Proper and unbiased testing is an integral part of any manufacturing process.  And this is especially vital in the pharmaceutical industry.  Because of the pharmaceutical industry’s inherent need for quality control, at the highest levels, a new form of testing was required to ensure the highest quality products available.  This form of testing is known as third party testing, where an independent third party testing operation, test the quality of the product in question, off site at one of their testing plants.  This ensures that both the government and the company itself cannot affect the testing, neither positively nor negatively, in any way.  This ensures a true unbiased assessment on the quality of the product.

Sounds pretty simple, right?  Well, yes it does, in theory, but when it comes to testing combination products, things get a bit more complicated.  Let’s clarify this.  Before the FDA tests a product, or takes the product to a third party testing operation, each FDA product is first assigned to a particular center within the FDA that will have primary jurisdiction over the product.  Combination products, on the other hand are assigned to different centers, based on their “Primary mode of action”, which means their primary purpose.  However, making this determination can sometimes be difficult and confusing.

Before these products can be tested either by the government, or a third party testing group, it has to be decided under what jurisdiction it will fall under.  Due to the large variations between the different levels of FDA research and testing departments, there are huge variations in terms of time and money required for FDA approval.  Because of this, a combination product’s designation to a particular department could have a major impact on the company’s ability to finance the product.  Because of this large variation, it has become a tremendous financial burden to some drug manufacturers, and they want a change.  And the change they want is third party testing.

Although the FDA’s feelings about this are mixed, they are not altogether opposed to looking into the idea.  But, to even be able to test combination products at third party testing sites, each product needs to have this same criteria.  In order to perform product testing on combination products certain standards are needed to establish what ingredients, or specific compounds, they are going to test.  If they are not specific in explaining what they need tested, then reliable testing can only be successful in testing single name brands.  Not only this, but many testing standards are different at different third party testing sites, which can complicate matters even more.

As the FDA and the pharmaceutical companies try to reach an agreement on this matter, much more standardized testing methods need to be instituted, before any real progress is made.  If your company would like to know more about third party testing methods of combination products, then contact your local pharmaceutical consulting firm for more information.

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 (don’t forget to mention www.smartconsultinggroup.com as the original source).

If your company is associated with the pharmaceutical industry in any way, whether it be manufacturing, supplying, or research and development, there’s a pretty good chance that your company will be audited with some kind of FDA inspection down the line.  When by chance, your company is audited, they will have to pass a series of FDA inspection tests, to ensure that your company is running in compliance to FDA standards, and that all your research and manufacturing information can be verified.  But you may be asking yourselves, what are the reasons for pre-approval inspections anyways, and what can my company do to get through it, and pass it the first time around?

The purpose of a Pre-Approval Inspection is for the federal government to ensure that all manufacturing facilities, as well as development facilities, meet all current GMP codes of conduct and stipulations.  Their main purpose is to verify that your company’s procedural activities are in line with their own commitments to ensure the authenticity and accuracy of any data contained in your company’s submitted application file.  It is the inspector’s job to thoroughly inspect your facility, as well as any records or data you have available, to make sure that your site produces reliable data information, and that all key GMP systems are up to code with current GMP standards.

Thorough preparation work is absolutely paramount when ensuring that your company is successful in getting through its pre-inspection test.  For your company to prepare itself sufficiently, many pharmaceutical experts recommend that your company start preparing itself at least 12 months prior to the inspection date.  One of the best things your company can do to ensure maximum preparation, is to hire an outside pharmaceutical consulting firm, or life sciences consulting firm, that specializes in pre-inspection audits, and can help your company to prepare itself the best way you can for your pre-approval inspection.

Companies should always be aware that preparing for your pre-approval inspection is not a last minute activity, and takes months of comprehensive training to be adequately prepared.  It is also advisable to organize comprehensive training programs for all personnel that will be in any way associated with the inspection.  It is not unheard of that personnel behaving in an inappropriate manner, or providing misleading information to inspectors, can cause inspectors to ask further, more difficult questions, as well as cause them to look into areas they may have overlooked.

This is why any personnel staff that could potentially come in contact with an inspector, should be thoroughly trained and briefed well ahead of time, to avoid any possible problems.  Your personnel should be instructed on how to conduct themselves around inspectors appropriately, as well as how to appropriately answer questions.  Phrases like “I guess”, “normally”, “usually”, “I think”, and “most of the time”, should all be carefully avoided.  Because of the wide range of do’s and don’ts associated with pre-inspection protocol, preparing your entire staff well ahead of time will be your best chance to safely make it through the pre-inspection process unscathed.

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 (don’t forget to mention www.smartconsultinggroup.com as the original source).

Lean process procedures are a companywide initiative, with the goal to achieve operational excellence.  It is a kind of systematic approach that facilitates improvement on every level, while putting process efficiency and product quality control at the top of the list, and delivering faster service and cost reduction.  The implementation of Lean philosophy is no longer being used in the old manufacturing sense, but is now being implemented in new and exciting ways all across the pharmaceutical industry and in the larger business community as well.  But what are the 5 basic steps to know if your Lean process plan is working?

1.Assess the Current State of the Company

Assessing the current state of your business, as well as its economics, business structure, processing structure, and value stream, are all part of assessing the current state of your business.  This involves mapping out the current state of your business while collecting process data along the way.  While you are gathering data about the different aspects of your company, make sure to take precise notes on all company information and material flow.

2.Determine Your Future State Workflow

Your future state workflow is dependant on your product, as well as your process layout.  For many organizations, developing the most efficient workflow strategy possible is the best way to organize your staff efficiently.  For many organizations having a streamlined workflow makes the whole process easier.  What you need to do first, is to set up a final layout and arrangement of the factory, to determine where the work cells will properly apply and where they will not.  The most important thing is not to make office processes invisible, but make them more visible and intelligently adapted to Lean principles.

3.Determine Future State of the Organizational Structure

Because having a solid corporate infrastructure depends very much on sustaining elements in an organization, it is vital that it serve a clear purpose in assisting your overall processes.  This includes scheduling, training, organizational structure, utility methods, quality methods, even attitudes and ingrained cultures of the organization.  Determine yours accordingly.

4.Identify Your Own Successful Lean Techniques and Methods

Based on what your supreme vision is for your company, choose the appropriate principles and tools of Lean process management that most closely mirror your organization.  You can also feel free to adopt other successful quality improvement techniques that may not be found in the standard Lean list of quality procedures.

5.Develop and Initiate the Plans

When you have a clear broad overview of your organization, as well as the proper procedures and quality improvement plans you’re wishing to administer, you can begin to plan out your course of action.  When implementing your plan on sustaining Lean improvements you need to gain the management’s commitment, as well as identify the key processes in your company.  After that you will need to train your employees accordingly.

Many companies have tried to find success by copying Lean strategies from other successful companies with little or no success.  This is because every company is different, with different needs and different procedures.  If you’re looking to improve your Lean strategies at your pharmaceutical company, be sure to contact a local pharmaceutical consultancy firm for more information.

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 (don’t forget to mention www.smartconsultinggroup.com as the original source).

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 one of the authors of the study, explained that they discovered that in the majority of cases where the clinical trial was stopped prematurely, the effects of the treatment were deceptive, and that these ambiguous estimations will most probably produce unwise decisions in regards to the estimation of the therapy’s risks and benefits.

He added that, “On average, treatments with no effect would show a reduction in relative risk of almost 30 percent in stopped early trials.  Treatments with a true relative risk reduction of 20 percent would show a reduction of over 40 percent.”

The clinical trials that were analyzed in the study were stopped prematurely due to a credible and normally large apparent difference between an experimental treatment and an established standard therapy.

The trials were stopped so that the people taking a placebo, or a medication that was less effective, could take the drug in trial.  In addition, this allowed doctors to prescribe the therapy earlier, since it would reach the market faster.

Dr. Montori explained that almost everyone doctors, researchers, investors, pharmaceutical firms, scientific journals, and even reporters benefits from the premature stop of a clinical trial; the only one that is affected is the patient, because he or she may wind up being treated with a therapy that is based on deceptive data in regards to its benefits.

The study investigated 63 medical questions about 91 trials that were stopped and compared them to 424 equivalent trials that remained active.  The discovery was that the trials that were prematurely stopped, especially small trials of a few hundred participants, showed effects that were exaggerated or deceptive, and these deceptive conclusions were aggravate over time because researchers wouldn’t go back to check what was previously considered a positive treatment.

It is recommended by the research team that clinical trials are stopped only when these are near the end and only for a very good reason, otherwise, patients, as much as doctors, will be making choices based on the wrong information and will be considering treatments that may not work as well as others.

The Medical Research Council of the U.K backed this study, and collaborated on it, together with Dr. Montori: Dirk Bassler, M.D.; Matthias Briel, M.D.; Qi Zhou, Ph.D.; Stephen Walter, Ph.D.; Gordon Guyatt, M.D.; and Diane Heels-Ansdell, all from McMaster University, Ontario; Melanie Lane, Mayo Clinic; and Paul Glasziou, M.B.B.S., Ph.D., University of Oxford, England.

Contact pharmaceutical consultants for more information, guidance, and to get the competitive edge you need to be the market leader in healthcare products.

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 (don’t forget to mention www.smartconsultinggroup.com as the original source).

According to Mexican researchers, agave, the plant from which tequila is made, may help fight osteoporosis and other bone diseases through one of its components.

Agave, as well as artichokes, garlic, onions, and chicory, is a powerful natural source of fructans, non-edible carbohydrates that consist of molecules of fructose joined together into chains.

Experimental studies indicate that fructans could be helpful for patients with diabetes or obesity, to stimulate the immune system, to decrease levels of bacteria that cause intestinal illness, to relieve constipation, and to reduce the risk of colon cancer.

Fructans have also been shown to stimulate the growth of good bacteria in the large intestine, boosting the body’s assimilation of minerals, including calcium and magnesium, essential for bone growth.  So, even though it is not a tequila shot per se, fructans may do a lot of good to a sick person’s bones.

Mercedes Lopez, from the National Polytechnic Institute in Guanajuato, tested the agave fructans on mice bone growth.  The sample fed with agave fructans absorbed more calcium from food, expelled less calcium in their feces, and increased in 50% their levels of a protein associated with the development of new bone tissue, all three, conditions that were not observed in other mice.

The natural conclusion is that by enriching the mice’s normal diet with agave fructans, bone loss was prevented and bone formation was enhanced.  This suggests that agave fructans may play an important part in maintaining bone health.

Agave fructans can be used in many products for children and infants to inhibit several illnesses, and also used as a sugar substitute in ice cream.

Lopez clarifies that the conventional tequila shot is actually not an option, since fructans become alcohol when agave is processed into the drink.

Ask your pharmaceutical consultant for more information or research on agave fructans; there’s no better source of valid information and advice in the pharmaceutical industry.

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 (don’t forget to mention www.smartconsultinggroup.com as the original source).

Starting now, and for the next 10 years, developing countries will start receiving pneumonia vaccines from GlaxoSmithKline and Pfizer Inc.

GAVI Alliance, the public-private partnership based in Geneva, recently announced this new commitment.  The program GAVI established to treat pneumococcal disease initially received $1.5 billion in funding, which came from the Italian, U.K., Canadian, Russian, and Norwegian governments, and from the Bill & Melinda Gates Foundation.

This new development promises to put new affordable vaccines in the hands of people that need them urgently.  GAVI states that the pneumococcal disease, which includes pneumonia, kills 1.6 million people per year, 800,000 of which are children under the age of five.  Over 90% of the deaths take place in developing countries, where pneumonia ends the life of one in every four children.

GAVI established the ‘Advance Market Commitment’ program to make drugs available to people in need, affirming that vaccines that are affordable could save 900,000 lives by 2015 and 7 million lives by 2030.

Glaxo will deliver 30 million doses and Pfizer an equal amount, for the next 10 years.

Pfizer is enhancing its manufacturing capacity to meet the global demand and to deliver Prevenar 13, which can be used in infants and small children throughout more than 40 countries.

Jeffrey Kindler, Pfizer Chairman and CEO, affirmed that, “Pfizer is dedicated to broadening access around the world to our medicines, and public-private partnerships such as the one involving the Advance Market Commitment are critical to achieving true inroads on this front.”

Glaxo announced it invested over $400 million to build a manufacturing plant in Singapore that will be devoted to producing hundreds of millions of doses of Synflorix, the drug it will be delivering, in the next years.

These vaccines will start being sold at $7 the dose, however, the price will drop to $3.50 and will remain so for the long run.  The vaccines will be paid by GAVI and the developing countries they will benefit.

According to GAVI, the total cost of the pneumococcal vaccines is only a fraction of their current cost in many industrialized countries.

Ask your pharmaceutical consulting firm for information and guidance to gain the competitive edge you need to be the market leader in healthcare products.

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 (don’t forget to mention www.smartconsultinggroup.com as the original source).

The time when body organs become replaceable is just around the corner.  Soon enough, scientists will be able to extend the life span of a human being dozens of years through his or her stem cells.

The first step has been taken already, with a 10-year-old boy receiving a revolutionary tracheal transplant in London, at the Great Ormond Street Hospital.

An organ that will grow inside the boy’s body through his stem cells has substituted the windpipe, bendable tube connecting the nose, mouth and lungs.

The boy was born with a condition known as long segment tracheal stenosis, which is a weakening condition that leaves the person with an airway of 1mm in width, putting him at risk of suffocation and death.

Previously, the boy was treated with stents, but these collapsed, interrupted the airflow and harmed the boy’s aorta.  After the child could barely breathe, his doctors called Paolo Macchiarini, at Careggi University Hospital in Florence, who decided to try a dangerous but bold procedure: re-growing the organ inside the boy’s body using stem cells.

Macchiarini’s team took a donor’s windpipe and removed all cells to prevent immune response.  The tissue was successfully implanted after having been seeded with the child’s stem cells and with a blend of chemicals that promote growth.  The patient responded well, he breathed normally and started talking right after the procedure.

This is truly a milestone in more than one way, because besides the implications it has for human life and health, this is the first time a child has received stem-cell organ treatment, it is the longest airway that has been substituted ever, and by letting the boy’s own cells re-grow the tissue, the costs were lowered considerably, by tens of thousands of pounds.

This success opens the door for stem-cell organ transplants to be performed in other medical facilities besides highly specialized hospitals, and although it won’t replace conventional transplants shortly, it most certainly can be applied to some aspects of these types of surgeries.

Regenerative medicine must become an important part of healthcare, and things are moving in that direction.  The next possible and intrepid step will be to perform larynx or esophagus stem cell transplants.

For now, doctors are waiting to see how the boy further responds to the transplant and if his recovery is as successful as expected.  If he recovers completely, as it is believed he will, we will have moved a step closer to immortality.

Talk to your life sciences consulting firm to learn about the latest developments in the pharmaceutical industry and to find the best ways to take advantage of the stem cell miracles that are unfolding around the world today.

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 (don’t forget to mention www.smartconsultinggroup.com as the original source).

It is no surprise, with the recent landmark health care debate unfolding on Capitol Hill, that many pharmaceutical executives are looking for new and innovative ways to cut costs in their own industry.  And one of these methods of innovation that many companies have been considering related to the use of  mutually beneficial partnerships that could theoretically replace the current model of selling drugs on price. Some industry commontators believe that this could  institute a new model that focuses more on quantifying and communicating total value.  But what do these innovations mean for the health care industry and the public as a whole?

According to many experts in the pharmaceutical industry, such as pharmaceutical executives, pharmaceutical consultancy firms, and even some doctors, all feel that the current system is simply unsustainable, while some would even go as far as to say it verges on being unethical..  Under the traditional pharmaceutical sales model, many pharmaceutical companies are primarily concerned with only getting to the sale, instead of any consequences that may be the end result from the sale.  Many patients feel that far too much emphasis is being placed on making the sale, and making the profit at any means necessary, while not having the patients’ overall wellbeing as their primary concern.

Many patients’ rights activists feel that pharmaceutical companies need to place greater emphasis on supporting what happens after a prescription is written, instead of being only concerned with making the initial sale.  But many experts, as well as activists do not necessarily see this as a damaging blow for the pharmaceutical industry.  While unproven, they feel that working closer with payers and providers to achieve better health care results will enable forward thinking companies to truly be able to differentiate themselves from their competition, thus potentially bringing in more public respect, and hopefully, higher profits.

Because of all the recent attention given to the health care industry over the last year, many in the pharmaceutical industry see this as a great opportunity for pharmaceutical companies to join with payers and providers to build better solutions together, than either group could do independently.  But this is just a theory that is sometimes easier said than done.  While pharmaceutical companies are working feverishly to become more focused on the patient’s needs as well as bring innovation to the payer-provider relationship, the botton line is, they still have to make money.  Because of ever increasing competition from oversees, not to mention increasing price pressures and growing market access restrictions, this process is proving far more difficult than previously imagined.

While both sides are working hard to come up with the best solution, the common consensus is that starting a healthy dialogue is key.  Through this healthy dialogue consumers as well as the pharmaceutical industry are expressing a newfound willingness to cooperate together, that just hasn’t been seen in recent years.  Through this dialogue some pharmaceutical companies have already taken steps in this direction particularly in the way they are  trying to  improve patient care whilst attempting to control costs. Only time will tell whether this new found cooperation will net any real positive gains for patients,providers and pharamaceutical companies, but many in the industry see this as an excellent step in the right direction.

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 (don’t forget to mention www.smartconsultinggroup.com as the original source).

Now that  the year long, and oftentimes ugly journey towards health care reform is coming to an end, many are curious as well as concerned about what this health care overhaul means for them.  What we have heard is that this new landmark legislation will extend health care coverage to 32 million Americans who are currently uninsured, and stop insurance companies from discriminating from patients with pre-existing conditions.

But what else will this milestone legislation cover? With so many half truths being spoken it is not surprising that the misinformation about health care circulating has confused most Americans. Now the question being asked  by many is what does this change actually mean for them personally and how will it change their lives?

While many of the provisions in this bill do not officially start until 2014, there are a few key provisions that will be effective immediately.  One of these provisions is that starting this year, children and young adults will able to stay on their parents’ health plan until they are 26 years old.  Another immediate provision, as we mentioned earlier, is that insurance companies can no longer discriminate towards people who may have pre-existing conditions, and these people, for the first time, will also be eligible for high risk insurance programs.

Other reforms starting this year include a small business tax credit of up to 35% of the cost of any premiums.  Also, insurance companies will be banned from lifetime caps on coverage and are  no longer able to cancel a policy

And yet another new provision that will take effect in the upcoming year is the provision of prohibiting insurance companies to enable pre-existing condition policies when it comes to the coverage of children.

While these reforms will be taking place immediately, the major bulk of the bill will take into effect as of 2014.  This is when new insurance marketplaces, or exchanges, will be set up in states all over the country to offer individuals competitive health policies for businesses or individuals that don’t have coverage.  Lifetime and annual limits on coverage will also be eliminated at this time.  Other stipulations include, starting 2014, that any persons who do not obtain coverage will have to pay a penalty of either $95 or 1% of their income, whichever one is the highest.

While many of these stipulations are real positive steps toward true health care reform, one of the main questions being asked is how these new laws will affect your current health care plan.  While there is still no consensus on this matter, many in the pharmaceutical industry like manufactures, pharmaceutical consultants, even doctors do not feel this will affect your plans in any way.  Many news reports about this health care bill, they feel, have been distorted in the way the spirit of the bill was intended.

Many believe that , not only will this new health care reform not change your existing insurance, it will be a positive step in the right direction towards true health care reform.

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 (don’t forget to mention www.smartconsultinggroup.com as the original source).

As many have probably noticed, the pharmaceutical industry has experienced a major surge in recent months, and many believe it is thanks, in part, to mobile technology.  This may seem like a strange marriage, but in actuality it makes perfect sense.  As the world’s population continues to become older, there is ever increasing demand for better drugs and treatments.  As pharmaceutical companies continue to struggle with these ever growing challenges, many companies are looking to mobile devices as an effective solution to help overcome these obstacles.

It may be surprising to hear, but mobile technology is actually taking center stage when it comes to advancements in the pharmaceutical industry.  Compared to other industries where mobile technology is being utilized, high tech mobile solutions are playing key roles in the overall growth of the pharmaceutical industry as a whole.  Mobile technology also helps personnel and researchers more easily access protocols, as well as guidelines and other vital training materials.  This helps to avoid larger, and potentially more costly violations in the future.  While this marriage between big pharma and the mobile industry may seem a strange one, it is turning out to be an immensely profitable one as well.

So you might be wondering, how does the mobile phone industry help to advance the pharmaceutical industry’s growth as it is being reported?  One way is through new high tech mobile applications.  These applications are helping pharmaceutical companies to streamline clinical research and trials, not to mention improve patient monitoring, as well as empowering sales teams all over the world.  Also, the advancements in mobile technology have helped pharmaceutical companies send vital information directly to physicians via mobile devices, such as Blackberries and iPhones.  It is also helping internal business run more smoothly within pharmaceutical organizations.

The mobile industry is also helping Big pharma grow in ways we previously had never imagined.  Mobile phones help sales reps and marketing reps by helping them to access more information on their handheld devices.  This makes their business visits far more effective, and also saves them time and energy.  Mobile technology also helps the R&D process run more efficiently and is proving to be more cost effective.  Because mobile solutions allow data to be collected at a much faster rate, this allows raw data to be 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 handheld mobile devices, it will not only make many jobs in the pharmaceutical industry, such as sales reps and researchers, easier, but also allow for further unprecedented growth in the industry at large.  As mobile technology continues to open up new doors for many in the pharmaceutical industry, many are extremely excited to see what this mobile future will bring.

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 (don’t forget to mention www.smartconsultinggroup.com as the original source).