essential innovation and research, such as COVID-19 clinical trials and cybersecurity development taking place right here in Maryland, could be forced to come to a screeching halt.

Image: Scientists work on the vaccine purification process as they design updates to the Novavax's COVID-19 shots in the company's research laboratory on May 24, 2022, in Gaithersburg, Maryland. In July, the U.S. Food and Drug Administration authorized use of Novavax’s more traditional kind of COVID-19 vaccine, which the company hopes can win over unvaccinated people and become a top choice for boosters. (AP Photo/Angie Wang) (Angie Wang/AP)

An NCI Technology Opportunity Webinar

We invite you to register and join us on November 15 from 11:00 am - 12:00 pm ET for a free NCI technology webinar.

Attendees will hear from Drs. Anand Swaroop, Ph.D. and Kamil Kruczek, Ph.D. of the National Eye Institute about a new gene therapy method for treating CRX-autosomal dominant Leber Congenital Amaurosis (LCA). LCA is a rare genetic disease that is responsible for about 20% of all childhood blindness. It’s caused by mutations in any of at least 25 genes that control photoreceptor development or function. LCA has both recessive and dominant forms. Currently, there is an FDA approved gene therapy for treating only one of the recessive forms of LCA caused by mutations in the RPE65 gene. In addition to most recessive forms, the dominant form of LCA with underlying mutations in CRX remains untreatable.

Click here to register or learn more.

BioHealth Innovation, Inc. (BHI) and Montgomery County are pleased to announce Jennifer R. Butler as the first Montgomery County “Executive in Residence”—a pilot project dedicated to providing 1:1 technical assistance to Montgomery County-based biotech startups.  

This is a year-long collaboration between the county government, which is funding the work as part of its mission to grow the local life sciences cluster, and BHI, a regional innovation intermediary supporting technology commercialization throughout Maryland, D.C., and Virginia.

The Polaris Genomics Leadership team of CEO Charles Cathlin, MPH, CSO Tshaka Cunningham, PhD, and CMO Anne Naclerio, MD, MPH visit BioTalk to discuss competing in the 7th Annual Crab Trap Competition, being a Veteran-Owned Business and growing in BioHealth Capital Region.

Listen now via Apple https://apple.co/3DOUiLK, Google https://bit.ly/3fowyob, or Spotify https://spoti.fi/3DNfd1F3

“There’s more dry powder powder than ever before.”

“There’s never been a better time to start a startup.”

“Discipline is the new scale.” (OK, OK, I made that last one up, but didn’t you kind of believe it?).

The tech industry loves generalizations — and don’t worry, I enjoy my fair share too — but as the downturn continues to play out, it’s increasingly important to think about the structural changes that may be forming in the venture capital landscape. Venture firms, unlike unicorns, often don’t have hundreds of employees to cut. Instead, venture firms cut costs in quieter ways.

SIOUX FALLS, S.D. and GAITHERSBURG, Md., Oct. 27, 2022 (GLOBE NEWSWIRE) -- SAB Biotherapeutics (Nasdaq: SABS), ("SAB”), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that produces specifically targeted, high-potency, fully-human polyclonal antibodies without the need for human donors, today announced the company has entered into an exclusive manufacturing services agreement with Emergent BioSolutions Inc. (NYSE: EBS). Emergent will provide contract development and manufacturing (CDMO) services to produce SAB’s fully-human polyclonal antibody products. Currently, SAB has clinical-stage programs in pan-influenza treatment, treatment of acute and recurrent C. diff., prevention of Type 1 diabetes, and discovery assets in immunology and oncology.

Under the terms of the agreement, Emergent will provide end-to-end Good Manufacturing Practice (cGMP) manufacturing services to SAB, including process development and manufacturing clinical investigational drug product to support SAB’s clinical programs, and commercial manufacturing services upon regulatory approval of SAB’s therapeutics. The agreement also provides the opportunity for Emergent to utilize SAB’s novel DiversitAb™ platform, the only one in the world that produces fully-human polyclonal antibodies utilizing transchromosomic cows, for future development of undisclosed programs. Financial details of the agreement were not disclosed.

Thanks to the Maryland Department of Commerce, an octet of the state’s public and private universities can now commit a collective $16.4 million toward professorships in STEM, health and adjacent fields.

Half of that sum, or $8.2 million, comes from matching grants that the stage agency endowed via its Maryland E-Novation Initiative Fund (MEIF), which it administers to match private fundraising for endowed professorships and chair positions. The other half, per the MEIF’s mandate, came from private fundraising that the beneficiary universities and colleges raised.

Image: Holmes Hall, one of Morgan State University's main campus buildings. (Image via Facebook)

Through this collaboration, FUJIFILM Diosynth Biotechnologies will incorporate RoosterBio's industry-leading process development technology for both MSC and extracellular vesicle (EV) / exosome programs into its manufacturing capabilities and offerings.

FREDERICK, MD. (PRWEB) OCTOBER 25, 2022

FUJIFILM Diosynth Biotechnologies, a world-leading contract development and manufacturing organization (CDMO) for biologics, vaccines, and advanced therapies, announced today a strategic collaboration with RoosterBio, Inc., a leading supplier of human mesenchymal stem/stromal cells (MSCs), highly engineered media, and bioprocess development services. Through this collaboration, FUJIFILM Diosynth Biotechnologies will incorporate RoosterBio's industry-leading process development technology for both MSC and extracellular vesicle (EV) / exosome programs into its manufacturing capabilities and offerings.

MANASSAS, VA. (PRWEB) OCTOBER 26, 2022

Diversity and inclusion in clinical trials are critical to achieving accurate and reliable results.(1) Participation in clinical trials is voluntary, and individuals of different ages, genders, races, ethnicities, genetic backgrounds, geographic locations, and environments will respond differently to the same treatments. An effective way to achieve diversity in clinical trials is through decentralization with standardized procedures across multiple sites.(2) To facilitate the efficient execution of multi-center clinical trials globally, Dr. Harsha Rajasimha, Founder and CEO of Jeeva Informatics, and his team have developed the modular Jeeva™ eClinical Cloud.

GAITHERSBURG, Md.--(BUSINESS WIRE)--Adaptive Phage Therapeutics, Inc. (“APT”), a clinical-stage biotechnology company advancing a phage bank, the world’s largest therapeutic phage initiative for treatment of bacterial infectious diseases, today announced the appointment of Edward Fang, M.D. as Chief Medical Officer. Dr. Fang’s responsibilities include overseeing clinical development for APT's phage bank treatment candidates through commercialization.

Tweet this “I am excited to welcome Dr. Fang, who brings broad expertise in therapeutic approaches to bacterial infectious disease and clinical trial execution to APT,” stated Greg Merril, CEO and Co-Founder of Adaptive Phage Therapeutics. “With Dr. Fang’s addition to APT’s leadership, I am confident that APT will achieve its short-term objective of rapidly progressing ongoing clinical trials, and longer-term objectives of leveraging expanding phage banks to deliver the first antimicrobials that adapt to the emergence of resistance. This approach does not decrease in coverage over time and will not require, or benefit from, market-suppressing stewardship.”

ROCKVILLE, MARYLAND, BioHealth Innovation Inc. (BHI) is pleased to welcome Monique Bennett, Ph.D., as the new Senior Life Sciences Business Strategist. In this role, Dr. Bennett will work one-on-one with entrepreneurs and will lead BHI’s team of strategists that provide a variety of client services including non-dilutive funding assistance and go-to-market strategies.