Regulatory Open Forum

I'm glad you liked the PDF, although this leaves me wondering whether this was artfully stated to avoid saying what you thought about what I wrote on it. :)

I am not sure how to relate your comment to my own comments, so I will just babble a bit.  Everything comes down to Process + Resources.  If you want to expedite a process, you can:

1) Change the process to make it faster.
One way to do this is to cut out steps. This is a favorite with managers who just want to look like they are taking action to expedite the process, because it's easy, especially if they cut out the "non-value-added" steps related to the quality of the outcome.

2) Change the resources (usually people).
There is often a limit to how many more resources you can add before you reach a point of diminishing returns, or of too many cooks in the stew, which can actually slow the process down.
Also, adding resources just to add them, without consideration of whether they are well suited for the process, often doesn't expedite it, and may slow it down.  Another favorite with managers who just want to look like they are taking action to expedite the process, because it's easy.  "Just throw more bodies at it."

When it comes to expediting a process without adversely affecting the quality of the outcome...that is usually not so easy.

I have been hearing for some years now that many of the experienced/knowledgeable/"good" people have been flooding out of FDA and have been replaced by inexperienced/not knowledgeable/"not-so-good" people.  No one has said the word "Millennials," but the implication seems to be there.

I can't speak to the truth of this myself, and I wasn't paying close attention until circa 2014.  But to me it at least raises the question of whether FDA actually CAN review and approve products for a novel virus.  I have long-standing doubts about CDRH's abilities, anyway, some of which go back to my early days.  Not so much a matter of "not-so-good" resources, but inadequate processes plus wrong resources, I think.

Anyway, I don't think the EUA process is going to expedite anything without negatively affecting the quality of the outcome, when quality is defined as meeting the needs of patients, especially the need to not be used for human experimentation without informed consent or IRB oversight.  When it is defined as meeting the needs of some other players, it seems a guarantee that it does, and that this is why it is still being used.

IMO.

I'm glad you liked the PDF, although this leaves me wondering whether this was artfully stated to avoid saying what you thought about what I wrote on it. :)

I am not sure how to relate your comment to my own comments, so I will just babble a bit.  Everything comes down to Process + Resources.  If you want to expedite a process, you can:

1) Change the process to make it faster.
One way to do this is to cut out steps. This is a favorite with managers who just want to look like they are taking action to expedite the process, because it's easy, especially if they cut out the "non-value-added" steps related to the quality of the outcome.

2) Change the resources (usually people).
There is often a limit to how many more resources you can add before you reach a point of diminishing returns, or of too many cooks in the stew, which can actually slow the process down.
Also, adding resources just to add them, without consideration of whether they are well suited for the process, often doesn't expedite it, and may slow it down.  Another favorite with managers who just want to look like they are taking action to expedite the process, because it's easy.  "Just throw more bodies at it."

When it comes to expediting a process without adversely affecting the quality of the outcome...that is usually not so easy.

I have been hearing for some years now that many of the experienced/knowledgeable/"good" people have been flooding out of FDA and have been replaced by inexperienced/not knowledgeable/"not-so-good" people.  No one has said the word "Millennials," but the implication seems to be there.

I can't speak to the truth of this myself, and I wasn't paying close attention until circa 2014.  But to me it at least raises the question of whether FDA actually CAN review and approve products for a novel virus.  I have long-standing doubts about CDRH's abilities, anyway, some of which go back to my early days.  Not so much a matter of "not-so-good" resources, but inadequate processes plus wrong resources, I think.

Anyway, I don't think the EUA process is going to expedite anything without negatively affecting the quality of the outcome, when quality is defined as meeting the needs of patients, especially the need to not be used for human experimentation without informed consent or IRB oversight.  When it is defined as meeting the needs of some other players, it seems a guarantee that it does, and that this is why it is still being used.

IMO.

I'm glad you liked the PDF, although this leaves me wondering whether this was artfully stated to avoid saying what you thought about what I wrote on it. :)

I am not sure how to relate your comment to my own comments, so I will just babble a bit.  Everything comes down to Process + Resources.  If you want to expedite a process, you can:

1) Change the process to make it faster.
One way to do this is to cut out steps. This is a favorite with managers who just want to look like they are taking action to expedite the process, because it's easy, especially if they cut out the "non-value-added" steps related to the quality of the outcome.

2) Change the resources (usually people).
There is often a limit to how many more resources you can add before you reach a point of diminishing returns, or of too many cooks in the stew, which can actually slow the process down.
Also, adding resources just to add them, without consideration of whether they are well suited for the process, often doesn't expedite it, and may slow it down.  Another favorite with managers who just want to look like they are taking action to expedite the process, because it's easy.  "Just throw more bodies at it."

When it comes to expediting a process without adversely affecting the quality of the outcome...that is usually not so easy.

I have been hearing for some years now that many of the experienced/knowledgeable/"good" people have been flooding out of FDA and have been replaced by inexperienced/not knowledgeable/"not-so-good" people.  No one has said the word "Millennials," but the implication seems to be there.

I can't speak to the truth of this myself, and I wasn't paying close attention until circa 2014.  But to me it at least raises the question of whether FDA actually CAN review and approve products for a novel virus.  I have long-standing doubts about CDRH's abilities, anyway, some of which go back to my early days.  Not so much a matter of "not-so-good" resources, but inadequate processes plus wrong resources, I think.

Anyway, I don't think the EUA process is going to expedite anything without negatively affecting the quality of the outcome, when quality is defined as meeting the needs of patients, especially the need to not be used for human experimentation without informed consent or IRB oversight.  When it is defined as meeting the needs of some other players, it seems a guarantee that it does, and that this is why it is still being used.

IMO.

I'm glad you liked the PDF, although this leaves me wondering whether this was artfully stated to avoid saying what you thought about what I wrote on it. :)

I am not sure how to relate your comment to my own comments, so I will just babble a bit.  Everything comes down to Process + Resources.  If you want to expedite a process, you can:

1) Change the process to make it faster.
One way to do this is to cut out steps. This is a favorite with managers who just want to look like they are taking action to expedite the process, because it's easy, especially if they cut out the "non-value-added" steps related to the quality of the outcome.

2) Change the resources (usually people).
There is often a limit to how many more resources you can add before you reach a point of diminishing returns, or of too many cooks in the stew, which can actually slow the process down.
Also, adding resources just to add them, without consideration of whether they are well suited for the process, often doesn't expedite it, and may slow it down.  Another favorite with managers who just want to look like they are taking action to expedite the process, because it's easy.  "Just throw more bodies at it."

When it comes to expediting a process without adversely affecting the quality of the outcome...that is usually not so easy.

I have been hearing for some years now that many of the experienced/knowledgeable/"good" people have been flooding out of FDA and have been replaced by inexperienced/not knowledgeable/"not-so-good" people.  No one has said the word "Millennials," but the implication seems to be there.

I can't speak to the truth of this myself, and I wasn't paying close attention until circa 2014.  But to me it at least raises the question of whether FDA actually CAN review and approve products for a novel virus.  I have long-standing doubts about CDRH's abilities, anyway, some of which go back to my early days.  Not so much a matter of "not-so-good" resources, but inadequate processes plus wrong resources, I think.

Anyway, I don't think the EUA process is going to expedite anything without negatively affecting the quality of the outcome, when quality is defined as meeting the needs of patients, especially the need to not be used for human experimentation without informed consent or IRB oversight.  When it is defined as meeting the needs of some other players, it seems a guarantee that it does, and that this is why it is still being used.

IMO.

I'm glad you liked the PDF, although this leaves me wondering whether this was artfully stated to avoid saying what you thought about what I wrote on it. :)

I am not sure how to relate your comment to my own comments, so I will just babble a bit.  Everything comes down to Process + Resources.  If you want to expedite a process, you can:

1) Change the process to make it faster.
One way to do this is to cut out steps. This is a favorite with managers who just want to look like they are taking action to expedite the process, because it's easy, especially if they cut out the "non-value-added" steps related to the quality of the outcome.

2) Change the resources (usually people).
There is often a limit to how many more resources you can add before you reach a point of diminishing returns, or of too many cooks in the stew, which can actually slow the process down.
Also, adding resources just to add them, without consideration of whether they are well suited for the process, often doesn't expedite it, and may slow it down.  Another favorite with managers who just want to look like they are taking action to expedite the process, because it's easy.  "Just throw more bodies at it."

When it comes to expediting a process without adversely affecting the quality of the outcome...that is usually not so easy.

I have been hearing for some years now that many of the experienced/knowledgeable/"good" people have been flooding out of FDA and have been replaced by inexperienced/not knowledgeable/"not-so-good" people.  No one has said the word "Millennials," but the implication seems to be there.

I can't speak to the truth of this myself, and I wasn't paying close attention until circa 2014.  But to me it at least raises the question of whether FDA actually CAN review and approve products for a novel virus.  I have long-standing doubts about CDRH's abilities, anyway, some of which go back to my early days.  Not so much a matter of "not-so-good" resources, but inadequate processes plus wrong resources, I think.

Anyway, I don't think the EUA process is going to expedite anything without negatively affecting the quality of the outcome, when quality is defined as meeting the needs of patients, especially the need to not be used for human experimentation without informed consent or IRB oversight.  When it is defined as meeting the needs of some other players, it seems a guarantee that it does, and that this is why it is still being used.

IMO.

I'm glad you liked the PDF, although this leaves me wondering whether this was artfully stated to avoid saying what you thought about what I wrote on it. :)

I am not sure how to relate your comment to my own comments, so I will just babble a bit.  Everything comes down to Process + Resources.  If you want to expedite a process, you can:

1) Change the process to make it faster.
One way to do this is to cut out steps. This is a favorite with managers who just want to look like they are taking action to expedite the process, because it's easy, especially if they cut out the "non-value-added" steps related to the quality of the outcome.

2) Change the resources (usually people).
There is often a limit to how many more resources you can add before you reach a point of diminishing returns, or of too many cooks in the stew, which can actually slow the process down.
Also, adding resources just to add them, without consideration of whether they are well suited for the process, often doesn't expedite it, and may slow it down.  Another favorite with managers who just want to look like they are taking action to expedite the process, because it's easy.  "Just throw more bodies at it."

When it comes to expediting a process without adversely affecting the quality of the outcome...that is usually not so easy.

I have been hearing for some years now that many of the experienced/knowledgeable/"good" people have been flooding out of FDA and have been replaced by inexperienced/not knowledgeable/"not-so-good" people.  No one has said the word "Millennials," but the implication seems to be there.

I can't speak to the truth of this myself, and I wasn't paying close attention until circa 2014.  But to me it at least raises the question of whether FDA actually CAN review and approve products for a novel virus.  I have long-standing doubts about CDRH's abilities, anyway, some of which go back to my early days.  Not so much a matter of "not-so-good" resources, but inadequate processes plus wrong resources, I think.

Anyway, I don't think the EUA process is going to expedite anything without negatively affecting the quality of the outcome, when quality is defined as meeting the needs of patients, especially the need to not be used for human experimentation without informed consent or IRB oversight.  When it is defined as meeting the needs of some other players, it seems a guarantee that it does, and that this is why it is still being used.

IMO.

It's a nice wrap up of different issues above and beyond drug companies that impact eventual pricing to patients like all of us where the author mentions a "Biotech Social Contract".

I stand by my experience that the overwhelming people in this space want to do right by the patient. Drugs have to be priced appropriately, but we need a solution to insurance as well.

Regardless, we need to support the funding and incentives for innovation to keep filling the funnel of research as we add drugs to our generic armamentarium.

Curious to hear of anyone on this thread has read it.

I'm glad you liked the PDF, although this leaves me wondering whether this was artfully stated to avoid saying what you thought about what I wrote on it. :)

I am not sure how to relate your comment to my own comments, so I will just babble a bit.  Everything comes down to Process + Resources.  If you want to expedite a process, you can:

1) Change the process to make it faster.
One way to do this is to cut out steps. This is a favorite with managers who just want to look like they are taking action to expedite the process, because it's easy, especially if they cut out the "non-value-added" steps related to the quality of the outcome.

2) Change the resources (usually people).
There is often a limit to how many more resources you can add before you reach a point of diminishing returns, or of too many cooks in the stew, which can actually slow the process down.
Also, adding resources just to add them, without consideration of whether they are well suited for the process, often doesn't expedite it, and may slow it down.  Another favorite with managers who just want to look like they are taking action to expedite the process, because it's easy.  "Just throw more bodies at it."

When it comes to expediting a process without adversely affecting the quality of the outcome...that is usually not so easy.

I have been hearing for some years now that many of the experienced/knowledgeable/"good" people have been flooding out of FDA and have been replaced by inexperienced/not knowledgeable/"not-so-good" people.  No one has said the word "Millennials," but the implication seems to be there.

I can't speak to the truth of this myself, and I wasn't paying close attention until circa 2014.  But to me it at least raises the question of whether FDA actually CAN review and approve products for a novel virus.  I have long-standing doubts about CDRH's abilities, anyway, some of which go back to my early days.  Not so much a matter of "not-so-good" resources, but inadequate processes plus wrong resources, I think.

Anyway, I don't think the EUA process is going to expedite anything without negatively affecting the quality of the outcome, when quality is defined as meeting the needs of patients, especially the need to not be used for human experimentation without informed consent or IRB oversight.  When it is defined as meeting the needs of some other players, it seems a guarantee that it does, and that this is why it is still being used.

IMO.

I'm glad you liked the PDF, although this leaves me wondering whether this was artfully stated to avoid saying what you thought about what I wrote on it. :)

I am not sure how to relate your comment to my own comments, so I will just babble a bit.  Everything comes down to Process + Resources.  If you want to expedite a process, you can:

1) Change the process to make it faster.
One way to do this is to cut out steps. This is a favorite with managers who just want to look like they are taking action to expedite the process, because it's easy, especially if they cut out the "non-value-added" steps related to the quality of the outcome.

2) Change the resources (usually people).
There is often a limit to how many more resources you can add before you reach a point of diminishing returns, or of too many cooks in the stew, which can actually slow the process down.
Also, adding resources just to add them, without consideration of whether they are well suited for the process, often doesn't expedite it, and may slow it down.  Another favorite with managers who just want to look like they are taking action to expedite the process, because it's easy.  "Just throw more bodies at it."

When it comes to expediting a process without adversely affecting the quality of the outcome...that is usually not so easy.

I have been hearing for some years now that many of the experienced/knowledgeable/"good" people have been flooding out of FDA and have been replaced by inexperienced/not knowledgeable/"not-so-good" people.  No one has said the word "Millennials," but the implication seems to be there.

I can't speak to the truth of this myself, and I wasn't paying close attention until circa 2014.  But to me it at least raises the question of whether FDA actually CAN review and approve products for a novel virus.  I have long-standing doubts about CDRH's abilities, anyway, some of which go back to my early days.  Not so much a matter of "not-so-good" resources, but inadequate processes plus wrong resources, I think.

Anyway, I don't think the EUA process is going to expedite anything without negatively affecting the quality of the outcome, when quality is defined as meeting the needs of patients, especially the need to not be used for human experimentation without informed consent or IRB oversight.  When it is defined as meeting the needs of some other players, it seems a guarantee that it does, and that this is why it is still being used.

IMO.