Andy

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. 

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.

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.

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. 

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

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.

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.