Tag Archives: Europe

  • The Drive Behind Lean Manufacturing Implementation

    … manufacturing solutions to production. Consider these few salient developments: · As a result of the FDA’s greater emphasis on and closer scrutiny of drug safety, pharmaceutical manufacturers in the U.S. face an extended time to market. · In the US and Europe combined, drug recalls have risen from 2,999 in 1995 to a high-water mark of 5,338 in 2005. · Governments are capping prices, but imposing more and more regulatory and compliance burdens. · Penalties for compliance infractions are on …

  • Is the Pharmaceutical Industry Going Green?

    Recent reports coming out of Europe and the United States are all showing that the pharmaceutical industry, at large, is taking tremendous steps into “Going Green”, so to speak.  Because of the recent economic decline, as well as market uncertainty, and overall economic uncertainty plaguing the Big Pharma industry, many pharmaceutical companies are doing whatever it takes to cut costs, and that includes looking for cheaper alternatives.  Recent studies indicate, that many large …

  • Advances in Chikungunya Virus DNA Vaccine

    … weakening joint pain, and it could take over a year to cure. It has been discovered that different mosquitoes normally found in developed countries, including Europe and the United States, can transmit the Chikungunya virus, making it a threat for people in other geographies outside its territories of origin.  The virus is already prevalent in several world regions and clearly has epidemic potential. Currently, there are no vaccines in the market to treat this virus.  The truth is that very …

  • Patient Safety Resides in Global Thinking

    Now is the time to establish a global vision in the path to a harmonious approach to product security that provides close-term benefits for patient safety.  While the US centers on how to achieve an e-pedigree system and the pharma industry in Europe incorporates a 2D datamatrix-based “bookend” system, patient safety is in possible danger due to the split approaches and expensive implementation strategies. The drugs supply chain is becoming more and more complex due to the increase in the …

  • Biosimilars at Full Speed

    … idea.  In Europe, biosimilars are labeled as having a ‘therapeutic similarity’, but until now, there are no serious efforts to deal with this concern.  Substitutability, which would enable, for example, a pharmacist to offer a biosimilar drug when the physician has prescribed the original, is very unlikely to be accepted. Life sciences consulting firms are working with their clients to prepare them for the changes ahead and ensure their survival and development of their full potential in …

  • The Future Lies in Two Words – Emerging Markets

    It is no surprise that as emerging markets, like China and India, continue to grow at a record pace, that drug makers all over the world need to wake up to the fact that the future of their business may depend on markets outside of the United States and Europe.  As these emerging markets in China and India, as well as Brazil continue to grow full speed ahead, it is becoming more evident to the pharmaceutical industry as a whole, that they better start paying more attention to these parts of the …

  • Why the Pharmaceutical Industry Needs to Adapt to Emerging Markets

    … pharmaceutical markets in the world were the United States, Japan, and Europe, accounting for nearly 75% of the growth in the global pharmaceutical marketplace.  Now compare that to today, where these major markets only account for nearly 45% of the global pharmaceutical growth rate, whereas the emerging markets have jumped from 8% to nearly 30% in this same period.  And this trend is only suspected to grow. While Europe and the US and Japan, are seen as the major players in the pharmaceutical …

  • U.S. Falls Behind Europe in Research and Drug Development

    The U.S. has fallen behind Europe when it comes to drug research and development. A new study shows that European pharmaceutical companies outrank their U.S. counterparts when it comes to biotech, first-in-class and orphan products. Pharmaceutical consultants state that this evidence is a blow to the United States. While President Obama tackles the controversial health care reform debate, this study raises further awareness of the high cost of out-of-pocket medication expenses for U.S. …

  • The Future of Engineering in Pharmaceuticals

    Pharma will experience a very big rush forward in the next years, and to be able to cope with it, the pharmaceutical industry will have to acquire a legion of skilled pharmaceutical engineers.  The US and Europe have been leading the industry until very recently, but now, Asia is joining them.  Engineering is the main activity these companies focus on, and the current economic downfall has affected even the strongest global leaders.  Nevertheless, the demand for capable pharmaceutical …

  • Federal Funding For Biomedical Research

    … (public, but mostly private cash) than any other in the world. The lack of price controls for drugs in the U.S. allow for better profit margins that can be reinvested in R&D.  All in all, the R&D machine in the United States is working just fine and, as a matter of fact, is subsidizing drug and treatment development in the rest of the developed world, where universal healthcare, drug price controls, and other hindrances of market forces are preventing Western Europe, Canada or Japan – …

  • Case Study: Lean Laboratory Process for Medical Device Company

    A medical device manufacturer had a failing QC testing group. Sister facilities in Europe had a higher rate of productivity and much higher rate of efficiency in terms of fewer laboratory investigations and samples analyzed. The project was to analyze the situation and produce a new lean laboratory solution to establish at least parity with the European laboratory. The Process: Both laboratories were assessed using a proprietary Smart Consulting Group tool and the results were process mapped to …