super insulin development [Hifsa, Akvile, Giorgio]

1. Additional information

1.1. requirements of the product

1.1.1. effective

1.1.2. affordable

1.1.3. safe

1.1.4. competitive

1.2. needs

1.2.1. lab space

1.2.1.1. machinery

1.2.2. consumables

1.2.3. funding

1.2.3.1. private

1.2.3.1.1. crowdfunding

1.2.3.1.2. companies

1.2.3.1.3. investors

1.2.3.2. public

1.2.3.2.1. govt (e.g. DFG)

1.2.3.2.2. tech parks

1.2.3.2.3. Diabetes organisations

1.2.3.3. bank loans

1.2.4. production facility

1.2.4.1. GMP

1.2.5. personnel

1.2.5.1. HR

1.2.5.2. hands-on expertise

1.2.5.3. marketing/sales

1.2.5.3.1. social media

1.2.5.4. legal team

1.2.5.5. R&D

1.2.5.6. supporting staff

1.2.5.7. securing funding team

1.3. stakeholders

1.3.1. diabetic patients

1.3.2. doctors

1.3.3. legal institutions

1.3.4. inverstors

1.3.5. share holders

1.4. constraints

1.4.1. lack of expertise

1.4.2. no novelty

1.4.3. no money

1.4.4. time

1.4.5. interest rates on bank loans

1.4.6. lab space

1.5. WHY? task: make your goal SMART

1.5.1. Short-term goals (1 year)

1.5.1.1. Proof of concept/Prototype

1.5.1.2. Budget: 10 000Eur

1.5.1.3. Time: Jan 2024

1.5.2. Middle-term goals (3 years)

1.5.2.1. Finishing clinical trials

1.5.2.2. Getting market approval

1.5.3. Long-term goals (>3 years)

1.5.3.1. production and distribution

1.5.3.2. profits

1.6. WHO?: Stakeholder analysis

1.6.1. doctors

1.6.1.1. positive opinion, neutral influence

1.6.2. patients

1.6.2.1. positive opinion, high influence

1.6.2.1.1. expectation: being cured for good, resistance: afraid of side effect

1.6.3. investors

1.6.3.1. neutral opinion, medium influence

1.6.3.1.1. expectation: gaining profit from the investment resistance: not believing in the project idea

1.6.4. share holders

1.6.4.1. positive opinion, medium influence

1.6.5. legal institutions

1.6.5.1. negative opinion, high influence

1.6.6. patient families

1.6.6.1. positive opinion, low influence

1.6.7. startup founders

1.6.7.1. positive opinion, high influence

1.7. RISK FACTOR ANALYSIS

1.7.1. side effects

1.7.1.1. Probability: high Damage: medium

1.7.1.1.1. Effect on completion: continued unless a patient dies

1.7.2. bankruptcy

1.7.2.1. Probability: high Damage: high

1.7.2.1.1. Effect on completion: not able to finish the product development

1.7.3. unethical behaviour

1.7.3.1. Probability: low Damage: high

1.7.3.1.1. Effect on completion: terminated clinical trials

1.7.4. sickness of the core team member

1.7.4.1. Probability: medium Damage: medium

1.7.5. lack of novelty

1.7.5.1. Probability: medium Damage: high

1.7.6. Intellectual property lawsuits

1.7.7. risk of a dysfunctional team

1.7.8. need to work remotely due to a lockdown

1.8. risks

1.8.1. bankruptcy

1.8.2. unethical behavior

1.8.3. legal punishments

1.8.4. risk for patients

1.8.4.1. long term side effects

1.8.4.2. overprizing

1.8.5. loss of competitiveness

1.9. Open questions

2. planning of phases

2.1. PHASE 1: Initialization (12h) MS1: a big picture is developed

2.1.1. Task 1.1: developing a mind map (12h)

2.1.1.1. think on constraints

2.1.1.2. think on risks

2.1.1.3. think on stakeholders

2.2. PHASE 2: Pre-study (200h = 5weeks) MS2: The approach is novel and has a niche in the market

2.2.1. Task 2.1: literature research (120h)

2.2.1.1. book 1

2.2.1.2. source 2

2.2.1.3. online resource 3

2.2.2. Task 2.2 Market analysis (80h)

2.2.2.1. Ask hospital

2.2.2.2. Search pharmacies

2.2.2.3. Search treatments online

2.2.2.4. Check pharma companies sales

2.3. PHASE 3: Concept (480h = 3mo) MS3: Resources and business plan established

2.3.1. Budget calculation (80h)

2.3.1.1. determine cost of material

2.3.1.2. determine salary compensation

2.3.1.3. determine return on invested capital

2.3.1.4. determine fees for lawyers and other services

2.3.2. Acquiring funding (160h)

2.3.2.1. Write grants

2.3.2.2. Apply for startup support programs

2.3.2.3. Attract attention of other companies

2.3.2.4. Ask your research institute

2.3.3. Finding resources (120h)

2.3.3.1. lab space

2.3.3.2. buying consumables

2.3.3.3. acquiring machinery

2.3.3.4. hiring people

2.3.4. Write a Business plan (120)

2.3.4.1. include market analysis

2.3.4.2. include costs and funds

2.3.4.3. include a plan for product distribution

2.4. PHASE 4: Realization (1120h = 7mo) MS4: obtain a prototype

2.4.1. experiments (800h)

2.4.1.1. design super insulin in silico

2.4.1.2. express it in a host

2.4.1.3. purify it

2.4.1.4. cell experiments

2.4.1.5. animal experiments

2.4.1.6. fine tune dosage response

2.4.2. patenting (320h)

2.4.2.1. research patent database

2.4.2.2. release pre-print of results

2.4.2.3. read about IP laws

2.4.2.4. contact lawyers

2.5. PHASE 5: Introduction (9 yrs) MS5: introduce the product to the market

2.5.1. Clinical trials (7 yrs)

2.5.1.1. choose a study institution

2.5.1.2. Prepare documents

2.5.1.3. gather participants

2.5.1.4. carry out the study

2.5.1.5. publish results

2.5.2. Start the production (1 yr)

2.5.2.1. find a factory

2.5.2.2. design the packaging

2.5.3. Getting a Market approval (8mo)

2.5.3.1. make the application

2.6. Utilization MS6: make profit

2.6.1. logistics of manufacturing and distribution

2.6.1.1. monitor and expand

2.6.2. monitoring sales

2.6.2.1. monitor profit

2.6.3. expand the market

2.6.3.1. other hospitals

2.6.3.2. other pharmacies

2.6.3.3. other countries

3. find distributors

4. miles stones (metrics of success)

4.1. first customers

4.2. being quoted on the stock market

4.3. first prototype

4.4. financial independence

4.5. social media outreach (followers/visualizations)

4.6. Approval for clinical trials

4.7. getting a patent

4.8. hiring people