All posts by anayansi vanderberg

https://www.linkedin.com/in/anayansivanderberg/

How the Pharmaceutical Industry became into existence?

The Birth of the Pharmaceutical Industry can be traced back to 1850 – 1875 where the first “authentic” drug was developed by extracting agents from plants.

In those years, there were also developed the microbial theory of disease, medicines and homoeopathy patent and there heavy use of powerful purgatives and cathartics medicines.

By 1875, the Drug Development becomes a science and the first synthetic drug was introduced. By 1900, vaccines and antitoxins form the basis of the new pharmaceutical industry.

From 1900 to 1925, began what is now known as the pharmaceutical century. The U.S. Pure Food and Drugs Act was passed (known today as the FDA) and the development of hormonal and chemotherapy was introduced.

After 1925, it began what is known today as the Antibiotic and Regulatory Era. Vitamins, antimalarials, anticarcinogenic compounds and anti-infectives discoveries were made. The FDA gains independence as a regulatory agency and is given compliance responsibility.

From 1950 thru 1975, a new generation of the drug became apparent. Vaccines for polio became mandatory, oral contraceptives appears on the market and cardiovascular therapies.

Also, an amendment to the Federal Food Drug and Cosmetic Act of 1938 Act was signed by President Kennedy to ensure that consumers will not be the victims of unsafe and ineffective medications. Additional information about this Act can be read here: Kefauver-Harris Amendments

The Globalization of the Pharmaceuticals industry started from 1975 thru 2000. New drugs therapies, new antiviral drugs, and the development of new drugs by biotechnology companies were in global high demand.

By 2000, over 2.8 million people participated in over 50,000 clinical trials and more research and development funding was increased.

R&D Expenditures by Body System

R&D Expenditures

Cost (Billions) Body System
7.0 Central Nervous System
6.0 Cancer, endocrine and metabolic
4.5 Cardiovascular
3.5 Infectious Disease
2.5 Biological and vaccines
5.3 Other

Current Trends in the Industry since the late 2000s

Biotechnology Medicines
Drug Intervention Targets
Vaccines

 

Role of Generic Drugs
Generic drugs account for over 47% of prescription drugs in the market in which 43 major prescription drugs come off patent by 2005.

What does this mean for pharmaceutical drugs?
Between 40% – 60% of sales are lost to the generic brand within the two years of coming off patent.

Factors that will impact the R&D future:

  • There has been over 40 mergers and acquisitions since 1985
    • Sanofi and Synthelabo
    • Zeneca and Astra
    • Monsanto and Pharmacia
    • Roche and Genentech
  • Employment grew at a 3% rate per year

Total Drug Development Time (Years)

Summary:
On average, it takes at least ten years for a new medicine to complete the journey from initial discovery to the marketplace, with clinical trials alone taking six to seven years on average. The average cost to research and develop each successful drug is estimated to be $2.6 billion.

Pharmaceutical Regulation

In 1902, about 10 children die after receiving a vaccine shot. The BIOLOGICS CONTROL ACT was passed to ensure purity and safety of serums, vaccines and similar products used to prevent or treat diseases in humans.

In 1906, “The Great American Fraud” reveals patent medicines laced with addictive drugs, toxic additive and alcohol.

In 1912, Public outcry over the sales of “snake venom” and other wonder cures.  The SHERLEY AMEND was passed to prohibit labelling medicines with false therapeutic claims intended to defraud the purchaser.

In 1927, the government forms a separate law enforcement agency called the Food, Drug and Insecticide Agency.

In 1937, about 107 people, including many children die after drinking a syrup called Elixir of Sulfanilamide. Due to safety concerns, The Federal, Food, Drug and Cosmetic Act (1938) was passed as the first attempt to regulate cosmetics and medical devices.

In 1962, the sleeping pill “Thalidomide“, developed what is known today as Grunenthal Pharmaceutical in Germany, resulted in thousands of birth defects in Western Europe. The KEFAUVER-HARRIS Drug Amend was passed to ensure drug efficacy and greater drug safety.

In 1983, the ORPHAN DRUG Act was passed enabling the FDA to promote research and marketing of drugs needed for treatment of rare diseases. This year there as an outbreak of HIV / AIDS cases.

In 1988, The FOOD and DRUG ADMINISTRATION ACT were established as the FDA under the Department of Health and Human Services.

In 1992, the pharmaceutical industry complained that life-saving drugs were being reviewed too slowly by the FDA. The PRESCRIPTION DRUG USER FEE ACT (PDUFA) is made into law.

Source:

Image: Courtesy of Google image

FDA website

Private information for college researched in the 2000s.

Want to become an {EDC} Developer? Take this test

I have been contacted on multiple occasions in recent years about how to become an {EDC} Developer or clinical programmer.

If you are currently working in the industry, the transition should be swift.  But for those working outside the pharmaceutical/biotechnology industry, I recommend you take a SAS programming course or data analytics/ visualization course since {EDC} training only is available for those already in the industry and for those sponsored by your employer.  There is no official public training for a specific {EDC} tool. Your company must be a user (Customer) of the tool for you to gain some knowledge.

Here are some examples of custom programs. Test your readiness.

Example 1:

Comparing two (2) strings a and b:

string dbtool=”Rave”;

if (dbtool == “Rave”)

if (dbtool.Equals(“Rave”))

OR how about…

String strA;

String strB;

If (strA == strB)

{

System.console.writeline (“StringA’s value is same as StringB’s value.”);

}

 

Example 2:

Switch case:  to store a value in int x if the value of n is “RAVE”, 2 if y is “INFORM”, 3 if y is “OCRDC”, and 0 otherwise.

switch (n)

{

case “1”:

Console.WriteLine(“You choosed RAVE”);

intVarEDC ==1;  break;

case “2”:

Console.WriteLine(“You choosed INFORM”);

intVarEDC ==2; break;

case “3”:

Console.WriteLine(“You choosed OCRDC”);

intVarEDC==3;  break;

default:

Console.WriteLine(“Invalid selection {0}”, n);

Console.WriteLine(“Please input 1, 2, or 3”);

intVarEDC == 0; break;

}

Example 3: Arrays

Can you guess the output to this program?

public static void printf(params object[] args)

{

for (int i = 0; i < args.Length; i++)

{

Console.WriteLine(“args[{0}] = {1}”, i args[i]);

}

}

public static void Main()

{

printf(“Thank you”, 4, “visiting”, “EDC Developer.”, “Says”);

}

Some tips or best practices when working with Rave Edit checks and custom fuctions:

  • Always put record position 0 in Edit Check Steps and Actions for standard DataPoints
    • Note: In the recent release of Rave, this is mandatory.
  • Use ChangeCount Property wherever possible to execute only for the submitted datapoints.
    • ex: If (dpAETERM != null && dpAETERM.Active && dpAETERM.ChangeCount  > 0)
  • Avoid using “true” parameter in the FetchAllDataPointsForOIDPath for Log forms.
    • Bad example: datapoints dpAE = CustomFunction.FetchAllDataPointsForOIDPath(“AESEV”, “AE”, “AE”, subject, true)
    • Good example: datapoints dpAE = CustomFunction.FetchAllDataPointsForOIDPath(“AESEV”, “AE”, “AE”, subject)

If you wrote similar programs or are comfortable writing these types of programs then you are ready for your next challenge. But if you do not know anything about C sharp programming or {EDC} in general, don’t despair. We are here to help.

Subscribe to my blog’s RSS feed and email newsletter to get immediate updates on the latest news, articles, and tips. I am available on LinkedIn or my personal webpages: EDC Developer or Clinical Programmer. Or contact me to discuss any projects or contracts you may have and need support with.

Back to the 80’s – Timeless

We all remember the time when the movie ‘Back to the Future’ was popular.  The movie was about a typical American teenager of the Eighties, is accidentally sent back to 1955 in a plutonium-powered DeLorean “time machine” invented by a slightly mad scientist.

That’s how I wish I could turn back time and go back to the 80’s. Of course, there is no time-machine available but If I could, I will go to every Cyndi Lauper concert imaginable.

Instead, in the last few months, I started to re-visit those years.

I acquired this new Turntable to play my favorite albums.

Victrola Turntable
Victrola Turntable

I have now started my collection of 80’s albums and proud to buy all Cyndi’s Lauper records. I have acquired some interesting LPs (33’s and 45’s) that I never had before. I remember the records I bought back in the ’80s cost me $15 dollars and for a teenager in the ’80s, that was a lot of money to spend on a record.

Here I was playing the drums with my Rock n’ Roll band from high school. On the background, I am wearing a hand-made T-shirt of Cyndi’s Lauper face.

I wish I could go "back in time" to when Cyndi first performed in the 83s.

Cyndi Lauper voice is absolutely timeless. What a beautiful and talented woman.

The ’80s was a phenomenal time to be young. There will never be a wonderful decade like it again.

I remember watching this ‘eccentric’ woman, dressed up with colorful clothing and colorful hair and I just wanted to be like her.  As her first LP record, “She’s so Unusual”,  she was a female vocalist/singer with a first debut album to achieve four top-five hits on the Billboard Hot 100.

Thank you for all your wonderful music and thank you for bringing so much happiness and happy memories into my life. We love you…

Website: https://cyndilauper.com/

Fair Use Notice: Images/logos/graphics on this page contains some copyrighted material whose use has not been authorized by the copyright owners. We believe that this not-for-profit, educational, and/or criticism or commentary use on the Web constitutes a fair use of the copyrighted material (as provided for in section 107 of the US Copyright Law).

Faded – Where are you now?

Ik hou van je en ik mis je heel erg

My favorite voice performance…

Baby I’m wasted All I wanna do is drive home to you -Faded lyrics ZHU

Where are you now
Where are you now
Where are you now
Was it all in my fantasy
Where are you now
Were you only imaginary
Where are you now
Atlantis
Under the sea
Under the sea
Where are you now
Another dream
The monsters running wild inside of me
Fair Use Notice: Images/logos/graphics on this page contains some copyrighted material whose use has not been authorized by the copyright owners. We believe that this not-for-profit, educational, and/or criticism or commentary use on the Web constitutes a fair use of the copyrighted material (as provided for in section 107 of the US Copyright Law).