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Fig. 1.15. R&D Spend by Research Phase (2002) (Adapted with permission from Thomson CenterWatch. Boston, MA. From An Evolution in Industry 4th Ed. 2003 Lamberti MJ Ed. Graph -Distribution of U.S. R&D spending, 2000. Pg 59.)

Fig. 1.15. R&D Spend by Research Phase (2002) (Adapted with permission from Thomson CenterWatch. Boston, MA. From An Evolution in Industry 4th Ed. 2003 Lamberti MJ Ed. Graph -Distribution of U.S. R&D spending, 2000. Pg 59.)

comprised of four components: (1) the laboratory efforts in the synthesis and extraction of the drug, (2) the creation of the product formulation (and testing of its viability and practicality), that is, tablet vs. liquid vs. injection, (3) process development, which is the work on manufacturing of the drug, and (4) all the testing of the processes and interim product at various stages of its evolution. Animal testing includes primarily pharmacology and toxicology studies with some pharmacokinetics efforts. The major cost area is clinical testing as shown at 35%. It is worth noting that the regulatory process of preparing both the IND and NDA at the company appears to be only 3%, but the real dollar number is about $24 million, a significant expense for meeting the regulatory application processes [22].

A representative research pipeline at a major pharmaceutical company is provided on Figure 1.16 for Novartis in 2003. Dr. Garaud presented these statistics at a conference in February 2004 for all the projects at four stages from preclinical to their phase 3 and regulatory submission stage. The table of 125 projects includes some drugs being studied for multiple indications; please be reminded that two different indications are potentially two different NDAs. Their business including research planning (product portfolio) is divided into eight distinct business units, and also two major areas, first into primary care areas and second into specialty therapeutics. Five areas exist for primary care therapeutics for Novartis and three specialty areas. Several criteria are important in establishing a successful and robust pipeline, some of which are demonstrated on this slide: product candidates in all four stages of development; a reasonable number of product candidates at each of these four stages, especially given that most will ultimately fail and not be carried forward; a reasonable number and balance of product candidates across the eight business/research areas; and therapeutic areas being represented with important patient care and significant business opportunities (sales potential). Other major criteria for a robust pipeline, not represented on the slide, are blockbuster potential for several candidates,

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Project Management Made Easy

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