New Members at NORD, Pangea, AstraZeneca Collaboration, Predicting Human Toxicity

New Members at NORD, Pangea, AstraZeneca Collaboration, Predicting Human Toxicity

By Clinical Research Staff

December 22, 2025 | The National Organization for Rare Disorders (NORD) adds seven new members its national NORD Rare Disease Centers of Excellence Network; Pangaea announces a multi‑year strategic collaboration with AstraZeneca; Sanford Burnham Prebys Medical Discovery Institute plan to develop computational models to predict human toxicity; and more.

Researchers at Sanford Burnham Prebys Medical Discovery Institute plan to develop computational models to predict human toxicity thanks to a grant from the Advanced Research Projects Agency for Health (ARPA-H). The multi-institution, $31.7 million contract funds a project called Pharmacological Research and Evaluation through Digital Integration and Clinical Trial Simulation (PREDICTS). In addition to reducing the long timeline usually associated with drug development, the goal is to also reduce the need for laboratory animal models and catch safety problems with new drugs before they are tested in people. Press release.

The National Organization for Rare Disorders (NORD) adds seven leading academic medical and research centers to its national NORD Rare Disease Centers of Excellence Network, expanding collaboration to improve care and accelerate research for the more than 30 million Americans living with rare conditions. The seven new members are: Cedars-Sinai Rare Disease Advocacy, Research & Excellence in Care (California); Children's Hospital Los Angeles & Keck NORD Center of Excellence for Rare Disorders (California); The New Jersey Center for Rare Disorders at Rutgers University (New Jersey); NYU Langone Health – NORD Rare Disease Center of Excellence (New York); Oregon Health & Science University Center of Excellence for Rare Diseases (Oregon); Rare Disease Center of Excellence at Children's Mercy Hospital and University of Kansas (Kansas); and University of California, Davis Health Center of Excellence for Rare Disorders (California). With these new members, the network now includes 46 institutions across 28 states and Washington, D.C. Press release.

Pangaea announces a multi‑year strategic collaboration with AstraZeneca to make AI-driven clinical decision-making available at scale, and improve how patients are identified, diagnosed, treated, and connected to existing therapies and clinical trials. As part of the collaboration, AstraZeneca and Pangaea will co‑develop an enterprise‑grade platform that fuses large‑scale clinical, imaging, genomic, pathology, and real‑world data using the latest breakthroughs in generative and predictive AI from Microsoft. Press release.

4D Path announces a collaboration with AMD and Oracle to advance predictive oncology and accelerate clinical trials. Using AMD EPYC CPUs on Oracle Cloud Infrastructure (OCI), 4D Path’s QPOR platform—a physics-informed, AI-driven, deterministic software engine—can convert routine biopsy images into interpretable biomarkers of tumor and immune response faster and at lower cost. By running natively on CPUs, QPOR achieves reproducibility, cost efficiency, and scalability at trial level. Clinicians, CROs, and sponsors benefit from explainable, regulatory-friendly insights, enabling faster clinical trial execution and more personalized cancer care. Press release.

A new study from Froedtert Hospital shows that patients with suspected infection who received the IntelliSep rapid sepsis test had a 42% lower mortality and spent fewer days in the hospital compared with those who were not tested. These findings are consistent with previously published peer-reviewed evidence performed at multiple health systems across diverse emergency department settings. The lab test delivers results in eight minutes, enabling clinicians to rapidly risk stratify patients at triage to accelerate care for high-risk patients and avoid unnecessary interventions in lower-risk cases. Press release.

Datavant expanded capabilities in medical record retrieval and clinical data abstraction through a partnership with Savant Bio. The integration combines Datavant’s industry-leading, privacy-first retrieval, and linkage infrastructure with Savant’s automated, provenance-rich abstraction technology to create a unified, end-to-end path from raw clinical records to structured, analysis-ready data. Delivered through a single, privacy-preserving workflow, these coordinated capabilities streamline one of the most resource-intensive stages of evidence generation by producing high-fidelity datasets with greater auditability, efficiency, and reliability. Press release.

PLL Therapeutics announces the opening of its New Zealand subsidiary, a critical move in advancing its Phase 2 trial and addressing the urgent unmet needs of ALS patients worldwide. The new entity will facilitate the enrollment of Amyotrophic lateral sclerosis (ALS) patients in New Zealand in PLL Therapeutics’ Phase 2 clinical trial, with the immediate goal of recruiting 12 patients at a single site, the Pacific Clinical Research Network. This initiative also paves the way for future “compassionate use” programs, addressing an urgent unmet need in a country where ALS incidence and mortality rates are among the highest in the world. Press release.

The University of Cincinnati launches a clinical trial testing a student-designed, machine-learning powered platform to match patients with cancer to support groups specifically tailored to their needs and concerns. The trial will use a platform called OncoSupport, developed by a nonprofit organization of the same name. Patients fill out a secure form with information, including the languages they speak, what type of cancer they have and the specific concerns they have, such as a fear of recurrence, the stress of taking care of children while fighting cancer, or the lack of a caregiver to help them through their treatment. The OncoSupport platform then uses its machine learning algorithm to match patients with a support group that should be the best fit for their needs and have fellow patients in the most similar situations. Press release.

Certara launches its Expedited Pharmacometrics (PMx) Regulatory Submissions offering, enabling sponsors to deliver complete PMx submission packages in four to six weeks, reducing typical timelines by more than half. The submission-ready PMxpackage may include population PK and exposure–response analyses, comprehensive simulations using Phase 1–3 clinical trial data to support dose regimen justification, full pharmacometrics analysis reports, and CTD Module 2 and 5 components formatted for direct inclusion in the eCTD. Press release.

Clinigen has had its near-term and long-term greenhouse gas (GHG) emission reduction targets validated by the Science Based Targets initiative (SBTi). This validation confirms that Clinigen’s roadmap to reduce scope 1, 2, and 3 emissions is scientifically aligned with the 1.5°C trajectory of the Paris Agreement. By 2030, Clinigen will target a 42% reduction across scope 1, 2, and 3 emissions, and by 2040, Clinigen will push for a 90% reduction across all scopes. Press release.

Alvotech announces that the European Commission has approved AVT03 as a biosimilar to Prolia and Xgeva (denosumab). Denosumab is widely used to manage osteoporosis and to prevent skeletal related events in patients with certain cancers. AVT03 is approved in two presentations: as a biosimilar to Prolia 60 mg/mL single use pre-filled syringe for the treatment of osteoporosis and bone loss, and as a biosimilar to Xgeva 70 mg/mL single use vial for the prevention of skeletal related events in adults with advanced malignancies involving bone. The European Commission’s decision represents continued progress across Alvotech’s biosimilar portfolio and underscores the company’s role as a longer-term partner to health systems across Europe. Press release.