Veeva Systems | May 21, 2021
A growing number of life sciences companies are adopting Veeva Development Cloud applications from Veeva Systems in an industrywide shift to streamline drug development. quite 650 companies use Veeva Development Cloud applications today, and quite 250 are leveraging multiple Veeva Vault applications across functional areas to enable and connect drug development and manufacturing teams.
Veeva Development Cloud brings together suites of unified applications for clinical, regulatory, quality, and safety on one cloud platform, eliminating organizational siloes. quite 350 companies are accelerating trial execution with Vault Clinical applications, quite 250 are streamlining regulatory processes with Vault RIM, quite 350 are unifying quality management with Vault Quality, and quite 35 are improving pharmacovigilance with Vault Safety.
Vault Connections in Veeva Development Cloud drive cross-functional business processes across the merchandise lifecycle. For instance, Connections enable companies to compile clinical operations and regulatory for faster submissions; quality and regulatory for simplified change control and variation management; and clinical data and operations for real-time visibility into patient enrollment.
"We're dedicated to bringing innovations to plug that help the industry accelerate drug development," said Jim Reilly, vice chairman of Veeva Vault R&D. "Veeva Development Cloud is enabling customers to enhance collaboration across teams and speed the delivery of treatments to patients."
About Veeva Systems
Veeva is that the global leader in cloud software for the life sciences industry. Committed to innovation, product excellence, and customer success, Veeva serves quite 975 customers, starting from the world's largest pharmaceutical companies to emerging biotechs. As a Public Benefit Corporation, Veeva is committed to balancing the interests of all stakeholders, including customers, employees, shareholders, and therefore the industries it serves.
CureVac, EMA | February 18, 2021
The European Medicines Agency (EMA's) Committee for Human Medicinal Products (CHMP) has begun a moving audit of CureVac AG's COVID-19 antibodies, CVnCoV.
The survey was started on the grounds that starter research facility contemplates and early clinical preliminary outcomes recommend the immunization triggers the creation of antibodies and insusceptible cells that target SARS-CoV-2, the infection that causes COVID‑19.
The survey will successively audit information as it opens up, beginning with the preclinical and beginning stage proof presently submitted. As opposed to a customary advertising authorisation application, in which all information on a medication's or immunization's viability, security and quality and all necessary archives should be prepared toward the beginning of the assessment.
Continuous preliminaries are proceeding to assess the immunization's wellbeing, immunogenicity and viability against COVID-19. EMA will assess information from these and other clinical preliminaries as they become accessible.
The moving audit will proceed until the CHMP concludes that adequate information is accessible for a conventional showcasing authorisation application. Because of the work attempted in the moving audit, it should take less time than typical to assess such an application.
EMA will survey the immunization's consistence with the typical norms for adequacy, wellbeing and drug quality inside the moving audit measure.
CVnCoV is an mRNA vaccine which encodes the SARS-CoV-2 Spike (S) protein. The mRNA sequence is formulated in minute lipid particles to prevent it from being broken down too quickly.
When a person receives the vaccine, some of their cells will use the mRNA molecules to temporarily produce the S protein. This activates the person’s immune system, priming it to respond more quickly to a subsequent SARS-CoV-2 infection.
The Mid-Atlantic Technology, | March 03, 2022
The Mid-Atlantic Technology, Research & Innovation Center announced it will establish the Center of Excellence for process design, defining a new standardized process development framework to streamline chemical manufacturing processes from laboratory bench through to commercial production. The initial projects will develop continuous processes for critical materials for the pharmaceutical industry currently substantially produced overseas. These new capabilities will be established as a result of the Department of Commerce’s recent Rapid Assistance (for) Coronavirus Economic Response grant to the RAPID Manufacturing Institute, of which MATRIC is a sub-awardee.
MATRIC—applying its unique infrastructure and subject matter expertise—will lead the specialty chemical manufacturing industry with this Center of Excellence focused on accelerated process design through modular processing. Onshoring the capability to move critical pharmaceutical material manufacturing processes from concept to commercial products will enable faster response times and fewer supply chain disruptions for the Nation.
“Today, the U.S. doesn’t have the manufacturing capability to produce some key raw materials and intermediates at scale to support our pharmaceutical industry and needs. The COVID pandemic and the current global supply chain issues have taught us the importance of supply chain stability and security, and this starts with critical raw materials produced domestically, distributed with purpose, and efficiently accessed.”
MATRIC Chairman & CEO Steven B. Hedrick
“At the beginning of the COVID pandemic, we struggled to get our families and front-line healthcare workers access to necessary PPE, disinfectants and other critical equipment. I applaud MATRIC for making this exciting investment and establishing the Center for Excellence right here in West Virginia. Their broad-based chemical technology expertise will also help improve domestic Active Pharmaceutical Ingredient (API) manufacturing, at a time when onshoring our pharmaceutical supply chain is critical,” said U.S. Senator Joe Manchin (D-WV). “West Virginia’s strategic location and MATRIC’s unique skillset will play a critical role in ensuring healthcare professionals across the country can quickly and efficiently get the equipment they need to safely do their jobs.”
MATRIC is a sub-awardee of the RACER grant from the Department of Commerce to the RAPID® Manufacturing Institute (RAPID). MATRIC will collaborate with RAPID, the project leader, and with partners at Teich Process Development and Procegence.
“Through its partnership with RAPID, Teich and Procegence, MATRIC’s Center of Excellence avails our economy with choices. Choices like this afford the opportunity to source from Americans for Americans, or to selectively buy from overseas, at their discretion,” said RAPID Executive Director & Chief Technology Officer Ignasi Palou-Rivera. “Just on the horizon, the most important raw materials and intermediates for pharma will again be made available inside the United States and not be locked down by a relatively inelastic supply chain originating in nations with substantial government control.”
RACER grants are awarded by the U.S. Department of Commerce to high-impact projects designed to fund awards for research, development, and testbeds to prevent, prepare for, and respond to coronavirus.
MATRIC is the strategic innovation partner of choice that provides uncommon expertise and infrastructure to solve the most challenging science and technology problems. Focusing on the areas of chemical, energy and environmental technologies, technical engineering and advanced software technologies, MATRIC delivers innovation from concept to commercialization. We utilize our experienced and renowned staff, unique laboratory and pilot plant facilities, and flexible intellectual property models to create value for customers and investors around the world. We are an energized and expanding company that works from facilities in South Charleston and Morgantown, W.Va.
About RAPID® Manufacturing Institute
RAPID serves as a nexus between process innovation, economic development, and job creation. The technology development and educational programming we sponsor will increase energy and operational efficiencies, enhance productivity, and improve sustainability, making U.S. manufacturing in the chemical process industries (CPI) more competitive in the global market and developing the next generation workforce for these industries.