The FDA must agree with you because they are looking for new ways to bring drugs to market faster.
Dr Martin Makary, the new FDA commissioner, is talking about using AI and cell line computational models to replace animal toxicology studies for testing biologics for safety and efficacy.
While this sounds good on the surface, it is uncertain how this might impact drug safety. In preclinical testing typically a compound has to be safety tested for 14 or 28 days in 2 species prior to being approved for Phase I. As the compound progresses it has to go through a series of longer duration toxicology studies before it is FDA approved for Phase 2 and 3.
How do you think moving from animal safety testing to AI and computational type models will impact cGMP and safety? It seems like AI and organ on a chip systems are primarily designed to stimulate investment in biotech and ensure speed to market. I might be wrong about this as I am not an expert but this looks similar to the Covid strategy, loosen up pipelines, stimulate investment to get products to market quickly. Profit over patient safety.
It would be interesting to get your thought on this topic and how it will impact cGMP. Again the FDA must not think this is about depopulation but speed to market. If your plan is to kill people why waste time coming up with new ways to accelerate drugs to market???
In my next book, predictive technologies feature as a key platform for change. These technologies exist, such as testing in human tissue, or what is known as in silico (computer modelling) and organ-on-a-chip, etc, However, Big Pharma doesn't want to do any of it, on their argument that if it ain't broke, why fix it? It is broke of course, but it's delivering the $$$$s for them.
I'm concerned that Makary will not be able to properly assess the advice he is getting, but I hope I am wrong...
you think these predictive models will do a better job at assessing safety compared to the traditional animal toxicology studies that have been run for example at CROs like Charles River? I guess I’m somewhat skeptical or on the fence at least.
Thanks Alison. First to say is that the CROs and CDMOs must dance to big pharma's tune, as they are the paymasters. Without big pharma paying the bills, they ain't in business.
What makes it worse is that big pharma can't get products to market without CROs and CDMOs. So, they are locked into a spiral of ever decreasing standards trying to get product approvals.
Next point is that predictive technology is one component of the drug development process that must change.
Fundamentally, however, we need to bring clinicians back to front and center, so that an intervention with a drug (medicinal product) is the last resort. It could be that a functional medicine (vits and minerals) could work to resolve an issue. That would require better use of in-vitro diagnostics to identify deficiencies.
I've written all this up, and a lot more, for Wiley in a 330 page book titled Transforming the Pharmaceutical Supply Chain, which publishes September 17th.
It will not be cheap at $109, but it is aimed at re-education of an industry that has lost its way, and probably is going to explode in the near future. It's a case then of 'what happens next.' RFK Jr will get a copy...and Marty Makary...
Agree completely! A medicinal product should be the last resort. If this happens, at least in the US, not sure about UK, I think we will likely see a significant economic downturn for a period of time especially in states like CA where the state is heavily invested in the biotech sector. Maybe you have a different take but I don’t see how this can be avoided with biotech tied to venture capital, big tech, banking and real estate. Under the impression the US needs to get back to manufacturing real goods and avoid blowing bubbles in industries like biotech where there is clearly no ROI until the fake pandemic. It will be interesting to see what happens and if the FDA commissioner continues to prioritize the economic health of the Pharma industry over patient health as they did with Covid.
The die is cast for biotech, Alison. The original definition of a biotech company in the 1990s described a business model that used the newly formed based of contractors emerging from big pharma's outsourcing of its physical assets, people and facilities. That allowed senior managerial and technical staff who lost their jobs to begin developing drugs themselves, using the contractors. They were funded by venture capital looking to make an eventual profitable 'exit'. Some biotech's even aimed to get a drug to market themselves, without big pharma, and I headed up the supply chain for three of them - British Biotech, Vernalis, and OSI pharmaceuticals (now Astellas). Vernalis brought frovatriptan to market and OSI brought Tarceva to market.
This is the crux of it. All the drugs those companies were developing were small molecule drugs (not biologics), made using industrial chemistry, where the supply chain is not hindered by temperature, potency and yield variation.
At some point in the 2000's, the definition of biotech changed to biotechnology, and today biotech = biotechnology.
That is when the rot set in. Venture capital, especially silicon valley, began funnelling $billions into biotech(nology), trying to emulate the success of monoclonal antibodies (mAbs) a la Genentech (GNE).
I visited GNE several times during 2004/5, and at the time, they had 7,000 employment vacancies. Not long after, GNE was acquired by Roche, and the entrepreneurial spirit and technical skills in biotechnology at GNE were lost forever.
When the supply chain for mAbs became impossible to manage safely, they turned to rare diseases, such as those in blood cancer, and CAR T-cell therapy emerged on the scene. The technology is gene modified cell therapy, as you know, aka genetic engineering. CAR T-cell therapy was given breakthrough designation by FDA in 2014, and in 2017, Novartis's Kymriah was approved by FDA. It now has an FDA Black Box warning due to the potential for neurological toxicity, cytokine release syndrome (sepsis) and secondary cancers. I have shared the package insert many time here, to prove it.
All that to say, if the new commissioner prioritizes the economic health of the Pharma industry, he will preside over the greatest crime against humanity in the history of the modern world.
Now Peter Marks is gone, he is likely to find that out, hopefully, sooner rather than later...
Over the decades, 10's of millions have sacrificed their lives in order to provide Pig Pharma with a buck or two...tens of billions of them. No one has any desire to stop the deadly carnage.
The FDA must agree with you because they are looking for new ways to bring drugs to market faster.
Dr Martin Makary, the new FDA commissioner, is talking about using AI and cell line computational models to replace animal toxicology studies for testing biologics for safety and efficacy.
While this sounds good on the surface, it is uncertain how this might impact drug safety. In preclinical testing typically a compound has to be safety tested for 14 or 28 days in 2 species prior to being approved for Phase I. As the compound progresses it has to go through a series of longer duration toxicology studies before it is FDA approved for Phase 2 and 3.
How do you think moving from animal safety testing to AI and computational type models will impact cGMP and safety? It seems like AI and organ on a chip systems are primarily designed to stimulate investment in biotech and ensure speed to market. I might be wrong about this as I am not an expert but this looks similar to the Covid strategy, loosen up pipelines, stimulate investment to get products to market quickly. Profit over patient safety.
It would be interesting to get your thought on this topic and how it will impact cGMP. Again the FDA must not think this is about depopulation but speed to market. If your plan is to kill people why waste time coming up with new ways to accelerate drugs to market???
Thanks Again Alison - you know your stuff!
In my next book, predictive technologies feature as a key platform for change. These technologies exist, such as testing in human tissue, or what is known as in silico (computer modelling) and organ-on-a-chip, etc, However, Big Pharma doesn't want to do any of it, on their argument that if it ain't broke, why fix it? It is broke of course, but it's delivering the $$$$s for them.
I'm concerned that Makary will not be able to properly assess the advice he is getting, but I hope I am wrong...
This is interesting. So do
you think these predictive models will do a better job at assessing safety compared to the traditional animal toxicology studies that have been run for example at CROs like Charles River? I guess I’m somewhat skeptical or on the fence at least.
Thanks Alison. First to say is that the CROs and CDMOs must dance to big pharma's tune, as they are the paymasters. Without big pharma paying the bills, they ain't in business.
What makes it worse is that big pharma can't get products to market without CROs and CDMOs. So, they are locked into a spiral of ever decreasing standards trying to get product approvals.
Next point is that predictive technology is one component of the drug development process that must change.
Fundamentally, however, we need to bring clinicians back to front and center, so that an intervention with a drug (medicinal product) is the last resort. It could be that a functional medicine (vits and minerals) could work to resolve an issue. That would require better use of in-vitro diagnostics to identify deficiencies.
I've written all this up, and a lot more, for Wiley in a 330 page book titled Transforming the Pharmaceutical Supply Chain, which publishes September 17th.
It will not be cheap at $109, but it is aimed at re-education of an industry that has lost its way, and probably is going to explode in the near future. It's a case then of 'what happens next.' RFK Jr will get a copy...and Marty Makary...
Agree completely! A medicinal product should be the last resort. If this happens, at least in the US, not sure about UK, I think we will likely see a significant economic downturn for a period of time especially in states like CA where the state is heavily invested in the biotech sector. Maybe you have a different take but I don’t see how this can be avoided with biotech tied to venture capital, big tech, banking and real estate. Under the impression the US needs to get back to manufacturing real goods and avoid blowing bubbles in industries like biotech where there is clearly no ROI until the fake pandemic. It will be interesting to see what happens and if the FDA commissioner continues to prioritize the economic health of the Pharma industry over patient health as they did with Covid.
The die is cast for biotech, Alison. The original definition of a biotech company in the 1990s described a business model that used the newly formed based of contractors emerging from big pharma's outsourcing of its physical assets, people and facilities. That allowed senior managerial and technical staff who lost their jobs to begin developing drugs themselves, using the contractors. They were funded by venture capital looking to make an eventual profitable 'exit'. Some biotech's even aimed to get a drug to market themselves, without big pharma, and I headed up the supply chain for three of them - British Biotech, Vernalis, and OSI pharmaceuticals (now Astellas). Vernalis brought frovatriptan to market and OSI brought Tarceva to market.
This is the crux of it. All the drugs those companies were developing were small molecule drugs (not biologics), made using industrial chemistry, where the supply chain is not hindered by temperature, potency and yield variation.
At some point in the 2000's, the definition of biotech changed to biotechnology, and today biotech = biotechnology.
That is when the rot set in. Venture capital, especially silicon valley, began funnelling $billions into biotech(nology), trying to emulate the success of monoclonal antibodies (mAbs) a la Genentech (GNE).
I visited GNE several times during 2004/5, and at the time, they had 7,000 employment vacancies. Not long after, GNE was acquired by Roche, and the entrepreneurial spirit and technical skills in biotechnology at GNE were lost forever.
When the supply chain for mAbs became impossible to manage safely, they turned to rare diseases, such as those in blood cancer, and CAR T-cell therapy emerged on the scene. The technology is gene modified cell therapy, as you know, aka genetic engineering. CAR T-cell therapy was given breakthrough designation by FDA in 2014, and in 2017, Novartis's Kymriah was approved by FDA. It now has an FDA Black Box warning due to the potential for neurological toxicity, cytokine release syndrome (sepsis) and secondary cancers. I have shared the package insert many time here, to prove it.
All that to say, if the new commissioner prioritizes the economic health of the Pharma industry, he will preside over the greatest crime against humanity in the history of the modern world.
Now Peter Marks is gone, he is likely to find that out, hopefully, sooner rather than later...
Over the decades, 10's of millions have sacrificed their lives in order to provide Pig Pharma with a buck or two...tens of billions of them. No one has any desire to stop the deadly carnage.