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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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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Companies today face a unique environment, one that demands flexibility and fast response to changing business needs.  In response, many businesses have adopted virtual organizations: decentralized, team-based and distributed structures that are supported by the advances in communication technologies.

Every virtual organization is unique.  They come in all shapes and sizes, in different locations, and have no defined structure.  Such an organization can modify business processes in a dynamic way to meet market demands, to coordinate contacts, to define different boundaries over time or according to customer, and to organize components’ relationships as needed.  In order to do this, the virtual organization’s employees, teams, departments, units, or firms, must be distributed geographically, have to be functionally and culturally varied, electronically linked, and connected through lateral relationships.

Virtual organizations add value to their clients by building networks around them.  No control or direction is required; instead, these want to display processes that demonstrate leadership, coaching, facilitation, and contracting skills.

Virtual organizations help their customers by improving their own performance, careers, and personal lives.   They are collaborative organizations that acknowledge that the old hierarchy-based structures are not valid anymore.

Some fundamental values that guide the work of a virtual organization are:

-    Steady learning
A virtual organization is an educative one.  It knows that behind every true change there is belief, and the education on those beliefs will allow for a fully dynamic environment.

-    Works by example
Successful virtual organizations walk the walk and talk the talk.  Their objectives are clear and achievable, leaving nothing behind.

-    Interdependence
These organizations work to create interdependent relationships with their clients, suppliers, and everyone else related to their business.  They help companies move from dependence, to independence, where it is easier to work and add value.

-    Customer understanding
The real focus of virtual organizations is on the value of a long-term relationship, not on the worth of a short-term transaction.

-    Win/win philosophy
Every relationship started and developed by a virtual organization must be valuable for both parties.  There is no such thing as I win; you lose.

-    Respect and courtesy
The organizations show genuine respect and interest in all of their clients and partners.

These values, in turn, give birth to the following factors, which are critical for success:

-    Value
Every client must feel that they are getting much more worth than what they are paying.

-    Constant improvement
Virtual organizations are always checking their processes to ensure the clients are getting what they need and more.  They always want to do better.

-    Impartiality
A virtual organization works under the premise that all its clients are equally valuable.  Every time a possibility of partiality emerges, the clients should be informed about it and its consequences.

-    Communication
The philosophy is of constant, clear, open, and friendly communication all the time.  In order to be successful, virtual organizations require modern information technology systems 24/7.

In order to be able to survive and excel under the new market panorama, pharmaceutical companies have to implement new practices and invest in the professional pharmaceutical consultancy that will be able to guide them wisely through troubled waters.

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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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The Pharma industry is facing extreme change.  Gone are the days when pharmaceutical manufacturers made million in profits no matter the times.  Today’s challenges are transmuting the field’s reality for the future: expiration of blockbuster drug patents, a decreasing pipeline of blockbuster drugs, pressure from generics, doubt about the future of healthcare compensation, mergers and acquisitions.

This somber panorama is moving Pharmas to evaluate the best ways to combine and manage themselves while urging external organizations to do the same in order to continue being competitive.

To maximize their profits, Pharmas are scanning their activities to achieve optimization, efficiency, and quality amid the crisis.  Manufacturing is in this scope, as companies try to lower costs throughout every area, prompting bold manufacturers to expand their Lean Six Sigma enterprises with predictive modeling techniques, to earn new perception, and encourage change within the organization.

For many years, the Pharma industry has been characterized for being delayed in manufacturing efficiency and productivity, specially because it is very expensive and involves a great deal of work to comply with regulatory principles, which call for revalidation of processes after a change.  This has established a road of inefficiency, waste, and lack of quality control.

Until now, pharmaceutical manufacturers had not had any economic motivators to support change, and now they face the consequences.  Luckily, in recent years, they have received some support from the FDA and other regulatory bodies, which recognize the lack of efficiency and quality control and have backed up a “quality by design” model to substitute the previous one of “quality by test results”.

The FDA has established the Process Analytical Technology (PAT) initiative, which aims at guiding pharmaceutical manufacturers towards consistent, predictable, and higher quality levels.  By accepting PAT, Pharmas are changing their focus to two management approaches: Lean manufacturing and Six Sigma, with the intention of reducing waste to meet customer demand and market changes, and to lessen the variation in products and processes, to avoid product defects.

Lean and Six Sigma are powerful tools to improve quality, compliance, productivity, costs, and speed, allowing for the Pharma to provide better products in a cheaper and faster way.

But it doesn’t stop there.  To effectively leverage PAT and Six Sigma, pharmaceutical manufacturers must use modeling tools that improve quality even before a product is manufactured.  They require predictive analysis that gives them information about the impact of numerous changes, in ingredients or processes, on the quality of the end product.  The Monte Carlo simulations is such a tool.  It uses probability distributions as process inputs, instead of one value.

In this way, pharmaceutical manufacturers can predict the quality of a product more accurately, thus, balancing the quality demands of Six Sigma against Lean principles, that aims to manufacture products faster and cheaper.  It may also help in predicting manufacturing demand and cycle periods, as well as the critical steps to achieve the best quality.

Imagine the improvement over current practices of testing quality once the manufacturing process is over!  To get started, research thoroughly the Monte Carlo model and even ask pharmaceutical consulting firms for detailed information on its implementation.

Embracing change today is the way to flourish.  New methods like Lean Six Sigma, supported by prediction tools, clear the path towards a better future and a better company, all for the common good.

There is a resurgence underway in the  pharma industry inpart because of new ways companies are approaching the business.  Efficiency, flexibility, passion for the job, relevancy, and connectedness have proven key for cost reduction and several other challenges.

The industry has been plagued with failed trials, conflicting drug information, and patent expirations, giving way to outsourcing, acquisitions, and layoffs.  However, the economy has been the strongest adversary, taking its heavy toll among Pharma.  Recently the focus has been on lowering costs in a number of operational areas.  The pharma industry is no longer a secure career area, however, it poses a great opportunity for rethinking personal qualities, motivations, and back-up plans.

Since Pharma is evolving and changing, people must be flexible, tenacious, and strong.  Mergers, acquisitions, closings, downsizing, and outsourcing are dark clouds hanging over the Pharma industry.

One characteristic of the Pharma work force is its good track record towards challenges, which comes in very handy in this situation.  Workers are facing layoffs and expected to do more with less.  Individuals must be willing to take on new jobs and leave their comfort zones.

Outsourcing overseas, in places like Singapore and India, has become a strong option for reducing expenses and maintaining expansion, thus, workers must be prepared for a sudden change in their current positions and look for other work alternatives.  These might range from assuming more responsibilities, specialization or moving overseas, to changing career paths completely, people in the Pharma industry must be vigilant towards what is happening in the industry.

Nevertheless, there are outsourcing opportunities appearing close to home as well as interesting partnerships that may guarantee making it through this period in a healthy manner.

For the time being, the most interesting projects within a company have been set aside to make room for people to manage different first-priority projects, as many are experiencing the lack of personnel due to staff reductions.  Many workers may be forced to change locations if they want to grow within a company and, if flexible, there may be important opportunities worth taking into consideration, like venturing into pharmaceutical consultancy.

Thus, a great plus is to possess good transferable, communication, and interpersonal skills, as well as to be able to assume new tasks in a fast and efficient way.  There are interesting opportunities arising within tech transfer, project and clinical trial management, QA, QC, regulatory, validation, and analytics.

Currently the sector that seems to be holding the industry upright is biopharma, but, whatever the case, there is always opportunity if individuals know where to look for it and are open to learning new skills and thinking outside the box.  One thing is certain, only good can come out of these new ways of approaching reality.

The Market
Given their specificity, biopharmaceuticals can cure diseases, not just treat symptoms, whilst often causing fewer side effects.  As the number of new diseases that can be treated with biopharmaceuticals increases, so does the demand for these around the world.  Biologics, which constitute 30% of all therapeutic compounds being developed, are very popular among Pharma companies and the country’s protein therapeutics market is expected to grow significantly by 2010.  Within this group, one of the most important biotherapeutics is monoclonal antibodies, and this global market is estimated to grow by billions of dollars.

Why Outsourcing Biopharmaceutical Manufacturing Works?

1. Biopharmaceutical products must be manufactured under the current Good Manufacturing Practice (cGMP) conditions for clinical trials.  Manufacturing for biologics is technologically complex and highly regulated by the FDA; this requires a great deal of experience and special skills to be able to produce large complex protein structures on a large scale.  The smallest of variations can alter the process, stability, and efficacy of the final product.  The manufacturing personnel must possess technical expertise in upstream and downstream operations, process development, project management, process engineering, quality assurance, analytical development, quality control, and regulatory compliance, among other specialized functions.
2. The investment of capital to build a manufacturing facility is enormous, going up to many $100 millions in some cases, and it takes several years for a facility to be ready for operation.  Large Pharma companies are able to build their own cGMP compliant manufacturing facilities, but small or medium companies are not.

With the maturity of the biopharmaceutical industry, the option of Pharma outsourcing services has become a viable and necessary production strategy.  Pharma outsourcing companies offer an attractive high-quality and economical alternative for all size companies, from virtual ones to large conglomerates.

By outsourcing some processes, Pharma companies can center their activity on their main capabilities while lowering production costs, improving manufacturing efficiency, minimizing risk, and decreasing development timelines.  They will be spending their resources in what they know to do best.

Contract manufacturing organizations (CMOs) offer services ranging from cell-line development, cell banking, bio-reactor production, process development, protein purification, scale-up, pilot scale production, cGMP production, analytical and testing services, validation, quality control testing, protein conjugation, modification and radiolabelling, to final formulation, lyophilisation, fill and finish.  It is clear they cover the whole spectrum of Pharma drug development and manufacturing processes.

CMOs play an important role in the Pharma industry, and they are a great way to give value to your clients.  They are prepared to design the best process suitable for each situation.  Ask your pharmaceutical consultant about this option; they will be able to explain how this kind of outsourcing can work for you.