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.