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

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

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

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

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

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

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

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

The mobile industry is also helping Big pharma grow in ways we previously had never imagined.  Mobile phones help sales reps and marketing reps by helping them to access more information on their handheld devices.  This makes their business visits far more effective, and also saves them time and energy.  Mobile technology also helps the R&D process run more efficiently and is proving to be more cost effective.  Because mobile solutions allow data to be collected at a much faster rate, this allows raw data to be collected exponentially faster during clinical trials.  As a result, protocol violations are reduced, and it also speeds up the time it takes for life-saving drugs to be launched into the marketplace.

As mobile technology evolves, many experts in the pharmaceutical industry such as pharmaceutical consultancy firms, and pharmaceutical executives believe this marriage will only get stronger in the foreseeable future.  As mobile companies continue to introduce more powerful tech savy software for handheld mobile devices, it will not only make many jobs in the pharmaceutical industry, such as sales reps and researchers, easier, but also allow for further unprecedented growth in the industry at large.  As mobile technology continues to open up new doors for many in the pharmaceutical industry, many are extremely excited to see what this mobile future will bring.

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The Lean manufacturing approach has worked for countless companies in the redesign of their business operations to minimize waste and cut costs through variations of process repetition.  Some might argue that these Lean manufacturing principles have been used most successfully in recent years by the pharmaceutical industry.  Basic Lean applications in the pharmaceutical industry up until this point have been focused on factory-based pharmaceutical manufacturing concepts and cost effectiveness.  But what will the Lean approach be in the ever evolving pharmaceutical world of the 21st century, and what innovative role will it play in directing companies towards less waste and more productivity?

Lean manufacturing principles go hand in hand with the pharmaceutical industry because they both rely on the principle of manufacturing thousands of batches of product with minimal variation, at the lowest possible price.  By determining out the most cost-effective way to develop a product, reducing as much waste as possible, the savings that accrew forin an industry as large as the pharmaceutical industry can be quite significant.  But as we move into an ever evolving technological world, what role will Lean strategies have in the 21st century pharmaceutical industry?

In the Lean manufacturing environment of the 21st century, pharmaceutical companies will not only run efficiently, but hyper-efficiently in every possible way.  With developing technology, and ever mindful waste reduction methods, the Lean laboratory of the future, will be quite different from what it is today.  In the future world of Lean manufacturing, every customer-supplier connection will be as direct as possible, with little opportunity for process confusion.to no ambiguity.  With technology such as emails, instant messaging, and social networks, there is little doubt that customers might soon be speaking directly to their drug manufacturers about product information, instead of their doctors or other medical professionals.

Also, in the Lean pharmaceutical environment of the 21st century, there is little doubt that cycle time reduction and quality will both increase dramatically.  Because cycle time is often quality driven, it is not uncommon for it to take longer to release a batch of drug products, than it takes to produce them.  Even with current Lean concepts in place, longer cycle times can disrupt the flow of the whole product itself.  In the future, however, there is no doubt that cycle time and quality will both be improved dramatically, ensuring higher quality products, with less production time for the company.Quality enhancing technologies such as PAT (Process Analytical technology), strategies will clearly play an important role in this LEAN approach.

Until recently, many in the pharmaceutical industry have been apprehensive in the adoption of Lean principles into their companies, even though they have shown great success in other industries.  These fears stem from a concern that a Lean manufacturing approach will cut down on the quality control of a product, resulting in lower quality products, which may result in lawsuits or non FDA approval.  But as more companies in the pharmaceutical industry begin to use Lean strategy with great success, many in the field are optimistic of its effectiveness in the future.

If your pharmaceutical company is looking to apply Lean strategies to your business, then contact a pharmaceutical consultancy firm that specializes in Lean business strategies.

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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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It has been proven through an FDA-approved clinical trial that treating heart attack patients with adult stem cells is safe and seems to repair damaged heart tissue.  The results of this study, which was conducted by Joshua M. Hare, M.D. and director of the Interdisciplinary Stem Cell Institute at the University of Miami Miller School of Medicine, and sponsored by Osiris Therapeutics of Columbia, Maryland, were published in the December 8th issue of the Journal of the American College of Cardiology.

The first phase of the trial intended to prove the safety and efficacy of injecting a formulation of adult mesenchymal stem cells, Prochymal, in patients right after they suffered a heart attack, to diminish the damage to the heart muscle.  The sample consisted of 53 patients who had suffered a heart attack between one to ten days before.  They were randomized to one of three doses of stem cells, each dose compared with placebo.  After six months, researchers analyzed the serious side effects that were related to the treatment and used echocardiography to measure the efficacy.

The study discovered that the patients treated with stem cells presented fewer side effects like cardiac arrhythmias and showed important improvements in their heart, lung, and global functions.  According to Dr. Hare, the echocardiography showed better heart function, especially in patients with lots of cardiac damage.  Up to date, damaged cardiac tissue cannot be repaired through any known scientific method, and close to a million United States’ citizens suffer heart attacks each year.

These results will put to rest some of the discussions in regards to clinical stem cell research for heart disease.  Although many think that it is too soon to test stem cells in patients, this study has proven the value of exact and controlled clinical trials. In doing so, it also establishes the basis for the development of novel cell heart therapies.

Many believe that this trial acts as a key point of reference for the advancement of these types of approaches. There are several advantages to mesenchymal stem cells as cell-based therapy; among these are:

-    Can be taken from donors that are genetically different
-    Are easy to prepare
-    Tend to gather around injured spots

It is certainly exciting to imagine what is ahead.  Each study will provide new information, new teachings, and new possibilities for the use of adult stem cell therapies to treat cardiac patients.

Contact your pharmaceutical consultancy firm for more information on stem cell research and the promising future it presents.

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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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From 2008 until 2023 there will be an improvement in vaccines, and their sale and use will experience a rebirth.  Vaccines will be one of the fastest growing areas of the pharmaceutical industry, and their profits will increase by the hundreds in percentage terms during this period.

The Global Vaccines Market, 2008-2023, is a report that describes the market trends in a qualitative and quantitative manner.  Vaccines have grown in importance in developed as well as developing countries because of the current epidemic patterns and healthcare needs.

The most important reason for the growth of vaccines is that they are extremely cost effective in fighting disease, thus, governments and private health providers will increasingly encourage their use.

There is increased awareness now in terms of  the benefits of preventive medicine relative to  the better quality of life and reduction of healthcare costs for consumers, and the vaccine industry is answering the call with new products, and making full use of the technological advances in biotechnology.  There is a lot of potential in this area, as much for therapeutics innovation as commercial return..  Currently, there are more than 1000 vaccine candidates in research and development around the world.

Therapeutic vaccines are different from the vaccines currently on the market.  These not only prevent infection, but work with the body’s immune system to fight disease and disorders, including cancer, addiction, and allergies.

The Global Vaccines Market report focuses on these aspects within the field of vaccines:

-    Sales projections for vaccines by disease area, brand and country, including new therapeutic vaccines

-    Analysis of strengths, weaknesses, opportunities, and threats in regards to the vaccine industry

-    Expert opinion from key leaders in the field

-    In-depth analysis of the vaccine pipeline

-    Analysis of the prospects for therapeutic vaccines

-    Geographical division of the vaccine market, including the leading emerging markets of China and India

-    Coverage of future trends in vaccine technology, formulation, and manufacturing

-    Identification of crucial industrial players in the vaccines market

This report gives a comprehensive analysis of the vaccines market using only primary and secondary research, and it includes full transcripts of interviews, company reports, filings, and industry databases.

This report, along with pharmaceutical consultancy, could mean the difference for the success of your business in the years to come.

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LIMS (Laboratory Information Management System) is becoming more and more crucial to ensure quality control and assurance in laboratories, because most analytical activities within a modern lab work to support the process control function, and QC is vital for that.

Currently, advances in IT and LIMS products are simplifying QA/QC through the computerization of: data entry from instrumentation, test result data specification review, assignment of lab activities and workload, and management analysis and reporting.

LIMS offers many advantages to the lab when trying to reinforce QA/QC controls such as:

-    Personnel qualification and training
-    Labeling, storage, and expiry of reagents, solutions and hazardous chemicals
-    Equipment documentation, calibration and validation
-    Integration of lab instruments and systems
-    Labeling and tracking of samples
-    Standard operating procedures and their use
-    Analytical method validation and documentation
-    Computer software validation
-    Records of deviations from lab procedures
-    Determination of the right QC controls, which deal with the daily quality of analytical data developed

LIMS can define specific lab personnel and their particular working environment, defining the activities they can perform and information they can access.  It offers a way to allow users to be approved to do certain functions, and the access can be limited to the information each user requires to do their job.  LIMS also computerizes the production of bar code labels when a sample is logged in, and permits the definition of storage information, like location and storage conditions, against the logged in sample.

LIMS allows for the tracking of instruments, systems, and equipment used in the lab.  It can be programmed to automatically flag and remove from operation the instruments that need regular service and calibration.  After analytical methods are defined in it, LIMS allows for the storage of the whole method description against its entry.  Each method can be programmed to show changes through time and to ensure that only the latest method is used.  Review and approval by different persons can be required before using the method.

LIMS can identify deviations in work practice and analytical data for tracking and reporting purposes.  It allows users to easily record and deal with unexpected events that inexorably happen in a lab, like sample breakage.  It can be merged will all principal instrument types in the laboratory to process results faster and to reduce errors in manual transcriptions.  LIMS has audit trailing mechanisms to record, track, and justify changes in lab data, and some even allow for the auditing of any item and the automatic sending of notifications to key individuals.

It is vital to ensure that the electronic data submitted to regulatory agencies is trustworthy, reliable, authentic and legal.  In order to comply with the 21 CFR Part 11 rule, LIMS has to provide a way to specify identification of regulatory data with the lab, audit trail mechanisms for regulatory data, security controls on the data, and mechanisms for signing electronically the regulatory data entries. This has promoted the cooperation of LIMS vendors and pharma companies to develop solutions that fully comply with this rule.

These are only some of the characteristics of LIMS that can help laboratories control and analyze data; there are many others. However, although LIMS offers a computerized secure framework for inputting, processing, and reporting information, as well as an important contribution for labs to comply with the changing regulatory requirements, it is only a part of the solution.  Pharmaceutical consultancy firms reinforce the fact that there must also be a thorough knowledge of the regulatory requirements and comprehensive QA/QC procedures.

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As the debate on whether to use stem cells, or not to use stem cells continues to rage, many people are starting to look to the potential upside of using stem cells as a deciding factor.  Stem cells have remarkable potential to be used to test new drugs, cure previously thought of as incurable diseases, and possibly cure many different types of cancer.  But the application of stem cell research has caused a heated debate over the last 20 years, and much of stem cell research was illegal until only recently.  So what are the reasons for this heated debate about stem cell research, and what are the possible applications of stem cells in the future.

You may wonder why there is any debate at all, over a medical treatment method, which may be able to cure some diseases that 20 years ago were thought of as altogether incurable.  But, as it often is, the discussion is much more complicated than it seems.  At the heart of the stem cell debate is the battle over abortion.  According to many opponents of stem cell research, using living stem cell tissue, usually from living embryos, is likened to abortion, since the embryo will be destroyed after testing.  On the other side of the argument, stem cells hold great promise for millions of families and patients thorough out the world, to cure previously incurable diseases such as Parkinson’s disease, Alzheimer’s disease, and even some forms of cancer.  But what exactly are stem cells, and how can they be used to cure diseases?

Stem cells are found all over our body in differentiated tissue and organ cells.  Stem cells are primarily used in the body to maintain and repair tissue cells, and only divide and repair when needed in case of disease or injury.  Stem cells can be found in bone marrow, brain cells, skeletal cells, blood vessels, even teeth.  Only until recently, scientists have been able to reprogram living stem cells, which provides very promising treatment options for the future.  By being able to reprogram adult stem cells the treatment of serious diseases such as cancer, and even curing blindness, are now thought to be within reach.  Even pharmaceutical firms and pharmaceutical consultancy firms are even coming out openly saying that the application of stem cells to cure disease is a real possibility and needs to be further examined.

However, there may be compromises available that will help stem cell research to move forward and into practical use.  Another method of extracting stem cells is through the process of taking adult stem cells from living blood or organs of healthy adults.  This would end the abortion issue about stem cells, and help research to move forward.  The only problem with this method is that many scientists are finding adult stem cells to be marginally helpful to scientists, and do not show the same promise as using living embryos.

Regardless of the debate over stem cell research, the practical usage of stem cells could ultimately be revolutionary in the field of medicine.  Stem cells could be used to test new drugs, they would allow for a wider range of drug testing for all kinds of drugs, including anti-tumor drugs in cancer cases.  They can be used to regenerate damaged cell tissue or even completely replace damaged tissue in the body.  It could help in the treatment, or possibly cure such diseases as Alzheimer’s disease, Crohn’s disease, diabetes, strokes, spinal cord injuries, severe burns, and heart disease.  Only time will tell what the future use of stem cells will bring to our society as a whole, but at this point many are seeing the possible, future benefit of using stem cells, outweighing any negative stigma regarding stem cell research.

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In preparation of a developing pandemic of any kind, whether it be influenza, or some other kind of fast spreading virus, the Food and Drug Administration (FDA) has devised a precautionary plan known as the FDA Pandemic Preparedness Strategic Plan.  The FDA Pandemic Preparedness Strategic Plan is coordinated with the President’s National Strategy for Pandemic Outbreaks, as well the CDC’s Pandemic Implementation Plan.  Under these guidelines the FDA works under federal and local levels to effectively contain a pandemic outbreak, if possible, and do whatever is in their power to minimize the harmful effects of an outbreak.  But what is the FDA’s Pandemic Preparedness Strategic Plan, and what does it mean to a normal citizen, like me or you?

The FDA Pandemic Preparedness Strategic Plan is a plan strategically shaped to coordinate Federal, State, and local levels of government, to work together to prepare for, and ultimately minimize the effects of a pandemic outbreak, such as the Influenza outbreak of 1918, or the recent pandemic, known as the Swine Flu.  The plan involves coordinating federal and local authorities to develop enough domestic vaccine production capacity, sufficient to provide enough vaccines to accommodate for the entire U.S. population.  The FDA would make sure that the vaccines developed are safe and effective enough to give to the population as a whole, as well as providing cross-protective immunity.

The FDA’s Pandemic Preparedness Plan also relies on the availability of improved diagnostic devices, which can be readily available, and can also detect pandemic viruses, as well as differentiate between seasonal viruses, and viruses that have pandemic potential.  This differentiation is important for not only effective patient management, but for effective pandemic preparedness and response.  The FDA will provide proper guidance to the use of the point-of-care tests, in both pre pandemic, and post pandemic phases.

However, some critics have their doubts on whether this plan can actually be fully implemented in an effective manner in case of an actual pandemic emergency event.  Critics are using such emergencies like the aftermath of Hurricane Katrina, as a catalyst of doubt, that the government can effectively handle and control a national crisis.  They are also using other national emergencies such as the terrorist events of 9-11, to point out an example of the lack of coordination between Federal and State authorities in case of a widespread emergency.  Because of these widespread doubts many citizens are taking matters into their own hands, and getting flu vaccinations on their own.

But is this FDA Preparedness Plan actually a viable option response to a real viral pandemic? Many have their doubts.  One of the major doubts people are having is whether the FDA can effectively create enough vaccines to have a real impact on a pandemic outbreak, if one were to break out unexpectedly.  The pharmaceutical industry, as well as many life sciences consulting firms, are having their doubts as well.  Upon witnessing the recent shortage of H1N1 flu vaccines, the pharmaceutical industry as a whole doubts that the FDA could effectively coordinate the mass amounts of vaccines need to quell a real pandemic outbreak.  Only time will tell, but the FDA stands firmly behind their Preparedness Response Program, and stands by its claims that it is ready for anything.

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