drug development Articles
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Adaptive Designs in nQuery - Case Study
Effective and Efficient Drug Development Challenge Increased Cost, Risk, and Competition in the Drug Development Processes Dr. Luis Rojas, the Executive Director Head of Biostatistics at Target Health, is a subject matter expert in study design and sample size calculations with more than 30 years of industry experience. He has worked in the leading CROs in the industry and has assisted ...
By Statsol
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Challenges in Small Molecule Targeted Drug Development
The classical mode of action of small molecule drugs is "occupancy-driven". Since the FDA approved the first oral small molecule targeted therapy for tumors-tamoxifen targeting the estrogen receptor (ER)-in 1977 for the treatment of breast cancer, small molecule drug development has typically focused on screening for high-affinity inhibitors. Small molecule inhibitors can bind to the active sites ...
By BOC Sciences
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Evolving relations between the pharmaceutical industry and public sector research
The interface between the pharmaceutical industry and public sector research (PSR) is increasingly diverse, dynamic and complex. As the industry consolidates at the top end, it is also differentiating and fragmenting. A new layer of small focused-activity companies are emerging, many from PSR. This paper examines patterns of knowledge exchange between PSR and industry along the length of the ...
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Fixing the paradigm for biopharmaceutical R&D: Where to start?
The basic thesis of this paper is that the R&D sector of the new medicines' business is experiencing evolutionary stress. Due to the failure of the regulatory framework and applied sciences to keep pace with advances in discovery, there is a bottleneck in the development phase of R&D. While improved process may help, there are still problems related to the products themselves, such as the need to ...
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Development of new levodopa treatment strategies in Parkinson`s disease-from bedside to bench to bedside
Abstract This review will illustrate the process of moving from an idea through preclinical research and Galenic developments into clinical investigations and finally to approval by regulatory agencies within the European Union. The two new treatment strategies described, levodopa/carbidopa intestinal gel and levodopa/carbidopa microtablets, for advanced Parkinson's disease, have been ...
By Sensidose AB
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Innovation management of Japanese pharmaceutical companies: the case of an antibiotic developed by Takeda
It is often argued that the Japanese pharmaceutical industry lacks international competitiveness partly because of its weakness in innovation – most new drugs developed by Japanese companies are imitative and lack appeal in overseas markets. To address this problem, I suggest a well-defined typology of drug innovation. I found in my previous studies that the dominant type of innovation among ...
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Artificial Intelligence for New Drug Design
Iktos Develops a Technology Platform for Deep Learning-Based de novo Drug Development Digital tools are a key to shortening the development of active pharmaceutical ingredients and thus market-ready drugs and therapies. Big data and artificial intelligence (AI) can significantly accelerate many processes and make them more efficient. The Paris, France-based start-up Iktos is developing a ...
By Iktos
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The biotechnology revolution: implications for the pharmaceutical industry
Until recently, many of the larger pharmaceutical companies were exclusively responsible for the discovery of novel treatments through the efforts of their own in-house research. However, the arrival of biotechnology was to change these traditional patterns of innovation. Today, pharmaceutical manufacturers no longer view themselves as the sole innovators in the industry. Rather, they are ...
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Observed and modeled effects of pH on bioconcentration of diphenhydramine, a weakly basic pharmaceutical, in fathead minnows
A need exists to better understand the influence of pH on the uptake and accumulation of ionizable pharmaceuticals in fish. In the present study, fathead minnows were exposed to diphenhydramine (DPH; disassociation constant = 9.1) in water for up to 96 h at 3 nominal pH levels: 6.7, 7.7, and 8.7. In each case, an apparent steady state was reached by 24 h, allowing for direct determination of ...
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Accelerating Drug Discovery: The Power of Protein-Small Molecule Docking
Protein-small molecule docking is a computational technique used to predict the binding mode of a small molecule to a protein. This technique has emerged as a powerful tool in drug discovery and design. Docking services can be used to identify potential drug candidates, optimize the activity and selectivity of drugs, predict the toxicity of drugs, and design new proteins with specific functions. ...
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New Technology to Promote Drug Development-AI Technology
For a long time, the research and development of each new drug has faced the challenges of high cost and long cycle. In response to these challenges, major pharmaceutical companies have shifted from targeting common diseases to developing drugs for specific diseases. At the same time, these companies are constantly looking for new technologies for new drug development, such as high-throughput ...
By BOC Sciences
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Molecular Glue And Its Application In New Drug Development
In recent years, targeted protein degraders have entered the mainstream of drug development at a very rapid rate. Thalidomide and its derivatives for the treatment of multiple myeloma and other conditions have demonstrated the potential of protein degraders, while ARV-471, an estrogen receptor degrader based on the drug development of thalidomide, is targeted at the early stage of breast cancer ...
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Ildong’s subsidiary secures 1st anticancer drug pipeline
Idience, a subsidiary of Ildong Pharmaceutical, has acquired IDX-1197, an immunotherapy drug, as its first pipeline. The introduction of the new pipeline came four months after Ildong Pharmaceutical established Idience as a no research and development only (NRDO) company in May. With the acquisition, Idience has decided to launch phase 1b and 2a clinical trial for the drug this year, which will ...
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Some Basic Facts about Forced Degradation Test for Drug Development
Benefits of forced degradation test The degradation pathway of the drug is closely related to the molecular structure of the drug. The ester group or amide bond in the molecular structure may be hydrolyzed under acid-base catalysis conditions. Provide support for drug safety. When toxicologically relevant impurities are not readily available, toxicological evaluation of samples degraded to a ...
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Choosing a CDMO: 7 Key Factors to Keep in Mind
The pharmaceutical industry is a highly dynamic industry. It is constantly innovating new and complex drugs with great efficacy. This poses a challenge for generic companies to keep up and develop drugs that match the same level of complexity and effectiveness within a reasonable timeframe and budget. To address this challenge, generic companies often outsource their drug ...
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Amorphous Content Determination in Medicine
In industrial production, the surface of the compound may become amorphous due to a small amount of structural damage. It is difficult for conventional instruments to detect this small amount of amorphous substance. Although the content of this amorphous substance is very low, it is very likely to affect the stability of the drug in the production and storage process, resulting in the failure of ...
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Application of Flow Cytometry in the Pharmaceutical Industry
Flow cytometry (FC) is an important tool for analyzing complex pathways and responses of single cells, which can track cell phenotypes and functions in multiple dimensions. It is also increasingly applied in drug development. FC not only can detect intracellular and extracellular components, but also detect soluble analytes in serum or plasma samples, such as cytokines, drug complexes, or ...
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Recursion Pharmaceuticals Puts Strength on Full Display
The drug developer's latest capital raise, a $150 million private placement, comes during a difficult market environment. The strongest companies can raise money in any environment. Recursion Pharmaceuticals (RXRX) - Get Free Report recently raised $150 million in gross proceeds from a private placement of common stock, including half from a single fund that has never before invested in the ...
By Recursion
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Application of site-identification by ligand competitive saturation in computer-aided drug design
Abstract Site Identification by Ligand Competitive Saturation (SILCS) is a molecular simulation approach that uses diverse small solutes in aqueous solution to obtain functional group affinity patterns of a protein or other macromolecule. This involves employing a combined Grand Canonical Monte Carlo (GCMC)-molecular dynamics (MD) method to sample the full 3D space of the protein, including ...
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Understanding the Importance of Preclinical Animal Models in Drug Development
In the world of pharmaceuticals, developing safe and effective drugs is a complex and time-consuming process. Before a new drug candidate can progress to clinical trials and ultimately reach the market, it needs to undergo rigorous testing in various model systems to assess its efficacy and safety. One critical component of this evaluation is the use of preclinical animal models. Preclinical ...
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