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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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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Currently, the relationship between doctors and pharmaceutical companies is being examined closely and legislators are looking for ways to regulate it, given the medical profession and the pharma industry’s complete failure in doing so themselves.  Up to now, the reliable and comprehensive information regarding the nature of the pharma industry sponsorship of doctors has been uncommon, thus, the US Congress is looking for ways to reveal the nature of their relationships.

Australia was one of the first countries to establish a code for greater transparency.  Australia’s pharmaceutical industry representative body, Medicines Australia, has a self-regulatory Code of Conduct that establishes the standards for ethical marketing and promotion of the products of its member companies.  Even though Australia is a good example of the path to follow, its disclosure requirements are not enough.

Australia’s code centers on monitoring the level and type of sponsorship of educational events instead of on documenting the monetary value of gifts and other payments to physicians.  In addition, it doesn’t encompass information about the educational value of sponsored events.  In the U.S., the disclosure has to dig deeper.

Medicines Australia’s information shows a high level of contact between pharma manufacturers and doctors, and suggests that companies generally do influence the educational content of events that are attended by doctors in training.  Students may be easily influenced; they are led to believe that certain pharmaceutical companies are the best for their medical field.  It has been proven that the attendance to these events changes the prescribing practices, and that it is highly affordable to sponsor such events, which provide a high return on investment.

It is necessary to observe the broader view of the interactions between the pharma industry and doctors, including face-to-face contact with representatives, advertising in medical journals, consultancies, membership to advisory boards, and stock holding.  Extravagant gifts and travel aid have been the center of attention in the past; however, these have been inhibited by the industry and professional codes.  Now we are seeing that regular, more modest, sponsored events may become more influential, and the main point of contact between pharma and doctors.

The Australian information is quite difficult to access.  Summary reports listing each function should be easily accessible to the public in a searchable, downloadable, and analyzable format.

Here is a list of the elements that should be included in every effective disclosure program for the pharmaceutical industry in line with the recent Institute of Medicine Report on conflicts of interest:

-    Number of attendees to an sponsored event and their professional status

-    Venue and description of the function

-    Nature of any hospitality provided

-    Total cost of hospitality and the function

-    Nature of any entertainment provided

-    Duration of the educational content of events

-    Continuing professional development and medical education points provided

-    Nature of any gifts provided

-    Names of the speakers

-    Dollar value of honoraria and travel aid provided to speakers

-    Disclosure of other financial ties between sponsoring companies and speakers

-    Role of the company in suggesting or selecting the educational topic and speaker

-    Brand names of drugs discussed in the event

As pharmaceutical consulting firms will argue, the intention is not to ban contact between pharma companies and doctors but make their relationship transparent and legitimate, in the best interest of the patient.

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Pharmaceutical companies have to develop a leadership approach to effectively deal with today’s confusing business climate, while at the same time address and rise above any cultural differences that could limit the value of development.

Nowadays, leadership is the key to maintaining competitive advantage in the market, thus, pharma companies must center on developing leaders to face the coming global challenges.

Even though a group of leaders from different regions may think they have reached an agreement, the cultural differences in language, meaning, and context, may influence everyone’s understanding of the commitment involved in completely different ways.  In order to get positive results across different cultural environments and avoid waste, there are 6 crucial principles that every pharma company must enforce:

1.    Be clear about why its important to forge leaders
Every leadership effort has to have clarity about its purpose; however, in the global arena, it is vital, in order to protect resources, create rapid change, and ensure perfect focus.

2.    Use customer input to guide leadership development
The rule now is to pay attention to what the customer expects and demands in regards to better service and high quality products.  There is competition rising from places we never imagined, and the way we communicate is being drastically transformed by technology, thus, leadership development has to offer the skills and capacities to help a company excel in this highly competitive, global market.  The easiest way to make this happen is to closely observe the customers from every country a company serves and to include this data in the leadership development program.

3.    Involve the line
The leadership development design process must involve the people it is directed towards, in order to encourage ownership of the program and the results.  This will also help develop solutions to problems that arise due to differences between several markets.  Leadership development design and implementation only succeeds globally when it helps people improve performance in a highly competitive world.

4.    Find the way to go global
In order to be global, a program must offer solutions that work across cultural and geographic settings.  Global initiatives work best if they represent a ‘neutral’ way, instead of one or the other culture’s way.  Just as with the American culture, other cultures may be strongly biased towards their ways, thus, it is necessary to find a consistent way across boundaries while at the same time allowing for local preferences.  Also important is to maintain key communication points in mind as markets globalize, organizations grow, and employees move to virtual teams:

-    Cultural dynamics.  Pay attention to the interaction of different communities in virtual teams and the linguistic value inspired, as well as behavioral problems that may arise.

-    Changed working conditions.  In order to synchronize global communication, there may have to be some compromise in terms of standard working practices.

-    Awareness.  Some employees may not realize they are a part of a virtual team, requiring training in new ways to work.

-    Project phases.  Employees have to be trained in which communication channels work best for different projects and their phases.

-    Roles and responsibilities.  Team members must recognize the skills, strengths, and weaknesses of everyone in the group.

-    Quick fixes.  In virtual teams it is easy to intensify minor problems because of the lack of human context, causing blockages in the process, thus, communication breakdowns must be solved fast.

5.    Build globally, adapt locally
The global basis must be clearly defined, this is, the fundamental concepts that should have the same meaning no matter where you are, and the use of local examples and methods to help trainees find a way to apply what they learned.

6.    Get sponsors that deliver
Sponsors at headquarters and each level of management must be enrolled and committed to the leadership program in order to deal effectively with variables like distance, time, language, and culture, otherwise, the focus and importance of the initiative could be lost across borders.

Pharmaceutical consulting firms are there to help pharma companies understand how leadership development must move to a completely new global perspective in order to keep competitive advantage under the new global equation.

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Very recently, Pfizer had to pay the highest amount ever, more than $2 billion dollars, to settle civil and criminal allegations in regards to federal violations ruling drug sales.  This pharmaceutical giant was accused of promoting the painkiller Bextra and three other drugs illegally, because it offered doctors benefits such as speaking fees and trips to resorts.

Although it is an important monetary amount, the price that Pfizer will pay indirectly due to lost shareholder value will be huge and more important than the dollar value.

A new research called “Regulatory Exposure of Deceptive Marketing and Its Impact on Firm Value” has put a price on the intangible costs a company has to pay when employing these dark marketing practices.  In order to do this, the research studies the declines in the financial market value of pharmaceutical companies that have been accused of dishonest marketing by the FDA.

In this case the amount Pfizer had to pay drew attention to the risks of employing deceptive marketing campaigns and served as an example to other pharmaceutical companies
.  It is possible that this outcome may help the industry by restoring some credibility towards pharmaceutical companies, which may effect the market value in the longer term.
This case is a  prime example  to illustrate how the FDA and the Justice Department are watching the industry with a view to protecting consumer interests.

The research recognizes that most marketing managers and researchers concentrate in finding ways to increase shareholder value instead of thinking about the consequences of dishonest marketing, which could end up costing much more.  Instead of focusing on value creation, this study evaluates marketing from a value destruction point of view.

The study states that pharmaceutical companies have been spending money on promotion at an annual growth rate of 10.6% since 1996, reaching $3 billion in 2005, and that since 1997, when the FDA allowed for direct costumer marketing, the average annual growth has been of 14.3%.  Merck, for example, in the year 2000, spent more on Vioxx than was spent on the megabrands Budweiser and Pepsi.

The reason why pharma companies invest so much on marketing is because R&D is not delivering enough new products. However, the question the authors ask is whether or not the punishment the industry is receiving is sufficient to discourage  dishonest practices?

In the case of this example it would seem so.
A comparison of the  stock prices before and after the exposure, resulted in important negative returns: a 1% drop in market value/$1 billion loss of shareholder value.

The indirect costs of negative events can really harm a company’s market value and will eventually lead to sharp investor’ response.

Three types of dishonesty were defined:

-    Omission of risk information
-    Effectiveness claims without support
-    Superiority claims without support

The level of value lost due to one or another varies, however it was found that in cases where  the less capable of understanding medical treatments and more vulnerable populations were the victims, the market consequences were worse.

The authors recognize that even though the FDA could catch dishonest companies, many may gain lots of added value from deceiving marketing practices before being caught.  In fact, many think the risk is worth it, since advertising has grown around 270% and the number of citations has decreased around 85%.  This makes pharma companies believe that the gamble may well be worth the risk.

Life sciences consulting firms strive to help companies be their best in an honest and responsible way.  Find someone who can really help your company succeed without sacrificing others’ lives, your personal integrity and your company’s reputation.

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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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The answer to this question is simple: pay more attention to innovation and not so much to marketing.

Even though big pharma has developed big mergers to support its business infrastructure and best-selling products, it still hasn’t found a solution for the need to develop new business models to address its main problem: the inability  to create unique treatments.

Today, big pharma is suffering due to dry product pipelines, the gruesome competition of generic manufacturers, consumer worries about safety, marketing statements that are not true, and the threat of the government’s increasing role on the purchasing and pricing of drugs.

The healthcare reform has been at the center of the public eye, but drug companies have remained in the background.  In return for promising the Obama administration they would contribute $80 billion in savings to aid in the financing of the proposed reform, the industry’s basic pricing structure would not be touched by the restructuring.  Basically, they avoided the hit and are low in profit growth; nevertheless they are lucky because there are many people in Congress that want to hit them harder.

By expanding the coverage to more than 40 million people that are not insured, the industry will gain a larger customer base and the profit growth would mean pure profit since the cost of creating a medicine is not based in the drugs production but in the research that goes into discovering a new medicine.  Eventually, there could be government demands on pricing, and the launch of new products will be subject to more inspection based on cost through public insurance or exchanges. With all these changes going on, it is certain that the drug industry will be closely regulated after the reform is approved.

Marketing practices are also being inspected at state and federal levels.  The states are tightly restricting the way in which drug marketers relate to doctors. They are putting limits to the gifts and other ways they used to stimulate the prescription of one drug over another.  The states are working on establishing programs where educators, with no specific economical interest, will visit the doctors to keep them informed about new treatments.  We are seeing much more monitoring of direct advertising to the customers due to safety problems.

Also, the generic drug threat is hanging over the pharmaceutical industry.  The generic drug industry is becoming more sophisticated in its efforts to create generic versions of a drug once its patent expires, to the extent that some pharmaceutical companies are thinking about getting into the generic field.

Clearly, there are new ideas being born that could create a meaningful change for the industry, like the fact that pharmaceutical companies are joining forces with biotech companies to create more sophisticated biologically based drugs and products Which may be easier to protect.  Biotech companies are small operations based on science, making them more groundbreaking than the traditional big companies.  In fact, in the next 10 years, large companies will invest more in small research-based operations for new  products, and will reduce or redirect expenditures on centrally based R&D and marketing..

Life sciences consulting firms agree that pharmaceutical companies should start emphasizing the comparative effectiveness of one drug over others for a specific treatment through the use of clinical trials and government approvals, even in the face of the risks this poses.  By keeping up with the actual marketing strategy, companies will only strengthen the already growing customer distrust.  Instead of fearing comparative effectiveness, companies should understand it and use it rationally; their focus should be innovation.

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As the Global economy continues to deteriorate in many parts of the world, the same can’t be said about the booming pharmaceutical industry.  According to researchandmarkets.com the global pharmaceutical market is expected to earn well over one trillion dollars in revenues by the end of 2011.  This forecast is based on many growing trends, which seem to not be affected by the global economic crisis of the past few years.  Some of these trends include the growth of developing pharmaceutical markets in emerging markets, strong growth in bio-tech based drugs, as well as a large increase in the prevalence of generic medicine.  But what other factors are contributing to this large boost in the pharmaceutical sector?

Some of the key research findings researchandmarkets.com found in their report are very conclusive.  With a Compound Annual Growth Rate (CAGR) growing at almost 8% per year, the pharmaceutical industry is one of the fastest growing industries in the global marketplace.  If the CAGR continues to grow at this pace, the global pharmaceutical market is expected to reach upwards to 1045 Billion in 2012.  Other research findings tell the same story.  The report also credits the growth in previously untapped markets, the Asia Pacific market like India and China, as being one of the most lucrative pharmaceutical markets of the future.  The report also credits the recent growth in Latin American markets, such as Mexico and Brazil, as being key players in the pharmaceutical industry, over the next 20 years.

Many pharmaceutical consulting firms are suggesting many other global trends that are factoring into this large boost in the pharmaceutical industry.  Some of these factors include growing market size, favorable government policies, expanding health coverage, and new developments in drug developing technology, just to name a few.  However, not everyone in the industry is convinced this unprecedented growth will sustain itself for much longer.

Many life sciences consulting firms are pointing out, that as patents held to key drugs begin to expire in the next ten years, it could hurt the growth of the North American pharmaceutical market.  Coupled with the growing prevalence of generic drugs all over the world, as well as dwindling drug pipelines, and the development of less blockbuster drugs and less and less economic cooperation, these factors may challenge the growth of the global marketplace in times to come.  Only time will tell.

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