The Drug approval process and how SAS can help shorten it

[#1]

So long, so expensive!

The drug approval process.

There is an old joke in the pharmaceutical industry.  I paraphrase:

What’s a drug’s favorite game? "Hide and Seek"—because it takes years to find its way to the pharmacy!

There are many minor daily mishaps such as missing your bus or spilling coffee on yourself before that important meeting which can feel frustrating but often don't have lasting consequences.

The detrimental unintended consequences of a new drug’s effect on humanity will be the opposite of a minor daily mishap; this will be life or death.

That is why the drug approval process has so much rigor built into it.

Let’s explore!

 

Figure 1 Drug approval process - Follow Link 1. in Supporting material below

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The Data and Analysis pieces are what we are interested to optimize using SAS. These are in order:

The Investigation New Drug (IND) process:

Investigational New Drug (IND) application is submitted to regulatory agency based on the results from initial testing to determine whether drug/biological product can be tested on humans.

SAS can make this quicker by helping create:

1. Single version of data truth and workflow, permissions and regulatory reporting and management (SAS special talent)
2. Explanatory Analytics (SAS special talent)
3. Exploratory Analytics (SAS special talent)
4. Predictive and future based analytics (SAS special talent)
5. Optimization analytics (SAS special talent)
6. Visualization, Dissemination and workflow of data single version of the truth and all analytics (SAS special talent).

 

Phase 1 - First In Human Study (FIH)

This is the first-in-human (FIH) study. It focuses on a drug’s side effects, optimal dosage ranges, and how it is metabolized in the body.​

SAS can make this quicker by helping create:

1. Single version of data truth and workflow, permissions and regulatory reporting and management (SAS special talent)
2. Explanatory Analytics (SAS special talent)
3. Exploratory Analytics (SAS special talent)
4. Predictive and future based analytics (SAS special talent)
5. Optimization analytics (SAS special talent)
6. Visualization, Dissemination and workflow of data single version of the truth and all analytics (SAS special talent).

 

Phase 2 - Validity testing.  Retesting results from Phase 1 for validity

Preliminary data is obtained on whether the drug works in people with a certain disease or condition. Safety and short-term side effects are evaluated.​

SAS can make this quicker by helping create:

1. Single version of data truth and workflow, permissions and regulatory reporting and management (SAS special talent)
2. Explanatory Analytics (SAS special talent)
3. Exploratory Analytics (SAS special talent)
4. Predictive and future based analytics (SAS special talent)
5. Optimization analytics (SAS special talent)
6. Visualization, Dissemination and workflow of data single version of the truth and all analytics (SAS special talent).

 

Phase 3 and pre NDA meeting - More Data, more complex testing, more NDA Compliance

Phase 3 is a larger-scale phase that gathers additional regarding the safety and efficacy of the drug and studies different populations. Furthermore, regulatory agency gathers in a Pre-NDA/BLA meeting to analyze results, combined and compared with the previous phases. This is where the single version of the truth comes into its own.

SAS can make this quicker by helping create:

1. Single version of data truth and workflow, permissions and regulatory reporting and management (SAS special talent)
2. Explanatory Analytics (SAS special talent)
3. Exploratory Analytics (SAS special talent)
4. Predictive and future based analytics (SAS special talent)
5. Optimization analytics (SAS special talent)
6. Visualization, Dissemination and workflow of data single version of the truth and all analytics (SAS special talent).

 

The NDA Submission - And all of that culminates into the New Drug Application (NDA) to the regulatory agency(s).

New Drug Application (NDA) is submitted to the regulatory agency to seek approval to market the drug.​

The drug sponsor submits the NDA, or the New Drug Application, to the regulatory agency to formally ask for the agency’s approval to market the new drug.

The NDA includes all the animal and human data collection and analyses as well as information about how the drug behaves in the human body and how it is manufactured. ​ ​

It is important to note here that as a SAS Clinical Programmer, you are responsible for gathering all the data from phases 1, 2, and 3 and generating all the results that are to be submitted as a part of the NDA.

This requires submission of all the results from the 3 phases.

This is why you need SAS; all you have done up to this point leads you to a submission.

If you do this with SAS, the single data version allows you to re-use and build on previous phases, so things happen quickly.

The analysis and preparation allow you to cut analytical mistakes, to show a yellow brick road of metadata that led you to all conclusions, and the regulating agencies accept SAS as a way to look at results already, so you don’t need a lot of reformatting to submit.

 

Phase 4 - And just when you thought you were done.....  Long term study

Since it is not possible to predict all of a drug’s effects during clinical trials, safety issues after the drug goes on the market are monitored during this phase. The sponsor, typically the manufacturer, is required to submit periodic safety updates to the regulatory agency. The role of the agency’s post-marketing safety system is to detect serious unexpected adverse events and take definitive action when needed.

 

One system through all the stages.

The detrimental unintended consequences of a new drug’s effect on humanity will be the opposite of a minor daily mishap; this will be life or death.

Using rigorous data management practices and rigorous analytical processes and rigorous regulatory compliance preparation, you can err on the side of life, in a quicker and cheaper way.

SAS Life Science Analytics framework.

 

Supporting Material

https://conquer-magazine.com/issues/special-issues/january-2021-a-patient-guide-to-recent-fda-approved-oncology-drugs/2021-fda-drug-approval-process-infographic   

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