Management
The Management Team at Pacific Data Designs has a combined 100 years experience in the Pharmaceutical, Biotech, and CRO industries, as well as the academic workplace.
Kelli Greene
Kelli has spent over 25 years in the discipline of Clinical Data Management. She began her career at Abbott Laboratories as a Research Data Coordinator and later became Section Manager, Clinical Services. She was directly responsible for the development and support of numerous clinical information systems, including a new clinical trials application, a computer assisted new drug application (CANDA) system, an imaging system, a data management quality assurance system, an on-line medication classification system, and remote data entry systems.
Kelli joined Genentech in 1993 where she was a Manager of Clinical Data Management. She also was an essential member of a management team charged with re-engineering Genentech's overall data management process. After her experience at large pharmaceutical companies, she envisioned the idea of providing the advantages of a CRO, but with the service and long term relationships she felt were lacking.
Pete Sandgren
Pete has over 15 years experience in Clinical Data Management. He directly manages the Data Management and Statistical Staffs, while also dealing directly with clients, ensuring that each project is handled in a professional and timely manner. "Our goal is to provide truly exceptional service and expertise. What sets us apart from other CRO's is our responsiveness and flexibility while maintaining a proactive approach with your project." Pete joined PDD from Genentech, where he was a Database Coordinator in Data Management. Pete was responsible for coordinating all data management tasks involved with the day to day running of projects for specific therapeutic areas.
Pete began his career at Abbott Laboratories, where he was Database Coordinator/Team Leader. He managed a Data Management team responsible for a 40 study, 4000 patient, fast-tracked interactive NDA. His responsibilities included the coordination of several CRO's contracted to assist with Data Management related activities. Through his leadership, this NDA was filed in a brief 16 month period. While at Abbott, Pete provided Data Management expertise on six separate NDA filings.
Todd Gross
Todd has more than 15 years experience in the areas of Statistics and SAS Programming. Since receiving his Ph.D. from UCLA in 1992, he has served as Director of Statistics for Medtronic (Diabetes division), Director of Clinical Studies for Quest Diagnostics and Director of Biostatistics and Clinical Data Management for Boston Scientific (Neuromodulation division). Todd's experience includes IDE and PMA submissions for medical devices, IND and NDA filings for pharmaceutical applications and extensive experience with combination Drug/Device products. While at Medtronic, Todd served as lead statistician for a first-to-market continuous glucose monitoring system, serving as sponsor representative at FDA advisory panels and pre- and post-submission FDA meetings. He holds three U.S. patents and has held adjunct faculty positions at California State University, Northridge and UCLA.
"I believe the role of a statistician is to make clinical results understandable to as wide an audience as possible."
