by Cancer patients receive personalized medication on the bed according to new laws, the telegraph can show.
Great Britain is the first country in the world that relaxes the strict manufacturing rules, causing delays into time -sensitive treatments.
An increasing number of new medication, including cancer and rare genetic disorders, includes the creation of a tailor -made drug for each patient by collecting his cells and modifying in a laboratory before they are injected back into the patient.
But because the samples have to be taken and processed in special facilities – often hundreds of miles removed – patients are too often exposed to delays. They can become too uncomfortable to get the medication, or the medicine itself may not survive the trip because of its short shelf life.
From now on, the last of these steps can be completed in more detail on the patient, which reduces the time that is necessary to create life -saving treatment from months to a few days, said the medical supervisory authority.
“Flexible, Reactivity System”
The new laws introduced by the regulatory authority Medicines and Healthcare Products (MHRA) will mean that the medication can be produced where the patient is located – and are handed over to them in the hospital or in their own houses.
Lawrence Tallon, the new managing director of MHRA, wrote in the Telegraph, said that it is about “creating a more flexible, reactionable system that meets the needs of modern medicine” instead of “enforcing the drug into an outdated system”.
“Some of these advanced therapies are produced with a person’s own cells. Others are based on their genetic code. Some are so sensitive that they cannot be frozen or stored, and must be handed over to the patient within just a few minutes after production.
“In these cases, delays can be critical. Some patients are too uncomfortable to maintain their treatment in good time. In other cases, medicine simply did not survive the trip.”
He added: “Hospitals can now do the last steps of manufacturing on site-after the same strict standards, but much faster.
“This means that a cancer patient can now grasp its immune cells, modified and return in the same hospital. A child with a rare genetic disorder can receive therapy that has been created on the bed.”
“Personalized therapies”
Mobile units are also used to end the production of medicinal products for patients who are too sick to leave their houses, or to restrict hospital visits due to weakened immune systems.
The MHRA said the movement reflected how chemotherapy and antibiotics are prepared locally, but emphasized that there would still be strict protection and regulatory protocols.
There will also be a “central control point” that monitors the personalized therapies in hospitals.
Wes Streeting, the health secretary, said it was a “game chanting”. “Cancer treatments that are not tailored in days, are cut.
“Our change plan promised to build an NHS that is suitable for the future. Today we enter this promise by supplying the patient directly at peak times if they need it most.
“This type of therapy means that patients can be treated and can return home faster.”
Wes Streeting, the health secretary, has the move as “Game Changer” – Lucy North/Pa
An example of personalized treatment that becomes more accessible to patients is car-t cancer therapy.
It contains genetically modified immune cells of a blood cancer patient, so that the immune system recognizes and kills the cancer cells that are otherwise undetected by the body and would spread further.
Before that, hospitals could only offer these treatments through complicated, unique agreements.
The changes have already come into force after the legislation, which was referred to as human medicines (modular production and care point), was passed last month.
It covers a number of innovations, including cell and genetic therapies, tissue treatments, 3D printed products, blood products and healing gases.
Lord Vallance, the scientific minister and the former scientific chairman of the government, said that the “worldwide framework gives the NHS and innovators a clear and safe way to bring advanced treatments from the patient’s bed”.
“It is a strong example of how intelligent regulation can help more patients benefit from the best British science.”
“Modern medicine needs a modern delivery system”
By Lawrence Tallon
The system works well enough for most medication. Medicines are more made from masses, sent and delivered to where they are needed in the world. So care has been delivered for decades. But a new generation of personalized therapies begins to question this model – and if we do not adapt, the patients could miss it.
Some of these advanced therapies are made with a person’s own cells. Others are based on their genetic code. Some are so sensitive that they cannot be frozen or saved – they must be handed over to the patient within just a few minutes after the production. This is a world away, as medication is usually mass -shaped and distributed today.
According to Lawrence Tallon, Managing Director of MHRA, the new processes for people with compromised immune systems will be safer
In these cases, delays can be critical. Some patients are too uncomfortable to maintain their treatment in good time. In other cases, medicine simply did not survive the trip. We need a more flexible, more reactionable system that meets the needs of modern medicine and does not forces the drug to fit into an outdated system.
Therefore, Great Britain was the first country in the world this week to introduce a new legal framework that enables these advanced medication at the time of care. According to new regulations, which were introduced by the regulatory authority of the Medicines and Healthcare Products (MHRA), hospitals can now take the last steps of the manufacture on site-according to the same strict standards, but much faster.
This means that a cancer patient can now capture its immune cells, modified and return in the same hospital. A child with a rare genetic disorder can receive therapy on the bed. No more shipping cells hundreds of kilometers away and hope that they will survive the return trip. It also offers a safer alternative for people who are too uncomfortable to travel or whose immune systems are risky.
“Support of early access to promising treatments”
This is part of a more comprehensive effort to modernize the way we support innovations in Great Britain. We have shortened the time that is needed to approved clinical studies to 40 days. We have introduced new routes for the approval of medication that have already been approved by trustworthy international supervisory authorities. And where the evidence is strong and the need is urgent, we support early access to promising treatments.
We pay special attention to rare diseases in which patients are often the longest confronted with new treatments. While every illness can affect only a few people, the overall effect is great: around 3.5 million people in the UK and an estimated 300 million worldwide live a rare illness. However, the development of treatments is often more difficult, with fewer participants in the clinical study and less commercial return.
That is why we offer targeted support. For companies that work on rare disease therapies, we have reduced or waived fees and increased access to experienced scientific advice. The aim is to make it easier and more affordable, to prepare safe treatments in which there are a high need and only a few other options.
We also support more intelligent paths to generate evidence. Large studies are not always possible in very rare conditions. We work with researchers to use high-quality real data such as NHS recordings and patient registers so that safe and effective treatments from a lack of conventional test data are not retained.
Medical innovation does not end with the discovery or what is in the vial. It is also about tackling the obstacles that stop new treatments, reach the patients. This means creating a secure system that is collected for the medication of tomorrow – especially for people with very few options – whether by changing approval, execution of experiments or how evidence is collected.
After all, life -changing treatment is only important because we can deliver it when and where the person needs it.
Lawrence Tallon is the managing director of Mhra
