RD Challenges and Issues

Research and development in the industry has to deal with much more than just the biology of a disease, or the creation of drug category, or filing the NDA. Many external forces impact a company's goal to develop blockbuster products; although most are not under a company's control, they must be dealt with or they will become inordinate barriers to research and marketing of products. Here we will discuss also some financing issues particularly for start-up companies. Company collaborations are a necessity for access to novel science and also efficient operations as we will discuss. Company culture is a major enhancement or barrier to operations' effectiveness. Finally, resource focus on specific technologies is a best practice to be reviewed as well.

The research and development process is complex (hundreds of actions in many stages by thousands of people) and lengthy (about 10 years) as already stated, and Figure 1.31 displays the situation well with a myriad of plans, activities, and regulatory issues. Four phases at the company are presented; that is, discovery, research (preclinical animal and related work), clinical research, and postapproval activities. Two other phases occur with and at the regulatory authorities for the review and hopeful approval of applications to proceed on to the next stage of R&D: Investigational New Drug application (IND in the USA) or Clinical Trials Application (CTA in Europe), and new drug application or biologics license application or common technical document (NDA or BLA in the USA or CTD in Europe). The regulatory authorities regulate and assist companies with product development and at the same time protect public safety, ensuring efficacy, safety, and quality product production. Each phase contains a variety of actions as summarized in the slide; each phase will be discussed at length in subsequent chapters in the book. Overriding these phases and activities is the planning processes for the portfolio, products, and projects, all of which will be discussed in the governance and planning chapter. Throughout the R&D process, certain activities are done, repeated, and refined in the areas of market research and manufacturing, in order to support the molecules and products as they progress and evolve though R&D requiring new

Discovery Preclinical Research: Studies Phase: (5-10 Yrs) (2-4 Yrs)

Focus: Disease, Focus: Safety &

Targets, & Hits/Leads

Medicinal Chemistry

Molecular Engineering

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