Course Identification

Course objectives:

The course will cover the main aspects of the drug development process and will expose students to the essential activities of drug development, from discovery, through to preclinical development, clinical development, manufacturing, and regulation. At the end of the course, the students will be familiar with the terminology and main stages in drug development in an industry setting.

Course requirements and grading policy:

Attendance requirement in at least 80% of the lessons

Final exam (multiple choice) in English (100% of the grade)

Topics to be covered in the course:

1. Introduction to Drug Development: introduction to the drug development process from planning to execution and probability of success; introduction to the functions/teams involved at different stages of drug development; overview for the rest of the course in which we will dive deeper into each of the stages; 
2. Preclinical pharmacology: the role of preclinical research in drug development in industry and its importance for the clinical development stages and for the regulatory requirements; understanding the therapeutic potential of a therapy in development, examples of experiments and the relevance of animal models.
3. Early-stage drug discovery: bioassay development and high throughput screening: early stages of drug discovery, methods to investigate biological activity, and approaches for high throughput screening.
4. The role of medicinal chemistry in drug discovery and development:  characteristics of molecules with medicinal potential; selection and optimization processes; natural molecules as a source of new drug candidates.
5. Preclinical safety:  introduction to the main topics in toxicology and ADME (absorption, distribution, metabolism, and excretion); objectives of the toxicology studies, the stages, the regulatory and clinical requirements; emphasis will be put on studies that cannot be performed in humans (for example, carcinogenicity, reproductive toxicology); learn the relevant terminology, such as Good Laboratory Practice (GLP).
6. Planning a clinical trial: familiarity with terms such as clinical development plan (CDP), target product plan (TPP), planning clinical trials in advanced phases (2-4), biomarkers, protocols and regulatory approvals, the placebo effect, criteria for participation in a clinical trial.
7. Clinical pharmacology:  pharmacokinetics and pharmacodynamics; the regulatory requirements for a clinical pharmacology program and examples.
8. Intellectual property (IP) in the pharmaceutical industry. What is a patent, why is it needed, different types of patents and basic concepts of patent law, patent infringement, and patentability issues.
9. Introduction to development of biologics and biosimilars: the stages involved in developing a biologic as compared to a small molecule drug; comparison of the processes for developing biologics as compared to biosimilars; the stages and challenges in developing biosimilars.
10. Computational Biology: The lecture will cover the two major approaches in the computer-aided drug design field, structure- and ligand- based, using data on protein structure and on the properties of bound ligands, respectively. Introduction to computational methods in these approaches: comparative modeling, docking, pharmacophore modeling, etc.
11. Analytics and big data: introduction to the role of technology, big data and analytics for drug development and clinical monitoring; use of sensors and wearables; digital biomarkers and predictive models.
12. Chemistry Manufacturing and Control (CMC): CMC main principles; how do physico-chemical properties of a drug substance (DS) influence its formulation into drug product (DP); process development for DS and DP; analytical method development and quality control; clinical and regulatory requirements, CMC in generic medicine development. 
13. Tour of the Teva site in Kfar Saba and of the BLAVATNIK CENTER for Drug Discovery at Tel Aviv University: (dates to be determined, limited number of places)     

The course will cover the main aspects of the drug development process and will expose students to the essential activities of drug development, from discovery, through to preclinical development, clinical development, manufacturing and regulation. At the end of the course, the students will be familiar with the terminology and main stages in drug development in an industry setting.