Tag-Archive for » life sciences consulting «

Thursday, January 28th, 2010 | Author: admin

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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Thursday, January 21st, 2010 | Author: admin

Researchers from the Hebrew University of Jerusalem have developed a new stem cell technology to aid in the better and faster healing of complicated bone fractures.

This technology, which involves the isolation of stem cells from the bone marrow, has been already used successfully in the treatment of severe fractures in seven patients at the Hadassah University Hospital in Jerusalem.

Up to today, the standard treatment in clinical orthopedics for serious bone loss has encompassed basically two options: amputation or long periods of disability.  Equally, prosthetic implants have proven inefficient in the long term.  When there is too much loss of bone, the fracture may not heal, and this is the case of more than a million people per year, just in the United States.

In the last years, there have been promising advances for biological therapy to treat complicated fractures and skeleton disorders, specifically by using mesenchymal or multipotent stem cells (MSC’s), which can differentiate between various cell types.  These cells are unique adult stem cells that can be rapidly isolated from various places in the body, mainly bone marrow and fat tissues, and used to repair different injured tissues like bone, cartilage, tendons, intervertebral discs, and even heart muscle.

The way in which MSC isolation is normally conducted is lengthy, expensive, and also harmful to the healing quality of the cells, because it requires long periods of growth inside incubators.  It was urgent to find a way that would allow for the immediate use of stem cells; the regenerative medicine field was begging for one, and the Hebrew University heard them.

The technology this group developed is called immuno-isolation.  Basically, MSC’s are sorted out in a bone marrow sample by using a specific antibody.  It was proven that this technique made it possible to immediately use the cells to create new bone tissue in lab animals.  After this discovery, several scientists from different interested parties joined forces to establish a clinical-grade protocol for the use of immuno-isolated MSC’s.

The head of orthopedics at Hadassah University Hospital, the Good Manufacturing Practice facility at Hadassah, and the Gazit group at the Faculty of Dental Medicine, conducted a clinical trial in order to establish the foundation for the use of immuno-isolated MSC’s in orthopedic surgery.

Seven patients have benefited so far from the treatment of combining their own immuno-isolated MSC’s and blood products.  The procedure lasted a few hours and didn’t require the growing of cells in a lab.

This success is expected to touch other skeleton injuries, like degenerated intervertebral disks and torn tendons.  It is expected that this treatment will help tackle morbidity in patients with skeletal fractures and diseases, and will help re-establish function and quality of life for many people.

In hopes of making this technology available to many more, the university has licensed the immuno-isolation technology to TheraCell Inc. in California since July 2009.  This organization will develop and commercialize this technology thoroughly for advanced regenerative medical purposes, like spinal fusion.

The mission of life sciences consulting firms is to help pharmaceutical companies land opportunities like this one, where they are able to change lives for the better, showing care and respect for patients in need, while staying at the head of innovation.

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Tuesday, December 29th, 2009 | Author: admin

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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Saturday, December 26th, 2009 | Author: admin

Here is a really useful link for the FDA’s Training and Continuing Education Courses.  This is the web page for educational tutorials offered by the Center for Drug Evaluation and Research. CDER’s primary mission is to make certain that safe and effective drugs are available to the American people:

http://www.fda.gov/Training/ForHealthProfessionals/default.htm

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Saturday, December 26th, 2009 | Author: admin

There are many factors affecting small biotech companies today; however, liquidity takes the first place.  There are two main reasons why this is so: firstly, initial public offering (IPO) has been discarded as an exit way for investors, and secondly, available capital is decreasing fast because investors are not able to comply with commitments to existing venture capital funds, and the funds that are available are frozen into existing investments which for various reasons can’t be left behind.  The outcome of these is obvious, serious liquidity issues.

It has been established that 25% of the 370 public biotech companies in the United States possess less than six months worth of cash, and private companies are probably in worse shape, making it urgent to find money and credit lines in new ways.  But, how?

1.    When a firm requires short-term liquidity it should look for the help of existing private investors who already have gambled on a company’s future.  Doing this during an economic crisis means existing investors will be very affected in terms of dilution of equity, thus, they will be very interested in giving bridge loans and other kinds of money contributions to offer managers the necessary time to get back on their feet and reposition their companies.

2.    Small biotech companies could monetize some of their assets.  Some specialized financial firms offer financing against future royalty payments or against existing or future revenues linked to specific clinical development programs.  Some other firms that specialize in giving loans to pharmaceutical companies may help the small biotech firm access credit lines to buy equipment.

3.    Reverse mergers have become very popular among biotech companies that need to better their liquidity.  Biotech firms with strong pipelines are joining forces with publicly traded firms with lots of money reserves but fewer than desirable pipelines.

4.    Biotech firms should go out and take advantage of the many funding opportunities available right now outside the commercial arena.  Funding from the government or charity organizations will definitely reinforce their money capabilities as well as their credibility in the market, and as if this is not enough, it also does not dilute equity.  Public funding has expanded importantly in fields like stem cell research, regenerative medicine, and cancer research, while non-profits are very supportive of areas like the therapeutic field, which is completely neglected by the big pharmaceutical companies.  There are also the organizations dedicated to a specific disease that are very interested in funding promising research directed towards their field of concern.

The future prospects for the biotech industry are positive.  The consumers are still spending money on its products, and the interest of big pharma companies in the new technologies developed by biotech firms is very strong.  Life sciences consulting companies agree that the firms that make it through this crisis will enjoy less competition in the future, but first, they have to work their way through the storm, and it will only be achieved if they acknowledge the challenges and adjust their finances and strategy accordingly.

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Wednesday, December 23rd, 2009 | Author: admin

The promise for the future is the delivery of high profile and high-value biosimilar products, which if realized will result in the industry reaching its full potential in relation to the availability of biopharmaceutical products. To achieve this the US will need to define an appropriate regulatory strategy which so far is absent.

The biosimilar area has become increasingly appealing and controversial.  Almost all generic manufacturers are actively involved in developing such products, be it directly or indirectly; however, success will only be found by  those who are patient and have the resources and money to invest right away in lieu of future profits.

Indeed, the future of the pharmaceutical industry is in biotechnology.  Biotech drugs currently conform around 10 to 15% of the pharma market, and the biotech area as a whole is the fastest growing; however, the market must be re-alined if it wants to take full advantage of the large numbers of products that are losing their patents in the next few years.  To date,  the progress has been  slow, with a great vdeal of attention centered on three crucial concerns that will probably determine the future of the whole pharmaceutical market:

1.    A regulatory deal is almost certain
To date,  the nonstop backbiting between the FDA, Congress and interested parties, along with the lack of a regulatory trail for biosimilars in the United States, has contributed to an overwhelming market expansion inside and outside the US.

Although it looks like some tyoe of regulatory deal may be struck this year, no one knows how supportive it will be to the development of biosimilars in the United States in an economically meaningful way.

2.    More valuable product variety is on its way
The Biosimilar products currently on the market are fairly inexpensive; nevertheless, the new ones, including monoclonal antibodies for the treatment of cancer and CNS, should prove to be more appealing and profitable for manufacturers.

3.    Acceptance from physicians

Biological drugs are a complex and an expensive way of treating serious diseases; in some cases this may result in physicians being reluctant to prescribe and use biosimilars as generic drugs.  Some countries, like France and Japanhave already expressed concerns about bioequivalence and are more reluctant than others, making it more difficult for biosimilars to be accepted.

The hope of biosimilar manufacturers is that the market will see biosimilars as therapeutically equivalent and thus, safe to prescribe in place of other drugs.

For branded manufacturers the opposite case is true. Here they hope is that the regulators will name these drugs as completely different drugs that cannot be replaced, thus protecting their branded monopoly.

As a result of these different financial  interests, there is considerable dialog on-going about  INN naming, because products with different INN names are more likely to be considered different and not interchangeable.

In countries where generic products are widely used and physicians know how to prescribe based on INN, biosimilars are expected to have a good acceptance.  The key is to ensure physicians are certain about the safety and efficacy of the drug so that they are willing to change; however, it is likely that an economic incentive will be required to bring this about.

The reason why physicians prescribe generics is to save money, and it is still not certain if biosimilars will generate enough savings..

In regards to patients, they will accept the properly approved biosimilars without a problem; however, they will prefer the newest drug available if it is within their means.

A crucial point in the biosimilar debate is the interchangeability and substitutability, of the products in the different regulated markets.  The legislation before Congress deals with specific provisions that permit the applicants to try to show interchangeability, but the FDA does not like the idea.  In Europe, biosimilars are labeled as having a ‘therapeutic similarity’, but until now, there are no serious efforts to deal with this concern.  Substitutability, which would enable, for example, a pharmacist to offer a biosimilar drug when the physician has prescribed the original, is very unlikely to be accepted.

Life sciences consulting firms are working with their clients to prepare them for the changes ahead and ensure their survival and development of their full potential in agreement with the new perspective in the industry.

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Sunday, November 29th, 2009 | Author: admin

rainbowchem2Very 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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Sunday, November 29th, 2009 | Author: admin

lifescienceIn 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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Saturday, November 28th, 2009 | Author: admin

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

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

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

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

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Friday, November 27th, 2009 | Author: admin

homeimage1The 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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