Protection of the Pharmaceutical Pipeline
What is the Pipeline?
The Pharmaceutical Pipeline is unique in many ways; not the least by the fact that from discovery or development of the molecule to final approval by the FDA and hence production normally takes 12 years. The Research and Development component on a new drugs life is a major expense for Pharmaceutical and R and D companies worldwide; this together with the need to protect their investment are paramount concerns from a business standpoint.
Apart from simple economics, Pharma companies are bound to protect their latest discovery by corporate ethics, FDA compliance and future consumer confidence.
In simple terms the Pharmaceutical Pipeline has two major stages, the first being the Pre-Clinical Stage and the second being the Clinical Stage. Within the Pre-Clinical stage the pharmacological profile of the drug is developed, animal testing is carried out on at least two species of animals and short term toxicity is tested.
In the USA the FDA is then advised and approval is sought for Clinical Trials to be conducted.
In the extensive Clinical Stage which we can describe as the stage where the drug is tested on humans; we have even a more robust set of testing criteria. There are four phases to this Stage.
Phase I : Studies are carried out on a small number normally 20 to 100 healthy volunteers. The purpose is to identify metabolic and pharmacological effects of the drug in humans, side effects and early evidence of effectiveness.
Phase II : This Phase centers on the effectiveness of the drug on patients with the particular disease/condition. It also attempts to check any possible side effects ad risks associated with the drug. This Phase is well controlled, very closely monitored and usually involves several hundred patients.
Phase III : If effectiveness has been confirmed in Phase II, Phase III attempts to test the overall benefit versus risk of the particular drug. This Phase can involve the participation of Medical Practitioners and several hundred or thousands of patients.
During this Phase the FDA reviews the data collected and approval is sought for post marketing testing.
Phase IV : This is sometimes known as the 'Post Marketing Surveillance' Phase. This phase is to establish the patient 'safety profile' of the drug.
It should be remembered that one drug out of several thousand do not make it past Phase III or IV.
Why protect it?
It takes approximately 12 years from discovery to the drug being a marketable product. This major expense to Pharmaceutical companies has to be regained by sales normally within the life of the various patents applied for to protect their investment in the drug.
These patents last up to 20 years however, Governments can and have shortened the protection period due to their concern for patients having the need for cheaper medicine within the marketplace.
Because of this major investment, Pharma companies have to protect this expense from persons willing and with the knowledge to copy the developing technology. Apart from the simple fact of money, Pharma companies have a much broader ethical and corporate responsibility to protect the reputation of their company and their brand name.
There have been instances where within Phase II, Phase III and Phase IV drugs both injectable and oral have been found counterfeited and within the public arena, some with negative effects. The image of these products when (and if) they are approved will be tarnished.
Dan Murdoch Risk Services are proud of the fact that we were instrumental in finding some of these illicit dealings and markets for these Pipeline Products.
Dan Murdoch Risk Services have also uncovered through our intelligence programs several companies offering to sell certain drug technology and the expertise to assist anyone who has the capability to produce finished products from raw materials both in Clinical Stage and approved.
The need to protect your investment, good name and corporate reputation is paramount. Pharma companies have to be proactive and not only react to a perceived problem that they have been presented with.
Pharmaceutical companies protect their investment by protecting their products in the developmental stage by registering a variety of patents on their molecule, the manufacturing process, the drug itself and the drugs usage.
For an in-depth look at the World Trade Organization's article on TRIPS and patents as they relate to the Pharmaceutical industry click here to view or download the 2006 article. It is still relevant today.
How we protect the Pharmaceutical Pipeline
Dan Murdoch Risk Services have been protecting the Pharmaceutical Pipeline and the products of major Pharmaceutical companies worldwide for many years, we know Pharmaceuticals, we know the development process and we know and understand the need for Pharma companies to be proactive in their thought processes to protect their investment and products.
Dan Murdoch Risk Services developed the processes many companies now use to proactively protect their supply chain and their products from illicit trade. However, we go one step further and understand the need to protect drugs in the early and late development stage from technology theft and illicit trade in this technology and the drugs illegal development.
Patent protection in a drugs embryo stage is vital.
WHAT YOU SHOULD DO:
Identify which of your Pipeline drugs could be at risk and could be attractive to illicit development and manufacture. One suggestion is not to look at whether or not a drug could be a 'blockbuster drug' this is not a criteria, the first criteria should be if the drug/molecule is in a class which would be commercially viable to illicit drug entrepreneurs.
Such classes as weight loss, cancer, HIV, hypertension, erectile dysfunction, OTC medication, antibiotics and cholesterol medication to name a few.
WHAT WE DO:
Dan Murdoch Risk Services will set up a unique online presence legally developed and anonymously labeled to act as an internet honeypot for any manufacturers, brokers or other person or company willing to trade in your technology, early or late stage developed product or molecule.
Our analysts will engage with anyone offering to trade in your Pipeline products and deliver this evidence to you for action.
Parallel to this proactive program we will manually monitor up to 100 trade and business sites worldwide for any activity that indicates that your pipeline products are being the subject of illicit activity. Dan Murdoch Risk Services report this to you for you to take action.
Dan Murdoch Risk Services also monitor all Chinese language web activity manually by our Chinese national staff to uncover any illicit activity in your Pipeline products. It is known that the great majority of illicit activity in the Pharmaceutical industry globally originates from China.
Our analysts manually select for your particular attention certain recommendations where we give to you solid reasons why these companies/persons should be further investigated and are of special interest.
Put simply we will be proactive for you and your company in protecting your Pipeline productsyou're your substantial investment.
Imagine if the FDA discovered that one of your Pipeline or developing drugs had been compromised.
Imagine if the public also became aware of this.
About Author / Additional Info:
Dan Murdoch has been protecting the interests of major pharmaceutical companies worldwide for many years and is regarded as an industry expert on online intelligence gathering methods. Refer to www.risk.co.th and www.yourintell.com for personal attention.