Meeting the manufacturing requirements is imperative to the success and profitability of a company. One of the most notable differences with a drug production is the amount of time needed to produce the drug, as described below with Intercept’s newest FDA approved medication, Ocaliva. Cycle time is the time starting when an operation begins to the point of time when the operation ends (Eshna, 2017). Takt time is the maximum acceptable time to meet the demands of the customer, or the speed with which the product needs to be created in order to satisfy the needs of the customer (Eshna, 2017). The takt time formula is below:
Net time available for production / Customer’s daily demand
Takt time formula with Ocaliva is below:
Cycle time for Ocaliva 14 years
Life expectancy upon PBC diagnosis (takt time) 16 years
Cycle time / takt time 14 / 16 = .875
On average, it takes a new medication approximately 10 years to complete the full cycle from initial discovery to FDA approval on market shelves. Ocaliva was initially discovered by Professor Roberto Pellicciari in the 1990’s in Italy. It was not until the inception of Intercept Pharmaceuticals in 2002 that the …show more content…
This starts with a lab to study the newly discovered compound. This lab and its personnel will examine and test the compound microscopically and on animals to determine its effect on the body. While this testing is being done, Intercept Pharmaceuticals will need to collaborate with the FDA, physicians and scientists to write a protocol for testing the drug on humans. After FDA’s approval of the protocol, Intercept will invite different hospitals to join the study and work with a clinical research office (CRO) to complete the logistics and regulatory aspects of the trial. The CRO is responsible for ensuring the trial is completed within legal parameters and the parameters set by the protocol
Net time available for production / Customer’s daily demand
Takt time formula with Ocaliva is below:
Cycle time for Ocaliva 14 years
Life expectancy upon PBC diagnosis (takt time) 16 years
Cycle time / takt time 14 / 16 = .875
On average, it takes a new medication approximately 10 years to complete the full cycle from initial discovery to FDA approval on market shelves. Ocaliva was initially discovered by Professor Roberto Pellicciari in the 1990’s in Italy. It was not until the inception of Intercept Pharmaceuticals in 2002 that the …show more content…
This starts with a lab to study the newly discovered compound. This lab and its personnel will examine and test the compound microscopically and on animals to determine its effect on the body. While this testing is being done, Intercept Pharmaceuticals will need to collaborate with the FDA, physicians and scientists to write a protocol for testing the drug on humans. After FDA’s approval of the protocol, Intercept will invite different hospitals to join the study and work with a clinical research office (CRO) to complete the logistics and regulatory aspects of the trial. The CRO is responsible for ensuring the trial is completed within legal parameters and the parameters set by the protocol