It wasn’t too long ago that much of the world was lacking in effective treatments for a wide range of life-threatening illnesses. Over the decades, both scientific and technological advances, along with innovations in the healthcare industry, have paved the way for the development of many treatments.
To learn more, refer to the infographic below created by the Maurice A. Deane School of Law at Hofstra University’s online Master’s in Health Law and Policy program.
Manufacturing processes have also seen considerable improvement, and an increased focus on safety also plays a key role in new drug development. However, while we are better able to understand the complex pathogens and develop effective treatments, many challenges still exist, particularly in the area of finding viable resources for the development of a new drug. Such challenges have hampered many research facilities and significantly delayed progress on drugs that could be extremely beneficial in conquering debilitating and deadly medical conditions and diseases.
Challenges also exist along the path of discovery—finding and identifying unknowns pertaining to a particular disease, applying new knowledge and methods and testing the results of a newly developed drug. Even with the aid of new innovative technologies, we are still far behind in successfully battling and eradicating many diseases, and while private funding often paves the way for the initial research to begin, it can be years before any significant progress is made as additional funding is continuously required.
Improved research tools, a better understanding of molecular technology and well-developed procedures and guidelines are all useful contributions to the development of a new drug. However, the costs associated with preclinical and clinical trials often offset productivity, sometimes delaying a particular drug’s development for years.
Additionally, scientific research and advances in molecular pathogenesis have provided a wealth of new information about the molecular structure of a disease. But this also means that new methodologies must be applied when attempting to find a suitable treatment. The new information also leads to several gray areas in drug discovery research, requiring more time and more funding.
While new drug development funding has actually risen significantly over the years, the number of new drug submissions to the FDA has, in fact, decreased. Additionally, clinical trial failure rates have risen above average. Some blame these failures on a lack of proper understanding of a disease molecule, despite the aid of advanced technologies.
Molecular studies have enabled a steady progression forward in overcoming many of the complications involved in disease research and drug development. Yet many tests still lead to major failures when animal testing occurs. Transitioning from animal to human clinical trials also presents its own set of problems and challenges, most distinctly, how a particular disease and its treatment often affect both animals and humans differently.
Problems within the realm of clinical safety and toxicology take a large share of the blame when a drug trial fails. Subsequently, the pharmaceutical and scientific research industries face many challenges, particularly when FDA approval of new molecular entities seems to have reached a plateau. Facing these challenges requires collaboration amongst the various industries and researchers involved—only by working together and sharing information can the success rate in human clinical trials begin to improve. The methods being utilized to improve the prediction of clinical efficacy desperately need to be addressed, and technologies must continue to be advanced in order to help make a smooth transition during the path of discovery from early phases of drug development through to the clinical trial periods.
Key factors relating to the collaboration and communication of all parties involved include making sure that all effectively and thoroughly understand the nature of the issues they face. Additionally, researchers and industries must be willing to stay open to change, especially when new information is presented as a result of new discoveries. FDA processes must also be suitably improved, serving to support new paradigms and ensuring the safety of new pharmaceuticals by properly inspecting that manufacturing facilities are in compliance with FDA regulations.
A clear roadmap from start to finish must be understood and adapted to—leaving the research open to adjust for design elements that might not have been fully known when the initial drug development study was first planned and implemented can help improve the chances of overall success. Today, new innovations in the industry are on a slow decline, and many profitable patents are expiring. Increased drug costs and a reliance on generic versions of popular drugs have also served to adversely affect the industry. A current estimated timeline of new drug development is a range of 10-15 years, with an attached cost of billions.
Without new advances in technology, an improved scientific development that serves to reduce research time (and subsequently the amount of funding needed) and more collaboration, there simply doesn’t seem to be a feasible and viable solution for decreasing the drug development timeline. Thankfully, small pharmaceutical companies may be the saviors the industry needs. Smaller pharmaceutical companies are currently developing the majority of drugs for possible future release, and while small companies often have a lower rate of success during clinical programs along with limited funding, it is these challenges that results in the spearheading of new innovations and approaches for new product testing.