Ms. Michelle Carpenter, J.D., RAC serves as Chief Regulatory & Clinical Officer at TearSolutions, Inc. (TearSolutions, LLC). Ms. Carpenter has been Vice President of Regulatory Affairs and Project Management at True North Therapeutics, Inc. since April 05, 2017. She served as a Vice President of Regulatory Affairs and Project Management at Afferent Pharmaceuticals, Inc. since November 19, 2015, where she was responsible for setting and implementing global regulatory strategy. She served as the President of RPSpharma. She served as Senior Vice President of Regulatory Affairs & Clinical Development at Kubota Pharmaceutical Holdings Co., Ltd. (alternate name: Acucela Inc.) since August 2011. She served as Chief Compliance Officer and Vice President of Clinical & Regulatory Affairs at Mylan Specialty L.P. She served as Executive Director, Regulatory Affairs at Valeant Pharmaceuticals and former Vice President of Global Regulatory Affairs and Project Management at Santen Inc. Ms. Carpenter served as Senior Vice President of Regulatory Affairs & Development Operations at Acucela Inc. since August 2011. She was responsible for operational execution of global development programs across all indications from Phase 1 through New Drug Application (NDA), as well as related activities for commercial purposes at Acucela Inc. Ms. Carpenter is a regulatory affairs professional with over 25 years of biopharmaceutical experience. She has particular expertise in leading regulatory strategies for ophthalmic products (glaucoma, dry eye and age-related macular degeneration) including due diligence, development and lifecycle management. She served as Executive Director of Regulatory Affairs at Dow Pharmaceutical Sciences, where she developed and implemented global regulatory approval and lifecycle management strategies while focusing on the Dow Pharmaceutical's internal research, commercialization and outsourcing capabilities. Ms. Carpenter served as Vice President of Regulatory Affairs and Quality at Sonoma Pharmaceuticals, Inc. (alternate name: Oculus Innovative Sciences, Inc.) since April 2008. She held a number of additional management positions in innovative Bay Area biotech companies. She joined Oculus as a pharmaceutical industry professional with 15 years of diversified experience in the areas of regulatory affairs, project management and compliance. She served as Chief Compliance Officer and Vice President of Clinical & Regulatory Affairs of DEY L.P (now Dey Pharma, L.P). Ms. Carpenter has responsibility for clinical and regulatory development strategies that result in successful and rapid product approvals. Ms. Carpenter's primary responsibilities includes overseeing DEY's Corporate Compliance Program. In the regulatory and clinical areas, Ms. Carpenter's team is responsible for DEY's clinical development programs and regulatory strategies that support new product approvals. Prior to joining DEY in April 2002, for seven years, Ms. Carpenter served as Vice President of International Regulatory and Project Management for Santen Incorporated. In that position, she managed all U.S. and European development and submission strategies and functioned as the primary liaison with regulatory authorities for key negotiations. Prior to working at Santen, she served at InSite Vision and Oclassen Pharmaceuticals in various management and regulatory functions. She is affiliated with the American and California State Bar Association, the Drug Information Association and the Food and Drug Law Institute, as well as other well respected organizations. Ms. Carpenter received her Doctor of Jurisprudence from Golden Gate University school of law with an emphasis on Public Health Law. She earned an Undergraduate Degree in Sociology with the majority of her coursework in pre-medicine at the University of California at Santa Barbara. She also holds a Regulatory Affairs Certification (RAC). Ms. Michelle Carpenter, J.D., RAC serves as Chief Regulatory & Clinical Officer at TearSolutions, Inc. (TearSolutions, LLC). Ms. Carpenter has been Vice President of Regulatory Affairs and Project Management at True North Therapeutics, Inc. since April 05, 2017. She served as a Vice President of Regulatory Affairs and Project Management at Afferent Pharmaceuticals, Inc. since November 19, 2015, where she was responsible for setting and implementing global regulatory strategy. She served as the President of RPSpharma. She served as Senior Vice President of Regulatory Affairs & Clinical Development at Kubota Pharmaceutical Holdings Co., Ltd. (alternate name: Acucela Inc.) since August 2011. She served as Chief Compliance Officer and Vice President of Clinical & Regulatory Affairs at Mylan Specialty L.P. She served as Executive Director, Regulatory Affairs at Valeant Pharmaceuticals and former Vice President of Global Regulatory Affairs and Project Management at Santen Inc. Ms. Carpenter served as Senior Vice President of Regulatory Affairs & Development Operations at Acucela Inc. since August 2011. She was responsible for operational execution of global development programs across all indications from Phase 1 through New Drug Application (NDA), as well as related activities for commercial purposes at Acucela Inc. Ms. Carpenter is a regulatory affairs professional with over 25 years of biopharmaceutical experience. She has particular expertise in leading regulatory strategies for ophthalmic products (glaucoma, dry eye and age-related macular degeneration) including due diligence, development and lifecycle management. She served as Executive Director of Regulatory Affairs at Dow Pharmaceutical Sciences, where she developed and implemented global regulatory approval and lifecycle management strategies while focusing on the Dow Pharmaceutical's internal research, commercialization and outsourcing capabilities. Ms. Carpenter served as Vice President of Regulatory Affairs and Quality at Sonoma Pharmaceuticals, Inc. (alternate name: Oculus Innovative Sciences, Inc.) since April 2008. She held a number of additional management positions in innovative Bay Area biotech companies. She joined Oculus as a pharmaceutical industry professional with 15 years of diversified experience in the areas of regulatory affairs, project management and compliance. She served as Chief Compliance Officer and Vice President of Clinical & Regulatory Affairs of DEY L.P (now Dey Pharma, L.P). Ms. Carpenter has responsibility for clinical and regulatory development strategies that result in successful and rapid product approvals. Ms. Carpenter's primary responsibilities includes overseeing DEY's Corporate Compliance Program. In the regulatory and clinical areas, Ms. Carpenter's team is responsible for DEY's clinical development programs and regulatory strategies that support new product approvals. Prior to joining DEY in April 2002, for seven years, Ms. Carpenter served as Vice President of International Regulatory and Project Management for Santen Incorporated. In that position, she managed all U.S. and European development and submission strategies and functioned as the primary liaison with regulatory authorities for key negotiations. Prior to working at Santen, she served at InSite Vision and Oclassen Pharmaceuticals in various management and regulatory functions. She is affiliated with the American and California State Bar Association, the Drug Information Association and the Food and Drug Law Institute, as well as other well respected organizations. Ms. Carpenter received her Doctor of Jurisprudence from Golden Gate University school of law with an emphasis on Public Health Law. She earned an Undergraduate Degree in Sociology with the majority of her coursework in pre-medicine at the University of California at Santa Barbara. She also holds a Regulatory Affairs Certification (RAC).

Ophthalmic Pathology