April 3, 2023
A highly organised global network is delaying the development of lifesaving drugs.
The network includes couriers, shipping agents, Customs agents, pilots and baggage handlers. Together, they control the movement of the results of critical drug safety studies between drug companies, scientists, pathologists and lab technicians.
These delays can add months to the development of new drugs. In the case of new lifesaving and/or lifechanging drugs, delays can be critical to patients – and expensive for drug companies.
There’s no suggestion of wrongdoing. The network operates totally above board. Every guideline and every regulation is observed. And yet, lifesaving drugs continue to be held up needlessly.
So, how do the delays come about? To understand that, consider the typical process of developing new drugs.
No drug comes to market without being thoroughly tested for adverse effects via safety assessment studies. Typically, these studies are validated by independent specialists. Often, the developing drug company, the primary pathologist and the review pathologist are in different states, countries or continents.
Tissue samples for testing are collected on glass slides. In order for a second pathologist to review these, they have to be physically shipped. This isn’t a simple process.
The drug company or their outsourced partner must pack the slides and fill out extensive documentation associated with shipping biological samples. A courier collects the slides and takes them to the depot. They are then taken to the local airport where they enter the airline’s freight management system. Paperwork is checked. The slides are loaded onto a plane. At the other end, they’re unloaded. Customs officers check the paperwork. The slides are handed to a courier who takes them to the depot for transfer to another courier for delivery to the primary pathologist.
The secondary pathologist receives the slides for peer review. He or she unboxes them, checks for broken slides, counts and organizes them by group, dose, animal, etc. The pathologist then reviews them, inputs their findings into the laboratory's information management system, exports the results, and packs up the slides along with their physical report. Finally, he or she fills out the necessary customs documentation and sends the samples and notes back to the primary pathologist.
If the drug safety assessment study does not prove the drug is safe enough to trial in humans, the whole process happens all over again.
If a drug company wants input from two different specialist pathologists (say, a heart specialist and a liver specialist), one can’t start until the other is finished. If each wants a second opinion, the time delays double again.
If it sounds convoluted, that’s because it is.
It’s also completely unnecessary.
In the 21st century, shipping glass slides is an avoidable delay in a drug’s development.
Digitisation, especially when combined with the latest applications of artificial intelligence, dramatically accelerates pathology reviews.
Using this new technology, a drug company can send digital images to multiple pathologists. Each of these pathologists can review the images simultaneously – from anywhere in the world.
Any substandard image (another cause of delays) is identified by the system at the time it’s uploaded.
With this new technology, a pathologist adds notes directly onto the image. With the old glass slide method, a pathologist’s notes were separate – a potential cause of error.
AI can scan vast databases of digital images to help a pathologist confirm his findings.
By cutting out the middlemen (the couriers, freight forwarders, Customs agents, pilots etc.), the time it takes for your life-saving drug to come to market is shortened.
Digitisation eliminates the delays caused by shipping slides and physical reports. AI improves workflow and gives more confidence in pathologist findings.
It’s not too dramatic to say that this will be a lifesaver for some patients.
A highly organised global network is delaying the development of lifesaving drugs.
The network includes couriers, shipping agents, Customs agents, pilots and baggage handlers. Together, they control the movement of the results of critical drug safety studies between drug companies, scientists, pathologists and lab technicians.
These delays can add months to the development of new drugs. In the case of new lifesaving and/or lifechanging drugs, delays can be critical to patients – and expensive for drug companies.
There’s no suggestion of wrongdoing. The network operates totally above board. Every guideline and every regulation is observed. And yet, lifesaving drugs continue to be held up needlessly.
So, how do the delays come about? To understand that, consider the typical process of developing new drugs.
No drug comes to market without being thoroughly tested for adverse effects via safety assessment studies. Typically, these studies are validated by independent specialists. Often, the developing drug company, the primary pathologist and the review pathologist are in different states, countries or continents.
Tissue samples for testing are collected on glass slides. In order for a second pathologist to review these, they have to be physically shipped. This isn’t a simple process.
The drug company or their outsourced partner must pack the slides and fill out extensive documentation associated with shipping biological samples. A courier collects the slides and takes them to the depot. They are then taken to the local airport where they enter the airline’s freight management system. Paperwork is checked. The slides are loaded onto a plane. At the other end, they’re unloaded. Customs officers check the paperwork. The slides are handed to a courier who takes them to the depot for transfer to another courier for delivery to the primary pathologist.
The secondary pathologist receives the slides for peer review. He or she unboxes them, checks for broken slides, counts and organizes them by group, dose, animal, etc. The pathologist then reviews them, inputs their findings into the laboratory's information management system, exports the results, and packs up the slides along with their physical report. Finally, he or she fills out the necessary customs documentation and sends the samples and notes back to the primary pathologist.
If the drug safety assessment study does not prove the drug is safe enough to trial in humans, the whole process happens all over again.
If a drug company wants input from two different specialist pathologists (say, a heart specialist and a liver specialist), one can’t start until the other is finished. If each wants a second opinion, the time delays double again.
If it sounds convoluted, that’s because it is.
It’s also completely unnecessary.
In the 21st century, shipping glass slides is an avoidable delay in a drug’s development.
Digitisation, especially when combined with the latest applications of artificial intelligence, dramatically accelerates pathology reviews.
Using this new technology, a drug company can send digital images to multiple pathologists. Each of these pathologists can review the images simultaneously – from anywhere in the world.
Any substandard image (another cause of delays) is identified by the system at the time it’s uploaded.
With this new technology, a pathologist adds notes directly onto the image. With the old glass slide method, a pathologist’s notes were separate – a potential cause of error.
AI can scan vast databases of digital images to help a pathologist confirm his findings.
By cutting out the middlemen (the couriers, freight forwarders, Customs agents, pilots etc.), the time it takes for your life-saving drug to come to market is shortened.
Digitisation eliminates the delays caused by shipping slides and physical reports. AI improves workflow and gives more confidence in pathologist findings.
It’s not too dramatic to say that this will be a lifesaver for some patients.
フォロー
Ireland
DCU Alpha Building, Innovation Campus,
11 Old Finglas Rd, Glasnevin, Co. Dublin D11 KXN4
