Kolaleh Eskandanian, chief innovation officer at Children’s National Hospital, said the partnership is meant to address the many challenges with developing devices for children and infants.

Published Jan. 2, 2025 - Elise Reuter, Reporter

A collaboration between a children’s hospital and the Food and Drug Administration aims to address challenges in developing medical devices for children and infants. 

Children’s National Hospital in Washington, D.C., struck a five-year research collaboration with the FDA’s Office of Science and Engineering Laboratories (OSEL) to build regulatory science tools to help evaluate pediatric devices. 

The partners will use de-identified clinical data, multimodal imaging and machine learning to develop open-source tools that can be used to design and test devices more efficiently. 

BHI is proud to support ARPA-H through its Partnership Intermediary Agreement (PIA), providing EIR commercialization services to advance groundbreaking technologies. Notably, BaySpec, one of BHI’s clients, was awarded ARPA-H’s first SBIR grant to develop cutting-edge diagnostics. Andy Kilianski, Program Manager at ARPA-H, recaps key 2024 milestones, including AI-driven drug discovery, RNA therapies, and the $204M APECx biologics program. These efforts underscore ARPA-H’s commitment to accelerating biomedical innovation.

Portfolio Views from 2024
Andy Kilianski
Program Manager at ARPA-H

December 30, 2024
Happy Holidays Everyone!

2024 was a BIG year for my team and our investments in the biomedical and biotechnology ecosystem. Our goal is to invest in transformative technology that allows biomedical R&D to be predictive of human outcomes, in ways that are currently impossible. I want to capture some of our key milestones (in semi-chronological order) to highlight the amazing work already underway with our team at the Advanced Research Projects Agency for Health (ARPA-H) . My team and our performers have been incredibly diligent and dedicated to get us to this point. There are a lot of efforts soon-to-be-announced from us as we head into next year, including the kick-off of the CATALYST program mid-2025.

Precigen has submitted a Biologics License Application (BLA) to the FDA, seeking priority review for PRGN-2012, which could become the first FDA-approved treatment for adults with recurrent respiratory papillomatosis (RRP)—a rare and chronic disease currently managed through repeated surgeries. PRGN-2012 has received Breakthrough Therapy and Orphan Drug Designations from both the FDA and the European Commission. The application, submitted under an accelerated approval pathway, is backed by Phase 1/2 study data showing over 50% of patients achieved Complete Response and more than 85% experienced fewer surgeries in the year following treatment. PRGN-2012 was also well-tolerated, with no dose-limiting toxicities and no severe treatment-related adverse events.

National Cancer Institute (NCI) has awarded a $357,000 SBIR grant to Arnold Consultancy & Technology, LLC to develop an open source model marketplace.

MIAMI BEACH, FL, UNITED STATES, December 30, 2024 /EINPresswire.com/ -- New cancer drugs have long been at the forefront of research and debate about rising healthcare expenditure in the United States; researchers and decision-makers rely on evidence to support fair pricing and ensure patient access. HE models support stakeholders in decision-making about the most cost-effective care for the available resources. Annually, stakeholders spend an estimated $1B on health economics and outcomes research (HEOR), much of it to create and recreate health economic (HE) models. Global government bodies use these models to formulate response and reimbursement decisions, aid resource allocation and suggest value-based pricing for new therapies. Sharing models by making their “source code” openly available would mitigate these problems, but prior initiatives to promote model sharing have had limited success in part because model authors fear the loss of their intellectual property and are not paid for their models being deposited.

BHI is excited to highlight Rachel Rath’s recent LinkedIn Post, where she reflects on her first 90 days as Head of JLABS @ Washington, DC. Rachel, who recently joined the BHI Board of Directors, discusses the Mid-Atlantic’s strengths—including its talent pool, investor activity, and opportunities for deeper collaboration.

We look forward to continuing to work with Rachel and JLABS to drive growth and innovation in the BioHealth Capital Region.

90 Days In: Reflections on an Evolving Life Science Landscape in the Mid-Atlantic

Children’s National Innovation Ventures is hosting the Symposium on Pediatric Medical Countermeasures (MCMs) and the SPARK for Innovations in Pediatrics Launch and Prize Competition—a premier event under the BARDA Accelerator Network 2.0. This exciting gathering will focus on advancing pediatric-focused MCMs, featuring insightful discussions and a live competition where finalists will pitch their groundbreaking solutions for a chance to secure non-dilutive funding from SPARK.

The event will also include a ribbon-cutting ceremony to officially launch the SPARK Hub, followed by a cocktail reception to celebrate this milestone in pediatric innovation.

BioHealth Innovation (BHI) is a proud partner in this initiative, supporting efforts to drive advancements in pediatric medical countermeasures and foster impactful innovation.

Event Details:

• Location: Children's National Research and Innovation Campus, 7144 13th Pl NW, Washington, DC 20012
• Date and Time: Tuesday, January 28, 2025, from 3:00 PM to 7:00 PM

For more information, visit https://lp.constantcontactpages.com/ev/reg/2p7f9t5.

Join us in celebrating this important step toward transforming the future of pediatric healthcare!

Italy, December 23, 2024. PQE Group is proud to announce its most recently-received official recognitions: ISO/IEC 27001 and A Women’s Business Enterprise (WBE) Certifications, which provide additional reasons to recognize PQE Group’s extensive capabilities; the ISO/IEC 27001 provides clients assurance that their information management systems are risk-aware and that PQE Group’s solutions can proactively identify and address weaknesses; the WBE Certification ensures that PQE Group has met the stringent eligibility criteria to be classified as a women-owned enterprise.

DEC 20, ANNAPOLIS, MD — Governor Wes Moore today signed an executive order to strengthen Maryland’s business climate and catalyze more economic growth in the state. The governor signed the order during a visit to the Frederick Hotel and Conference Center project site in Frederick—a public-private development project that is expected to generate $1.5 billion in new private sector spending over the next 25 years, more than 200 jobs, and more than $4 million in state and local tax revenue annually. 

SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced the world’s first transplant of a UKidney, which it produced, into a living person on November 25, 2024.

Guillermo Flor -
How to pitch to investors
The basics:
1. Venture Capitalists have an investment thesis they have to follow. If your startup doesn’t fit the investor’s thesis don’t bother pitching

2. Most times you’ll start pitching to associates. Then the associates will have to share the opportunity with the rest of their investment team. The easier you make their job the more chances you have.

3. How you pitch your startup gives out a lot of information about you to investors. Make sure your investment materials are organized, your pitch is concise and to the point and you are likeable.

GAITHERSBURG, Md., Dec. 16, 2024 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) today announced that the Biomedical Advanced Research and Development Authority (BARDA) within the Administration for Strategic Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services has awarded a $50 million option to Emergent’s existing contract (HHSO100201600030C) for the acquisition of CYFENDUS^® (Anthrax Vaccine Adsorbed, Adjuvanted).

GAITHERSBURG, Md., Dec. 13, 2024 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced progress in Q4 2024 advancing its corporate growth strategy through its partnership with Sanofi. The Company has achieved a milestone associated with its Phase 2/3 clinical trial for its COVID-19 vaccine in children, triggering the first $50 million milestone payment from Sanofi.

By Ana Lucía Murillo – Staff Reporter, Washington Business Journal Dec 12, 2024 - Connected DMV has tapped a new chief executive to lead the regionally focused nonprofit.

George Thomas, who has been with Connected DMV since its inception in 2019, is now president and CEO. The group’s founder and only CEO in its history, Stu Solomon, is now listed as executive chairman on the organization’s website. It’s unclear when the transition took place; Solomon was president and CEO as recently as May.

WASHINGTON, Dec. 11, 2024 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (60 Degrees Pharmaceuticals or the “Company”), a pharmaceutical company focused on developing new medicines for infectious diseases, announced today it has entered into a clinical trial agreement with Brigham and Women’s Hospital (BWH) in Boston to conduct a double-blind, placebo-controlled study evaluating the safety and efficacy of tafenoquine in combination with standard of care treatment for hospitalized babesiosis patients.

RICHMOND, VA, UNITED STATES, December 11, 2024 /EINPresswire.com/ -- Liquet Medical Inc., a pioneering medical device company committed to advancing patient care through innovative technologies, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Versus™ Catheter.

This innovative medical device is set to enhance the treatment of pulmonary artery blood clots by offering real-time pulmonary artery pressure measurements, empowering clinicians to optimize treatment based on individual patient responses. This novel technology enables a new treatment category called “Hemodynamics-Led Thrombolysis (HLT).”

Emmes®, part of Emmes Group®, a leading specialty tech and AI-enabled global contract research organization (CRO), today announced the appointment of Bryan Patterson to the newly created role of Senior Vice President, Government Business Development & Capture. This strategic expansion of Emmes’ leadership team underscores the company’s commitment to the U.S. Federal Government clinical research efforts, and to exceed expectations, drive innovation, and deliver even greater value.

GAITHERSBURG, Md., Dec. 10, 2024 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced that the first participants have been dosed in its COVID-19-Influenza Combination (CIC) and stand-alone seasonal influenza Phase 3 trial. The trial will evaluate the immunogenicity and safety of the CIC and stand-alone seasonal influenza vaccine candidates compared to Novavax's updated 2024-2025 COVID-19 vaccine (NVX-CoV2705) and a licensed seasonal influenza vaccine comparator in adults aged 65 and older.

FREDERICK, Md., Dec. 10, 2024 /PRNewswire/ -- Theradaptive, a privately held, clinical stage biologics company developing protein therapeutics for spine, orthopedics, soft tissue repair, and targeted immuno-oncology, announced today that the US Food and Drug Administration (FDA) has approved an expansion to its Phase I/II clinical program, broadening it to include three spinal fusion indications and tripling the number of investigational sites in the US.

The OASIS trial was approved by the FDA earlier this year to assess the safety and efficacy of OsteoAdapt™ SP, Theradaptive's implant with targeted biologics to treat degenerative disc disease, in a transforaminal interbody fusion (TLIF) approach. The recent approval encompasses two other common spinal fusion approaches: anterior lumbar interbody fusion (ALIF) and lateral lumbar interbody fusion (LLIF). The company anticipates enrollment of its first ALIF and LLIF study subjects in early 2025.

On December 4th, TEDCO hosted its 10th Entrepreneur Expo in Baltimore, bringing together over 1,000 entrepreneurs, investors, and industry leaders for a day of connection, learning, and celebration. As a premier event in Maryland, the Expo showcased the state’s vibrant entrepreneurial ecosystem through workshops, roundtable discussions, and exhibitions, featuring 95 speakers and 84 companies, including 34 startups. The BioHealth Innovation, Inc. (BHI) team was proud to participate in this dynamic gathering, further strengthening its commitment to fostering growth and commercialization in the BioHealth Capital Region.

BELTSVILLE, Md., Dec. 10, 2024 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class, and best-in-class therapies to treat cancer, today announced that the U.S. Food and Drug Administration (FDA) accepted an Investigational New Drug (IND) application for initiation of a Phase 1 clinical trial to evaluate LNCB74, a B7-H4-targeting antibody-drug conjugate (ADC) as a therapeutic for treating multiple cancers.

ANNAPOLIS, Md., Dec. 10, 2024 /PRNewswire/ --  Alphyn, a clinical-stage dermatology company developing first-in-class Multi-Target Therapeutics^®, announced today that the U.S. Patent and Trademark Office (USPTO) has granted the company a patent covering compositions and methods of use for the drug formulation of Zabalafin Hydrogel (AB-101a) for atopic dermatitis (AD). The patent covers Zabalafin Hydrogel through 2042 and is eligible for listing in the U.S. Food and Drug Administration's (FDA) Orange Book, which provides additional protective benefits once Zabalafin Hydrogel receives FDA approval.

Read more ...

ANNAPOLIS, MD – Governor Wes Moore today announced that applications are being accepted for the Maryland Soft Landing Exchange Program, which allows Maryland companies to explore international markets at a reduced cost by connecting them with business incubators and accelerators abroad. The program, administered by the Maryland Department of Commerce, is designed to support companies who are ready to expand their existing export capabilities, and serves as an important enhancement to existing state export assistance.

The Maryland Business Innovation Association (MBIA), with support from TEDCO, has announced the launch of the FY25 MBIA Commercialization Innovation Grant (MCIG). Designed to provide strategic funding to Maryland-based innovative companies, the program opens its application window on Tuesday, December 10, at 12pm noon ET. The MCIG offers eligible companies the opportunity to secure funding that supports entrepreneurial advancement and commercialization efforts, driving growth in Maryland’s innovation ecosystem and economy.

Baltimore, MD—The Baltimore Development Corporation (BDC) and the Maryland Department of Commerce are pleased to announce the Baltimore City Board of Estimates' approval of a $200,000 conditional loan to support the establishment of 4MLK Connect Labs, a state-of-the-art flex lab space in the University of Maryland BioPark in Baltimore, Maryland. This joint funding effort marks a significant step toward strengthening Maryland’s position as a national leader in the life sciences industry.

The $200,000 convertible loan from Baltimore City, combined with the state’s $2 million conditional loan, awarded through Advantage Maryland (formally known as MEDAAF), will fund specialized scientific lab equipment for approximately 35,000 square feet of flex lab space. The space will be operated by 4MLK Connect Labs JV LLC, a joint venture formed by affiliates of Wexford Science & Technology, LLC, and Ventas, Inc. It is projected to create at least 100 full-time permanent jobs in Baltimore by 2028.

WASHINGTON (Dec. 4, 2024) — In a significant collaboration to help advance pediatric health, Children’s National Hospital and the U.S. Food and Drug Administration’s (FDA) Office of Science and Engineering Laboratories (OSEL) in the Center for Devices and Radiological Health (CDRH) have signed a five-year research collaboration agreement to develop regulatory science tools (RSTs) intended to assist in the technical evaluation of pediatric and perinatal medical devices. 

This partnership aims to address long-standing challenges in testing novel medical devices for children and for perinatal care. By sharing de-identified clinical data and leveraging advanced technologies such as multimodal imaging and machine learning, the collaboration will generate data that may help inform the design and development of new pediatric and perinatal device-centered RSTs.

The National Cancer Institute (NCI) Technology Transfer Center is hosting a webinar on an exciting new technology that could revolutionize MRI metabolic imaging. Scheduled for Wednesday, December 18, 2024, at 11:00 AM ET, this free webinar will introduce a novel Signal Amplification By Reversible Exchange (SABRE) catalyst technology, co-developed by the National Heart, Lung, and Blood Institute (NHLBI) and NCI. This innovation promises to enhance MRI imaging capabilities, enabling groundbreaking advancements in the detection and monitoring of cancer, cardiovascular disease, stroke, and traumatic brain injury.

FREDERICK, Md., Dec. 03, 2024 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the “Company”), a clinical-stage biotechnology company pioneering mRNA cell therapy for autoimmune diseases, today announced updated efficacy and safety data from the Phase 2b trial of Descartes-08 in participants with generalized myasthenia gravis (MG) and provided details on the design of its planned Phase 3 AURORA trial. The updated data will be presented today at the 2^nd Annual Cell Therapy for Autoimmune Disease Summit being held in Philadelphia.

In this episode of BioTalk, host Rich Bendis welcomes Ric Hughen, CEO of Linshom Medical, and Talia Feldman, Software Engineer at Linshom Medical, to discuss their groundbreaking advancements in respiratory monitoring technology. As the main winners of the 2024 Crab Trap Competition at the 10th Annual BioHealth Capital Region Week, Ric and Talia share Linshom’s mission to improve patient safety through their innovative and accessible respiratory monitoring devices.

Ric explains how Linshom is addressing critical gaps in respiratory monitoring by bringing operating-room-quality data to patient bedsides and homes. Talia shares insights from the engineering side, highlighting the challenges and breakthroughs in developing reliable and user-friendly technology.

Listen now via your favorite podcast platform:
Apple: https://apple.co/4eVTWSO
Spotify: https://spoti.fi/4geg0c2
Amazon Music: https://amzn.to/4g5bIUy
TuneIn: https://bit.ly/4f5e3hu
YouTube Music: https://bit.ly/41deVxa

The conversation explores Linshom’s roots in the BioHealth Capital Region and how its partnerships and resources have been instrumental to the company’s growth. Talia reflects on her experience presenting at the Crab Trap Competition, and Ric discusses how this recognition aligns with Linshom’s broader visibility and growth objectives.

Chevy Chase, MD, 2 December 2024 – Uncommon Cures®, a pioneering organization dedicated to accelerating the development of orphan drugs, has announced a strategic collaboration with TASK, a leading global clinical research organization specializing in various therapeutic areas. This collaboration will combine Uncommon Cures’ innovative approaches to orphan drug development with TASK’s extensive clinical trial expertise, particularly across Europe and South Africa.

Under this partnership, Uncommon Cures and TASK will work together to streamline clinical trial processes, ensuring a faster and more efficient path to regulatory approval for orphan drugs. The collaboration aims to reduce the barriers associated with rare disease drug development, facilitating access to essential treatments for underserved patient populations.

Uncovering bias in AI models used in medical diagnosis. Identifying patients with potentially life-threatening antibiotic-resistant infections. Predicting the spread of disease with advanced computing.

These are just a few of the advances in medical care in the works at the University of Maryland Institute for Health Computing (UM-IHC), which uses high-performance computing and artificial intelligence to benefit public health in ways unimaginable just a few years ago.

GAITHERSBURG, Md., Nov. 26, 2024 (GLOBE NEWSWIRE) -- Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) (“Shuttle Pharma”), a discovery and development stage specialty pharmaceutical company focused on improving outcomes for cancer patients treated with radiation therapy (RT), announced today first patient enrollment and dosing at the UVA Cancer Center in its Phase 2 Clinical Trial of Ropidoxuridine for the treatment of patients with glioblastoma. UVA is one of six cancer centers conducting the clinical trials. Shuttle Pharma previously announced the dosing of patients at Miami Cancer Institute, part of Baptist Health South Florida.

Washington, D.C. – November 25, 2024 – Arlington Capital Partners (“Arlington”), a Washington, D.C.-area private investment firm specializing in government regulated industries, today announced it has acquired TEAM Technologies, Inc (“TEAM Tech”), a leading global manufacturer of essential healthcare products, from Clearlake Capital Group (“Clearlake”).

TEAM Technologies is a leading provider of specialized manufacturing and strategic supply chain solutions to blue-chip healthcare customers. The Company provides a broad array of end-to-end outsourced design and manufacturing services to medical device and pharmaceutical OEMs, with a growing specialty in advanced medical devices that are critical to the healthcare system. Through its comprehensive suite of vertically integrated processes, TEAM Tech enables customers to streamline their supply chains and reduce lead times in delivering critical products. TEAM Tech has approximately 1,000,000 square feet of manufacturing space across nine campuses in the U.S., Mexico, and Singapore.

In this episode of BioTalk with Rich Bendis, Dr. Eric Edwards, Co-Founder and CEO of MedPhlow, shares how his innovative company is reshaping emergency medicine through cutting-edge drug delivery systems. Dr. Edwards discusses his journey from co-founding Kaléo, where he helped develop life-saving products like AUVI-Q, to leading MedPhlow, a subsidiary of Phlow Corp. Based in Richmond, VA, MedPhlow is dedicated to addressing critical challenges in essential medicine delivery, with its first product focused on improving outcomes during sudden cardiac arrest.

Dr. Edwards explains the groundbreaking technology behind MedPhlow’s platform and how it is poised to transform emergency care. He also highlights the impact of investor partnerships, such as those with Virginia Venture Partners, and discusses MedPhlow’s next milestones in its mission to make emergency medicine more efficient and accessible.

As a part of the BioHealth Capital Region, Dr. Edwards reflects on the advantages of being based in this vibrant hub of innovation and his contributions as a BioHealth Innovation (BHI) board member. Tune in to learn about the future of MedPhlow and the inspiring work being done to advance life-saving solutions in healthcare.

Listen via your favorite podcasting platform:

Apple: https://apple.co/3Z7GqWf
Spotify: https://spoti.fi/3YYh6Sq
Amazon Music: https://amzn.to/4i16tXI
TuneIn: https://bit.ly/4hWAiJ7