Even though the pharmaceutical industry has experienced unprecedented growth in recent years, there are many emerging trends that may challenge this.  And one of these factors is the growth of emerging markets such as India, Brazil, Russia and China, to name a few.  With economic growth rates reaching double digit percentages in some of these countries, there is no doubt that they will be major players in the global marketplace of the future.  That is why it is no surprise that this recent economic growth is not only catching the attention of key financial players all over the world, but catching the attention of multinational drug companies as well.

As the global pharmaceutical industry continues to grow, some key trends are showing that this growth could soon taper off.  Many pharmaceutical consulting firms have seen these trends coming for along time.  Trends like the loss of marketing exclusivity, as well as lower contributions from newer products, along with the growing prevalence of generic drugs all over the world, the global pharmaceutical marketplace could be facing a cruel reality.  Many pharmaceutical consulting firms are recognizing this trend, and are seeing a pharmaceutical industry in the future, that is very different from the one of the last 50 years.

There is no doubt that the pharmaceutical landscape of the future will be vastly different from the one we know today.  For example, back in 1999, before the turn of the century, the top leading 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 industry, the rest of the world is catching up fast.  With the economic downturn in the United States and Europe affecting the growth of these two previously booming economies, emerging economies like China and India are expected to be the beneficiaries in the long run.  With their two economies growing at a much faster pace than the US and Europe, there is no doubt that they will be major players in the pharmaceutical industry of the 21st century.  Pharmaceutical consultants believe the two main questions will be if drug companies will pick up on this trend, and start marketing more vigorously to emerging markets, or if they will ignore it and continue doing business as usual.

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Doctors, lawyers, pharmaceutical companies, life sciences consulting firms, and health care providers are all keeping a very close eye on the development of government regulations of DTC genetic testing.

As of this post, federal regulations differ from state to state with each having its own full or partial regulations or complete restrictions. Only 12 States allow direct to consumer testing, 13 have complete restrictions in place and 24 have partial limitations to what they will allow.  At the present time, both New York and California have complete restrictions against direct to consumer genetic testing, and the companies that want to provide these services are wondering if other states will follow their lead.  Many of these companies are locating in the U.S. because of these loose regulations.  Countries like the U.K. are not as attractive to this business as strict regulations are already in place.

But many consumers are keeping a close watch on these developments too.  There are definitely three factions in the game, those who want it, those who don’t and those who agree that partial restrictions are okay.

Advocates of DTC genetic testing feel that it helps consumers take a proactive approach to their own healthcare.   Many believe that testing for diseases such as cardiovascular disease, or cholesterol problems would encourage people to seek professional help sooner than they normally would, and in most cases before symptoms even occur.  They are also in support of genealogical testing that can alert individuals to health concerns that may be inherited.

For those against DTC testing, the issues are more moral and ethical. Their concern centers on the many emotional, social and even financial factors that could be overlooked without the guidance of a health care professional.  Other moral concerns might be that the day would come, for example, when health insurance companies demand genetic testing before approving policies, or employers demand it before hiring for positions.

Those who support partial regulation can see both the good and the bad.  Some of the simpler testing could perhaps be left in the hands of the consumer.  The more complicated tests, and those with greater impact on the lives of the consumer, should be administered with both the psychological and medical guidance of the appropriate health care professional.

There are also those who fear that a lack of federal regulation would allow genetic testing companies to take advantage of those somewhat desperate consumers and advertise falsely needed services or charge exorbitant fees.

And then, of course there is the argument that without interpretation of test results by competent professionals, consumers could make poor decisions regarding their present and future health care.

It is, to say the least, a most complex issue, and one that is undergoing very close scrutiny by everyone.

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The U.S. life sciences industry is a business sector which faces the significant task of developing, testing and manufacturing pharmaceuticals.  Due to the complex environment in which pharmaceuticals are developed, there is a strong need for IS and other quality systems to monitor, manage and control the production processes.  The quality systems can drive each of the steps with the product life cycle and is a critical factor for guaranteeing that the optimum quality standards are met.

The FDA plays an important role in this systematic testing process by applying rigorous oversight to the pharmaceutical industry, to ensure high quality standards, efficacy, and the safety that the general public demands.  Throughout the research, development, and the manufacturing life cycle of drugs, vaccines, and other biopharmaceutical products, the FDA’s role is that of a principal supervisory agency.  Their job is to assure that optimum quality is being achieved, and the best practices are being followed.

So how can you prepare your bio-pharmaceutical company for one of these surprise inspections?  Well, one thing you can do is to hire a life sciences consulting firm that specializes in the development of quality systems, in which they can design, or redesign your entire system, to meet FDA regulations.  The FDA uses it’s oversight to guarantee that such issues and problems with contaminants and failed processes are quickly sniffed out and identified.  Without the help of an experienced consulting firm, your company may fail to take the preventive actions necessary to successfully pass an FDA audit.  Because of the severity of the consequences in developing possible faulty pharmaceutical products, the FDA has very little tolerance for variability or deviation from its quality inspection regulations.  This means if your products do not pass this FDA quality inspection, you will be shut down, and shut down fast.

The pharmaceutical industry, like any traditional manufacturing industry, uses traditional, older production processes and many companies have outdated information systems.  In the past, the work flow in the pharmaceutical industry was optimized for straightforward production including cost reductions, rather than focusing on transparency and quality production.  Furthermore, even though many pharmaceutical companies are starting to catch up to the rest of the manufacturing industry, and have begun to develop more sophisticated systems, many companies wouldn’t be able to pass a simple FDA regulatory inspection if they had to.  If you want your company to be properly prepared, talk to a pharmaceutical consulting firm that specializes in quality control, and they will be able to prepare your company properly in case of a surprise FDA inspection in your company’s future.

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The use of disposable bioprocessing components began with the use of plastic bags designed for buffer preparation and very swiftly moved to disposable bioreactor bags on platforms. Now a considerable range of products for cell culture in upstream and downstream operations of the reactor is available.

A completely disposable bioprocess stream is now thought possible and perhaps will be available in the near future. The challenges ahead are mainly in the areas of biosensors and chromatographic purification. Progress in use of these disposable sytems is on the rise.. The ease of use, flexibility, cost savings, and environmental convenience make the shift toward disposable bioprocessing streams virtually unstoppable.

The ability to transition between products and projects without having to go through extensive cleaning and validation protocols is an important advantage that contract manufacturers especially have come to greatly appreciate. Also, the risk of cross-contamination between streams is enormously reduced.

The use of disposable components in bioprocessing also enables manufacturers to quickly scale up their production whenever necessary. For example, with the recent so-called swine flu quasi-pandemic, the need for higher production of flu vaccine at a time of emergency was suddenly painfully evident. Disposable bioprocessing manufacturing components make it possible for a plant to transition from one level of production to another with ease.

Pharmaceutical consultancy in these areas has grown by leaps and bounds as more and more manufacturers wish to enable their plants with these new technologies. Medium and small – some boutique-sized – pharmaceutical companies had been blazing the trail in these initiatives for years as they attempted to bridge the gap of competitiveness with big pharma. However, given the recent complexities brought by lower margins in the pharmaceutical market, it is the big pharma firms who are pushing for faster improvements in disposables.

It remains to be seen how much more speed can be put into developments within this year, but it is clear that the lower risk, lower cost, and faster transitions that are possible by adopting the use of these new technologies is already revolutionizing the way pharmaceutical bioprocessing facilities are engineered and how production is planned. We are likely to see an accelerating trend toward smaller facilities with fewer production lines. Utilities at these facilities will be strategically placed so as to allow multiple configurations of storage tanks, reactors, filters, hoses and other common components. The time it will take for a bioprocessing facility to switch from one product to another or from one batch volume to a larger or smaller one, will become shorter and shorter as more disposable components become available. Indeed it seems disposables are here to stay.

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The issue of the cost of pharmaceutical products has been questioned for quite some time, but the industry has been unable to deliver concrete answers. Why exactly are pharmaceuticals so expensive? In the late 1950s, the same was asked by Senator Estes Kefauver, who was the first to pass an indictment against some fraudulent practices by the pharmaceutical industry. Senator Kefauver saw some inconsistencies, which are still alive: prices are extraordinarily high and profit margins excessive; prices are increased by marketing expenditures; and new products are not always more effective than those already in the market.

One main problem is that, even back in the 50s and, of course, to this day, the marketing budget is a lot higher than what is spent on research and development (known as R & D). In the US, direct marketing is legal, so pharmaceutical companies can invest on direct to the customer publicity, which results in more sales and therefore more profit to the business. It is commonly held, however, that the reason why pharmaceutical products are so expensive is that millions are spent on research. This is true, but there is also a considerable amount of money spent on marketing trying to pursued customers to buy their products and this inflates the overall costs.

A recent study by the Public Library of Science demonstrated that, actually, companies spend double on marketing campaigns than on R & D for their products.

Moreover, in global terms, about 30 percent of the money spent on marketing is not accounted for in the companies’ figures and books. This means that even more is spent on that part of the commercial process associated with marketing  pharmaceutical products. In all, it is estimated that a total of  $57.5 billion was spent on marketing needs on 2004, while only $31.5 billion was spent on Research and Development.

A pharmaceutical company is crucial to the economic, social, and vital growth of a country. As a leading country in pharmaceutical production, the US should set the grounds on the ethical and moral implications this has on the rest of the world. Pharmaceutical consultants have the experience and knowledge to, among other areas, be able to advise companies on what the best course of action regarding budget and expenditure is. The industry now faces times of economic turmoil and, more than ever, needs to adapt to the new times ahead.

For some people in the pharmaceutical business, the concept of a Lean Laboratory is only a trend that will soon pass. However, far from being just a momentary trend, it made the whole industry conscious of how much time and resources were wasted because of poor organization and analysis. Nowadays, the differences between lean laboratories and conventional ones have become enormous, especially in terms of productivity and efficiency. Results corroborate that conventional laboratories have at present only two choices left: embracing change or disappearing.

But, what are the issues forcing conventional labs to fall behind? Here is a list of the main negative points, as identified by life sciences consulting firms.

LACK OF FOCUS: Test routing can be variable and depend on product type and/or intended market. There is no control of the progress of individual samples as the focus is in test accuracy or individual test run efficiency.

LONG AND VARIABLE LEAD TIMES: “Efficient test runs” cause the delay of sample testing results. Before the tests are performed, an important amount of samples have to queue for a long time until the right amount of similar samples arrive.

INEFFECTIVE “FAST TRACK” SYSTEMS: There is clearly a problem in prioritization of samples. Fast track systems were originally designed for urgent results, but as the amount of prioritized samples is excessive, the system becomes clearly ineffective.

HIGH LEVELS OF WORK IN PROGRESS (WIP): Too much time spent in controlling, tracking, and prioritizing samples and/or designing analyst work. You can try to optimize time by investing in IT tools, but that doesn’t solve the problem. The solution? Re-engineering the whole process.

VOLATILE INCOMING WORKLOAD: It’s difficult to understand the capacity of a laboratory, as the workload is generally unpredictable. Peak moments with high productivity but poor lead performance are followed by dramatic dips with very low productivity. Stabilizing the incoming workload is a key issue here.

Lean laboratories win the first battle by defining clearly what the value add and non value add activities are, as well as providing clear maps of the overall process, so there is logic in whatever part of the lab process people are participating. By leveling the workload and the mix of samples as well as  eliminating non value add or incidental tasks, they improve efficiency. By managing performance  in every part of the process (using KPI’s), they keep control over all lab operations, all the time.

How can conventional laboratories fight that? Apparently, to stay in the market they have only one solution: change. But no generic approach will provide good results, unless they perform careful analysis of all lab activities and they undergo a complete re-engineering process with the help of a pharmaceutical consulting firm. The process will involve changing the minds of those involved, too. Only lean analysis specialists will be able to identify clearly the key issues in all areas, and provide the most adequate solution. Conventional laboratories  must then lay back and stick to the old saying: “if you can’t beat them, just join them”

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 under Medicaid or Medicare.

It is the chronic condition treatment drugs that pose the biggest cost to government-sponsored universal health coverage and a great potential gain for pharmaceutical companies, most pharmaceutical sales consulting firms would agree. Amongst seniors in the United States, 22% of men and 28% of women take five or more medicines on a regular basis. And that is only counting seniors.

Some of the things that could go wrong, for example, might be a decision by the government to allow the importation of brand and generic drugs into the U.S. in order lower drug prices. There are other possible hurdles, but two points are worth rehashing:

1. The biggest potential for drug companies is in the treatment of chronic conditions
2. Chronic condition treatment costs are precisely the pitfall that the U.S. government is trying to avoid

We shall see where this ends up.

Senator Charles E. Grassley of Iowa may leave the Senate Committee on Finance in order to take the top republican spot at the Senate Judiciary Committee, according to rumors that transcended last week.

Mr. Grassley has been a thorn in the side of pharmaceutical and other healthcare industries due to the czar role he’s played since early 2004. He has closely examined safety issues related to the testing and introduction to market of drugs such as Vioxx and Paxil. He’s also brought the FDA to task on similar issues, including medical devices.

There is no question that the distribution and availability of drugs in the open market is greater than ever. Prescription drugs go over-the-counter quicker than ever, and this is because the introduction of new drugs enhances pharmaceutical companies’ revenues greatly. The glut of prescription drug ads on T.V. is something only seen in the past 15 years. Drug development and marketing does seem to have accelerated. Might this have had an influence in the increase of safety concerns? Might Mr. Grassley have paid attention to and attempted to curtail a true phenomenon? The jury is out, and a lot more investigation is needed.

In the meantime, it is said some FDA staff and many executives at major pharmaceutical companies are keeping their fingers crossed, as this could mean a break for them after five years of tough scrutiny. As they say, though, you must be careful what you wish for… there could always come a replacement with a much tougher approach.

Pharmaceutical consultants have been on the forefront of compliance and quality control work for many companies. No matter the sophistication and organization of research and control of trials, pharmaceutical companies do make mistakes which can be very costly. It is a lot less costly to have testing done one or two more times by outside entities, or perhaps have a parallel trial series conducted by a third party than to have to face an Attorney General or a Senate Committee hearing.