To automate today’s high-throughout screening, researchers need a combination of hardware and software. As always, robotic arms and liquid-handling systems bring improvements to these processes, but keeping such complicated workflows efficient requires software tools that track the processes and samples.
As the U.S. Food and Drug Administration finalizes regulations to establish a pathway for...
There is a discernible cycle associated with the application of information technology:...
The difficulty of delivering large molecules—proteins, peptides, and nucleic acids—into cells...
In order to add assurance that the biosimilar candidate is as similar to the originator as possible, multiple tests should be used to assess similar qualities, an approach termed as “orthogonal” in the U.S. Food and Drug Administration draft biosimilar guidelines.
The drug discovery business is changing rapidly. More pharmaceutical companies are working with smaller biotech firms to create early-stage compounds, and thus need quicker and standardized solutions to early-stage development problems.
A positive genotoxicity result can throw the fate of a promising drug candidate—in which a firm has invested significant time and money—into doubt. The statistical improbability and challenges of bringing a drug to market become paramount.
Cancer is a disease of dysregulated cellular growth and signaling characterized by the loss or gain of function—through mutation or epigenetic change—of important regulatory proteins and cellular processes. Foremost among these is the tumor suppressor protein known as p53.
The industry has changed a great deal over the last decade and will continue to evolve in the coming years. In order to survive the multitude of technological, political, and regulatory changes that will no doubt arise, the biopharmaceutical industry must prove its adaptability.
The appeal of cell culture–based production of drugs has increased demand for single-use bioreactors that can move into the process-development lab and help manage peaks and tight development schedules. Single-use bioreactors can be used for monoclonal antibodies, recombinant proteins, stem cells, and vaccines.
The U.S. Food and Drug Administration cannot determine whether its four-year-old Risk Evaluation and Mitigation Strategies program is working because drug companies have not provided key information when requested and the agency has not taken enforcement action against them.
Apoptosis, or programmed cell death, plays an essential role in organismal development and tissue homeostasis. During development, apoptosis is critical for the sculpting of organs and the elimination of unnecessary structures. Many cells die an altruistic death daily to secure homeostasis of the whole organism.
A key function of heat shock proteins (HSPs) is to act as molecular chaperones to assist in the folding and stabilization of numerous client proteins. One family of HSPs—heat shock protein 90—stabilizes a diverse range of client proteins, many of which are involved in key pathways in malignancy.
The neverending din of partisan squabbling coming out of Washington can be deafening at times. Luckily for everyone, legislation like The Food and Drug Administration Safety and Innovation Act of 2012 seemed more or less immune to this cacophony, passing the Senate with 92 yay votes.
The day-to-day pressures on a compound manager come from several directions. There is pressure to support the increasing demands for samples in more diverse delivery formats; pressure to keep operational and supply costs down; and there has been the unfortunate trend toward staff reductions.
Scientists recently demonstrated that biphasic vesicles can deliver large-molecule or macromolecule drugs into the skin. Success with biphasic vesicles offers the potential for needle-free administration of many pharmaceuticals that could previously only be administered by injection.
Predicting the side effects of drugs remains one of the industry’s greatest challenges, with a large percentage of new drugs failing in clinical studies due to cardiac toxicity. The overall success rate from Phase 1 studies is only 11%, with 30% of these failing for safety reasons.
Drug discovery and development depends increasingly on imaging, from traditional microscopy to high-content screening. Moreover, these techniques provide sophisticated capabilities. To make the most use of these tools, researchers need advanced software that provides automation, analysis, and ease-of-use.
New ideas from new places are critical to helping the industry pull back from the brink and get on stable footing. The only mistake here was waiting until the situation reached this point before taking advantage of these promising new avenues.
Less than 1% of current drugs have a companion diagnostic, and 60% of the drugs in clinical trials have a companion diagnostic in mind. Companion diagnostics are an important component in moving the ball forward in personalized medicine and making those moves depends on biomarkers.
As the New Year progresses, drug manufacturers are seeking to navigate changing—and increasingly stringent—governmental, financial, and commercial environments. Several recent studies and reports provide useful data and insights. The average cost of developing a new drug has jumped tenfold.
Since the isolation and propagation of the first immortalized cell line some 60 years ago, a multitude of relevant cell types and lineages now serve as a cornerstone in scientific research. However, as the “toolbox” grows so does our understanding of potential shortcomings in these models.
A drug entering the body undergoes a series of biotransformations via phase I and phase II metabolic pathways. The metabolites produced have a similar chemical structure to the parent drug and are more pharmacologically active at the therapeutic receptor sites.
A scientist needs a purified sample of a protein to unravel its function. The complexity of acquiring such a purified protein depends largely on the complexity of the original sample. Most protocols for purifying proteins include some form—and maybe more than one—of chromatography.
In the last issue’s Policy and Projection’s column, Ted Agres wrote about the allure of pharmerging markets—17 countries that have shown, and are expected to continue to show, strong growth, but still have a modest per capita gross domestic product. With sales projections in the United States and Europe forecast to slow and shrink respectively, the idea of a foreign port in the storm is an attractive one.
In 1986, organic chemists first reported the use of microwave energy to accelerate small-molecule synthesis transformations. It was not long after this seminal work that peptide chemists were using microwave technology to improve the solid-phase synthesis of more complex biomolecules.
The old pharmaceutical mantra to “fail early” hasn’t been working out very well recently. Bristol Myers’s BMS-094 hepatitis C drug took a $1.7 billion Phase 3 dive due to toxicity, while monoclonal antibodies against Alzheimer’s disease plaques from Pfizer, Johnson & Johnson, Eli Lilly, and Medivation have all met with costly late-stage failures of their own.
Neuropathic pain is a type of chronic pain and is defined by the Neuropathic Pain Special Interest Group (NeuPSIG) of the International Association for the Study of Pain as “pain arising as direct consequence of a lesion or disease affecting the somatosensory system”.
Recent technological advances have dramatically broadened the scope of safety pharmacology studies as originally envisioned in the International Conference on Harmonization (ICH) S7A and S7B guidances, where “the use of new technologies and methodologies in accordance with sound scientific principles” was encouraged.