How Biotech Can Help Pharma Better Tackle Rare Diseases

Recent outbreaks in the United States, such as Zika and dengue fever in the South, have made it clear that rare infectious diseases know no bounds. Yet, as the threat of infectious diseases rises, government funding for research and development of cures has hit an all-time low, forcing pharmaceutical companies to do more with less. Healthcare funding and research differ in three main ways: approvability, academic value, and the state of the market. To determine whether a company should invest in developing certain drugs, the company will first determine whether the research will be incentivized by these three factors. For example, if a disease is rare and affects a small percentage of the population, then the company may not see a monetary incentive for developing it. If no company decides to invest in the cure, then the government will have to support the research. Besides financial incentives, approvability is also important, particularly when looking at drug investment. The focus doesn’t just center on whether a drug works, but also if its chemical makeup, or any other mechanisms related to its creation, will hinder its approval during the regulatory process. With more infectious diseases springing up across the globe, pharmaceutical research and development has reached a critical point, and biotechnology may provide the answer for gaining an advantage over rising global health conce s. Biotech’s Potential Impact on Pharma One of biotech’s greatest influences on modern healthcare is its ability to gather, categorize, and share unprecedented amounts of information from around the world. When dealing with rare diseases, this ability can help pharmaceutical companies gather accurate data to support and legitimize their claims. Rather than trying to sort through different kinds of research, biotech will allow them to prioritize data and gain a clearer grasp on the financial impacts of the research. In addition to information gathering, biotech can also be used in terms of developing and testing tools and methods to advance the approval process, or the chemistry, manufacturing, and controls categories of drug development. Pharma researchers will also benefit from standardizing these and other testing methods through biotechnology to make future research more efficient and successful. How to Reap Biotech’s Rewards For biotech to truly have a positive impact on pharmaceutical research and development, companies will have to learn where to implement it within their own workflows. Three tips to make the most of biotech innovations are: 1. Use biotech to control methodology: During the manufacturing stage, the U.S. Food and Drug Administration requires a detailed report of a company’s day-to-day methodology controls. Using biotech innovation, companies can control the methodology and generate these reports with minimal impact on the overall workflow. 2. Use biotech in clinical studies: Biotech isn’t limited to research capabilities. Pharmaceutical executives can also use it to collect and process data, which is especially important for streamlining clinical studies and processes. 3. Use biotech to help with FDA regulations: Methodologies differ among diseases and their treatments. With biotech innovation, personalizing methodologies to suit specific applications will be much simpler, making it easier to successfully navigate the FDA’s regulatory requirements. The United States remains a leader in the global marketplace, but its competitive advantage is increasingly tenuous. Many of today’s potentially disastrous diseases are still considered rare, and government agencies and pharmaceutical companies may find it difficult to secure funding to find cures. However, by innovating research and development, clinical studies, and approval processes, biotechnology can help us do more for more people across the globe while using fewer resources.