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Information Technology in a Pharmaceutical Company

Supporting Rare Disease Research

The process of developing new therapies for rare diseases requires laboratories. That’s obvious, isn’t it? Another critical lab function that may not be so obvious involves quality assurance. All batches of medicines undergo rigorous testing to ensure the manufacturing process produced pure products.

Automation drives and controls medical research labs far more than your chemistry or biology lab courses did in school. Today’s automated lab instruments produce data constantly, recording moment-by-moment conditions in experiments and tests. IT Patch Panel in Rare Disease CompanyRare Disease Company IT Patch Panel

While the format of the data may result in small files, the nature of the data has led to many regulations and requirements for how the data is handled.

Data in Pharmaceutical Companies

Some kinds of data fall under strict guidelines and regulations. Anything that has to do with the manufacture of medicines and the subsequent quality control testing processes remains subject to FDA and international public health agency regulations. Violations of those regulations could actually lead to those public agencies shutting down companies in a matter of minutes. At a very high level, anything, networks and servers included, that could alter the data that would affect manufacturing or lab analysis must be validated, qualified, and controlled rigorously.

What does that mean? When a computer system becomes part of the manufacturing or laboratory environment, extensive tests certify that the application that may control a lab instrument will never invent its own data. This requirement makes sense if you think about it. Variations in data lead researchers to conclude they either have a blockbuster for treatment of a rare disease, or they don’t. If a computer system monitoring temperature of an experiment failed to record or report data for five minutes, how would anyone know if the temperature spiked and recovered, or did nothing abnormal at all?

The same concern applies to control of a manufacturing process. Manufacturing equipment may heat or cool ingredients, and most certainly measure quantities. Moment-by-moment data points assure Pharmaceutical companies and their customers the final product is the same as it has been from the first batch, and remains as safe and as effective as ever.

We all know computers require regular software updates and security-related patches. Microsoft updates usually require system reboots to take effect. Anti-virus software updates can cause a workstation to suddenly block required traffic. Normal IT procedures could have a large negative effect if updates change or disrupt the flow of data in labs or manufacturing.

“Good Manufacturing Practices” in IT in Pharmaceutical Companies

The regulations that control the manufacture of food and drug products create a set of requirements known as “good manufacturing practices” or GMP. A GMP process adheres to the stringent requirements laid out by regulatory agencies worldwide. The industry standard vernacular is “current good manufacturing processes” or CGMP.

GMP regulations or practices affect network design and the configuration management of systems involved in the manufacture or testing of medicines and foods. When a network and systems attached to it connect manufacturing or quality control lab equipment, their configurations have to be validated. Additionally, processes related to changes and maintenance have to be documented.

This complicates the “basic” tasks of network design and architecture. Many network components supporting the business side of a pharma company must change constantly to accommodate new business requirements and protect from new security threats. The two goals of enabling and protecting business operations and supporting manufacturing and disease research seem at odds with each other. However, networking professionals can take measures to satisfy requirements of both interests.

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What is a Rare Disease Company?

Rare Disease

Let’s answer the question of what a rare disease company is by first defining the term “rare disease.”

The Wikipedia definition of a rare disease is one that affects a small percentage of the population.  The Rare Disease Act of 2002 defines a rare disease to be one that affects fewer than 200,000 people in the United States, or approximately 1 in 1,500 people.  Similar definitions were made in Japan and the European Union.

Governments were driven to define rare diseases in order to craft policies and programs that would promote research and development of treatments.

Rare diseases are typically genetic by origin, so they are present throughout a person’s life. Symptoms can appear immediately after birth and usually become evident before adulthood, although some experience the onset of symptoms in early adulthood.  Another trait of rare diseases is that many are life-threatening. A chilling statistic is that approximately 30% of children with rare diseases die before their fifth birthday.

Rare Disease Company

Many pharmaceutical companies research and develop drugs and treatments for diseases that affect more people.  A larger potential consumer base implies greater sales.  Every company is in business to accomplish its primary mission and make money in the process to fund product manufacture, research and development, salaries, rent, etc.  Simple math shows that more sales revenue equals longevity, so several pharmaceutical companies compete with each other for effective treatments for diseases that affect millions of people annually.

A rare disease company focuses on treatments and therapies for rare diseases and therefore will not have the same volume of patients as larger pharma companies.  They must still fund research and development, testing, FDA and other global FDA-equivalent agency approvals, stringent manufacturing processes, etc, all of which are incredibly expensive. Since prices of treatments fund the company’s operations, it stands to reason that the per-unit cost of rare disease therapies is much higher, since far fewer patients are treated.

Another challenge facing a rare disease company is in marketing. The medical community-doctors, nurses, etc may not have heard of either the definition of a particular disease, or a treatment, if one exists. Many doctors learn of new treatments and therapies from sales reps that constantly travel from practice to practice, or at conferences.

There’ a lot of personal gratification and satisfaction to be had when working for a company that produces a medicine or treatment actually saving the lives of children or young adults, helping them live their lives as most “normal” people. This is true especially when the severity of the disease causes a great deal of pain and suffering before certain death.

The World’s Rare Disease Company dedicates itself to serving the smaller population of rare disease sufferers.

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