CHARLOTTESVILLE, Va., October 8, 2024 -- AMPEL BioSolutions announced a precision medicine blood test that could save lives by predicting heart disease before it happens and providing decision support for prophylactic therapies.  Inflammatory and immune system abnormalities identified in the blood of individuals predisposed to heart disease by AMPEL two years ago were confirmed and extended in the peer-reviewed Cell iScience paper announced today. Examination of genes expressed in single cells isolated from atherosclerotic coronary artery plaques revealed biomarkers that can be measured by AMPEL's CardioGENE^® blood test.

Program aims to reduce drug safety failure rate and improve efficacy prediction before clinical trials start 

The Advanced Research Projects Agency for Health (ARPA-H), an agency within the U.S. Department of Health and Human Services (HHS), today announced a new funding opportunity through its Computational ADME-Tox and Physiology Analysis for Safer Therapeutics (CATALYST) program. CATALYST intends to create human physiology-based computer models to accurately predict safety and efficacy profiles for Investigational New Drug (IND) candidates.  

The Maryland MedTech ecosystem is unique for several reasons, particularly its rich blend of resources, institutions, and infrastructure that support innovation in medical technology. Here are some key features that make it stand out:

1.      Proximity to Leading Research Institutions

• • Johns Hopkins University and the University of Maryland are world-class research institutions that have robust medical and biomedical engineering programs. These universities foster cutting-edge research and serve as breeding grounds for MedTech innovation.

• • Maryland is also home to the National Institutes of Health (NIH), the world’s largest medical research agency, which provides funding, research collaborations, and access to critical expertise.

2.      Federal Agencies and Regulatory Bodies

• • The presence of FDA headquarters in Maryland gives local companies close access to regulatory experts. This is crucial for MedTech startups, as navigating the regulatory approval process is often one of the biggest challenges they face.
  • Other federal agencies like the Centers for Medicare & Medicaid Services (CMS) and various defense agencies that have a stake in health technologies are also located nearby.

3.      Vibrant Start-up and Investment Scene

• Maryland’s ecosystem has a growing number of incubators and accelerators focused on MedTech.  Notable ones include the LaunchPort Accelerator, which supports medical device startups by providing them with the resources to prototype, manufacture, and commercialize their innovations.
• There is strong financial support from angel investors and venture capital firms specializing in healthcare technologies, creating opportunities for funding and scaling businesses.

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Federal Reserve Bank of Richmond’s R. Andrew Bauer and Fulton Bank’s Joe Durham will be the morning keynote at the upcoming premier event

COLUMBIA, Md., (October 3, 2024) — TEDCO, Maryland’s economic engine for technology companies, announced the two morning keynote speakers for its Entrepreneur Expo – R. Andrew (“Andy”) Bauer of the Federal Reserve Bank of Richmond and Joe Durham of Fulton Bank. The upcoming event will take place on December 4, 2024, at the Renaissance Baltimore Harborplace Hotel.

The NIH Common Fund is funding five new research awards to Health Equity Research Hubs that will support community-led research projects. These awards total more than $37 million over five years, pending availability of funds.

Structural factors in communities such as access to education, health care, and social context shape the health of those communities and contribute to ongoing health disparities. Developing new programs that target the causes of these disparities is integral to improving equal access to health resources. The needs of communities vary, so input from individuals and local leadership is critical to develop successful, sustainable initiatives. The Community Partnerships to Advance Science for Society (ComPASS) Program was designed for community-based organizations to lead the way in researching, designing, implementing, and assessing projects that address community needs and reduce health disparities.

GAITHERSBURG, Md., Oct. 02, 2024 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) announced today that it entered into a new credit agreement on September 30, 2024 providing for an asset-based revolving loan facility (ABL) with the lenders party thereto and Wells Fargo Bank, National Association, as administrative agent. The credit agreement provides for revolving loan commitments in an aggregate principal amount up to $100 million (availability is based on a borrowing base set forth therein) with a fixed maturity date of September 30, 2029, subject to early maturity triggers based on the maturity of its other material indebtedness. The new credit facility brings additional liquidity to support Emergent’s multi-year transformation plan. As of September 30, 2024, Emergent had a cash balance of approximately $150 million and undrawn access to $100 million under the ABL.

NIJMEGEN, Netherlands and BOSTON, Oct. 1, 2024 /PRNewswire/ -- Tagworks Pharmaceuticals BV ("Tagworks"), a precision oncology company using its proprietary Click-to-Release treatment platform to develop a new standard of care for patients suffering from solid tumors by targeting clinically validated tumor markers that so far have remained out of reach of current therapies, today announced the appointment of Ken Mills as Chief Executive Officer and member of the Board of Directors. As part of this planned CEO leadership transition, Marc Robillard, Ph.D., the founding CEO of Tagworks, will continue in the role of Chief Scientific Officer and as a board member.

WASHINGTON, Oct. 01, 2024 (GLOBE NEWSWIRE) -- Ten medical technology innovators focused on pediatric cardiology have been selected to compete for $300,000 in grants in the “Make Your Medical Device Pitch for Kids!TM” competition on Oct. 14 in Toronto, Canada.  

The competition is presented by the Alliance for Pediatric Device Innovation (APDI), a nonprofit consortium led by Children’s National Hospital and funded through the Food and Drug Administration (FDA), and Additional Ventures, a nonprofit focused on accelerating research progress and improving clinical care for individuals born with single ventricle heart defects. Selected by an internal committee, ten finalists will compete for up to $50,000 each in grant funding and opportunities to access support services and technical expertise provided by APDI and Additional Ventures, including engineering, regulatory, reimbursement, clinical trials study design and data science services.  

Join us for our Fourth Annual IPWatchdog LIVE Conference

Bringing together the intellectual property community – from politicos, to business executives, to attorneys, and inventors, IPWatchdog LIVE gives everyone from all sides of the debate the opportunity to have a fulsome discussion of the most important issues facing the industry from their perspectives. With a focus on exceptional networking opportunities, and A+ content. Our philosophy has always been that “Content is King”, and that will show clearly at this Conference. With A+ speakers and top-level content, we will create a center of gravity to attract the IP community. Making networking a priority, we will have THREE (3) networking cocktail receptions, two breakfasts, two lunches, and 5 networking breaks, where attendees can and do mingle with numerous high-ranking in-house counsel (just look at our speaker list), current and former government officials, current and former Judges, top lobbyists, and Hill Staffers. #IPWLIVE2024

GAITHERSBURG, Md., Sept. 30, 2024 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced completion of patient enrollment in IMPACT, its Phase 2b biopsy-driven trial evaluating pemvidutide in metabolic dysfunction-associated steatohepatitis (MASH) and provided an update on additional development and regulatory initiatives related to pemvidutide.

By Alan Kline – Senior Editor, Washington Business Journal - Sep 26, 2024 - Children’s National Hospital has landed another large gift from the government of the United Arab Emirates (UAE), this time to help support prenatal and neonatal care and research. 

The $35 million donation, announced Thursday, comes some five years after the UAE donated $30 million to help Children’s build its research and innovation campus at the former Walter Reed Medical Center and 15 years after it provided a gift of $150 million for construction of the Sheikh Zayed Institute for Pediatric Surgical Innovation, named for the UAE’s founding father.

The UAE’s support of Children’s National dates to the early 1990s, when the UAE opened a medical office in D.C. Since then, the partnership has yielded 82 U.S. patents and “countless medical breakthroughs for kids and their families,” Children’s National said in a news release. 

The UAE government also counts on Children’s National to provide care to dozens of Emirati families that travel to D.C. each year to access the hospital’s advanced services and treatments. 

The donation, among the largest in Children's history, is biggest the hospital has received since Michelle Riley-Brown replaced Kurt Newman as president and CEO about 15 months ago. Just before Newman retired, an anonymous family donated $96 million to help fund research and treatments for pediatric brain tumors. 

“I am deeply grateful for the UAE’s most recent gift,” Riley-Brown said in a statement. “The contribution will positively impact children and families and support the teams of researchers and specialists who dedicate their lives to developing innovative medical care.”

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GAITHERSBURG, Md., Sept. 26, 2024 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) (“Emergent”) today announced that two contract options have been secured to procure additional treatment courses of TEMBEXA^® (brincidofovir) to sustain the U.S. government’s national preparedness posture against human smallpox. TEMBEXA^® is indicated for the treatment of human smallpox disease in adult and pediatric patients, including neonates. The order is valued at $67.4 million and executes procurement options CLIN0004A and CLIN0005A under Emergent’s existing 10-year contract.

At RESI Boston 2024, held on September 25th at the Westin Copley Place, Montgomery County-based biotechnology company miRecule, a client of BioHealth Innovation Inc. (BHI), showcased its groundbreaking RNA therapeutic programs. As part of Biotech Week Boston, RESI Boston provided a premier opportunity for miRecule to engage in in-person networking with potential investors and partners, followed by virtual partnering sessions on September 26-27. miRecule presented the innovative work stemming from its DREAmiR™ platform, which leverages genomic and patient outcome data to create highly personalized RNA therapies for cancer and muscular dystrophy.

EchoGuide is Sonavex’s pipeline product designed to improve cannulation for dialysis patients.

Baltimore, MD (September 25th, 2024) – Sonavex, Inc., a privately held medical device company with ultrasound technologies that deliver quantitative blood flow and other critical vascular data at the point of care, announced today that it was awarded a $2 million Small Business Innovation Research (SBIR) Phase IIB Grant from the National Institutes of Health (NIH) to advance EchoGuide^TM, Sonavex’s pipeline product designed to reduce cannulation injury for dialysis patients. The grant will support activities necessary to pursue regulatory clearance from the Food and Drug Administration and fund a clinical trial.

GAITHERSBURG, Md., Sept. 24, 2024 (GLOBE NEWSWIRE) -- Today, Georgiamune Inc., a privately held, clinical-stage biotechnology company, announced that the first participant has been dosed with GIM-407 in a first-in-human, phase 1 clinical trial in healthy volunteers, which is the stepping stone of the clinical development plans to develop it for patients with autoimmune diseases. Based on novel biology, GIM-407 is the only selective T-regulatory cell activator of its kind in development. It is a small molecule that is administered orally marking the first autoimmune disease program for the company.

The 10th Annual BioHealth Capital Region Forum has once again brought together some of the most influential leaders and innovators in the biohealth industry. This year’s Forum features a stellar lineup of returning presenters and keynotes, each contributing unique insights into the state of the biohealth sector, both locally and nationally. Here’s a look at some of the standout sessions from this year’s event.

"The caliber of speakers at this year’s BioHealth Capital Region Forum was truly exceptional. From industry veterans to emerging leaders, the insights shared reflected the depth of expertise and innovation driving the growth of our biohealth ecosystem. We were honored to host such influential voices who are shaping the future of healthcare and biotechnology, and their contributions made this year’s event one of the most impactful yet," said Rich Bendis, President and CEO of BioHealth Innovation, Inc.

The BioHealth Capital Region Forum had the honor of hosting Maryland Governor Wes Moore, who addressed attendees at the 10th Annual event held at the US Pharmacopeia (USP) in Rockville. Prior to his speech, Governor Moore met with a select group of local leaders and industry experts, including Montgomery County Executive Marc Elrich, Rich Bendis, President and CEO of BioHealth Innovation, Inc., Ronald T. Piervincenzi, Ph.D., CEO of USP, Peter S. Briskman, Executive Managing Director of Brokerage at JLL and others.

Governor Moore’s attendance underscored the strategic importance of the biohealth industry to Maryland’s economy. His participation signified the state’s commitment to remaining at the forefront of biotech innovation, supporting the growth of life sciences companies, and fostering partnerships between government, industry, and academia. By engaging directly with industry leaders, Moore highlighted Maryland’s pivotal role in shaping the future of healthcare and biotech.

ROCKVILLE, MARYLAND, September 23, 2024 – BioHealth Innovation, Inc. (BHI) and Georgetown University’s Office of Technology Commercialization (OTC) have entered into a strategic collaboration to accelerate the commercialization of innovative research and technologies developed by Georgetown University faculty, staff, and student entrepreneurs.

BHI and its experienced Entrepreneurs-in-Residence (EIRs) and network of analysts will provide support, mentorship, and commercialization expertise to the recently launched Georgetown Tech Ventures (GTV). GTV is supported by the Build to Scale (B2S) program, which is led by the Economic Development Administration’s Office of Innovation and Entrepreneurship. As part of this initiative, BHI will assist GTV in strengthening its entrepreneurial ecosystem by interacting with Georgetown’s faculty, staff, and student entrepreneurs and will leverage BHI's extensive experience in commercialization and entrepreneurship to help GTV effectively manage the development and launch of innovative ventures. This effort will include conducting seminars, offering one-on-one mentorship, and leveraging BHI’s network to increase visibility for GTV’s programs. The collaboration will also help raise the profile of Georgetown’s innovation initiatives by tapping into significant events like the BioHealth Capital Region Forum and BHI’s various communication platforms such as weekly newsletters, blogs, and the BioTalk podcast.

The commercialization and technology transfer arm of the storied Baltimore university is helping to foster the region’s burgeoning tech scene.

BY Steven Melendez

During the opening day of the BioHealth Capital Region Forum at US Pharmacopeia in Rockville on September 17^th, 2024, Virginia Governor Glenn Youngkin was awarded the 2024 Governor of the Year by the Biotechnology Innovation Organization (BIO). This prestigious award recognizes governors who have demonstrated strong leadership and commitment to advancing biotechnology in their states.

Governor Youngkin, who has been instrumental in driving economic development across Virginia, spoke about the Commonwealth’s expanding role in the life sciences sector. “Investing in biotechnology is investing in Virginia’s future,” he remarked, highlighting the importance of Virginia’s research triangle and ongoing efforts to foster innovation. Under his leadership, Virginia has secured nearly $71 billion in capital investments, transforming the state into a significant hub for biotechnology and other industries.

Montgomery County Executive Marc Elrich helped kick off the 10th Annual BioHealth Capital Region Forum once again this year, reinforcing the county’s pivotal role as the epicenter of the BioHealth Capital Region. In his opening remarks, Elrich highlighted the county’s vast biohealth assets, including NIH, NIST, FDA, USP, and a thriving network of innovative companies. He also emphasized that this significant event has been proudly hosted in Montgomery County for the past decade.

Throughout his speech, Elrich reiterated Montgomery County’s commitment to fostering growth and innovation in the biohealth sector. He spoke on the importance of collaboration between government, industry, and academia to drive advancements that will benefit the region and have a global impact on healthcare and biotechnology.

The 2024 Women’s Health Innovation Summit USA taking place from September 23-25, 2024, in Boston, MA. This event will serve as a leading platform for accelerating innovation, investment, and partnerships within the women's health sector. The summit will bring together key industry players, including professionals from pharma, biotech, medical devices, femtech, and startups, as well as investors, healthcare providers, and researchers, to discuss cutting-edge advancements in women's health care.

BETHESDA, Md. and SINGAPORE, Sept. 23, 2024 /PRNewswire/ -- VerImmune Inc., ("VerImmune"), a venture-backed biotechnology company developing a groundbreaking Virus-inspired Particle (ViP™) platform technology, today announced the successful first closing of $4.5 million in its Pre-Series A financing round.

The financing was led by Beiley Biofund, an early-stage venture capital firm focused on cutting-edge technologies that address high unmet medical needs. New investors, including Dr. John Ballantyne, PhD, co-founder and former CSO at Aldevron, participated in the round, alongside returning investors Proxima Ventures, Mana Ventures, Gaingels, and others.

Network will analyze and improve how genomic information is integrated into patient care.

The National Institutes of Health (NIH) is awarding $5.4 million in first-year funding to establish a new program that supports the integration of genomics into learning health systems.

Present in many hospitals across the United States, learning health systems are a type of clinical practice that bridges research and patient care. These systems use a variety of methods to continually analyze patient data. Clinicians then use the results of those analyses to refine practices and improve future care.

The new Genomics-enabled Learning Health System (gLHS) Network aims to identify and advance approaches for integrating genomic information into existing learning health systems. As genomic testing becomes increasingly common, more and more genomic data are available in clinical settings, and learning health systems present an opportunity to translate this evidence quickly and directly into improvements in medical care.

Day 1 Recap: A Dynamic Start to the 10^th Annual BioHealth Capital Region Forum

The 10^th Annual BioHealth Capital Region Forum kicked off with a strong showing of leadership from both Maryland and Virginia, setting the tone for the rest of the week. BHI President and CEO Rich Bendis opened the day by thanking Ronald T. Piervincenzi, Ph.D., CEO of USP, for hosting the conference for the third year in a row. Ronald T. Piervincenzi, Ph.D., introduced Montgomery County Executive Marc Elrich, who welcomed attendees to Montgomery County, where this event has been held all ten years. Elrich highlighted the importance of Montgomery County, which is the epicenter of the BioHealth Capital Region.

BioHealth Capital Region Week 2024 welcomed Immobazyme, a biotech company from Stellenbosch, South Africa, to compete in the 9th Annual Crab Trap Competition. Specializing in precision fermentation products, Immobazyme focuses on developing treatments for diabetic foot ulcers (DFUs), with the goal of reducing amputation rates and improving the quality of life for diabetic patients worldwide. Ethan Hunter, Chief Operations Officer of Immobazyme, represented the company and delivered a compelling pitch to the panel of judges.

Linshom Medical, a TEDCO-backed company, located in Baltimore, MD, was named the winner of the 9th Annual Crab Trap Competition during the BioHealth Capital Region Forum. Linshom impressed the judges with their groundbreaking wearable respiratory monitoring device, the first FDA-cleared technology to deliver an operating room-quality respiratory profile to the patient bedside.

By continuously providing critical metrics such as Respiratory Rate (RR), Tidal Volume (TV), and Minute Ventilation (MV), Linshom’s device predicts respiratory decline up to 70 minutes before an emergency, reducing costly ICU transfers, rapid response activations, and potentially saving lives. Unlike bulky, expensive equipment limited to the ICU or operating rooms, Linshom’s device brings precise, predictive respiratory monitoring to the bedside, addressing a fundamental gap in patient care. Judges praised Linshom for its technological innovation, clear path to market, and the critical need it addresses in modern healthcare, particularly in post-operative and emergency settings.

U.S. Pharmacopeia (USP) is currently seeking Expert Volunteers from diverse professional backgrounds to contribute to its vital mission of safeguarding the quality of medicines, dietary supplements, and food ingredients. For over 200 years, USP has maintained trust in healthcare products through rigorous standards, and now they are calling on scientists, healthcare professionals, regulatory experts, and academicians to join them for the 2025–2030 cycle.

Volunteering with USP offers a unique opportunity to work alongside global experts from academia, industry, and regulatory bodies to help review and revise USP standards. These standards are essential for public health, legally recognized in the U.S., and used in over 150 countries. Volunteers will lend their expertise to address emerging health concerns, build awareness, and reduce the risk of substandard healthcare products. As a part of an Expert Committee, you’ll help shape global healthcare and contribute to ensuring that consumers worldwide have access to safe and reliable products.

This biotechnology company aims to save lives through their transformative medical device.

COLUMBIA, Md., (September 23, 2024) — TEDCO, Maryland’s economic engine for technology companies, announced a recent $250,000 Builder Fund investment in CarrTech, a life sciences company working to support patients and healthcare providers. The Builder Fund is part of TEDCO’s Social Impact Funds, an umbrella of funds designed to support underserved founders and communities.

“The purpose of CarrTech and our medical device FROG®, is saving lives by mitigating the risk of preparing ampoule-based medication,” said CarrTech’s founder and CEO Sue Carr. “My team and I are incredibly optimistic about the huge impact TEDCO’s investment could bring to the healthcare community.”

WILMINGTON, Del., September 20, 2024 – FLUMIST® has been approved in the US as the only self-administered influenza vaccine. FLUMIST, a needle-free nasal spray, was approved to be self-administered by adults up to 49 years of age or administered by a parent/caregiver to individuals 2-17 years of age.1

The approval by the US Food and Drug Administration (FDA) was based on a comprehensive submission, which included results from a usability study demonstrating that individuals over 18 years of age could self-administer or administer FLUMIST to eligible individuals 2-49 years of age.1

What’s happening? ARPA-H is launching the Emerging Health Innovators (EHI) Initiative to increase access to government research funding for early career researchers and community health innovators to address health care gaps in the U.S.

Why it matters? Early career researchers and community health innovators, including those from minority-serving institutions and community-based organizations, will now have more opportunities to pursue bold and technically risky R&D projects, but who have been unable to take these leaps using traditional funding opportunities.

Clinicians caring for children are often left to rely on off-label devices and medications approved for adults, especially during national disasters and other emergencies. Children’s National Hospital is launching a new partnership with the federal Biomedical Advanced Research and Development Authority (BARDA) to develop much-needed solutions for this vulnerable population.

This new pediatric-focused hub will be known as the SPARK Hub—or the Hub for Special Populations Acceleration, Research and Knowledge for Innovations in Pediatrics. It will join a network of four existing BARDA hubs to develop various tools for national health emergencies, including infectious disease outbreaks or chemical, biological, radiological and nuclear attacks. The new opportunity for Children’s National positions the organization as a leader among those working to ensure clinicians and their patients have the resources they need in crises, approved for kids and ready for clinical use.

With COVID-19 still spreading and mpox emerging as a public health emergency of international concern, the National Institutes of Health (NIH) is upping preparations for future pandemics.

The Research and Development of Vaccines and Monoclonal Antibodies for Pandemic Preparedness network (ReVAMPP) will research pathogens that currently lack effective treatments and vaccines, with the NIH’s National Institute of Allergy and Infectious Diseases (NIAID) committing up to $100 million per year to the effort so long as funds are available, the agency announced Sept. 13.

“In the wake of the COVID-19 pandemic and ongoing outbreaks of emerging infectious diseases, the need for robust pandemic preparedness is evident,” NIAID Director Jeanne M. Marrazzo, M.D., said in the release. “The ReVAMPP network will enable researchers to fill key knowledge gaps and identify strategies to develop safe and effective medical countermeasures for targeted virus families before the need becomes critical.”