Bioengineering, and more specifically, tissue engineering, gives a new perspective to personalized medicine.

The use of cells and therapies has become a strong practice to get the body to heal itself, as it already happens with blood transfusions, bone marrow transplants, and autologous chondrocyte implantation to re-grow cartilage.

These procedures have prepared the road for over 2000 clinical trials linked to cell therapies, like stem cells for ischemic heart regions, neural precursor cells for Parkinson’s disease, and oligodendrocytes resulting from embryonic stem cells to heal spinal cord injuries.

The key to success is to detect the best mechanism to transfer these cells.  For example, cell-based therapy is employed to treat osteoarthritis of the knee, where the damage to cartilage and the subchondral bone produces less fibro cartilage repair than the mechanical properties of articular cartilage.  The majority of patients develop an acute degenerative joint disease, and over 250,000 knee replacements are done in a year.  In this case, injecting a suspension of autologous cultured chondrocytes into the problem area won’t work effectively because the cells have the tendency of forming fibro cartilage and of losing their round shape.  The best way to treat osteoarthritis of the knee is to embed the chondrocytes in the cartilaginous matrix that wears away just as the cartilage does.

If the chondrocytes are enveloped in gels, this permits the cells to maintain their rounded shape, and the properties of the gels can be controlled to let the tissue regenerate.  The mesh has to be small enough to hold up the cells, and open enough to get water and nutrients.  Equally, the gel structure has to disintegrate at the right rate so that the extracellular matrix that is secreted is not limited only to the area that surrounds each chondrocyte.

The cartilage tissue that is engineered can replicate the structural characteristics of native cartilage to such an extent that the cell orientation and the regenerated cartilage look like native cartilage.  The cells that are enveloped in this kind of matrix can migrate to and from the cartilage at the surface.

A vital matter brought up by cell-based therapy is how to make the most of the utility of cells delivered to an environment that is passive or tolerant, where there is context for the kind of cell required but in which very few biological signals are produced to support normal cell function.

In the end, bioengineers picture a material system in which the embedded cells emit a signal so that deeper cells form bone white cells close to the surface form cartilage.

Regenerative medicine anticipates several things:

-A rising impact of cell-based therapies in clinical medicine

-Methods that make it easy to regenerate skin, bone, cartilage, bladder, and trachea from bone marrow stem cells, and also the regeneration of blood vessels and heart valves

-The restoration of function in complex tissues like the spinal cord

-Going after the goal of regenerating more complex tissues and neo-organs

-Tackling big challenges, like the identification of cell sources and clinically relevant cell numbers, the integration of new cells into existing tissue matrices, and the accomplishment of functional properties of tissue equivalents using expanded range of biomaterials

Contact your life sciences consulting group for more information and guidance on how to make the most of the regenerative medicine market.

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Diabetes is a chronic metabolic disorder that develops because the body is not able to produce the hormone insulin and/or is unable to respond effectively to the insulin that is produced.

There are two types of diabetes:

-Type 1, which accounts for 5 to 10% of worldwide diagnosed diabetes cases.
-Type 2, which accounts for 90 to 95% of the totality of diagnosed cases.

The treatment for Type 1 diabetes depends on diabetic medical supplies, above all, diabetes drugs and insulin, while Type 2 diabetes is normally treated by getting involved in the patient’s life.

The World Health Organization estimates that there will be over 350 million diabetics by 2030.  This huge number clearly shows that the diabetes market will be strongly influenced, particularly the market related to diabetes drugs, which includes injections like the insulin and exenatide types, and oral drugs like Metformin, Sulfonylureas, Thaizolidinediones, Dipeptidyl inhibitors, Meglitinides, Alpha Glucosidase inhibitors, and combination medications.

Presently, cases of diabetes are growing all over the world at a very fast pace.  The causes for this incidence are several, among which we can name:  increased life expectancy, inactive lifestyles, and rising rate of obesity.

The majority of developed and developing countries worldwide suffer from these three factors, and this is why diabetes is becoming an epidemic.

In Brazil, the diabetes drug market is permanently showing a double-digit growth rate.  The insulin market in Russia is expected to grow drastically due to the 20 million Russians that are presumed will become diabetic by 2025.

China is currently the country with more diabetics, and it is expected to have over 71 million people with the illness by 2025; but India will soon top the list, and this is why many pharma companies in India have already launched insulin versions that are easy to use, in hopes of dominating the diabetes market in this country.

Diabetes is very rapidly becoming one of the most important areas in the pharmaceutical industry, and from 2010 until 2025, the market’s growth will speed up dramatically.

Following are some indicators that reveal the future of the diabetes market and that are the focus of pharmaceutical consultants and their top clients:

-The diabetes market will have access to highly superior diabetic products.

-Research and development for diabetes therapies will center on technologies that enhance clinical effectiveness, tolerability, and simplicity of use.

-Insulin has the largest market share among the treatments for this disease, with a piece of 45%, and it is expected to rule the market until the year 2025.

-The future influence of inhaled insulin in the market is not clear yet.

-Another important piece of the market is taken by pre-insulin, which has developed a lot of safer and novel diabetes therapies like the DPP-IV inhibitors and GLP-1 analogs.  These therapies’ comparative performance will probably shape the market 2013-2014, and in the long run, until 2025.

-After the new FDA guidelines were released in December 2008, pharma companies that work on diabetes drugs have had to perform more thorough studies to prevent ‘unacceptable’ cardiovascular risk.  They have to perform meta analyses for cardiovascular safety during Phase II and III trials, and must discard the chance of an increased cardiovascular disease risk by 80% or more.  What this means is that safer options of anti diabetes drugs are just around the corner.

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The medical world is showing its ugly, hostile face to pharma sales reps.  The number of doctors that are willing to meet with pharma sales reps on a regular basis is dropping alarmingly, and the group that doesn’t want to meet with them at all is growing even faster.

ZS Associates, a marketing consulting firm, has issued a report showing that just 58% of doctors are open to reps, meaning that they meet with 70% of the sales people who visit them.  This percentage shows a drop of 18% from last year.

In the same way, doctors that completely refuse to meet with reps account for 9% of the total, while last year they were 6%.  In one year, the percentage has doubled.

But the trouble doesn’t stop there.  The doctors that are open to sales reps are getting pickier, almost all of them are not willing to see reps more than once a month, not even their favorite ones.

According to this data, it is estimated that about 8 million planned sales calls are worthless, since companies are assigning reps to call on doctors who absolutely decline seeing them or who won’t see them as often as management would like.  To put it simply, this is a waste of time and money, more exactly, a waste of $1 billion a year.

How does this leave pharma marketing?

On one side, it kind of exonerates pharma sales reps, because management should be able to accept that doctors won’t open up just because they are forcing their reps on them.

On the other side, it is an indicator for the need of a more efficient sales model, where marketing efforts are adapted to local conditions.  In places where doctors are very unfriendly, it may be more beneficial to establish new strategies like online detailing, for example.  Doctors who want to see reps only once a month should be respected and contacted only within the time frame they consider acceptable.

Your pharmaceutical consultancy firm will confirm it; the worse you can do, image, money, and employee satisfaction wise, is to force yourself on others out of desperation; that will only bring you down faster and more painfully.

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Scientists from the University of Nottingham have uncovered the gene that allows an amazing worm to regenerate its body parts after these have been amputated; and we’re talking about even its whole head and brain!

The discoveries made about the Planarian worm could be a huge step forward into one day seeing real results in regards to the regeneration of old or damaged human organs and tissues.

For the first time, this research, headed by Dr. Aziz Aboobaker, a research Councils UK Fellow, and published in the open access journal PLoS Genetics, shows that a gene called ‘Smed-prep’ is crucial for the correct regeneration of the head and brain of planarian worms.

These worms have an incredible ability to regenerate body parts.  They contain adult stem cells that are incessantly splitting and are able to become all of the missing cell types; they have the correct set of genes at work to achieve this in the right way, so that when the body parts grow back, it happens in the right place and in the right size, shape, and orientation.

Dr. Abbobaker’s team has had the opportunity to see the tissue regeneration process in a very simple animal that is capable of regenerating itself to an amazing extent and that does it regularly.  They want to understand how it is that adult stem cells can work together in any animal to form and replace damaged or missing organs and tissues, because any new understanding in animals can be very important, very fast, for humans.

If scientists understand what is going on when tissues are regenerated under normal circumstances, they can start working on how to replace damaged or sick organs, tissues, and cells in an organized and safe way after an injury has happened for any reason.

This kind of knowledge would be very helpful for treating Alzheimer’s, for example, and scientists would also be able to measure the consequences of what happens when stem cells go wrong during the normal renewal processes, like in the blood cell system, where rogue stem cells can cause Leukemia.

Smed-prep is vital to correctly differentiate and to locate the cells that compose the head of the planarian worm and to define where this organ is located in the worm.

The scientists have discovered that even though Smed-prep is crucial for the head and brain to be in the right place, the worm stem cells can nevertheless be persuaded to form brain cells due to the action of other unrelated genes.  However, without Smed-prep, these cells are unable to organize themselves to form a normal brain.

The team knows that it is crucial to understand the molecular basis for tissue regeneration and remodeling in order to advance in regenerative medicine.

The planarians are famous for their incredible regenerative capabilities, and these scientists have been able to characterize the first gene, the Smed-prep, that is necessary for correct anterior fate and patterning during regeneration.

Contact your pharmaceutical consultant for guidance and more information in regards to tissue regeneration milestones.

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).

Scientists from the University of Nottingham have uncovered the gene that allows an amazing worm to regenerate its body parts after these have been amputated; and we’re talking about even its whole head and brain!

The discoveries made about the Planarian worm could be a huge step forward into one day seeing real results in regards to the regeneration of old or damaged human organs and tissues.

For the first time, this research, headed by Dr. Aziz Aboobaker, a research Councils UK Fellow, and published in the open access journal PLoS Genetics, shows that a gene called ‘Smed-prep’ is crucial for the correct regeneration of the head and brain of planarian worms.

These worms have an incredible ability to regenerate body parts.  They contain adult stem cells that are incessantly splitting and are able to become all of the missing cell types; they have the correct set of genes at work to achieve this in the right way, so that when the body parts grow back, it happens in the right place and in the right size, shape, and orientation.

Dr. Abbobaker’s team has had the opportunity to see the tissue regeneration process in a very simple animal that is capable of regenerating itself to an amazing extent and that does it regularly.  They want to understand how it is that adult stem cells can work together in any animal to form and replace damaged or missing organs and tissues, because any new understanding in animals can be very important, very fast, for humans.

If scientists understand what is going on when tissues are regenerated under normal circumstances, they can start working on how to replace damaged or sick organs, tissues, and cells in an organized and safe way after an injury has happened for any reason.

This kind of knowledge would be very helpful for treating Alzheimer’s, for example, and scientists would also be able to measure the consequences of what happens when stem cells go wrong during the normal renewal processes, like in the blood cell system, where rogue stem cells can cause Leukemia.

Smed-prep is vital to correctly differentiate and to locate the cells that compose the head of the planarian worm and to define where this organ is located in the worm.

The scientists have discovered that even though Smed-prep is crucial for the head and brain to be in the right place, the worm stem cells can nevertheless be persuaded to form brain cells due to the action of other unrelated genes.  However, without Smed-prep, these cells are unable to organize themselves to form a normal brain.

The team knows that it is crucial to understand the molecular basis for tissue regeneration and remodeling in order to advance in regenerative medicine.

The planarians are famous for their incredible regenerative capabilities, and these scientists have been able to characterize the first gene, the Smed-prep, that is necessary for correct anterior fate and patterning during regeneration.

Contact your pharmaceutical consultant for guidance and more information in regards to tissue regeneration milestones.

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).

Maintaining a top-functioning Quality System in regulated pharma environments can add serious problems to the company’s bottom line.  Nevertheless, the ROI can be significant with solutions that automate routine and administrative tasks related to Quality System maintenance.

Within the pharmaceutical industry, it is not easy to find a Quality System model that offers a meeting point for agreement, be it direct or indirect, with the FDA’s cGMP initiative, 21 CFR Parts 210 and 211 regulations, the FDA’s Critical Path Initiative, ISO 9000 standards, and/or the requisites of foreign regulatory bodies.

However, in the ‘Quality Systems Approach to Pharmaceutical cGMP Regulations’ support document, the FDA introduces a potential Quality Systems model that could offer the elements that pharmaceutical companies require to start, or keep on, growing a top-functioning Quality System capable of meeting the institution’s regulations and requisites.

The quality systems model proposed by the FDA is divided into four major categories:

1.Management responsibilities
2.Resources
3.Manufacturing operations
4.Evaluation activities

Here, we’ll discuss the first category, Management Responsibilities, and how many administrative chores related to pharmaceutical Quality Systems management could be automated.

According to the Quality System model proposed by the FDA, management staff in pharmaceutical environments has two main responsibilities:

-First responsibility: “Senior management must show commitment to developing and maintaining their Quality System.”
Developing a Quality System is a task that takes time and requires dedication.

Even if a quality manager knows a lot about the difficulties and particulars of different Quality System models, he or she will most definitely have to show commitment to developing the Quality System itself.

The management staff also holds the responsibility of maintaining the Quality System.  There are five stages linked to Quality System maintenance:

1.Observation of the Quality System
2.Identification of deviations and nonconformance events
3.Reporting
4.Analysis
5.Appropriate action

Management has to be accountable for every stage of Quality System maintenance and normally will hold the biggest responsibility in regards to data analysis and later decision making.

In spite of this, it is common to see managers spending most of their energy on the first three levels, which are the ones that pose the heaviest burden and are also the ones that are perfect for automation.

The benefits of automation are very clear:

_More time for analysis and associated research
_Less administrative responsibility

There are software options that act as an “observer” of the company’s quality system, and with these, quality management staff in regulated pharmaceutical environments can benefit from the advantages of automation.

These solutions should offer data and trending technology that simplify the identification of Quality System deviations and nonconformance events, as well as sophisticated auditing capabilities, and should allow for the effortless creation of reports that show data trends.

With good automation technology in place, management will still hold the major responsibilities in regards to Quality System maintenance, but timely and uninteresting administrative chores disappear from the picture.

-Second responsibility: “Quality System plans should be aligned with a manufacturer’s strategic plans to ensure that the system is part of the manufacturer’s mission and quality strategies.”
A Quality System is not an entity unto itself, it meddles in everyone’s business, and this is why it is crucial that the Quality System be linked to other pharmaceutical systems and processes’ goals and realities.

Nevertheless, it may not be easy to line up Quality System management with the other processes and departments because these have a tendency to be disorganized and subjective.

Good automation will let pharma companies connect quality, compliance, and everyday routine processes with solutions that take-off from one platform.  This sole platform offers two benefits:

-Faster and more effective communication between departments
-Less quality system errors due to manufacturing and quality disconnects

Within pharmaceuticals, the aspects of management responsibility seem countless, but there are modern quality management solutions that have been designed to consolidate and greatly simplify the job of pharma management staff.

Your pharmaceutical consulting firm has powerful inside information to guide your choice of quality management solutions for your company.  They are there to help you make the right choices!

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A vendor audit is a vehicle used by pharmaceutical companies, and other large companies as well, to inspect and evaluate a vendor’s quality management system, as well as its practices, products, and documentation.  The need to conduct vendor audits stems from a higher need for quality control in an industry that needs to be more regulated than any other industry in the world.  This need for a closer monitoring of a vendor’s qualities and practices stems from an ever-evolving quality control market, and an industry where quality products are a necessity, not a luxury.

One reason why organizations use audits is to reduce cost and improve quality control.  They do this by creating the leverage of expertise of product and service providers as an alternative, instead of building equivalent capabilities in-house.  This way of outsourcing partnerships between pharmaceutical companies and external pharmaceutical vendors has reached the top of many companies’ strategic imitative plans in recent years.  This system of vendor auditing is being used by different companies, in different industries all over the world, but has really gained ground as a reliable business principle in the pharmaceutical industry.

The FDA requires that all inherent systems used to support agency regulated activities need to be validated and compliant with FDA rules and regulations.  In more precise words, the system administrator is responsible for demonstrating that the application that was developed and tested is operating and maintained according to FDA quality control standards.  In addition to this, the system administrator needs to be able to demonstrate the proper use of the procedural and technical controls, and that all applicable regulations are met.

The primary areas that need to be evaluated in a vendor audit are vendor viability, management responsibility, system accuracy, and data integrity.  The main objectives for a vendor audit are to assess the quality management of the whole organization, through its procedures and data processes.  It is an assessment of quality control measures taken by the vendor to assure that their products and services are acceptable for business transaction.  During this audit they will also verify computer systems developed or used by the vendor, make sure they meet all of the regulatory requirements, as well as have the testing documentation requirements.

A vendor audit should not be only limited to making lists of good or bad things.  It should be looked at more as an overall assessment of finding, from which you can draw your own conclusion.  A vendor audit should be conducted to help your organization make quality decisions about services, products, vendors, and quality practices.  It will provide your company a means to verify that third party vendors meet the applicable FDA laws and regulations, while reducing liability and effort on your part.

When done correctly a vendor audit can provide a great value to your company and organization, especially, in the system implementation and validation process.  It allows for vendors and buyers to quickly establish relationships that will not only increase product quality, but reduce duplicated testing efforts, and start a new and constructive dialogue between buyer and vendor.  To learn more about how to properly administer vendor audits in your company, contact a leading pharmaceutical consultant in your area.

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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.

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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.

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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.

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