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Development of the MedTone Insulin Inhaler -
Darlene Rosario, Mannkind Corporation
Wednesday, December 10, 2008 7 PM
CLU - Richter Hall, Ahmanson Science Building
Insulin therapy usually involves subcutaneous injections of insulin. Patients dislike injecting themselves with insulin due to inconvenience and pain, so tend not to comply adequately with prescribed treatment regimens. Even when properly administered, subcutaneous injections of insulin do not replicate the body’s first-phase insulin spike. This results in high blood glucose levels early after meal onset followed by hypoglycemia, during the period between meals. Hypoglycemia can result in loss of mental acuity, confusion, increased heart rate, hunger, sweating and faintness and, at very low glucose levels, loss of consciousness, coma and death.
Patients and their physicians have sought alternative insulin delivery methods. Insulin pumps are generally considered appropriate only for a small segment of the diabetes population. Oral insulin delivery has been hampered by formulation problems, specifically delivering a sufficient supply of insulin to the body at the time when it is needed.
Another alternative being pursued by a number of pharmaceutical and biotechnology companies is the inhalation of an insulin formulation into the deep lung, where it can be absorbed directly into the bloodstream.
Darlene Rosario,
Executive Director of Worldwide Regulatory Affairs
MannKind Corporation
Darlene Rosario has extensive experience in the drug development process. She has served on FDA-sponsored committees to improve safety reporting, and to study inhalation drug delivery in particular. Prior to her current position, Darlene was Director of Regulatory Affairs at Aradigm and Associate Director of Regulatory Affairs at Dura Pharmaceuticals.
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