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BIOGRAPHICAL SKETCH Provide the following information for the Senior/key personnel and other significant contributors in the order listed on Form Page 2. Follow this format for each person. DO NOT EXCEED FOUR PAGES. NAME POSITION TITLE Donna Bigley Investigational Drug Study Clinical Pharmacy Specialist bigleyd Denver Health Medical Center EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, Denver, COsuch as nursing, include postdoctoral training and eRA COMMONS USER NAME (credential, e.g., agency login) residency training if applicable.) INSTITUTION AND LOCATION California Polytechnic State University, San Luis Obispo, CA Creighton University School of Pharmacy and Health Professions, Omaha, NE Grant Medical Center, Columbus, OH DEGREE (if applicable) MM/YY BS 1999 Biochemistry and Biology PharmD 2005 Pharmacy PGY1 Residency 2006 Pharmacy Practice Resident FIELD OF STUDY A. Personal Statement My expertise over nearly two decades in pharmacy and research experience has given me a wide background in clinical and operations not only in the inpatient hospital areas, but in all areas of pharmacy from outpatient, research, investigational drug studies as well as the outpatient clinic settings. I started my career working within the biotechnology pharmaceutical industry applying my analytical skills from my undergraduate degree training. This early work in already marketed and new to market drug development and diagnostic testing kits set my interest in the clinical research process. I then pursued a higher level of education at Creighton University School of Pharmacy and Allied Professions. Working toward this Doctorate in Pharmacy I involved myself with research at the institution and took any teaching opportunity as it was available. At Creighton I had the opportunity to be a paid research assistant and worked on a Medical Safety Study where they were investigating the early implementation of an electronic prescription directly inputted from a handheld device to a printer compared to standard written prescriptions. I pursued a PGY1 residency in clinical practice at Grant Medical center to broaden my clinical skills as a pharmacist and designed and implemented my residency research project where I developed a screening process for non-critically ill diabetic patients that is still used at the institution. After residency I started my pharmacy practice experience where I staffed as a patient care pharmacists and served as the interim operations manager at Mount Carmel Health Systems West. Currently I work as the Investigational Drug Study and Research Pharmacist which is a clinical pharmacist position here at Denver Health. I do staff occasionally in the inpatient pharmacy in all areas, Trauma/Emergency Medicine, Oncology, Prior Authorization Coordinator, General Medicine, Behavior Health, Critical Care and Anticoagulation. Prior to being in this position I was a Staff Pharmacist at Denver Health trained in all areas of the hospital including the Discharge Pharmacy, ICU, General Medicine Floors, Oncology Infusion Center, Anticoagulation Services Inpatient and Outpatient. The research pharmacists responsibilities are to maintain all investigational studies that handle medications in the hospital and to support research at our institute including protocol development, IRB submission, IND Development, interpret data, provide pharmacy support, regulatory support, and study design. This proposed project seeks to build a unique integrated team from a multidisciplinary approach Page 30 and I fully support the proposed project and will provide onsite guidance for the initial set up, pharmacy support for the duration of the study, including storage of the product and the regulatory issues surrounding dispensing Scheduled I substances. In addition will provide additional support throughout the conduction of the clinical trials to help interpret any issues or problems related to pharmacy, contribute to interpretation of adverse events, and assist with publications and presentations during the research dissemination phase of the project. B. Positions and Honors Positions and Employment 1995-1999 Pharmacy Assistant, California Polytechnic State University Health Center Pharmacy, San Luis Obispo, CA 1999 Chemist, Pharmaceutical Quality Control Lab, Oread, Palo Alto, CA 1999 Chemist, Pharmaceutical Quality Control Lab, Genentech, South San Francisco, CA 1999 - 2000 Chemist, DNA Probe Synthesis Lab, GenProbe, Mira Mesa, CA 2001 Research Associate, R&D Lab, Ista Pharmaceuticals, Irvine, CA 2003 Research Assistant, Creighton University, Omaha, NE 2003 Laboratory Teaching Assistant, Creighton University, Omaha, NE 2002 Pharmacy Intern, Walgreens, Omaha, NE 2002 – 2005 Pharmacy Intern, Target Pharmacy, Omaha, NE 2005 – 2006 Pharmacy Practice Resident (PGY1), Grant Medical Center, Columbus, OH 2005-2014 Pharmacist Per Diem, Target Pharmacy, Ohio and Colorado Territories 2006 - 2007 Patient Care Pharmacist/Interim Operations Manager, Mount Camel Health System West, Columbus, OH 2008 - 2010 Staff Pharmacist, Denver Health Medical Center, Denver, CO 2010Investigational Drug Study Clinical Pharmacy Specialist, Denver Health Medical Center, Denver, CO 2012COMIRB Panel B Reviewer, Colorado Multiple Institutional Review Board, Aurora, CO Other Experience and Professional Memberships Membership 2004American Society of Health-System Pharmacists (ASHP) 2003American College of Clinical Pharmacy (ACCP) 2009Rho Chi Honors Society Teaching Experience 2009Early Practice Experience (IPPE) Preceptor for Doctorate of Pharmacy Program University of Colorado School of Pharmacy 2010Early Practice Experience (IPPE) Preceptor for Doctorate of Pharmacy Program Regis University School of Pharmacy 2010Early Practice Experience (APPE) Preceptor Drug Information Rotation for Doctorate of Pharmacy Program University of Colorado School of Pharmacy Page 31 201020122012- Early Practice Experience (APPE) Preceptor Institutional Rotation for Doctorate of Pharmacy Program University of Colorado School of Pharmacy Early Practice Experience (APPE) Preceptor Drug Information Rotation f for Doctorate of Pharmacy Program Regis University School of Pharmacy Early Practice Experience (APPE) Preceptor Institutional Rotation for Doctorate of Pharmacy Program Regis University School of Pharmacy Professional Experience 2005-present Active License of Pharmacy, State of Ohio 2008-present Active License of Pharmacy, State of colorado 2009Board Certified Pharmacotherapy Specialist 2010Human Subjects Training, CITI Basics Course, HIPPS, GCP 2014 Pilot Tester ACCP Pharmacotherapy PSAP Honors 2005 Graduate Creighton Pharmacy School with Honors C. Selected Peer-reviewed Publications D. Research Support Page 32