BUSINESS INSIGHTS, PHARMACY MARKET
Globenewswire | March 24, 2023
Curia, a leading contract research, development and manufacturing organization, today announced a collaboration with Corning Incorporated to expand and accelerate continuous-flow development and manufacturing programs for the chemical and biopharmaceutical industries globally. The collaboration with Corning’s Advanced-Flow™ Reactor (AFR) team includes the first installation of Corning’s G1 production system, designed for the continuous industrial production of active pharmaceutical ingredients (API).
Continuous flow chemistry is critical for the development and manufacture of pharmaceutical intermediates and APIs, and provides advantages compared with traditional batch processing. It is an inherently safer technology that delivers faster and more robust material production with a higher selectivity of desired products.
“Innovation in drug development and production calls for safety at high speed,” said Christopher Conway, president, Research & Development, Curia. “The implementation of Corning’s G1 Production Reactor at our Albany facility expands our capability to provide scalable solutions that address complex development and manufacturing requirements facing the pharmaceutical industry. Using advanced technology and standardized workflows, Curia offers continuous flow chemistry from targeted development to commercial scale globally.”
The G1 production reactor includes an updated set of dosing lines and controls that enable continuous operations and compliance to cGMP standards.
“Collaborating with an innovation-focused company like Curia will help drive advancements in the chemical-processing industry,” said Alessandra Vizza, business director, Corning Advanced-Flow Reactors. “The implementation of Corning’s G1 production system can deliver a host of benefits. The system is an inherently safer technology that will help Curia reduce time to market with higher-quality chemical and API processing, increased efficiency of chemical and API synthesis, and lower production costs.”
“Additionally, the space-saving, energy-conserving, and waste-reducing benefits of Corning’s AFR Technology may help customers reduce the environmental impact of their manufacturing business – a key attribute as the field continues to gain momentum in the U.S. and around the world,” said Vizza.
Curia’s expertise and global network of facilities, combined with Corning’s continuous flow technology, can help drive business efficiencies and, ultimately, improve patients’ lives.
Curia is a leading contract research, development, and manufacturing organization providing products and services from R&D through commercial manufacturing to pharmaceutical and biopharmaceutical customers. Curia’s nearly 4,000 employees at 29 locations across the U.S., Europe, and Asia help its customers advance from curiosity to cure.
BUSINESS INSIGHTS, PHARMACY MARKET
businesswire | April 17, 2023
OM1, a leading real-world data, outcomes and technology company with a focus on chronic conditions, today launched PhenOM™, its artificial intelligence-powered platform for personalized medicine. Calibrated using OM1’s longitudinal health history datasets, PhenOM uses AI to identify unique digital phenotypes associated with conditions and outcomes and compare patients’ records to them to highlight risks and opportunities. PhenOM powers personalized healthcare insights at scale across the entire healthcare ecosystem, from life science research to point-of-care clinical decision making.
PhenOM is an AI that gathers detailed information from large patient datasets – including unstructured clinical notes and disease activity metrics – to isolate unique patterns associated with patients with distinct characteristics. PhenOM synthesizes these patterns into unique digital phenotypes or ‘fingerprints.’ These phenotypes can be studied to inform research and deployed in real-world datasets – inside and outside OM1 – as well as in health systems and through standalone patient-facing web portals.
Calibrated using OM1’s differentiated, high-quality data cloud – which is based on billions of data points from more than 300 million patients – PheonOM was built with expert clinician oversight. With an overarching mission to improve individual care and population health, the platform powers five solutions that address pain points across the healthcare system
Diagnostic Insights: Finding patients with rare, undiagnosed, or misdiagnosed conditions, including subgroups of interest
Treatment Insights: Personalizing treatment recommendations to improve access to care and individualizing treatment selection
Risk Insights: Predicting risk of specific negative outcomes, including disease progression, complications, and catastrophic events
Utilization Insights: Enabling focus on patients at risk for higher utilization, and utilization growth, over time
Clinical Trial Insights: Accelerating trial startup and recruitment by identifying patients most likely to meet qualifications for enrollment, including those potentially overlooked
Patient expectations over the last several years have shifted – from the adoption of virtual care and accessibility to the use of advanced technology to improve outcomes – but a persistent gap remains between population-level insights and individual patient experience: personalization. Recognizing this gap, OM1 developed PhenOM to translate patterns in large-scale data into meaningful outputs at the individual level and to better understand patient populations, diagnoses, progression, and treatment response.
“Most people have now heard of the promise of AI through GPT-4, but we still have not seen many really mature, real-world clinical applications using advanced language models,” said Dr. Joseph Zabinski, Managing Director of AI & Personalized Medicine at OM1. “PhenOM is groundbreaking technology because it uses AI to translate actionable insights from our highly enriched datasets and phenotyping technology into opportunities for more personalized healthcare. This capability creates a huge potential for impact for all stakeholders, from identifying patients with under-diagnosed conditions to enabling personalized assessments of benefit for particular therapies and accelerating clinical trial enrollment.”
With specialization in chronic conditions, OM1 is re-imagining real-world data and evidence by developing large electronically connected networks of clinicians and health data in rheumatology, dermatology, gastroenterology, cardiometabolic, respiratory, mental health, central nervous system, and other specialty areas. Leveraging its extensive clinical networks and an unparalleled technology and artificial intelligence (AI) platform, OM1 offers industry leading enriched healthcare datasets, research analytics, data modeling, decision support, and retrospective and prospective clinical studies. With a focus on high-quality data and clinical outcomes, the offerings are used for accelerating research, demonstrating treatment effectiveness, supporting regulatory submissions, monitoring safety, and informing commercialization.
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.