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12 product approvals from FDA including 6 new chemical entities, a 510k device, and three major pharmaceutical efficacy indication supplemental approvals. All received 5-10 years of regulatory exclusivity (Hatch-Waxman, Orphan Drug). These products are generating over $100 million dollars in revenues annually.

Expert has also filed over 30 investigational new drug applications spanning pharmaceutical, biologics, biotechnology, and veterinary medicine with none placed on clinical hold by the FDA. These INDs span indications in oncology, metabolism, antidotes, neurology, gastrointestinal, anesthetics, sepsis, autoimmune disease amongst others.

He has also assisted 4 young previously unlicensed manufacturing and testing firms in obtaining their first FDA establishment licenses. Expert is an inventor on almost 20 patents; at least one with each employer.

Expert and his firm are developing an antisense DNA molecule for use in down regulating the p53 protein initially for treatment of cancer. In addition to his general management responsibilities, Expert manages world wide regulatory strategy, quality assurance, quality control and assists with manufacturing strategy, intellectual property and general management.

Accomplishments: Set up Employer Regulatory and Quality Assurance functions from scratch, hired 2 regulatory and one quality staff. Filed for and obtained chemical abstract registry number which allowed Employer to obtain the cenersen generic name from USAN and the WHO, obtained AML orphan drug designation in the United States and Europe (melanoma & CLL pending), obtained subpart E designation for cenersen US IND positioning drug for fast track and priority NDA review. Conducted two end of phase II meetings with FDA (melanoma, AML), initiated special protocol assistance process with FDA for registration trials in AML, obtained SME status in Europe allowing for complete fee waiver on AML Scientific Advice submission. Two meetings were organized and conducted with the EMEA for cenersen. Scientific advice was obtained for cenersen from the EMEA, COMP and CHMP. A Canadian CTA was filed and approved for AML. Organized internal trade name generation, filed and obtained approval from the US Patent and Trademark Office for Aezea™ (cenersen) for injection. Aezea trade name was filed with both the EMEA and the US FDA for advance regulatory approval (both in process and pending). Statutory patent extension submission prepared positioning cenersen to obtain the full additional 5 years of patent term restoration upon FDA approval of the NDA. Set up Employer for filing electronically via uplink to both the EMEA (Eudralink) and FDA (Electronic Secure Gateway).

In two years the Employer regulatory database includes over 600 entries pertaining to communications with regulatory body’s world wide on the first drug product cenersen. The quality assurance system was initiated and put in place for controlled documents, which now contains over 150 documents including master batch records, methods, specifications, protocols and SOPs.

Awards: Expert received an award from the Minnesota Intellectual Property Lawyers Association February 22, 2006 for his patents in support of Xyrem and Orphan Medical Inc.

Jazz Pharmaceuticals Inc., Palo Alto California June –December 2005



Expert was contracted through the end of 2005 by Jazz to transfer all duties and responsibilities from Minnesota to Palo Alto. These included manufacturing, quality control, quality assurance, regulatory affairs and patent activity following the Jazz acquisition of Orphan Medical. Also, was incentivized by Jazz to obtain FDA approval for a pending Xyrem (sodium oxybate) label expansion clinical supplemental NDA. sNDA005 was approved by Rusty Katz on the user fee deadline with no queries or questions from the FDA Division of Neurology Products.