Machine Learning Platforms Generates More Alerts For Drug Errors

Thailand Medical News | January 02, 2020

A new machine learning platform can generate clinically valid alerts for medication errors that might be missed with existing clinical decision support (CDS) systems, according to a study published in the January issue of The Joint Commission Journal on Quality and Patient Safety. Dr Ronen Rozenblum, Ph.D., M.P.H., from Harvard Medical School in Boston, and colleagues examined the ability of a machine learning system (MedAware) to generate clinically valid alerts, and estimated the associated cost savings with potentially prevented adverse events. Alerts were generated on outpatient data from two academic medical centers between 2009 and 2013. MedAware alerts were compared with those in an existing CDS system.

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The development of novel therapeutic products involves a complex network of internal departments and external partners. Different groups across Process Development organizations typically use a variety of approaches to capture, manage, analyze and report data. These can range from paper and Excel to in-house developed electronic systems or commercial solutions. Regardless of their IT maturity, the lack of a consistent approach has a negative impact on the agility of the business including.


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PHARMA TECH

IACTA Pharmaceuticals and TALLC Corporation Announce Strategic Collaboration to Utilize Novel SmartCelle Topical Delivery Technology

IACTA Pharmaceuticals, Inc. | December 16, 2021

IACTA Pharmaceuticals, Inc. an innovation leader in ophthalmic therapeutics, and TALLC Corporation Inc. a pioneering ophthalmology company focused on the growing unmet needs of patients with corneal and retinal conditions, announced that they are entering into a strategic collaboration and licensing agreement. The agreement grants IACTA the use of TALLC’s proprietary SmartCelle™ micellar technology, a novel platform for pan-ocular drug delivery, for future clinical development. IACTA plans to utilize TALLC’s SmartCelle technology to deliver one or more of its novel ophthalmic therapeutics, as well as co-develop new ophthalmology therapeutic candidates that leverage IACTA’s formulation and clinical expertise with TALLC’s novel delivery technology. The collaboration also includes an option agreement, granting IACTA exclusive rights to negotiate a separate license agreement for the right to co-develop TALLC’s lead product candidate TA-A001, a novel anti-inflammatory anti-angiogenic molecule with analgesic properties in various disease state models. “I am thrilled to be able to partner with TALLC, a company with a shared vision focused on addressing the growing and significantly underserved ocular pain market. IACTA was formed with the mission of developing and commercializing innovative ocular therapies through novel compounds and utilizing leading drug delivery technologies, and we view this collaboration as the perfect synergy to realize the full potential of our ophthalmology pipeline. We are excited to explore how best to deploy the SmartCelle technology within our current pipeline, as well as the future co-development opportunities this partnership provides.” Damon Burrows, Chief Executive Officer of IACTA Pharmaceuticals TALLC’s proprietary SmartCelle pan-ocular drug delivery technology employs 30nm micelles that enable delivery of difficult to formulate drugs into corneal and retinal tissues after topical delivery. The company’s pipeline is led by SmartCelle TA-A001, a novel CB2 receptor activator, delivered topically to treat the effects of dry eye syndrome and age-related macular degeneration. “We are delighted to partner with the IACTA team for this important program. IACTA, with its in depth scientific and commercial understanding of the ophthalmic space is an ideal partner for TALLC as we drive towards further commercialization of the SmartCelle platform and TA-A001,” said Damon Smith, Ph.D., Chief Executive Officer of TALLC. “We look forward to working closely with the IACTA team and to co-developing SmartCelle versions of the IACTA pipeline.” About TALLC, Inc. TALLC is a Montreal-based developer of ophthalmic medicines actively engaged in the commercialization of SmartCelle TA-A001, and its pipeline of SmartCelle-delivered drug candidates, as treatments for acute and chronic inflammation. Focused initially on unmet needs in inflammatory front of eye indications, TALLC plans also to develop SmartCelle TA-A002 and TA-A003 in other chronic conditions including macular degeneration and glaucoma. SmartCelle enables pan ocular delivery of drug candidates by topical application directly to the ocular surface, by injection or by insufflation. About IACTA Pharmaceuticals, Inc. IACTA is an innovation leader in ophthalmic therapeutics, led by former top executives from one of the leading eye care companies in the world. The company currently has four products in development for major market opportunities. IC 800 is a novel, non-opioid, dual enkephalinase inhibitor, being studied for the treatment of acute ocular pain. In addition, IACTA’s IC 265, is a SYK kinase inhibitor being developed as a potential novel treatment for dry eye disease.

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PHARMACY MARKET

AIkido Pharma Reports Improved Manufacturing Process and New United States Patent for Pancreatic Drug

AIkido Pharma Inc. | March 04, 2022

AIkido Pharma Inc.reported an improvement in the manufacturing process for its pancreatic cancer drug, DHA-dFdC, licensed from the University of Texas at Austin. The Company also reported the issuance of an additional U.S. patent covering the drug, and the filing of a continuation patent application intended to expand patent coverage to other facets of the drug. With respect to manufacturing process, the Company reported the successful development of a new means for the scaled production and isolation of the key intermediate compound in the manufacture of DH-dFdC. The Company has now executed a further contract with its contract manufacturing organization, Parimer Scientific, to employ the new process to produce several thousand milligrams of the drug for use in formulation development and stability studies. The Company also reported that the U.S. Patent Office recently issued new U.S. Patent No. 11,219,633, which provides additional intellectual property protection for the drug compound. The term of the patent is expected to continue until May of 2035 with the payment of required maintenance fees. Prior to the patent issuance, the Company authorized the timely filing of a patent continuation application, U.S. Serial No. 17/539,682, in which additional claims related to various aspects of the drug and formulation will be pursued. "This new process significant step forward in the development of our pancreatic cancer drug and should permit production of the drug on a commercial scale at a lower cost. I am also pleased that we can continue to report expansion of the patent estate." Anthony Hayes, CEO of AIkido Richard T. Pace, Owner and Principal Scientist of Parimer Scientific, stated, "The newly developed manufacturing method is a large step forward for this innovative technology. I believe it will reduce cost per unit and at the same time increase batch production volumes." About AIkido Pharma Inc. AIkido Pharma Inc. was initially formed in 1967 and is a biotechnology Company with a diverse portfolio of small-molecule anticancer and antiviral therapeutics. The Company's platform consists of patented technology from leading universities and researchers, and we are currently in the process of developing an innovative therapeutic drug platform through strong partnerships with world renowned educational institutions, including The University of Texas at Austin and University of Maryland at Baltimore. Our diverse pipeline of therapeutics includes therapies for pancreatic cancer, prostate cancer. We are constantly seeking to grow our pipeline to treat unmet medical needs in oncology. The Company is also developing a broad-spectrum antiviral platform that may potentially inhibit replication of multiple viruses including Influenza virus, SARS-CoV (coronavirus), MERS-CoV, Ebolavirus and Marburg virus.

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BUSINESS INSIGHTS

Breckenridge Signs New-Product Agreement with PTS Pharma

Breckenridge Pharmaceutical, Inc. | April 23, 2022

Breckenridge Pharmaceutical, Inc. announces today that it has signed a new-product agreement with PTS Pharma, LLC. under which PTS will support a technology transfer to Towa Pharmaceutical Europe, S.L. of a complex "For Suspension" product developed by PTS. The remainder of development and commercialization will be performed at the Towa facility. According to industry sales data, the product and its generics had annual sales of approximately $75 million during the twelve months ending February 2022. The companies are actively negotiating and look forward to collaborating on additional complex formulations under the same business model. About Breckenridge Breckenridge Pharmaceutical, Inc., a subsidiary of Towa Pharmaceutical, partners with manufacturers nationwide and around the world to bring quality, cost-effective generic pharmaceuticals to U.S. patients. With our dedication to customer service, on-time delivery, reliable supply and quality manufacturing, we improve the health and quality of life of the patients we and our customers serve. About PTS Pharma, LLC PTS Consulting, LLC and PTS Pharma LLC., is a formulation development, clinical trial production, regulatory services and analytical control laboratory based in Kansas. PTS Consulting is actively involved in regulatory consulting services. PTS Pharma operations include the capability and expertise to develop complex formulations of tablets, capsules, granules, modified dosage forms, topical dosage forms, suppositories, film products, solution, and suspension formulations and sterile injectables, with involvement in multiple aNDA and NDA filings over the years. The activities are housed in dedicated GMP suites in the facility in Kansas City, USA. PTS Pharma is also involved in active raw material clinical production by fermentation technology processes. The firm was founded in 2003 by Paul Sudhakar, an industry veteran who is the Owner, President, and CEO of the firm.

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BUSINESS INSIGHTS

Oramed Completes Patient Enrollment in Phase 2 Oral Insulin NASH Trial

Oramed Pharmaceuticals Inc. | March 17, 2022

Oramed Pharmaceuticals Inc. a clinical-stage pharmaceutical company focused on the development of oral drug delivery platforms, announced it has completed enrollment of all patients in a Phase 2 trial of its oral insulin capsule ORMD-0801 for the treatment of non-alcoholic steatohepatitis. An estimated 1.5% to 6.5% of adults in the U.S., or between 4 million and 17 million people, have NASH and about half of these also have diabetes, according to the National Institute of Diabetes and Digestive and Kidney Diseases. The double-blind, multi-center trial with clinical sites in the U.S. and Israel is assessing the safety and potential efficacy of ORMD-0801 in Type 2 diabetes patients with NASH. Efficacy endpoints including safety and percentage change in liver fat content, liver fibrosis, and liver steatosis from baseline are measured via MRI-PDFF following 12 weeks of dosing. "There is currently no drug approved to treat this disease, leaving NASH with a serious unmet medical need. With direct action on the liver, we believe that ORMD-0801 has the potential to address over 50% of people with diabetes who also suffer from NASH, a population with unfortunately increased mortality. We look forward to analyzing and reporting topline data, which we expect will confirm our prior pilot study's efficacy and safety results," Oramed Chief Executive Officer, Nadav Kidron The global market for drugs to treat NASH is expected to reach $84 billion by 2029, according to a publication by Research and Markets on the Global Non-Alcoholic Steatohepatitis (NASH) Drugs Market. About NASH Non-alcoholic steatohepatitis is a serious, progressive liver disease caused by a buildup of fat in the liver and accompanied by inflammation, liver cell damage, and in some cases, scarring of the liver. Over time, NASH may progress to cirrhosis, liver cancer, liver failure, and even death. Currently, no pharmacotherapy is globally approved for the treatment of NASH, and people with NASH are left with very few treatment options. About Oramed Pharmaceuticals Oramed Pharmaceuticals is a platform technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection. Established in 2006, with offices in the United States and Israel, Oramed has developed a novel Protein Oral Delivery (POD™) technology. Oramed is seeking to transform the treatment of diabetes through its proprietary lead candidate, ORMD-0801, which is being evaluated in two pivotal Phase 3 trials and has the potential to be the first commercial oral insulin capsule for the treatment of diabetes. In addition, Oramed is developing an oral GLP-1.

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Spotlight

The development of novel therapeutic products involves a complex network of internal departments and external partners. Different groups across Process Development organizations typically use a variety of approaches to capture, manage, analyze and report data. These can range from paper and Excel to in-house developed electronic systems or commercial solutions. Regardless of their IT maturity, the lack of a consistent approach has a negative impact on the agility of the business including.

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