Tag Archives: clinical trials

  • WHO Ebola Vaccine Meeting

    … many complex policy issues that surround eventual access to experimental Ebola vaccines. Ways to ensure the fair distribution and financing of these vaccines were discussed in an atmosphere characterized by a high sense of urgency. This sense of urgency was conveyed in many ways – from plans for the different phases of clinical trials to be performed concurrently rather than consecutively, to suggested partnerships for expediting clinical trials, to proposals for getting all development …

  • 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 …

  • The Future of Regenerative Medicine

    Bioengineering, and more specifically, tissue engineering, gives a new perspective to personalized medicine. The use of cells and therapies has become a strong practice to get the body to heal itself, as it already happens with blood transfusions, bone marrow transplants, and autologous chondrocyte implantation to re-grow cartilage. These procedures have prepared the road for over 2000 clinical trials linked to cell therapies, like stem cells for ischemic heart regions, neural precursor cells …

  • The Future of Regenerative Medicine

    Bioengineering, and more specifically, tissue engineering, gives a new perspective to personalized medicine. The use of cells and therapies has become a strong practice to get the body to heal itself, as it already happens with blood transfusions, bone marrow transplants, and autologous chondrocyte implantation to re-grow cartilage. These procedures have prepared the road for over 2000 clinical trials linked to cell therapies, like stem cells for ischemic heart regions, neural precursor cells …

  • FDA Inspection Wizard: What’s Scary Can Turn Out to Be a Piece of Cake

    … ‘routine inspection’, prompted by a New Drug Application (NDA) submission.  The typical candidates for a routine inspection are clinical sites that enroll the majority of patients in the NDA’s critical clinical  trials. -‘For Cause inspections’ are not common, and are prompted when the FDA receives a report of, or becomes aware of, suspicious behavior.  Here are some reasons that may bring about such an audit: _ The carrying out of many clinical trials _ The carrying out …

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

    A study of almost 100 clinical trials that were stopped prematurely because they showed positive treatment effects has shown that a large number of those effects were exaggerated. The study was published in the Journal of the American Medical Association and recommends that researchers do not fall for the temptation to end clinical trials prematurely but rather continue with them for longer periods of time before thinking about ending them. Victor Montori, M.D., Mayo Clinic endocrinologist and …

  • The Marriage between Big Pharma and Mobile Technology

    … collected exponentially faster during clinical trials.  As a result, protocol violations are reduced, and it also speeds up the time it takes for life-saving drugs to be launched into the marketplace. As mobile technology evolves, many experts in the pharmaceutical industry such as pharmaceutical consultancy firms, and pharmaceutical executives believe this marriage will only get stronger in the foreseeable future.  As mobile companies continue to introduce more powerful tech savy software for …

  • How to Do a SWOT Analysis as Part of a Business Plan or Business Process Strategy

    … identified, a plan to take advantage of them should be created. Threats could include clinical trials in this area by other competing companies, new regulations that would make it difficult to get approval, adverse press garnered by any preannouncements of what you are working on, or a loss of any type of funding for the project.  Threats may or may not be real – but contingency plans to address them should be in place. A SWOT analysis of your main competitor’s position is an opportunity to …

  • GMP Guidelines/Regulations in Stem Cell Research

    Good manufacturing practice or (GMP) is a common term for the control, management and manufacturing of quality control practices, applied to the pharmaceutical industry.  These common practice standards are specifically designed for pharmaceutical substances and products being made for clinical trials and production.  And one recent area of cGMP concern is over the newly emerging stem cell research industry.  How will stem cell research be affected by these ever tightening restrictions, and …

  • Adult Stem Cells Show Potential for the Treatment of Cardiac Patients

    … scientific method, and close to a million United States’ citizens suffer heart attacks each year. These results will put to rest some of the discussions in regards to clinical stem cell research for heart disease.  Although many think that it is too soon to test stem cells in patients, this study has proven the value of exact and controlled clinical trials. In doing so, it also establishes the basis for the development of novel cell heart therapies. Many believe that this trial acts as a key …

  • CDER’s Small Business Assistance Bulletin

    … safety of clinical trials and marketing applications for biotechnology-derived pharmaceuticals. http://edocket.access.gpo.gov/2009/pdf/E9-29991.pdf and http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM194490.pdf 4. FDA Clinical Trial Requirements, Regulations, Compliance and GCP. The Food and Drug Administration (FDA) Florida District, in cosponsorship with The Society of Clinical Research Associates, Inc. (SoCRA), is announced in a Federal Register notice …

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

    … groundbreaking than the traditional big companies.  In fact, in the next 10 years, large companies will invest more in small research-based operations for new  products, and will reduce or redirect expenditures on centrally based R&D and marketing.. Life sciences consulting firms agree that pharmaceutical companies should start emphasizing the comparative effectiveness of one drug over others for a specific treatment through the use of clinical trials and government approvals, even in the …