6 BIG Challenges In Drug Development

Thanks to scientific (and technological) advances in the healthcare industry, the development of many treatments has increased over the decades. Problems still exist, though. According to Bernard Munos (FasterCures), $160 billion is spent by the pharmaceutical/health industry by public companies. For all the funding that is spend, there are some areas of disease and disorder treatment that remain challenging for the industry. If you’ve got a few minutes, I’d like to go over some of these challenges with you.

1. Drug Development

Developing drugs is a cost-expensive and time-intensive process (particularly during the formulation development period). The United States Food & Drug Administration (FDA) has since updated the process to five steps. The process is still time-consuming, however, as the first step (“Drug discovery”) can only occur once researchers find new insights into a disease process. Not to mention that

2. Animal Models

Sadly, more often than not animal models cannot fully recapitulate a whole disease or disorder. This is imperative for ensuring patient identification is as seamless a process as possible. In recent years, however, researchers have advanced in the world of stem cell technologies. These stem cell technologies, which model “human” disease pathologies, may provide faster alternatives to animal models.

3. Nervous System Disorders

A disease’s mechanisms, target identification (as well as validation), finding predictive models, developing biomarkers for patient stratification—not to mention evaluating the reliability of published data—make target identification for people suffering with brain disorders a huge problem.

So huge, in fact, that many companies refuse to develop medications that treat nervous system disorders. Luckily, UsNews.com published a report of the top global universities for neuroscience programs. The top three are: Harvard University (Cambridge, MA, USA), Stanford University (Stanford, CA, USA) and University College London (United Kingdom, London).

4. Fake Drugs

At the beginning of 2018, the World Health Organisation (WHO) revealed that an estimated 1-in-10 medical products (in low and middle-income countries) is either substandard or falsified. In 2017, officials from Health Canada seized $2.5 million worth of counterfeit pharmaceuticals.

Good news, though. FarmaTrust, a London-based company, has developed a global tracking system for pharmaceuticals; thereby reducing the amount of counterfeit drugs being sold in the pharmaceutical industry.

5. Phenotyping/Endotyping

Due to the high heterogeneity of patient populations, accurate phenotyping and endotyping remains a struggle. Digital phenotyping—which relies on users’ social media posts and Smartphone usage—is a new field that could potentially keep track of phenotype and endotype records and the connection between users and their mental health across the vast patient population.

6. Lackluster Collaboration

Collaboration usually refers to researchers who work in the same field. Therefore, a staggering amount of problems arise between academia, industry and governments, stemming from a result of not sharing sources, insights or new discoveries with each other. Clearly, collaborative science—through open communication—would drastically reduce inadequacies.


Yes, these challenges are significant. However, there are equally significant improvements in the development of drugs (called Industry 4.0). Systems used during automation process evolve over time, allowing full visibility of operations, respond promptly to information, and ensure equipment connectivity.