Regulatory Affairs

Mary Newman

Ms. Newman serves as a regulatory affairs expert consulting on many ophthalmology programs creating development strategies for small molecules, biologics, devices and gene/cell therapies. Her deep experience helps clients to navigate regulatory requirements for US FDA and EU EMEA submissions for clinical studies, global regulatory authority meetings and product registration. Most recently, Ms.

Brian Christian

Dr. Christian is a regulatory toxicologist with over 30 years of experience in the contract pharmaceutical research industry.  Prior to joining OSOD he served as the scientific lead for the ocular toxicology services offered at Covance/Labcorp Laboratories which included planning and directing nonclinical toxicology and pharmacology studies as senior study director.  Brian is a diplomate of the American Board of Toxicology and has served on the Executive Committee of the Ocular Toxicology Specialty Section of the Society of Toxicology.    

Charles O'Neill

Dr. O'Neill serves as a member of the Executive Board and provides consulting on many aspects of vision science with a specific focus on study design and regulatory requirement considerations for IND submission.  Dr. O'Neill is an Assistant Adjunct Professor in the Pharmacology and Toxicology Graduate Group at University of California-Davis. He has contributed to 26 regulatory submissions in the US, EU, Australia and Japan, coauthored over 40 peer-reviewed publications, and been a Diplomate of the American Board of Toxicology since 1995.

Robert Shimizu

Dr. Shimizu has over 35 years of corporate experience in ophthalmology.  In 1992 his focus transitioned from research to product development.  Rob has led cross-functional teams focused on product development of pharmaceuticals (including drug delivery), ocular devices and combination products.  These activities developed treatments for diseases in both the anterior and posterior segments of the eye.  Rob has led pharmaceutical development, device development, preclinical testing, clinical evaluation and regulatory activities addressing global markets.

Gary Leatherberry

Our administrative team includes specialists who have direct experience working both in research and industry settings. Together, they have the knowledge and skills necessary to manage day-to-day activities, facilitate partnerships, and build an increasingly effective research-industry operation.

Robert Shimizu, PhD

Dr. Rob Shimizu brings over 35 years of corporate experience in ophthalmology ranging from research to development of pharmaceuticals, ocular devices, and combination products for diseases in both the anterior and posterior segments of the eye.  Rob has successfully led multinational—interdisciplinary teams through regulatory activities leading to approvals in North America, the EU, and Asia.