As O-1 visa/status is targeted for aliens of extraordinary ability or achievement, the applicant needs to demonstrate that he or she possesses a level of expertise indicating that the person is one of the small percentages who have risen to the top of the field of endeavors. Can a person with no citations, no national awards, no patents granted to him/her nor media coverage about him/her be qualified for O-1? The answer could still be positive. Because the field of endeavor is a relatively subjective and your immigration attorney can help you identify and narrow down you field. In Matter of ______, EAC 95 060 50139 (AAU May 29, 1996), “a review of the record establishes that the petitioner, while involved in a relatively obscure branch of mathematical study, has distinguished herself to such an extent that she may be said to have achieved national or international acclaim and to be within the small percentage at the very top of her field.” That is to say, in a relatively small field with few experts and public attention, you may be able to establish your national or international acclaim with less citation numbers, media coverage or other evidence just because the nature of your field. We recently secured an approval for our client Ms. C, who has no citation records, national awards nor media coverage.
Ms. C is a clinical research associate currently working for a pharmaceutical company that specialized in clinical trial protocols with focus on uro-oncology. One of the drugs the company is currently developing, named “ABC”, is an orphan drug that provide treatment for a disease “DEF” affecting only 7500 people in the US. Because of the small number of affected patients, “DEF” was classified as one of the orphan diseases, which previously received little or no funding for clinical research. Currently, there is no non-surgical drug available for treating DEF. The current standard of care for DEF is complete or partial surgical removal of the involved kidney and upper urinary tract, which is costly, sub-optimal and burdensome that severely affect patient’s quality of life.
Working for this company, Ms. C, designed innovative clinical trial protocols that significantly expedited the drug development of ABC to treat DEF. In the petition letter, we characterized Ms. C as and clinical research expert specialized in creating clinical protocol for orphan drug development such as DEF, supporting with the evidence that her protocols significantly contributed to FDA’s granting of Breakthrough Therapy Designation, Orphan Drug Designation and Fast Track Designation to this drug. The three designations are expedited pathways offered by FDA (US Food and Drug Administration) for drug developments and are very coveted by pharmaceutical companies. With these designations, the drug development process can be significantly shortened and thus has the potential of saving thousands of people’s life and improving their life quality.
Therefore, by developing these protocols, Ms. C made significant contributions to the field of Orphan Drug development, specifically, the DEF development. We also argue that the granting of Breakthrough Therapy Designation, Orphan Drug Designation and Fast Track Designation is comparable evidence of national award (one of eight evidential criterial of O-1) as they went through similar scrutinization and judging process. Eventually, USCIS recognized our arguments and approve the O-1 petition for Ms. C.