HemaGen/PFC - Director of Chemical Research
- Develop a sufficiently diverse product portfolio to attract venture capital financing of
a startup pharmaceutical firm.
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)
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.