Processes Workflows It Standards And Architectures

The conventional R&D process—documented extensively by most research-based biopharmaceutical companies—is sequential (Figure 1). After target identification and validation by the "biologists," the medicinal "chemists" take over and screen extensive libraries of hundreds of thousands of chemical compounds against the target of eventually finding a suitable candidate for a drug. After the IND (initial new drug) application to the FDA, the drug candidate is tested in preclinical animal studies before it is handed over to the clinical development organization for clinical trials that proceed through three phases. If the drug candidate survives through phase III, all the supporting information collected will be submitted to the FDA in form of a new drug application (NDA) dossier that has to be compiled such that FDA's rules and regulations are respected and followed. After FDA approval, phase IV trials may be conducted to collect postmarketing surveillance data about adverse drug reactions or to position the drug for new indications not yet covered by a given FDA approval.

To manage the process effectively and to terminate failed projects as early as possible, R&D organizations have created a set of disciplined processes designed to optimize project portfolios and to track the progress of individual projects by milestones or decision gates (Figure 2). Industry leaders such as

Basic Research

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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