Tag Archives: risks

  • Bottlenecking Theory

    … computer stimulation to better scope out any potential risks. As pharmaceutical consultants, we understand that by approaching your pharmaceutical/scientific method in this way, you will be well equipped to combat any sort of bottlenecking issues that you may come across in your research. For more information on the bottlenecking theory please refer to Lean Biomanufacturing by Dr. Nigel J. Smart.                     …

  • Risks in Lean Compliance

    … risks is what truly gets people talking and from there brilliant ideas are drawn up. Now, in the biopharmaceutical industry going lean is all about taking risks and understanding that risk. So what about the 80:20 rule you may ask? What’s all of the fuss about in regards to identifying risk in lean compliance? Let’s try and wrap our brains around this concept a bit. “Risk is a balance of certainty and uncertainty, in addition to the probability of something occurring.” It’s vital to …

  • Reaching into Research and Development of a Supply Chain Strategy

    Critical materials and suppliers are selected early in development. By the time Technology Transfer occurs for commercialization, it is often too late to make changes to these critical components without having to do additional testing or even repeating clinical trials. Regulatory authorities have made securing the supply chain a priority and have promised serious repercussions for companies and their management who do not manage risks to the supply chain. We propose developing a strategy for …

  • Behind The Increasing Need for Pharmaceutical Consultants

    … still remaining competitive. One of the three main drivers in the push toward outsourcing is, of course, FDA regulations. A few of the major developments in the last few years are: August 2002: The FDA set in motion a new initiative entitled the Pharmaceutical Current Good Manufacturing Practices (cGMP) for the 21st Century: A Risk-Based Approach. This initiative focuses on the risks to public health that could result from flaws in manufacturing procedures. The stated purpose is to ensure that …

  • Guilty as Charged: The Premature Stop of Clinical Trials Exaggerates the Effects of Treatment

    … one of the authors of the study, explained that they discovered that in the majority of cases where the clinical trial was stopped prematurely, the effects of the treatment were deceptive, and that these ambiguous estimations will most probably produce unwise decisions in regards to the estimation of the therapy’s risks and benefits. He added that, “On average, treatments with no effect would show a reduction in relative risk of almost 30 percent in stopped early trials.  Treatments …

  • REMS Risk Management Strategies

    REMS is a recent and emerging regulatory requirement for all pharmaceutical companies, whereby the FDA expects these companies to monitor, submit plans, and proactively manage any and all safety risks in the sphere of their companies’ operations.  REMS stands for Risk Evaluation and Mitigation Strategy required for pharmaceutical and biotechnological companies.  Common REMS issues include drugs with abuse potential, risk of Qtc prolongation, drug-drug interactions, drugs with the risk of …

  • The Future of Influenza Vaccine Design

    … certain age groups, for example, kids 6 months to 9 years of age, with evidence of a massive reduction in secondary bacterial infections causing otitis media. The more live influenza virus vaccines are used, the more benefits, risks, and economic consequences of this approach will be known. 2.    Genetically engineered live influenza virus vaccines The introduction of techniques to engineer site-specific changes in the genomes of negative-strand RNA viruses has allowed the consideration of …

  • Dishonest Marketing in Pharmaceuticals Demands a Big Price to Pay

    … and more important than the dollar value. A new research called “Regulatory Exposure of Deceptive Marketing and Its Impact on Firm Value” has put a price on the intangible costs a company has to pay when employing these dark marketing practices.  In order to do this, the research studies the declines in the financial market value of pharmaceutical companies that have been accused of dishonest marketing by the FDA. In this case the amount Pfizer had to pay drew attention to the risks of …

  • How Do Pharmaceutical Companies Develop Value in These Current Times?

    … face of the risks this poses.  By keeping up with the actual marketing strategy, companies will only strengthen the already growing customer distrust.  Instead of fearing comparative effectiveness, companies should understand it and use it rationally; their focus should be innovation. If you liked this article, tell all your friends about it. They’ll thank you for it. If you have a blog or website, you can link to it or even post it to your own site (don’t forget to mention …

  • Pharmaceutical Industry Contributes to Future of Personalized Medicine

    … mission is to validate DNA-variants (which is useful in predicting risks associated with drug-related adverse events). Their collective research focuses on the impact that genes have on people’s response to medication. Pharmacogenomics paves the way for the development of life-saving drugs. By determining biomarkers, pharmaceutical and biotech companies identify new disease subgroups and design drugs to target these new subgroups.  This personalized medicine approach includes genetic …

  • Developing Quality Pharmaceutical Systems

    … this new system is trying to achieve. By using these new knowledge based management systems and quality risk management systems effectively, companies will be able to implement these new strategies cost effectively and without incident.  It is very important in this new system that quality risk management be an integral component.  It can provide a proactive approach in identifying and scientifically evaluating potential risks to quality.  This facilitates continual improvement of process …

  • What is Environmental Monitoring and Why it is So Critical

    … it should be carefully planned in terms of the size, scope, importance, and risks of your project.  The cost in monitoring should only be a small fraction of the overall cost of the project, or it will not prove to be balance-effective.  However, it is usually a small price to pay in regards to the potential benefits that come from successful management of ecological systems. Through an aggressive adaptive management approach, environmental monitoring firms can become an excellent source of …