BUSINESS ASPECTS OF BIOTECHNOLOGY
Chapter 1: Biotechnology Industry Profile.............................................................................................. 3
1. Biotechnology Entrepreneurship ................................................................................................. 3
2. Definition of Biotechnology & History ....................................................................................... 3
3. The history of Biotechnology: Modern Biotechnology ............................................................... 5
4. The Biotech Industry Today ........................................................................................................ 7
Chapter 2: Entrepreneurship in Life Sciences: Ablynx – A Technology Transfer Case ........................ 12
1. Nanobodies & VUB/VIB .......................................................................................................... 12
2. The Initial Ablynx Business Plan .............................................................................................. 17
3. Starting Up the Company .......................................................................................................... 18
4. Building the Company............................................................................................................... 21
5. Growing the Company .............................................................................................................. 30
6. Ablynx today ............................................................................................................................. 31
Chapter 3: Biotech Business Models & Business Development ........................................................... 32
1. What is a Business Model?........................................................................................................ 32
2. Marketing Authorization ........................................................................................................... 32
3. A Brief History of the Red Biotech Business Model................................................................. 32
4. Biopharma Business Models ..................................................................................................... 33
5. Business Development .............................................................................................................. 35
Chapter 4: Funding and Financial Management in Biotechnology ....................................................... 36
1. Companies and Financing ......................................................................................................... 36
2. Funding Stages and Sources ...................................................................................................... 37
3. VC Market in Europe ................................................................................................................ 44
4. Dilution...................................................................................................................................... 47
5. Due Diligence ............................................................................................................................ 48
6. Valuation.................................................................................................................................... 48
Guest Lecture 1: An Introduction to the Regulatory Framework of Red Biotechnology – Marc Martens
............................................................................................................................................................... 54
1. General Introduction on Biotechnology .................................................................................... 54
2. Red Biotechnology .................................................................................................................... 55
Guest Lecture 2: Biotechnology in Agrifood Industry (Flanders’ Food) – Inge Arents ........................ 68
1. Who Are We and What Do We Do? .......................................................................................... 68
1 Biotechnology in Agrifood Industry .......................................................................................... 69
2 Benefits of Biotechnology in Food Industry ............................................................................. 69
3 Fermentation.............................................................................................................................. 70
4 Challenges &Barriers ................................................................................................................ 70
Guest Lecture 3: Avecom: Optimizing Microbial Processes – Stijn Boeren ......................................... 73
1
, 1. History ....................................................................................................................................... 73
2. Challenge ................................................................................................................................... 73
3. Mission ...................................................................................................................................... 73
4. Competences of Avecom ........................................................................................................... 75
Guest Lecture 4: Precirix: Precision Pharmaceuticals – Ruth Devenyns .............................................. 76
1. Introduction to the Company ..................................................................................................... 76
2. Discovery Centers around Single Domain Antibodies as Targeting Molecules ........................ 76
3. Versatile Platform ...................................................................................................................... 76
4. Precirix Capabilities .................................................................................................................. 77
5. Precirix’ Journey in a Nutshell .................................................................................................. 77
6. Discussion: challenges in building a biotech company ............................................................. 80
Guest Lecture 5: IPR in Biotechnology – Liesbeth Weynants .............................................................. 82
1. IP Rights .................................................................................................................................... 82
2. Company Life Cycle ................................................................................................................. 91
Chapter 6: Licensing Deals and Negotiations ....................................................................................... 95
1. Introduction ............................................................................................................................... 95
2. 2 Dollar Game ........................................................................................................................... 95
2
,Chapter 1: Biotechnology Industry Profile
1. Biotechnology Entrepreneurship
1.1 Introduction
Why bother with biotechnology entrepreneurship?
Biotechnology entrepreneurship is unique in its own way. An example of this is the Bayh-Dole act 1982:
all research findings at universities with federal money are owned by the university. This is unique to
biotechnology. Universities can create spin-offs of licensing (and sell patents to a company).
Example: Ablynx
Ablynx is a spin-off of VIB and the VUB engaged in the discovery and development of nanobodies.
Ablynx signed a drug deal worth millions of dollars → biotech creates not only jobs, but also value.
What do we have to think about when we’re going to talk about (biotechnology) entrepreneurship?
• Research & Development
• Technology Transfer (Bayh-Dole act)
• Business Model
• Finance
• ID
• Regulation
We will mostly look at applications in medical biotechnology, because this BT field had the most
entrepreneurial activity.
1.2 The Starting Point
= patent
= way to protect a technical invention by gaining the right to prevent other parties from applying the
invention commercially during a certain time.
It blocks others from using your idea, but it doesn’t mean you can use the invention yourself (e.g. if you
need another patent → you have the patent on “car”, but you can’t produce any cars, because you don’t
have the patent on “wheel”). For this you need freedom to operate.
2. Definition of Biotechnology & History
Biotechnology = the application of science and technology to living organisms, as well as parts, products
and models thereof, to alter living or non-living materials for the production of knowledge, goods and
services.
Biotechnology is not a sector, but a technology used in a wide variety of sectors, like agriculture,
healthcare, environment,…
3
, 2.1 Types of Biotechnology
• Red biotechnology: human and animal healthcare (therapeutics, diagnostics, cell and tissue
engineered products)
➔ Use and application of key biotechnology tools in research and development of innovative
medicines.
• White biotechnology: industrial applications
➔ Application of nature’s toolset to the production of biobased chemicals, materials and fuels,
from renewable sources, using living cells and/or their enzymes.
➔ Based on fermentation technology and biocatalysis in a contained environment
(bioreactors).
• Green biotechnology: agriculture
➔ Collection of technologies using plant organisms and plant cells for the production of or
transformation of food, biomaterials and energy (genetic modification)
• Blue biotechnology: marine applications
➔ Applications and processes in marine and aquatic environments.
• Black biotechnology: biological warfare
2.2 First: the Germ Theory
The cause of many diseases is a small living organism, a “micro-organism”. This discovery was
important in medical history, because it facilitated many following discoveries, like:
• The nature of contagious diseases: if germs were the cause of fermentation, they could just as
well be the cause of contagious diseases.
• Laboratory manipulations of the infectious agents can be used to immunize people and animals.
• Post-infection treatment of rabies with weakened viruses. This treatment proved to work and
has saved countless lives.
• Zymotechnology = the study of the (industrial) processes of fermentation in yeast and bacteria
in the production of foods and beverages such as bread, cheese, tofu, beer, wine, sake, nato, etc.
2.3 1943: Penicillin
Penicillin is an antibacterial substance, discovered by Alexander Fleming. It was very difficult to
produce this agent, but it was extended to an industrial scale (by purification to a stable form) following
a call from the US army in WWII.
Ernst Chain discovered how to isolate and concentrate penicillin. Norman Heatley suggested
transferring the active ingredient of penicillin back into water by changing its acidity. This produced
enough of the drug to begin animal testing.
2.4 Sixties and Seventies
The use of new technologies in developing countries avoided
famine (→ huge growth in world population after WWII) but
resulted in huge environmental, social and economic challenges.
These technologies came to be:
• Pesticides
• Nitrogen fertilizer → caused increase of nitrogen in the
atmosphere
4
Chapter 1: Biotechnology Industry Profile.............................................................................................. 3
1. Biotechnology Entrepreneurship ................................................................................................. 3
2. Definition of Biotechnology & History ....................................................................................... 3
3. The history of Biotechnology: Modern Biotechnology ............................................................... 5
4. The Biotech Industry Today ........................................................................................................ 7
Chapter 2: Entrepreneurship in Life Sciences: Ablynx – A Technology Transfer Case ........................ 12
1. Nanobodies & VUB/VIB .......................................................................................................... 12
2. The Initial Ablynx Business Plan .............................................................................................. 17
3. Starting Up the Company .......................................................................................................... 18
4. Building the Company............................................................................................................... 21
5. Growing the Company .............................................................................................................. 30
6. Ablynx today ............................................................................................................................. 31
Chapter 3: Biotech Business Models & Business Development ........................................................... 32
1. What is a Business Model?........................................................................................................ 32
2. Marketing Authorization ........................................................................................................... 32
3. A Brief History of the Red Biotech Business Model................................................................. 32
4. Biopharma Business Models ..................................................................................................... 33
5. Business Development .............................................................................................................. 35
Chapter 4: Funding and Financial Management in Biotechnology ....................................................... 36
1. Companies and Financing ......................................................................................................... 36
2. Funding Stages and Sources ...................................................................................................... 37
3. VC Market in Europe ................................................................................................................ 44
4. Dilution...................................................................................................................................... 47
5. Due Diligence ............................................................................................................................ 48
6. Valuation.................................................................................................................................... 48
Guest Lecture 1: An Introduction to the Regulatory Framework of Red Biotechnology – Marc Martens
............................................................................................................................................................... 54
1. General Introduction on Biotechnology .................................................................................... 54
2. Red Biotechnology .................................................................................................................... 55
Guest Lecture 2: Biotechnology in Agrifood Industry (Flanders’ Food) – Inge Arents ........................ 68
1. Who Are We and What Do We Do? .......................................................................................... 68
1 Biotechnology in Agrifood Industry .......................................................................................... 69
2 Benefits of Biotechnology in Food Industry ............................................................................. 69
3 Fermentation.............................................................................................................................. 70
4 Challenges &Barriers ................................................................................................................ 70
Guest Lecture 3: Avecom: Optimizing Microbial Processes – Stijn Boeren ......................................... 73
1
, 1. History ....................................................................................................................................... 73
2. Challenge ................................................................................................................................... 73
3. Mission ...................................................................................................................................... 73
4. Competences of Avecom ........................................................................................................... 75
Guest Lecture 4: Precirix: Precision Pharmaceuticals – Ruth Devenyns .............................................. 76
1. Introduction to the Company ..................................................................................................... 76
2. Discovery Centers around Single Domain Antibodies as Targeting Molecules ........................ 76
3. Versatile Platform ...................................................................................................................... 76
4. Precirix Capabilities .................................................................................................................. 77
5. Precirix’ Journey in a Nutshell .................................................................................................. 77
6. Discussion: challenges in building a biotech company ............................................................. 80
Guest Lecture 5: IPR in Biotechnology – Liesbeth Weynants .............................................................. 82
1. IP Rights .................................................................................................................................... 82
2. Company Life Cycle ................................................................................................................. 91
Chapter 6: Licensing Deals and Negotiations ....................................................................................... 95
1. Introduction ............................................................................................................................... 95
2. 2 Dollar Game ........................................................................................................................... 95
2
,Chapter 1: Biotechnology Industry Profile
1. Biotechnology Entrepreneurship
1.1 Introduction
Why bother with biotechnology entrepreneurship?
Biotechnology entrepreneurship is unique in its own way. An example of this is the Bayh-Dole act 1982:
all research findings at universities with federal money are owned by the university. This is unique to
biotechnology. Universities can create spin-offs of licensing (and sell patents to a company).
Example: Ablynx
Ablynx is a spin-off of VIB and the VUB engaged in the discovery and development of nanobodies.
Ablynx signed a drug deal worth millions of dollars → biotech creates not only jobs, but also value.
What do we have to think about when we’re going to talk about (biotechnology) entrepreneurship?
• Research & Development
• Technology Transfer (Bayh-Dole act)
• Business Model
• Finance
• ID
• Regulation
We will mostly look at applications in medical biotechnology, because this BT field had the most
entrepreneurial activity.
1.2 The Starting Point
= patent
= way to protect a technical invention by gaining the right to prevent other parties from applying the
invention commercially during a certain time.
It blocks others from using your idea, but it doesn’t mean you can use the invention yourself (e.g. if you
need another patent → you have the patent on “car”, but you can’t produce any cars, because you don’t
have the patent on “wheel”). For this you need freedom to operate.
2. Definition of Biotechnology & History
Biotechnology = the application of science and technology to living organisms, as well as parts, products
and models thereof, to alter living or non-living materials for the production of knowledge, goods and
services.
Biotechnology is not a sector, but a technology used in a wide variety of sectors, like agriculture,
healthcare, environment,…
3
, 2.1 Types of Biotechnology
• Red biotechnology: human and animal healthcare (therapeutics, diagnostics, cell and tissue
engineered products)
➔ Use and application of key biotechnology tools in research and development of innovative
medicines.
• White biotechnology: industrial applications
➔ Application of nature’s toolset to the production of biobased chemicals, materials and fuels,
from renewable sources, using living cells and/or their enzymes.
➔ Based on fermentation technology and biocatalysis in a contained environment
(bioreactors).
• Green biotechnology: agriculture
➔ Collection of technologies using plant organisms and plant cells for the production of or
transformation of food, biomaterials and energy (genetic modification)
• Blue biotechnology: marine applications
➔ Applications and processes in marine and aquatic environments.
• Black biotechnology: biological warfare
2.2 First: the Germ Theory
The cause of many diseases is a small living organism, a “micro-organism”. This discovery was
important in medical history, because it facilitated many following discoveries, like:
• The nature of contagious diseases: if germs were the cause of fermentation, they could just as
well be the cause of contagious diseases.
• Laboratory manipulations of the infectious agents can be used to immunize people and animals.
• Post-infection treatment of rabies with weakened viruses. This treatment proved to work and
has saved countless lives.
• Zymotechnology = the study of the (industrial) processes of fermentation in yeast and bacteria
in the production of foods and beverages such as bread, cheese, tofu, beer, wine, sake, nato, etc.
2.3 1943: Penicillin
Penicillin is an antibacterial substance, discovered by Alexander Fleming. It was very difficult to
produce this agent, but it was extended to an industrial scale (by purification to a stable form) following
a call from the US army in WWII.
Ernst Chain discovered how to isolate and concentrate penicillin. Norman Heatley suggested
transferring the active ingredient of penicillin back into water by changing its acidity. This produced
enough of the drug to begin animal testing.
2.4 Sixties and Seventies
The use of new technologies in developing countries avoided
famine (→ huge growth in world population after WWII) but
resulted in huge environmental, social and economic challenges.
These technologies came to be:
• Pesticides
• Nitrogen fertilizer → caused increase of nitrogen in the
atmosphere
4
