What are CROs, CDMOs, CMOs and CRAMS? How are they different from each other and what value do they add to the Pharma Value Chain? To understand these concepts, we took a look at the drug discovery process.
Thread on Drug Development process 🧵
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Topics Covered :
1.Introduction to CRO,CDMO,CMO & CRAMS
2.Discovery
3.Clinical Trials
4.Commercialization and Surveillance
5.Success Rates
6.CRO
7.CMO
8.CDMO
9.CRAMS
What are CROs, CDMOs, CMOs and CRAMS? How are they different from each other and what value do they add to the Pharma Value Chain? To understand these concepts, we took a look at the drug discovery process.

The discovery of a new drug starts in the research lab where researchers study hundreds of diseases. They analyse what part of the body a disease affects and what reaction the body has to these diseases.

Once all this data has been collected, they file an Investigational New Drug (IND) Application with the US FDA. The US FDA reviews the IND within 6 months of filing. Once the IND is approved,
3. Clinical Trials:
The drug now moves to the Clinical Trials phase. It will be the first time a novel drug will be given to human beings. The clinical trials itself take place in 3 phases.

If the FDA approves the NDA, the company can manufacture and market the drugs to the public. But the testing does not end here. The drug now moves into Phase 4 testing.
Approximately 70% of the drugs move from Phase 1 to Phase 2, 33% move from Phase 2 to Phase 3, 25-30% move from Phase 3 to Phase 4. About 70-90% of drugs in Phase 4 are successful in staying in the market.
So where do the CROs and CDMOs come in? Contract research organizations help with the first 2 phases whereas Contract development and manufacturing organizations help with the last 2 phases

CROs support the innovators by providing services from drug discovery right up to commercialization. They provide services like target discovery, pre clinical trials, management of clinical trials, help with regulatory filings and pharmacovigilance(Phase 4).

Contract manufacturing organizations (CMO) on the other hand provide outsourced manufacturing solutions to the innovator. They are involved with the manufacturing of APIs and Formulations and oftentimes even involved with the final packaging of the product.
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You offer me 80% cost arbitrage (discount relative to Japan/EU/US) along with low confidence / assurance on Critical Success Factors and I won't give you a single NCE/NBE to discover, develop or manufacture. Capex/opex arbitrage is too low in the disruptive-science-pecking-order! https://t.co/O2l8dK4BUv

@unseenvalue Given high capex/opex cost structures of US/Japan/EU, how will they be able to compete with Indian API companies? https://t.co/OYhC2PUZpL
— Hiren (@hiren_investing) August 11, 2021
H was always unseen in S2NL :)
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Those who exited at 1500 needed money. They can always come back near 969. Those who exited at 230 also needed money. They can come back near 95.
Those who sold L @ 660 can always come back at 360. Those who sold S last week can be back @ 301
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