In this episode of BioTalk, Amy C. Hay, Chief Business and Strategy Officer at the Cell Therapy Manufacturing Center (CTMC), joins the conversation to explore the evolving landscape of cell and gene therapy. Amy shares insights from her extensive career in oncology care and innovation, highlighting the role CTMC—a joint venture between National Resilience and MD Anderson Cancer Center—is playing in accelerating the transition from discovery to commercialization. She discusses the current state of the industry, what disruption really means in this context, and how new business models can drive stability and impact for early-stage biotech companies. Amy also offers her perspective on how manufacturing must evolve to meet clinical demand, and how CTMC is positioned to lead in this next era of therapeutic development.

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BETHESDA, Md.--(BUSINESS WIRE)--BrainScope®, a leader in AI-enabled EEG technology for brain health assessment, today announced the launch of its next-generation deep learning platform. BrainScope developed and has commercialized the first FDA-cleared AI/machine learning medical device in the field of neurology. Building on that foundation in machine learning, BrainScope's new capabilities enhance its ability to deliver fast, objective, and clinically actionable insights across brain health conditions including concussion, stroke, and early Alzheimer's detection.

NORTH BETHESDA, Md., June 11, 2025 /PRNewswire/ -- AllSci, a pioneer in AI-driven tools for scientific research, has been awarded a grant from Montgomery County, Maryland's Technology Innovation Fund – accelerating its mission of making science more accessible, connected, and collaborative. The grant supports AllSci's continued development of its AI-powered research platform, empowering scientists at every level, from students to senior researchers, to formulate hypotheses, validate findings, and contribute to the scientific record, furthering its commitment to transforming the research process into one that is more open, intuitive, and inclusive.

ROCKVILLE, Md. and LONDON, June 11, 2025 (GLOBE NEWSWIRE) -- MaxCyte, Inc. (Nasdaq: MXCT; LSE: MXCT), a leading, cell-engineering focused company providing enabling platform technologies to advance the discovery, development and commercialization of next-generation cell therapeutics, and Oribiotech Ltd. (Ori), a leader in advanced cell and gene therapy (CGT) manufacturing technology, today announced a strategic collaboration aimed at enhancing efficiency, scalability, and productivity in cell therapy manufacturing.

GAITHERSBURG, Md., June 11, 2025 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX) today announced results of the initial cohort of its COVID-19-Influenza Combination (CIC) and stand-alone trivalent hemagglutinin nanoparticle seasonal influenza (tNIV) Phase 3 trial that showed both the CIC and flu vaccine candidates induced immune responses similar to licensed comparators Nuvaxovid^® and Fluzone HD, respectively. This cohort was designed to provide descriptive data on three flu strains (H1N1, H3N2, B) and SARS-CoV-2 (COVID-19) to inform a future registrational Phase 3 program.

"Both our combination and stand-alone flu vaccine candidates induced robust immune responses and were well tolerated," said Ruxandra Draghia-Akli, MD, PhD, Executive Vice President and Head of Research and Development, Novavax. "This data set adds to findings from our Phase 2 trial and will help inform discussions with potential partners."

Medical device manufacturer looks to revolutionize wound care with AI-driven nanosensors

COLUMBIA, Md., (June 11, 2025) — TEDCO, Maryland’s economic engine for technology companies, announced a recent $250,000 Pre-Seed Builder Fund investment in NanoBioFab. The Pre-Seed Builder Fund invests in and provides executive support to Maryland-based technology companies run by entrepreneurs who demonstrate economic disadvantages.

“We are excited to continue our business journey,” said Xiaonao Liu, Ph.D., CEO of NanoBioFAB. “TEDCO has been instrumental in our progress and success. Entrepreneurs looking to expand their business should look at the different opportunities that TEDCO offers.”

WASHINGTON, June 10, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the first dose in the first-in-human clinical trial to evaluate the safety and tolerability of VCA-894A, an antisense oligonucleotide (ASO) therapeutic, for a patient with a rare variant in the IGHMBP2 gene causing Charcot-Marie-Tooth disease Type 2S (CMT2S).

ANNAPOLIS, MD — Governor Wes Moore today announced that the Maryland Department of Commerce has awarded 10 grants totaling $6.95 million through the Build Our Future Grant Pilot Program. The recipients represent projects that will support innovation infrastructure development in eligible technology sectors.

ROCKVILLE, MD, June 10, 2025 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (Nasdaq: MGNX), a clinical-stage biopharmaceutical company focused on discovering, developing, manufacturing and commercializing innovative antibody-based therapeutics for the treatment of cancer, today announced that it has entered into a royalty purchase agreement with Sagard in exchange for a capped royalty interest on future global net sales of ZYNYZ (retifanlimab-dlwr). ZYNYZ is a PD-1 inhibitor originally developed by MacroGenics and licensed to Incyte pursuant to an exclusive global collaboration and license agreement in October 2017. MacroGenics retains its other economic interests related to ZYNYZ, including future potential development, regulatory and commercial milestones. MacroGenics will also continue to support a portion of global commercial manufacturing needs for ZYNYZ.

COLLEGE PARK, Md.--(BUSINESS WIRE)--IonQ (NYSE: IONQ), a leading commercial quantum computing and networking company, announced results of a collaborative research program between IonQ, AstraZeneca, Amazon Web Services (AWS), and NVIDIA to develop and demonstrate a quantum-accelerated computational chemistry workflow which has the potential to power world-changing innovation in healthcare, life sciences, chemistry, and more.

In this episode of BioTalk, Sam Tetlow, Founder and CEO of Grant Engine, joins the conversation to share insights on how early-stage biotech and life science companies can navigate today’s complex federal funding environment. With a career spanning entrepreneurship, investment, and grant strategy, Sam breaks down what’s changed under the current administration, how companies should position themselves for success, and the durable tactics that still matter in securing SBIRs, ARPA-H contracts, and other non-dilutive awards. He also discusses the evolving priorities at HHS, the role of program officers, and how Grant Engine is adapting to help clients align with shifting agency goals. This episode builds on the upcoming June 10th, 2025 webinar co-hosted by Sam and BioHealth Innovation’s Rich Bendis, “Turning Uncertainty to Opportunity: Mastering Government Funding in 2025.” Learn more and register at: https://info.grantengine.com/turning-uncertainty-into-opportunity-mastering-government-funding-in-2025

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Amazon - https://amzn.to/4jELdqn
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ROCKVILLE, Md.--(BUSINESS WIRE)--GlycoMimetics, Inc. (Nasdaq: GLYC) (“GlycoMimetics”) today announced that its stockholders have approved the proposed merger (the “Merger”) with Crescent Biopharma, Inc. (“Crescent”), along with all proposals related to the Merger. The proposals were voted upon at GlycoMimetics’ special meeting in lieu of the annual meeting of stockholders held on June 5, 2025 (the “Special Meeting”), including a reverse stock split of GlycoMimetics’ common stock to be effected at the discretion of the board of directors of GlycoMimetics (the “Board”) within the parameters approved by GlycoMimetics’ stockholders.

ROCKVILLE, Md., June 5, 2025 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced new positive interim data from the Phase I/II AFFINITY DUCHENNE trial. Updates include positive functional, safety and biomarker data for RGX-202, REGENXBIO's potential best-in-class, investigational gene therapy for Duchenne muscular dystrophy. The functional data demonstrate consistent benefit among dose level 2 participants at 9 and 12 months following treatment with RGX-202.

Charlottesville, VA – June 5, 2025 – Luminoah, a medical device company transforming chronic disease care through personalized enteral nutrition delivery, announced today that it has been selected to join the MedTech Innovator 2025 Accelerator Cohort. Luminoah is one of only 65 companies—representing the top 4% of nearly 1,500 global applicants—chosen for this year’s program.

MedTech Innovator (MTI) is the world’s largest accelerator for medical technology startups. The highly competitive four-month program provides participants with world-class mentorship, strategic guidance, and access to a robust network of investors, providers, payers, manufacturers, and industry experts.

“We are honored to join this year’s MedTech Innovator cohort,” said Neal Piper, Founder and CEO of Luminoah. “This opportunity gives us a powerful platform to validate our technology, accelerate key partnerships, and expand the reach of our mission to set a new standard in enteral nutrition.”

COLUMBIA, Md., June 4, 2025 — Welldoc^®, a leader in AI-powered digital health innovation, today announced it will power the newly launched Lilly Health™ Personalized Health & Medicine Platform* (Lilly Health app) with its cardiometabolic digital health platform. The Lilly Health app is designed to support a tailored patient experience for individuals interested in or using Eli Lilly and Company’s incretin-based therapies, for the treatment of cardiometabolic conditions, such as obesity, type 2 diabetes, and moderate- to-severe obstructive sleep apnea and obesity. Initially, the Lilly Health app will be available for patients prescribed Zepbound® (tirzepatide)** or Mounjaro® (tirzepatide)**.

Lilly and Welldoc aim to build a more seamless patient experience through educational resources and targeted support. The Lilly Health app will provide features to help patients with their cardiometabolic health goals and weight, such as medication logging, reminders, device connectivity and health data tracking.

COLUMBIA, Md., June 4, 2025 /PRNewswire/ -- The Maryland Stem Cell Research Commission ("Commission") is pleased to announce the release of Requests for Applications (RFAs) for the July 2025 funding cycle. The deadline for application submissions is July 9, 2025.

The upcoming cycle supports a broad spectrum of grant programs, including early-stage basic research, translational efforts, clinical trials and manufacturing support. Maryland-based academic institutions, nonprofits and companies are encouraged to apply. Additionally, companies/non-profit entities outside Maryland are eligible to apply, provided the funded research occurs within the state. Supplemental funding is available for research projects involving collaboration between public and private sectors, accelerating the development of therapies for unmet medical needs.

Lab will help enable broader adoption of advanced manufacturing technologies and state-of-the-art quality solutions 

Rockville, MD - June 4, 2025 - The U.S. Pharmacopeia (USP) announced today the opening of its Advanced Technologies Laboratory in Rockville, Maryland. USP will use this lab, and related solutions and expertise, to develop, pilot, and scale innovations that foster more efficient and expanded production of quality medicines for stronger and more secure supply chains. 

The lab expands USP capabilities to help manufacturers overcome barriers in the adoption of advanced manufacturing technologies by developing new approaches and processes for flow chemistry and additive manufacturing coupled with advanced analytical techniques such as process analytical technologies (PAT) that can enable real-time quality monitoring. The lab will also support development of alternative and novel synthetic routes to produce active pharmaceutical ingredients (APIs) and key starting materials. Taken together, these capabilities are essential in efforts to create stronger supply chains through strategic onshoring, distributed manufacturing, and personalized medicine. 

COLLEGE PARK, MD – June 3, 2025 - IonQ (NYSE: IONQ), a leading commercial quantum computing and networking company, today announced the successful completion of its acquisition of Lightsynq Technologies, Inc., a Boston-based startup specializing in photonic interconnects and quantum memory. This strategic acquisition accelerates IonQ’s fault-tolerant quantum computing roadmap and advances progress toward the development of the quantum internet.

Lightsynq’s photonic interconnect platform supports high-fidelity, multi-nodal qubit operations and modularity, which are essential for scaling quantum computers. The company’s innovations in quantum memory and repeater technology complement IonQ’s trapped-ion quantum computing approach and will advance IonQ’s quantum networking systems.

In this episode of BioTalk, we welcome Rick Wieczorek, President and CEO of the NIH Federal Credit Union (NIHFCU), to discuss how credit unions like NIHFCU are uniquely positioned to support the biohealth and healthcare communities. With over 40 years of industry experience, Rick shares his journey from teller to CEO and reflects on NIHFCU’s 85-year history, its mission-driven approach to service, and the importance of tailoring financial solutions to meet the needs of life science professionals. He also explains the benefits of membership, the value of the NIHFCU "At Work" program for employers, and how the credit union’s “Banking with Heart” philosophy is making a difference across the BioHealth Capital Region.

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Ralph Berrier Jr. //June 1, 2025// - A $4.9 million grant from the commonwealth will allow leaders from the Roanoke and New River valleys to build upon efforts by Virginia Tech Carilion School of Medicine and the Fralin Biomedical Institute at VTC to turn the region into a hub for biomedical research.

“As we build the biotech sector, this statewide grant will help us where we have gaps,” explains Erin Burcham, CEO of the Roanoke Blacksburg Innovation Alliance (RBIA), a regional economic development organization.

The money is a slice of a $14.3 million pie from state economic development initiative GO Virginia to fund the multiregional Project VITAL (Virginia Innovations and Technology Advancements in Life Sciences), an endeavor to make Virginia a biotechnology leader.

FREDERICK, Md., May 30, 2025 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (“Cartesian” or the “Company”), a clinical-stage biotechnology company pioneering cell therapy for autoimmune diseases, today announced that the first participant has been enrolled in its Phase 3 AURORA trial of Descartes-08 in patients with myasthenia gravis (MG).

Descartes-08, Cartesian’s lead cell therapy candidate, is an autologous engineered chimeric antigen receptor T-cell therapy (CAR-T) product candidate targeting B-cell maturation antigen (BCMA). Descartes-08 is designed to be administered without preconditioning chemotherapy in an outpatient setting and does not use integrating vectors.

By Nate Doughty – Staff Reporter, Washington Business Journal - Virginia Tech this week unveiled the Institute for Advanced Computing at its Potomac Yard campus to offer academic and research opportunities in AI and quantum computing — and it's looking for more companies to work with.

At buildout, the institute will employ 50 full-time faculty members and occupy about a third of Virginia Tech's Academic Building One, a $302 million, 300,000-square-foot facility in Alexandria that opened in January. That's all somewhat subject to grant funding, enrollment and the total number of partnerships, according to Kirk Cameron, professor of computer science at Virginia Tech and interim director of the institute.

Baltimore, Md. (May 28, 2025) – CoapTech Inc., a Baltimore-based medical device company, announced today the initial close of a Series B funding round, which was led by Good Growth Capital, an early-stage venture capital firm that invests in transformative science and technology, with participation from the University System of Maryland (USM) Momentum Fund (Momentum Fund) and the University of Maryland, Baltimore (UMB), a previous investor.  Additional funds joining the round included NuFund, TEDCO, The Abell Foundation, and Ecphora Capital.  

Bethesda, Maryland - The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (HJF) and MDC Studio, Inc (MDC) are proud to announce their groundbreaking collaboration through the HJF-MDC Venture Fund LLC.

This collaboration aims to revolutionize medical technology development and commercialization, benefiting military and civilian health care sectors.

The HJF-MDC Collaboration

This new initiative seeks to grow existing collaborations to accelerate the development and commercialization of dual-use medical technologies for military and civilian applications. As part of this initiative, MDC Studio has established a satellite office within HJF's innovation facility in Bethesda, Maryland.

Introducing the HJF-MDC Venture Fund

HJF and MDC formed the HJF-MDC Venture Fund, as an independent entity that aims to invest in a diversified portfolio of early-stage companies commercializing military medical technologies with civilian applications. HJF is participating as a non-voting member of the Fund with a minority interest. The Fund's focus areas include medical devices, wearables for health, and rehabilitation / assistive robotics. The Fund will be overseen by a Board of Managers, who will make investment decisions based on objective selection criteria, including alignment with military medical needs, benefits to civilian health, risks, and expected returns.

State and local leaders touted the promise of a proposed mixed-use development to be built over an existing North Bethesda Metro station as a way to grow Montgomery County’s burgeoning life sciences and tech industries.

The facility is still years away from breaking ground. But Montgomery County Executive Marc Elrich said the effort could transform the area into something similar to Kendall Square in Cambridge, Massachusetts, where technology firms are located close to MIT.

“I had been fascinated by the people I had been talking to about life sciences, and talking to me about Kendall Square in Boston, and talking about the urban campus, and talking about the value of collision spaces … rather than everything being done in office parks, where you never talk to the scientists in the next building,” Elrich said.

ROCKVILLE, Md., May 27, 2025 /PRNewswire/ -- AbelZeta Pharma, Inc. ("AbelZeta" or the "Company"), a global clinical-stage biopharmaceutical company focused on discovery and development of innovative and proprietary cell-based therapeutic products, today announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to its investigational therapy, C-CAR168, for the treatment of refractory Systemic Lupus Erythematosus (SLE), including Lupus Nephritis (LN).

Baltimore, MD, May 27, 2025 —Rapafusyn Pharmaceuticals Inc., a leader in non-degrading molecular glues, announced today the joining of the Roche Accelerator, Roche’s innovation hub, which connects pioneering biotechs with Roche’s expertise.  Rapafusyn was selected to join the Roche Accelerator, based on Rapafusyn’s innovative RapaGlue™ platform and promising pipeline of potential first-in-class and best-in-class therapeutics.

VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (“CEL-SCI” or the “Company”) (NYSE American: CVM), a clinical stage cancer immunotherapy company, today announced the closing of its underwritten public offering of 2,000,000 shares of its common stock at a public offering price of $2.50 per share. Total gross proceeds from the offering, before deducting the underwriting discount and other offering expenses, were $5,000,000. In addition, the Company has granted the underwriters a 45-day option to purchase up to an additional 190,000 shares to cover over-allotments at the public offering price, less the underwriting discount.

University research has grabbed plenty of headlines over the past few months. Not for the breakthroughs that propel so much of American innovation. Not for the work that advances our health and well-being, that protects our safety, our security, our sustainability. Even so, the discoveries keep coming.

No, the new headlines about academic research deal in the grave threats it now faces: massive cuts in the way university R&D is funded, the revocation of grants that don’t align with federal priorities, the slow-walking of new grant approvals.

Defending science and scientific inquiry is vital right now, for all the reasons you might imagine—and for one you might not. When academic research is an integrated, meaningful part of the undergraduate experience, it develops students into more critical and creative thinkers, better communicators, collaborators, and problem solvers. Undergraduate research builds learners’ confidence and focuses their career plans. It predicts better grades and graduation rates, and reduces equity gaps, particularly in STEM. Students consistently say that research is among the most valuable components of their college career.

ASHBURN, Va., May 22, 2025 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the “Company” or “Quoin”), a clinical stage, specialty pharmaceutical company focused on rare and orphan diseases, today announces FDA clearance to initiate a second Netherton Syndrome (NS) pivotal clinical study CL-QRX003-002 for QRX003. Quoin’s lead product, QRX003, is a topical lotion formulated with a broad-spectrum serine protease inhibitor that has been shown to significantly downregulate the hyperactivity of the kallikreins in the skin responsible for the excessive skin shedding associated with this disease. Clinical data from Quoin’s ongoing studies has demonstrated clear evidence of rapid, prolonged and almost complete skin healing following twice-daily application of QRX003 to the treatment areas along with the almost complete elimination of key symptoms such as chronic, debilitating pruritus and has facilitated zero nightly sleep disturbances.

GAITHERSBURG, Md.--(BUSINESS WIRE)--GeneDx (Nasdaq: WGS), a leader in delivering improved health outcomes through genomic insights, today announced the publication of a new article in the American Journal of Medical Genetics, demonstrating GeneDx’s leadership in applying artificial intelligence (AI) to accelerate and enhance genetic diagnostics. The article was published as part of an essay collection written by global experts addressing how AI is shaping, and will continue to shape, the future of medical genetics.

The GeneDx-authored article, “AI in the Clinical Genomics Laboratory,” underscores the promise of harnessing AI to increase diagnostic yield, reduce manual workflows, and scale precision medicine for all patients with suspected genetic conditions.

Navigating the Shifting Federal Funding Landscape

Strategies, Insights, and AI-Driven Approaches for Winning Non-Dilutive Capital

The federal funding landscape is undergoing a significant transformation. With a new administration in office, the dynamics of securing non-dilutive capital are shifting—requiring organizations to move strategically and with precision to stay ahead. In this high-impact 45-minute session, Grant Engine and BioHealth Innovation bring together their leadership to break down the latest changes, clarify what remains uncertain, and showcase what top-performing companies are doing right now to secure meaningful, large-scale funding.

By Sara Gilgore – Staff Reporter, Washington Business Journal - May 21, 2025 - Once the Department of Health and Human Services unveiled a plan to cut 10,000 positions, United Therapeutics Corp. didn’t waste time.

The publicly traded Silver Spring drugmaker saw an opportunity to scoop up some of that talent, hiring a handful of former HHS employees, including from the Food and Drug Administration, and entering into consulting agreements with others, according to Dewey Steadman, UT's head of investor relations. The 1,305-person company, which counts about 250 D.C.-area employees, has even created a role for one professional with “specific skills that are critical to us,” he said.

United Therapeutics (NASDAQ: UTHR) isn’t alone. AstraZeneca, Lonza Group, Kite Pharmaceuticals and Thermo Fisher Scientific are among the local life sciences firms actively hiring, and while no one is cheering the loss of so many public-sector jobs, “there’s a clear opportunity to connect federal talent with private-sector innovation," said Richard Bendis, president and CEO of Rockville’s BioHealth Innovation Inc.

“These are folks with deep regulatory, scientific, and policy expertise who know how to navigate complex systems and bring big ideas to life,” Bendis said. “And in a region like ours, that’s a serious asset.”