The Program Management Core will essentially function as a drug development decision-making body. Thus, it will oversee all aspects of the drug development paradigm, and program administration. Overall program management will be the responsibility of the P.I., assisted by the Co-I., in coordination with three advisory groups (see Figure 18, Program Introduction): 1. Project P.l.s and Core P.l.s; 2. Internal Drug Development Advisory Committee, including: a. Dr. Stephen Frye, Director of the Medicinal Chemistry and Novel Molecular Entity Screening Core, UNC CTSA/School of Pharmacy. Note, Dr. Frye is a former worid-wide head of medicinal chemistry for GSK and has been at UNC as Director of the CTSA MedChem Core for the past three years. b. Dr. Anthony Hickey, Ph.D., Professor of Pharmacy, UNC School of Pharmacy. Dr. Hickey is an expert in aerosol drug delivery, and the founder of Cirrus Aerosol Development Corp. and Oriel Inhaled Device Company. c. Dr. Lisa Lavange, Professor in Practice, Director, Carolina Computing Center. Dr. Lavangeis a former VP for Biostatistics at Inspire Pharmaceuticals and Senior Statistician at Quintiles. d. Dr. Joseph Eron, Professor of Medicine. Dr. Eron is an experienced clinical trials expert in HIV and serves on the UNC Conflict of Interest Committee. 3. External Advisory Group - TBN Central to all aspects of the direction/oversight of the Program Oversight Committee is the integration of advice from the Project and Core P.l.s, the Internal Drug Development Committee, and the External Advisory Board into the decision-making process. To accomplish this goal, there will be monthly meetings of the tPPG P.I./co-P.I. with the Project and Core P.l.s and the Internal Drug Development Committee. In addition, there will be quarteriy teleconferences (one meeting/yr will be face to face) with this group with the External Advisory Committee to discuss progress and seek input. It is likely that the External Advisory Committee will consist of three individuals with the following skills: 1) expertise in mucus biochemistry/biophysics;2) industry drug development;and 3) clinical trials in COPD. Finally, as part of this overall program management function, the requisite administration, personnel, and communication activities will be a function of this Core.
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