Biomedical Research and drug approved for mental illness in the 21st Century - Pubrica
                     BIOMEDICAL RESEARCH 
 AND DRUG APPROVED  
FOR MENTAL ILLNESS 
IN  THE 21ST CENTURY
An Academic presentation by
Dr. Nancy Agens, Head, Technical Operations, 
Pubrica  Group: www.pubrica.com
Email: [email protected]
Today's 
Discussion
Outline of In brief
Topics Introduction
Use of Biomarkers and Surrogate 
Measures  Data Summaries of Clinical 
Records  Conclusion
Future scope
In 
Brief
To sum up, the 21st Century Cures Act is a ground-breaking  
piece of legislation receiving tremendous bipartisan support in 
 Congress. The Act's 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.
Introductio
n
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.”
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.
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.
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  
Conclusio intellectual health cure protected in the regulation.
n 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.
Future 
scopes
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.
Contact 
Us
UNITED KINGDOM
+44-1143520021
INDIA
+91-9884350006
EMAIL
[email protected]
om