We previously discussed some of the failures in drug discovery for several chronic diseases. Now, we explore the partnerships that have been created to address these failures. Dr. Sandeep Pingle1 continues with the second part of his three-article series on the partnerships that are critical for identifying the right biomarkers for new drug development innovation!
Drug development is a billion-dollar undertaking; after accounting for the failures of drug candidates in various stages of development, the price tag approaches $1 billion for each drug approved by the Food and Drug Administration (FDA). Most of the drug development efforts today are being carried out by pharmaceutical companies. However, this model in its present form is financially unsustainable. In order to adapt, pharmaceutical companies are making various changes such as selective outsourcing. In spite of this, the overall cost involved in drug development has largely remained unchanged. Hence, pharmaceutical companies are eager to address this issue and improve their rates of success. From a clinical point of view, drug candidates failing in clinical studies are a major concern for patients and physicians. These drug development failures further exacerbate the problem of lack of effective therapies to address unmet clinical needs.
Most drug candidates fail clinical trials in late stages of development – stages II and III. The main reasons for failure at this late stage are lack of efficacy and unexpected, severe adverse effects. Fortunately, both these can be corrected. This problem was recognized by professionals in government, academia, pharma and biotech. These experts determined that the key to developing drugs that are efficacious and without debilitating adverse effects is identifying the “right targets,” or biomarkers, to focus on during drug discovery.
The targets that can serve as indicators of the disease and/or be used for developing drugs are commonly referred to as biomarkers. A detailed study of disease biomarkers can provide scientists clues as to what are the best targets for drug development. Identifying such targets and validating them before embarking on expensive drug development ventures will help develop effective diagnostics and therapeutics for diseases. This approach will also reduce the failure rate in drug development by ensuring efficacy and safety.
With this goal in mind, the National Institutes of Health (NIH) recently launched a collaborative project called Accelerating Medicines Partnership (AMP)1 to address this knowledge gap for 3 diseases: Alzheimer’s disease, type 2 diabetes, and autoimmune diseases (rheumatoid arthritis and systemic lupus erythematosus). This collaboration will involve the NIH, 10 drug companies, and nonprofit organizations.
As part of the AMP, scientists will identify biomarker targets for each of the 3 diseases that are most likely to respond to drug therapy. These biomarkers will help develop therapies that are more effective and hence less likely to fail in late stages of clinical development. This public-private effort may represent a high-risk venture that provides the change in tactics essential to reduce failure rates in modern drug development efforts. Stay tuned for next week’s article to learn more about the AMP initiative and how this initiative can improve drug development.