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Elan Pharmaceuticals, Inc. formerly Athena Neurosciences, Inc. ; Director Feb. 1999 May 2002 ; , Associate Director Apr. 1997 Feb. 1999 ; , Manager Oct. 1995 Mar. 1997 ; Responsible for defining regulatory strategy for biologic and drug products in international development and commercialization. Represented Regulatory Affairs on development and commercialization teams. Primary regulatory contact to FDA CBER, CDER, and DDMAC ; and TPD as well as international corporate partners Canada, Germany, Japan, Switzerland, UK, and US ; . Supervised staff of six to support five marketed products, five US INDs for drug products, one US IND for a therapeutic vaccine, and five Canadian INDs. Represented Regulatory Affairs on the clearance committee to review and approve promotional materials. Established regulatory standards for promotional material, communicated them to marketing colleagues, and ensured compliance. Provided regulatory intelligence to colleagues and trained regulatory staff on regulatory intelligence activities. Participated in due diligence of two products that were successfully in-licensed Mysoline and Frova ; . Collaborated with European colleagues on international product development, regulatory strategy, and regulatory submissions. Accomplishments included: o Filing INDs in the US and Canada for a therapeutic monoclonal antibody Tysabri ; and a US IND for a therapeutic vaccine for Alzheimer's disease AN-1792 ; . o Negotiated approval of an NDA and an NDS for an orphan drug product Diastat ; and negotiated NDA approval of an anti-epilepsy drug Zonegran ; . Cygnus, Inc., Manager Aug. 1994 Oct. 1995 ; Responsible for all regulatory activity for five investigational transdermal products. Coordinated all planning for an NDA. Supported an on-site manufacturing facility by providing detailed review and approval of SOPs, analytical specifications, stability protocols, and master records. Supervised a staff of two. Collaborated with Analytical colleagues to define a comprehensive format for stability reports. Monitored Federal Register and FDA guidances, evaluated their impact on the company, and communicated assessment to colleagues. Represented Regulatory Affairs in re-engineering the drug development process at Cygnus. The Du Pont Merck Pharmaceutical Co., Manager 1992 1994 ; , Senior Regulatory Associate 1991 1992 ; Responsible for all US regulatory activity for two experimental anti-cancer drugs, including all FDA negotiations. Coordinated all planning for the preparation and submission of marketing applications in Europe, Canada, and the US. Monitored Federal Register and FDA guidances, evaluated their impact on the company, and communicated assessment to colleagues.

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