Biomedical Research and drug approved for mental illness in the 21st C

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BIOMEDICAL RESEARCH AND DRUG APPROVED FOR MENTAL ILLNESS IN THE 21ST CENTURY An Academic presentation by Dr. Nancy Agens Head Technical Operations Pubrica Group: Email:

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In brief Introduction Use of Biomarkers and Surrogate Measures Data Summaries of Clinical Records Conclusion Future scope Outline of Topics Todays Discussion

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To sum up the 21st Century Cures Act is a ground-breaking piece of legislation receiving tremendous bipartisan support in Congress. The Acts important aims are impactful and will significantly alter future medical and healthcare research into cancer neurology and precision therapies as well as support patients with mental health disorders and opioid dependency. In Brief

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On 13 December 2016 President Barack Obama signed the 21st Century Cures Act into law. This 6.3 billion law provides resources to accelerate cancer scientific and medical research through the so-called Cancer Moonshot. Which enhance human brain understanding through the Brain Research initiative by Advancing Innovative Neurotechnologies BRAIN and extend precision medicine through the Precise Medicine Initiative PMI to include all diseases. The twenty-first Century Cures Act defines the phrase extensively and includes “any scientific statistics concerning the usage of a drug derived from sources different than randomized scientific trials.” Introduction

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Use of Biomarkers and Surrogate Measures Despite generally favourable views involving the enactment of this landmark bill into law issues have been raised about certain elements of the legislation. Specifically the Act discusses the use of biomarkers surrogate measures affected person experience information and observational records from movements clinical use or “real-world evidence” to facilitate extra speedy drug and machine approval. Researchers regularly define real-world evidence as healthcare-related records that are derived from more than a few sources along with electronic health records claims and billing data registries and health applications.

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Data Summaries of Clinical Records Another potentially concerning difficulty is that additional wording in the Act permits for the approval of new warning signs for existing medications to be primarily based only on “data summaries” submitted through manufacturers. Currently the FDA assesses all of the submitted records for new drug approvals and supplemental indications. Some manufacturers have been found to overestimate the benefits and underestimate the risks of their medicine when summarizing their very own clinical records in the past. Clinicians should be mindful of the types of documents behind acceptance and recognize that when designing and implementing treatment plans and patient therapy.

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We strongly suggest that the funding mechanisms of the Cures Act be assessed to make sure that all men and women are in a position to gain from the enhancements in dependency and intellectual health cure protected in the regulation. Without a cautious interest in the funding mechanisms included in this legislation the Cures Act has the conceivable to exacerbate racial disparities instead than alleviate them. Conclusion

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The 21st Century Cures Act marks a step on the right path in the U.S. because it is the first legislative initiative to decriminalize addiction by providing therapeutic programs. To that end through care and recovery services the Cures Act adopts a public health approach to mental well-being and addiction which serves as a clear departure from the approach to criminal justice. Absent a legislative focus on reducing the racial disparities created by the criminal justice system however the twenty-first Century Cures Act may aim to theoretically result in continued racial inequity in health and justice. Future scopes

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