Info

Novel Drugs (hits) & Categories

Novel Mechanisms Of Drug Action

Fig. 3.11. Science Leadership

Fig. 3.11. Science Leadership k Disease biology r Compound screening k Recombinant DNA

technology r Monoclonal antibodies k Polymerase chain reaction r Nucleotide blockade k Gene therapy k Combinatorial chemistry k Molecular engineering k Medicinal chemistry r Transgenic animals

Structure/activity relationship

High -throughput screening

Micro -Array assays

Genomics

Proteomics

Pharmacogenomics

Ribozymes

Protein kinases

Receptorology

Cell therapy

Tissue engineering

Bioinformatics

Fig. 3.l2. Techniques in Product Discovery amount of work per unit of time 10- to 1000-fold, pharma-cogenomics to identify the best or worst responders or more susceptibility to adverse drug effects, and bioinformatics to store and manipulate the vast volume of data available. New product categories for drug discovery over this 20-year period include the following examples each for a different technology: (1) recombinant DNA technology to reproduce proteins as therapeutics (e.g., Kepivance® for mucositis in cancer patients), (2) monoclonal antibodies for 20 different diseases (e.g., Rativa® for psoriasis), (3) molecular engineering to have improved second generation protein molecules (e.g., Pegasys® for hepatitis C), (4) nucleotide therapeutics with, for example, antisense antiRNA (e.g., Vitravene® for CMV retinitis), (5) tissue engineering (e.g., Fortaflex™ for rotator cuff repair), (6) protein kinase receptor interference (e.g., Gleevec® for acute myelogenous leukemia), (7) peptides (e.g., Fuzeon® for HIV infections). Proteomics, ribozymes, combinatorial chemistry, and more are being studied in laboratories to find yet new generations of products.

Studies are yet another set of outcomes from the R&D organization, which will be discussed at length in Chapters 4 and 5 and are listed in the next figure (Fig. 3.13). These studies often are done at a university through research grants. The seven study types encompass the full cycle of research at a company from early work in the basic sciences for disease pathology and mechanism of action of products; through pre-clinical work in animals for pharmacology, toxicology, and pharmacokinetics; human trials for metabolism and pharma-cokinetics, early small clinical trials (phases 1 and 2) to demonstrate proof of principle; to full large pivotal trials for the marketing application to establish safety and efficacy (phase 3) and also postmarketing (phase 4 and postmarketing surveillance); economic trials to establish cost-effectiveness, quality of life improvements, and the value of a product to the health care system; and other studies as needed for disease epidemiology, drug interactions, or product stability in various patient care situations.

The outcome for R&D that measures overall productivity is the pipeline, usually organized by business areas for a company, and/or therapeutic categories focused on by the company, and/or the stages of research. In Figure 3.14, the data covers the pipeline for Novartis company by the end of 2003, which was presented in February 2004 by a lead scientist at an pharmaceutical conference. A robust pipeline possesses several characteristics, which are represented in this table for Novartis. A reasonably large number of molecules is needed in general. A sufficient number of molecules in each cell is the next prerequisite for a robust pipeline. All the therapeutic areas and businesses are covered. Each stage of research is covered, such that, as the pipeline evolves and products advance to approval, no gap will exist in a year with no approvals, and the businesses will have a steady stream of new products. In addition, the following characteristics are important for defining a robust pipeline: unmet medical needs being met, diseases with high patient populations, chronic diseases being treated, high sales

Fig. 3.13. Types of Studies

Bus. Un.

Bus. Franchise

Precl.

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