Case Summary:

When a senior Syrian lecturer with a Ph.D. in pharmaceuticals working in drug delivery came to our firm for his National Interest Waiver application, our team made sure that he was academically and professionally equipped to deal with the requirements of the case. As an expert in the field of drug delivery, his proposed endeavor was to work on developing new oral insulin delivery materials and drug delivery carriers with a one-step reproducible process in order to develop DNA and RNA vaccines to treat cancer and other diseases. Other information pieces that came in handy to prove his worth for the nation and the scientific community are as follows:

• His endeavor is of great importance because it improves treatment for a range of conditions. He has developed nanocarriers for insulin to treat diabetes. His research is conducive to improving treatment for diabetes, and thus, it addresses a major public health concern. Overall, his work represents an important advancement in pharmaceutical development, because nanocarriers for drug delivery have a number of benefits.
• His proposed endeavor also has broad implications for the United States as he has devoted great effort to improving treatment for diabetes and cancer by developing nanoparticle-based drug delivery systems for these conditions.
• This is why of his 4 recommendations, 2 experts wrote:

“Diabetes, cancer, and viral infections pose a problem for the United States, and [the client’s] research addresses each of these areas through the development of novel drug delivery systems. As such, it is important to develop new drugs and more effective drug delivery technologies to help patients manage these diseases, while also lowering the costs associated with diabetes and cancers. Given his expertise in the design and development of such methods, especially orally administrated and targeted drug delivery technologies, [the client’s] ongoing research is indeed important to the United States.”

“One area of major significance in [the client’s] research is his work on the creation of orally administrable insulin. Normally, when insulin is administered orally, it is decomposed once it encounters stomach acid, rendering it ineffective for managing diabetes. Through his work, [the client] has created a specially suited drug delivery system for oral insulin to preserve the insulin through the stomach acid to allow for absorption in the intestine. Thus, his work is of tremendous national value. Considering the value of [the client] in the field of drug delivery research to these and similar national issues, his ongoing work is of clear and irrefutable significance to the United States.”

Not only this but in the 8 years of his consistent work, he has been invited to conduct peer reviews at least 9 times to date and his research has resulted in 14 peer-reviewed journal articles (3 of them first-authored and 6 of them corresponding-authored) and 3 first-authored book chapters. These research publications have also gone on to influence his peers. That is, they have been cited a total of 105 times according to Google Scholar.

Given these favorable facts, our client’s case got an approval in less than 6 months, and that too without an RFE. We are grateful to him for choosing our firm and we wish him the best for the future.