Old 10-14-2021, 13:35   #1876
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The cost and complexity of taking a new drug to market requires the infrastructure of one of the established pharma companies. They're not the bad guys. It's the cost associated with the process. Frankly, I don't see a point to reform without risks such as reduction in drug safety/efficacy
I think you forgot the caveat "almost none of this applies to the current batch of COVID vaccines".
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Old 10-14-2021, 14:03   #1877
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I'm just glad to see that it takes something as big as a 99.7% survivable virus that primarily threatens the elderly and the ill to push our entire country to the brink of dysfunction.

Have your peas mother fuckers HAVE THEM NOW !!!
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Old 10-14-2021, 14:28   #1878
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I'm just glad to see that it takes something as big as a 99.7% survivable virus that primarily threatens the elderly and the ill to push our entire country to the brink of dysfunction.

Have your peas mother fuckers HAVE THEM NOW !!!
You always get to the heart of the matter with such brevity.
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Old 10-14-2021, 21:42   #1879
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Well, being intimately involved in drug discovery/development for the last 25 years I have few thoughts on this subject:

1. It is easy to blame pharmaceutical companies, although not blameless, they are not totally responsible either.
2. Government funding is usually at the very early stage (discovery and proof-of concept) and amounts to <1% of the amount required to bring a new drug to market. Most of the government funding goes to University salaries and overhead. Universities retain the patent rights and recover their investment when the technology is sold (usually to a venture capital company).
3. The VC company will bundle the new technology and push it down to one of its portfolio companies to further develop the technology through the pre-IND and on to the IND/clinical phase of development. The cost to this stage is ~$100 million.
4. The pharmaceutical company's sweet spot for acquisition of a new drug candidate is the Phase II clinical trial stage. There is easily $300-$500 million to bring a drug candidate through this stage of development and ready for acquisition by a pharmaceutical company.
5. The acquisition cost will be $1-$2 Billion at least.
6. Now the real costs begin, including Phase 3 clinical studies, formulary costs, pharmacy benefit managers, insurance providers, and various other 'middle-men'. This phase adds a 10x multiple to a new drug's cost before it ever reaches market!

The cost and complexity of taking a new drug to market requires the infrastructure of one of the established pharma companies. They're not the bad guys. It's the cost associated with the process. Frankly, I don't see a point to reform without tisks such as reduction in drug safety/efficacy
Trapper John,

Your comments (as usual) are correct. Case in point with 1980 dollars:

40+ years ago, I was implementing a manufacturing system in one of the J&J companies. We had worked for about 12 months of an estimated 3 year effort.

They had developed a new product that revolutionized a reproductive health issue, and the Phased testing so far had gone extremely well (SPEND TO DATE Phase 1 +/- $100 Million, Phase 2 +/- $350 MILLION). We had just finished a Phase 2 approval, and the results were so good that the Division VP took the team out for a “celebratory” dinner.

We started Phase 3 with high expectations…so high in fact that J&J Senior Management directed a “pre-build” of inventory so that they could have product in the pipeline when Phase 3 was approved (ADDITIONAL SPENDING +/- 1.2 BILLION).

They had 2 warehouses full with inventory, and were starting to stage in another J&J Divisions facility.

Then the REJECTION came for the Phase 3 clinicals. They had discovered a non-recoverable major occluding issue in late phase testing.

The product was cancelled, the warehouses scrapped the inventory, and the company wrote off over $1.65 BILLION (in 1980 dollars). I have no idea what that amount would be in 2021 money, but I expect it would be north of $5 BILLION. Profit losses over the next 17 years would probably have been in the $2-3 BILLION range annually..

SnT
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Old 10-15-2021, 00:42   #1880
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Well, being intimately involved in drug discovery/development for the last 25 years I have few thoughts on this subject:

1. It is easy to blame pharmaceutical companies, although not blameless, they are not totally responsible either.
2. Government funding is usually at the very early stage (discovery and proof-of concept) and amounts to <1% of the amount required to bring a new drug to market. Most of the government funding goes to University salaries and overhead. Universities retain the patent rights and recover their investment when the technology is sold (usually to a venture capital company).
3. The VC company will bundle the new technology and push it down to one of its portfolio companies to further develop the technology through the pre-IND and on to the IND/clinical phase of development. The cost to this stage is ~$100 million.
4. The pharmaceutical company's sweet spot for acquisition of a new drug candidate is the Phase II clinical trial stage. There is easily $300-$500 million to bring a drug candidate through this stage of development and ready for acquisition by a pharmaceutical company.
5. The acquisition cost will be $1-$2 Billion at least.
6. Now the real costs begin, including Phase 3 clinical studies, formulary costs, pharmacy benefit managers, insurance providers, and various other 'middle-men'. This phase adds a 10x multiple to a new drug's cost before it ever reaches market!

The cost and complexity of taking a new drug to market requires the infrastructure of one of the established pharma companies. They're not the bad guys. It's the cost associated with the process. Frankly, I don't see a point to reform without tisks such as reduction in drug safety/efficacy



I'm just curious........what phase of testing are we in now with these covid vaccines? I'm guessing this is probably the first time humans have been used for phase II and phase III tests?
I only bring this up because, to my knowledge, the quickest testing and brought to market ever done was on the mumps vaccine and that took 4 years.
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Old 10-15-2021, 00:56   #1881
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Wuhan flu is an infectious disease process that has a 99.8% survival rate. The most at risk folks are those that are already suffering from multiple health problem.

Smug is incurable. The prognosis is poor. Once you are infected with Smug, it seems to stick with you forever.
Tragically, the people that are most impacted by terminal smug are decent, hard working, peace loving, good nature individuals that are constantly getting fucked over by the smug. It's not a coincidence that so much smug can be found in the typical airport VIP lounge.

Not everyone that goes into an airport VIP lounge comes out smug - but the ones that do are changed forever. Truth be told - if I was granted access to the VIP lounge and had to walk past the USO to get there - I'd almost always stop at the USO to chat with the 80 year old volunteer that keeps the coffee pot full.

Even if Saint Fauci was right and masks could protect you from COVID - masks don't do shit to prevent smug. In fact, there are several studies that suggest folks still walking around outside with a mask on are almost certainly infected with some degree of smug...
...and its going to get worse



Having grown up very poor I developed immunity to smug. I know this because in the past I have infiltrated those lounges while traveling international. The cause of me changing my traveling class was an Arab woman on a flight leaving New York one midnight, heading to Jordan. She was sitting in my seat by the window and refused to move during the boarding process. She played the "no speaky english" card. The young pretty flight attendant went and got a Arab male flight attendant who had words with her in a language she understood. She begrudgingly moved over to the aisle seat. When I sat down she proceeded to put her purse in front of my feet, in my storage area. Being very tired at this time, I had used up all the patience that I had, so I took her purse and threw it on her lap. I then proceeded to elbow her because she felt inclined to want to take up my seat space. Once airborne she found it more comfortable to move to another aisle.
Maybe I created another suicide bomber, I don't know, but my diplomacy was exhausted.
I relate the above because from that flight on I refused to fly coach on international flights and paid for the upgrade to business class. It's that business class ticket that gets you into those lounges full of people afflicted with smug. I'm back to international travel again for the time being, but damn if I make enough money to fly in the upgraded class now. Seems like those seats have quadrupled in price in the past 15 years. I have not had any issue with the smug from my exposure in those years, so I know I have an immunity.
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Old 10-15-2021, 07:14   #1882
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Fauci's fantasy world. I wonder if NIH put out a bid or proof of concept.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8223067/

https://pubmed.ncbi.nlm.nih.gov/33713140/

https://pubmed.ncbi.nlm.nih.gov/33679209/

https://pubmed.ncbi.nlm.nih.gov/32834324/

https://pubmed.ncbi.nlm.nih.gov/34195618/
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Old 10-15-2021, 08:36   #1883
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I think you forgot the caveat "almost none of this applies to the current batch of COVID vaccines".
You are correct! I was referring to the typical process. Operation "Warp Speed" was a government driven special case.
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Old 10-15-2021, 09:01   #1884
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Trapper John,

Your comments (as usual) are correct. Case in point with 1980 dollars:

40+ years ago, I was implementing a manufacturing system in one of the J&J companies. We had worked for about 12 months of an estimated 3 year effort.

They had developed a new product that revolutionized a reproductive health issue, and the Phased testing so far had gone extremely well (SPEND TO DATE Phase 1 +/- $100 Million, Phase 2 +/- $350 MILLION). We had just finished a Phase 2 approval, and the results were so good that the Division VP took the team out for a “celebratory” dinner.

We started Phase 3 with high expectations…so high in fact that J&J Senior Management directed a “pre-build” of inventory so that they could have product in the pipeline when Phase 3 was approved (ADDITIONAL SPENDING +/- 1.2 BILLION).

They had 2 warehouses full with inventory, and were starting to stage in another J&J Divisions facility.

Then the REJECTION came for the Phase 3 clinicals. They had discovered a non-recoverable major occluding issue in late phase testing.

The product was cancelled, the warehouses scrapped the inventory, and the company wrote off over $1.65 BILLION (in 1980 dollars). I have no idea what that amount would be in 2021 money, but I expect it would be north of $5 BILLION. Profit losses over the next 17 years would probably have been in the $2-3 BILLION range annually..

SnT
That is a fairly typical case for a drug that fails in the Phase III stage of development. Thanks for posting that. It is instructive for folks to understand the madnitude of $s and risk that is at stake by Pharma in drug development! No other business sector comes close!

An additional note in comment to your post: I think the failure you are referring to in Phase III should have been picked up in IND enabling pharmacological safety studies in canine species. I'll bet ya the responsible CRO paid dearly for that F'up.
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Old 10-15-2021, 09:08   #1885
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I'm just curious........what phase of testing are we in now with these covid vaccines? I'm guessing this is probably the first time humans have been used for phase II and phase III tests?
I only bring this up because, to my knowledge, the quickest testing and brought to market ever done was on the mumps vaccine and that took 4 years.
Phase I, II and III are always conducted in humans. The difference in the case of vaccines is the size (#of test subjects) and complexity (# and type of cohorts, and #of test locations).

This is why I, as a small, private drug developer, would never, never embark down the path of vaccine development. The economics, risk/reward just don't work for a small company!

Oh, and to your question about the speed of development re: the mumps vaccine. The shortened development timeline was due entirely to the development of the antigen by using the newly developed mRNA technology rather than using killed virus or developing an inactivated variant. None of the safety/efficacy studies were abbreviated or altered in any way to shorten the Covid vaccine approval.
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Old 10-15-2021, 10:16   #1886
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None of the safety/efficacy studies were abbreviated or altered in any way to shorten the Covid vaccine approval.
I am ignorant of the inner working of the process - is this a "good" thing for the populace or a "bad" thing for the populace?

It sounds good - since nothing was altered or abbreviated - is there a down side? It certainly seems like using NEW technology would have slowed an otherwise unaltered process down instead of speeding it up.

If nothing was abbreviated or altered to shorten the approval - why does everything else take so long?
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Old 10-15-2021, 11:33   #1887
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8 prominent doctors & scientists engage in a remarkable exchange

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Old 10-15-2021, 12:49   #1888
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I'm just glad to see that it takes something as big as a 99.7% survivable virus that primarily threatens the elderly and the ill to push our entire country to the brink of dysfunction.

Have your peas mother fuckers HAVE THEM NOW !!!

This is advertising GOLD....Hahahaha...
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Old 10-15-2021, 13:48   #1889
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This is advertising GOLD....Hahahaha...
You dont have to eat them - but by god you're going to have them come hell or high water.
...and after you've had some, you're going to have more
...and more

You'll have them until Lord Biden and Darth Fauci decide that you've had enough.
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Old 10-16-2021, 10:14   #1890
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I am ignorant of the inner working of the process - is this a "good" thing for the populace or a "bad" thing for the populace?

It sounds good - since nothing was altered or abbreviated - is there a down side? It certainly seems like using NEW technology would have slowed an otherwise unaltered process down instead of speeding it up.

If nothing was abbreviated or altered to shorten the approval - why does everything else take so long?
There are a couple of questions embedded in that response so my apology in advance for a lengthy reply:

1. The mRNA technology, although new, was off the shelf and ready to enter clinical safety (Phase 1) and efficacy (Phase 2) trials. The pre-clinical IND enabling studies had already been completed. This saved 1-2 years right off the bat. (Pretty good pun imho.)

2. Conventional vaccine development would have required development of an inactive live virus or validated that a killed virus would induce an appropriate immune response. This would have taken an additional 1-2 years prior to entering the clinical IND phase. So all things being equalized. The mRNA technology shortened the development time 2-4 years.

3. "Operation Warp Speed" accelerated manufacturing by removing the financial risk associated with scale-up of manufacturing processes and therefore the time required for the vaccine being ready for distribution. I am getting outside of my wheelhouse at this stage. SurfnTurf can probably more adequately respond here.

4. As to your question: "If nothing was abbreviated or altered to shorten the approval - why does everything else take so long?" I was referring to the pre-clinical and clinical safety studies. Everything else just takes time and therefore $s. I hope that through my and SnT's reesponses in this thread you all can begin to appreciate the huge risks, and costs that the Pharma industry faces in order to bring all of us safe and effective medicines! Can we do better? Yes indeed! I can confidently say that my colleagues with different technologies and new drug candidates all are driving towards a lower cost point for patients as a success metric!
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