- Teacher: Dr Priyatosh Ranjan
- Teacher: Dr. Parth Sarthi Sen Gupta
- Teacher: Prof.Shashi Singh
- Teacher: Ms Unnati Sunil Darak
- Teacher: Dr. Surabhi Sonam
Name of the Course: MMB 5003 Bio-entrepreneurship
- Course Instructor:
Name: Prof. Manoj Kumar AS
Office Number: 352
Phone: 9967181502
Email: manoj.kumar@dypiu.ac.in
Office hours: 9 am to 5 pm
Location: Akurdi
- Teaching Assistant:
None
- Level (who can take this course?): Graduates in Bioengineering and Biotechnology
- Credit:
L T P C
3 0 0 3
- Evaluation: Based on attendance, interactiveness, business model project, mid term examination score and end of semester examination score
- Breakup of evaluation:
Total marks: 100
Attendance & Responsiveness: 10%
Mid term Exam: 20%
Business Model Project: 20%
End of Semester Exam: 50%
- Maximum Number of Students: 30
- Actual Number of Students: 9
Prerequisite: Must be a student of M.Sc Medical Biotechnology
Course Syllabus:
Module no |
COURSE DESCRIPTION |
Lectures (hrs) |
Unit I:
|
Introduction and Overview of the Medical Biotechnology Industry Part I: translational biotechnology industry overview (include the commercialization pathways for drug, medical device, diagnostic companies) Part II: entrepreneurship/intrepreneurship) Part III: Lean Launchpad (LLP) methodology Part IV: Commercialization Knowledge Survey (CKS)
Starting a Company Part I: formation of BEEnopoly companies Part II: team assessments Business Model Part I: the business model canvas Part II: biotechnology business models
How to startup a Startup Part I: corporate structure (LLC, LLP, C-Corp, S-Corp, etc.) Part II: ownership/vesting Part III LLP check in (customer development
|
12 |
Unit II
|
Funding Part I: the funding process
Intellectual Property Part I: basic concept of intellectual properties (patents, Trademarks, Copyrights) |
|
Unit III
|
Regulatory Strategies Part I: The regulatory agencies Part II: reimbursement
Clinical Development Part I: pre clinical development (animal studies, admetox, etc.) Part II: clinical development, considerations for human experimentation. Part III: clinical trial design
Industry Perspective and Experiences
Oversight/Governance |
10 |
Lesson Plan (Class room lecture):
Sr. No |
Content |
Date of Lecture |
1 |
Overview of Bio-entrepreneurship |
August 2024 |
1 |
Translational biotechnology industry overview (including the commercialization pathways for drug, medical device, diagnostic companies) |
August 2024 |
2 |
Development and Commercialization of Plasma products (including preclinical and clinical development) |
August 2024 |
3 |
Development and Commercialization of Biosimilars (including preclinical and clinical development) |
August 2024 |
4 |
Development and Commercialization of Gene therapy products (including preclinical and clinical development) |
September 2024 |
5 |
Development and Commercialization of Cell therapy products (including preclinical and clinical development) |
September 2024 |
6 |
Development and Commercialization of Vaccines (including preclinical and clinical development) |
|
7 |
Development and Commercialization of Biotech services |
|
8 |
Regulatory agencies and Regulatory pathways in Biotech business |
September 2024 |
9 |
Student presentations on fundamental techniques in the development of Biotech products and services |
September 2024 |
10 |
Biotech Business Models |
October 2024 |
11 |
Starting a Biotech company, the Lean start up concept, the Lean Launchpad methodology, and the Business Model Canvas |
October 2024 |
12 |
Intellectual Property - Patents, Trademarks and Copyrights |
October 2024 |
|
Funding for Bio-entrepreneurship |
October 2024 |
13 |
Team building and Team assessment |
November 2024 |
14 |
Corporate structure – LLC, LLP, C-Corp, S-Corp, Ownership / Vesting |
November 2024 |
15 |
Customer development and Customer satisfaction |
November 2024 |
16 |
Ethical considerations in Bio-entrepreneurship |
November 2024 |
17 |
Oversight and Governance of Biotech business |
November 2024 |
- References:
(i) Steve Blank and Bob Dorf: The Startup Owner's Manual: The Step-By-Step Guide for Building a Great Company. K & S Ranch.
(ii) Craig Shimasaki, ed.: Biotechnology Entrepreneurship: Starting, Managing, and Leading Biotech Companies. Elsevier Inc., 2014.
(iii) Lawton Robert Burns: The Business of Healthcare Innovation. Cambridge University Press, Cambridge UK, 2005
(iv) Burrill & Company Annual Biotechnology Industry Report
(v) Cynthia Robbins-Roth: From Alchemy to IPO: The Business of Biotechnology. Basic Books, 2001
(vi) Barry Werth: The Billion Dollar Molecule: One Company’s Quest for the Perfect Drug Simon & Schuster, 1995.
- Course Outcome:
The overall aim of the course is to give the participants an insight into field of bio-entrepreneurship, i.e. business within the life sciences. Upon completion of the course, the student will be able to describe the processes of product and service development in the life science sector, understand the similarities and differences in the development of different bioproducts and bio services, demonstrate a general understanding of the central role that business development plays for the biomedical industry, assess and compare different forms of IP and perform basic IP analysis, apply idea creation tools, write, and critically review a business plan, perform a basic market analysis in the life science sector and analyze and critically asses a case study.
- Teacher: Dr Manoj Kumar