Sanofi | November 17, 2020
When a new drug goes in front of the FDA for consideration, a lot of moving pieces must be in place for a successful review—manufacturing standards included. That didn't happen for Sanofi, which is pressing pause on a rare disease candidate after the FDA found issues at a contract manufacturer's plant.
The FDA blasted a third-party manufacturer of Sanofi's rare blood disease drug sutimlimab in a complete response letter, citing "certain deficiencies" at the contractor's site, the French drugmaker said Friday.
A Sanofi spokeswoman declined to specify who the manufacturer cited in the FDA's letter was or what the nature of the deficiencies were.
With its application on hold, Sanofi said it would work with its manufacturer and the FDA to resolve the issues in a "timely manner." The drugmaker didn't say how quickly it expected to turn around a new application.
The untimely feedback from the FDA dims C1 inhibitor sutimlimab's chances in cold agglutinin disease (CAD), a rare blood disease characterized by anemia, fatigue and other symptoms.
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.
Nuventra, CATO SMS | May 27, 2021
CATO SMS, a global provider of regulatory and clinical research services, announced today the acquisition of Nuventra, Inc., to expand its offering into the critical area of clinical pharmacology. Nuventra, headquartered in Durham, North Carolina, is a leading company in clinical pharmacology science and services. The acquisition expands CATO SMS's portfolio of specialized solutions that help biopharmaceutical companies with drug development by providing a key set of skills targeted at significantly reducing development risk, costs, and timelines.
CATO SMS now provides customers cutting-edge clinical pharmacology services such as strategic consulting, pharmacokinetics/pharmacodynamics (PK/PD), pharmacometrics (population PK), and biosimulation. Nuventra is well-known for its track record of transforming complex data into meaningful insights for over 650 biopharmaceutical companies across a wide range of therapeutic areas. Its team of scientific experts and senior consultants use the most advanced mathematical modeling tools in the industry to inform clinical design and predict trial outcomes.
Nuventra's range of solutions include:
• pharmacokinetics and pharmacodynamics (PK/PD), which describes the movement of drugs through the body from absorption to elimination (PK), as well as the body's biological response to drugs (PD) to determine optimal dosing paradigms, safety margins, and efficacy characteristics.
• population pharmacokinetics (popPK and popPK/PD), which studies the variability in drug concentrations among individuals in a group of interest receiving clinically relevant doses of a drug.
• clinical pharmacology strategic consulting, which includes overall and targeted clinical pharmacology strategy in support of marketing applications for drugs and biologics.
• physiologically based pharmacokinetic (PBPK), which incorporates blood flow and tissue composition of organs to predict the absorption, distribution, metabolism, and excretion (ADME) of drugs.
• quantitative systems pharmacology (QSP), which models the interplay of the drug (dose, dosing regimen, etc.) with target biology, using computational systems to characterize the interaction between drugs, biological systems, and disease processes.
• model-informed drug development (MIDD), which uses modeling techniques to improve the decision-making process in drug development, thereby leading to clinical trial efficiencies and, in some cases, replacing trials altogether.
Nuventra is the pharmaceutical industry's preferred provider of clinical pharmacology, pharmacokinetics, and pharmacometrics consulting services. Nuventra provides pharmaceutical companies and contracts research organizations (CROs) with unique access to a hands-on team of industry-leading consultants with extensive experience in complex studies and analyses. By taking complex pharmacokinetic and pharmacometrics concepts and making them understandable and usable for common sense drug development, we embrace the notion that simplicity and clarity lead to smart decisions.
About CATO SMS
CATO SMS is a provider of specialized clinical research solutions formed in 2019 by the merger of Cato Research and SMS-oncology. CATO SMS, with over 30 years of professional experience focusing on the needs of small and emerging biopharmaceutical companies, effectively designs and executes studies from strategy to approval in complex indications and modalities throughout a wide range of therapeutic areas, with a proven center of excellence in oncology. The regulatory, therapeutic, and operational expertise of CATO SMS enables the company to meet and exceed expectations.