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The pharmaceutical industry is under huge pressure to address the high attrition rates in drug development. While there are many factors that can cause efficacy- and safety-related failures, including the difficulty of detecting rare events in small clinical trial populations, a predominant reason for failure is that preclinical animal models, as well as some long-established …

How to Nail Data Integrity During Dug Development

In the 2010s, regulatory agencies made data integrity of computerized systems a central concern. While data integrity is not a new topic – electronic-specific enforcement began in the U.S. in 1997 – pharmaceutical companies now face heightened scrutiny over their practices. PerkinElmer realizes the challenges that accompany documenting electronic processes and has created a solution …

New Whitepaper Looks at the 2021 Trends Driving CMC information for Clinical Trials

Chemistry, manufacturing, and control (CMC) information about an investigational new drug is a vital part of every clinical trial application. CMC is used to ensure the safety, identity, quality, purity, strength, and potency of the investigational drug. CMC information must also be updated as a drug proceeds through clinical trials. Following successful clinical trials, the …

Modifying the expression of genes for therapeutic purposes – a process known as gene therapy – has gained attention in recent years due to its promise for treating various genetic disorders. The technique involves replacement, inactivation, or introduction of new genes by a vector that will deliver the gene into the cells and incorporate those …

Veni, Vidi, In Vivo: Conquering Non-invasive Imaging for Pre-clinical Drug Development

We may have taken poetic liberty on Julius Caesar’s quote, but the point is clear: More than ever, we need the best minds working the best tools conquering the biggest challenges. To that point, pre-clinical drug development workflow includes toxicity evaluation at iteratively higher biological levels: cellular, tissue, organ, and whole organism. The ability to …

3D Cellular Imaging in Pre-clinical Drug Development

The pre-clinical drug development workflow includes toxicity evaluation at iteratively higher biological levels: cellular, tissue, organ, and whole organism. The ability to model and image at each of these levels is a powerful tool for molecule evaluation and development. Ex vivo 3D cellular modeling and imaging is a valuable early step in a candidate molecule’s …

Antibody therapies have become an important tool in treating diverse conditions such as autoimmune diseases, cardiovascular diseases, allergic conditions, infectious diseases, and cancers. Proven methods for developing such antibody therapies include using mice with genetically humanized immune systems and human B cells to produce fully human antibodies. These approaches have recently been used to develop …

As the effects of the novel virus are felt worldwide, researchers across the globe are mobilizing to find anti-viral therapies to fight against this new infection. Tackling this challenge by traditional de novo drug discovery approaches is a critical piece of the puzzle but also demands time and sizable investments. As an alternative approach, screening …

With the current global pandemic, tests for detecting antibodies against SARS-CoV-2 have become widely available. These tests are used to determine if a person has been exposed to the virus and can suggest whether they have developed immunity. Traditional wash-based ELISA assays are the most prevalent assay format used for these tests. Detection of anti-virus …

Finding a best-fit or combination of pre-clinical models in immuno-oncology drug development poses a unique series of challenges. Foundational knowledge of the tumor microenvironment and its evasion of the immune system continues to evolve based on emerging data from areas including regulation, academia, and industry. When functioning under homeostatic conditions, the immune system exhibits immunosurveillance …

A Quiet Revolution The nanotech world just witnessed a revolution. For the first time in history, scientists at the University of South Carolina’s Center for Environmental NanoScience and Risk (CENR) and PerkinElmer have precisely quantified the uptake of metal nanoparticles by individual cells. Using PerkinElmer’s innovative NexION® Single Cell Inductively Coupled Plasma Mass Spectrometer (SC-ICP-MS), …

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