A group of top researchers is focusing on understanding how an embryo’s developing pancreas recognize which cells produce insulin and which ones have other functions.  This understanding is crucial in the use of stem cells, developed into beta cells that produce insulin, to treat type-1 diabetes.

Today, Lund University scientists have new discoveries to announce in this regard, and they will do it in the journal Cell, which is one of the top biomedical journals.

Diabetes researcher Henrik Semb’s team has been analyzing two vital scientific questions:

1.    How are tubes formed in organs where they fulfill vital functions?  For example, the tubes that filter urine in the kidneys, the tubes that carry blood in the blood vessels, and the tubes that carry air in the lungs.

2.    How is the differentiation of cells, the development of immature cells into various mature ones, related to the formation of tubes?

These two processes are known to happen simultaneously in an embryo, but it was not known if they were related, until now.  Henrik Semb’s research team can explain step by step how certain cells in the developing pancreas form miniature cavities that join together to create a system of tubes, and how cells that end up in different parts of this tube system are exposed to different environments, thus they develop in separate ways.  Some produce insulin, others, enzymes that digest food in the intestines, and yet others take part in the tube’s construction.

This research team also discovered that there is a critical gene related to these processes, it is called Cdc42.  They found this out through knock-out mice that had this gene removed.  The lack of Cdc42 blocks the formation of tubes in the pancreas, thus, the dominant environment is like the one around enzyme-producing cells instead of the most important insulin-producing beta cells one.

These discoveries provide knowledge that is critical for the future of medical treatments.  A new door has opened for the research on stem cell treatment for type-1 diabetes, given the new understanding of how immature cells grow into beta cells.  This knowledge will also be valuable for diseases where cyst formation in the tubes produces organ failure, for example, in kidneys and liver.

Every important article published in Cell requires committed and lengthy research, and this is exactly what the Lund scientists have done.  They have devoted years to studying tube formation, cell differentiation, and the role of Cdc42 in the mentioned processes.

Their secret resides in the team itself, formed by amazing scientists capable of keeping their passion alive and energy focused even when they were tempted to publish several partial findings in other journals.  They definitely knew better.

If you wish to know more about stem cell research and their future medical potential, talk to your pharmaceutical consultants; they should be on top of the latest developments and market opportunities.

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The vaccine manufacturer MedImmune announced at the end of last year that the H1N1 vaccine had lost effectiveness since it first appeared.  Nevertheless, according to U.S. officials, this does not imply a safety issue.

The mentioned manufacturer withdrew thirteen lots of the vaccine against the H1N1 influenza out of its own free will because these had lost part of its effectiveness since they were first manufactured.

In response, Norman Baylor, the director of the Office of Vaccines Research and Review at the Food and Drug Administration, stated that this situation does not create a safety issue because every lot had passed the pre-release testing required to ensure safety, purity, and effectiveness.  He maintained that the loss of effectiveness was a slight one.

The thirteen lots that were withdrawn were a part of 4.7 million doses of the intranasal vaccine, whose origin is a live weakened virus; however, officials think that the majority of these were administered during October and November of 2009, when the vaccine was still performing at its maximum effectiveness.  At the moment of the announcement, the manufacturer still had in its possession 3000 doses affected by the withdrawal, but it is not clear how many are scattered around the country.

This is not the first time lots of the H1N1 vaccine have been withdrawn.  Some weeks after MedImmune’s incident, Sanofi-Aventis withdrew 800,000 doses of the vaccine for children for the same reason; their effectiveness had decreased.

Baylor accepted that this pattern is not normal, having two withdrawals of a seasonal flu vaccine in the same season; however he explained that these are biologicals created from living organisms and thus, it is normal for the vaccine to lose effectiveness over time.

It is for this reason that the vaccine has an authorized shelf life of 18 weeks and that the FDA demands that companies measure its effectiveness regularly.  MedImmune tests its products on a weekly basis, and it was on one of these occasions that the loss of effectiveness was accounted for.

Baylor noted that the withdrawal was a measure of precaution.  He added that those who received vaccines from these lots are fully protected and don’t need to get another shot.  According to him, there is no negative impact whatsoever on the vaccine’s safety and effectiveness.

Contact your pharmaceutical consulting firm, because it should have a lot to say on this respect and lots of important recommendations.

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A leader in vaccine design, development, and distribution, Inovio Biomedical Corporation, informed that its SynCon™ Chikungunya virus DNA vaccine generated protective neutralizing antibody responses in a monkey model.

The Chikungunya virus is a new alpha virus carried by mosquitoes that originated in tropical Africa and Asia.  It has been known to have an infection rate of up to 45%.  Although not life threatening, this virus causes acute human morbidity, presenting serious fever and weakening joint pain, and it could take over a year to cure.

It has been discovered that different mosquitoes normally found in developed countries, including Europe and the United States, can transmit the Chikungunya virus, making it a threat for people in other geographies outside its territories of origin.  The virus is already prevalent in several world regions and clearly has epidemic potential.

Currently, there are no vaccines in the market to treat this virus.  The truth is that very little is known about the disease, including the mechanism of viral clearance based on immunity and why it causes clinical symptoms.  Thinking about the potential the Chikungunya virus has for spreading disease globally, it is crucial to understand its pathogenic mechanism and to develop effective treatment alternatives.

Inovio used its SynCon™ approach to create a Chikungunya virus DNA vaccine that is delivered as a single DNA plasmid construct including harmonious sequences of key surfaces antigens.  Its design is based on the alignment of various primary sequences of key surface antigens and on the selection of the most common amino acid or base pair at each site.

In the study with money models, the entirety of the sample that was vaccinated developed protective neutralizing antibody responses against the original virus, demonstrating the vaccine’s effectiveness in a preclinical model.  This data presents solid evidence highlighting the likelihood of  nearterm future human clinical progress.

Inovio’s new SynCon™ technology allows them to design DNA-based vaccines that can protect against known or unknown pathogen strains.  It can synthetically define antigens and gene sequences that are common between different viral sub types or families of diseases like HIV, HCV, HPV, and influenza.

This company recently disclosed provisional information regarding a Phase I therapeutic HPV/cervical cancer vaccine test that showed important and strong immune responses from T-cells and antibodies, highlighting the possible broad use of its DNA vaccine technology platform and application to various diseases, among which is the Chikungunya virus.

This is a clear example of how pharma companies and pharmaceutical consultants who are on top of things win the race on innovation and market trust.

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Now is the time to establish a global vision in the path to a harmonious approach to product security that provides close-term benefits for patient safety.  While the US centers on how to achieve an e-pedigree system and the pharma industry in Europe incorporates a 2D datamatrix-based “bookend” system, patient safety is in possible danger due to the split approaches and expensive implementation strategies.

The drugs supply chain is becoming more and more complex due to the increase in the globalization of the pharma trade.  Manufacturers, distributors, re-packagers, and retailers may be all located in different countries or even continents.  Given the complexity of the supply process, drugs have become a profitable target for illegal distribution and forgery.

Many methods have been proposed to protect patients, however, the answer may be very simple: an approach in phases, which initially focuses on the point of dispensing and avoids the significant difficulties and costs that a full supply chain pedigree system encompasses.

Currently there are two main initiatives that are fragmenting the resources of the industry: The European Federation of Pharmaceutical Industries and Associations (EFPIA) initiative, and the California ePedigree network.  Not long ago, the pharma industry overcame many years of irrational enthusiasm in regards to the near-term potential of RFID technology.  It is time to learn from mistakes and select an approach that leads to improvements in patient safety that are achievable instead of considering a large-scale solution focused on the supply chain.  In this regard, the European initiative is better.

Key organizations and agencies have to become aligned in regards to a global approach that can be launched in any region and using the available technologies.  This global approach should have a main goal: checking drugs at the most critical transaction in the supply chain, when they are delivered to patients.  The EFPIA follows this route, however it requires two important and costly developments: all products must be serialized at the unit level, and an industry wide data routing and data management system has to be established.  These developments will allow for significant short-term improvements to patient safety through point-of-dispensing verification, will offer important knowledge, and will enable other developments of supply chain pedigree programs that can build on this foundation.

Like bank ATM’s and credit cards, this system would permit global use with universal results: the approval or denial to sell a drug.  Along with serialization as an aspect of an authentication program, authentication technologies are also needed.  Explicit and secret product authentication characteristics used by the manufacturer in the product’s packaging or in the product itself, give the manufacturer the capacity to detect abnormalities fast.

In order to make this a reality, the EFPIA, EMEA, FDA, PhRMA, and WHO will have to join forces to define an industry standard with a data exchange infrastructure that could strengthen the broad implementation of unit-level serialization.  Eventually, this system will evolve into a more extensive track and trace system, forming the supreme supply chain management tool.

It is everyone’s responsibility to work towards a solution for patient safety in view of the growing global danger of distribution of illegal and forged drugs.  As pharmaceutical consultants will agree, global problems beg for global solutions.

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Until recently, many big name pharmaceutical companies have been gun-shy about entering into the realm of social media.  But recent trends are telling a different story.  Only two weeks after pharmaceutical giant Nova Nordisc announced development of its brand new twitter page, Pfizer quickly followed suit introducing plans for its own page in the next few months.  Both companies plan to use Twitter as a social platform to announce new products, new drug treatments, as well as developing better relationships with their consumers.  But is social media really an effective marketing tool for large pharmaceutical companies? And why now are they starting to jump on the social media bandwagon, after years of resistance?

As the economic downturn continues to adversely affect pharmaceutical companies all over the world, many pharmaceutical consultants are starting to recommend giving social media a try.  Until recently, much of the pharmaceutical industry has shied away from entering into the interactive realm of social media, for various reasons.  The common belief was that implementing effective marketing strategies using social media was too difficult, given the legal and regulatory hurdles.  Also, the lack of a means to measure the financial success of using social media, has kept many pharmaceutical companies away from using these possible lucrative marketing tools.  However, signs are showing that these trends are starting to change.

Many pharmaceutical consulting experts are coming out in droves stating that many of these negative claims about social marketing are highly over exaggerated.  It is true that many pharmaceutical companies have stayed away from blogs and other social media because of legal and regulatory issues, but this trend is beginning to change.  Many pharmaceutical companies, in recent years, are simply bypassing many of these regulatory concerns, or simply finding ways around them.  Many drug companies are hiring outside firms to run blogs and message boards for them, but at the same time not being directly associated with the company.  This is an important step for pharmaceutical companies, as customers can discuss their reaction to different drugs and therapies, without and legal concerns.

With over 80% of Internet consumers, searching online for health and drug information, breaking into social media is absolutely vital for the continued success of pharmaceutical industry in the technologically evolving business climate of the 21st century.  Many pharmaceutical consulting experts are finding it more and more important for the pharmaceutical industry to enter into this realm of social media, and find it will be more common place in the next 5 years.  Because social media is an excellent place for drug companies to utilize online support groups, as well as discuss treatments and medications with patients online, this trend will only continue to grow.  Marketing through social media will help create not only better informed patients, but will help patients to make better health decisions about what kind of medicines or treatments they should be choosing.

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It is no surprise that as emerging markets, like China and India, continue to grow at a record pace, that drug makers all over the world need to wake up to the fact that the future of their business may depend on markets outside of the United States and Europe.  As these emerging markets in China and India, as well as Brazil continue to grow full speed ahead, it is becoming more evident to the pharmaceutical industry as a whole, that they better start paying more attention to these parts of the world.  But what is behind this recent economic boost? Why is it so important for the pharmaceutical industry to starting taking notice of it?  Could these emerging markets like China and India really surpass the US and Europe as the key players in the pharmaceutical marketplace of the future?

Because of this uninhibited growth in emerging markets all over the world, the pharmaceutical and life sciences industry is beginning to pay attention.  However, as many pharmaceutical consultants are beginning to notice, the same strategy that has worked in large, super-industrialized countries such as the US and Europe, may not be as effective in emerging markets such as Brazil and India.  Many of these consulting firms are recommending completely different strategies when it comes to being successful in these emerging markets such as differential pricing.

Differential pricing is a tactic that most pharmaceutical companies might not try in larger, more developed countries, but might be a good tactic in emerging markets such as India and Brazil.  Differential pricing takes into account the per capita income, when setting prices.  For example, the middle class income rate for Indians or Brazilians is far lower than that of those who reside in the United States and Europe.  By differentiating their pricing structures, this could lead to a widespread increase in business abroad.  However, not everyone is convinced this will be good for business.

Some critics have argued that under the price differential plan, pharmaceutical companies would suffer major loses, unless propped up by large demand or government subsidies.  Others have argued that many will just take these cheap branded medicines and resell them in the black market, to other parts of the world for substantially higher prices.  Regardless of the best method to price these drugs, no one disagrees with the importance of forward thinking drug companies tapping into these untouched emerging markets.  Its seems that whichever company figures out the best plan first to how to successfully tap into these emerging drug markets, will lead the global pharmaceutical marketplace well into the 21st century.

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In order to assure that a company has a well functioning organizational structure executive management needs to be very proactive. No where is this more the case than in the QC laboratory environment.
Audits and warning letters are very common within the pharmaceutical industry, and issues connected with both of these are very common in dealing with  laboratory operations. Given the complexity of QC operations, situations where this is under control is impressive given the criticality relative to drug development processes.

There are regulations to ensure that the products comply with certain standards of safety, efficacy, purity, and stability.  These regulatory inspections are conducted anytime, without warning by the FDA, thus, laboratories must perform regular self-evaluations to ensure they meet the regulatory standards.

Following are several basic elements of a laboratory control system that ensure the production of high-quality products:

1.    The facility
It should be of  the right size and design To function with a good product and personnel flow.
The operators must pay close attention to and permanently monitor airflow, temperature and humidity conditions to ensure all laboratory operations are carried out under a controlled environment.  Work areas must be spotlessly clean at all times.  Test articles must be separated to make sure samples are not contaminated or stressed, as well as not mixed or handled incorrectly.

2.    The equipment
There should be enough space for both existing and  new equipment.  Every piece of equipment must be accurately qualified for its use purpose and  must be regularly calibrated and maintained to ensure that the results are accurate and valid.  Maintenance must be based upon standard operating procedures and manuals.  Equipment with critical status has to be given high priority in relation to preventive maintenance and calibration, and must be  fully qualified and validated.  Other types of equipment may require qualification or validation, depending on their use.

3.    The Validation
Every laboratory process must be qualified & validated; this includes facilities, equipment, analytical methods, and computer programs used to test pharmaceutical products.  Every supplier needs to be audited and qualified And should be part of an approved vendor process.
The validation includes many qualification activities that ensure every process has complied with its pre-determined acceptance criteria.  It has documented testing performed under strictly controlled conditions, confirming a mode of operation that provides a consistent result.  Revalidation is necessary at defined intervals or every time a validated system changes subject to change control review & approval, and calibration is also done as this may change based on use.  Every written procedure must be sufficiently detailed and accurate to make sure that it is operated satisfactorily..

4.    The documentation
This is the way to record how a product is produced, tested, packaged and stored, so, all documentation must be clearly identified and complete.  Every procedure must be clearly documented to ensure controlled use and any implementation of planned changes.  Procedures should reflect the actual practices and must govern the quality and integrity of the data being produced to support the product.  Every change, no matter how small, must be immediately documented.

5.    The laboratory records
These must be current, permanent, legible, accurate, clear, consistent, and complete.  Work that is not documented was never performed.  Records must include the ‘what’ and ‘how’ of the matter, and regular reviews must be performed to assure their accuracy, showing the signatures of those who were responsible for the tasks.  Electronic records must exist as a back up.

6.    The materials and methods
Every single material must be described and verified for quality and acceptability.  The identity and concentration of reagents must be documented and labeled, as well as storage requirements and expiration dates.  All suppliers must be qualified and approved.  If, at any time, a manufacturer can’t supply a specific reagent, equivalent alternates are needed for specific branded products utilized in procedures.  The transfer of materials must be documented as well, and every product has to be identified by proper labels.  Materials and methods have to ensure the product is free from contamination and deterioration.  Reference material must be completely characterized and documented, well-stored, secured, and used during testing.

7.    The training
All personnel must be highly-qualified and experienced to perform the job.  General as well as functional training must be validated.training should include a thorough knowledge of cGMP practices.

8.    The laboratory investigations
These should identify the causes of a problem, and should include initial observations, immediate actions, and correction, to ensure the issue doesn’t happen again.  Where necessary,investigators should dispose of the affected products and issue a formal report on the case.  Future inspections must be performed to check that everything is back to normal.

Be practical and look for the necessary information and advice from a pharmaceutical consultant before you and your image have something to regret.  Better safe than sorry!

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Not too long ago, a bipartisan group of senators in the United States introduced legislation that could spell big problems for the pharmaceutical industry.  The “Pharmaceutical Market Access and Drug Safety Act” is a piece of legislation being pushed through the Senate to immediately reduce drug prices for consumers, which will ultimately force the Bio-Pharma Industry to have to drastically reduce the price of drugs here in the United States.  According to the Congressional Budget committee, this piece of legislation could ultimately save the American consumer upwards to 50 billion dollars over the next decade.  However, some in the pharmaceutical industry are crying foul.

Many pharmaceutical consultancy firms are seeing this as a big headache for the pharmaceutical industry.  They see this move by the federal government as being very poorly timed, as the pharmaceutical industry, which was a booming field for so long, has started to face some major setbacks.  The pharmaceutical industry, already suffering from losses coming from cheaper, generic medicines, doesn’t know if it can take another 50 billion dollar hit over the next ten years.  Along with many important patents expiring in the next few years, and sparsely populated drug pipelines, this measure is causing plenty of headaches in the pharmaceutical industries executive branch.

Another part of the bill, that is getting less publicity, could be even more damaging to the pharmaceutical industry.  The other section of bill outlines a plan that mandates that drugs may be imported to the United States, only if they are imported from FDA approved manufacturing plants.  Now this would sound like a pretty reasonable stipulation, if the United States imported its drugs from a lot of FDA approved manufacturing sites.  But as of right now, only about 1 in every 13 foreign plants are inspected by the FDA, and some fear that in lesser developed countries like India and China, they would face an even tougher time passing inspection.

India and China are some of the fastest growing drug makers on the globe, but they are also some of the least inspected.  There is no doubt that their pharmaceutical industries would be hit hardest by this measure.  However, not everyone feels this measure has enough teeth to really make any substantial change in the quality of imported drugs.  Many critics are citing the lack of oversight in many of these foreign countries, as well as widespread corruption, and doubt that these widespread FDA inspections will really make any impact.

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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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Recently, an international team of researchers based in Texas and Japan, have been experimenting with an obesity treatment nicknamed “Fatostatin”, that has been shown to not only make mice lose weight, but also shows great promise in the treatment of diabetes, and even the lowering of cholesterol.  These scientists have identified a small molecule therapy program that alters the genetic code involved in the way the human body turns food into fat.  Because it has been proven to be effective in dramatic weight loss, and in lowering cholesterol levels, it has been considered to be an efficient treatment in the struggle to treat diabetes.

This Fatostatin drug works to block increases in body weight, fat accumulation, and blood glucose, even with unconstrained food intake.  It is important to note that the only successful tests done so far have only taken place with the use of animal subjects, but the scientists are very optimistic.  They believe this new, experimental drug could have a huge impact, not only in weight loss, but in controlling cholesterol levels, blood glucose levels, and insulin levels in the body, which could be used to treat diabetes.  The scientists believe it goes back to the origin of fat synthesis, where scientists believe they have actually found a way for the body to stop gaining weight.  But is this even possible?

This new Fatostatin drug works by interfering with element binding proteins that influence a group of genes that are triggered during excessive food consumption.  It works by essentially, switching off the body’s negative reaction to food, by turning food directly into energy, or waste, and not stored fat.  After one month of treatment, the mice used in this study have seen a 12% reduction in their body fat levels, as well as a staggering 70% drop in their blood sugar levels.  As promising as this may seem, many obesity drugs, even with prior success on animal test patients, have had little success in humans.  But according to some high ranking pharmaceutical consultants, this drug could be the way of the future for not only fighting obesity, but curing complications to obesity like cholesterol, heart disease and diabetes.

According to some in the bio-tech industry, as well as prominent pharmaceutical consultants, further testing is needed to really find out if Fatostatin is the new miracle drug of the future, or if it’s just a flash in the pan.  But as new technology surfaces in the ever evolving Bio-Tech industry, molecular breakthroughs like this could be commonplace.  As for now, scientists are very excited about Fatostatin and are looking to test it out on humans soon.

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