Not two weeks after Nova Nordisc announced its branded Twitter page, Pfizer followed suit with its own page as a new foray into social media.  Both companies plan to use the 140 character social phenomenon as a platform for “tweeting” press releases and announcements for new products, and Nova Nordisc uses a spokesman to tweet about experiences with drug treatments using their products.

So far, Pfizer’s page has been full of useful links about big news in the pharmaceutical industry, health care news from Washington, and both jobs and investor reporting from the company itself.

These entries into social media mark a new trend for traditional pharmaceutical companies that have mostly been gun-shy of entering into anything that smacks of a short-lived Internet fad.  It also shows a fresh, new approach to reaching market segments that no longer read newspapers or watch TV like the older generation does.

This not only points to the validity of Twitter as a marketing tool that is here to stay, but also to the need for other pharmaceutical companies to modernize their marketing strategies and campaigns – and enter the year 2009!

Hiring a pharmaceutical consultant to create a comprehensive marketing plan or remarketing plan may be a brilliant step towards maximizing profits during our current down economy.

A Twitter approach may or may not be the correct one for you – but with all the negative press and misinformation about pharmaceutical companies that exist today in the social media, as well as the massive readership levels social media attracts – it doesn’t pay to ignore Web 2.0 in any marketing campaign.

Will a Twitter-based approach help drive market share for Pfizer and Nova Nordisc?  Only time will tell.

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If you go back to the latter part of the 20th century, the pharmaceutical industry was very vocal about the challenges of operating a global business successfully, in an environment of often regional GMP regulations.  In an attempt to harmonize these practices, an informal ICH working group, in July 2003, agreed on a vision to develop a pharmaceutical quality system that would be applicable across the entire life cycle of a product.  They wanted to emphasize an integrated approach to quality risk management mixed with science.  But did they achieve their goals?

What the committee wanted to achieve was the ability to focus on the entire life cycle of the product, not just manufacturing.  Because the linkage between development and commercial manufacturing is so critical to the successful introduction of a product, and the successful transfer of knowledge, there was no doubt that something had to be done.  In the end the EWG wanted to augment regional GMP regulations and move from GMP compliance to robust process understanding.  Any good pharmaceutical consultant will tell you that knowledge management, knowledge transfer, and technology transfer, are key aspects of Quality Systems Management.

There has always been a fear in the industry that too many companies were taking commercial GMP requirements and forcing them upon development and manufacturing activities.  That is why it is so important for the elements of the new system to be applied in a manner that is appropriate and proportionate to each product life cycle stage.  This is why the old system was broken, because it failed to recognize the fact that the goal of development is oftentimes much different than the goal of manufacturing.

However, these new guidelines do not replace existing GMP regulations, but rather are used in accordance with the existing regulations.  Because regional GMPs don’t necessarily address all stages of the product life cycle, nor promote innovation or continual improvement, it is important to take this overall step towards a more quality controlled environment.  Under the new quality control system, the system encourages more use of science and better use of risk-based approaches at every stage of the life cycle.  Using this new system promotes better quality and initiates continual improvement across the product life cycle, resulting in better quality.  By using innovative methods like these, there is no doubt the pharmaceutical industry is well on its way to achieving the kind of process control and quality that is expected in the 21st century quality system approach.

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A comprehensive new model has been introduced, for an effective pharmaceutical quality system that not only complies with the International Standard Organization (ISO), but includes the correct manufacturing regulations as well.  This new guideline applies to the systems supporting the manufacture and development of pharmaceutical drug substances, including biotechnology and biological products throughout the product life cycle.  By recognizing the differences between each stage of development, it allows manufacturers to recognize the different goals of each stage, further developing quality.

This is new system is quickly picking up steam in the life sciences consulting industry because it is a better overall system.  They see this new system as an innovative approach to quality systems management because it enhances the quality and quantity of medicines around the world.  Implementation of the new quality control system will facilitate innovation and continual improvement throughout the products’ life cycle, while at the same time strengthening the link between pharmaceutical development and manufacturing.

This kind of new quality risk management can also be extremely useful in identifying and prioritizing areas for continual improvement.  To properly identify and implement appropriate product quality improvements, which is the goal of any pharmaceutical company, you need to increase the ability to fulfill needs consistently.  And this is what this new system is trying to achieve.

By using these new knowledge based management systems and quality risk management systems effectively, companies will be able to implement these new strategies cost effectively and without incident.  It is very important in this new system that quality risk management be an integral component.  It can provide a proactive approach in identifying and scientifically evaluating potential risks to quality.  This facilitates continual improvement of process performance and product quality throughout the entire life cycle of a product.

Using the correct quality risk management approach is extremely vital to the effectiveness of your pharmaceutical quality system.  It is an important system in the process of acquiring a systematic approach to analyzing, storing and disseminating information related to products and manufacturing.  Without it, it will be impossible to correctly develop activities using scientific approaches, and provide the correct knowledge for product and process understanding.  The product and process knowledge should be managed through the entire development of the product’s life cycle, through the commercial life of the product all the way to the end of the product, including discontinuation.  Without using this quality systems management approach, the product quality will suffer and so will the integrity of the company.

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The pharmaceutical industry is a highly competitive space, and staying on top means knowing what your competitors are doing.  However, a comprehensive competitive analysis is often back-burnered, as there is always enough to do to fill a 30 hour day for most of us in this industry!

This is one item that should NOT be ignored, as keeping and maintaining an ongoing, complete competitive analysis will alert you to key industry trends, customer trends, and areas of need that have not yet been met by any other company.  These create areas of opportunity for you and your company.

A good competitive analysis can save many man-hours of research work – and there is no recouping costs for work that has been done to create the wrong solution.

A pharmaceutical consulting firm can help supplement your staff by creating these analyses for you.  As they are not part of your organization, they will prepare an analysis that is unbiased and representative of the true state of the market based on their experience and inside knowledge.

A good competitive analysis will include price points, the mechanism by which a problem or medical condition is addressed, cost estimates, distribution and sales channels, and any strengths or weaknesses of the competitive solution.  It will also include solutions that are used by consumers in lieu of any pharmaceutical solution.

It is also important to keep your competitive analysis updated on a regular basis, as market conditions are highly dynamic – and larger competitors can change strategy very quickly.  Doing a quick review of conditions once a month and making needed changes should be sufficient for keeping up to date.

Price points and the price elasticity of similar products may need to be watched more closely than once a month, as many companies drop pricing in an effort to gain market share when results are not what they would have wanted to see.  Missing a competitive price reduction can lead to losing market share unexpectedly.

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Winning funding for a new pharmaceutical company, as well as becoming successful in this lucrative market space requires the creation of a carefully crafted blue print which details every aspect of your new (or existing business). Running a business without a business plan is analogous to flying a plane without a flight plan!

Pharmaceutical consultants have traveled this road before you, and have an understanding of what investors want to see, as well as what pitfalls you may have before you as you progress towards your goals.  They can help you clarify your key objectives, and solidify your marketing, operations, and management strategies.

A good business plan has many elements.  It should first have a comprehensive overview of what you want to accomplish, your measurable deliverables, and your key defensible advantages.  This is particularly key, as you must be able to show investors that other companies have barriers to entry, and cannot simply copy your technology and beat you in the marketplace.

Next, you must demonstrate the need for your product or products by showing the market size, and market projections going forward.  This section needs to be carefully crafted so that it paints a realistic yet optimistic picture of the market landscape.

In the pharmaceutical industry, the operations plan receives a lot of attention. How are you going to make your products cost effectively?  What manufacturing techniques will you use?  What is the size of your production facility, and what are your plans for keeping it productive and controlling costs?  What qualifications and standards must you meet in order to be able to release product, and how long will it take?

A Go-to-Market plan is essential to any complete business plan, and details your strategy for receiving market focus and actually selling your product.  Here, you should describe your Marcom plan as well as your sales channel plan.  Without a plan to reach actual customers, no product can be successful.

The final element in any business plan is what wraps it all together – your financial projections.  Pharmaceutical consultants can help you develop something that is both conservative and interesting to investor – which is no easy task. If you are too aggressive – your plan will lose credibility.  If you are too conservative, no one will want to invest.  This is the area where a consultant with expertise can add considerable value, and save you time and money.

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Just as you use a map when going on a road trip to be sure you arrive at the right destination, a business, such as a pharmaceutical consultancy firm, will also use a “map” to improve and monitor processes to ensure efficient and smooth flowing operations.  Within business, this is known as process mapping.

Because a business usually involves a variety of different processes, mapping them, or drawing them out with charts and maps, makes the work more visible.  This in turn increases communication and understanding among the employees who are doing the work.  A Process Map basically outlines the steps it takes to get to the ultimate goal, which is customer satisfaction.  A Process Map can also highlight areas where improvements to systems are needed and make it easier to develop solutions to a problem.

Understanding process mapping is something that takes time and training, but there are some tips you can follow to make the whole process a little easier.

1.    Choose the right person or team to create the map.  These people should be well educated in the process involved and have an interest in improving the process.

2.    Be certain to establish the basic rules of the mapping process and display them on a chart for all to see.  Examples of these rules might be that all persons remain in the room until the session is complete, that there is no finger pointing or blaming allowed, that anyone can give input, etc.

3.    Be sure the meeting room is large enough for the number of attendees so everyone is comfortable and has enough personal space.

4.    Have a good supply of paper and sticky notes on hand.

5.    Use a laptop to record details as you go, and if possible use it with a projector so everyone in the room can see the information.

6.    Try to keep everyone in the room actively involved in the process.

7.    Create a rough draft of the process first and work on a good copy when all the data has been collected and arranged.

8.    Always respect each person’s contribution however small it may be.

9.    Push on past the point when everyone seems to be out of ideas.  This is often when the most creative ideas emerge.

10.    Be patient.   A good process map may take a while to come together.

Process Maps are a valuable addition to any business.  They are well worth the time and effort it takes to create a visual portrayal of processes and procedures that employees can easily understand.

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For any pharmaceutical firm, building successful teams within the company is essential to achieving long term goals and improving the overall collective performance of the employees.  However, before you can expect any team to develop successfully, it must be led by a manager who is well trained in, and understands the dynamics of building a successful team. Hiring a pharmaceutical consultant is one way to train your managers on how to motivate and encourage employees to work together to meet objectives and reach goals.  Being clear on the four stages of team building is a fundamental step in any successful team building endeavour.

Forming
During the forming stage the team is usually coming together for the first time.  This can be a stressful stage as the members of the team are often nervous, uncertain of expectations and unfamiliar with the manager in charge of the team.  It is the manager’s job at this time to reassure and relax the group, and bring them together with a positive, honest and motivating attitude.  During this stage the rules and roles of team members are established and the goals and objectives defined.

Storming
This second stage of team building is quite aptly named as this is the stage that may create some stormy waters that the team will have to navigate.  Perhaps roles and rules that were defined in the forming stage were interpreted quite differently by team members, resulting in unexpected conflicts and disagreements.  The manger will have to readdress the issues and make sure that all team members are on the same page.

Norming
This third stage of team building is often referred to as the calm after the storm.  Issues and misunderstandings have been cleared up and hopefully everyone is ready to work together and move forward. Individuals within the team are now better acquainted with one another and feel more confident within the group.  As a result of this confidence, team members are more accepting of the input and ideas of other members and conflicts are handled within the previously established ground rules.

Performing
In a well built team, the performing stage begins the real process of meeting goals and making progress. Team members have taken ownership of combined objectives and are ready to provide their individual values to the team’s efforts.  Sharing of ideas and experiences, and open communications move the team along during this stage.  Members begin to grow and develop within the process and take pride in accomplishments of the team as a whole.

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The U.S. life sciences industry is a business sector which faces the significant task of developing, testing and manufacturing pharmaceuticals.  Due to the complex environment in which pharmaceuticals are developed, there is a strong need for IS and other quality systems to monitor, manage and control the production processes.  The quality systems can drive each of the steps with the product life cycle and is a critical factor for guaranteeing that the optimum quality standards are met.

The FDA plays an important role in this systematic testing process by applying rigorous oversight to the pharmaceutical industry, to ensure high quality standards, efficacy, and the safety that the general public demands.  Throughout the research, development, and the manufacturing life cycle of drugs, vaccines, and other biopharmaceutical products, the FDA’s role is that of a principal supervisory agency.  Their job is to assure that optimum quality is being achieved, and the best practices are being followed.

So how can you prepare your bio-pharmaceutical company for one of these surprise inspections?  Well, one thing you can do is to hire a life sciences consulting firm that specializes in the development of quality systems, in which they can design, or redesign your entire system, to meet FDA regulations.  The FDA uses it’s oversight to guarantee that such issues and problems with contaminants and failed processes are quickly sniffed out and identified.  Without the help of an experienced consulting firm, your company may fail to take the preventive actions necessary to successfully pass an FDA audit.  Because of the severity of the consequences in developing possible faulty pharmaceutical products, the FDA has very little tolerance for variability or deviation from its quality inspection regulations.  This means if your products do not pass this FDA quality inspection, you will be shut down, and shut down fast.

The pharmaceutical industry, like any traditional manufacturing industry, uses traditional, older production processes and many companies have outdated information systems.  In the past, the work flow in the pharmaceutical industry was optimized for straightforward production including cost reductions, rather than focusing on transparency and quality production.  Furthermore, even though many pharmaceutical companies are starting to catch up to the rest of the manufacturing industry, and have begun to develop more sophisticated systems, many companies wouldn’t be able to pass a simple FDA regulatory inspection if they had to.  If you want your company to be properly prepared, talk to a pharmaceutical consulting firm that specializes in quality control, and they will be able to prepare your company properly in case of a surprise FDA inspection in your company’s future.

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Clinical Trial Management is the process of capturing, managing, and the reporting of safety data in the pharmaceutical industry.  It involves data collection, qualitative check on collected data, and lastly, the creation of a database that is the validated and organized information derived from the data collected.  It usually takes a series of highly complicated procedures, and also experts in the industry, to carry out these tests correctly and safely.  That is why hiring a pharmaceutical consultancy firm, which specializes in clinical trial management, can be an excellent idea for a company looking to stay a few steps ahead of the competition.

Clinical safety is extremely important in ensuring the safety of drugs in the pre-marketing stages, as well as the post marketing stages.  Your clinical safety program should be standardized, yet elaborate enough to promise complete safety in the product, and also for the manufacturers.  Because most pharmaceutical companies can take as much as one or even two decades to bring a drug to the market, let alone spend billions of dollars in the production and development phase, it is important that the necessary trials are done to ensure the safety of the product.

Because a significant portion of this cost in accounted in the developing stages of the product, it is important that the company does not miss any steps along the way.  By the time they even get to the stage of clinical trials, it has already been through years of previous development and testing procedures, and this is the last step before it is submitted to the FDA for final product approval.  That is why it is so important that each step of the production process is carefully manipulated, so that the company doesn’t fail the clinical trial process, and has to go back and start from scratch.

Most often, pharmaceutical clinical trial management will be subcontracted or outsourced to an outside pharmaceutical consulting or life sciences firm.  This takes place for a number of good reasons.  Because the final stages of developing the drug are extremely expensive, most drug companies will prefer that an unbiased party perform the testing, to eliminate any predisposed dispositions.  Another reason why drug companies usually hire outside firms for this testing process is liability.  If the drug produced ends up harming a lot of people, the drug companies can protect themselves by subcontracting this testing phase to an outside firm, in which case they could be found negligent.

All in all, the FDA prefers this method over any other method because they prefer the duo process involved with outside firms conducting the testing.  There is too much risk, and temptation involved with drug companies approving their own products, after they have spent billions developing them.  They might just overlook certain harmful aspects of the testing process, and many lives could be at risk.  Outside firms are professional, unbiased, and will provide the very best clinical management testing the industry has to offer.

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Problem solving is an element of every business. Effective problem solving is a result of using the right tools and strategies to include all members of the team to get to the best possible solution.  In life sciences consulting and other types of training programs, brainstorming is one of the easiest and most effective tools to use.

There are basically two types of brainstorming strategies that when used in conjunction with one another, will lead a team to the best possible solution to a problem.  These two methods are often referred to as Round Robin and Free Wheeling.

In Round Robin brainstorming, everyone is asked for their input into how to solve the issue at hand.   The team leader will go around the group to each person in turn and ask for ideas which are then written on a flip chart or whiteboard.  There is no discussion, evaluation or judgement of ideas at this time.   This helps to encourage members of the session who may be a bit shy into speaking up without feeling intimidated.  The team leader also refrains from any comments at this time about the ideas.  All discussion is saved for later.

During the Round Robin session, a team member who is unable to think of an idea will simply pass and the leader will move on to the next person.  When the majority of the team begins to pass, then it is time to move on to the Free Wheeling part of the session.

The team leader will continue to gather and write ideas on the board during this session as well.  However, the difference is, the team leader can stimulate discussion within the group and anyone can shout out any idea at any time.  This gathering of ideas continues until it appears there are no more ideas to write down.  It is crucial when this happens, however for the team leader to push a little harder at this point as this is often when the most creative ideas are generated.

Once the team is satisfied that all ideas have been expressed, it is then time to go back to the very beginning and start discussing the first ideas that were written down.  With each idea, the team leader will ensure that everyone understands the idea that was put forth.  Often, in clarifying the idea, new ideas will develop as well.

At this point, every idea will now be discussed by the group to determine its potential value in helping to solve the problem at hand.  As the team progresses through the ideas, some will be eliminated, some expanded upon, and some will be set aside to come back to at a later time.

Eventually by eliminating, changing and combining ideas, a viable solution to the problem will be found, and all team members will feel instrumental in achieving the desired results.

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