Drug development process

Raph Amsili

Since the mid-19th century, pharmaceutical industry has had an increasing role in healthcare business. It has become a global phenomenon and governments had had a dual position between supporting research and regulation drug safety and efficacy. For patients, drugs have taken on new medical roles and value. It has become common for people to take drugs for years to cure or reduce the impact of a disease. Pharmaceutical industry has rapidly interested a large span of investors and is now one of the best market sectors to invest in. Big pharmaceutical firms have giant economic impact as they are generally highly quoted in the secondary market, managing a vast range of assets, from human medicines to cosmetics, and involving each category of customers.

Drug development process is known to be very rewarding although very long and costly. To bring new pharmaceutical drugs to the market, the discovered potential treatment needs to go through a regulated process. The US Food and Drug Administration (FDA) distinguishes 5 compulsory stage.

Step 1: Discovery and development

Pharmaceutical companies work on new drugs discovery. Discovery could be due to new insights into a disease, or to existing treatments that have unanticipated effects. However, the main reason for a new drug discovery remains the improvement of technology allowing Scientifics to specialise their research on one site of the body or use more powerful genetic materials.

Once they discover a new chemical entity (NCE), comes the phase of development. They conduct experiment to gather information on the promising sample such as the absorption, distribution, metabolism and extraction. They explore the benefits and mechanism of actions; side effects, the best dosage and potential interaction with other medicines. Then, they test its effectiveness compared to similar drugs.

Step 2: Preclinical research, information on drug safety.

NCE emerge from drug discovery but little is known about safety, toxicity, pharmacokinetics and metabolism on humans. The primary goal of preclinical research is to provide physicochemical properties of NCE, mark up, stability and solubility, in order to have a detailed result on the drug’s toxicity that is side effects. The research of toxicity is done using in vitro (isolated cells) and in vivo (animal testing). This process needs to comply with Good Laboratory Practice (GLP) which is regulated by the FDA.

Researchers then review their findings and decide whether the drug should be tested on people. To do so, they need to provide two major reports: the First-in-man (FIM) study and First-human-dose (FHD) study.

Step 3: Clinical research, study of interaction with human body.

Developers write the clinical research report on how they will conduct their experiments. This protocol is called the Investigational new Drug Process (IDP). The IDP is issued by drug developers or sponsors and is submitted to FDA before the beginning of clinical research. FDA can approve within 30 days but it can also refuse the IDP for many reasons, such as significant or unreasonable risks, investigator unqualified, misleading materials or incomplete information.

Once the protocol is approved, the clinical research required 4 phases:

Phase 1 deals with safety and dosage in healthy customers. On average, 70% will pass to the second phase.

Phase 2 treats a small number of sick patients and works on efficacy and side effects. Approximately 33% will pass to the third clinical phase.

Phase 3 still works on efficacy and monitors adverse reaction found in phase 2, with a larger number of sick patients. Only 25% manage to pass this phase.

Phase 4 is the last clinical phase and is about safety and efficacy. This stage is often called Post market surveillance studies. It’s a condition made by the PDA and is conducted after the public release of the drug.

As the drug goes to higher phase, the process becomes longer and involves more patients.

Step 4: FDA Review.

If the drug has strong evidences to be safe and effective for its intended use, the pharmaceutical company needs to file a New Drug Application (NDA). The NDA tells the whole story of the drug and details results of each stage.

Once the FDA receives the NDA, they decide to market the drug or not, giving its effectiveness and safety, within 6-10 months.

Step 5: FDA post market safety monitoring.

The stages in which the drug had to go through have limitations, therefore, once marketable; the drug is still being monitored over months and years. The FDA can decide to add cautions to dosage or usage information. FDA regulates prescription drug advertisement and promotional labelling. By law, pharmaceutical companies are prohibited from advertising unapproved uses of their products.

New drugs are protected by patents. Once the patent expires, other drug manufacturers can develop generic versions of drugs, which are products similar to the initial drug in dosage form, strength, quality and performance characteristics, and intended use. Therefore, they only have to conduct a bio-equivalence study.

Once going through this tough process, the drug can be marketable. As mentioned previously, the drug is protected by patents and thus, only the initial pharmaceutical firm has the right to benefits from its sale all over the world. This extremely regulated procedure is very long, at least 10 years, and highly expensive. Although an average of this cost is hard to estimate due to the long time line, many studies agree that the cost of marketing a new drug stands between $500 million to $2 billion depending on the drug testing requirement. Therefore, without clear cost estimation, the valuation of pharmaceutical investment is very hard to determine. However, the outcome of drug discovery going successfully through each required step is extremely rewarded. Pfizer, the first pharmaceutical firm in the world by revenue, has generated $24bn since 2003 when they first released Viagra, a medication mainly used for erectile dysfunction. For its high revenue over costs and its bright future with improvement of technology, the pharmaceutical industry is quickly expending and is consequently becoming a very interesting market sector.

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