Substantial Intrinsic Merit – The 1st NIW requirement

Definition of Substantial Intrinsic Merit

This is generally the easiest of the 3 factors to prove. Working in an area of “substantial intrinsic merit” means work in a field that is valuable to the national interest of the U.S.

Research in any scientific field, for example, can be said to have substantial intrinsic merit to the national interest of the U.S.

Documents required to prove substantial intrinsic merit

In order to prove substantial intrinsic merit, you need to support your statements with proper evidence.

Documentation and statistics must clearly explain in layman’s terms why your field of work is important and what are the practical applications and benefits.

Evidence should prove that your occupation area is of significant national importance and how your work is a national benefit.

Example of proving Substantial Intrinsic Merit:

Dr. Smith’s research objective is to use phage peptide-display technology to identify peptide ligands (peptide ligands are short amino acid binding motif that binds to the targets which are expressed in higher amount during the disease) that home (binds) to diseased organ in experimental models of autoimmunity, and use those peptides for molecular imaging and targeted drug delivery system. Previously, Dr. Smith used these peptides for acute myocardial infraction (heart attack) and T cell delivery in tumors. Presently, he is employing this innovative technology to identify novel sensing peptides for targeted therapy of experimental multiple sclerosis and systemic lupus erythematosus. The long-term goal of his studies is to develop similar advanced therapies for patients with these diseases.

Molecular Imaging emerged in the early twenty-first century as a discipline at the intersection of molecular biology and in vivo imaging. It enables the visualization of the cellular function and the follow-up of the molecular process in living organisms non-invasively, without perturbing them, reducing the burden of the long, risky and painful invasive process. Molecular Imaging may be used as a substitute for invasive procedures, which can sometimes leave large painful wounds that take a long time to heal. The multiple and numerous potentialities of this field are applicable to the diagnosis of diseases such as cancer, neurological, autoimmunity and cardiovascular diseases. This technique also contributes to improving the treatment of these disorders by optimizing the pre-clinical and clinical tests of new medication. They are also expected to have a major economic impact due to earlier and more precise diagnoses.

Molecular and Functional Imaging has taken on a new direction since the description of the human genome. New paths in fundamental research, as well as in applied and industrial research, render the task of scientists more complex and increase the demands on them. Dr. Smith’s past and present research shows an enormous facility to drastically improve the research and treatment objectives in the U.S.  One form of molecular imaging is Near infrared imaging (NIR). Near infrared imaging technologies have undergone rapid growth over the past few decades now play a central role in medical imaging. But the truly transformative power of imaging in the clinical management of patients lies ahead. Today, imaging is at a crossroads – molecularly targeted imaging agents are expected to broadly expand the capabilities of conventional anatomical imaging methods. Molecular imaging will allow clinicians to not only see where a disease is located in the body, but also to visualize the expression and activity of specific molecules (e.g., proteases and protein kinases) and biological processes (e.g., apoptosis, angiogenesis and metastasis) that influence disease behavior and/or response to therapy. This information is expected to have a major impact on disease detection, individualized treatment and drug development, as well as our understanding of how these complex diseases arise. Dr. Smith has used the NIR imaging technology to measure apoptosis in the myocardium (layer of heart) in a model of acute myocardial infraction (heart attack).

The second field in which Dr. Smith pursues his research is Targeted drug delivery. Sometimes called “Smart drug delivery”, it is a method of delivering medication to a patient in a manner that increases the concentration of the medication in the diseased parts of the body compared to normal healthy tissue. For this useful technology a targeting ligand (a drug is modified in a way so that it can sense the disease, the disease overexpresses particular receptor, a molecular signature, which is sensed by the targeting ligand) is a key essential component. Peptide ligands are short amino acid binding motif that binds to the targets which are expressed in higher amount during the disease. The advantages to the targeted release system is the reduction in the frequency of the dosages taken by the patient, having a more uniform effect of the drug, reduction of drug side-effects, and reduced fluctuation in circulating drug levels. Targeted drug delivery systems have been developed to optimize regenerative techniques. The system is based on a method that delivers a certain amount of a therapeutic agent for a prolonged period of time to a targeted diseased area within the body. Dr. Smith successfully used this method to deliver targeted T cells in the tumor model.

To find the binding partners to the molecular signatures expressed in the cells Dr. Smith used technology called Phage display technology –  it is a simple yet powerful technology that is used to rapidly characterize protein- protein interactions from amongst billions of candidates. This widely practiced technique is engineering peptides, antibodies and other proteins as both diagnostic tools and as human therapeutics. Dr. Smith used these technologies to identify candidate ligands and use them in molecular imaging and targeted drug therapy (mentioned above). The homing peptides bind preferentially to these target tissues that carry unique molecular signature, accessible to circulating cells.

Peptide ligands could be organ-selective, or disease selective, but they mainly address the signatures in the endothelial surface of tissue which are undergoing inflammation. Identification of these binding ligands are peptide sequences, usually 7-12 amino acids, represent the first step towards identifying selective endothelial markers, which is useful in targeting cells, drugs and genes into selected tissues.

One challenge to treating heart and brain diseases lies in the fact that the antibody-based drugs are large in size and cannot penetrate the fine vasculatures, while the peptides have greater promise since they are smaller in size, with better tissue penetration, less possibility of immunogenicity, lesser possibility of liver and bone marrow toxicity, easier processing and lower production cost. Because they also have fast blood-pool clearance, there are less side effects and they are especially useful in imaging because they give less background noise to signal which easily helps to distinguish disease from a normal healthy condition.

  • Given the prevalence of these complex autoimmune diseases and Dr. Smith’s significant contribution to this field, it is absolutely imperative that his research is sustained. – XXX, Associate Professor of Medicine, University of Maryland, USA (Exhibit 10)
  • T cell-based therapy is highly needed but unmet medical need so far, and over last decade several attempts have been made to achieve the targeted T cell therapies. To resolve this problem. Dr. Smith developed an approach in which he anchored the apoptotic cell-binding peptide ligand to T cell and delivers them to the tumor along with the drug. The on-going apoptosis in the tumor was used as a homing signal to attract more T cells. – XXX, Associate Professor- Department of Pathology, John Hopkins (Exhibit 11) (Independent advisory opinion)
  • Smith described the in vivo imaging signals of myocardial cell death using phage library-derived peptide probe, which binds to apoptotic and necrotic cells. He correlated a long term heart function with imaging signals of myocardial cell death – Dr. XXX Professor, School of Medicine, University of Maryland (Exhibit 9)

Dr. Smith’s research, as discussed above and in more detail below, provides new and potentially groundbreaking ways to save millions of lives claimed by the cardiovascular, cancer, and autoimmune diseases every year. His work as a researcher already has and will continue to contribute toward the establishment of the U.S. as a global leader in medical science, medical technology, and healthcare, while also creating actual public good.

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Substantial Intrinsic Merit – The first NIW requirement

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