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Last Build Date: Fri, 12 Nov 2010 11:48:44 GMT

 



Pharmaceutical Consulting May Get Boost From BMI's Fourth-Quarter Updates

Fri, 12 Nov 2010 11:48:44 GMT

Pharmaceutical consulting, according to the latest estimates from the Business Monitor International's Pharmaceuticals & Healthcare Business Environment Ratings, may be positioned to play an increasingly valuable role over the next five years. Projections for the fourth quarter of 2010 and beyond indicate that industry growth is likely to be meager at best.Although the US pharmaceuticals market is currently in good shape, being ranked first regionally and internationally, the compound annual growth rate (CAGR) over the next five years is projected to be only 1.76%. This slowing growth will be the result of a coming confluence of factors: patent expirations, increasing FDA scrutiny, pending healthcare reforms, the wider economic climate, and decreasing use of medications and medical services. With this imminent industry environment, pharmaceutical consultants may well be the key competitive-edge factor for many companies.The previous quarter of 2010, especially with respect to the OTC segment, saw several events that will likely culminate in greater compliance and regulatory burdens for drug manufacturers. Johnson & Johnson, for example, has withdrawn 21 lots of medicines, including certain Tylenol products as well as Benadryl and Motrin. Further, the FDA recently initiated a new program for posting online safety evaluations of drugs and vaccines that have been recently approved. And in August of this year, major groups in the consumer, physician, and chemical-manufacturing arenas pledged to support a proposed bill intended to protect the US drug supply by allowing the FDA to expanded authority to "safeguard" pharmaceutical supply chains.Intimately bound together, the economic climate and healthcare reform strategies will also play a role-a role that opens the door wider for pharmaceutical consulting-in the projected five-year industry slowdown. Real Gross Domestic Product (GDP) is expected to decline from 2.8% this year to 1.8% in 2011. The weakening economy, along with the dismal labor market, means that fewer patients are choosing to fill prescriptions, and the number of medical services used by insured people is falling. All of this means that companies can benefit more than ever from the services of knowledgeable pharmaceutical consultants. The outlook is far from bleak: pharmaceutical spending in the US was nearly $306 billion in 2009, and the market is expected, by 2014, to reach $334 billion in value at consumer prices. Still, competition in a market with decreasing growth and a growing presence of the state is increasing, so ensuring a competitive edge becomes that much more important. Preventive treatment for both patients and the industry is crucial right now.Pharmaceutical consultants can provide assistance in these increasingly critical areas:• Quality and compliance• Good manufacturing practices (GMP)• FDA regulatory concerns and adherence • Laboratory services• Lean manufacturing• Training and coachingAnd the best consultants possess the ability and willingness to examine situations and problems from every perspective and thus, by analysis and testing, formulate multiple possible solutions. Then, management and consultants, together, can determine the best solution. Smart Consulting Group has the qualified pharmaceutical consultants, with extensive industry-specific experience, to guide companies through the upcoming years of slowing market growth and help them sustain profitability. Their goal is to "provide the competitive edge you need to be the market leader in medical products."The market has demanded life sciences consulting, pharmaceutical consultants,pharmaceutical consultants are joining forces to make them happen.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 but do not forget to mention our pharmaceutical consulting blog as the original source.[...]



Lean Manufacturing Works for Pfizer in Ireland

Fri, 12 Nov 2010 11:19:56 GMT

Lean manufacturing works, not only for manufacturing processes, but also in quality control labs. Laboratories are, obviously, very different from manufacturing environments and require specific adaptations of the generic lean approach. With the proper adjustments and adaptations, lean manufacturing can benefit labs in terms of both productivity and speed. And Pfizer's labs at its Grange Castle, Ireland, site are proof.At the March 2010 PDA Annual Meeting in Orlando, Ciaran Crosbie, Operational Excellence Specialist at Pfizer's Grange Castle facility, delivered an address titled "The Search for Efficiencies in Your QC Labs - The Future is Lean" (Paul Thomas, "PDA 2010: Pfizer Lets Its Lab Flow," pharmamanufacturing.com). In it Crosbie delineated the process of implementing lean manufacturing at five labs in Grange Castle, as well as explaining why it was done and what benefits resulted from the implementation.But first, here are just some of the benefits for Pfizer's Grange Castle labs:• Consistent performance that reliably meets the needs of the business• Equitable and transparent division of labor within labs• Fewer "fires" to put out• Less required tracking of samples• Decreased need for planning and scheduling by supervisorsThe overall assessment is that the eight-month "leaning" of these labs has been measurably successful.This successful lean implementation was initiated because, according to Crosbie, it was time for change at the facility: it was moving past the start-up-site stage and becoming a "steady-state production facility." The early focus was on speed, but the focus was shifting to "efficiency and cost-effectiveness." Pfizer has been using lean techniques for some time, and "you can and should apply" them in labs. But, as Crosbie trenchantly noted, "Pfizer is not Toyota, and labs are not the same as manufacturing environments."Some of the lean principles deployed at the Grange Castle labs included bridging the gap between leveled demand rate and the staffing level and thus eliminating that form of waste. In addition, lab managers enforced creation of flow and used it to reduce throughput times for samples. Managers also ensured queuing time for leveling by using differences between throughput time and lead time. As a result, lab capacity and resources were more amenable to control.Another key component in this, Crosbie explained, was the effort to provide lab techs visual verification and updates concerning their efforts. An efficient visual management system eliminates several risks, for example, losing samples and bottlenecks. With the proper visual management, "[a]s soon as you walk in the lab, you can tell how many tests are being run, how many samples per batch, how many samples per assay... all the information is right there. It's not very high tech, but it worked."Pfizer's successful efforts at implementing lean manufacturing techniques-in five labs at Grange Castle in only eight months-was accomplished as a two-phase process. In the first, and perhaps most important, phase management utilized the expertise of qualified consultants. The chief objective in this phase was to "fully internalize the learning from the very start." Then, after first-phase goals had been realized, internal staff took over to conduct the second phase.The experienced lean manufacturing consultants with Smart Consulting Group have as their goal providing "the competitive edge you need to be the market leader in medical products."Smart-lean-manufacturingcan help you build your cost cutting lean manufacturing strategies and lean manufacturing techniques with a free 30 minute consultation. To schedule your strategy session visit smart-lean-manufacturing.com[...]



Latest Drug Recalls and Bad Press for Pharma Train Spotlight on Lean Manufacturing

Fri, 12 Nov 2010 11:03:58 GMT

Recent drug recalls and the inevitable bad press for the pharmaceutical industry are forcing drug makers to shift their focus to the manufacturing aspect of the drug-production process. Reigning in outsourcing and implementing lean manufacturing solutions can help pharmaceutical companies polish up their tarnished image and regain a competitive edge.

The latest rash of drug recalls has only exacerbated the consumer and media backlash against drug makers. Here are just a few examples of the most recent:

- 9 October 2010 -Reports of an uncharacteristic odor caused Pfizer to recall the 40-mg bottles of LIPITOR. (fda.gov)

- 8 October 2010 - FDA pressure led the manufacturer of Merida (sibutramine), Abbott Laboratories, to recall the drug in the US, Canada, and Australia owing to the possibility of cardiovascular events after long-term use. (drugrecalls.com)

- 7 October 2010 - Owing to FDA violations with respect to its anti-aromatase ingredient, all lot codes of the testosterone enhancer Novedex XT are being recalled by Gaspari Nutrition. (fda.gov)

- 25 September 2010 -Amgen is voluntarily recalling certain lots of EPOGEN and PROCRIT because of possible contamination by glass flakes. (usrecallnews.com)

But these recent events, coming on the heels of the massive triple recall by Johnson & Johnson, have also created a new opportunity for the pharmaceutical industry to emphasize manufacturing and to implement much needed lean manufacturing solutions.

In 2009, drug recalls (for both prescription and over-the-counter drugs) soared to an unprecedented high of 1,742 from just 426 in 2008, largely a result of outsourcing and indiscriminately cutting costs to the bone. With the current dearth of new blockbuster drugs and the cost of bringing new drugs to market in the neighborhood of $1.5 billion, drug companies are struggling. The opportunity is at hand, therefore, for them to benefit from a new image and from this manufacturing implementation.

Lean manufacturing techniques work, but their effective implementation in the pharmaceutical industry requires knowledge of the special conditions that obtain in the industry: the difficulties involved in altering batch sizes, the fact that 75% of drug recalls can be attributed to manufacturing defects, compartmentalization of various departments within the process, and burdensome regulatory compliance concerns. And an added ingredient in the mix is pharmaceutical companies' growing use of contract manufacturing organizations (GMOs). Companies now have to manage increasingly complex external relationships while still ensuring quality.

According to Nigel Smart, Managing Partner of Smart Consulting Group, "With so much talk about outsourcing off-shore, American jobs are being lost at an alarming rate in an area where there's been traditional strength. Strategically, this is a problem for the US Pharmaceutical industry. Perhaps now's the time for us to re-assert this strength? However, we'll only be able to do that if we apply the appropriate techniques and methods in a logical and consistent fashion." Fortunately, manufacturing is the one aspect of drug production most amenable to change and improvement, where companies can rebuild their image and regain their competitive edge.

Smart-lean-manufacturingcan help you build your cost cutting lean manufacturing strategies and lean manufacturing techniques with a free 30 minute consultation. To schedule your strategy session visit smart-lean-manufacturing.com



Qualified Lean Manufacturing Consultants - The Make-Or-Break Ingredient

Fri, 12 Nov 2010 10:00:44 GMT

Toyota is generally credited with developing and articulating the basic principles and techniques of lean manufacturing back in the 1950s. Since then, companies in industries other than the automotive have successfully implemented lean manufacturing-reducing waste, increasing production efficiency, improving quality, and becoming more responsive to customer demand. But the pharmaceutical industry has, for the most part, been dilatory in this respect.Pharmaceutical companies have been reluctantly late in adopting and implementing lean manufacturing techniques because they fear that production solutions coming from the auto industry can't really be successfully applied to the special conditions of the pharmaceutical industry. This fear both is and is not justified. And the difference usually boils down to the use of qualified lean manufacturing consultants with industry-specific knowledge and experience. Here's an apt illustration from another sector that closely parallels the final segment of drug manufacture.In an article titled "Lean Manufacturing for High-Speed Production" (AutomationWorld.com), Wes Iverson underscored the necessity of using qualified consultants. First, he adduced some startling statistics: 25% of companies that have implemented this manufacturing (or Six Sigma) process report "some progress," but only a slim 2% report anything close to outstanding results-which means that almost 75% fall somewhere in the failure range. This doesn't have to be the case, however.Iverson then went on to give the example, drawn from Scott Watson's, a consultant with E2M, Inc., presentation at the Pack Expo Las Vegas 2009, a packaging-industry exhibition and conference. Iverson stated in his prefatory abstract that "blindly following precepts is unlikely to work for those running high-speed packaging lines, Watson told the audience. While all of the classic tools of this Manufacturing can be applied to achieve benefits on a high-speed line, the application of Lean concepts must be translated to fit the production environment." And there is the take-away for drug companies: that "the application of Lean concepts must be translated to fit the production environment" peculiar to pharmaceutical manufacturing.Engineers at a juice-bottling company were "advised by Toyota experts to eliminate all of the conveyors between machines because classic Lean principles brand conveyors as excess and unnecessary," a recommendation whose purpose was to promote "single-piece flow." This recommendation was good in theory, but it failed to take into account "the differences between automotive production and packaging, not only in the speed of the line, but in the differences in materials being used." The packaging materials used in the bottling plant were "highly variable, meaning that frequent stops [were] inevitable... much too often to stop the entire line for each occurrence."So this manufacturing techniques of "close-coupling" and "single-piece flow" had to be adapted to the special conditions of that particular high-speed packaging line. What had to be added into the manufacturing mix was an "appropriate amount of accumulation or buffer to accommodate the inevitable 'micro-stops,'" but not so much that it amounted to waste. Using the right tools, including overall equipment effectiveness (OEE) techniques and computer simulation, engineers at the plant were able to modify and adapt lean techniques so that implementation at their plant was successful.Iverson summed it up this way: "In general, those looking to deploy Lean in their plants must remember the differences between their own operations and those of Toyota." Similarly, qualified lean manufacturing consultants with knowledge of and experience in the pharmaceutical industry can sometimes be the make-or-break ingredient in a successful lean manufacturing implementation for pharmaceuti[...]



Lean Manufacturing Implementation - The Right Emphases for Right Thinking

Fri, 12 Nov 2010 09:17:38 GMT

A pharmaceutical company's lean manufacturing implementation can be either fairly seamless and efficient or met with resistance and merely partial. A lot of it has to do with perceptions and attitudes and the right implementation emphases. And these are the areas where lean manufacturing consultants can provide the most and most effective assistance.The perceptions and attitudes that impede successful, effective implementation of this solutions in the pharmaceutical industry start at the top. Not many in management today view the manufacturing aspect as an area for gaining a competitive edge. One result of shrinking profit margins and increasing cost pressures is that companies are increasingly reducing their own production and shifting that production overseas, where costs are lower, by means of outsourcing.What has happened is that pharmaceutical executives are reducing the task of reducing costs to a simplistic equation. These outsourcing decisions, many times, are made simply on the basis of nothing more than a comparison between the cost of production at a company's own facility and the cost of production in the target outsourcing country. But is this really the best solution? Or would it be better to apply lean manufacturing solutions instead and eliminate waste, continuously strive for more efficient production processes, and become more responsive to customer demand?Further, as has often been noted but seldom dealt with, there is the compartmentalized or siloed nature of departments within the pharmaceutical industry. A separation between manufacturing and R&D has long been the norm-a separation that has had far-reaching consequences, the weight of which are now being fully felt. Quality product development, however, depends on input from manufacturing. In accordance with lean manufacturing's emphasis on seamless, unified production processes, there needs to be ongoing, two-way dialogue between manufacturing and the lab.Industry analysts and lean manufacturing consultants suggest that, as a first step, effectiveness should be emphasized over efficiency. But because the larger cost savings result from efficiency-driven aspects of lean manufacturing implementation, senior managers often want to emphasize efficiency rather than effectiveness right out of the gate, which often does see some initial benefits but no real long-term success. Early efforts, then, need to focus on reducing of variability in core manufacturing processes and thus increasing the quality of these processes. For example, a first step might be to perform more preventive maintenance to cut down on unplanned maintenance later on-a step that enhances effectiveness first in order to promote manufacturing quality and efficiency.Also, a thoroughgoing lean manufacturing implantation requires a paradigm shift in thinking from top to bottom-shifting the emphasis to thinking about processes in terms of continuous improvement. According to Thomas Friedli ("Operational Excellence: Pharma's Missed Opportunities," pharmamanufacturing.com), "This challenge is never really over. [It] is a continuously ongoing journey that requires management attention on each level." And he further states, "To get buy-in on all levels in an operational excellence program it is mandatory that people understand the meaning and objectives of the program.... This will ensure that the program is seen as improving the survival and competitiveness of the plant."Smart Consulting Group has the qualified pharmaceutical consultants, with extensive industry-specific experience, to guide companies through the process of shifting emphases and attitudes to achieve an effective lean manufacturing implementation. Their goal is to "provide the competitive edge you need to be the market leader in medical products."Smart-lean-manufacturingcan help you build your cost cutting lean manufacturing implementation strategies and lean manufacturing cons[...]



Pharmaceutical Consultants - An Invaluable Asset in a Rapidly Changing Industry

Fri, 12 Nov 2010 08:09:39 GMT

When market conditions, methods of manufacture and testing, and technology remain virtually unchanged for long periods, companies in an industry can generally manage quite well doing everything in-house. But when an industry finds itself in the throes of rapid and unexpected change, outside experts can often provide the knowledge and expertise necessary for corporate survival. And so it is in our industry where the value of pharmaceutical consultants is becoming undeniable.In a ten-year-old article titled "Industry Focused: Pharmaceutical Consultancy" (Science, 17 November 2000), Tim Peakman offered some observations that are more to the point now than they were then. He wrote: "The pharmaceutical industry has undergone radical changes in the last 15 years. It has trimmed the fat and become more efficient, but in the next 2 to 5 years [which time we've now passed] the way it operates is going to alter fundamentally. Change is being driven from all sides, particularly through the impact of new technologies across the whole discovery and development process and from changes in the way that health care is funded and delivered."The changes Peakman spoke of have progressed even further, and there are others even more radical than those he had in mind in 2000. Growing FDA intrusion and compliance burdens, a dwindling number of blockbuster drugs and looming patent expirations, slowing growth in the market and shrinking profit margins, imminent novel healthcare reforms and increasingly heavy-handed government intervention, rapid technological advances and a growing number of combination products-all these are happening now or are on the near horizon. So the role of pharmaceutical consultants is expanding in scope and, at the same time, narrowing by dint of needed specialization.In the past, according to Peakman, pharmaceutical companies, for the most part, used general consultants for large business-wide endeavors like "cost reduction exercises or mergers and acquisitions." "But now," he explained, "the pervading beliefs about consultants [that they don't really know much about the pharmaceutical industry or the science involved] are being overtaken by a recognition that using outsiders with specialist knowledge can have its advantages when dealing with the massive changes the industry is facing. Whilst there is still a need for what might be termed generalists in consultancy, more and more consulting organizations are arranging themselves into industry-specialised groups."This means, then, that when a drug company turns to a pharmaceutical consulting firm to bolster profitability and hone its competitive edge, the consultants called upon need to have knowledge and expertise that are both broad and deep. Perhaps even more important, good consultants can serve in sort of "prophetic" capacity-spotting and keeping abreast of incipient trends in a rapidly changing industry, preparing companies to remain competitive when the trends are in full swing, and thus applying a preventive medicine.Quality pharmaceutical consultants, then, can prove to be an invaluable asset. They provide the necessary analytic consulting support that enables clients, with whom relationships are formed, to manage costs, improve business performance, and enhance the quality of pharmaceutical products. Consultants with industry-specific experience can also provide solutions for the manifold certification and approval processes required by the government and other official entities for healthcare products and services.Smart Consulting Group operates on the understanding that the client-consultant relationship is a partnership that promotes finding the best solutions to achieve the desired business objectives. That's why, with Smart Consulting, "you will have access to a team of professional full-time and associate pharmaceutical consultants who possess the experti[...]