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HemaGen/PFC - Director of Chemical Research

Responsibility

• Develop a sufficiently diverse product portfolio to attract venture capital financing of a startup pharmaceutical firm.

Significant Accomplishments

• Developed and patented a novel perfluorochemical emulsion, Oxyfluor. This product is expected to be a useful "blood substitute" in surgical hemodilution and shock/trauma resuscitation. There have been no drug related adverse events in surgical clinical trials to date.

• Established a working research relationship with 3M to screen and evaluate perfluorochemicals free of common toxicological side effects such as pulmonary hyperinflation and thrombocytopenia. This collaboration resulted in a co-authored patent on the active ingredient of Oxyfluor, perfluorodichlorooctane.

• Participated in the negotiation with Baxter Healthcare that led directly to a licensing agreement for Oxyfluor, providing an unrestricted $10 million payment which funded research in other areas.

• Developed the production process, including analytical and microbiological QC/QA, for Oxyfluor and successfully transferred the process to Pharmacia (Clayton, NC), where clinical supplies are being produced.

• Developed and patented an inexpensive synthetic route to a novel class of alkylglycerophosphoryl chloline based surfactants.

• Developed and patented a novel lipid emulsion drug delivery system that reduces the toxicity of Taxol.

• Principal investigator and sole author of awarded SBIR grant (National Heart, Lung and Blood Division of the NIH) for a method of delivering therapeutic agents to the lung using novel water in perfluorochemical (WIP) microemulsions.

• Developed magnetic resonance imaging (MRI) contrast agents suitable for blood pool and hepatic imaging. Pre-clinical evaluation in rodents and baboons has demonstrated a significant therapeutic advantage.

• Performed the statistical analysis of pharmacokinetic, absorption, distribution, metabolism and excretion (PK-ADME) data obtained from GLP rodent and baboon studies in pre-clinical work directed toward the IND submission for Oxyfluor. Wrote the PK-ADME report used in the approved FDA submission.

• Staffed and equipped synthetic and process research laboratory, which houses eight chemists (3 PhDs, 5 BS/MS), and is equipped with FT-NMR, FTIR, UV, HPLC, GC, and GC/MS . The space also houses pilot emulsification equipment, including Microfluidics and Gaulin homogenizers, as well as laser light and resistivity (Coulter) based particle sizing equipment.

• Procured and installed all computer hardware and software for HemaGen/PFC, and installed a local area network of 17 Macintoshes. Wrote all data acquisition software to obtain and workup data from HP-3390 series of recording integrators. Wrote software system used for filing HemaGen/PFC documents.