Start-ups, Investment and Regulatory Approval

Question 1

What is a university spin-out?

Answer 1

A company based on university-owned IP, created to commercialise academic innovations.

Question 2

How is a start-up different from a spin-out?

Answer 2

A start-up may not be based on university IP, whereas a spin-out is.

Question 3

Why are university Bioengineering spin-outs high risk for investors?

Answer 3

They are highly technical, niche, and require skilled staff.

Question 4

Name some examples of spin-out business models.

Answer 4

●Technology for sale
●Technology for collaborative development
● Consumer product producer
● Original equipment manufacturer
● Consultancy/contract research

Question 5

What Sheffield spin-out launched MySkin?

Answer 5

CellTran (2000), founded by Prof. Sheila MacNeil

Question 6

What is IP?

Answer 6

Creations of the mind that can be legally protected: ideas, inventions, processes, designs…

Question 7

Name three forms of IP that exist automatically.

Answer 7

Copyright
Design rights
Know-how/trade secrets

Question 8

What IP requires registration?

Answer 8

Patents, trademarks, and registered designs.

Question 9

What is a patent?

Answer 9

A legal agreement giving the inventor a market monopoly for 20 years in exchange for full public disclosure.

Question 10

What is a patent claim?

Answer 10

A legal definition outlining the scope of the invention and what is protected.

Question 11

Why is IP protection important for spin-outs?

Answer 11

It prevents competition, enables licensing, and de-risks investment.

Question 12

What does TRL stand for?

Answer 12

Technology Readiness Level.

Question 13

What is TRL 1?

Answer 13

Basic principles observed and reported.

Question 14

What is TRL 9?

Answer 14

Proven system used in operational conditions—ready for market.

Question 15

What’s the difference between invention and innovation?

Answer 15

Invention: Patentable idea.
Innovation: Commercially viable application of the invention.

Question 16

What are ATMPs?

Answer 16

Advanced Therapy Medicinal Products—human-use products based on cells, tissues, or genes. This includes TE products.

Question 17

What is the MHRA responsible for?

Answer 17

Overall regulation of medicines/devices
Granting trial licenses
Inspecting manufacturing sites.

Question 18

What does the Human Tissue Authority regulate?

Answer 18

Human tissue or cells as starting materials for ATMPs.

Question 19

What is the HRA?

Answer 19

The Health Research Authority, responsible for ethical approval of clinical trials.

Question 20

What document is needed to approve a clinical trial, what what information does it include?

Answer 20

IMPD (Investigational Medicinal Product Dossier).

Source and quality of material
Manufacturing controls
Stability data
Preclinical studies + outcomes

Question 21

What is GMP?

Answer 21

Good Manufacturing Practice

The minimum standards for production, ensuring product safety and quality, enforced by the MHRA.

Question 22

What is tested in Phase 1 clinical trials?

Answer 22

Safety and dosage on a small healthy patient cohort. (20-80)

Question 23

What is tested in Phase 2 clinical trials?

Answer 23

Efficacy of the drug on 100-300 participants.

Question 24

What is tested in Phase 3 clinical trials?

Answer 24

Safety and efficacy (compared to existing therapies) on 1000-3000 participants.

After success, regulatory approval is sought

Question 25

What is the purpose of a review between phase 3 and 4?

Answer 25

Confirmation of safety and effectiveness

Question 26

What is the purpose of phase 4 clinical trials?

Answer 26

Multicentre evaluation over larger population (1000+) for long-term or rare side effects

Question 27

Describe some funding sources for an early stage concept (unproven idea). Explain what the purpose of the funding is for.

Answer 27

For testing feasibility (preclinical studies). Translational funding: Grant-based funding to bridge the gap between research and commercialisation. 3F's: Informal investments from personal networks Impact Acceleration: Programmes designed to help researchers and innovators turn ideas into real-world applications.

Question 28

Describe some funding sources for a product undergoing proof of concept. Explain what the purpose of the funding is for.

Answer 28

Initial research and experiments validate whether the idea has practical applications. It can help fund patent applications and clinical trial design. Medium Grant Opportunity (£100k-£250k): Grants that provide capital to further test and refine the concept.

Question 29

Describe some funding sources for a working prototype. Explain what the purpose of the funding is for.

Answer 29

To fund clinical trials and regulatory approval. Business Angels: High-net-worth individuals investing in early-stage startups in return for a share of the company’s equity. Large Grant Opportunity (£500k-£5m) VC (Venture Capital) Series A (£100k - £5m): Initial VC funding to commercialize and scale.

Question 30

Describe some funding sources for a growing business. Explain what the purpose of the funding is for.

Answer 30

For scaling up operations and ongoing phase 4 clinical trials. VC Series B (£5m - £10m): marketing, hiring, expansion VC Series C ( >£10m): Massive scaling, market dominance, IPO preparation

Question 31

What did Alvetex (Durham spin-out) develop?

Answer 31

Porous polystyrene scaffolds for 3D cell culture.

Question 32

What technology did Kirkstall develop?

Answer 32

Quasi Vivo® cell flow systems that mimic in vivo conditions

Question 33

What does MatTek specialise in?

Answer 33

Cell culture models and toxicology testing services.

Question 34

What was the first PHA-based device to receive FDA clearance?

Answer 34

TephaFLEX® absorbable suture (2007). Used to create MonoMax monofilament absorbable suture.