Laboratory personnel are exposed to a high risk of injury due to repetitive movements during normal lab procedures like pipetting, microscope use, operating microtomes, using cell counters and video display terminals.  This type of injury develops with time and it happens when the muscles and joints are stressed, tendons are swollen, nerves are pinched, and blood flow is restricted.  Another health risk for lab workers comes with standing and working in uncomfortable positions in lab hoods and biological safety cabinets.

Here we show you several ways to control some of these risk factors and to ensure your personnel is working in a comfortable, productive, and safe lab environment.

1.    Pipetting
This task involves various ergonomic strains like thumb force, repetitive movements, and awkward postures of the wrists, arms, and shoulders.  In order to alleviate these hazards follow these tips:

-    Use pipettes that fit comfortably in the user’s hand and that have triggers that need less force to be activated. Also, aspirate with the pointer finger and dispense with the thumb.

-    Use an electric pipette with mixing function to mix and aliquot, and use multichannel pipettors for big aliquot jobs.

-    Use shorter pipettes that decrease hand elevation.

-    Use low profile waste containers for used tips.

-    Take 3-5 minute breaks for every 20-30 minutes of pipetting, exercise and stretch your hands and arms while resting.

-    Clean pipetters regularly.

-    Adjust the workstation so that the employee can work with arms close to the body.

-    Rotate pipetting with other lab tasks and people.

-    Use thin wall pipette tips that fit correctly and eject easily, and use minimal force when applying them.

-    Maintain samples and instruments within easy reach.

-    Use an adjustable chair when sitting at a lab bench.

-    Use anti-fatigue mats when you need to stand for an extended period while pipetting.

2.    Computer workstation
Some researchers spend long hours entering data with a keyboard and mouse over a very high bench, making the person elevate the arms excessively.  This is what you need to do:

-    Install adjustable keyboard trays under the benches, and monitors at viewing distance between 18 and 30″ and with top of screen at eye level.

-    Locate computers away from doors, entrances, and passageways.

-    Use adjustable seating.

-    Hold documents adjacent to and in the same plane as the screen.

-    Install foot rests.

-    Offer different keyboards and mouse attachments for personnel with muscle problems.

-    Order 2-5 minute breaks for every 20-30 minutes of computer use.

-    Do not go from keyboarding to pipetting or vice versa without resting at least 15 minutes.

3.    Microscopy
Microscopy workstations must be adjustable to fit every size of person:

-    Don’t use a microscope for more than 5 hours per day.

-    Locate the microscope on the edge of the table to achieve an upright position.

-    Use a cut-out work table.

-    Elevate the microscope and place it at an angle at which you can look directly into the eyepiece.

-    Keep neutral spine.

-    Give arm rests for while using the adjustment knobs.

-    Use an ergonomic chair with good back support.

-    Ensure there is enough room under the table so that the person can pull the chair up to the ocular.

-    Install footrests and avoid foot rings on stools.

-    Provide sit-stand seats for areas with little leg room.

-    Order regular breaks.

-    Use television systems instead of binocular eyepieces.

4.    Overhead Lifting
Lack of space can force you to store equipment and supplies on overhead shelves, if this is so, follow these tips:

-    Store heavy objects on lower shelves.

-    Use a stable stool or ladder to reach overhead shelves.

-    Do not twist while you lift.

-    Use rotating carrousels to store materials close to the worker.

The well being of personnel is vital for the good functioning of any laboratory.  Any pharmaceutical consultant will agree that people are a pharmaceutical company’s strongest asset; by caring for their health you are taking your company far ahead in the market.

If you liked this article, tell all your friends about it. They’ll thank you for it. If you have a blog or website, you can link to it or even post it to your own site (don’t forget to mention www.smartconsultinggroup.com as the original source).

Don’t Forget to Subscribe by RSS or Email:

Now is the time to establish a global vision in the path to a harmonious approach to product security that provides close-term benefits for patient safety.  While the US centers on how to achieve an e-pedigree system and the pharma industry in Europe incorporates a 2D datamatrix-based “bookend” system, patient safety is in possible danger due to the split approaches and expensive implementation strategies.

The drugs supply chain is becoming more and more complex due to the increase in the globalization of the pharma trade.  Manufacturers, distributors, re-packagers, and retailers may be all located in different countries or even continents.  Given the complexity of the supply process, drugs have become a profitable target for illegal distribution and forgery.

Many methods have been proposed to protect patients, however, the answer may be very simple: an approach in phases, which initially focuses on the point of dispensing and avoids the significant difficulties and costs that a full supply chain pedigree system encompasses.

Currently there are two main initiatives that are fragmenting the resources of the industry: The European Federation of Pharmaceutical Industries and Associations (EFPIA) initiative, and the California ePedigree network.  Not long ago, the pharma industry overcame many years of irrational enthusiasm in regards to the near-term potential of RFID technology.  It is time to learn from mistakes and select an approach that leads to improvements in patient safety that are achievable instead of considering a large-scale solution focused on the supply chain.  In this regard, the European initiative is better.

Key organizations and agencies have to become aligned in regards to a global approach that can be launched in any region and using the available technologies.  This global approach should have a main goal: checking drugs at the most critical transaction in the supply chain, when they are delivered to patients.  The EFPIA follows this route, however it requires two important and costly developments: all products must be serialized at the unit level, and an industry wide data routing and data management system has to be established.  These developments will allow for significant short-term improvements to patient safety through point-of-dispensing verification, will offer important knowledge, and will enable other developments of supply chain pedigree programs that can build on this foundation.

Like bank ATM’s and credit cards, this system would permit global use with universal results: the approval or denial to sell a drug.  Along with serialization as an aspect of an authentication program, authentication technologies are also needed.  Explicit and secret product authentication characteristics used by the manufacturer in the product’s packaging or in the product itself, give the manufacturer the capacity to detect abnormalities fast.

In order to make this a reality, the EFPIA, EMEA, FDA, PhRMA, and WHO will have to join forces to define an industry standard with a data exchange infrastructure that could strengthen the broad implementation of unit-level serialization.  Eventually, this system will evolve into a more extensive track and trace system, forming the supreme supply chain management tool.

It is everyone’s responsibility to work towards a solution for patient safety in view of the growing global danger of distribution of illegal and forged drugs.  As pharmaceutical consultants will agree, global problems beg for global solutions.

If you liked this article, tell all your friends about it. They’ll thank you for it. If you have a blog or website, you can link to it or even post it to your own site (don’t forget to mention www.smartconsultinggroup.com as the original source).

Don’t Forget to Subscribe by RSS or Email:

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.

If you liked this article, tell all your friends about it. They’ll thank you for it. If you have a blog or website, you can link to it or even post it to your own site (don’t forget to mention www.smartconsultinggroup.com as the original source).

Don’t Forget to Subscribe by RSS or Email:

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.

If you liked this article, tell all your friends about it. They’ll thank you for it. If you have a blog or website, you can link to it or even post it to your own site (don’t forget to mention www.smartconsultinggroup.com as the original source).

Don’t Forget to Subscribe by RSS or Email:

This is the drug manufacturer’s nightmare: the phone rings and an FDA official announces an upcoming inspection.  Even though they are clearly necessary, FDA inspections are a weight on pharmaceutical companies’ shoulders.  Without these inspections, pharma companies cannot keep the FDA’s approval to sell their products.

It is the FDA’s duty to call in advance to announce an inspection, its purpose, duration, and number of people involved.  On inspection day, the FDA official will ask to see the top management person on site, and he will show his credentials and an FDA ‘Notice of Inspection’ to that person.  Afterwards, a thorough inspection of the facilities will begin, while one or more key employees tag along.  After a few days, the FDA will send an ‘Inspectional Observations form’ to the leadership team informing them about any unacceptable conditions they have found in regards to products, processes, or other violations to the FD&C Act.

The results of such an inspection can range from no needed actions to a complete closing of the facilities and administrative, civil, or criminal actions against the company.  Normally, the FDA will recommend actions to improve operations in line with the FD&C Act.

Given the serious nature of this process, it is necessary to plan ahead and be ready for the eventual call.  Here are 5 tips to welcome the FDA with a smile on your face:

1.    Implement regular internal FD&C Act compliance training
The best way to ensure a successful FDA inspection is to ensure the facility complies with FDA regulations.  Every employee must be aware of the products and processes’ FDA standards for the area he or she tends to.  Employees have to be trained to stay calm, be respectful, and follow the FDA official’s requests, as well as to know their rights about what they have, or not have, to say or show the FDA.

2.    Identify and work on weaknesses
Smart professionals work on identifying the weaknesses that could attract the FDA’s attention before this happens.  Some examples are potential contamination, under maintenance, and unclean areas.

3. Select key people to accompany the FDA official
Train two or more employees who supervise the major processes to follow the FDA official.  Teach them how to treat and interact with this person.

4.    Write an operations manual
Operations manuals should be the main reference in the facility.  Employees must have continuous access to them in order to check actions and steps to maintain FDA compliance at all times within their areas.  This provides education and encouragement to go through any inspection with confidence.

5.    Make regular FDA compliance checks
Don’t wait until the FDA is there to identify the problem areas, identify them yourself and work with your personnel to fix them.  This will give your people confidence because they know what they are dealing with and they know how to solve it.

FDA inspections are normally not happily welcomed because they require a lot of additional resources and energy, however, every pharmaceutical consultant will tell you that being prepared is not only the best way to pass the inspection, but also to get your business under control and avoid worrying about what is out of your hands.

If you liked this article, tell all your friends about it. They’ll thank you for it. If you have a blog or website, you can link to it or even post it to your own site (don’t forget to mention www.smartconsultinggroup.com as the original source).

Don’t Forget to Subscribe by RSS or Email:

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.

If you liked this article, tell all your friends about it. They’ll thank you for it. If you have a blog or website, you can link to it or even post it to your own site (don’t forget to mention www.smartconsultinggroup.com as the original source).

Don’t Forget to Subscribe by RSS or Email:

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

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.

If you liked this article, tell all your friends about it. They’ll thank you for it. If you have a blog or website, you can link to it or even post it to your own site (don’t forget to mention www.smartconsultinggroup.com as the original source).

Don’t Forget to Subscribe by RSS or Email:

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

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

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

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

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

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

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

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

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

If you liked this article, tell all your friends about it. They’ll thank you for it. If you have a blog or website, you can link to it or even post it to your own site (don’t forget to mention www.smartconsultinggroup.com as the original source).

Don’t Forget to Subscribe by RSS or Email:

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.

If you liked this article, tell all your friends about it. They’ll thank you for it. If you have a blog or website, you can link to it or even post it to your own site (don’t forget to mention www.smartconsultinggroup.com as the original source).

Don’t Forget to Subscribe by RSS or Email: