How new hazardous waste pharmaceuticals rule will impact LTC

mcknights | April 29, 2019

In the last few years, we’ve seen legislation for the disposal of pharmaceuticals on the state and federal level grow due to our nation’s opioid crisis. One of the most recent rules we’ve seen is the Management Standards for Hazardous Waste Pharmaceuticals. In February 2019, the Environmental Protection Agency published the long-awaited rule in the Federal Register, which will help establish cost-saving, streamlined standards for handling hazardous waste pharmaceuticals. Not only will these new standards help how the healthcare sector operates, but it will better protect the health of individuals and the environment. Annually, it’s estimated up to 2,300 tons of pharmaceuticalsare disposed of down the drain. The EPA predicts that by enacting this new rule, it will reduce the amount of hazardous waste pharmaceuticals entering our waterways. This new rule will prohibit long-term care facilities from dumping pharmaceuticals down the drain, making our drinking and surface water safer and healthier.

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Questex’s Digital Pharma East 2022 brought hundreds of pharma marketers together to network, discover the latest marketing trends and digitization transformation efforts, share ideas and help shape the future of pharma marketing.

Spotlight

Questex’s Digital Pharma East 2022 brought hundreds of pharma marketers together to network, discover the latest marketing trends and digitization transformation efforts, share ideas and help shape the future of pharma marketing.

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PHARMACY MARKET

TC BioPharm Begins Dosing Phase 2B Clinical Study Evaluating its Lead Compound, OmnImmune®, in Patients with Acute Myeloid Leukemia

TC BioPharm | November 23, 2022

TC Biopharm a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer today announced the dosing of its first three patients within its Phase 2b clinical trial of OmnImmune®, an allogeneic unmodified cell therapy focused on treating Acute Myeloid Leukemia. The initial 5 patients in the trial are deemed a "safety cohort", spaced two weeks apart with safety review by an oversight board to confirm no drug related toxicity issues, subsequent to 5 patients being dosed the study will advance to open enrollment. This safety cohort is in line with TCBP's step-wise clinical trial advancement, moving from donor matching in the Phase 1b to a universal donor model with no HLA matching of donor to patient. "The launch of our Phase 2B trial is a key milestone in the development of our lead therapeutic, OmnImmune®, for patients with AML and for TC BioPharm's emerging pipeline of 'off-the-shelf' gamma-delta T cell therapies. This study design includes a 5 patient safety cohort prior to open enrollment, we expect to complete the safety cohort before the end of 2022. The next step in the study is a 19 patient interim review, which will allow TCBP to review dosing and increase dosing to a higher level should our team deem it necessary for efficacy, or we can elect to maintain our current dosing level of 7x10^7 or 700 million cells per dose. We look forward to moving ahead with our Phase 2b trial with a target for open enrollment in January 2023, as well as our efforts to expand our clinical efforts in the US in the first half of 2023." Bryan Kobel, CEO of TC BioPharm TC BioPharm's Phase 2B trial, dubbed ACHIEVE, will enroll adults diagnosed with AML who have either relapsed or are refractory to prior treatments as well as a cohort for patients with myelodysplastic syndromes conditions that can occur when the blood-forming cells in the bone marrow become abnormal. The trial is expected to enroll approximately 37 patients. About TC BioPharm PLC TC BioPharm is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of gamma-delta T cell therapies for the treatment of cancer with human efficacy data in acute myeloid leukemia. Gamma-delta T cells are naturally occurring immune cells that embody properties of both the innate and adaptive immune systems and can intrinsically differentiate between healthy and diseased tissue. TC BioPharm uses an allogeneic approach in both unmodified and CAR modified gamma-delta T cells to effectively identify, target and eradicate both liquid and solid tumors in cancer. TC BioPharm is the leader in developing gamma-delta T cell therapies, and the first company to conduct phase II/pivotal clinical studies in oncology. The Company is conducting two investigator-initiated clinical trials for its unmodified gamma-delta T cell product line - Phase 2b/3 pivotal trial for OmnImmune® in treatment of acute myeloid leukemia using the Company's proprietary allogenic CryoTC technology to provide frozen product to clinics worldwide. TC BioPharm also maintains a robust pipeline for future indications in solid tumors as well as a significant IP/patent portfolio in the use of CARs with gamma-delta T cells and owns our manufacturing facility to maintain cost and product quality controls.

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BUSINESS INSIGHTS, PHARMA TECH

Neochromosome Announces Successful Collaboration with Sumitovant Biopharma

Sumitovant Biopharma, Inc. | January 20, 2023

On January 19, 2023, Neochromosome, Inc., announced a partnership with Sumitovant Biopharma, Inc., a technology-driven biopharmaceutical firm expediting the discovery and commercialization of novel therapeutics. This collaboration blends Neochromosome's neoYeast™ platform with Sumitovant's DrugOME™ computational ecosystem to identify new proteins that would benefit from non-canonical amino acid chemistries that are unavailable in nature. As part of the collaboration, Sumitovant used a combination of natural language processing (NLP), artificial intelligence (AI), machine learning (ML), and computational algorithms to identify opportunities for Neochromosome to enhance the discovery and production of proteins limited by evolution and traditional fabrication processes. For example, non-canonical amino acid inclusion allows new-to-nature proteins with improved structures and functions but often requires chemical synthesis, which is expensive, size- and complexity-restricted, and environmentally damaging. neoYeast™, based on Neochromosome's world-leading genome-scale cell engineering technology stack, enables the highly efficient and environmentally friendly integration of non-canonical amino acids into proteins, with both discovery and manufacturing possible in a single genome-engineered yeast strain. Sumitovant used DrugOME to explore libraries of traditional and non-traditional sources of data to recommend targeted protein development candidates for neoYeast. Co-Founder and CEO of Neochromosome, Leslie Mitchell, commented, "The combination of Sumitovant's technology platform and life-sciences expertise with Neochromosome's ability to both discover and biomanufacture novel proteins in a single system enables Neochromosome to accelerate and streamline the delivery of better therapies for patients." She added, "We are excited to partner with the world-class team at Sumitovant to identify opportunities to create better versions of existing drugs, along with new-to-nature compounds, and to manufacture them efficiently at scale." (Source – Business Wire) Sumitovant Biopharma, Inc. The firm has supported the development of multiple FDA-approved products and a strong pipeline of early-through late-stage investigational assets addressing unmet needs in pediatrics, oncology, urology, women's health, specialty respiratory, and infectious diseases through its proprietary computing and data platforms, scientific expertise, and diverse company portfolio. It is a wholly-owned subsidiary of Sumitomo Pharma.

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BUSINESS INSIGHTS, PHARMACY MARKET

XtalPi and EDDC collaborate in AI-empowered drug discovery program for Non-Small Cell Lung Cancer

XtalPi Inc. | December 20, 2022

XtalPi, a pioneering pharmaceutical technology company powered by artificial intelligence and automation, announced a strategic collaboration with the Experimental Drug Development Centre Singapore's national platform for drug discovery and development hosted by the Agency for Science, Technology and Research of Singapore to discover novel treatment candidates for non-small cell lung cancer. Lung cancer is the second most common cancer and the leading cause of cancer death worldwide. NSCLC accounts for over 80% of all lung cancer cases and its incidence continues to increase globally. The estimated global market size for NSCLC therapeutics will exceed USD20 billion by 2027, according to Research and Markets. Despite increasing interest and investment in drug research, there remains significant unmet needs for effective targeted therapy options for NSCLC patients to achieve better outcomes. In this collaboration, XtalPi joins forces with EDDC to apply its AI technology, automation platform, and expert domain knowledge to discover promising candidates against a NSCLC target chosen by EDDC. XtalPi will leverage its quantum physics and AI-driven platform to generate and screen through millions of molecules in de novo drug design. The predicted top-performing molecules with desirable drug properties will be validated and optimized in its robotics-powered synthesis and testing lab through iterations. EDDC will offer valuable insight and data on the novel NSCLC target, further accelerating the drug discovery process and propelling the program towards development. "We are delighted to establish this strategic collaboration with EDDC. XtalPi is committed to serving patients globally by advancing the speed, scale, novelty, and success rate of drug R&D with AI and automation. Through this partnership, we hope to continue expanding our collaborations with top-tier research institutes in the booming Pan-Asia biotech community, drive the quick translation of new discoveries into much-needed therapeutics, and contribute to the improved health and longevity of patients in Asia and around the world." Dr. Shuhao Wen, co-founder and chairman of XtalPi Professor Damian O'Connell, Chief Executive Officer of EDDC, comments: "We are excited to partner XtalPi in the translation of science and research into effective and targeted therapies that enable the treatment of cancer. With XtalPi's expertise in AI and automation technologies, we are confident that this collaboration will accelerate the development of potential targeted therapy options for NSCLC patients, which are very much needed." About XtalPi Founded in 2014, XtalPi founders recognized a common hurdle in drug development having to do with solid polymorphism, which could be successfully tackled with quantum physics predictions. Since then, XtalPi has maintained its focus on identifying and then attacking traditional bottlenecks in biopharmaceutical R&D through innovative technologies. Through considerable capital investments in automation and personnel, XtalPi now has four locations worldwide and employs approximately 1000 employees.

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