HJF

A new hub for biotech and medical device startups is on the horizon. The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (HJF) is preparing to open the doors to HJF Innovation Labs in North Bethesda, Maryland, with occupancy beginning Fall 2025.

This first-of-its-kind incubator is tailored to support the development of dual-use medical technologies—those that serve both military and civilian needs. From navigating the complexities of military medical product development to accessing HJF’s expansive research infrastructure and stakeholder network, startups will gain the tools they need to scale innovation and bring critical solutions to market.

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Maintaining biotechnology superiority is essential to the U.S. economy and national security, and it must be supported with strategic federal funding that leans into America’s strengths by encouraging private investment, according to a three-year-long Congressional study.

“From more productive seeds and targeted cancer therapies to the possibility of genetically enhanced soldiers, biotechnology’s reach extends far beyond the laboratory,” says the report from the National Security Commission on Emerging Biotechnology (NSCEB), released April 8. “Falling further behind would signal a global power shift toward China and create an array of new strategic challenges for the U.S. government.”

TedcoNeuros

COLUMBIA, Md., (April 14, 2025) — TEDCO, Maryland’s economic engine for technology companies, announced a recent $25,000 Pre-Seed Rural Business Innovation Initiative (RBII) investment in Neuros Biotechnology, Inc. TEDCO’s RBII was designed to enhance technology commercialization and provide technical and business assistance to small and early-stage companies based in rural Maryland.

AI for Smart

The Maryland Department of Commerce, in collaboration with the University of Maryland, College Park, is hosting the AI for Smart Manufacturing Productivity Forum on Tuesday, May 13, from 1:00 PM to 6:00 PM at A. James Clark Hall.

This half-day event brings together experts, industry leaders, and policymakers to explore how artificial intelligence can transform manufacturing productivity, especially for small and medium-sized enterprises. Highlights include a keynote from Dr. Jay Lee, Director of the Industrial AI Center, and panel discussions featuring leaders from IBM, Hardwire, Fraunhofer USA, and more.

MCEDCIH

BioHealth Innovation, Inc. (BHI) was proud to join innovators, resource partners, and public officials at the first-ever BioConnect event—a new platform designed to foster collaboration across Montgomery County’s life sciences community. Held at the University of Maryland Institute for Health Computing (UM-IHC) in North Bethesda, the event was co-hosted by Montgomery County, MCEDC, and UM-IHC, and marks the start of a recurring series aimed at deepening connections between startups, investors, and regional stakeholders.

BHI’s Executives-in-Residence Luis Gutiérrez, and Jennifer Butler attended the event alongside Montgomery County Councilmembers Andrew Friedson and Natali Fani-Gonzalez, offering an opportunity to express appreciation for the County’s continued support of the BHI EIR program and broader innovation infrastructure.

Medtech

On April 8, 2025, the Maryland MedTech Summit convened nearly 370 leaders from across the medical technology ecosystem at the University of Maryland, College Park, spotlighting the depth and diversity of the region’s growing MedTech community. Held at the Stamp Student Union as the flagship event of the inaugural Maryland MedTech Week, the summit offered a full day of programming, networking, and insights into the future of device innovation. This was the 2nd Annual Maryland MedTech Summit, and the Inaugural Maryland MedTech Week, which also featured investor-focused events hosted by Ecphora Capital, The LaunchPort, and the two-day MedTech Innovator East Coast Road Tour.

BioHealth Innovation, Inc. (BHI) was proud to serve as a sponsor of this year’s summit and sent a strong delegation of Entrepreneurs-in-Residence (EIRs), including Luis Gutiérrez, Albine Martin, Jon Kay, Ray Blanchard, and John Sullivan, all of whom provide strategic commercialization support to MedTech startups and early-stage companies across the BioHealth Capital Region and beyond.

Mark Esser

by Kate Andrews - Mark T. Esser, vice president for vaccines and immune therapies at pharmaceutical giant AstraZeneca, will be the inaugural chief scientific officer and leader of the Paul and Diane  at the , U.Va. announced Thursday.

Esser, who will join U.Va. May 1, earned a Ph.D. in microbiology in 1998 from U.Va.’s medical school, and has worked in translational medicine at AstraZeneca, MedImmune (which was acquired by AstraZeneca) and Merck. He was involved with development of Evusheld, a medicine that helped prevent and treat COVID-19; infection and cancer vaccine programs; human papillomavirus vaccines; and a monoclonal antibody that helps prevent RSV in infants.

The $350 million Manning Institute, launched in 2023 with a $100 million donation from Albemarle County investors Paul and Diane Manning, is a hub for biotech research, development and manufacturing at U.Va., which is building a 350,000-square-foot structure in Fontaine Research Park in  that’s expected to open by late 2026 or early 2027, according to Paul Manning. A member of the university’s board of visitors, Manning founded PBM Products, an infant formula and baby food business, which he sold to Perrigo for an estimated $808 million in 2010. He then started PBM Capital, a private equity firm that invests in pharmaceutical and life sciences startups.

Tammy

By Alex Keown - Tammi Thomas is a proponent of agape love, a selfless form of unconditional love that puts the needs of others first. Agape love is not static; it requires demonstrative action, something that drives Thomas in both her personal and professional lives.

“This is the kind of love where you see humanity before you see their differences,” she says.

This mindset is critically important for Thomas, who serves as Chief Development and Marketing Officer at TEDCO (Maryland Technology Development Corporation) headquartered in Columbia. TEDCO supports early-stage technology and life sciences companies in Maryland through resources, connections, and funding opportunities that allow businesses to grow.

In her role, Thomas leads the overall strategic direction, execution, and management of the organization’s marketing and fundraising strategies. Through careful crafting and shaping of TEDCO’s strong brand identity, Thomas says entrepreneurs across the state have learned that the organization is a reliable source for venture capital investments – within the top 20 investors in the Mid-Atlantic region, according to Pitchbook. The constant stitching and storytelling Thomas directs continues to promote scaling and stickiness that brings diverse stakeholders together in a collaborative way.

60degree

WASHINGTON, D.C., April 08, 2025 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (“60 Degrees” or the “Company”), a pharmaceutical company focused on developing new medicines for infectious diseases, today announced the signing of a Patent License Agreement with Yale School of Medicine and Yale School of Public Health to jointly advance the development and commercialization of tafenoquine for the treatment and prevention of babesiosis.

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On April 1st, Georgetown University celebrated a landmark moment in its growing innovation ecosystem with a full-day dedicated to advancing research, entrepreneurship, and industry collaboration. Hosted by Georgetown’s Office of Technology Commercialization (OTC) in partnership with Georgetown Entrepreneurship, the day’s programming highlighted the university’s commitment to translating bold ideas into real-world solutions.

The day began with the Innovation Awards Luncheon, where outstanding inventors were recognized for their contributions to scientific advancement and commercialization. The Crystal Awards, in particular, honored researchers who are successfully bridging the gap between discovery and application, turning transformative research into real-world impact.

GeneDX2

GAITHERSBURG, Md.--(BUSINESS WIRE)--GeneDx (Nasdaq: WGS), a leader in delivering improved health outcomes through genomic insights, today announced the commercial expansion into Inborn Errors of Immunity (IEI), a group of nearly 500 genetic disorders that impair immune function2, increasing susceptibility to infections, autoimmunity, and inflammatory conditions. The strategic expansion reinforces GeneDx’s mission to improve patient outcomes by providing exome and genome testing solutions for an ever-growing number of patients, now including those with inherited immunological conditions.

United Therapeutics logo

SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, announced today that Great Place to Work® and Fortune magazine recognized the company as one of the Fortune 100 Best Companies to Work For® in 2025. United Therapeutics ranked number 73 out of the 100 companies across the nation included in the list.

“We are honored to be recognized by Fortune as one of the 100 Best Companies to Work For,” said Michael Benkowitz, President & Chief Operating Officer of United Therapeutics. “This reflects a key management objective that United Therapeutics be a destination employer, where Unitherians can have their best career while fulfilling our mission to help very sick patients through the development of novel therapeutics and progress toward an unlimited supply of transplantable organs.”

MaxMaryland

This summer, your business can tap into Maryland’s top graduate business talent and get rewarded for it. The Maximizing Maryland Graduate Internship Program, run by the Center for Global Business (CGB) at the Robert H. Smith School of Business, offers companies a $1,500 reimbursement per intern hired—while connecting you with highly skilled students trained in global marketing, supply chain, finance, and business strategy.

2025 BHCR Save the Date Square website

Mark your calendars! The 11th Annual BioHealth Capital Region Forum will return September 23rd–24th, 2025, once again hosted at US Pharmacopeia (USP) in Rockville, Maryland. This year’s theme, “The BioHealth Capital Region: Where Human and Artificial Intelligence Converge in the BioHealth Industry,” sets the tone for a timely and necessary conversation. As our sector faces new challenges and opportunities, 2025 is a critical year to align on strategy, innovation, and regional collaboration.

In addition to the Forum, we are excited to bring back the 8th Annual BioHealth Capital Region Investment Conference on September 25th, also at USP. Designed to foster meaningful connections between startups and investors, this conference continues to be a key driver of funding and momentum across our ecosystem.

A Call for Sponsors

We invite returning and new sponsors to help make this year’s event possible. Your support not only fuels the success of the Forum and Investment Conference but also ensures these events remain free to attend for all participants across the region. With your help, we’ll once again bring together over 1,000 leaders from government, industry, and academia to chart the course for the future of biohealth.

quoin

ASHBURN, Va., April 02, 2025 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the “Company” or “Quoin”), a late clinical stage, specialty pharmaceutical company focused on the development and commercialization of therapeutic products that treat rare and orphan diseases, today announces additional highly positive clinical data from its ongoing Investigator Pediatric Netherton Syndrome (NS) study. After 6 weeks of continued whole body application of QRX003, the subject’s skin remains almost completely healed demonstrating the durability of ongoing daily treatment with the product. In addition, the patient has continued to have no requirement for previously necessary medications such as antibiotics, antivirals, antihistamines and glucocorticoids. Importantly, with the patient’s pruritus or itch almost completely eliminated, she continues to experience zero nightly sleep disturbances without the need for any sedating medication, marking the first continuous period of uninterrupted sleep in the patient’s life. No adverse events have been reported to date after 6 weeks of whole body treatment with QRX003.

IGC

POTOMAC, MD / ACCESS Newswire / April 1, 2025 / IGC Pharma, Inc. (NYSE American:IGC) today announced the expansion of its Phase 2 clinical trial, CALMA, evaluating IGC-AD1 for the treatment of agitation in Alzheimer's dementia, to MIND Institute at Miami Jewish Health in Miami, Florida. This addition further advances the company's efforts to accelerate the trial's completion and builds on promising interim data suggesting the potential of IGC-AD1 to improve patient outcomes.

Miami Jewish Health specializes in healthcare and living options for seniors, providing services for more than 85 years and hosting cutting-edge Alzheimer's disease clinical trials. The organization is dedicated to advancing research and innovative treatments for neurocognitive disorders, improving care for individuals living with Alzheimer's and related conditions.

Vanda

WASHINGTONMarch 31, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) today announced that a New Drug Application (NDA) was submitted to the U.S. Food and Drug Administration (FDA) requesting marketing approval of Bysanti™ (milsaperidone) for the treatments of acute bipolar I disorder and schizophrenia. The NDA is supported by several clinical studies assessing the efficacy and safety of Bysanti™.

Tars

U.S. tariffs on imports could increase the cost of biotechnology operations, threatening innovation that helps patients, according to a survey of biotech firms by the Biotechnology Innovation Organization (BIO).

Nearly 90% of U.S. biotech companies rely on imported components for at least half of their Food and Drug Administration (FDA)-approved products, and they say tariffs would hurt their business, the survey of BIO member companies found.

“This survey demonstrates the far-reaching and potentially damaging impacts of the proposed tariffs on our biotechnology industry, on biomedical research and on patients,” said BIO President & CEO John F. Crowley.

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BETHESDA, Md., March 31, 2025 (GLOBE NEWSWIRE) -- CorVista Health today announced a poster presentation showcasing preliminary results of its machine learning-based algorithm for non-invasively estimating pulmonary capillary wedge pressure (PCWP) elevation – a key indicator of heart failure with preserved ejection fraction. The poster titled ‘Point-of-Care Testing for Pulmonary Capillary Wedge Pressure Elevation Using Machine Learning on Non-invasive Signals’ was presented at the American College of Cardiology’s Annual Scientific Session (ACC.25) in Chicago on March 30, 2025.

Currently, PCWP is measured through an invasive right heart catheterization (iRHC) procedure that requires a cardiologist, pulmonologist or intensivist. The CorVista capture device collects non-invasive signals for 3.5 minutes in patients at rest, which could potentially provide an alternative to iRHC in certain patient populations. The data demonstrate how machine learning signal analysis of a symptomatic population may provide a robust, non-invasive alternative to measuring PCWP elevation, potentially making early detection of HFpEF and PH subtypes more accessible.

Solaxa

Bethesda, MD — March 28, 2025 – Solaxa Inc., a biopharmaceutical public benefit corporation focused on rare neurological conditions, has announced plans to conduct a registrational clinical trial evaluating its investigational therapy, SLX-100, for spinocerebellar ataxia type 27B (SCA27B).

This pivotal-powered study will be funded in part by a $7.3 million dollar grant awarded to Dr. Susan Perlman, MD, at the University of California, Los Angeles by the Congressionally Directed Medical Research Program. Solaxa will serve as the regulatory sponsor of the trial and partner with leading ataxia centers of excellence. Additional clinical trial sites will be announced later this year.

There are currently no FDA approved therapies for SCA27B, a rare hereditary ataxia. “We are thrilled to move one step closer to impacting the lives of people living with SCA27B,” said Christian Walker, CEO & Founder of Solaxa.

George Mason

Emily Seymour | InsideNoVa Mar 28, 2025 - George Mason University held the grand opening of its new life sciences and engineering building in Manassas on Thursday, celebrating the addition to its Science and Technology Campus.

The $107 million project supports the university’s growing need for specialized instructional labs, classrooms and support spaces for students, officials said. The building has classrooms and more than 30 different lab spaces for teaching, design and fabrication, offering hands-on learning for students across a number of disciplines.

University leaders celebrated the opening Thursday, joined by local leaders, including Virginia Del. Luke Torian, Del. Ian Lovejoy, Del. Briana Sewell, state Sen. Danica Roem and several members of the Prince William Board of County Supervisors.

Eluta

SILVER SPRING, Md., March 27, 2025 (GLOBE NEWSWIRE) — Elutia Inc. (Nasdaq: ELUT) (“Elutia” or the “Company”), a pioneer in drug-eluting biomatrix products, announced that it has entered into an agreement with Advantus Health Partners (“Advantus”), to provide access of Elutia’s EluPro™ Antibiotic Eluting BioEnvelope to Advantus’ core group purchasing organizations (GPO) solutions portfolio.

“Teaming up with Advantus is another major step forward in meeting the strong customer demand for EluPro,” said Dr. Kimberly Mulligan, GM and VP of Elutia’s Cardiovascular Division. “Our pilot launch of EluPro has exceeded our expectations as physicians recognize the unique value that this antibiotic envelope brings in preventing infection for patients that use a cardiac implantable electronic device. Broadening our GPO coverage with Advantus allows us to benefit from their sustainable contracting solutions, making EluPro more widely available to physicians nationwide.”

4MLK

By Dan Beyers, Katelyn Keiser - CoStar News - March 26, 2025 - If there is a field of dreams in Baltimore these days, it might be 4MLK, the gleaming new eight-story, 250,000-square-foot lab and office building that stands at the gateway of the University of Maryland's life science and technology center, BioPark.

When it is fully leased, 4MLK hopes to house the largest cluster of bioscience companies in the greater Baltimore region, bringing 1,000 jobs to the city and doubling the size of the workforce now employed by nearly three dozen companies at the center. It's an ambition that earned the project a 2025 CoStar Impact Award as judged by real estate professionals in the market.

Robert H Smith school

COLLEGE PARK, Md.March 26, 2025 /PRNewswire/ -- Registration is open for "Business of Life Sciences and Healthcare for Leaders" (B-LSHC) — an immersive five-day program focused on leadership development and honing critical-thinking and problem-solving skills in medical product development presented by Smith Executive Education at the University of Maryland's Robert H. Smith School of Business.

The in-person program takes place June 23-27, 2025, at Van Munching Hall on UMD's College Park campus and is designed for mid-to-advanced career professionals in the LSHC ecosystem including pharmaceutical, biotech and medical device industries; health policy; patient advocacy; regulators; investors; and leaders across medical and regulatory fields.

Program sessions will begin at 8:30 a.m. each day "and end with a luminary keynote speaker who will inspire and challenge participants to think outside the box toward the goals of creating innovative solutions for some of our most challenging problems in the LSHC ecosystem," says Wendy Sanhai, PhD, professor of the practice in management and organization for the Smith School and one of the workshop's organizers. 

Seal of Prince William County Virginia

March 25, 2025 - John Knowles, Studio B Writer - The BioCapital Region, which includes Washington, D.C., Maryland and Virginia, is one of the top life sciences clusters in the United States.

Prince William County has rapidly emerged as a key player in Northern Virginia’s life sciences sector. The Prince William County Department of Economic Development and Tourism, or PWCDEDT, has been focused on diversifying the economy and leveraging assets like George Mason University’s Science and Technology Campus to attract innovative companies to the region.

PWCDEDT Deputy Director Trevor Johnson said that the county’s life sciences growth can be traced back to its abundant rural land, offering a rare opportunity for expansion in the Greater Washington area.

Secretome

PLANO, Texas & BALTIMORE--(BUSINESS WIRE)--Secretome Therapeutics, a clinical-stage biotechnology company developing novel therapies derived from neonatal cardiac progenitor cells (nCPC), today announced dosing of the first patient in its Phase 1 clinical trial evaluating STM-01 as a treatment for heart failure with preserved ejection fraction (HFpEF).

This is the first-ever clinical study of an allogeneic, off-the-shelf stem cell therapy in HFpEF, a leading cause of hospitalization, morbidity, and mortality worldwide. An estimated 6.7 million adults in the U.S. are affected by heart failure, with HFpEF comprising at least half of these cases.

NanoQT

NanoQT, a Tokyo-based quantum computing company, recently announced its expansion into Maryland, with the intent to strengthen the company’s research and development capabilities and commercialization in the U.S.

The move follows the company’s participation in Maryland’s Global Gateway program, which incentivizes foreign companies to “soft land” in the U.S., offering affordable office spaces at Maryland incubators as well as access to advisors and other resources. As a Global Gateway participant, NanoQT took up residency at the Quantum Startup Foundry incubator on the University of Maryland campus, where the company will maintain its presence.

LunaLabs

Technology development company will invest $200,000 and create 20 new jobs 

RICHMOND, VA — Governor Glenn Youngkin today announced that Luna Labs USA, LLC, a product development company accelerating breakthrough solutions to multiple industries, will invest $200,000 to expand its operations in the City of Charlottesville. The company will create 20 new jobs.  

“Luna Labs' expansion demonstrates Virginia's ability to cultivate and retain innovative technology companies,” said Governor Glenn Youngkin. “When high-tech firms choose to grow in the Commonwealth, it reinforces our position as a hub for research and development, particularly in sectors like aerospace, energy and defense. LunaLabs' success story showcases how Virginia's world-class talent pipeline and collaborative ecosystem help companies thrive.” 

Welldoc

Digital Health Leader's Innovation in Real-Time Sensor-Based AI Sets New Standards for Personalized Cardiometabolic Care

COLUMBIA, Md.--(BUSINESS WIRE)--Welldoc®, a digital health leader revolutionizing cardiometabolic care, today announced the issuance of four new patents, marking its 54th patent grant. This milestone underscores Welldoc’s relentless commitment to innovation and leadership in leveraging artificial intelligence (AI) and advanced predictive capabilities based on real-time sensor data. The company’s digital health platform empowers individuals with personalized AI-driven digital coaching to enable self-management of cardiometabolic conditions, positive lifestyle changes and improved overall health and outcomes.

The new patents focus on Welldoc's unique approach to combining dense, sensor-based data specifically collected from Continuous Glucose Monitors (CGM), with AI to predict future engagement levels, health metrics and improved outcomes. This includes the development of a "CGM-GPT" model using generative AI techniques to predict future glucose values.

Hememics Biotechnologies Inc Logo

Biosensor company receives additional funding to continue development and research

COLUMBIA, Md., (March 19, 2025) — TEDCO, Maryland’s economic engine for technology companies, announced a recent $250,000 Venture Funds investment in Hememics Biotechnologies, Inc. TEDCO’s evergreen Venture Funds are dedicated to funding and growing the next generation of early-stage businesses in Maryland.

“I am excited to be a part of Hememics’ mission to transform the future of diagnostics,” said John Warden, CEO of Hememics Biotechnologies, Inc. “Thanks to TEDCO’s latest investment, we are looking forward to continuing our growth and development. If you’re an entrepreneur in Maryland looking to flourish, I highly recommend connecting with TEDCO; there are several resources and opportunities the organization can offer – it’s so much more than just funding.”

sapio logo color 2

BALTIMORE--(BUSINESS WIRE)--Sapio Sciences, the science-aware™ lab informatics platform, today announced the integration of the NVIDIA BioNeMo platform into the Sapio Lab Informatics Platform. This integration brings AI-driven computational drug discovery directly into Sapio ELN (Electronic Lab Notebook), helping to streamline workflows and improve decision-making in drug discovery.

With the BioNeMo platform, researchers can accelerate drug discovery by leveraging science-specific AI frameworks, pre-trained models, and generative AI tools to streamline the identification of potential drug candidates and improve target selection accuracy. NVIDIA BioNeMo provides scientists with a framework for training and deploying large biomolecular language models at supercomputing scale.

GeneDX

GeneDx recognized for its innovative approach to accelerating genetic diagnosis and transforming the future of healthcare by ending the diagnostic odyssey

GAITHERSBURG, Md.--(BUSINESS WIRE)--GeneDx (Nasdaq: WGS), a leader in delivering improved health outcomes through genomic insights, announced today they have been named to Fast Company’s prestigious list of the World’s Most Innovative Companies of 2025, and recognized as the No. 2 in the Biotech category. This year’s list shines a spotlight on businesses that are shaping industry and culture through their innovations to set new standards and achieve remarkable milestones in all sectors of the economy.

Phlow

Validation Completed for a Novel, Cost-Competitive Epinephrine Active Pharmaceutical Ingredient Process, Drug Master File Successfully Filed

Richmond, Virginia, March 17, 2025 (GLOBE NEWSWIRE) -- Phlow Corp., a U.S.-based certified B Corporation on a mission to bring medicines to life through advanced development and manufacturing in America, today announced a major milestone, achieving a successful process validation campaign for Epinephrine active pharmaceutical ingredient (API) production. This achievement positions Phlow to continue advancing toward full domestic production capabilities in its state-of-the-art U.S. facilities for this life-saving medicine.

AZ

The British drugmaker is paying up to $1 billion to buy the Belgian startup, whose technology it sees as useful in treating cancer as well as autoimmune conditions.

AstraZeneca is bolstering its cell therapy capabilities, agreeing on Monday to pay up to $1 billion for a biotechnology startup making treatments that reprogram cells inside the body.

The British drugmaker is buying EsoBiotech, a Belgian startup, for $425 million in cash upfront. EsoBiotech’s investors, among them Invivo Partners and UCB Ventures, could receive up to $575 million in additional payouts should the startup’s programs hit certain development and regulatory milestones, AstraZeneca said in a statement.

NIHGrants

The National Institutes of Health (NIH) is vital in driving scientific discovery and economic growth across the United States. Recent reports from United for Medical Research (UMR) and Forbes highlight just how impactful NIH funding has been—generating $94.58 billion in economic activity in FY2024 alone and supporting more than 407,000 jobs nationwide. For every $1 invested, NIH research funding returns $2.56 in economic impact.

For the BioHealth Capital Region (BHCR)—home to NIH, the FDA, and a growing network of research institutions and life sciences companies—this funding is critical. NIH grants fuel the work of startups, researchers, and small businesses developing groundbreaking technologies in biotech, AI-driven drug discovery, personalized medicine, and advanced therapeutics. Without sustained investment, the entire innovation ecosystem is at risk, impacting job creation, commercialization efforts, and, ultimately, patient outcomes.