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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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).

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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The biggest health care reform act since Medicare was created in 1965 has just been signed by the President– amidst more controversy than any bill passed in the last twenty years.  How will this affect the pharmaceutical industry?

This bill is estimated to carry a $940B price tag, but will insure an additional 32M Americans by 2019.  However, it does include hefty taxes – over $70B, and HMOs.   Insurance companies won’t be able to deny new customers based on pre-existing conditions, and companies with over 200 workers will have to automatically enroll employees in some form of insurance coverage.

Although government subsidies for the uninsured won’t kick in until 2014, costs will be incurred almost immediately, which is why many have opposed this plan.  Cuts in Medicare will also be used to partially fund the bill, and this is causing concern in certain quarters as Medicare is considered to be a  “sacred cow” to many.

Although many are questioning the effect this will have on the development of new medicines, pharmaceutical companies large and small are expected to be the big winners in the end, as many more people will be insured and able to afford life-saving medications, new treatments, and maintenance medications that would have been simply too expensive for them before this legislation was enacted.

Democratic leaders are claiming that whenever a business sector gains a larger customer base, it wins!  Obama Care is no exception to this rule, as many more children and elderly will gain coverage which will increase the number of prescriptions for medicines and other health care services.

The amount of money, time and energy spent by Big Pharma in promoting this bill has left the American public suspicious and a bit cynical about industry intentions.  Will this tarnish industry perceptions?  Most informed industry observers believe that the industry won’t be in any worse shape than it suffered during the Clinton era when scrutiny was very high, or more recently when the sector came under significant criticism for  huge profits during the period of economic corrections

As pharmaceutical consulting firms point out, patents have expired, and generic availability has increased, meaning the industry has been forced to become more “lean and mean”. in its approach to generating revenues.

This bill hits the industry with over $10B in increased taxes to pay for the expanded insurance coverage promised.  This is probably going to offset at least some of the gains made as a result of having a larger available customer base.  And it has been argued that more expensive, and controversial treatments that would have led to miracle cures, saved lives and higher profit margins will be slower to reach the market under this plan.

Given the length of time it will take to create insurance coverage for these millions of Americans who stand to benefit under the bill, it will take some time before the expected benefits will accrue.  In the meantime, we can expect the pharmaceutical giants to continue their consolidation by purchasing smaller companies, expansion into new and emerging markets, and lobbying for greater protection from cheap, foreign-made “knock-off” drugs that are dangerous to both patients and branded drugs profit margins.

We can also expect the Obama Care controversy to persist long after the ink has dried on the signed legislation, as opponents protest over loss of freedoms, and proponents rejoice at the expansion of coverage.  We can only hope that the promised benefits actually happen, and are not watered down by amendments that are almost certain to follow.

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REMS is a recent and emerging regulatory requirement for all pharmaceutical companies, whereby the FDA expects these companies to monitor, submit plans, and proactively manage any and all safety risks in the sphere of their companies’ operations.  REMS stands for Risk Evaluation and Mitigation Strategy required for pharmaceutical and biotechnological companies.  Common REMS issues include drugs with abuse potential, risk of Qtc prolongation, drug-drug interactions, drugs with the risk of hepatotoxictiy, just to name a few.  These risk management programs may also include elements to assure safe use, a proper implementation strategy, assessment tools, and a clear timetable for the submission of assessments.

A REMS report is required for any pharmaceutical and biotechnological company that has been notified during an FDA review, that their products will require preliminary safety testings, because of stricter FDA safety concerns.  Simply stated, REMS testing is the method in which the FDA will balance expedited approval for new beneficial drugs, against the potential serious side effects that might occur from the drug once they are widely distributed.  REMS testing can range from periodic assessments of different products post marketing safety profile, to limits on prescribing the drug, to a complete removal of the drug from the marketplace.

Because of recent safety concerns from possibly dangerous drugs such as Accutane, some industry experts, including many pharmaceutical consultants, foresee that in the not too distant future, almost every single approved product will have some form of REMS testing or another.  Because of more public awareness about possibly dangerous drugs being widely distributed, many public safety groups, as well as the federal government are starting to question whether a package insert containing important safety information is enough to ensure public health.  Many feel that additional safety measures need to be taken.

There are a number of different conditions in which a risk evaluation may be required.  One of the most common circumstances is when new safety information becomes available about a drug that might result in further testing of the drug’s overall safety.  The FDA might also require that if a group of medications all have the same risk, then those from that same drug class be tested as well.  The FDA may also require a risk evaluation test on new medications if there is any concern about any potential side effects.  New safety information may be defined as any information that might be derived from a clinical trial, adverse event reports, post approval studies, or any other scientific information that may have emerged.

If your pharmaceutical company is expecting a REMS review, the most important thing you can do is to develop a strong REMS strategy to counter your upcoming inspection.  The best way to do this is to contact a pharmaceutical consultancy firm that specializes in preparing pharmaceutical companies for REMS inspections just like these.  They can help to give you the knowledge and the confidence to take any REMS inspection head on.

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FTC Commissioner J. Thomas Rosch will speak about the three main areas of antitrust concern for pharma manufacturers, at ACI’s 5th Annual In-House Counsel Forum on Pharmaceutical Antitrust, to take place at the Helmsley Park Lane Hotel in New York City on February 17th and 18th, 2010.

The three areas he will cover are:

-    Reverse settlement payments
-    Authorized genetics
-    Pharmaceutical mergers

In past months, a consensus position by DOJ and the FTC has been noticed on antitrust matters.  In fact, DOJ took back its previous position on reverse settlement agreements, and currently, both organizations consider these agreements anticompetitive.  There is pending legislation that could define, by itself, a prohibition on these agreements if several circumstances are not present.  This shows that the Congress is supporting the antitrust efforts of both organizations in the pharma industry.  Moreover, the European Commission’s Directorate General’s Pharmaceutical Sector Inquiry report adds a more global scope to this dense field.

The Director of the FTC’s Bureau of Competition, Richard Feinstein, along with FTC attorneys Markus Meier, Assistant Director of the Health Care Division, and Michael Moiseyev, Assistant Director of the Mergers l Division, will speak at this event, which is recognized as the place where the leading antitrust authorities meet every year to discuss their upcoming enforcement plans.  Also participating will be Philip Weiser, Deputy Assistant Attorney General from the DOJ’s Antitrust Division, and Harald Mische, member of the EC’s DG Competition’s Pharmaceutical Task Force.

Sunsieray McCall, ACI’s Senior Conference Producer, recalls that the attendance of antitrust enforcers from both the U.S. and EU will offer this conference’s attendees a deep understanding of antitrust priorities under a new global enforcement system.

If you want to know more about ACI’s 5th Annual In-House Counsel Forum on Pharmaceutical Antitrust, contact your life sciences consulting firm, visit American Conference/ PharmaAntitrust, or contact Sunsieray McCall directly at s.mccall@americanconference.com or at the phone number 212-352-3220, ext. 498.

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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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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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