Info

People

Principles

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Portfolio of Products

Fig. 2.5. Paradigm of Product Development (P to 8th)

Fig. 2.5. Paradigm of Product Development (P to 8th)

experiences over 20 years by the authors. Plus, a large mass of selected published literature addresses problem areas in drug development, environmental factors for research, diseases and industry opportunities, and ideas to maximize organizational structure, processes, and productivity [1-22, 17-21, 39, 40].

This paradigm of eight "Ps," "P to the eighth power," suggests eight major parameters exist that together enhance success in product development (five components through one set of actions yielding two outcomes equals the eight parameters) (Fig. 2.5). The five parameters are (1) processes, (2) profits, (3) principles, (4) people, and (5) pipeline, which need to be executed and integrated well, that is, (6) excellence

Plans Package 1 Protocols 1 Portals 1

Projects Practices Proof PLA/NDA

B Ps for Profits from "Blsckblusters"

Plans Package 1 Protocols 1 Portals 1

Projects Practices Proof PLA/NDA

Fig. 2.6. Processes in the Paradigm (P 8th Power)

in performance, and collectively they result in (7) product approvals, and (8) a portfolio of products in R&D. The paradigm of eight parameters (Ps) and an overview of the process of product development in the pharmaceutical industry are displayed in the following commentary and diagrams.

Regarding processes (Fig. 2.6), the rule of Ps and eights continues in the operational components at a company culminating in product approval. These eight Ps for processes start with plans for research and build all the data and documents that finish with a BLA, NDA, CTD, or IDE. A plan, for example, includes all the projects, goals (target indications and product profile), protocols, resources (internal and external, people and budgets), and time frames. The project can be a single clinical trial or the collection of all trials that comprise the planned trials to be done for the NDA, BLA, or CTD. The package is the container system of the product, as well as the final formulation, that is, the physical vial, bottle, or boxes containing the product, and the product labeling on these packages. The practices are the company's operational guidelines and the standard operating procedures (SOPs), as well as their values and ethics, in conducting their work, including regulatory requirements. Compliance with these SOPs is an absolute requirement for an NDA, BLA, or CTD, and the regulatory authority performs audits to assure the compliance. Protocols are the study documents wherein each summarizes the intended conduct of a study, such as objectives, justification, and background for the product use in the target disease, patient selection, drug administration, monitoring parameters, study controls, and intended statistical analyses. Proof includes the clinical evidence from the clinical trials for safety and efficacy, as well as pharmacology, toxicology, pharmacokinetic, formulation, and manufacturing data, in the form of investigator brochures, final study reports, abstracts for medical meetings, and publications. Portals are the decision points by management for go-no go decisions over time for the studies and projects for a product. The PLA (BLA, NDA, or CTD) is the complete and final set

B Ps for Profits from "Blsckblusters"

Patient Need

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Prescription Volume

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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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