Saturday, April 17, 2010

Speaking to Inform Project 1 - Drug Development Process

I was involved with Drugs last year!  Don’t be shocked. I was not a drug addict.  I was not a drug peddler either.  I worked for a firm which developed software solutions for world’s leading drug manufacturers.
When you fall sick your doctor prescribes drugs. You swallow them and get back to normal. But have you ever wondered what it takes to make these drugs?
I came to know about the very fascinating and interesting process of drug development during my job.
I am going to share what I learnt with all of you today.  This will help you to appreciate better the effort involved in making the drugs that cure you.

A drug lifecycle has 3 stages – Pre-Clinical R&D, Clinical Trials, and Post Marketing Surveillance.

In Pre-Clinical R&D the symptoms and the causes of the disease are studied.  Through extensive research, candidate drug compounds are identified.  Sometimes these compounds are discovered accidently.
This is how Alexander Fleming discovered the first antibiotic -Penicillin.  One day he forgot to cover the Petri dish containing the bacteria culture which he was investigating and went on a vacation. On returning he found that a mold had formed over this culture and destroyed it.  This mold was Penicillium notatum which was found to contain powerful anti-bacterial compounds.
Once potential drug compounds are identified, they must be isolated from their sources and produced in sufficient quantities for testing.  For Penicillin this work was taken up by the researchers Florey and Chain.
Isolated drug compounds are then tested on animals. Compounds found to be too toxic or ineffective are rejected.
Drugs which seem promising are ready for the second stage – the clinical trials.  But before they begin the clinical trials the drug manufacturer must obtain clearance from the drug regulatory authorities like FDA in USA, Drugs Controller General in India.  This is because the drugs will now be tested on people. Volunteers are identified to participate in the clinical trials. All the pros and cons are told to the volunteers who sign up.
Clinical Trials consists of 3 Phases.
In Phase I the drug is tested on 20-30 healthy volunteers. This is to find out whether the drug has any obvious adverse reactions on human beings.                                                                                                          
In Phase II about 100 patients who suffer from the disease, participate.  The researchers study the effectiveness of the drug and arrive at a proper dosage in this phase. 
In Phase III the drug is tested on several thousands of patients. This is to confirm the effectiveness, the dosage and the side effects of the drug.
 If clinical trials indicate that the drug is effective and safe, an application is filed with the regulatory body for approval. All the data gathered during the trials are also submitted along with the application. The regulatory body reviews all the information and decides whether the drug is sufficiently effective and safe to be marketed. If they approve, the drug is manufactured and sold.
Florey and Chain did clinical trials with penicillin on wounded soldiers of World War II. Their amazing success inspired them to develop methods for mass production and mass distribution of Penicillin in 1945. Fleming, Florey and Chain received Nobel Prize for Medicine the same year.
The final stage of Drug Development is the Post-marketing surveillance.  The drug manufacturer, with the help of doctors and pharmacists must continuously monitor the use of the drug and promptly report any additional, previously undetected rare side effects to the regulatory body. The firm where I was working was developing software to computerize and automate this process. The regulatory authorities will withdraw approval if new evidence indicates that a drug may cause severe side effect.
Thalidomide a sedative was sold worldwide in late 1950s. But then it was discovered that when pregnant women consumed it, it caused nearly 20,000 babies to be born with physical deformities.  It was withdrawn from the market in 1961. The thalidomide tragedy brought in very strict regulatory norms for drug testing on pregnant women.
The whole process of drug development takes between 2 to 12 years depending on the complexity of the disease and the drug compounds.
It is a very rigorous and painstaking process. Drug firms research and test 10,000 substances before one of them could be successfully introduced into the market.
Drug business is highly expensive and risky. It costs nearly $2 billion to introduce a new drug to market. And only one drug out of three introduced in the market recovers its development cost.

This is how a drug is identified, tested and introduced in the market.
Let me conclude by saying that the next  time you recover from an illness,  apart from thanking the doctor who treated you,  also spare some thought and -
thank the researchers who sweated out in their labs and the philanthropists who funded the research; thank the animals that were tortured during testing and the volunteers who participated in the trials; thank the regulatory authorities, doctors and pharmacists who rigorously monitored the process.
They all ensured that you lead a happy and healthy life!
[Date Delivered:  April 10 2010

  • Select new and useful information for presentation to the audience.
  • Organize the information for easy understandability and retention.
  • Present the information in a way that will help motivate the audience to learn.
Time: Five to Seven minutes.

As mentioned above the I chose to speak on the topic because I found the whole process of drug development very interesting when I first came to know about it.
I requested for Eight to ten minutes for this speech, since to give all the information in a easy to understand manner with examples and personal experiences it was virtually impossible to complete this speech within seven minutes as specified in the manual. I ended up speaking for nine and half minutes.]

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