Author: Nigel J Smart PhD

Sustainable Pharmaceutical Manufacturing

Nowadays there are numerous initiatives, incentives, and award programs aimed at promoting and advancing innovations in sustainable development for chemistry.  Companies and institutions can personally confirm the economic advantage that a change for sustainable development options provides. Recognized advances in processes like the enzymatic catalysis of synthetic reactions, solvent substitutions and recycling of byproducts and wastes, besides diminishing the environmental impact, through the improvement of synthetic efficiency and general productivity, may lessen waste streams, energy input and the necessity for dangerous reagents. Sustainable development processes are not extra costly anymore.  Today, the major obstacle for changing the industry is humans’ resistance to change.  This is specially true for the organic chemistry area. The E-factor, which represents the mass efficiency of a process or mass waste/unit of a product to show the big potential for using waste-prevention plans to improve the cost-effectiveness of manufacturing, is in excess of 100 g of waste for 1 g of drug produced in the pharmaceutical industry. Some professionals believe that the difficulty behind changing this has its origin in the training of organic chemists in charge of developing the reaction routes.  Chemistry degree programs lack toxicology classes, thus, it is left out of the thinking during the initial design phase of a process. The industry has always been centered on developing the most efficient and fastest synthesis route; but, along with the concern for...

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Change Management Within Pharmaceutical Companies

Since the topic of change management is so complex, each pharmaceutical company has created its own process to address change management. If there is something that characterizes the pharmaceutical manufacturing environment today it is change.  Whether it is because of a new product, a new delivery method, a merger, new materials, or new equipment, pharmaceutical companies must be ready to learn new ways of doing things. Some companies do not keep records of the number of document control or quality assurance changes they perform, which may range from 30 to 160 a month, depending on the size and type of company.  For compliance this randomness culture must be managed in order to be controlled. Management of Change (MOC) programs aim to develop a process that is time, effort and financially efficient.  The first step is to set a basic requirement and strategy, however, numerous QA managers in pharmaceutical companies do not adequately understand MOC or quality control, which results in firefighting and crisis management. The FDA has still to issue a document directing companies on change management, but, in the meantime, the U.S. Occupational Health and Safety Administration (OSHA) provides a good model on how to manage it. Among the MOC model, OSHA regulation 29 CFR 1910.119, Process Safety Management requirements are: Establishing written procedures and documentation for all changes Documenting the purpose of each change Reviewing each change...

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Federal Funding For Biomedical Research

It is unquestionable that the United States is a research and development powerhouse when it comes to revolutionary advances in biotechnology and pharmacogenomics (the study of how a person’s genetic inheritance affects the body’s reaction to drugs); as to the reasons why, these many times end up in political debate. It has often been heard as an argument that a reduction in the government’s spending in research is the direct cause of a lack of advance in the search for cures for this or that disease. One recalls, for instance, the actor Michael J. Fox going on T.V. to support a certain party and candidate for president because this would mean more U.S. government budget money for Parkinson’s disease research. Another actor, Christopher Reeve, comes to mind – not as a supporter or detractor of any political candidate, but as the subject (after his death) of a politician’s argument, that more or less stated that if federal dollars had gone into stem-cell research, Mr. Reeve might still be amongst us. Of course probably worse examples than these can be found, as politics is not a make-nice practice. To offer some perspective, though, we can offer the following data: In the early 1990s, National Institutes for Health (NIH) biomedical R&D spending was about  $10 billion By 2003, R&D for NIH was $25 billion From 2003 to 2007, the figure stayed...

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Universal Health Coverage Dilemma

Massachusetts already has universal health care coverage. The state mandated it since 2006. This has made the state a laboratory of sorts for what might happen in the rest of the United States. One of the arguments for universal health care coverage is that there are millions of uninsured or underinsured individuals who have no other way of availing themselves of medical treatment but the emergency room (ER). Of course ER treatment cannot be denied and supposedly all the write-offs that come from treatment of people who can’t afford treatment is both affecting the health industry and presenting a moral dilemma to the country. Well, some stats are in, and they suggest that ERs aren’t really filled with the uninsured. From 2005 to 2007, the number of trips to the ER rose 7%. This data for two years may be too little to draw any conclusions. However, according to a study last year by the Annals of Emergency Medicine, between 1996 and 2004 nationwide visits to the ER increased by 26%, with a disproportionate number of those attending having income of at least four times what’s considered poverty level.  But the percentage of uninsured patients remained flat – at 15% through this same period. What do all these numbers tell us? Perhaps nothing conclusive, but it seems that basing the convenience of a universal health coverage plan for the...

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Universal Healthcare And Drug Company Revenues

Could the end of blockbuster drugs be a reality? Back in the 1990’s we saw many new drugs come to the market that seemed to be created to be mass-marketed directly to the public – in spite of the fact that they were prescription drugs. These drugs, in their majority, were designed to treat on-going conditions. The pharmaceutical industry’s focus switched toward the creation of drugs geared toward the treatment of conditions that require said treatment for a long time – perhaps lifelong. So it is that Viagra became a lifestyle and allergy medicines the stuff of everyday living. With patent protection for the blockbuster drugs of the 90’s coming to an end, and a dearth of new drugs coming to market, the pharmaceutical industry is facing tough times. The response so far has been to engage in JV’s, acquisitions and mergers, such as Glaxo Smithkline’s JV with Pfizer, or the acquisition of Schering-Plough by Merck. There is a light at the end of the tunnel, though. With one of President Obama’s campaign promises being to achieve universal healthcare coverage, drug companies may get a break in the sense that prescription and non-prescription drug coverage for acute and chronic conditions alike will most likely be covered. This means the addition of lifestyle-enhancement drugs (or so considered today), such as Viagra, to the list of drugs that might be covered...

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