Module 4 - Supply Chain Management and Innovation in Biopharma/Medical

Question 1

Once you get approval for you drug, can you switch materials in your supply chain?

Answer 1

You cannot switch materials once the drugs is approved, otherwise you have to argue that it is the same drug with the same effect for approval.

Question 2

What is Novo Circular for Zero?

Answer 2

Circular supply, company and products across the supply chain

1) Supply based on 100% renewable energy (Commitment of suppliers)
2) Zero CO2 emission from own operations and transport (Green aviation fuel + Cardinal Solar Power Park for US operations)
3) Zero production waste to landfill (Disposal of pens)

Question 3

What are the growth drivers for Novo Nordisk currently?

Answer 3

1) GLP-1 is going up!
- Ozempic, rybelsus, victoza
2) Obesity is dramatically going up!
- Wegovy (semaglutide), Cagrisema, Saxenda
3) Insuling going down
- Price pressure and biosimilars
4) Biopharma is sideways developing
- Competitive pressure, new product launches underways

All in all, from 2015-2022, the portfolio has made significant changes to what is being sold!

Question 4

How many ideas reach FHD?

Answer 4

Out of 5000 ideas in the lab, 5 hit FHD and 1 may reach the market.

Question 5

How long does it take from idea to commercialization?

Answer 5

Normally, 10-15 years from initial work to market launch.

NN has new goal of 500 days to FHD (whereas it is much more in the industry currently, like 1.500 days or more.)

Question 6

What is the estimated average cost for a pharmaceutical drug?

Answer 6

Around 2,6 billion for the development costs of a drug.

Question 7

What does the process of drug development look like?

Answer 7

1) Pre-discovery - Identifying leads
2) Lead optimization - Selection of a drug candidate after lead optimization
3) Preclinical evaluation/trials: testing toxicity and effectiveness in animal
models + dosage and mode of administration
4) Phase I (early clinical): tests safety (dosage and side effects) in a small group of healthy individuals (approximately 20- 80 individuals).
5) Phase II (early clinical): efficacy testing for the targeted disease. Long-term effects, optimal dose and efficacy. 100-1000 patients
6) Phase III (late clinical): Confirmatory trials up to 10.000 patients. Safety and efficacy
7) NDA and approval (late clinical): New drug application (NDA) is sent to the FDA for marketing approval of the drug.

Question 8

Why are patents important in bioopharma?

Answer 8

They are at the heart of high-risk investment decisions.
- Secures appropriate returns and thus the will to invest in medical innovation and new therapies.

Question 9

How did the early innovation in Novo Nordisk look vs. today?

Answer 9

Many smaller s-curve innovations and maturity of technology contributing to one bigger s-curve.

21st century/now:
- One big S-curve for different technologies like (Oral insulin, Liver-selective insulin, pathway-specific insuling etc.)

Today there is also a much shorter time from NDA to approval (15 months for Novo Eight)

Question 10

How does supply chain interplay with drug development?

Answer 10

1) Choice of materials during drug development and device design
2) Choice of process during choosing suppliers and manufacturing
3) Choosing equipment, capabilities and location
4) Choosing product offering and service
5) Markets and patients

Question 11

Increased complexity in the pipeline has led to?

Answer 11

Increasing complexity in the pipeline (need for higher quantities, new and different raw materials) has led to involvement of the supply chain organisation much earlier in the product development

Question 12

Why is particularly Phase III important with a supply chain POV?

Answer 12

Many optimizations are more difficult to implement after phase III

Question 13

What has changed focus for NN in their supply chain after the Circular for Zero initiative?

Answer 13

Moved from internal flows and standardization to 2020 End-to-end network optimization

Question 14

Supply chain management (SCM) is?

Answer 14

○ the management of the flow of goods & services
○ includes all processes that transform raw materials into final products

Question 15

Why is supply chain management important in new drug development and the achievement of the corporate strategy?

Answer 15

New Drug Development
● Supply chain organisation involved in early product development
● Many optimisations are more difficult to implement after phase III
● Affects the direction of the development of the drug. (Design, Materials)
● Affects manufacturing processes: Equipment, Location and capabilities, Product offerings and services

Supply chain has to be part of the R&D as you can’t change the supply/material after a certain phase in the clinical trials.

Corporate Strategy
● Meeting customer demand in terms of quality & quantity
- Choice of suppliers
- New and different raw materials
- Need for higher quantities

Question 16

Why is supply chain management important in new drug development and the achievement of the corporate strategy? (Brief)

Answer 16

2) Increasing complexity in the pipeline
3) Involved in early product development, selecting processes and designs now.
4) Many optimizations are more difficult to implement after phase III
5) Change in sustainability view has forced a shift to focus on the full supply chain (end-to-end network optimization. Think aviation fuel)