Tag Archives: career in clinical research

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.

Let’s Talk Clinical Research Organization (CRO)

And the winner of the Worst “CRO” goes to?

Did you think I would tell? Besides, you would think it is my opinion and not a fact. I spent most of my career working directly with sponsors (pharmaceuticals, biotechnology companies and healthcare organizations) in their goal to submit drugs for FDA approvals.

So why would I think clinical research organizations aka CROs are that bad? They help sponsors with tasks, they themselves do not have the capacity or the resources or the time for.

Let’s examine some CROs (names replaced):

CRO Q: Back in the day, I used to hear ex-employees of this CRO talk about this CRO as “a  sweatshop (or sweat factory)”. It was a good place to gain experience and move on. This CRO is still in business and with a lot of sponsor’s project. I guess, things just stay the same as long as it does not hit the bottom line ‘$$$$$‘.

CRO T: This CRO has been around under multiple names. As soon as their employees hear the phrase ‘we lost a big project’ or ‘we are about to merge again’, employees move on or leave this company.

CRO C: This CRO model is to leased out their own staff (more like a recruitment agency) than a CRO. I used to know someone who was transferred from Europe to USA under this CRO. Eventually, my friend move on into a pharma client and it is happy ever since. Why would anyone want to work for this CRO and let them leased out your skills and services when you could just register as a business and do it yourself?

If you google around, you will see many questions about salary, interviews, and career options but there are no discussion of the various work environments you might encounter at a CRO.

CRO B: I briefly worked for this small CRO and let me tell you. It has got to be the worst experience yet. Not only managers are like total control-freaks aka ‘micro-management’ but their unhealthy work environment can make you sick (open-floor). There was no sense of team work. How can you work on this kind of environment? I prefer consulting, home-based projects for reasons like this one.

I have no time for bad-managers.

CRO P: The people at this CRO that have been there the longest are the ones that make it such a horrible place to work and there are only a few of them. High turnover CRO with a passive aggressive/sabotaging culture.

CRO I: What happened to the word ‘paperless’? Instead, manual review, re-work and more paper is available. In the world where technology has advanced, this CRO still using old technologies where paper-based process are implemented for EDC-based clinical trials.

CRO P: If you have a degree in chaos, a knack for scapegoating and the top notch ability to kiss the clients ass, this is the place for you. I am not saying this, by the way. I found it online and it sure made me laugh.

CROs All: These CROs who want you to account for every minute of your day. They produce nothing, they leased out your skills and experience to the sponsors. If the sponsor goes, you might be laid off.

Discussing our clinical research experiences at different CROs is the bread and butter of this industry. With so many outsourcing, mergers, who could you work for?

As one CRA posted online “deciding which CRO to call home in the current job booming environment is more difficult than before. The CROs (especially the mid-size and large ones) are filling up all the Internet job search websites with their multiple job postings. And if you talk to any of the recruiters, they will confirm that the company they represent is the best fit for you, they value their people, have an excellent health/dental/vacation day package, and have the hard to find “work/life balance” that eludes us all. Well, the sad truth is that there is no ideal CRO fitting that description. Oh, some have their merits (and some are better than others, for sure), but ideal they are not.”

I could not have agreed better with her point of view. With all the mergers and changes in the industry in the last few years, there is a new landscape to explore.

CROs have a bad reputation for ‘high turnover’. It is too bad that this issue of turnover is not addressed from the Top level. Management is probably too busy worrying about their multi-million dollars bonuses that what is going on at the office.

Good luck and hope this article brought you some insights to the clinical research world we live in.

For a better career solution, joining an employee-owned culture is best. There a few in the industry. I represent RA eClinica.

Our company was founded on the belief that those who contribute to the company’s success should own a stake in the company and benefit from its success. Because each of us has such a high degree of trust in one another we are all more motivated to please each other and to do excellent work. We are constantly striving for perfection, together.

If you want to take charge of your life, career and freedom, join us in this quest. Note that we are not a CRO nor an EDC vendor. We would like to think of us as ‘where Clinical Research meets Technology”.

Source: MedZilla

Source: LinkedIn Pulse