Course Identification

Practical aspects of innovative Pharma and Biotech business
20213052

Lecturers and Teaching Assistants

Dr. Avri Havron
N/A

Course Schedule and Location

2021
Second Semester
Wednesday, 09:15 - 11:00, FGS, Rm 1
24/03/2021
31/08/2021

Field of Study, Course Type and Credit Points

Life Sciences: Lecture; Elective; Regular; 1.00 points
Life Sciences (Molecular and Cellular Neuroscience Track): Lecture; Elective; Regular; For PhD students only; 1.00 points
Life Sciences (Computational and Systems Biology Track): Lecture; Elective; Regular; For PhD students only; 1.00 points

Comments

All courses in the second semester will be held via zoom.
MSc students are welcome to participate for credit if number of registered PhD students will be less than 24

Prerequisites

Students having the following background can join the course.

  • BSc or BE in one of the following: biology, chemistry, pharmacy, agriculture, biotechnology, chemical engineering, biotechnology engineering, food engineering,
  • MD, DVM, DDM

Restrictions

24
For PhD students only

Language of Instruction

English

Registration by

09/02/2021

Attendance and participation

Obligatory

Grade Type

Pass / Fail

Grade Breakdown (in %)

100%

Evaluation Type

Final assignment

Scheduled date 1

N/A
N/A
-
N/A

Estimated Weekly Independent Workload (in hours)

3

Syllabus

The course is appropriate for students in chemistry and life sciences who contemplate possible careers in the pharamceutics and biotech industry and who seek to deepen their understanding of the relevant business context. The course provides perspective on the evolving landscape of pharma and bio-technology from the standpoint of new entrepreneurial companies. It focuses on changes and challenges in the industry, as well as opportunities for startups and new entrants. 

The course provides insights through a range of approaches and materials, including readings, cases, lectures, outside speakers, and class discussion.  The course meets once a week in a two-hour session.

The written assignments include one of the following:

  • An assessment of an existing or  novel biotech business
  • Case write-ups
  • A final paper that pursues one of the course topics (your choice) in depth
  • Presentation of a new proposed start-up

The assignments can be written and submitted jointly with another student. All assignments will be presented to the class during the last 2-3 meetings (pending number of participants). There will be no final exam in this course. 


TOPICS AND CLASS SESSIONS

  • Class 1 – Introduction  
  • Class 2 – Overview of the Biotech Industry and supporting services
  • Class 3 – Development Process of a new chemical or biological drug
  • Class 4 – Development Process of a new medical device
  • Class 5 –  Pre-Clinical Development 
  • Class 6 – Clinical Development 
  • Class 7 – Regulatory development 
  • Class 8 – Building a start-up (business plan, strategy)
  • Class 9 – What Do We Want to Be? Business Models & Business Development
  • Class10 – Financing the early stage healthcare company
  • Class 11 – National Incubator Program
  • Class 12 – The Role of Universities and Technology Transfer Offices
  • Class 13 – Intellectual Property 
  • Class  14 - CMC (chemistry, manufacturing, control)
  • 15 ,16 – Presentations of students' assignments (In this concluding classes, students will present findings from their final paper).

Learning Outcomes

Upon successful completion of the course- students should be able to:

  1. Critically review various aspects and plans related to the development of their future career within a company they'll join or consider founding.
  2. Demonstrate understanding of what are the key success factors for a life-science company utilizing  innovative technology.
  3. Demonstrate familiarity with the development process of a new drug or a device; the pre-clinical and clinical development; Economical aspects such as business models; increasing valuation and fund raising methodologies will be discussed; contract work, Business development and partnering; intellectual property; the importance of team work; and "crisis management".

Reading List

  1. Bioentrepreneur - Nature Biotechnology’s monthly portal dedicated to scientists interested in commercializing their research
  2. BioWorld Today - Daily news from the biotech industry publishe 5 times a week by Thomson Reuters'.
  3. BIO SmartBrief - Biotechnology Inonnvation Organization daily update
  4. FierceBiotech - The biotech industry daily monitor

Website

N/A