Expertise DescriptionI have more than 45 years of experience in Internal Medicine. Scientific highlights from my clinical research include developing orphan drugs for sickle cell disease and thalassemia, documenting that hemoglobin A1c could be used as a measure of longer term “control” in diabetes mellitus, the observation that patient self monitored glucose values along with HBA1c values could be used as two independent means of quantifying “control,” documentation that improved glucose levels improve outcome of pregnancy in women with diabetes and reverse several pathologies associated with the disease, discovery of an assay that could be used to document levels of alcohol consumption over time, and the first use of atomic force microscopy to visualize cells. I also have experience with telemedicine, and hold 15 U.S. patents, have sponsored 7 INDs to the FDA. I have published over 400 peer reviewed primary articles, chapters, editorials, reviews and 21 books and monographs. I have over 30 years expert witness experience with consultations, deposition, and expert testimony.
Areas of Expertise
My experience includes basic and clinical research begun at an institution during my medical training, working as the Research/Medical Director and CEO of a medical research institute, and working as Chief Resident of a hospital and university hospital.
I have a strong background in protein chemistry, compound stability and continuous product quality monitoring, quality assessment, and quality control.
I have been associated with blood and blood product banking for 40 years primarily while caring for people with rare hematologic diseases who are transfusion dependent and while I was Director of the Division of Blood Diseases and resources at the NIH. There are two general issues here – donor selection and protection before and during the procedure and donor protection from sequelae after the procedure. Donor deferral criteria are based on determining that the donation will not adversely affect the donor’s health. Indications for deferral of the donor include a hemoglobin less than 12.5 g/dL for women , temperature above 37.5°C, blood pressure above 180 mmHg systolic or 100 mmHg diastolic, pulse outside the established limits of 50 to 100 beats/minute, certain arrhythmias detected on pulse examination, and a variety of medical conditions. Measurement of pre-donation hemoglobin level serves to detect potential donors who are anemic, and low hemoglobin renders them ineligible to donate, thereby protecting them against further reduction of hemoglobin mass. Certain populations are more vulnerable such as young or pregnant women, frequent donors, those with chronic illness, etc. Post-donation reactions can be minimized by restricting donation to less than 15 percent of a donor’s estimated blood volume (ie, for younger donors at some United States blood centers, estimated blood volume must be >3500 mL in order to be accepted for donation), encouraging applied muscle tension during donation, providing approximately 500 mL of water before donation, making sure the donor feels well before being allowed to walk to the refreshment table, and encouraging the donor to stay at the table for at least 10 to 15 minutes for observation and fluid replenishment.
I have certainly worked with devices and drugs as a sponsor and with the FDA on various committtees.
|M.B.A.||Business Administration||University of California||Irvine|
|I.F.P.||International and Public Affairs||Columbia University||NY|
Medical Licensure: California, New York, Washington
Awards & Affiliation
American Chemical Society
American College of Physicians (Fellow)
American Diabetes Association
American Federation of Clinical Research
American Society for Clinical Investigation
American Chemical Society