The answer is ‘far less than you would think!’
In this STAT article Letting academic medical centers make CAR-T drugs would save billions, medical centres in the US, and their healthcare professionals (HCPs), assert “There’s a better way, one that will lower the price, enable more precise and individualized targeting for specific patients, and allow for a faster process: Let medical centers do this.”
So, what would it take for medical centres, or NHS hospital networks in the UK, to become DIY drug developers?
What have hospitals already got? These below:
- Customers (patients)
- Healthcare professionals (convert sick patients into well patients)
- Planning systems
- Physical facility professionals (handle buildings, machinery and equipment)
- Land
- Internal transport and storage (move and store things)
- Skilled at operation of machinery and equipment
What have they not got (yet)? These below?
- Experience of Good Manufacturing Practice (GMP)
- GMP for advanced therapies
- Certain skills in drug development
- Aseptic manufacturing skills
- Certain equipment, such as cryogenic storage, bioreactors, etc
- Close links with pharma companies
What would it take to close the gap?
Most of drug development is already carried out by contract development and manufacturing organisations (CDMOs) and contract research organisations (CROs) with all the skills required to bring a drug to market.
An experienced team with deep knowledge of the regulatory terrain, medical aspects, quality management systems, and supply-chain management would be well suited to close the gap, working closely with healthcare networks.
If interested, feel free to make ‘no strings’ contact for more info.