Course Identification

Title:

Fundamentals in Drug Development

Code:

20223041

Lecturers and Teaching Assistants

Lecturers:

Prof. Avraham Yaron

TA's:

N/A

Course Schedule and Location

Year:

2022

Semester:

First Semester

When / Where:

Tuesday, 16:15 - 17:45

First Lecture:

26/10/2021

End date:

09/01/2022

Field of Study, Course Type and Credit Points

Life Sciences: Lecture; Elective; Regular; 2.00 points
Life Sciences (Molecular and Cellular Neuroscience Track): Lecture; Elective; Regular; 2.00 points
Life Sciences (Brain Sciences: Systems, Computational and Cognitive Neuroscience Track): Lecture; Elective; Regular; 2.00 points
Life Sciences (Computational and Systems Biology Track): Lecture; Elective; Regular; 2.00 points

Comments

Two lectures will be held on Sunday at the same time:
24.10 first lecture
9.1- last lecture

Prerequisites

No

Restrictions

Participants:

60

Language of Instruction

English

Registration by

Registration By:25/10/2021

Attendance and participation

Required in at least 80% of the lectures

Grade Type

Numerical (out of 100)

Grade Breakdown (in %)

Final:

100%

Evaluation Type

Examination

Scheduled date 1

Date / due date

10/02/2022

Location

N/A

Time

-

Remarks

N/A

Scheduled date 2

Date / due date

07/03/2022

Location

FGS, Rm C

Time

1000-1200

Remarks

N/A

Estimated Weekly Independent Workload (in hours)

1

Syllabus

Lecture	Date	Title	Presenter
#1	24.10.21 SUNDAY	Introduction to drug development + Pre-clinical development	Dr. Aric Orbach, Teva
#2	2.11.21	Early stage drug discovery, bioassays development and high-throughput screening	Dr. Eddy Pichinuk, BLAVATNIK Center for Drug Discovery at TAU
#3	9.11.21	The role of medicinal chemistry in drug discovery and development	Dr. Elvira Haimov, BLAVATNIK Center for Drug Discovery at TAU
#4	16.11.21	Nonclinical safety, toxicology and ADME	Dr. Hilla Kedar, Teva
#5	23.11.21	Planning a clinical trial	Dr. Eran Harary, Teva
#6	30.11.21	Clinical pharmacology	Dr. Laura Rabinovich , Teva
#7	7.12.21	Introduction to intellectual property	Dr. Sharon Hausdorff, Teva
#8	14.12.21	Introduction to biological drugs development & Computational Biology	Dr. Nir Shapir , Teva Dr. Luba Ischakov, Adva Yehezkhel, BLAVATNIK Center for Drug Discovery at TAU
#9	21.12.21	Analytics and big data in drug development & Ethical issues in Drug Development	Dr. Shay Zakov, Teva Dr. Miriam Bentwich, BIU
#10	28.12.21	Generic R&D and CMC	Dr. Daniella Gutman , Teva
#11	4.1.22	Regulatory Affairs & Technology Transfer	Levana Volovsky, MSc, Teva & Dr. Tali Aloya, Ramot, TAU
#12	9.1.22 NOTE SUNDAY CLASS	Academia to Industry – case studies from University PI/Entrepreneurs	BIU - TBD TAU – Dr. Maayan Gal WIS - TBD

Learning Outcomes

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.

Reading List

Further reading:

Introduction to drug development:
- https://www.fda.gov/patients/learn-about-drug-and-device-approvals/drug-development-process
- https://www.fdareview.org/issues/
- Guide to Drug Development: A Comprehensive Review & Assessment (1st Edition) by Bert Spilker (Editor). Hardcover, 1232 Pages, Published 2008.
- FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring, August 2013. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/oversight-clinical-investigations-risk-based-approach-monitoring
Introduction to nonclinical safety testing:
- ICH M3(R2) guideline. 11 June 2009. https://database.ich.org/sites/default/files/M3_R2__Guideline.pdf
- Principles of Toxicology by David L. Eaton and Curtis D. Klaassen. In: Casarett & Doull's Toxicology: The Basic Science of Poisons, Eighth Edition. Unit 1: Editor: Curtis D. Klaassen. Chapter 2, pages 13-48. Publisher: McGraw-Hill Professional Publishing, 2013.
Regulatory Affairs:
- Communication from the Commission 2010/C 82/01 — Detailed guidance on the request to the competent authorities for authorisation of a clinical trial on a medicinal product for human use, the notification of substantial amendments and the declaration of the end of the trial (CT-1), March 2010
- US Code Title 21, Part 312, Investigational New Drug Application, Revised as of April 1, 2020
- FDA Guidance for Industry: Formal Meetings Between the FDA and Sponsors or Applicants, May 2009
- European Commission: Notice to Applicants Vol. 2A: Procedures for marketing authorisation, June 2013
- European Commission. (2008, May). Volume 2B: Notice to Applicants: Medicinal products for human use. Presentation and format of the dossier: Common Technical Document (CTD).
- The CDER Handbook, produced by the Department of Health and Human Services, Food and Drug Administration, March 1998
- CDER 21st Century Review Process, Desk Reference Guide, produced by the Department of Health and Human Services, Food and Drug Administration, September 2014

https://www.fda.gov/media/78941/download

Website

N/A