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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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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Under the Hatch-Waxman Act, every generic candidate has to give the holder of the approved New Drug Application (NDA) notice of the filing of the ANDA.  As soon as they receive it, in turn it files a patent infringement lawsuit that starts a thirty-month stay, making it impossible for the FDA to approve the ANDA without a final court judgment favoring the generic candidate.

With the proposed HR 1427 and HR 1548, the generic candidate has to notify the Biologic License Application (BLA) holder about the filing, however, there is no statutory stay defined if a lawsuit is filed promptly.

In regards to the marketing exclusivity, both views, the current and the proposed, are parallel, giving similar exclusivity periods.  However, most possibly, the patent litigation resulting from a follow-on biologic application will last longer than the period of exclusivity, creating the possibility of a risky launch of the follow-on biologic, where the candidate markets its product before any final judgment is given.  This will definitely increase preliminary injunction filings and appeals to the U.S. Court of Appeals for the Federal Circuit, thus, when deciding where to file suit, BLA holders have to consider the court’s track record on preliminary injunctions and if the court provides for a shorter time to trial so as to minimize the possibility of an at-risk launch.

So, under this new panorama, filled with challenges like the one above, and with lots of uncertainty, how can you be better prepared to face the new structure for approval of follow-on biologics?

President Obama has been clear in showing his support for the progress of a structure for approving follow-on biologics.  His interest is so high that the federal budget for the fiscal year 2010 includes a proposal to develop this structure.  So, no matter what the future brings, these are some considerations you must pay attention to so that you are prepared to face any future follow-on biologics approval process and any patent litigation conditions that may come along.

1.    Understand your patent portfolio
HR 1427 and HR 1548 do not mention the creation of an Orange Book equivalent for follow-on biologics, but require that the BLA holder identify relevant patents when the follow-on biologic candidates request it.  Review your patent portfolio right away to understand which characteristics of your products and processes are protected, what the scope of this protection is, when the patent term ends, and if you own or license-in the technology involved.  In addition, ask for legal counsel and pharmaceutical consultancy to start a full due diligence investigation so that you are ready to identify the patents that cover your biological product.

2.    Understand your product and manufacturing processes
Get your scientists and manufacturing engineers on board and check everything about your product and its creation process, to acknowledge if a generic manufacturer could create something different from your patents but still be biosimilar and interchangeable.  Also, it will help you determine how long it will take a generic manufacturer to develop the follow-on biologic and what problems it faces, alerting you as to when you could be hearing about an application filing.

3.    Think ahead
Since HR 1427 and HR 1548 give extensions based on pediatric studies and new therapeutic advances, talk to your teams in production, clinical research, and regulation, to see if any of these studies are possible or if new uses are being tested.  Never stop thinking about how this new legislation can affect your company and its strategy.

Although nothing is final yet, the new legislation will surely be different from the Hatch-Waxman ANDA litigation.  If anything, staying in the loop will allow you to act based on a plan established under valuable and decisive information.

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No matter what happens with the biosimilar legislation, patent holders will have to go through their patent files carefully.

The current generic drug industry was born from the Hatch-Waxman Act of 1984.  Among its creations, this Act accounts for a specialized form of patent litigation called Abbreviated New Drug Application (ANDA) litigation.  The Act defined an abbreviated approval process for small molecule drugs’ generics; however, it didn’t establish a structure for approving follow-on biologics, known as biosimilars and generic biologics.  The US Congress is now studying legislation to create such a structure.  If this legislation is ratified, it will most probably create a patent litigation structure very different from the ANDA form.

Through modern technologies, biologic drugs are isolated from living matter or produced in living cells.  Biologics vary from small molecule drugs in various ways related to safety and product variability, aspects that are critical for the definition of an approval process for follow-on biologics:

-    They are large and complex molecules or mixes of molecules.
-    They are produced in living cells, offering great potential for greater variability based on the precise host cells or organisms used to create them, the growth conditions for culturing them, and the purification methods employed to isolate the biologic from contaminants.
-    They show distinctive safety issues, like the possibility of producing negative immune responses.

Biologics are so complex and variable that it is difficult to define an approval process.  These characteristics prevent the implementation of a therapeutic equivalence standard similar to the one used for small molecule generic drugs in the Hatch-Waxman Act.  As an alternative, the standards of biosimilarity and interchangeability in HR 1427 and HR 1548 are proposed.

HR 1427 defines biosimilar as “no clinically meaningful difference between the biological product and the reference product would be expected in terms of safety, purity, and potency if treatment were to be initiated with the biological product instead of the reference product”.  HR 1548 requires that a follow-on biologic candidate exhibits biosimilarity “based upon data derived from: analytical studies that demonstrate that the biological product is highly similar to the reference product, from animal studies, and from clinical studies that are sufficient to demonstrate safety, purity and potency”.

In regards to interchangeability, both HR’s agree in that the biological product should be biosimilar to the reference one, and that the patient should go from one to the other without risk.

The similarity standards proposed pose new issues for patent litigations because there is no requirement that the follow-on biologic should be identical to the reference product.  Follow-on biologic candidates can say that their biologic doesn’t infringe any patents covering the reference product or its manufacturing process, and generic manufacturers may obtain approval on the basis of biosimilarity or interchangeability: it gives the same results but is different enough.  In addition, the manufacturer will probably try to make the product in a different way from the patented process, creating concerns about the follow-on biologic not being truly biosimilar or interchangeable.  It will certainly be a challenge for the reference product manufacturer to protect its investment.

In chain reaction, these possibilities will increase litigation costs, due to testing and characterization of the biologics, inspections of sites, and declarations of those involved.  There will be lots of pharmaceutical consulting for sure.

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