PHARMACY MARKET, PHARMA TECH
prnewswire | March 31, 2023
PANTHERx® Rare, one of the largest and fastest growing rare pharmacies in the United States, is pleased to announce the launch of Joenja® (leniolisib), an oral selective small-molecule PI3K delta inhibitor indicated for the treatment of APDS in adult and pediatric patients ages 12 or older.
"Our patients living with rare and devastating diseases deserve the best that medicine can offer. Through innovation and technology, we continue to make a positive impact on the quality of life of those living with rare diseases. We are pleased to add Joenja® to the list of medications in PANTHERx® portfolio," said Rob Snyder, president of PANTHERx® Rare.
Activated Phosphoinositide 3-Kinase-Delta Syndrome, or APDS, is a rare primary immunodeficiency affecting approximately one to two people per million with disease onset occurring as early as infancy. This condition results from a variant in the genes PIK3CD or PIK3R1 with both genes playing a role in the regulation of white blood cell maturation. The presence of a mutation in these genes lead to hyperactivity of the PI3Kδ pathway resulting in a failure for the immune cells (B and T cells) to mature and properly function. Imbalance in the PI3Kδ pathway results in immunodeficiency and dysregulation. Those with APDS may develop recurrent respiratory tract infections, bronchiectasis, lymphoproliferation as well as neurodevelopment delay and failure to thrive. Clinical presentation is highly variable ranging from asymptomatic adults to those suffering from lymphoproliferation or development of profound immunodeficiency.
Snyder explained Joenja® exerts its effects by blocking the active binding sites of PI3Kδ inhibiting the signaling pathway hyperactivity that leads to dysfunction and dysregulation of B and T cells. In clinical trials, Joenja® achieved both co-primary efficacy measures of reduction in lymph node size and correction of immunodeficiency in the target population. The most common adverse reactions (>10%) were headache, sinusitis, and atrophic dermatitis.
About PANTHERx Rare
PANTHERx Rare is one of the largest and fastest growing rare pharmacies in the United States. PANTHERx transforms lives by delivering medicine breakthroughs, clinical excellence, and access solutions to people living with rare and devastating conditions. Although the overall incidence of rare diseases is as common as diabetes, less than 7% of the 7,000 known rare and devastating disorders have an FDA-approved therapy. Changes in federal policy and advances in science have led to a surge in FDA orphan drug approvals, providing tremendous hope to the rare disease community.
PANTHERx was recently awarded Specialty Pharmacy of the Year by the National Association of Specialty Pharmacy and earned the inaugural Accredited Distinction in Rare Diseases and Orphan Drugs from the Accreditation Commission for Health Care. PANTHERx is now a five-time winner of the prestigious MMIT Patient Choice Award, including the 2022 honor. PANTHERx is headquartered in Pittsburgh, licensed in all 50 states, and holds accreditations from URAC, NABP, and ACHC.
BUSINESS INSIGHTS, PHARMACY MARKET
Prnewswire | April 05, 2023
PathAI, a global leader in AI-powered pathology, announced the launch of PathExplore™, the world's first structured, standardized and scalable panel of human interpretable features (HIFs) offering unprecedented resolution of the tumor microenvironment (TME) from H&E whole-slide images. Powered by artificial intelligence, PathExplore1 spatially characterizes the TME with single-cell resolution, giving oncology drug developers the ability to unlock insights to inform the next phase of targeted oncology drug development.
The last decade has seen significant strides in oncology therapeutic development, but challenges remain – many cancer patients do not respond to available treatment, and many aren't eligible for potentially transformative therapies because of a lack of actionable insight into their disease. Researchers are looking to the tumor microenvironment, one of the most promising areas of oncology research, for answers and insights that will impact patient outcomes.
"PathExplore will enable researchers to identify novel spatial signatures predictive of outcomes," said Andy Beck, M.D., Ph.D., chief executive officer and co-founder of PathAI. "We're hopeful that by giving oncology drug developers access to this level of detail and data from routine H&E samples, this next generation of pathology will drive advances in cancer therapy development."
Current technologies to measure and analyze the TME force researchers to make tradeoffs between resolution and scalability. Now with PathExplore, drug developers will have the ability to analyze the TME with deep resolution using a scalable platform that can be deployed on massive numbers of patient samples. PathExplore produces a panel of more than 600 quantitative HIFs: standardized and reproducible measures of counts, densities, areas and spatial relationships across cell types and tissue regions. PathExplore also generates overlay visualizations of cell types and tissue regions, delivered on PathAI's AISight™ Translational Research platform.
PathExplore has been trained using over 6.5 million pathologist annotations on 66,000 slides. It is currently available for breast cancer, colorectal cancer, gastric cancer, melanoma, non-small cell lung cancer, pancreatic cancer, prostate cancer, and renal cell carcinoma, with more indications planned to launch later this year, including ovarian and bladder cancers. The standardized, structured quantification of the TME across disease areas will enable reproducible, comparable, and scalable analysis across drug programs.
"PathExplore will shift the research paradigm, bypassing long standing constraints we experience with some of the existing multi-omics modalities and allowing for more open exploration and discovery of relationships that were not identifiable by human analysis alone," said Mike Montalto, PhD, chief scientific officer at PathAI. "The degree of granularity, speed, efficiency and scale delivers unmatched insights that will change the way we view the tumor microenvironment."
PathAI's HIFs have been used in over 15 scientific abstracts, presentations, and publications. To learn more about PathExplore, visit www.PathExplore.com or visit us at booth 315 at the American Association for Cancer Research (AACR) April 14th-19th in Orlando, FL.
PathAI is the only AI-focused technology company to provide comprehensive precision pathology solutions from wet lab services to algorithm deployment for clinical trials and diagnostic use. Rigorously trained and validated with data from more than 15 million annotations, its AI-powered models can be leveraged to optimize the analysis of patient samples to improve diagnostic efficiency and accuracy, as well as to better gauge therapeutic efficacy and accelerate drug development for complex diseases.
BUSINESS INSIGHTS, PHARMA TECH
prnewswire | April 11, 2023
Cerner Enviza, an Oracle company, along with John Snow Labs, are now helping support the U.S. Food and Drug Administration's drug safety Sentinel Initiative. By developing artificial intelligence (AI) tools aimed at extracting critical information from clinical notes within electronic health records (EHR), Oracle and John Snow will aid the FDA in better understanding the effects of medicines on large populations. Looking at the asthma drug, montelukast, and its possibility of mental health side effects, this two-year project will demonstrate how the use of machine learning and natural language processing (NLP) technology with unstructured data may help fill gaps in knowledge.
Cerner Enviza leverages decades of life sciences expertise spanning commercial, real world, clinical and regulatory research. This includes working with a broad range of Oracle provider networks to help accelerate the discovery, development, and deployment of health insights and therapies. John Snow Labs is known for its AI and NLP in healthcare and is the developer of the Spark NLP library. Together, Cerner Enviza and John Snow Labs will develop a new methodology to enhance computerized queries, or phenotyping, of digital patient data and clinical notes to support pharmacoepidemiology.
Cerner Enviza, who will lead the team, was chosen by the Sentinel Innovation Center, who is headed by Mass General Brigham and Harvard Pilgrim Health Care Institute.
"Development and evaluation of tools that can enhance our ability to utilize unstructured EHR data is a key strategic priority for the Sentinel Innovation Center. We look forward to this new relationship and exciting initiative led by Cerner Enviza," said Rishi Desai, Ph.D., Mass General Brigham executive leadership team member, Sentinel Innovation Center.
Traditional manual methods for analyzing clinician notes often can be a bottleneck for fully understanding the symptoms and outcomes that patients experience at the population level. However, advances in AI offer a scalable and transportable NLP processes.
"This is an incredible opportunity to work with these exceptional leaders to use Oracle's de-identified EHR data to help transform unstructured clinical notes into validated and useable data for physicians and researchers," said Mike Kelly, global head, Cerner Enviza. "Connected technologies and unified data can accelerate innovation and, in turn, help providers realize better recommendations and outcomes for their patients."
"We are thrilled to team with Cerner Enviza to apply NLP in such an important real-world evidence project," said David Talby, CTO, John Snow Labs. "We're honored by the Sentinel Innovation Center's vote of confidence in our joint ability to help investigate this use case. Together, Cerner Enviza and John Snow Labs have all the right expertise, data, and technology to make it happen."
The project known as the Multi-source Observational Safety Study for Advanced Information Classification Using NLP (MOSAIC-NLP) is also supported by the participation of Children's Hospital of Orange County, National Jewish Health, and Kaiser Permanente Washington Health Research Institute who will provide clinical expertise and consulting.
About John Snow Labs
John Snow Labs is an AI and NLP company that provides software, models, and data to help healthcare and life science organizations put AI to good use. The company is the developer of Spark NLP and host of the NLP Summit.