The Life Cycle of A Drug: Drug Developments in Big Pharma - K2 Scientific

The Life Cycle of A Drug: Drug Developments in Big Pharma

The process of creating viable drug treatments involves millions of dollars and the cooperation of numerous industries. Learn about the life cycle of a drug and how they’ve changed our world for the better.

Making History: Drugs That Changed the World

Pharmaceutical companies understand better than most the urgency of drug development and their potentially life-altering outcomes. Here are some examples of revolutionary drugs that have defined the upper limits of human progress and forever changed disease prevention and treatment.

1. HIV Protease Inhibitors: To date, the industry recognizes protease inhibitors as the most successful drug therapy in combatting AIDS, a disease that ravages at-risk populations in destitute countries. Protease promotes viral growth and the maturation of active proteins; drug inhibitors block the active sites of protease to prevent the virus from multiplying. There are currently 26 anti-HIV compounds proving to have highly effective antiretroviral properties, changing a once-fatal disease into a manageable, chronic condition.

2. Chemotherapy: During World War II, researchers discovered that nitrogen mustard significantly reduces white blood cell count, which led researchers to believe that it may be effective in halting the continuous division of tumor cells—they were right. Doctors used nitrogen mustard to curtail tumor growth in cases where the cancer was too advanced for surgical excision, marking the beginning of using toxic agents as cancer drug therapy.

3. Aspirin: Aspirin became the first inexpensive, over-the-counter pain relief medication that altered the patient and doctor experience forever. The natural source of aspirin’s anti-inflammatory properties comes from willow bark, which has been treating pain and fevers for centuries. The substance in willow bark that makes aspirin so powerful is salicylic acid. In order to create aspirin, pharmaceutical scientists chemically restructure the bonds of salicylic acid to mitigate the intestinal discomfort and other adverse effects common with prolonged use of the drug.

4. Penicillin: Some of the most ground-breaking advancements in medicine were accidentally discovered, one of the most notable being the discovery of penicillin. In 1928, Dr. Alexander Fleming left a culture of staphylococcus out during a 2-week vacation. His carelessness resulted in the growth of a fungus throughout the culture, which he noticed prohibited the growth of the Staphylococcus bacteria. Pharmacists marketed this mold as penicillin—the first drug to effectively kill bacteria. During World War II, penicillin saved millions of soldiers from dying from infected wounds. Today, it treats not only infections but conditions such as syphilis, gangrene, Lyme disease, and leptospirosis.

Stages of the Drug Life Cycle: Laboratory Drug Formulation

The above-listed drugs have saved countless lives, but where did they get their start? Scientists formulate and discard millions of drugs annually because they fail to comply with rigorous testing standards. We can break the life cycle of a drug down into the following sequence of vital steps:

Discovery and Targeting

Laboratory researchers must first understand the disease at the cellular level before developing a targeted treatment. Uncovering the gene sequences of bacteria or protein mutations enable researchers to identify the biological mechanisms behind a disease condition. After targeted identification of the drug and disease interaction, researchers experiment to identify promising compounds and their potential interference with the disease. Drugs can start with up to 10,000 selected compounds but are significantly reduced to 10 to 20 of the most effective ones.

Preclinical Testing and Characterization

Testing the drugs’ safety is a significant priority for researchers and pharmaceutical companies. Initially, they must thoroughly investigate the drug’s stability and label them according to proper dosage, absorption, distribution, metabolism, side effects, drug interaction, and how it may affect groups based on sex, gender, or race. Scientists rigorously examine the results via regulatory teams whose approval dictates whether they can submit the drug for human testing.

Clinical Testing

At this point, clinical trials begin. Typically, thousands of drugs fail the rigorous testing and thus, do not enter the consumer market. Clinical trial testing occurs in four stages:

  • Phase I: A small group of participants receives experimental drugs to determine what side effects, if any, result, to assess the safety of the drug.
  • Phase II: During this phase, scientists conduct randomized trials using a control group to further test the drug’s efficacy.
  • Phase III: Pharmaceutical scientists scale up phase III trials to include a larger number of trial participants, usually in the thousands. After this phase is complete, pharmaceutical companies can request FDA approval to market their new drug.
  • Phase IV: After selling a drug to consumers, drug companies continue to monitor its long-term effectiveness as well as the cost-effectiveness of the drug compared to other similar narcotics on the market.

Marketing

Scientists submit drugs that pass phase III clinical trials to the FDA for another round of regulatory inspections. In order to receive authorization to mass market new drugs, the Center for Drug Evaluation and Research (CDER) must evaluate the drugs health benefits and risks. They send data to CDER whose physicians, chemists, and pharmacologists review the data and labeling. If the drugs pass inspection, they approve it for sale.

Modern Refrigeration Techniques

In order to maintain certain drugs and vaccines approved for sale, they need to be stored at certain temperatures to remain viable. The potency of a vaccine is severely diminished when taken outside temperature regulated handling zones such as proper pharmaceutical freezers and refrigerators.Each vaccine has a unique handling procedure which dictates whether or not transportation and vaccine storage occur in a refrigerator or freezer—the two are not interchangeable.

While there isn’t a universal temperature range for all vaccines, it is necessary that all vaccines stay within 2 to 8° C of the recommended temperature. Refrigeration techniques for the handling of vaccines have improved tremendously in modern times, allowing doctors to distribute life-saving measures among all the world’s ill. However, there are still barriers to vaccine distribution, especially in displaced and financially destitute nations. Distributors often mishandle vaccines due to poor quality control measures and the lack of access to proper pharmaceutical freezers and refrigerators. Though measures are being taken to avoid the breakdown of the cold chain in vaccine distribution, worldwide manufacturing still has a long ways to go to be truly egalitarian and available to deprived populations.

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