1 / 15

Drug Discovery Process

Drug Discovery Process. Massimiliano Beltramo, PhD. Drug Discovery Process. Aim of the two lessons : To give an overview of the drug discovery process. At the end of the lessons you will gain a general idea of the steps necessary to move a new drug from the bench to the bedside.

Download Presentation

Drug Discovery Process

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript


  1. Drug Discovery Process Massimiliano Beltramo, PhD

  2. Drug Discovery Process Aim of the two lessons: To give an overview of the drug discovery process. At the end of the lessons you will gain a general idea of the steps necessary to move a new drug from the bench to the bedside. • Lesson I outline: • General notions about drugs and the drug discovery process • Target selection/identification/validation • Lesson II outline: • Target validation • Assay development and screening • Lead identification/selection • Preclinical development • Clinical development

  3. What is a drug? In pharmacology, a drug is "a chemical substance used in the treatment, cure, prevention, or diagnosis of disease or used to otherwise enhance physical or mental well-being”.

  4. Various types of drugs • Drugs that interfere with the cause of the disease • “ disease modifying agents “ • Their action is intended to remove the cause of the disease (antibacterial, antivirals, vaccines, etc) • Drugs which compensate for deficits • Insulin, vitamins therapy, etc • Drugs which alleviate the symptoms • Symptomatic treatments (analgesic, antiallergic, etc)

  5. Various classes of drugs • Natural product • plant extracts • animal fluids (e.g., snake venoms) • Synthetic small molecules • Medicinal chemistry derived • Combinatorial chemistry derived • Biologicals • Natural products (isolation) • Recombinant products • Chimeric or novel recombinant products

  6. A new drug: why? • To address unmet medical needs • To reduce social cost of diseases • To improve the quality of life

  7. Pathologies with poor • or no treatment • - Cancer, Alzheimer’s, • Stroke, etc • New diseases • - Swine flu • Improvement of available therapy • - Better efficacy • - Reduced side effects Unmet Medical Need

  8. Disease associated costs • The medical care costs in USA in 2005 were around $2 trillion. • Direct costs are those connected with the use of medical care in the prevention, diagnosis, and treatment of disease and in the continuing care, rehabilitation, or terminal care of patients. Examples include: • expenditures for hospitalization, • drugs • outpatient clinical care, • nursing home care, • services of primary physicians and specialists, etc • Indirect costs measure the value of time that patients lose from employment or other productive activity due to mortality or morbidity. These costs also include reduced productivity once the patient returns to work, including unwanted job changes and loss of opportunities for promotion or education • Burden of illness exceeds economic costs. Estimates of the economic costs of illness do not capture some important aspects of the burden of illness such as reduced functioning, pain and suffering, and deterioration in other dimensions of health-related quality of life including emotional and psychological impacts on families, friends, and co-workers. (Source: NIH)

  9. The first pharmaceutical researcher • First drugs were of natural origin: herbs, seeds, fruits, roots, part of animals, rites and ceremonies

  10. MEDICINE AND PHYSIOLOGY BIOINFORMATICS CELLULAR BIOLOGY MOLECULAR BIOLOGY MEDICINAL AND COMBINATORIAL CHEMISTRY MULTIDISCIPLINARY EXPERTISE COMPUTER BASED DRUG DESIGN IN VIVO AND IN VITRO PHARMACOLOGY AUTOMATION AND ROBOTICS The Drug Discovery Today

  11. The Drug Discovery Process

  12. R&D timing • The whole process takes between 10 to 15 years.

  13. High risk activity Only 25 out of 100 new chemical entities (NCEs) tested in man reach the market Target-RelatedFailures (35%) Other Failures (10%) Toxicity Failures (10%) PharmacokineticFailures (10%) SuccessfulNCE (25%) MetabolismFailures (10%)

  14. Increase of R&D costs to develop a drug • In 17 years (1986-2003) the cost to develop a drug is increased more then ten times.

  15. Drugs withdrawn from the market

More Related