Pneuma Systems Corporation | April 08, 2022
Medical technology company, Pneuma Systems Corporation, has entered a multi-faceted business collaboration with West Pharmaceutical Services, Inc. with the goal of improving the patient's experience with drug therapy.
West is a leading global manufacturer in the design and production of technologically advanced, high-quality, integrated containment and delivery systems for injectable medicines. Pneuma Systems Corporation has developed a family of fluid flow technologies that are aimed at scientific and medical applications. The global intravenous pump market segment is expected to reach USD 20.5 billion over the next five years.
Pneuma will provide a novel closed-loop fluid flow control platform that West will use to develop drug delivery solutions for pharmaceutical companies and clinical end users. West will provide technical and financial support to Pneuma and access to the emerging West Digital Platform, designed to improve transmission of data and other information.
"West's almost century-long commitment to the development of drug delivery systems dovetails with our cutting-edge flow control technology. West's latest foray into a broad digital architecture is very important to us. When you improve both fluid flow and information flow, the result is an improvement in workflow, which results in higher levels of patient safety and lower costs," said Pneuma CEO Jeffrey Carlisle. "We are aiming at disruptive improvements in workflow."
"We are excited about our collaboration with Pneuma and the potential of their technologies to address a variety of flow control challenges to drive improvements in healthcare. At West our mission is to improve patient lives not only through our products and services but also by investing in small innovative companies and offering our deep technical and commercial expertise to help them bring their transformation technologies to the market,"
Scott Young, VP Venture & External Collaboration at West
Pneuma Systems, together with its strategic partners, plans to install PneumaDrive™ technology-based infusion devices in infusion centers, home care, and acute care settings around the world. The low cost PneumaDrive™ technology can replace existing infusion pumps and automate "gravity drip" infusions, providing patients with a safer and easier experience.
Pneuma Systems is a New Hampshire based company founded by Jeffrey Carlisle, also Founder of the recently acquired Ivenix. Pneuma is dedicated to improving fluid flow, information flow, and workflow for the IV therapy process.
West Pharmaceutical Services, Inc. is a leading provider of innovative, high-quality injectable solutions and services. As a trusted partner to established and emerging drug developers, West helps ensure the safe, effective containment and delivery of life-saving and life-enhancing medicines for patients. With approximately 10,000 team members across 50 sites worldwide, West helps support our customers by delivering over 45 billion components and devices each year.
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.
McQuade | January 06, 2022
The McQuade Center for Strategic Research and Development, LLC, a member of the global Otsuka family of pharmaceutical companies, and Mindset Pharma Inc. announce a collaboration that will support the development of psychedelic medicines. MSRD has made a strategic investment to support the discovery and development of novel chemical entity assets of Mindset, a drug discovery and development company focused on creating optimized and patentable next-generation psychedelic medicines to treat neurological and psychiatric disorders with unmet medical needs.
“Exploring multiple paths is essential as we work to address the unique needs of individuals living with mental health conditions. We look forward to collaborating with Mindset on these assets and are hopeful that medical psychedelics could be approved to treat mental illness in the future.”
Robert McQuade, Ph.D., president, McQuade Center for Strategic Research and Development, LLC, and chief strategic officer, Otsuka Pharmaceutical Development & Commercialization, Inc
MSRD, which identifies and supports early-stage opportunities that can change the landscape of treatments for mental illness and renal disorders, will financially and operationally support the development of two families of Mindset’s novel medical psychedelic compounds through Phase 1a and Phase 1b clinical trials. MSRD has made an upfront cash payment of $5 million USD to Mindset and under the terms of the agreement, MSRD and Mindset may agree to expand the collaboration to continue to develop the compounds as pharmaceutical products.
In addition, Mindset has granted MSRD a right of first refusal with respect to any asset sale, exclusive licensing or collaboration opportunities pertaining to the drugs and a right of first negotiation with respect to a merger, acquisition or asset sale related to Mindset, both in exchange for the upfront payment, further collaboration, and funding of the development of Mindset’s novel compounds. MSRD also has the ability to potentially receive single-digit percentage royalty payments under certain circumstances when the right of first refusal is not consummated or the agreement is terminated.
“It is our great pleasure to collaborate with MSRD, a member company of Otsuka, to further the development of two of our families of novel psychedelic compounds. We look forward to leveraging their extensive experience in drug development and CNS indications to accelerate and de-risk our development pathway as we prepare to launch clinical trials,” said James Lanthier, chief executive officer of Mindset. “There is a high unmet need for innovative treatments of mental illness. This collaboration further validates our belief that optimized and patentable next-generation psychedelic compounds will be the future of treatments for mental illness.”
Mr. Richard Patricio, chairman of Mindset’s board, added, “This transformational transaction is a validation of what our team has accomplished over the last several years. We are ecstatic that Otsuka has chosen to collaborate with Mindset in the novel psychedelic drug development space and see this as a pivotal moment in Mindset’s maturation. Our team is excited to work closely with MSRD to help meet the unmet needs of millions of people worldwide suffering with a variety of mental disorders. The future is truly exciting.”
About Mindset Pharma
Mindset Pharma Inc. is a drug discovery and development company focused on creating optimized and patentable next-generation psychedelic medicines to treat neurological and psychiatric disorders with unmet needs. Mindset was established in order to develop next generation pharmaceutical assets that leverage the breakthrough therapeutic potential of psychedelic drugs. Mindset is developing several novel families of next generation psychedelic compounds, as well as an innovative process to chemically synthesize psilocybin as well as its own proprietary compounds. For further information on Mindset,
About the McQuade Center for Strategic Research and Development (MSRD)
Established in 2019, by the Otsuka pharmaceutical business in the U.S., the mission of MSRD is to search for, identify, and fund innovative early-stage research and development programs that have the potential to build the future portfolio of Otsuka products.
Otsuka is dedicated to investing in innovative and creative products in areas of unmet need and MSRD was created as an extension of this commitment to support and identify early-stage opportunities that can change the landscape of treatments for mental illness and renal disorders.
Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: “Otsuka–people creating new products for better health worldwide.” Otsuka researches, develops, manufactures, and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.
Ankura | March 09, 2022
Ankura Consulting, LLC a leading global expert services and advisory firm announced the expansion of its Pharmaceutical and Biopharma Regulatory Compliance offering with the addition of a Pharmaceutical Data Integrity solution within the Data and Technology practice, bolstering its comprehensive client advisory capabilities.
With this solution, Ankura has enhanced its team of experts to support pharmaceutical clients' compliance with the Data Integrity guidelines of multiple regulators through advanced digital technology. The offering includes Early Warning System (EWS), an automated platform to help identify data integrity anomalies in real-time and assist companies in performing forensic data integrity investigations and remediation for any regulatory action such as form 483, warning letter, and import alert.
"In the endeavour to embrace industry 4.0, the pharmaceutical industry should explore giving up manual and fragmented means of managing compliance procedures and implement digital technologies in the quality control laboratories to proactively identify any data integrity (DI) gaps in real-time. EWS enables this transition and allows for early identification of any anomaly, falsification activities, and DI deviations from a regulatory compliance perspective,"
Amit Jaju, Senior Managing Director in Ankura's Data & Technology practice
The EWS solution also solves the challenge of integrating multiple quality systems (such as CDS, NON CDS and LIMS) into one platform, enabling the quality control department to take advantage of the integrated monitoring capabilities and providing alerts for any non-compliant activities. It also provides the flexibility to customize and deploy the solution to an on-premises environment and customize the workflows and analytics models to each organization.
"The cost of being non-compliant to data integrity can be a high-priced affair, and in many cases becomes difficult for companies and organizations to gain back the trust of regulators once breached. Many regulators now recommend appointing a qualified consultant for the investigation and remediation activity," said Paul Walker, Senior Managing Director in Ankura's Data & Technology practice. In light of this, Ankura's Data Integrity investigation and remediation offering is a pivotal tool to support clients in performing comprehensive data integrity analysis using big data and advanced analytical approach on 100% of the data as compared to the sample manual review approach followed in the industry."
Ankura Consulting Group, LLC is an independent global expert services and advisory firm that delivers services and end-to-end solutions to help clients at critical inflection points related to change, risk, disputes, finance, performance, distress, and transformation. The Ankura team consists of more than 1,700 professionals serving 3000+ clients across 55 countries who are leaders in their respective fields and areas of expertise. Collaborative lateral thinking, hard-earned experience, expertise, and multidisciplinary capabilities drive results and Ankura is unrivaled in its ability to assist clients to Protect, Create and Recover Value.