The Date
U.S. Department of Homeland Security
Bureau of Citizenship and Immigration Services
To Whom It May Concern:
I am ____ (name and title here) in XYZ Co., Ltd., the largest pharmaceutical company in Japan and a world-class research-based corporation. After obtaining my Ph.D. from ______ university, I carried out my post-doctoral research in ______ university and then joined XYZ in year ____. So far I have published __ (a number here) peer reviewed research papers and __ (a number here) patents. In my capacity as ____ (title here) I have managed and evaluated __ (a number here) drug discovery collaborations both in Japan and overseas. I came to know Dr. Li’s research work and his exceptional ability in 200X when I presided over the quarterly review meeting between XYZ and ZXY, with whom XYZ had a joint research collaboration to develop novel oral drugs to treat diabetes.
Diabetes mellitus has reached epidemic proportions worldwide as we enter the new millennium. The World Health Organization estimates that there are 177 million people worldwide with diabetes. In the United States alone, approximately 18 million Americans have diabetes. Diabetes is one of the leading causes of death and disability in the United States and the complications of uncontrolled diabetes result in an estimated $132 billion in medical costs annually.
Type 2 diabetes is a therapeutic area with huge potentials. It is characterized by a few available drugs, a large patient population, and high levels of dissatisfaction with the efficacy of current drugs. In type2 diabetes, either the body does not produce enough insulin or the cells ignore the insulin. Insulin takes the blood sugar (glucose) from the blood into the cells. When glucose builds up in the bloodstream instead of going into cells, the glucose eventually overflows into the urine and passes out of the body. Since glucose is the energy source for cells, the body becomes starved for energy. Over time high blood sugar levels may hurt organs such as eyes, kidney, nerves or heart.
Normalizing elevated glucose in diabetic patients remains the goal for diabetes therapy, whose global market is going to reach $20 billion in 2006. To meet this unmet medical need, XYZ and ZYX has teamed up since 199X to discover and develop a new class of drugs that act to reduce blood sugar levels in diabetic patients. Currently XYZ is working with ZYX to develop AB-123, a first-in-class oral inhibitor for the treatment of type 2 diabetes. This drug entered human clinical development in 200X and Phase II testing in patients is currently proceeding in the United States.
During the last three years at ZYX, Dr. Li has made a significant impact on the diabetes project, whose focus was to discover and develop a backup compound for AB-123. In case AB-123 fails to reach its end points in ongoing clinical trials, the backup compound will replace AB-123 as the experimental drug in clinical trials. Relying on his impressive expertise in organic chemistry, Dr. Li, in 200X, discovered numerous novel methods to introduce different spacer groups into AB-123 structure as a way to improve its drug activities. The syntheses of these spacer groups were difficult and required a great deal of creative thinking, good science and hard work. Since Dr. Li was the first in the world to synthesize these novel spacers, his pioneering work represented a significant advance in anti-diabetic research and served as a springboard to other drug discovery activities.
Building on his creativity in drug discovery, Dr. Li then spearheaded the development efforts at ZYX in 200X to discover a large-scale process route for DE456, another leading backup compound for diabetes clinical trials. Previously a comprehensive drug property study of DE456 was hindered because the original method to make DE456 suffered from low yields (2.5% overall) and contained three difficult purification steps. The largest amount made by the old method was only 0.7 g. After months of intensive research, Dr. Li revamped the old synthesis and established a new, reliable synthetic route to DE456. This was truly a breakthrough since the new synthetic pathway not only eliminated three purification steps but also improved the overall yield to 40% (which accounts for 16 fold increase in efficiency). The new route developed by Dr. Li has been applied successfully by XYZ scientists in Japan to produce DE456 on several hundred gram scales. I am impressed with Dr. Li’s outstanding research and development capabilities, which helped XYZ scientists to better understand the properties of DE456 as an important diabetes drug candidate.
Dr. Li continued his quest for a second-generation inhibitor for the treatment of diabetes in 200X and 200X. He led his team to design and synthesize over a hundred compounds that are structurally similar to DE456. These compounds have a unique core structure that is different from any existing diabetes drugs, including the experimental drug AB-123. More than a dozen of them were extremely potent on the enzyme level and had good oral efficacy in animal models to lower blood sugar levels. The syntheses of these novel compounds were truly innovative. Dr. Li demonstrated his excellent research ability by integrating new techniques and solving practical problems to discover new ground in diabetes research.
I have supervised hundreds of scientists and managed scores of international collaborations. Based on my assessment Dr. Li is currently one of the top experts in the world in the field of diabetes drug discovery targeting gluconeogenesis pathway. Dr. Li is certainly an outstanding researcher in medicinal chemistry and organic chemistry. His significant contributions to the diabetes research are vital for both the scientific communities and diabetic patients worldwide.
Sincerely yours,
Signature and title