General Drug Development Methodology

Assume you are a successful IT project manager who has been assigned to work for a new client; or you're a consultant and you find employment at a pharmaceutical company, where you are to head up a large multinational team of chemists and doctors to develop a new revolutionary drug. Can you do it? Yes, if you have a thorough grasp of project principles, understand process, and are able to learn quickly.

A new drug development methodology is best defined as a process followed for all those project activities and tasks from the identification of a lead compound to the approval by a regulatory agency for marketing a new drug. The project management methodology is surely one of the most crucial aspects for taking the new drug development through to its conclusion (see Figure 4.15).

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Figure 4.15: New drug development methodology. Source: FDA requirements, Overviewofthe drug development process, www.fda.gov/cder/handbook/develop.htm. Reprinted with permission.

Many drug and pharmaceutical companies rely on the research and development of new drugs to prevent life-threatening diseases and viral outbreaks throughout the globe. Engaging in any new drug project is a comprehensive task and should not be taken lightly. It requires considerable investment and resources, and may take up to fifteen years to get approval by monitoring agencies, such as the Federal Drug Agency (FDA). Even getting the IT systems in place to support the drug development process is audited by the FDA and also requires formal methodologies, which necessitate formal documentation and regulatory requirements.

New drug development is an R&D project, where the risks are notably high and can cost from the tens to hundreds of millions of dollars to develop and market. The research costs are astronomical during clinical trials. Therefore, drug companies want not only the best pharmaceutical and medical minds developing these vital drugs, but also a structured project methodology for this effort. Without a development process, the process simply will not work.

Many drug-related projects face failure because of the high risks and research involved. The success rate is small. After a drug has been registered and approved, the sponsoring drug company will have applied for a patent. Modern-day patents for drugs are limited to a 20-year period, thus limiting their product earnings capability. This leaves manufacturers with only a short time to commercialize and recover the research and development costs before the patent expires. Competitors quickly start developing generic equivalents after the patent elapses and offer the drugs at much lower costs than the original manufacturer, which forces prices down dramatically.

More importantly, these pharmaceutical companies adhere to certain standards and guidelines. The new drug development methodology is an example of such a process. It divides new drug development into the following main categories:

Concept.

Preclinical research.

Clinical studies.

NDA review.

Project Management Made Easy

Project Management Made Easy

What you need to know about… Project Management Made Easy! Project management consists of more than just a large building project and can encompass small projects as well. No matter what the size of your project, you need to have some sort of project management. How you manage your project has everything to do with its outcome.

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