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Biologics, specifically monoclonal antibodies, are becoming more prevalent therapeutics in the doctor's toolkit for combating diseases. Historically, approval of medical products (e.g. drugs and medical devices) by the United States Food and Drug Administration (FDA) have been lower than products marketed as supplements. Tighter regulations, especially those enforced by the FDA, generally leads to fewer products being approved to market. The research and development road from compound identification through preclinical and clinical trials is both expensive and arduous, where safety and efficacy data often determine whether a potential drug is approved. Rigorous standards help ensure that the few approved products that reach the shelves for consumer purchase deliver a therapeutic benefit. Drug pipelines and treatment options are not created equal. Some medical fields benefit from having innovative new therapies available for patients each year while other specialists are left in a therapeutic drought, relying on limited options in their medical toolkits. This brings us to Alzheimer's disease, a form of dementia that progressively diminishes neurological function. This debilitating condition impacts the patient, family and surrounding community. When novel therapies are not abundant, a single drug approval is sufficient to provide hope. The major question, of which we only scratch the surface, is whether it is acceptable to approve therapies that show inferior safety and efficacy data if it means providing an available option for patients where there was previously a medical void. Is a subpar drug better than no drug? This is a very difficult question to answer and it's important to note that the lack of successful therapies in certain medical fields (e.g. in the treatment of neurological disorders) is not from lack of trying. Amazing scientists and clinicians are working endlessly on these problems to provide the therapies of the future. What better return on investment is there for decades of research, millions of dollars in funding and collaborative global efforts to see the emergence of a smile on a patient just informed that their disease or disorder is either in remission or fully treatable. Que up your favorite medical drama, dream up that MD PhD from Johns Hopkins and get ready to press play...you're in for a good one!
Biologics, specifically monoclonal antibodies, are becoming more prevalent therapeutics in the doctor's toolkit for combating diseases. Historically, approval of medical products (e.g. drugs and medical devices) by the United States Food and Drug Administration (FDA) have been lower than products marketed as supplements. Tighter regulations, especially those enforced by the FDA, generally leads to fewer products being approved to market. The research and development road from compound identification through preclinical and clinical trials is both expensive and arduous, where safety and efficacy data often determine whether a potential drug is approved. Rigorous standards help ensure that the few approved products that reach the shelves for consumer purchase deliver a therapeutic benefit. Drug pipelines and treatment options are not created equal. Some medical fields benefit from having innovative new therapies available for patients each year while other specialists are left in a therapeutic drought, relying on limited options in their medical toolkits. This brings us to Alzheimer's disease, a form of dementia that progressively diminishes neurological function. This debilitating condition impacts the patient, family and surrounding community. When novel therapies are not abundant, a single drug approval is sufficient to provide hope. The major question, of which we only scratch the surface, is whether it is acceptable to approve therapies that show inferior safety and efficacy data if it means providing an available option for patients where there was previously a medical void. Is a subpar drug better than no drug? This is a very difficult question to answer and it's important to note that the lack of successful therapies in certain medical fields (e.g. in the treatment of neurological disorders) is not from lack of trying. Amazing scientists and clinicians are working endlessly on these problems to provide the therapies of the future. What better return on investment is there for decades of research, millions of dollars in funding and collaborative global efforts to see the emergence of a smile on a patient just informed that their disease or disorder is either in remission or fully treatable. Que up your favorite medical drama, dream up that MD PhD from Johns Hopkins and get ready to press play...you're in for a good one!