We summarise a recent report, published in Expert Opinion on Drug Discovery, that explored the challenges facing drug development processes in a post COVID-19 pandemic era.
The ongoing COVID-19 pandemic has had a devastating impact on human life, healthcare systems and the global economy. Nonetheless, it has also mobilised and united efforts, particularly in the drug discovery and development process, to seek therapies and address this public health emergency. While it typically takes over 10-15 years for a vaccine to be developed, researchers have developed and rolled out several vaccines in less than a year.
As the world is focussed on the COVID-19 pandemic, several intricate diseases are still lingering across communities. Despite ongoing advances in technology, we are still unclear about the aetiology, progression and molecular mechanisms of many diseases. To successfully solve unmet medical needs the development of efficient strategies, novel technologies and policies are critical.
The vast majority of the deadliest diseases are partially preventable. Death rates typically depend on access to healthcare and effective medicines. There has been a drastic reduction in death rates for many devastating diseases in developed nations but a lesser extent in developing countries. Below are some of the current global medical challenges:
- Infectious diseases: There are over 200 million new infections and around half a million deaths from malaria every year. Despite attempts, no successful vaccine with long-lasting benefits has been developed. Tuberculosis remains one of the top ten causes of death worldwide. Additionally, influenza virus causes up to 650,000 deaths every year despite the availability of vaccines. The past half century has seen the outbreak of several novel viruses, including SARS-CoV-2 and Ebola. Another urgent issue is the emergence of multidrug resistance. It is projected that antimicrobial resistance will cause 10 million deaths per year by 2050.
- Cancer: Cancer remains the second leading cause of death worldwide. It causes around 10 million deaths per year, which experts expect to increase. Precision medicine and immunotherapy represent partial solutions to this challenge.
- CNS diseases: Dementia affects around 50 million people and is expected to increase by 2050, imposing a healthcare burden of 1.1 trillion dollars. As of today, no medications exist that can reverse the progression of Alzheimer’s disease.
- Rare diseases: Collectively rare diseases are a problem affecting 6-8% of the world population. Among the 7,000 rare diseases, treatments are available only for 5%.
Challenges in drug development
While it is imperative to generate novel treatment strategies, fair pricing and quick access to medicines remain massive global challenges. Chronic shortages and rising demands for critical drugs affect patient communities. Drug development and discovery is often controlled by private entities which are driven by economic interests and boundary conditions. The development of new tools and approaches as well as infrastructural changes will be important to streamline drug discovery review processes. Another challenge is data sharing and the irreproducibility of published research. A 2016 survey of 1,576 researchers by the journal Nature found that over 70% of researchers have failed to reproduce other scientist’s experiments. The authors noted the following key challenges:
- Cost and risk: Estimates indicate that the cost of drug development ranges from ~ 1 billion to 11.8 billion for a single drug. Most importantly, around 90% of drugs in development do not reach the market due to safety and efficacy concerns. Pharma often abandon drugs like antibiotics and orphan drugs due to there being little or no commercial value.
- Pace: The drug discovery and development process is extremely slow. It takes at least 7-10 years for a lead candidate to reach the marketplace. This is mainly due to the rigorous processes to ensure safety and efficacy. Duplication and reproducibility are other factors that slow the pace of drug discovery.
Overall, inefficient data sharing, irreproducibility, high cost, high failure rates and slow pace remain significant challenges for the drug discovery and development process. This year has emphasised the value of collaborations between the government, pharma and academic institutions. As the global momentum continues to materialise in the effort to fight the virus, valuable lessons must be applied to address other global health-related challenges.