Flatiron Health announced its renewed collaboration with the Oncology Center of Excellence (OCE) of the United States Food and Drug Administration (FDA) to jointly develop and implement specific research projects to advance the use of real-world data (RWD) and explore the potential strengths and limitations of using real-world evidence (RWE) for regulatory purposes. The partnership will specifically evaluate RWD study designs and analytic methods through the collaborative development of priority, clinically meaningful research questions regarding care, treatment, and outcomes of patients with cancer. Press release. 

Medidata launched the Medidata Diversity Program for improving diversity, equity, and inclusion in clinical trials. The Medidata Diversity Program supports biopharmaceutical and medical device companies and clinical research organizations (CROs) by addressing common systemic and clinical barriers that can hinder a diverse range of individuals from participating in clinical trials. By combining capabilities across Medidata AI and Medidata Patient Cloud portfolios, the program creates a novel and unique approach to achieving diversity throughout the clinical trial process by improving awareness and experiences for patients, streamlining access to trials, enabling decentralization, and supporting data-driven decision-making needed to execute the modern diversity action plans required for regulatory success. Press release. 

ACD/Labs announced a collaboration with MilliporeSigma, the U.S. and Canada Life Science business of Merck KGaA, Darmstadt, Germany. The collaboration represents MilliporeSigma’s joint steps toward breakthrough innovation to make research and quality control in the lab more efficient and sustainable. The new ChemisTwin platform combines ACD/Labs’ industry-leading NMR predictors with Millipore Sigma’s digital reference materials (dRMs). Press release. 

The Astellas Institute for Regenerative Medicine (AIRM) has licensed Genedata Selector to help confirm the biosafety of cell therapies using NGS-based assays within a validated environment. AIRM aims to shorten the time it takes to reach first-in-human studies and deliver safe and effective cell therapies to the market. AIRM plans to leverage the Genedata Selector to help automate workflows, reduce bottlenecks, and speed up progress toward cell therapies. Press release. 

10x Genomics announced the commercial availability of a new kit, Feature Barcode Multiplexing, to expand the capabilities of its Chromium Single Cell Gene Expression Flex assay to include high-throughput multiomic cellular profiling. The new kit enables streamlined, multiomic characterization of cell populations so that researchers can expand their options at a larger scale and detect simultaneous gene and protein expression. It will enable researchers to fix and store samples without losing data quality, detect proteins at single cell resolution with workflows that enable small- to large-scale studies, batch and scale to profile up to one million cells in a single run and save up to 75% on per-sample costs, and bring scRNA-seq with industry-leading sensitivity to fresh, frozen or fixed tissue—even FFPE. Press release. 

Deciphex and Xybion are partnering to enhance the pathology reporting processes and optimize workflow efficiency for pathologists working in the pharmaceutical and biotech industries. The collaboration between Deciphex and Xybion introduces a groundbreaking integration that offers a seamless synergy between their platforms. This integration provides real-time digital slide availability during pathology data entry. In addition, for Pathology Peer Review, embedded finding searching, filtering and viewing results in accelerated and higher quality processes. By combining Patholytix's scalable digital pathology management solution with Xybion's unified cloud software ecosystem, professionals in the pharmaceutical and biotech industries can streamline their operations and focus on delivering improved regulatory submissions. Press release. 

The Jackson Laboratory for Genomic Medicine is offering a fully validated, clinical whole genome sequencing test. The APML is CLIA-certified and CAP-accredited and the JAX Genome test is the only clinical whole genome sequencing test currently offered in Connecticut. It will enable area clinicians to reveal the genetic contributions to their patients’ undiagnosed conditions. Press release. 

Integrated DNA Technologies (IDT) and Aldevron inked a new global distribution agreement to expand key CRISPR solutions for cell and gene therapy customers. IDT will stock and sell three additional research use only (RUO) and current good manufacturing practice (cGMP) CRISPR nucleases with unique performance characteristics, manufactured by Aldevron, to provide researchers with an accelerated path to the clinic. The following Aldevron-manufactured enzymes are now available through IDT: SpyFi Cas9 Nuclease, designed for greater editing efficiency and reduced off-target effects; Eureca-V Nucleas, which supports research and development in the allogeneic cell therapy space; and SpCas9 Nuclease, meant for use in development work as well as standard cGMP products for clinical studies. Press release. 

Praxis has named Tricia Barrett as its new president. Barrett most recently served as the company’s chief operating officer. In her role, Barrett will continue to be the driving force behind Praxis’ client relationships while overseeing daily business operations, providing strategic direction and driving company objectives. Press release. 

PingCAP has achieved Amazon Web Services (AWS) Data and Analytics Competency status. This designation recognizes PingCAP’s demonstrated success in helping customers collect, store, govern, and analyze data at any scale. Achieving the AWS Data and Analytics Competency differentiates PingCAP as an AWS Partner Network (APN) member that provides specialized software solutions designed to help enterprises adopt, develop, and deploy complex projects on AWS. To receive the designation, APN members must possess deep AWS expertise and deliver solutions seamlessly on AWS. Press release. 

Dewpoint Therapeutics and Chemify partnered up to develop a suite of digitally discovered and automatically synthesized novel molecules on Chemify's programmable chemistry platform against condensate targets of interest in Dewpoint's oncology and neurodegeneration pipeline. Under the partnership, Chemify will design and deliver novel compounds to augment Dewpoint's advanced oncology and neurodegeneration pipeline. Dewpoint may choose to exercise an option to acquire the compounds designed by Chemify. In exchange, Chemify will receive pre-negotiated, success-driven clinical and regulatory milestones and tiered royalties. Press release. 

The U.S. Department of Health and Human Services (HHS) announced new details of its agreement with Regeneron to extend its public-private partnership to develop life-saving monoclonal antibodies as part of Project NextGen enhancing our preparedness for COVID-19 strains and variants. This agreement included a clause where Regeneron committed that if a new product is commercialized, its list price in the United States will be equal to or less than its retail price in comparable markets globally. Inclusion of this clause is the result of HHS’s and Regeneron’s shared interest in ensuring enduring and equitable access to therapeutics developed under public-private partnerships for all Americans. Press release. 

Phesi partnered up with Krystelis to launch its new Diversity, Equity, and Inclusion (DEI) Data Service. The new service harnesses data from Phesi Trial Accelerato and Krystelis’ writing services to empower sponsors to improve diversity from the trial planning stage onwards. Enabling sponsors to minimize costly protocol amendments (at an average cost of $500,000/amendment) and to meet new global DEI rules from regulators including the FDA – ensuring any therapeutic is efficacious for all intended patient populations. Press release. 

The Broad Institute of MIT and Harvard announced a new research alliance with Novo Nordisk aimed at addressing critical unmet clinical needs in diabetes and cardiometabolic diseases. The collaboration will focus on advancing three programs over the next three years. Two programs aim to identify drug targets for clinically important subtypes of type 2 diabetes, which affects more than 37 million people in the United States alone, and one program aims to unravel the genetic roots of cardiac fibrosis, or scarring of the heart, which occurs in many cardiovascular diseases that can lead to heart dysfunction and failure. Press release. 

Charles River Laboratories International and PathoQuest SAS announced the publication of the results of a seminal study in Vaccine (DOI: 10.1016/j.vaccine.2023.07.019). This unique study demonstrated that PathoQuest’s proprietary, good manufacturing practice (GMP) grade NGS-based assay had a greater capability of detecting viral contaminants when compared to in vivo assays. Press release. 

BioSkryb Genomics announced a partnership with Research Instruments Pte Ltd, a premier distributor for genomic and life science research products in Southeast Asia, to distribute BioSkryb’s ResolveDNA and ResolveOME single cell amplification tools throughout Singapore and Southeast Asia. Research Instruments (“Everlife-RI") is part of Everlife Asia, a leading Asia-focused market access and distribution group with strong capabilities in life sciences, clinical diagnostics, and analytical instrumentation operating in seven countries across Asia. Press release. 

Trialbee has launched its Rescue Kit to keep trials experiencing recruitment delays on track for Last Patient In (LPI). As speed is paramount, Trialbee Rescue Kit energizes trials experiencing delays with digital recruitment campaigns that achieve Go Live in as few as four weeks from the contracting process. Press release.