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Dr. Cleveland has an extensive North American and European Regulatory Affairs experience base gained in 20-plus years in the industry in both traditional large pharma and small biotech environments. For more than a decade her focus has been in the biological products area including work with monoclonal antibodies, eiRNA-based plasmid DNA, therapeutic neurotoxins, immuno-stimulants and recombinant vaccines. During a ten year career with SmithKline Beecham, she provided the lead US regulatory support for approved (Engerix-B) and investigational recombinant vaccines including submission of the first fully electronic BLA to CBER (LYMErix, approved 1998). Pat subsequently joined Medeva PLC where she was instrumental in preparation of licensing applications for a recombinant vaccine in the US, Canada and Europe. With the Celltech/Medeva merger in 2000 assumed the role of VP Regulatory Affairs for North America. During this time she provided the senior global oversight for investigational biological products including anti-TNF biological products. Pat later provided regulatory consultancy to a variety of programs and served as Solstice Neurosciences� VP Regulatory Affairs before joining Ception Therapeutics. Pat holds a B.S. Pharm., M.S. Pharmaceutics and a Ph.D. in Medical Sciences. She is a Registered Pharmacist and a member of DIA and RAPS. | 