Digital tool aims to cut costs and risks of underperforming trials

Pharmaphorum | June 07, 2019

Digital tool aims to cut costs and risks of underperforming trials
ArcheMedx, which provides tech solutions for life sciences and healthcare, has launched a new digital service that aims to cut risks and costs associated with under-performing clinical trials. The company will unveil the tool called Ready at this year’s Drug Information Association (DIA) annual meeting, which takes place in San Diego later this month. According to the company based in Charlottesville, Virginia, the tool enables those running trials to evaluate and improve the preparedness of project teams and site personnel. The tool analyses the behaviour of each participant as they engage in personalised learning experiences. Insights delivered by the platform serve as an early warning detection system to identify risks sooner, ensure resources are more effectively deployed, and enhance staff and site performance. Joel Selzer, CEO of ArcheMedX, said: “As the complexity and cost of clinical research increases, a key to reducing the risk of under-performing trials is ensuring the preparedness of staff and sites.” “Ready arms clinical operation leaders with a powerful new tool to take action and mitigate trial risk and DIA is the perfect event to unveil its capabilities and expand our understanding of how the platform can better support contract research organisations (CROs), sponsors, and other trial stakeholders.” In late 2017 the company said it closed $2.5 million in equity financing by early stage investors Jaffray Woodriff and Greyson Williams. Earlier this week, the American Society of Clinical Oncology (ASCO) warned that trials are being held back by outdated and outmoded recruitment eligibility criteria. A study showed that relaxing three rules used to screen patients almost doubled the number of patients on a dummy lung cancer trial.

Spotlight

The US Food and Drug Administration (FDA) has approved Zejula (niraparib) as a maintenance treatment for women with certain types of recurrent cancers, including epithelial ovarian, fallopian tube, and primary peritoneal cancer.


Other News
PHARMACY MARKET

Virpax Pharmaceuticals Recaps Milestones and Highlights Product Portfolio

Virpax® Pharmaceuticals, Inc. | December 29, 2021

Virpax® Pharmaceuticals, Inc. "Company" achieved significant milestones relating to its pipeline of product candidates as of the end of 2021, which are summarized below. “I believe that Virpax has made significant progress this past year toward our stated goalsThese accomplishments include accelerated development of our existing product candidates, broadening our pipeline of product candidates, and utilizing grants where appropriate. We recently announced that we anticipate commencing our initial human trial for Epoladerm™ in the second quarter of 2022. Anthony P. Mack, Chairman and CEO of Virpax “Virpax initially focused strictly on pain product candidates. However, our unique Molecular Envelope Technology delivery platform licensed from Nanomerics, Ltd. has enabled the development of product candidates for central nervous system and anti-viral indications. In the second half of 2021, we advanced the development of AnQlar™, a prophylactic, over-the-counter anti-viral product candidate formulated to prevent the spread of respiratory infections like influenza, SARS-CoV-2 and rhinovirus. We added VRP324 which is an intranasally delivered cannabidiol formulation for the management of epilepsy in adults and children. Our Envelta™ IND-enabling studies, completed by the National Center for Advancing Translational Sciences as a part of our Cooperative Research and Development Agreement, determined that the MET intranasal delivery formulation bypasses the liver which we believe reduces drug-to-drug interaction concerns for treatments using this technology. “On the corporate front, we strengthened our Board by appointing two new members adding expertise in commercialization and financial strategy. Additionally, in 2021 we raised approximately $58 million in aggregate gross proceeds from our initial public offering and an underwritten follow-on public offering. These funds are being used for research and development activities of our product candidates. We are on track to add accomplishments in 2022 and I remain confident that we have the significant financial strength to continue advancing our pipeline,” concluded Mr. Mack. Epoladerm™ Epoladerm is a diclofenac topical spray film product candidate that is being developed for pain associated with osteoarthritis of the knee. Virpax recently reported successful results of a Charles River Laboratories single dose toxicology and pharmacokinetic study of dermal administration of Epoladerm in minipigs as part of the required Investigational New Drug Application enabling trials. Single-dose transdermal delivery of Epoladerm was well-tolerated in all minipigs. There were no treatment-related clinical observations, changes in body weight, or dermal irritation observed. The maximum plasma concentration was reached at 4 hours post-dose, and concentrations of plasma Epoladerm remained at 24-hour post-dose for all animals. Upon completion of all the required IND enabling studies and subsequent review by the FDA, Virpax intends to conduct a Phase 1 study to evaluate the relative bioavailability and pharmacokinetics of Epoladerm™. Virpax recently announced the execution of a clinical trial agreement with Altasciences Company, Inc., to conduct this study in Canada. Virpax anticipates enrollment of the first patient by early second quarter of 2022. Probudur™ Probudur is an injectable bupivacaine liposomal hydrogel for postoperative pain management which Virpax believes has improved onset and extended duration of action compared to existing treatment options. Additional pre-clinical trials are being conducted with Lipocure, the product developer, to improve the formulation to potentially enhance manufacturing efficiencies, prolong duration and extend patent protection. Once completed, we plan to perform seven preclinical animal studies as part of required FDA IND enabling trials. Envelta™ Envelta is an endogenous enkephalin intranasal spray for acute and chronic pain, including pain associated with cancer. This product leverages Nanomeric’s MET platform technology which Virpax licensed to deliver the endogenous enkephalin formulation through an intranasal delivery enabling the enkephalin to permeate the blood-brain barrier while bypassing the liver. This product candidate is being funded through an in-kind CRADA with the NCATS. Virpax recently announced that under this CRADA, the National Institutes of Health has awarded multiple contracts to support the research, development and manufacturing of Envelta. These contracts are to support Good Manufacturing Practices production of drug substance and drug product, as well as to support Good Laboratory Practices toxicology, safety studies and preclinical efficacy studies. The NIH has contracted with a clinical research organization to conduct additional pre-clinical efficacy studies and has procured a device to be used with the manufactured GMP drug product for preclinical and clinical studies. The NIH has also engaged a firm to manufacture Leu-enkephalin, the active ingredient in Envelta, and a company to manufacture the MET carrier that delivers L-ENK to the brain to promptly suppress pain. AnQlar™ AnQlar is a high-density intranasal molecular masking spray in development as an anti-viral OTC product for protection against respiratory infections, such as SARS-CoV-2 and influenza, that Virpax anticipates will be used as an adjuvant to barrier-based personal protective equipment. Virpax recently announced a manufacturing and supply agreement with Seqens to provide AnQlar for both clinical studies and the long-term commercial supply of AnQlar. Additionally, Virpax engaged Sinclair Research to initiate IND-enabling studies for AnQlar. The Company anticipates that these preclinical animal studies will begin in early 2022. VRP324 Virpax has acquired the exclusive worldwide rights from Nanomerics to use its MET platform for the nasal delivery of CBD for the management of epilepsy in children and adults. Under this agreement, Virpax has the global rights to develop, manufacture, market and sell VRP324, the first investigational formulation delivered via the nasal route to enhance CBD transport to the brain. This product candidate will be formulated to potentially treat seizures associated with tuberous sclerosis complex, Lennox-Gastaut syndrome and Dravet syndrome in patients one year of age and older. Lennox-Gastaut syndrome and Dravet syndrome are rare CNS diseases considered serious epileptic encephalopathies that cause epileptic seizures, as well as cognitive and behavioral changes, and are generally resistant to treatment. Preclinical studies of VRP324 have been initiated by Nanomerics which it anticipates will be completed in the first quarter of 2022. Upon completion, Virpax will collaborate with RRD International, a clinical drug development company which Virpax has engaged, to prepare the pre-IND briefing documents for the FDA. About Virpax Pharmaceuticals Virpax is developing branded product candidates for non-addictive pain management and neurological disorders using its proprietary technologies that optimize and target drug delivery. Virpax is initially seeking FDA approval of its three different patented drug delivery platforms. Epoladerm™ is a topical diclofenac spray film formulation being developed to manage pain associated with osteoarthritis of the knee. Probudur™ is a single injection long-acting liposomal bupivacaine formulation being developed to manage post-operative pain. Envelta™ is an intranasal Molecular Envelope Technology enkephalin formulation being developed for the management of acute and chronic pain, including pain associated with cancer, as well as post-traumatic stress disorder under the name PES200. MET technology is also used in AnQlar™, a candidate to inhibit viral replication caused by influenza or SARS-CoV-2. Virpax acquired global rights to VRP324, a product candidate for the nasal delivery of a pharmaceutical-grade cannabidiol for the management of epilepsy in children and adults.

Read More

BUSINESS INSIGHTS

Omnicell Completes Acquisition of ReCept

Omnicell, Inc. | December 30, 2021

Omnicell, Inc. a leading provider of medication management solutions and adherence tools for health systems and pharmacies, has completed the previously announced acquisition of ReCept Holdings, Inc. The addition of ReCept’s specialty pharmacy management services for health systems, provider groups, and federally qualified health centers expands Omnicell’s Advanced Services portfolio to address the growing and complex specialty pharmacy market. ReCept provides implementation and managed services for health systems and other provider organizations to optimize their specialty pharmacy programs and the related pharmaceutical aspects of patient care. This total solution supports on-site management, including payor contracting, staffing, licensing, quality assurance, 340B administration, and preferred pricing agreements designed to improve margin and profitability, while keeping the patient at the center of care. “ReCept’s specialty pharmacy management services capabilities naturally complement Omnicell’s intelligent infrastructure, giving us deeper expertise to address the growing market need for managing complex specialty medications as part of a broader, more comprehensive medication management strategy,” Randall Lipps, chairman, president, CEO, and founder of Omnicell Under the terms of the purchase agreement, the acquisition price was $100 million, subject to customary adjustments, as provided for in the agreement and plan of merger. The ReCept business that is being acquired recorded annual recurring revenue of $24 million (unaudited) for the 12 months ended September 30, 2021, and is expected to accelerate Omnicell’s Advanced Services revenue growth. Omnicell used cash on its balance sheet to fund the transaction, which is expected to be accretive to Omnicell’s non-GAAP EBITDA beginning in the first quarter of 2023. About Omnicell Since 1992, Omnicell has been committed to transforming the pharmacy care delivery model to dramatically improve outcomes and lower costs. Through the vision of the autonomous pharmacy, a combination of automation, intelligence, and technology-enabled services, powered by a cloud data platform, Omnicell supports more efficient ways to manage medications across all care settings. Over 7,000 facilities worldwide use Omnicell automation and analytics solutions to help increase operational efficiency, reduce medication errors, deliver actionable intelligence, and improve patient safety. More than 60,000 institutional and retail pharmacies across North America and the United Kingdom leverage Omnicell's innovative medication adherence and population health solutions to improve patient engagement and adherence to prescriptions, helping to reduce costly hospital readmissions.

Read More

PHARMACY MARKET

KromaTiD Announces Launch of KromaTiD Pinpoint FISH TP53/CEP17 Kit for Synthetic Oligonucleotide-Based FISH Assay

KromaTiD Inc | January 14, 2022

KromaTiD is excited to announce early access to our KromaTiD Pinpoint FISH TP53/CEP17 Kit, our new product designed to supply the highest resolution, lowest background, and lowest limit of detection available. KromaTiD's Pinpoint FISH™ Kit, allows for better hybridization conditions and eliminating strand degradation steps. Pinpoint FISH™ allows researchers to expand beyond the capabilities of conventional FISH probes to detect smaller targets and design ultra-high specificity tests. Our technology is fully compatible with your standard FISH equipment/conditions and BAC probes and works with your established samples, workflow, and imaging system. "Single-cell genomic measurements from KromaTiD have unique capabilities to analyze and understand the underlying genomic drivers of human disease. Pinpoint FISH has an unmatched resolution, extraordinary ease of use, consistency from analysis to analysis, and an unprecedented ability to distinguish fine genomic structural variation" Dr. Tompkins continues, "While this is the first catalog product from KromaTiD, we have a ten-year history of building a custom assay for Pharma and Biotech companies based on the PPF and dGH platforms. As we begin to build out a comprehensive line of blood cancer measurement kits, we are delighted to bring Pinpoint FISH to a worldwide market". Pinpoint FISH™ is available now from KromaTiD for researchers' use in oligonucleotide-based FISH assays. Christopher Tompkins, KromaTiD's Chief Technology Officer About KromaTiD, Inc. KromaTiD is transforming the fields of genome engineering through the discovery and characterization of genomic structural changes that help leading gene editing and pharmaceutical companies advance therapies to market. KromaTiD offers a powerful suite of products and services for studying genomic rearrangements, custom assay development services and preclinical research support. KromaTiD's proprietary Pinpoint FISH™ and directional Genomic Hybridization platforms (dGHTM) have applications throughout genomics, supplying direct, definitive data on structural variations that no other technologies can provide. We provide the essential genomic structural context to sequence.

Read More

PHARMACY MARKET

The McQuade Center for Strategic Research and Development and Mindset Pharma Collaborate to Develop Psychedelic Medicines

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. About Otsuka 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.

Read More

Spotlight

The US Food and Drug Administration (FDA) has approved Zejula (niraparib) as a maintenance treatment for women with certain types of recurrent cancers, including epithelial ovarian, fallopian tube, and primary peritoneal cancer.

Resources