Business
Management
Summary of all lectures - 2022
©2022 A. Arp All Rights Reserved
,Business Management Part 1
HC1 Introduction
USP = Unique Selling Point; waarom ben je speciaal en moet iemand je product kopen?
HC2 Business Plan – Eric Claassen
Efficiency of drug development has gone down with at least 4 to 5 times. Reason is needs more
time to develop idea to product now than 20 years ago. From 4 to 12 years. Now average of product
development is 12 years. Consequence is: costs money.
IPR = Intellectual property right = property that you created you can protect. Can sell it for 20 years
under this protection. Here recover those costs of the production (~1.3 billion).
1. Industrial right → registration with governments & have to pay for
a) Patentlaw
Want to look like competition, but give superior product.
Ex: In-n-out burger vs. Mc Donalds, logo’s look like each other but judge though there is
enough difference between them. In-N-out burger has better quality than Mc Donalds, so
when people enter think first they are in Mc Donalds and later are surprised by the good
quality.
b) Brand name is worth money. If Apple only changes his name to Pear, still get a trillion
dollars for brand name. But everyone knows that products still from Pear, so Apple is in
principal worth nothing anymore for customers, only name is taken over by someone
else.
Viagra = drug that everybody knows, but almost no one uses it. Means brand is very
strong, can make sure you buy the drug that is best profile while another drug might be
better.
c) Drawings and model rights. Pfizer is brand, form is copyright, Vgb100 is trademark. So
the better working drug Cialis had to have a different form, colour etc. than Pfizer.
Placebo effect works for people very well. So people that get a drug that looks like Pfizer
Viagra, 25% is convinced it works.
Filing = day after you submit patent protected for 20-25 years. In first year (priority year)
can still change patent. You cannot change the essence (so not entirely other object) but
can add things. So you have one year to test the product and you can be faster than the
competition. Can also withdraw patent if it goes wrong and ask for a new patent later.
But then do have chance that competition is catching up on you. If you withdraw the
patent in time (so before those 18 months) you can make sure that competitions does
not know where your working on. Only after 18 months (1.5 year) patent gets publicly
published. So first 18 months it’s a secret between you and patent office. After this
people can go into discussion.
Patent not valid if already been invented somewhere ever, because it is not
new/discovered.
Ex: little air balls in sunken ships. After 18 months patent got public and discussion
began that this was already written some time ago in a Donald Duck → could not use
the idea anymore due to prior art.
An innovation has to be new, innovative and industry applicable.
After 12 years when medicine goes on to the market, only have 8 years left (20 years in
total). So have to be very quick on making profit when launching product on market.
After those 8 years, generally only a quarter of the product still gets sold.
Ex: Aspirine still most sold brand and is the one that started the product: Bayer. Kruidvat
aspirine is also available now since patent is expired after 20 years.
Good that patent is only 20 years, because then new innovations can be built on the old
ones. This way every car now has airbags and belts etc.
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, Can request until 3 patents sequentially, which causes a plateau in the graph where profit
stays longer in equilibrium at the top. But, patent has to be slightly different each time.
Ex: first you file for a patent on the form, then on colour then something else. Has to be an
improvement every time. For example, first injection later becomes a pill.
Can take multiple years before you can get the patent granted. Can then also get some
extension on the patent.
After the expiration date of the patent, revenue stream of a product never decreases to
zero; decreases until stabile level. Ex: Aspirin from Bayer is still one of the most widely used
medications in the world, even though there are other forms of aspirin.
2. Other rights → no registration and free
a) Copyright
Last name + copyright symbol + year
Is mine, only use it when ask me. If someone uses it without consent you are protected.
Ex: if people use picture of you for an add without paying you/asking for consent.
Therefore, also do not use someone else’s work that has copyright, because you will
have to pay for what you used.
Important lesson: everything you do in business development is waiting until they
launched their product on the market and they cannot get back. Keep analyzing it and
wait for the moment that they are producing it. They will have to pay you if it’s on the
market, otherwise they don’t and can withdraw the product.
Copyright can exist next to portrait right. If someone takes picture of class has copyright
of the picture. Portrait right = if you make picture of class is not portrait right. If you are
alone on the picture and it is sold you have the right of money. However, if someone is
on the picture who is famous and can be recognized, he or she has portrait right.
Copyleft = form of licensing. Author may give every person who received a copy of the
work permission to reproduce, adapt or distribute it, with the accompanying
requirement that any resulting copies or adaptations are also bound by the same
licensing agreement / Offering people the right to freely distribute copies and modified
versions of a work with the stipulation that the same rights be preserved in derivative
works down the line.
b) Databases → Ex: Tesla = clients, driving behavior, parts of the care
c) Trade secrets = secret in the company. Secret is not with one person, but everyone has
part of the secret. No one knows entire recipe/secret so is connected with each other.
Ex: Coca Cola.
At pharma difficult to keep trade secrets because have to say what the active component
is, what you discovered, if it is tested and if it is safe. So do have to tell what is in the
product, but not necessarily the amounts/percentages.
Phases during process developing medicine:
- Preclinical = with minimum 2 animals testing. If works fine, then go to clinical.
- Clinical = testing with people, exists of 4 phases:
1. Human pharmacology: with healthy volunteers (students). Starts with low dosis, look at
side-effect of drug. If at high doses are a lot of side-effects, medicine not produced.
During this phase approximately 20-30% of the medicine not going to phase 2. Depends
on safety/side-effects and the seriousness of the disease and if there is already
something on the market. Ex: Unmet-need for MS is very high.
Takes several months. 70-80% succesfully tested. Test safety.
2. Exploratory/confirmatory: volunteers that have sickness/symptoms have what the
medicine is made for. Here, toxic drugs are tested (e.g. chemotherapy skips phase 1).
During this phase approximately 30-35% not going through phase 3 because of safety.
Majority of drugs not going to next phase because this phase is testing on sick people,
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, not as resilient as healthy people. Can be a pro-drug (has to be converted in the body)
that sick people cannot convert OR because sick people are in danger because the drugs
is working but the organs cannot do anything with it because of their organs not
functioning.
Takes several months until 2 years. 30-35% successfully tested. Test short term safety,
mainly effectiveness.
3. Confirmatory: testing a lot of patients. FDA/EMA cannot give too much advise, but only
give directions. Unless this is about rare diseases, then there is more coaching.
Takes 1-4 years. 25-30% successfully tested. Test safety, dosage and effectiveness.
4. Marketphase
1 succesfull drug out of 33.000 discovered and 250 in research.
Antivirus takes longer and more money to develop. Therefore many companies produce vaccine
because is cheaper. Can see hopeless when looking at total spendings you need. However, when
looking at the risks that reduce once you get to the next phase are reinforcing. So important to know
the risk in failure and what the market wants to pay.
Can make calculations also in money instead of time per phase. Then more obvious what the process
will cost. Can then go to pharmaceutical companies for a risk-analysis (what is it going to cost and
what will it bring us).
HC3 Learning to Innovate From a Personal and Human Resource (HR) Perspective
Being innovative is hard work because
- Crossing (personal) borders
- Out of the box
- Culture
- Learning
- Human resource – have to hire right person for right thing to do
- Forming the right team
Simon Sinek: start with why. The goals is to let people believe what you believe.
1. Outside in methode: tell what you sell and how it works + why you have to have it.
2. Inside out methode: start with why and work your way out (how and what). Inspired
business begin with why (Ex: Apple, why should anyone care, why you believe).
Ex: Apple. “Everything we do, we believe in changing the status quo. We think different. Challenge is
to make design creative etc. Therefore, we happen to make great computers. Want to buy one?”
Include the ‘why’ in your report. Why do you want to do this? Can professional investors believe in
you and your team?
- Some investors rather invest in a good team with crappy plan than invest in good plan with a
lousy team. Plan can be fixed, team can’t.
Teambuilding checklist/Team member skills profile
- Hard factors: finance, technology, content
- Soft factors: initiative, endurance, diplomacy and self-knowledge.
- Networking: build a network and ask for feedback. Network web (mindmap)
Characteristics effective team. Investors want to see the team has:
- Complementary skills and strengths
- Shared vision
- Approximately 3 till 6 people
- Flexible
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