Optimising timelines for a drug launch

1. OPTIMISING TIMELINES
FOR A DRUG LAUNCH
Ruthvik Biradar
B 31

2. INTRODUCTION
 For drug to be launched, clinical trials need to be conducted
 Trials need to pass the animal testing as well as human testing just like how car prototypes
are bashed up for impact testing
 Trials take about 8-10 years with investment of 1.2 billion by the company
 Optimising is done because faster the drug is launched in the market, longer it can enjoy
the patient period

3. Steps in Optimising
 First thing to decide is the location. Location analysis is done to find the right customer
base and right patient population
- eg: we cannot conduct ebola trial in India since there are no patients
 Secondly, we need investigators in the area to conduct the clinical trials- basically the
doctors
 Once we have got local people to work for us, we need somebody from the team to be
there who can oversee the store/clinical trial

4.  Company would not want to conduct clinical trial in a country where they don’t want to launch the product.
Eg: Apple never bothered setting up India website. Only later when they opened their sales they decided to customise to Indian
markets
 Budget also plays a very important role. Some countries patients can be paid off cheaply and not so in other countries
 Regulations of that particular country also needs to be considered.
Eg: They cannot check for diseases in women of Iraq because no women would turn up for the trial
Eg: McDonald's doesn’t serve beef burgers in India whereas in other countries it does.
Optimising is basically done such that the country is selected on time, such that trials begin or else they will spend 10 months just
seconding the right country and if wrong country is selected , the company loses time.

5. Role of Decision Scientist
 Understand the risk associated with the Countries shortlisted for launch
 Understand the past performance of the countries on the basis of similar trials and see if trial
was completed on time
 Decision scientist studies the deviations and the audit findings
 Based on the above findings and the current situation of the company , decision scientist
predicts the average deviation and chances of deviations

6. Role of Decision Scientist
 Classifies the countries based on the performance and for each category provides the chance
of deviation
 Once we have the country with their respective risks, the site is chosen
 Predicts the number of patients to be recruited for each trial and how many sites to be
opened in a country for trial
 Then head to tracking the live trials

7. Role of Decision Scientist
 Web analytics is carried out by the decision scientist
 Since it’s the new age and everything is digital - need to check the performance of the
website and optimise the traffic flow
 Retrospective studies are done to check how the hub which is the collection of countries have
performed