The data associated with drug-product serialization will be Everest-like; accessing it may pose every bit the security risk. The difference is millions of people may be trying to access the summit … every day. What’s clear today is that a national program for drug serialization looms large on the horizon, and rises, if you will, high into the data clouds.
Most of us like to think that we’re good sports about it. If it’s a little thing, we may laugh it off good-naturedly. If it’s a major mistake, we shoulder responsibility, accept consequences, and correct course. As scientists, most of us probably think we have a healthier than average relationship with our human tendency to err. We are, one could argue, obsessed with the possibility of being wrong. We are wrong far more than we are right on the path to knowledge. Ninety-five percent of drug candidates fail during development. Our egos are buff. We dust off, and keep going.
The newest round of Star Wars mania got me thinking about one of the themes in the movie series — mentoring.
Quantitative systems pharmacology (QSP) sits at the interface between pharmacometric modeling and simulation, and systems biology. It uses mathematics to describe biological processes. While pharmacokinetics describes what the body does to the drug, pharmacodynamics quantifies what the drug does to the body; the pharmacological response. QSP is a mechanistic modeling approach and an emerging technology, which mathematically integrates pharmacokinetics, pharmacological response and disease progress/modulation.
Trends in biomanufacturing follow a slow cycle, partly due to the regulated nature of the industry and the substantial costs and risks that introducing a change in the process can bring. But that ignores the benefits that changes in bioprocessing over the past 10 years have brought, from better expression systems, to new modular and flexible facilities, sensors, and control systems for downstream operations.
Inappropriate drug storage can reduce the quality of product, potentially affecting efficacy and safety, so manufacturers, patients and prescribers must be aware of these risks. World Courier looks at the importance of ‘last mile distribution’ to understand the effects it has on patient safety as well as cost for pharmaceutical companies.
After its parent Merck® merged with Schering-Plough, Merck Research Laboratories (MRL) found itself with differing lab computing models and standards including many outdated systems with data communications and security issues. The MRL information technology (IT) team developed a standard environment that addressed these challenges and substantially improved the integrity and stability of their lab computing infrastructure. As a partner for implementing these standards, Merck selected PerkinElmer® OneSource® Laboratory Services for a pilot project to upgrade 220 systems to the new environment.
There are limitations to the drug approval system we currently have in place that is based on clinical trials. Data disclosures are often deemed inadequate, regulatory review and approval can be a lengthy process, and many would argue there is a bias in the industry and academia against publishing negative results.
The pharmaceutical industry lags in the sophistication and performance of its supply chains when they are compared with best-in-class companies in other industries. This is due to the complexity that has come with new drugs, more complex production technologies and evolving regulatory requirements. In this environment, integrating and aligning the supply chain makes it more flexible, bolstering operational performance and financial competitiveness.
Industry research shows that about 90% of all drugs in clinical development will be rejected by the FDA or will fail to reach the final stages of regulatory review for other reasons. Given the FDA’s stringent rules and standards for review of drugs, this failure rate is not completely surprising. But while we tend to associate a development program’s failure with dangerous adverse events or underwhelming efficacy data, analysis of the true risks associated with clinical research yields some surprising conclusions.
Combination products are therapeutics combining two or more products that are regulated and sold as a single unit. When developing a combination product, there are many aspects that need to be considered. Read this white paper to learn about the regulatory and clinical development strategies that help define pharmaceutical and biologic combination products, the need for early establishment of regulatory and clinical strategies, and how to best understand user needs and determine product requirements.
It's a given next-generation medical devices will be smaller and smarter. But to achieve such designs, improve patient adherence, and limit the risk of product recalls, manufacturers will need to follow Design for Manufacturing (DFM) principles aimed at creating more usable, intuitive, and desirable devices for patients. Learn how having an integrated product development process combining Human-Centered Design (HCD) principles with a Design for Manufacturing (DFM) philosophy can make a dramatic difference in the outcomes of combination product design.
Ever since the phenomenon known as Low Endotoxin Recovery (LER) was presented publicly at a PDA Annual Meeting in 20131 by Genentech scientist Joseph Chen, the field of endotoxin testing has been preoccupied with concerns about the safety of parenteral products. LER, also referred to as endotoxin masking, is the inability to recover a spiked amount of lipopolysaccharide (LPS), the biologically active component of the endotoxin molecule, in a study designed to demonstrate the stability of assayable endotoxins.
If your job is to develop and produce medicines to prevent disease and mitigate suffering around the world, quality is the guiding principle of your business model.
Healthcare is increasingly moving out of the hospital and into the home as self-administration of medications becomes more cost-effective. As the population ages, and people live longer with chronic conditions, the need for safe and effective drug delivery devices will continue to increase.
WellSpring provides peace of mind to pharmaceutical companies for their contract manufacturing and packaging needs. When you work with WellSpring, you'll have a whole team of professionals backing your project. Our team will oversee the entire operation; while a project manager will help you plan all stages. You'll also have a dedicated technical team to manage all aspects of the project. All this at one convenient location, offering everything from clinical to commercial manufacturing, packaging and analytical testing services for virtually all non-sterile dosage form products including, tablets, capsules, creams, lotions, ointments, gels and oral liquids.
Patheon Inc. is a leading provider of contract development and manufacturing services to the global pharmaceutical industry. Patheon provides products and services to more than three hundred of the world’s leading pharmaceutical and biotechnical companies.
Since it was founded in 1976, Ropack has become much more than a remarkable and efficient packaging service provider. Every effort is constantly made to make Ropack an extension of your company, a strategic partner that provides turnkey production services and avant-garde solutions.
World Courier is the largest, most successful specialty courier company in the world. World Courier pioneered the offering of specialty logistics services for the medical and bio-pharmaceutical communities, transporting the first human heart tissue for transplant in 1984.
Pfizer CentreSource (PCS) is a leading pharmaceutical contract manufacturer that offers a range of GMP compliant sourcing and outsourcing services to meet your pharmaceutical production requirements.
Phillips-Medisize is a global contract manufacturer with 1.7 million square feet of manufacturing space designed to meet demands associated with drug delivery devices and pharmaceutical packaging needs. Our dedicated specialists understand the complexities of product development, and offer a full range of product development services through commercialization with a constant focus on quality.
Welcome to OutsourcedPharma.com, the website dedicated to pharmaceutical drug development services.
Outsourced Pharma provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and health care markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their Bio and Pharma sponsors. Outsourced Pharma is part of the Life Science Connect media group, and also a sponsor of Outsourced Pharma West conferences.
With regular sections on pharmaceutical drug development, contract manufacturing, contract research services, contract packaging services, formulation & development services, contract analytical testing, API (Active Pharmaceutical Ingredients) manufacturing, stability testing services and other areas in pharmaceutical contract development and manufacturing, we bring complete coverage of outsourcing trends and issues to the pharmaceutical contract development and manufacturing marketplace.
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