COVID-19 Pandemic: Rapid Delivery of Medical Countermeasures

Contract Pharma | April 03, 2020

COVID-19 Pandemic: Rapid Delivery of Medical Countermeasures
Immeasurable efforts are underway to develop treatments and vaccines to address the COVID-19 pandemic. Numerous discovery methods and technologies are currently being explored in clinical trials such as DNA and RNA-based vaccine candidates, adjuvant platform technologies, recombinant nanoparticles, and monoclonal antibodies, to name a few. As promising therapies begin to emerge, they’ll need to be rapidly scaled up for trials and potential commercialization, which is not without its challenges in a pandemic setting.

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PHARMA TECH

Capacity and Citeline Connect Partner for AI-Powered Clinical Trial Recruitment Experience

Capacity | August 12, 2021

Capacity, an AI-powered support automation platform, today announces its partnership with Citeline Connect, the all-in-one clinical trial recruitment platform developed by Informa Pharma Intelligence. The companies partnered to launch Moderna's clinical trial recruitment website with an AI-powered chatbot to provide a comprehensive experience for potential study participants. This partnership enables customers like Moderna to create engaging clinical trial recruitment websites. With the power of Capacity's chatbot and support automation software alongside Citeline Connect technology, users are able to actively complete registration and pre-screening through an easy-to-use interface. "Our work with Citeline Connect is reflective of our ultimate goal at Capacity, leveraging a company's existing knowledge base with support automation to help teams do their best work," said David Karandish, CEO of Capacity. "As we see relief from the COVID-19 pandemic on the horizon, there is still a way to go before we are in the clear. In working with Citeline Connect, we're honored to have the opportunity to provide helpful technology for healthcare providers, researchers, and patients." Capacity and Citeline Connect's first-of-its-kind work will enhance the patient experience. With user-friendly technology, Capacity's chatbot provides an expansive knowledge-base and user-friendly solution. "We are proud of our ability to create more opportunities for the public to engage with important clinical trials," said Chris Venezia, chief commercial officer at Citeline Connect. "Working with Capacity is a no-brainer to provide an extensive solution that meets the needs of potential patients and the clinical trial sponsors. They make it easy for both potential and current study participants to ask questions, find clinical trial information, and begin their study enrollment journey" This partnership comes on the heels of Capacity's growth and recognition across industries. Capacity was recognized as the "Adaptive Learning Innovation of the Year" in the 2021 EdTech Breakthrough Awards, as a "Tech 100 Mortgage Winner" by HousingWire, and was a 2021 FinTech award winner for the "Most Innovative Financial Services Machine Learning UI Solution - North America" by Wealth and Finance International. Capacity was also recognized by Knowledge Management World as one of the top 100 companies that matter most in knowledge management, and secured $12M in Series C funding late last year to continue innovating solutions for its customers. About Capacity Capacity is an AI-powered support automation platform that connects your entire tech stack to answer questions, automate repetitive support tasks, and build solutions to any business challenge. Capacity was founded in 2017 by David Karandish and Chris Sims, and is part of the Equity.com incubator.

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RESEARCH

eDeviation the Latest Protocol Deviations Cloud Software Solution

eDeviation | April 21, 2021

Ethical GmbH, a Swiss organization that provides personalized software solutions for clinical research committee management, has created a new software solution to help with protocol deviation (PD) evaluation and management. The new eDeviation® solution will allow clinical trial sponsors, CROs, and EC/IRBs to handle all protocol deviations in a single repository, assess them electronically in a blinded or unblinded manner, and track all operations. Protocol deviations (PD) are a recognized problem for clinical trials because they can jeopardize subjects' safety, rights, and welfare, as well as the study's data integrity, and thereby violate Good Clinical Practice standards. PDs must be established and submitted to the Institutional Review Board of clinical trials (IRB). They may also be classified as major or minor based on the effect on patient care and data integrity. Finally, corrective measures must be taken to ensure that the PDs do not reoccur, and all decisions and actions must be reported for GxP compliance. Clinical research teams face a significant administrative burden when it comes to managing and assessing PDs. In this context, a software platform that can support and document both PD assessment and management activities will significantly simplify the work of clinical research teams. "With eDeviation®, Ethical's portfolio of clinical research software solutions continues to expand to help our customers run their trials more efficiently and effectively," says Mimmo Garibbo, Director of Ethical GmbH. "In an era of increasingly complex clinical trials, we are pleased to have a solution that will assist sponsors, CROs, and EC/IRBs in minimizing the risk associated with protocol deviations." About Protocol Deviations A protocol deviation is any change, divergence, or departure from the approved protocol, consent agreement, recruitment process, or study materials (e.g., questionnaires) originally approved by the EC/IRB. The expression "protocol deviation" refers to protocol exceptions, modifications made to avoid immediate damage to subjects, and protocol violations. Protocol deviations may be classified as major or minor based on their effect on patient safety and data integrity. About eDeviation eDeviation® is a Protocol Deviations and Violations management cloud software designed to collect, manage and review protocol deviations in a simple, effective, and GxP-compliant way.

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RESEARCH

MindMed Signs Partnership with Swiss Psychedelic Drug Discovery Startup MindShift Compounds AG

MindMed | February 15, 2021

MindMed, a leading psychedelic medicine biotech company announced another partnership with Swiss startup MindShift Compounds AG to develop and patent next-gen psychedelic compounds with psychedelic or empathogenic properties. As a component of this partnership, MindMed and MindShift Compounds AG have agreed to develop next-gen psychedelic and empathogenic substances together. The first initial compounds have just been combined by MindShift Compounds AG and related patent applications were documented by MindMed. MindMed plans to begin first-in-human Phase 1 clinical trials as ahead of schedule as Q1 2022 through its existing clinical preliminary stage for psychedelic and empathogenic compounds in Switzerland. The partnership on these initial targets will expand MindMed's current, grounded clinical pipeline with extra reinforcement and expansion compounds with comparative and possibly improved restorative properties. The connected combination intellectual property and drug technology will be possessed through and through by MindMed, and MindShift Compounds AG will give all intellectual property identified with the new psychedelic compounds only to MindMed. This partnership adds to MindMed's existing IP portfolio development endeavors in progress in collaboration with the University Hospital Basel's Liechti Lab for exemplary psychedelic compounds including LSD, MDMA, Psilocybin, MDMA-LSD combinations, personalized dosing technologies and a LSD Neutralizer technology, which depend on multiple clinical trials and long stretches of exploration led by the Liechti Lab. MindMed plans to work with the accomplished drug discovery group at MindShift Compounds AG to encourage extensively cover preclinical psychedelics investigation into novel compounds and hopes to continue to record a substantial number of licenses on countless novel substance matters, production innovations, and later clinical applications, allowing MindMed to additionally unite its leading situation in the in general psychedelic-medicine market as it moves these next-gen compounds into the clinic through advanced patient clinical trials. MindShift CEO, Dr. Felix Lustenberger, said "Our innovative psychedelic drug-discovery platform based in Switzerland is pioneering next-gen psychedelic compounds that complement in a synergistic pipeline approach the later-stage development work underway at MindMed. The compounds we are working on are typically derivatives or analogues of known substances with psychedelic properties, such as phenethylamines, tryptamines, and ergolines, and are therefore enhanced versions of both the established and classic psychedelic compounds such as mescaline, psilocybin, DMT, and LSD, as well as compounds with expected combined psychedelic-empathogenic effect profiles. These novel chemical structures, for example MDMA and LSD-like compounds, are designed and synthesized with expected ameliorated psychoactive properties and duration-of-effect profiles with potential added therapeutic benefits." About MindMed MindMed is a psychedelic medicine biotech company that discovers, develops and deploys psychedelic-inspired medicines and therapies to address addiction and mental illness. The company is assembling a compelling drug development pipeline of innovative treatments based on psychedelic substances including psilocybin, LSD, MDMA, DMT and an Ibogaine derivative, 18-MC. The MindMed executive team brings extensive biopharmaceutical experience to the company's groundbreaking approach to developing the next generation of psychedelic-inspired medicines and therapies.

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Spotlight

We support the drug development industry with solutions that improve the identification, activation, training and management of clinical trial sites.