Drug Development: From Concept to Marketing Discussion

For this Drug Development: From Concept to Marketing discussion, refer to the following from our reading materials: 

Write 3 paragraphs, discussing the complexities of navigating a new drug into the marketplace.

Provide relevant examples of products that were approved in the past year or two.

Book: New Drug Development: A Regulatory Overview – (Mathieu) 8 Revised Edition

ANSWER

Drug Development: From Concept to Marketing Discussion – Order a customised paper

Drug development is a high, long-risk, and expensive business that takes 10-15 years and is linked with an extreme attrition rate (Tamimi & Ellis, 2009). The drug development business is driven by the medical need, the likelihood of success, and disease prevalence. Considerably, before administering the drug to humans, the biochemistry and pharmacology of the drug are established using an extensive range of vivo test approaches.

The process of launching a new drug is a long and complicated one. It can take years, even decades, to bring a new drug to market. Cowlrick, Wolf, Hedner, and Olausson (2009) state that getting drugs into the market can take an average of 10-15 years. In that time, the landscape of the healthcare industry can change drastically, making it difficult to predict what will be needed to bring a new drug to market. This complexity is compounded by the fact that many different stakeholders are involved in the launch of a new drug. From the pharmaceutical company developing the drug to the physicians prescribing it to the patients taking it, each group has its own needs and wants. Previous studies have shown that only 11 percent of the drugs have been approved in different therapeutic areas (Lalonde, 2007).

All stakeholders must be considered when launching a new drug. Failure to do so can result in delays or even prevent the launch altogether. Launching and developing a drug while factoring in the cost of failed prospective drugs exceeds 1.5 billion (Tamimi & Ellis, 2009). Pharmaceutical companies must first consider the regulatory landscape when launching a new drug. Depending on the country, varying regulations must be met to bring a new drug to market. In the United States, for example, drugs must go through clinical trials and be approved by the Food and Drug Administration (FDA) before selling them.

The next step is to develop a marketing strategy. This involves creating awareness of the new drug among potential prescribing physicians and patients. Creating an effective marketing strategy is important because it can mean the difference between a successful launch and a flop. Once the drug is on the market, it is important to monitor its performance and ensure that patients get the results they expect through post-marketing surveillance. Drug development from concept to market is a complex process that makes the business a risky, long, and expensive investment.

Drug Development: From Concept to Marketing Discussion: References

Cowlrick, I., Wolf, R., Hedner, T., & Olausson, M. (2009). Perception of risk through phases of drug research and development: a questionnaire survey. Drug Information Journal, 43(5), 617-622.

Lalonde, R. L., Kowalski, K. G., Hutmacher, M. M., Ewy, W., Nichols, D. J., Milligan, P. A., … & Miller, R. (2007). Model‐based drug development. Clinical Pharmacology & Therapeutics, 82(1), 21-32.

Tamimi, N. A., & Ellis, P. (2009). Drug development: from concept to marketing! Nephron Clinical Practice, 113(3), c125-c131.

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