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Richard S. Schwartz, M.D.
Biopharmaceutical Clinical Research Consultant
Pharmaceutical and Biotechnology Development
Burlingame, California USA
Tel: (650) 344-6260
e-mail: rss@netwiz.net

1. Product license applications approved by FDA as a result of clinical trials - principal responsibility for inception of study, protocol design and development, and clinical summary report:

a. Koate®-HT Antihemophilic Factor
b. Koate®-HS Antihemophilic Factor
c. Konyne®-HT Factor IX Complex
d. Konyne®-HT Inhibitor Treatment Indication
e. Intravenous Gammaglobulin (IGIV)

Gamimune® (pH 5.25) Immune Thrombocytopenic Purpura (ITP) indication
Gamimune®-N (pH 4.25) ITP indication
400 mg/kg x 5 and 1000 mg/kg x 2
Childhood and adult ITP studies

f. Prolastin® (alpha1-proteinase inhibitor) (Orphan Drug)
g. Thrombate III® (Antithrombin III) - licensed 12/30/91 (Orphan Drug)
h. Kogenate® (Recombinant Factor VIII)
i. Infection prophylaxis of pediatric AIDS patients with intravenous gammaglobulin (Orphan Drug Indication)

a. Koate®-HT
b. Koate®-HS
c. Prolastin® (Alpha1-Proteinase Inhibitor)
d. Thrombate III® (Antithrombin III)
e. Kogenate® (Recombinant Factor VIII)

a. Konyne®-HT
b. Konyne®-HT Inhibitor Indication
c. Koate®-HT
d. Koate®-HS
e. Prolastin® (alpha1-proteinase inhibitor) (Orphan Drug)
f. Hepatitis B immune globulin
g. Rh immune globulin
h. Gamimune® (intravenous gammaglobulin) ITP indications for IGIV pH 5.25 and IGIV pH 4.25 for both 400 mg and 1000 mg dose regimens
i. Thrombate III ® (antithrombin III) (Orphan Drug)
j. Kogenate® (Recombinant Factor VIII)
k. Prophylaxis of pediatric AIDS patients with Intravenous Gammaglobulin (Orphan Drug Indication)

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Curriculum Vitae

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