Location

Cherry Auditorium, Kirk Hall

Start Date

10-18-2012 1:00 PM

Description

Since the FDA approved the first recombinant DNA product in the early 1980s, biomolecules (e.g., peptides, proteins, DNA, and vaccines) have created new therapeutic areas, which were not possible with traditional small molecule drugs. The number of biopharmaceuticals reaching the clinic has increased exponentially over the past two decades and still more biopharmaceuticals are expected to enter the market in the near future. In contrast to small molecule drugs, biopharmaceuticals cannot be administered by pills and tablets because they are degraded significantly in the stomach and intestine, are not easily absorbed through the mucus membrane of the intestine, and if they enter system circulation they are then degraded further by the liver. For these reasons, biopharmaceuticals are administered mostly by hypodermic injection to ensure high bioavailability; however, injections have low patient compliance due to fear of pain and the necessity of training or medical personnel to administer the injections and to safely dispose of the sharp biohazardous needles.

Two innovative transdermal delivery methods, microsecond thermal skin ablation and dissolving microneedle patches, were designed to enable patients to more simply administer biopharmaceuticals without using hypodermic needles. Microsecond thermal skin ablation selectively and superficially removes the skin barrier without deeper tissue damage; thereby, enhancing the permeability of skin to large biomolecules by up to 1,000-fold. Dissolving microneedle patches encapsulate biomolecules, preserve their activity, and enable them to be delivered into systemic circulation in a minimally invasive way. In conclusion, these technologies are expected to enable medications to be self-administered by the patient, resulting in comparable bioavailability and/or therapeutic efficacy to injection by needle and syringe.

Comments

Downloadable file is a PDF of the original event flier.

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Oct 18th, 1:00 PM

The Era of Self-Administration of Biopharmaceuticals

Cherry Auditorium, Kirk Hall

Since the FDA approved the first recombinant DNA product in the early 1980s, biomolecules (e.g., peptides, proteins, DNA, and vaccines) have created new therapeutic areas, which were not possible with traditional small molecule drugs. The number of biopharmaceuticals reaching the clinic has increased exponentially over the past two decades and still more biopharmaceuticals are expected to enter the market in the near future. In contrast to small molecule drugs, biopharmaceuticals cannot be administered by pills and tablets because they are degraded significantly in the stomach and intestine, are not easily absorbed through the mucus membrane of the intestine, and if they enter system circulation they are then degraded further by the liver. For these reasons, biopharmaceuticals are administered mostly by hypodermic injection to ensure high bioavailability; however, injections have low patient compliance due to fear of pain and the necessity of training or medical personnel to administer the injections and to safely dispose of the sharp biohazardous needles.

Two innovative transdermal delivery methods, microsecond thermal skin ablation and dissolving microneedle patches, were designed to enable patients to more simply administer biopharmaceuticals without using hypodermic needles. Microsecond thermal skin ablation selectively and superficially removes the skin barrier without deeper tissue damage; thereby, enhancing the permeability of skin to large biomolecules by up to 1,000-fold. Dissolving microneedle patches encapsulate biomolecules, preserve their activity, and enable them to be delivered into systemic circulation in a minimally invasive way. In conclusion, these technologies are expected to enable medications to be self-administered by the patient, resulting in comparable bioavailability and/or therapeutic efficacy to injection by needle and syringe.