Pharma Opertations

Hello,

For a pharma operations case, my approac would be to break it down in the following steps:

1) Research stage: This is where multiple molecules or compunds are designed and tested.

2) Development stage: If the first stage passes, then at this stage economic viability is assessed by doing tests at a larger scale

3) Internal approval: This is when the pharma company feels that this drug has the potential to succeed in the market and solve a problem. It receives a go ahead internally.

4) Regulatory approval: One of the most riskiest stages in drug development is to get regulatory approval (e.g. from FDA)

5) Manufacturing: Once regulators give it a go ahead, the next step is to go ahead with large scale manufacturing

6) Marketing and Distribution: Final step is to discuss the marketing and distribution approach. Selling to pharmacies, doctors, retailers, online etc.

All the best!

Rushabh

So I'd recommend being careful with learning frameworks as the framework you'll need to use will depend on the question being asked. However, I can understand if you need to learn the process of how a drug gets to development. 

As others have said, I'd think about:

1. Discovery and Development
2. Preclinical Research: Drugs undergo laboratory and animal testing to answer basic questions about safety.
3. Clinical Research: Drugs are tested on people to make sure they are safe and effective.
4. FDA Drug Review: FDA review teams thoroughly examine all of the submitted data related to the drug or device and make a decision to approve or not to approve it.
5. Marketing: Liaise with hospitals, key influencers etc., to promote usage
6. FDA Post-Market Drug Safety Monitoring: FDA monitors all drug and device safety once products are available for use by the public.

Hi there,

Normally you can think of the overall process as drug selection, R&D, approvals, production, distribution.

In terms of actual production it's really like any other “manufacturing” industry. You need to receive supplies (chemicals, organic matter, etc.), then produce the drug through a process, then package and distribute it.

Hello!

I don't think you are thinking about this the right way. 

Each case is a unique business problem with a very clear TARGET and very clear CONSTRAINTS. Hence, even if we shared overall frameworks here, that won't serve you! Without the knowledge of which problem we are trying to solve, we cannot do much. 

Hope it helps!

Cheers, 

Clara