オーダーメイド医療の将来

Abstract

Personalized Medicine: The impact of proteomics on drug discovery and clinical trial design is a management report that analyses how proteomics will streamline drug development and lead to the more cost-effective development of niche personalized products of the future.

Proteomics promises lower R&D costs and the opportunities of new revenue streams through the identification of new drug targets in the treatment of diseases such as cancer and Alzheimers. Use this report to identify the most important technologies, their applications in drug discovery and clinical trial design and the leading companies driving development of this exciting new area.

The pharmaceutical industry has so far been slow to take up proteomic technology and strategic alliances and acquisitions will be central to the pharmaceutical industrys uptake of proteomics. This report identifies the key technologies that will enable pharmaceutical companies to develop new niche products, improve drug attrition rates, increase the speed of clinical development and target new drug markets.

Key findings of the report

Proteomics has the potential to reduce drug development time and drug attrition rates. If total development time is reduced by three years and the number of successful NDAs doubled, R&D costs could be cut by as much as 30% per year. Companies investing in proteomics to target niche markets can reap considerable financial rewards as exemplified by Gleevec (Novartis) and Herceptin (Roche) which generated around $1bn in worldwide sales in 2003. There is a high unmet clinical need for early disease detection, such as in cancer and neurodegenerative diseases. The development of diagnostic tools using "biomarkers" has the potential to result in better prognosis for patients and to satisfy this unmet need. More that $700m has been invested in proteomics companies by venture capitalists and through IPOs (Initial Public Offerings) in the last four years. As the main bottleneck in proteomics is the ability to analyze the colossal amount of data generated, it is essential for companies to invest heavily in bioinformatics.

Table of Contents

CHAPTER 1: INTRODUCTION TO PROTEOMICS

• The human genome versus the proteome
• Identification of human genome
• Applications to proteomics
• The relationship between the proteome and the genome
• The genome
• Proteins
• From genes to proteins
• Proteomics

CHAPTER 2: PROTEOMIC TECHNOLOGIES

• Laboratory methods used in proteomics
• Separation techniques
• Identification techniques
• Interactions techniques
• Separation techniques
• Identification techniques
• Protein-protein interaction techniques
• Automation
• Pre-fractionation
• Separation
• Identification
• Complete proteomics solutions
• Bioinformatics and databases
• Data Analysis
• Databases
• Laboratory information management systems (LIMS)

CHAPTER 3: PROTEOMIC APPLICATIONS IN DRUG DISCOVERY

• Optimizing the R&D process
• Early selection of efficacious and non-toxic drug targets
• Toxicoproteomics
• Pharmacoproteomics
• Accelerating the discovery of new targets for therapeutic candidates
• Therapeutic proteins
• Protein targets
• Mining the proteome is an alternative approach for drug discovery

CHAPTER 4: PROTEOMIC APPLICATIONS IN CLINICAL TRIAL DESIGN AND PERSONALIZED MEDICINE

• Development of new biomarkers
• Biomarkers as clinical endpoints
• Responders and non-responders
• Patients with adverse reactions
• Patients in different stages of a disease, or other subsets of patients
• Monitor clinical responses in new and comparator drugs - allowing potential strategic alliances
• Patients with disease resistance
• Niche markets
• Application of biomarkers in different therapy areas
• Oncoproteomics
• Application in the diagnosis of: ovarian
• cancer, prostate cancer, breast cancer and
• esophageal cancer
• Neuroproteomics Application in the diagnosis of:
• Alzheimers diseases and amyotrophic lateral sclerosis (ALS)
• Cardioproteomics
• Cardiovascular markers
• Respiratory markers
• Application in organ transplantation
• Post-marketing applications of biomarkers

CHAPTER 5: PHARMACEUTICAL AND PROTEOMIC COMPANY ALLIANCES

• Recent collaborations and alliances of pharmaceutical and proteomic based companies