Lawyers pitch massive opioid negotiation plan to bring 'global peace' to legal battle

fiercepharma | June 17, 2019

Thousands of cities and counties have sued opioid drugmakers and distributors for an alleged role in a nationwide epidemic, and now lawyers for the plaintiffs have pitched a novel process to aid settlement talks. It's an idea that could simplify the legal process and offer drugmakers "global peace" to complex litigation, they contend. Lawyers for plaintiffs filed documents outlining a novel “negotiation class” that would represent every city and county in the U.S., or 24,500 jurisdictions, in settlement talks with drugmakers and distributors. About 1,850 cities and counties have already filed lawsuits, Reuters reports, but the lawyers wrote that others are still affected by a nationwide epidemic. “It is self-evident that each city and county has a vital interest in, and a real need for, financial relief from, and better practices by, the defendants,” the lawyers wrote in a Friday filing. Cities and counties would be able to opt out if they choose. The class would allow representatives of the plaintiffs to negotiate with drugmakers and distributors on potential deals. If the lawyers receive settlement offers, cities and counties will be able to vote, and only offers that get a 75% vote would go to the judge for final approval. The group would split the settlement funds based on the number of people with opioid addiction in the area, plus the number of opioid overdose deaths and the amount of opioids that have been distributed there.

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The Drug Supply Chain Security Act (DSCSA) has been on the mind of pharmaceutical manufacturers since it was enacted in 2013, and the latest requirements are rapidly approaching. Beginning in November 2017, manufacturers will be expected to mark their products with a National Drug Code (NDC), Serial Number, Lot Number, and Expiration= Date.


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MEDITECH Wins Google Cloud Industry Solution Partner of the Year Award for Healthcare

MEDITECH | June 15, 2022

MEDITECH announced that it has received the 2021 Google Cloud Industry Solution Partner of the Year award for Healthcare. MEDITECH was recognized for its achievements in the Google Cloud ecosystem, helping joint customers to develop systems that complement their EHR with scalable, secure data storage and access. Built to harness Google Cloud for patient data storage and access, provider mobility, and organizational efficiency, MEDITECH Expanse encompasses a growing suite of solutions that deliver innovative, cost-effective healthcare technology. The company also deployed MEDITECH Cloud Platform, a set of new applications including Expanse Patient Connect, Expanse Now, Virtual Care, and High Availability SnapShot that provide providers and patients with a better, more mobile healthcare experience. “We’re proud to recognize MEDITECH as our Industry Partner of the Year for Healthcare, based on their deep knowledge and evident experience in helping customers across the healthcare industry succeed,” said Bronwyn Hastings, VP of Global ISV Partnerships and Channels, Google Cloud. “MEDITECH has demonstrated strong technical and service capabilities over this past year, and we look forward to expanding our work together to help healthcare organizations digitally transform their businesses.” Most recently, MEDITECH released Expanse Ambulatory for independent physician practices, representing its entry into a new segment of the healthcare market and leveraging Google Cloud to deliver an intuitive cloud-based practice management solution to more organizations. MEDITECH maintained a strong pace of new customer signings and solution deployments that further expanded its reach and bolstered the company’s reputation as a proven partner for health systems of all sizes. Propelled by the deployment of new solutions such as Ambulatory and impressive sales of the cloud-based MEDITECH as a Service (MaaS) deployment model, MEDITECH secured the second-largest market share growth in the EHR space in 2021. The company’s continued market growth in the large hospital segment again earned plaudits from the global healthcare research firm KLAS, which ranked MEDITECH Expanse #1 in Acute Care EMR (Community Hospital), Patient Accounting & Patient Management, and Home Health EHR. “Our embrace of Google Cloud-powered solutions is a further evolution of MEDITECH’s stance that the time for incremental change is over. We have set out to redefine what an EHR can be,” said MEDITECH Vice President Scott Radner. “We are honored to be recognized by Google Cloud for creating healthcare solutions that ensure faster development, lower costs, and better health outcomes. Our goal is to help healthcare organizations realize tomorrow’s possibilities, today.” About MEDITECH MEDITECH empowers healthcare organizations around the world to expand their vision of what’s possible with Expanse, the intuitive EHR setting new standards for usability, efficiency, and personalization. Our agile innovation is advancing the productivity of busy clinicians in 23 countries, driving positive clinical outcomes and patient experiences. MEDITECH solutions span every care setting, from acute centers and ambulatory practices, to home health and hospice, long-term care and behavioral health facilities, outpatient services, patients’ homes and beyond. Expand your possibilities.

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PHARMACY MARKET

Vivera Partners with NINDS of NIH to Identify Potential Stuttering Treatments

Vivera Pharmaceuticals, Inc. | May 18, 2022

Vivera Biosciences, a division of Vivera Pharmaceuticals dedicated to the research and development of innovative medical technologies and pharmaceutical therapies, is pleased to announce its collaborative progress on a Cooperative Research and Development Agreement with the National Institute of Neurological Disorders and Stroke an Institute within the National Institutes of Health that aims to foster and advance cutting-edge neuroscience research to reduce the burden of neurological disease. The collaboration aims to identify therapeutic agents for the potential treatment of stuttering disorders, estimated to affect approximately 70 million people worldwide. Stuttering, also referred to as childhood-onset fluency disorder, is a neurological condition characterized by speech disfluencies, which can be disabling to patients affected. While there are currently no FDA-approved therapies for stuttering, in recent years, much has been discovered to understand the underlying neurological basis for the disorder. Scientists at Vivera and NINDS have discovered differences in the structure and function of the areas of the brain that regulate the timing and initiation of speech related to stuttering. These neurological revelations and the potential to develop related therapeutics inspired the partnership between Vivera and NINDS. The initiative is unique because of the individuals it will be led by: Vivera Biosciences' Investigator, Gerald A. Maguire, M.D., D.F.A.P.A., and NINDS' Principal Investigator, Shahriar SheikhBahaei, Ph.D. Both are persons who stutter and doctors who have dedicated their careers to understanding the disorder they share with millions of others and one they are working to develop novel treatments for. "I am grateful to the NIH, NINDS, and Vivera Biosciences for supporting this translational collaborative research with my friend and colleague, Dr. SheikhBahaei, as we potentially develop therapeutics to assist our stuttering community," said Dr. Maguire. Dr. Maguire is a world-renowned clinical researcher. He has over three decades of experience as an academic psychiatrist and has served as principal investigator for numerous studies involving investigational medications for various neuropsychiatric disorders, specializing in stuttering. "This collaboration may be an initial step toward developing novel and personalized therapeutic approaches for changing the course of the disorder for people who stutter," Dr. SheikhBahaei. Dr. SheikhBahaei's graduate studies focused on how astrocytic networks control activities of respiratory motor circuits within the brainstem. He currently leads the Neuron-Glia Signaling and Circuits Unit at NINDS, whose goal is to understand how different glial and neural cell types in the brain contribute to the neural circuits controlling voluntary speech production to enhance the ability to intervene in motor control disorders like stuttering. "Vivera is confident in our choice in partnership with NIH," said Vivera's Chief Medical Officer, Stephen J. McColgan, M.D., M.B.A. "Since day one, Vivera has been dedicated to the research and development of patient-centric treatments," said Paul Edalat, CEO of Vivera. "This partnership with NIH and NINDS is about bettering the lives of people who stutter, further solidifying the Company's commitment to our mission." About Vivera Pharmaceuticals Vivera Pharmaceuticals is an innovative, science-driven pharmaceutical company located in Southern California. The Company has global exclusivity to license the patented and patent-pending TABMELT® sublingual drug delivery system for pharmaceutical use and holds its own issued patents on ZICOH®, a smart dose-controlled electronic medical device. The Company has also received a Notice of Allowance for its portable telemedicine station, MDZone. With multiple divisions, including its pharmaceutical, neurosciences, medical technology, biosciences, and advanced diagnostics divisions, Vivera Pharmaceuticals is vertically integrated with patented technology, manufacturing capabilities, and distribution for its products.

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PHARMA TECH

Novotech and Medidata expand partnership to continue advancements in clinical research

Medidata | June 16, 2022

Medidata, a Dassault Systèmes company, announced its renewed, expanded partnership with Novotech, a leading contract research organisation to continue scaling clinical studies in various therapeutic areas from 2022. Leveraging Rave EDC, Rave RTSM, eCOA and eConsent technology from Medidata, Novotech is equipped with flexible, configurable tools that can address clinical research needs at scale and facilitate accelerated drug and device development in Asia Pacific and the U.S. Since its partnership in 2018, Novotech has doubled its growth and has also acquired CRO companies in APAC and the U.S. as well as invested in advanced DCT and data companies to deliver a seamless CRO platform amidst the increasing demand for clinical trials services in the region. The partnership extends access to a suite of end-to-end solutions from Medidata Clinical Cloud, the industry's only unified platform dedicated to clinical research. It also underscores Medidata and Novotech's commitment to work collaboratively towards accelerating clinical trials and research efficiently, while improving clinical trial timelines and patient experiences. The Medidata Clinical Cloud is the only unified technology platform dedicated to clinical research, with solutions that leverage centralized data to address the holistic research process from start to finish. With the physical limitations and fragmentation of healthcare ecosystems caused by the COVID-19 pandemic, the need for digital integration for accelerated clinical development is crucial, and a unified platform allows for streamlined management of studies, sites, users, and access from a single location. "The pandemic has underscored the importance of redesigning how trials are run, with more stakeholders realising the vital role that technology plays in clinical development. Medidata is pleased to continue our strong partnership with Novotech and is dedicated to providing support in their acceleration of clinical studies. Working with leading technologies, we can deliver better patient experiences and accelerate drug development in the new normal in clinical research." Edwin Ng, Senior Vice President, Asia Pacific, Medidata Andries Claassen, Senior Director Biometrics, Novotech, added, "We are excited to continue our partnership with Medidata, with their sustained support in driving clinical research and business growth with customers. Novotech has always invested heavily in the latest technology to provide our clients with better data visibility for improved decision-making. Together, we will help sponsors deliver more efficient, effective, and scalable trials." Medidata is a wholly owned subsidiary of Dassault Systèmes, which with its 3DEXPERIENCE platform is positioned to lead the digital transformation of life sciences in the age of personalized medicine with the first end-to-end scientific and business platform, from research to commercialization. About Medidata Medidata is leading the digital transformation of life sciences, creating hope for millions of patients. Medidata helps generate the evidence and insights to help pharmaceutical, biotech, medical device and diagnostics companies, and academic researchers accelerate value, minimize risk, and optimize outcomes. More than one million registered users across 2,000+ customers and partners access the world's most trusted platform for clinical development, commercial, and real-world data. Medidata, a Dassault Systèmes company (Euronext Paris: FR0014003TT8, DSY.PA), is headquartered in New York City and has offices around the world to meet the needs of its customers. About Dassault Systèmes Dassault Systèmes, the 3DEXPERIENCE Company, is a catalyst for human progress. We provide business and people with collaborative 3D virtual environments to imagine sustainable innovations. By creating virtual twin experiences of the real world with our 3DEXPERIENCE platform and applications, our customers push the boundaries of innovation, learning and production to achieve a more sustainable world for patients, citizens, and consumers. Dassault Systèmes brings value to more than 300,000 customers of all sizes, in all industries, in more than 140 countries. 3DEXPERIENCE, the Compass icon, the 3DS logo, CATIA, BIOVIA, GEOVIA, SOLIDWORKS, 3DVIA, ENOVIA, NETVIBES, MEDIDATA, CENTRIC PLM, 3DEXCITE, SIMULIA, DELMIA, and IFWE are commercial trademarks or registered trademarks of Dassault Systèmes, a French "société européenne" (Versailles Commercial Register # B 322 306 440), or its subsidiaries in the United States and/or other countries. About Novotech Novotech is the leading Asia Pacific biotech specialist CRO with labs, phase I facilities, and drug development consulting services. Novotech has accumulated experience in over 3,700 clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. Novotech is positioned to serve biopharmaceutical clients conducting clinical trials in Asia and globally and serves biotechs globally leveraging deep relationships built with hundreds of Asia-Pacific sites over the last 25 years. As of May 2022, Novotech has over 2,500 FTEs working across our offices in 12 geographies in Asia-Pacific and the United States.

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BUSINESS INSIGHTS

Integral Molecular and Optimeos Life Sciences Enter Partnership to Develop mRNA and DNA-Based Gene Therapies Using Molecular Targeting

Integral Molecular | June 09, 2022

Integral Molecular and Optimeos Life Sciences announce a partnership to develop next-generation mRNA and DNA therapeutics that will use antibody-based molecular targeting to direct vaccines and gene therapies to relevant tissues in a patient's body. This partnership combines Integral Molecular's experience in antibody discovery and mRNA immunization with Optimeos' technology for nanoparticle-based drug delivery systems. DNA and mRNA therapeutics harness a patient's own molecular machinery to encode proteins. Integral Molecular and Optimeos plan to encapsulate these therapeutic molecules within nanoparticle spheres that are decorated with antibodies on the outer surface. The antibodies can then target the particles to specific tissues. Currently, gene therapies and mRNA vaccines are delivered into the body via infusion or injection, but only a fraction of the molecules arrive at their intended site. The proposed molecular targeting strategy has the potential to transform the delivery of vaccines and therapeutics by dramatically reducing dosages, decreasing toxicity, and enabling scalable administration. Integral Molecular will apply its industry-leading antibody discovery expertise against complex cell-surface proteins to provide targeting moieties for the therapies. Its specialized MPS Antibody Discovery platform is tailored to work with challenging membrane protein targets and routinely uses mRNA-based immunization strategies. "Precision targeting of an isolated cell type with gene therapy holds great promise for genetic diseases and may provide brand-new directions in cancer immunotherapy including in vivo CAR-T cell therapeutics," said Joseph Rucker, Co-founder and VP of R&D at Integral Molecular. Optimeos' technology allows the robust and scalable incorporation of mRNA and DNA therapeutics and other biologics into customizable nanoparticles. "We are excited to work with Integral Molecular towards the next generation of gene-therapy that no longer relies on viral-based delivery systems," said Robert Prud'homme, Co-founder and Chief Technical Officer of Optimeos. Integral Molecular and Optimeos will be attending the BIO International Convention in San Diego later this month. About Integral Molecular Integral Molecular is the industry leader in developing and applying innovative technologies that advance the discovery of therapeutics against difficult protein targets. With 20 years of experience focused on membrane proteins and antibodies, Integral Molecular's technologies have been integrated into the drug discovery pipelines of over 400 biotech and pharmaceutical companies to help discover new therapies for cancer, diabetes, autoimmune disorders, and viral threats such as SARS-CoV-2, Ebola, Zika, and dengue viruses. About Optimeos Life Sciences Optimeos Life Sciences has developed a novel, highly differentiated, non-viral, nanoparticle technology, for delivery of new therapeutic drugs to address important unmet medical needs. The technology is a patented and scalable polymeric drug delivery system, which was developed and refined in Professor Prud'homme's lab at Princeton University over 20 years. Optimeos' technology enables encapsulation of mRNA, DNA, peptides, proteins or small molecules, as well as their targeted delivery to cells and tissues beyond the liver.

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Spotlight

The Drug Supply Chain Security Act (DSCSA) has been on the mind of pharmaceutical manufacturers since it was enacted in 2013, and the latest requirements are rapidly approaching. Beginning in November 2017, manufacturers will be expected to mark their products with a National Drug Code (NDC), Serial Number, Lot Number, and Expiration= Date.

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