d) Other Publications (including being member of a large Study
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Ronald L. Gibson, Jr., M.D., Ph.D. CURRICULUM VITAE Ronald L. Gibson, Jr., M.D., Ph.D. March 2009 1. Education Undergraduate: 1972-75 Graduate: 1976-82 University of Washington, Seattle, Washington - Major field of Biology, B.S. Washington University Schools of Medicine and Arts & Sciences, St. Louis, Missouri - M.D. and Ph.D. Doctoral Thesis: The role of oligosaccharide chains in the maturation and physical properties of the G protein of vesicular stomatitis virus 2. Postgraduate Training Internship: 1982-83 Residency: 1983-85 1985 Fellowship: 1985-88 Pediatrics, University of Washington School of Medicine, Seattle, Washington Pediatrics, University of Washington School of Medicine, Seattle, Washington Assistant Chief Pediatric Resident, University of Washington School of Medicine, Seattle, Washington Pediatric Pulmonology, Department of Pediatrics, University of Washington School of Medicine, Seattle, Washington 3. Faculty Positions Held 1988-1994 Assistant Professor, Department of Pediatrics, University of Washington School of Medicine, Seattle, Washington 1991-1997 Research Affiliate, Child Development and Mental Retardation Center, University of Washington, Seattle, Washington 1994-2003 Associate Professor, Department of Pediatrics, University of Washington School of Medicine, Seattle, Washington 2003-present Professor, Department of Pediatrics, University of Washington School of Medicine, Seattle, Washington 4. Hospital Positions Held 1988-present Attending Physician, Seattle Children's Hospital, Seattle, Washington 1988-present Consultant, University of Washington Medical Center, Seattle, Washington 1994-99 Consultant, Swedish Hospital & Medical Center Special Care Nursery, Seattle, Washington 5. Honors and Awards 1975 1975 1976-82 B.S. summa cum laude in Biology, University of Washington Phi Beta Kappa, University of Washington, Seattle, Washington Medical Scientist Training Grant from the National Institutes of Health, Washington University School of Medicine, St. Louis, Missouri PAGE 10 Ronald L. Gibson, Jr., M.D., Ph.D. 1977 1982 1982 1991 1997 1997 1999 2000 2000 2001 2002 2004 2005 2005 2005 2006 2007 2007-08 2008 2008 Richard S. Brookings Medical Prize, Washington University School of Medicine, St. Louis, Missouri Alexander Berg Prize in Microbiology, Washington University School of Medicine, St. Louis, Missouri Alpha Omega Alpha (AOA), Washington University School of Medicine, St. Louis, Missouri Outstanding Teacher Award, University of Washington School of Medicine, Pediatric Residency Training Program Stanley Stamm Role Model Award in Medicine (for conscientious teaching and patient care), University of Washington School of Medicine, Pediatric Residency Training Program Society for Pediatric Research, Elected Member Outstanding Teacher Award, University of Washington School of Medicine, Pediatric Residency Training Program Family Choice Award from the Parent Advisory Council at Children’s Hospital & Regional Medical Center (CHRMC), Seattle, WA Voted one of Seattle’s Top Doctors per Seattle Magazine poll of peers Nominee, Family Choice Award from Parent Advisory Council at CHRMC Nominee, Family Choice Award from Parent Advisory Council at CHRMC Outstanding Teacher Award, University of Washington School of Medicine, Pediatric Residency Training Program Voted one of Seattle’s Top Doctors per Seattle Magazine poll of peers Nominee, Family Choice Award from Family Advisory Council at CHRMC Selected to the Best Doctors in America Voted one of Seattle’s Top Doctors per Seattle Magazine poll of peers Voted one of Seattle’s Top Doctors per Seattle Magazine poll of peers Selected to Best Doctors in America Mentoring Award from the University of Washington School of Medicine, Department of Pediatrics (recognizes outstanding mentoring of junior faculty) Voted one of Seattle’s Top Doctors per Seattle Magazine poll of peers Grants/Research Awards 1985-1990 1987 1987 1988 1988-91 1990-95 1991-93 1991-94 1993-98 National Institutes of Health, Program Project (PI, W.A. Hodson): Neonatal Pulmonary Circulation: Co-Investigator (R. Gibson) Research Training Fellowship, American Lung Association, 1987-88 Research Grant, American Lung Association: The Specificity and Bacterial Stimulus of Pulmonary Hypertension in Neonatal Sepsis Research Training Fellowship, American Lung Association, 1988-89 RJR Nabisco Research Scholar Award: Bacterial-Host Cell Interactions that Stimulate Proinflammatory Mediators in Neonatal Group B Streptococcal Sepsis Maternal Child Health, Pediatric Pulmonary Center Training Grant (P.I.: G. Redding, Co-I: R. Gibson) Research Grant, Washington Technology Center: The Role of Pulmonary Microvascular Endothelial Cell Response in Lung Disease Edward Livingston Trudeau Scholar Award, American Lung Association: Group B Streptococcus Endothelial Cell Interactions Co-PIs (B. Ramsey, R. Gibson)/Mentors of Leroy Matthews Physician Scientist Award PAGE 10 Ronald L. Gibson, Jr., M.D., Ph.D. 1995-2000 1996-97 1996-97 19981998-2003 19992000-2005 1999-2002 2000-2005 2003-2008 2003-2007 2004-2009 2007-2009 2009-2014 2009-2014 Maternal Child Health, Pediatric Pulmonary Center Training Grant (P.I.: G. Redding, Co-I: R. Gibson) Cystic Fibrosis Foundation Grant Gene Therapy in the Developing Airways of Mice Cystic Fibrosis-Research Development Program Pilot Grant Cystic Fibrosis Clinical Care Center Grant (PI, R. Gibson) Cystic Fibrosis Foundation Therapeutics Development Center (Co-PIs R. Gibson/Moira Aitken) Director of the Clinical Core, CFF- Research Development Program Maternal Child Health, Pediatric Pulmonary Center Training Grant (P.I.: G. Redding, Co-I: R. Gibson) Food and Drug Administration Orphan Product Development Grant TOBI in Young Children with Cystic Fibrosis (Co-PI, R. Gibson) National Institutes of Health: Inhaled Tobramycin in Young Cystic Fibrosis Patients (#RO1 DK57755-01, PI-B. Ramsey, Co-PI R. Gibson) Cystic Fibrosis Foundation Therapeutics Development Center (Co-PIs R. Gibson/Moira Aitken, $500,000) Cystic Fibrosis Foundation Therapeutics: Standard vs. Biofilm Susceptibility Testing in CF (PI: J. Burns/Moskowitz, Co-I: R. Gibson) Cystic Fibrosis Foundation Therapeutics: Early Pseudomonas Infection Control (EPIC)-Observational Study (PIs: M. Rosenfeld, R. Gibson) Cystic Fibrosis Foundation Therapeutics: Early Pseudomonas Infection Control (EPIC)-Observational Study- DNA Collection Amendment (PI: R. Gibson) Cystic Fibrosis Foundation Therapeutics: Early Pseudomonas Infection Control (EPIC)-Observational Study-Phase II (PIs: M. Rosenfeld, R. Gibson) Cystic Fibrosis Foundation Translational Therapeutics Development Center (Co-PIs: R Gibson, M. Aitken). 6. Board Certification 1982 19881992-1999 2000-2006 2007-2013 National Board of Medical Examiners Board Certified in Pediatrics (#36845) Board Certified in Pediatric Pulmonology (#303) Re-certified in Pediatric Pulmonology (PRCP-MS) Re-certified in Pediatric Pulmonology (PRCP-MS) 7. Current License to Practice 1983-present Washington (# MD00021155) 8. Professional Organizations National: 1986-88 198619921994-1998 1997- American Academy of Pediatrics American Thoracic Society Pediatric Pulmonary Training Directors Association American Society for Microbiology Society for Pediatric Research PAGE 10 Ronald L. Gibson, Jr., M.D., Ph.D. Local: 198919901990- Washington Thoracic Society Western Society for Pediatric Research Washington Chapter, American Academy of Pediatrics 9. Teaching Responsibilities Medical Students- Interact with 2-3 medical students each week of inpatient service with daily case-based teaching in subspecialty rounds, or in weekly Chest/CF Clinic at CHRMC Residents- Interact closely with 6 residents on the Pulmonary Team and 1-2 additional residents on the pulmonary elective for each week of subspecialty attending (10-12 weeks the past two years). These interactions include cased-based teaching at the bedside and in outpatient clinics, and 1-2 mini-lectures per week of attending. Pediatric Pulmonology Fellows- co-Director of fellowship program with active role in recruitment, curriculum development, evaluation of trainees, and career counseling; Goal of one first-year fellow each year. Graduates of our Pediatric Pulmonology Program (1992-2005): Timothy D. Murphy, M.D. Associate Professor, Univ. of Pittsburgh Margaret Rosenfeld, M.D.,M.P.H. Associate Professor, Univ. of Washington John P. Osborn, M.D. Clinical Assoc. Professor, Univ. of Virginia Sonia K. Budhecha, M.D. Assistant Professor, Univ. of Nevada, Reno Toby S. Lewis, M.D., M.P.H. Assistant Professor, University of Michigan Samuel M. Moskowitz, M.D. Assistant Professor, Univ. of Washington Jason S. Debley, M.D., M. P. H. Assistant Professor, Univ. of Washington Martha McKinney, M.D., M.P.H. Asst. Prof., Queens Univ., Kingston, Ontario Lucas R. Hoffman, M.D., Ph.D. Assistant Professor, Univ. of Washington Danny Hsia, MD Oakland Children’s Hospital DB Sanders, MD, MPH Asst. Prof, University of Wisconsin, Madison 10. Editorial Responsibilities: no editorial boards 11. Special National and Regional Committees/Activities 19921993 1995- 1997 1998-2003 19981998 Member, Pediatric Pulmonary Training Directors Association (PEPTDA) Member, Committee to Review the Uniformed Services Pediatric Seminar Scientific Awards Competition for the Andrew Margileth Award Coordinator/Moderator for Regional, Quarterly CF Clinical Conferences including the University of Washington Adult Program, Spokane Affiliate Program, Tacoma Affiliate Program, Anchorage Affiliate Program, and Invitees from the University of Oregon and British Columbia Site Visit to Affiliate CF Program in Spokane, WA Member, Steering Committee for the Cystic Fibrosis Therapeutic Development Center Network Member, Pediatric Planning Committee for the Cystic Fibrosis Foundation (CFF) Therapeutic Development Center Network (TDN) Member, PEPTDA Workforce and Recruitment Subcommittee PAGE 10 Ronald L. Gibson, Jr., M.D., Ph.D. 1998 1998 1997 1998 1998 1999 1998 1999 1999 2000 2000 2000 20002001 20012001 2002 2002-04 2002 20022003 2004-2007 2004 2004 20042004- Chairperson, Committee to develop Standard Operating Procedure for Spirometry within the Cystic Fibrosis Foundation Therapeutic Development Network (TDN) Member, Committee to develop a Standard Operating Procedure for Nasal Potential Difference Measurements within the CFF TDN Member, Data Safety Monitoring Committee for Intrabiotics-367 Multicenter Phase I Study Speaker/Panelist at Roundtable Discussion on Guidelines for Assessing Affiliate CF Centers at the 1998 North American CF Foundation Meeting Member, Committee to Review the Uniformed Services Pediatric Seminar Scientific Awards Competition for the Andrew Margileth Award Site Visit to Affiliate CF Program in Anchorage, Alaska Visiting Professor, University of California, San Diego, including Grand Rounds at Children’s Hospital, San Diego entitled “Cystic Fibrosis: Pathophysiology and Update on Treatment” Invited Speaker for Post-Graduate Symposium on Aerosolized Antibiotics at the American Thoracic Society International Meeting Roundtable Discussion Leader on Aerosolized Antibiotics in Cystic Fibrosis at the 1999 International North American Cystic Fibrosis Foundation Meeting Site Visit to Affiliate CF Program in Spokane, WA Chairperson, Committee on Early Interventions in Cystic Fibrosis, Northwest Cystic Fibrosis Consortium, Epidemiologic Study in Cystic Fibrosis (Genentech) Invited to Cystic Fibrosis Foundation Williamsburg Conference Member, Cystic Fibrosis Foundation (CFF) Clinical Research Committee for National Review of Research Grants Invited Speaker at American Thoracic Conference, “Impact of Early Antibiotic Treatment in Young Children with Cystic Fibrosis” Member, CFF-TDN Committee to Establish Quality Control Standards for Pulmonary Function Testing Member, CFF-TDN Task Force for Re-Structuring of the Therapeutics Development Network Member, Nominating Committee for Pediatric Pulmonary Training Directors Association Officers Member, Steering Committee on Joint Project between the CFF and Proteome Systems (Australia) Invited Speaker at the 2002 European CF Conference in Genoa, Italy, “Tobramycin Solution for Inhalation in Young Children with CF: Eradication of Lower Airway Pseudomonas” Member, Protocol Development Committee for the CF Therapeutics Development Network Invited Speaker, “Pseudomonas Summit”, Cystic Fibrosis Foundation, Bethesda, MD Member, Steering Committee for the Cystic Fibrosis Therapeutic Development Center Network Invited Speaker at the 2004 European CF Conference in Birmingham, England “Early Intervention Strategies in CF Lung Disease” Member, National Committee to Develop Educational Slide Set on Early Intervention in Cystic Fibrosis Member, International CF Foundation Antimicrobial Task Force for Drug Development Member, Steering Committee, Early Pseudomonal Infection Control Study PAGE 10 Ronald L. Gibson, Jr., M.D., Ph.D. 20042006 2007-2008 2007 2008 Chair, Publications & Presentations Committee, Early Pseudomonal Infection Control Study Faculty for CF Foundation-sponsored national training course on GCP Clinical Research at 2006 North American CF Conference Selected Site in Cystic Fibrosis (CF) Foundation Leadership & Learning Collaborative V-National Continuous Quality Improvement Project to Improve Pulmonary Outcomes in CF Co-Chairperson, Pseudomonas Workshop, Williamsburg Cystic Fibrosis Conference Workshop Leader, International Consensus Conference on Pseudomonas Serology in CF, Bethesda, MD 12. Special Local Responsibilities/Committees 19881988-1990 1989 1989 1990-2005 1990 1991-2001 1991 1991 199219921992 1993-5 1993 1994 1994 1994-95 1995 1995 1995 1996 1996 1996 1996-1998 University of Washington Pediatric Housestaff Selection-interviewer University of Washington Pediatric Intern Selection Committee WAMI Visiting Professor, Sacred Heart Medical Center, Spokane, Washington WAMI Visiting Professor, Yakima Pediatric Associates, Yakima, Washington Associate Director, Pediatric Pulmonary Center Training Grant (MCH #539167) WAMI Visiting Professor, Yakima Pediatric Associates, Yakima, Washington Pharmacy and Therapeutics Committee, Children's Hospital & Medical Center, Seattle, Washington Pediatric Grand Rounds at Children’s Hospital & Regional Medical Center: Update on Bronchopulmonary Dysplasia WAMI Visiting Professor, Yakima Pediatric Associates, Yakima, Washington Co-Director, Pediatric Pulmonary Fellowship Program, University of Washington School of Medicine, Seattle, Washington Co-Director, Pediatric Pulmonology Weekly Journal Club, Children's Hospital & Regional Medical Center, Seattle, Washington WAMI Visiting Professor, Yakima Pediatric Associates, Yakima, Washington PMD Representative to Virginia Mason, South, Children's Hospital & Medical Center, Seattle, Washington WAMI Visiting Professor, Yakima Pediatric Associates, Yakima, Washington Chairman, Asthma Clinical Care Pathway, Children's Hospital & Medical Center, Seattle, Washington WAMI Visiting Professor, Yakima Pediatric Associates, Yakima, Washington POD C Outpatient Clinics Workgroup, Committee Member, Children's Hospital & Medical Center, Seattle, Washington Pediatric Grand Rounds at Children’s Hospital & Regional Medical Center: Review of Asthma Clinical Pathway Speaker at Parent’s Day Educational Conference on Cystic Fibrosis WAMI Visiting Professor, Yakima Pediatric Associates, Yakima, Washington and Toppenish Farm Workers Clinic/Providence Hospital, Toppenish, Washington Chairman, Asthma Clinical Care Pathway Revision I, Children’s Hospital & Medical Center, Seattle, WA Member, Laboratory Space Committee for the Department of Pediatrics, University of Washington School of Medicine, Seattle, WA WAMI Visiting Professor, Yakima Pediatric Associates, Yakima, Washington and Toppenish Farm Workers Clinic/Providence Hospital, Toppenish, Washington Associate Director of the Cystic Fibrosis Center, Children’s Hospital & Medical Center, Seattle, Washington PAGE 10 Ronald L. Gibson, Jr., M.D., Ph.D. 19961996 1997 1999 1997 1998 1998 1998 1998 1998- 1998- 1998 19981999 1999 1999 1999 1999 2000 2000 2000 2001 2002 2002 2002 2003 2003 2004 2004 2004 2004 Member, Grand Rounds Steering Committee, Children’s Hospital & Medical Center, Seattle, WA Member, Cardiovascular Surgery Quality Assurance Committee, Children’s Hospital & Medical Center, Seattle, WA Asthma Managed Care Focus Group, Children’s Hospital and Regional Medical Center, Seattle, WA Chairperson, Asthma Clinical Pathway Revision II, Children’s Hospital & Regional Medical Center, Seattle, WA Member of Internal Review Committee for Child & Adolescent Psychiatry Training Program, University of Washington/CHRMC, Seattle, WA Speaker at Parent’s Day Educational Conference on Cystic Fibrosis Team Member for Care Coordination Pilot with Asthma Patients, CHRMC, Seattle, WA Team Member for the Cystic Fibrosis Managed Care Readiness Project, CHRMC, Seattle, WA Acting Director of the Cystic Fibrosis Center, CHRMC, Seattle, WA Center Director, Pediatric Program Director for the Cystic Fibrosis Center, University of Washington, Children’s Hospital & Regional Medical Center, Seattle, WA Director/Moderator of CF Center Quarterly Regional Conferences on Clinical Care- includes Pediatric CF Center at CHRMC, Adult CF Program at UWMC, Affiliate CF Programs at Mary Bridge in Tacoma, WA, Deaconess Hospital in Spokane, WA, and invitees from Kaiser in Portland, OR and CF Centers in Victoria and Vancouver, BC, Canada. Chairperson, Cystic Fibrosis Clinical Pathway Revision Committee, CHRMC, Seattle, WA Local Spokesperson for Great Strides Fundraiser for Cystic Fibrosis Speaker at Parent’s Day Educational Conference on Cystic Fibrosis Member, Asthma Clinical Pathway Revision Committee, CHRMC, Seattle, WA CHRMC Quarterly Curbstone Consult: Chronic Cough (Editor, Dr. S. Dassel) Chairperson, CHRMC Pharmacy & Therapeutics Subcommittee for Palivizumab (Synagis) Guidelines Speaker at 19th Annual F. Richard Dion Pediatric Update, Seattle, WA: Asthma Speaker at Parent’s Day Educational Conference on Cystic Fibrosis WWAMI Visiting Professor, Peninsula Children’s Clinic, Port Angeles, WA CHRMC Quarterly Curbstone Consult: Asthma Pathway (Editor: Dr. S. Dassel) Speaker at Parent Day Educational Conference on Cystic Fibrosis Site Visit to Affiliate CF Center, Anchorage, Alaska Invited Speaker at Puget Sound Allergy & Asthma Society Meeting: Update on the Diagnosis and Management of CF Speaker at CF Regional Quarterly Conference: Macrolides and CF Site Visit to Affiliate CF Center, Spokane, Washington Speaker, CF Quarterly Regional Conference: Early Intervention for Pseudomonas in Children with CF Member, Inpatient Medicine Project Subcommittee on Education WWAMI Visiting Professor, Yakima Pediatric Associates, Yakima, WA and Toppenish Farm Workers Clinic/Providence Hospital, Toppenish, WA Member, Cystic Fibrosis Research Faculty Search Committee, Department of Pediatrics/CHRMC (Chair: B. Ramsey) Member, Neonatal Research Faculty Search Committee (Chair: D. Woodrum), Department of Pediatrics, University of Washington School of Medicine PAGE 10 Ronald L. Gibson, Jr., M.D., Ph.D. 2004 2005 2005 20052005-2007 200620062006 2006 2006 2006-8 2007 2007 20072007 2007-9 2008 2008 2008 20082008 20082009 Member, Institutional Review Board Forms Committee, CHRMC, Seattle, WA Speaker at Parent’s Day Educational Conference on Cystic Fibrosis Speaker at CF Quarterly Regional CF Conference: Hypertonic Saline in CF Director, Pediatric Pulmonary Fellowship Program, University of Washington School of Medicine, Seattle, Washington Member, Scholarship Oversight Committee for Pediatric Critical Care Fellow, Iain Asplin, MD, PhD Member, CUMG Physician Education, Billing, and Compliance Committee Member, Human Subject Protection Program Advisory Committee, CHRMC WWAMI Visiting Professor, Pocatello Children & Adolescent Clinic, Pocatello, ID, and St. Luke’s Regional Medical Center, Boise, ID (3-day trip) Panel Member, R2 Pediatric Retreat on Academic Career Options Scientist/Poster Presenter at CHRMC Centennial Kick-off Research Event Ad hoc member, Scholarship Oversight Committee, Danny Hsia, MD Invited Speaker at 7th Annual Madigan Pediatric Update Conference: Update on the Treatment of CF Lung Disease. Speaker at Parent’s Day Educational Conference on Cystic Fibrosis Member, Steering Committee, Center for Clinical and Translational Research, Seattle Children’s Hospital Research Institute Presentation of the CHRMC Cystic Fibrosis Center Quality Improvement Program to the CHRMC Board Ad hoc member, Scholarship Oversight Committee, DB Sanders, MD WWAMI Visiting Professor, Peninsula Children’s Clinic, Port Angeles, WA Participant in Medical Ward Team Configuration Meeting, CHRMC Member, Review Committee for the Center for Clinical and Translational Research Mentored Scientist Program, Seattle Children’s Hospital Member, Recruitment Subcommittee for the Center for Clinical and Translational Research, Seattle Children’s Hospital Case Presenter at Sconyers/Godfrey Ethics Grand Rounds, CHRMC Member, Appointments and Promotions Committee, Depart ment of Pediatrics, University of Washington School of Medicine Speaker, CF Parent Education Day 13. Research Funding Name of Individual: Ronald L. Gibson, MD, PhD ACTIVE (Renewable annually) Project Number: C117-04 Dates of Current Project: 7/1/08-6/30/09 Principal Investigator: Ronald L. Gibson, MD, PhD Percent Effort: 15% Source: Cystic Fibrosis Foundation Direct Costs: $230,322 Title of Project: Cystic Fibrosis Center Grant Major goals this project: Funding for ongoing support of the Cystic Fibrosis Clinical Center. Name of Individual: Ronald L. Gibson, MD, PhD ACTIVE Project Number: GIBSON98Y0 Dates of Entire Project: 4/1/09-3/31/14 Principal Investigator: Ronald L. Gibson, MD, PhD Percent Effort: 10% Source: Cystic Fibrosis Foundation Current Direct Costs: $200,000 Title of Project: Translational Therapeutic Development Center Major goals of this project: To develop and conduct Phase I/II clinical trials in cystic fibrosis related research as part of the Cystic Fibrosis Foundation's Therapeutic Development Network. Name of Individual: Ronald L. Gibson, MD, PhD PAGE 10 Ronald L. Gibson, Jr., M.D., Ph.D. Role: Co-Investigator, Director of Clinical Core for Research Development Program ACTIVE Project Number: R565 Dates of Project: 10/1/08-9/30/09 Principal Investigator: E. Peter Greenberg, PhD Percent Effort: 5% Source: Cystic Fibrosis Foundation Direct Costs: $42,000 Title of Project: Molecular Biology of Cystic Fibrosis: Clinical Core Major goals of this project: To provide a national resource for development of well-designed clinical investigations in patients with CF and to foster collaboration with basic scientists to promote pilot studies by providing patient specimens or clinical data. Name of Individual: Ronald L. Gibson, MD, PhD Role: Co-Investigator Project Number: BURN03A0 Dates of Project: 6/1/04-12/31/07 Principal Investigator: Jane Burns, MD Percent Effort: 3% Source: Cystic Fibrosis Foundation Direct Costs: $228,355 Title of Project: Standard versus Biofilm Susceptibility Testing in Cystic Fibrosis Major goals of this project: To compare the microbiological efficacy, clinical efficacy, and safety of using standard versus biofilm susceptibility testing of P.aeruginosa sputum isolates to guide antibiotic selection of airway infection in clinically stable patients with CF. Name of Individual: Ronald L. Gibson, MD, PhD Role: Co-Principal Investigator Dates of Project: 4/1/09-3/30/14 Percent Effort: 15% Source: Cystic Fibrosis Foundation Direct Costs: $1,328,747 Title of Project: EPIC Observational Study Major goals of this project: A large, multicenter, prospective, descriptive study of the risk factors for and outcomes associated with initial acquisition of Pseudomonas aeruginosa as well as outcomes associated with therapy among CF patients 1 to 12 years of age. GIBSON07K0 (Gibson – PI) 9/1/07 – 8/31/09 Cystic Fibrosis Foundation Percent Effort: 5%; Direct Costs: $650,000 DNA Collections for Gene Modifier Studies The goal of this project is to collect DNA samples from children with cystic fibrosis (CF) who are currently participating in the Early Pseudomonas Infection Control (EPIC) Role: PI CURRENT ADDITIONAL CLINICAL STUDIES: Percent Effort: 10% Sponsor: Cystic Fibrosis Foundation Title of Study: Quality of Life in Adults and Adolescents with Severe Cystic Fibrosis Sponsor: NIH/John Hopkins University Title of Study: Genetic Modifiers of Cystic Fibrosis (CF Twin/Sibling Study) Sponsor: Corus Pharma, Inc. Title of Study: CP-AI-006 - A Phase 3, Open-label, Follow-on Study of Multiple Courses of Aztreonam Lysinate for Inhalation (AI) in Cystic Fibrosis Patients (AIR-CF3) Sponsor: Inspire Pharmaceuticals Title of Study: A Phase 3, Double-Blind, Multicenter, Multinational, Randomized, PlaceboControlled Trial Evaluating Denusoful in Patients with Cystic Fibrosis PAGE 10 Ronald L. Gibson, Jr., M.D., Ph.D. 14. Bibliography a) Peer-Reviewed Publications 1. Gibson, R, Leavitt, R, Kornfeld, S, and Schlesinger, S: Synthesis and infectivity of vesicular stomatitis virus containing nonglycosylated G protein. Cell 13:671679, 1978. 2. Gibson, R, Schlesinger, S, and Kornfeld, S: The nonglycosylated glycoprotein of vesicular stomatitis virus is temperature sensitive and undergoes intracellular aggregation at elevated temperatures. J. Biol. Chem. 254:3600-3607, 1979. 3. Li, E, Gibson, R, and Kornfeld, S: Structure of an unusual complex-type oligosaccharide isolated from Chinese hamster cells. Arch. Biochem. Biophys. 199:393-399, 1980. 4. Gibson, R, Kornfeld, S, and Schlesinger, S: A role for oligosaccharides in glycoprotein biosynthesis. TIBS 5:290-293, 1980. 5. Gibson, R, Kornfeld, S, and Schlesinger, S: The effect of oligosaccharide chains of different sizes on the maturation and physical properties of the G protein of vesicular stomatitis virus. J. Biol. Chem. 256:456-462, 1981. 6. Gibson, RL, Truog, WE, and Redding, GJ: Hypoxic pulmonary vasoconstriction during and following infusion of group B streptococcus in neonatal piglets: vascular pressure-flow analysis. Am. Rev. Respir. Dis.137:774-778, 1988. 7. Gibson, RL, Truog, WE, and Redding, GJ: Thromboxane-associated pulmonary hypertension during three types of gram-positive bacteremia in piglets. Pediatr. Res., 23:553-556, 1988. 8. Truog, WE, Gibson, RL, Juul, SE, Henderson, WR, and Redding, GJ: Neonatal group B streptococcal sepsis: Effects of late treatment with dazmegrel. Pediatr. Res., 23:352-356, 1988. 9. Gibson, RL, Jackson, JC, Twiggs, GA, Redding, GJ, and Truog, WE: Bronchopulmonary dysplasia: survival after prolonged mechanical ventilation. Am. J. Dis. Child., 142:721-725, 1988. 10. Redding, GJ, Gibson, RL, Davis, CB, and Truog, WE: Effects of respiratory alkalosis on thromboxane-induced pulmonary hypertension in piglets. Pediatr. Res., 24(5):558-562, 1988. 11. Gibson, RL, Redding, GJ, Truog, WE, Henderson, WR, and Rubens, CE: Isogenic group B streptococci devoid of capsular polysaccharide or β-hemolysin: pulmonary hemodynamic and gas exchange effects during bacteremia in piglets. Pediatr. Res., 26(3):241-245, 1989. PAGE 10 Ronald L. Gibson, Jr., M.D., Ph.D. 12. Redding, GJ, Gibson, RL, Standaert TA, Truog, WE: Regional pulmonary blood flow in piglets during group B streptococcal bacteremia. Am. Rev. Respir. Dis. 141:1209-1213, 1990. 13. Truog, WE, Gibson, RL, Henderson, WR, Redding, GJ: Tumor necrosis factorinduced neonatal pulmonary hypertension: effects of dazmegrel pre-treatment. Pediatr. Res. 27(5):466-471, 1990. PAGE 10 Ronald L. Gibson, Jr., M.D., Ph.D. 14. Redding, GJ, Walund, L, Walund, D, Jones, JW, Stamey, DC, and Gibson, RL: Lung function in children following empyema: influence of pleural drainage. Amer. J. Dis. Child. 144:1337-1342, 1990. 15. Gibson, RL, Redding, GJ, Henderson, WR, Truog, WE: Group B streptococcus induces tumor necrosis factor (TNF) in neonatal piglets: effect of the TNF inhibitor, pentoxifylline on hemodynamics and gas exchange. Am. Rev. Respir. Dis. 143:598-604, 1991. 16. Ramsey, B, Wentz, K, Smith, A, Richardson, M, Williams-Warren, J, Hedges, D, Gibson, R, Redding, GJ: Predictive value of oropharyngeal cultures for identifying lower airway bacteria in cystic fibrosis. Am. Rev. Respir. Dis., 144:331-337, 1991. 17. Standaert, TA, Willham, BE, Mayock, DE, Watchko, JF, Gibson, RL, Woodrum, DE: Respiratory mechanics of the piglet during the first month of life. Pediatr. Pulm. 11:294-301, 1991. 18. Truog, WE, Gibson, RL, Henderson, WR, Redding, GJ, Standaert, TA: Effect of pentoxifylline on cytokine and eicosanoid induced acute pulmonary hypertension in piglets. Pediatric Res. 31(2):163-169, 1992. 19. Gibson, RL, Truog, WE, Henderson, WR, Redding, GJ: Group B streptococcal sepsis in piglets: effect of combined pentoxifylline and indomethacin pretreatment. Pediatr. Res. 31(3):222-227, 1992. 20. Murphy, TD, Mayock, DE, Standaert, TA, Gibson, RL, Woodrum, DE: Group B streptococcus has no effect on piglet diaphragmatic force generation. Am. Rev. Resp. Dis. 145:471-475, 1992. 21. Gibson, RL, Lee, MK, Soderland, C, Chi, EY, Rubens, CE: Group B streptococci invade endothelial cells: type III capsular polysaccharide attenuates invasion. Infection & Immunity, 61(2):478-485, 1993. 22. Murphy, TD, Gibson, RL, Standaert, TA, Mayock, DE, Woodrum, DE: Effect of group B streptococcal sepsis on diaphragmatic function in young piglets. Pediatr. Res. 33(1):10-14, 1993. 23. Berger, JI, Gibson, RL, Redding, GJ, Standaert, TA, Clarke, WR, Truog, WE: Effect of inhaled nitric oxide during group B streptococcal sepsis in piglets. Amer. Rev. Respir. Dis. 147:1080-1086, 1993. 24. Ramsey, BW, Astley, SJ, Aitken, MR, Burke, W, Colin, AA, Dorkin, HL, Eisenberg, JD, Gibson, RL, et al.: Efficacy and safety of short term administration of aerosolized recombinant human deoxyribonuclease in patients with cystic fibrosis (CF). Amer. Rev. Respir. Dis. 148:145-151, 1993. 25. Ramsey, BW, Dorkin, HL, Eisenberg, JD, Gibson, RL, Harwood, IR, Kravitz, RM, Schidlow, DV, Wilmott, RW, Astley, SJ, McBurnie, MA, Wentz, K, Smith, AL: The efficacy of high dose tobramycin aerosol administration in patients with cystic fibrosis. N. Engl. J. Med. 328(24):1740-1746, 1993. PAGE 10 Ronald L. Gibson, Jr., M.D., Ph.D. 26. Berger, JI, Gibson, RL, Clarke, WR, Standaert, TA, Redding, GJ, Henderson, WR, Truog, WE: Effect of amrinone during group B streptococcus induced pulmonary hypertension in piglets. Peds Pulmonol 16(5):303-310, 1993. PAGE 10 Ronald L. Gibson, Jr., M.D., Ph.D. 27. Gibson, RL, Davis, CB, Standaert, TA, Truog, WE, Redding, GJ: Lung vascular responses and EQ \O(V,_) A/ EQ \O(Q,_) matching after chronic hypoxia in neonatal piglets. J. Develop. Physiol. 19(4):157-163, 1993. 28. Fuchs, HJ, Borowitz, DS, Christiansen, DH, et al. and the Pulmozyme Study Group (RL Gibson, member): Effect of aerosolized recombinant human DNase on exacerbations of respiratory symptoms and on pulmonary function in patients with cystic fibrosis. N. Engl. J. Med. 331:637-742, 1994. 29. Gibson, RL, Berger, JI, Redding, GJ, Standaert, TA, Mayock, DE, Truog, WE: Effect of nitric oxide synthase inhibition during group B streptococcal sepsis in neonatal piglets. Pediatr Res 36: 776-783, 1994. 30. Murphy, TD, Gibson, RL, Standaert, TA, Woodrum, DE: Diaphragmatic failure during group B streptococcal sepsis in piglets: the role of thromboxane A 2. J Appl Physiol 78 (2): 491-498, 1995. 31. Gibson, RL, Soderland, C, Henderson, WR, Chi, EY, Rubens, CE: Group B streptococci injure lung endothelium in vitro: increased invasion and eicosanoid production with microvascular compared to pulmonary artery cells. Infect Immun 63:271-279, 1995. 32. Juul, SE, Kinsella MG, Truog WE, Gibson RL, Redding GJ. Lung hyaluronan decreases during group B streptococcal pneumonia in neonatal piglets. Amer J Respir Crit Care Med 153: 1567-70, 1996. 33. Zabner J, Ramsey BW, Meeker DP, Aitken ML, Balfour RP, Gibson RL, Launspach J, Moscicki RA, Richards SM, Standaert TA, Williams-Warren J, Wadsworth SC, Smith AE, Welsh MJ. Repeat administration of an adenovirus vector encoding CFTR to the nasal epithelium of patients with cystic fibrosis. J Clin Invest 97 (6): 1504-11, 1996. 34. Nizet V, Gibson RL, Chi EY, Framson PE, Hulse M, Rubens CE. Group B streptococcal β-hemolysin expression is associated with injury to lung epithelial cells. Infect Immun 64(9): 3818-3826, 1996. 35. Nizet V, Gibson RL, Rubens CE. The role of group B streptococci betahemolysin expression in newborn lung injury. Adv Exp Med Biol 418:627-630, 1997. 36. Gibson RL, Nizet VF, Rubens CE. Group B streptococcal β-hemolysin promotes injury of lung microvascular endothelial cells. Pediatric Research 45:626-634, 1999. 37. Burns JL, Gibson RL, McNamara S, Yim D, Emerson J, Rosenfeld M, Hiatt P, McCoy K, Castile R, Smith AL, Ramsey BW. Longitudinal assessment of Pseudomonas aeruginosa in infants with cystic fibrosis. Journal of Infectious Diseases 183: 444-52, 2001. 38. Noone PG, Hamblett N, Accurso F, Aitken M, Boyle M, Dovey M, Gibson R, Johnson C, Kellerman D, Konstan M, Milgram L, Mundahl J, Rodman D, PAGE 10 Ronald L. Gibson, Jr., M.D., Ph.D. Williams-Warren J, Wilmott R, Zeitlin P, Ramsey R. Safety of aerosolized INS 365 in patients with mild to moderate cystic fibrosis: results of a phase I multicenter trial. Pediatric Pulmonology 32: 122-8, 2001. 39. Rosenfeld M, Gibson RL, McNamara S, Emerson J, McCoy K, Schell R, Borowitz D, Konstan M, Retsch-Bogart G, Wilmott R, Burns JL, Ramsey B. Serum and lower respiratory tract drug concentrations produced by tobramycin for inhalation in young children with cystic fibrosis. Journal of Pediatrics 139 (4): 572-7, 2001. 40. Rosenfeld M, Gibson RL, McNamara S, Emerson J, Burns JL, Castile R, Hiatt P, McCoy K, Wilson CB, Inglis A, Martin TR, Ramsey, BW. Early pulmonary infection, inflammation, and clinical outcomes in infants with cystic fibrosis. Pediatric Pulmonology 32: 356-366, 2001. 41. Aitken ML, Moss RB, Waltz DA, Dovey ME, Tonelli MR, Gibson RL, Ramsey BW, Carter BJ, Reynolds TC. A Phase I study of aerosolized administration of tgAAVCF to CF subjects with mild lung disease. Human Gene Therapy 12:19071916, 2001. 42. Brogan TV, Finn LS, Pyskaty Jr DJ, Redding GJ, Ricker D, Ingliss A, Gibson RL. Plastic bronchitis in children: a case series and review of the medical literature. Pediatric Pulmonology 34: 482-487, 2002. 43. Conway K, Gibson RL, Perkins J, Cunningham ML. Pulmonary agenesis: expansion of the VCFS phenotype. American Journal of Medical Genetics 113: 89-92, 2002. 44. Emerson J, Rosenfeld M, McNamara S, Ramsey B, Gibson RL. Pseudomonas aeruginosa and other predictors of mortality and morbidity among young children with cystic fibrosis. Pediatric Pulmonology 34:91-100, 2002. 45. Aitken ML, Tonelli MR, Pier MV, Burns JL, Emerson JC, Goss CH, McNamara SC, Gibson RL. Analysis of sequential aliquots of hypertonic saline induced sputum from stable patients with cystic fibrosis. Chest 123:792-799, 2003. 46. Gibson RL, Emerson J, McNamara S, Burns JL, Rosenfeld M, Yunker A, Hamblett N, Accurso F, Dovey M, Hiatt P, Konstan MW, Moss R, RetschBogart G, Wagener J, Waltz D, Wilmott R, Zeitlin PL, Ramsey B, and the CFF Therapeutics Development Network Study Group. A significant microbiologic effect of inhaled tobramycin in young children with cystic fibrosis. Am JResp Crit Care Med 167:841-849, 2003. 47. Cunningham ML, Perry RJ, Eby PR, Gibson RL, Opheim KE, Manning SC. Primary pulmonary dysgenesis in velocardiofacial syndrome: a second patient. American Journal of Medical Genetics 121A:177-9, 2003. 48. Ordoñez CL, Henig NR, Gibson RL, Hamblett N, Accurso FJ, Burns JL, Chmiel JF, Daines C, McNamara S, Retsch-Bogart GZ, Zeitlin PL, Aitken ML. Validation of sputum induction as an outcome measure for lower airway sampling in subjects with cystic fibrosis. American Journal of Respiratory and Critical Care Medicine 168:1471-5, 2003. PAGE 10 Ronald L. Gibson, Jr., M.D., Ph.D. 49. Gibson RL, Burns JL, Ramsey BW. State of the Art: Pathophysiology and management of pulmonary infections in cystic fibrosis. American Journal of Respiratory and Critical Care Medicine 168: 918-951, 2003. 50. Rosenfeld M, Ramsey BW, Gibson RL. Pseudomonas aeruginosa acquisition in young patients with cystic fibrosis: pathophysiology, diagnosis, and management. Current Opinion in Pulmonary Medicine 9(6):492-7, 2003. 51. Moss, RB, Mayer-Hamblett N, Wagener J, Daines C, Hale K, Ahrens R, Gibson RL. et al. A randomized, double-blind, placebo-controlled, dose escalating study of aerosolized interferon (-1b in patients with mild to moderate cystic fibrosis lung disease. Pediatr Pulmonol 39(3):209-218, 2005. 52. Deterding R, Retsch-Bogart G, Milgram L, Gibson RL, et al. Safety and tolerability of Denufosol tetrasodium inhalational solution, a novel P2Y2 receptor agonist: results of a phase 1/phase 2 multi-center study in mild to moderate cystic fibrosis. Pediatr Pulmonol 39(4):339-348, 2005. 53. Moskowitz SM, Gibson RL, Effman E. Cystic fibrosis lung disease: genetic influences, microbial interactions, and radiologic assessment. Pediatr Radiol 35(8):739-757, 2005. 54. Debley JS, Carter ER, Gibson RL, Rosenfeld M, Redding GJ. The prevalence of ibuprofen-sensitive asthma in children: a randomized controlled bronchoprovocation challenge study. J. Pediatr 147:233-8, 2005 55. Kulich M, Rosenfeld M, Campbell J, Kronmall R, Gibson RL, Goss CH, Ramsey BR. Disease-specific reference equations for lung function in patients with cystic fibrosis. Am J Resp Crit Care Med 172:885-91, 2005. 56. Hoffman LR, Yen E, Van Niel C, Effman, E, Gibson RL. Lipoid pneumonia due to Mexican folk remedies: cultural barriers to diagnosis. Arch Pediatr Adolesc Med 159(11):1043-8, 2005. 57. Moskowitz SM, Foster JM, Emerson JC, Gibson RL, Burns JL. Use of Pseudomonas biofilm susceptibilities to assign simulated antibiotic regimens for cystic fibrosis airway infection. J Antimicrob Chemother 56(5):879-886, 2005. 58. Halbert CL, Miller AD, McNamara S, Emerson J, Gibson RL, Ramsey B, Aitken ML. Prevalence of Neutralizing Antibodies to Adeno-associated Virus Types 2, 5 and 6 in Cystic Fibrosis and Normal Populations: Implication for Gene Therapy using AAV Vectors. Human Gene Therapy 17(4):440-7, 2006. 59. Gibson RL, Retsch-Bogart G, Oermann C, Milla C, Pilewski J, Daines C, Ahrens R, Leon K, Cohen M, McNamara S, Callahan TL, Markus R, Burns JL. Microbiology, safety, and pharmacokinetics of aztreonam lysinate for inhalation in patients with cystic fibrosis. Pediatr Pulmonol 41:656-665, 2006. 60. Hoffman LR, Deziel E, D’Argenio DA, Lepine F, Emerson J, McNamara S, Gibson RL, Ramsey BW, Miller SI. Selection for Staphylococcus aureus small-colony variants due to growth in the presence of Pseudomonas aeruginosa. Proc Natl PAGE 10 Ronald L. Gibson, Jr., M.D., Ph.D. Acad Sci USA 103(52): 19890-5, 2006. 61. Hentschel-Franks K, Bebok Z, Rowe SM, Gibson R, Aitken M, Zeitlin P, Berclaz Y, Knowles M, Foy G, Moss R, Oster R, Ramsey B, Sorscher EJ, Bedwell DM, Clancy JP. No detectable improvements in CFTR by nasal aminoglycosides in CF patients with stop mutations. Am J Resp Cell Mol Biol 37(1):57-66, 2007. 62. Gibson RL, Emerson J, Mayer-Hamblett N, Burns JL, McNamara S, Accurso FJ, Konstan MW, Chatfield BA, Retsch-Bogart GZ, Waltz DA, Acton J, Zeitlin P, Hiatt P, Moss R, Williams J, and Ramsey BW for the Inhaled Tobramycin in Young Children Study Group and the Cystic Fibrosis Foundation Therapeutics Development Network. Duration of treatment effect after tobramycin solution for inhalation in young children with cystic fibrosis. Pediatr Pulmonol 42(7):610-23, 2007. 63. Treggiari M, Rosenfeld M, Retsch-Bogart G, Gibson R, Ramsey B and the EPIC Clinical Trial Group. Approach to eradication of initial Pseudomonas aeruginosa in children with cystic fibrosis. Pediatr Pulmonol, 42(9): 751-6, 2007. 64. Dovey M, Aitken ML, Emerson J, McNamara S, Waltz DA, Gibson RL. Oral corticosteroid therapy in cystic fibrosis patients hospitalized for pulmonary exacerbations: a pilot study. Chest 132:1212-8, 2007. 65. Veenstra DL, Harris J, Gibson RL, Rosenfeld M, Burke W, Watts C. Pharmacogenomic testing to prevent aminoglycoside-induced hearing loss in cystic fibrosis patients: potential impact on clinical, patient and economic outcomes. Genetics in Medicine 9(10):695-704, 2007. 66. Retsch-Bogart GZ, Burns JL, Otto KL, Liou TG, McCoy K, Oermann C, Gibson RL. A phase 2 study of aztreonam lysine for inhalation to treat patients with cystic fibrosis and Pseudomonas aeruginosa Infection. Pediatr Pulmonol 43(1): 47-58, 2008. 67. McCoy KS, Quittner AL, Oermann CM, Gibson RL, Retsch-Bogart GZ, Montgomery AB. Inhaled aztreonam lysine is effective in intensely-treated patients with cystic fibrosis. Am J Resp Crit Care Med 178(9): 921-8, 2008. 68. Moskowitz SM, Chmiel JF, Sternen DL, Cheng E, Gibson RL, Marshall SG, Cutting GR. Clinical practice and genetic counseling for cystic fibrosis and CFTRrelated disorders. Genetics in Medicine 10(12): 851-68, 2008. 69. Sagel SD, Gibson RL, Emerson J, McNamara S, Burns JL, Wagener JS, Ramsey BW. Impact of Pseudomonas and polymicrobial infection on inflammation and clinical status in young children with cystic fibrosis. J Pediatr 154(2): 183-8, 2009. 70. Retsch-Bogart GZ, Quittner AL, Gibson RL, Oermann CM, McCoy KS, Montgomery AB, Cooper PJ. Efficacy and safety of inhaled aztreonam lysine for airway Pseudomonas in cystic fibrosis. Chest, in press, 2009. 71. Treggiari MM, Rosenfeld M, Retsch-Bogart G, Gibson RL, Mayer-Hamblet N, Williams J, Emerson J, Kronmal R, Ramsey B for the EPIC Study Group. Early PAGE 10 Ronald L. Gibson, Jr., M.D., Ph.D. Anti-Pseudomonal Intervention in Young Patients with Cystic Fibrosis (EPIC): Rationale and Design of the Clinical Trial and Observational Study. Contemporary Clinical Trials, in press, 2009. b) Book Chapters 1. Schlesinger, S, and Gibson, R: A role for oligosaccharide in the synthesis of the G protein of vesicular stomatitis virus. In: The replication of negative strand viruses. DHL Bishop and RW Compans (eds.), Elsevier North Holland, Inc., pp. 665-672, 1981. 2. Nizet, V, Gibson RL, Rubens CE. The role of GBS β-hemolysin expression in newborn lung injury. In: Streptococci and the Host. T Horaud, M Sicard, A Bouvet, R Lelerq, H DeMontclos (eds) Plenum Publishing Co., New York, pp 627-629, 1997. 3. Tait J, Gibson RL, Marshall SG, Sternen DL, Cheng E, Cutting G. Cystic Fibrosis. In: Gene Clinics: Medical Genetics Information Resource [database online]. Copyright , University of Washington, Seattle. Available at HYPERLINK http://www.geneclinics.org http://www.geneclinics.org 2001. 4. Moskowitz S, Gibson RL, Sternen DL, Cheng E, Cutting G. CFTR-Related Disorders. In: Gene Clinics: Medical Genetics Information Resource [database online]. Copyright , University of Washington, Seattle. Available at HYPERLINK http://www.geneclinics.org http://www.geneclinics.org , August 2004. 5. Gibson RL. Cystic Fibrosis. In: Pediatrics. L Osborn, T DeWitt, L First, J Zenel (eds). Elsevier Mosby, Philadelphia (pub), pp1198-1207, 2005. d) Other Publications (including being member of a large Study Group)/Book Reviews 1. Gibson, RL. Review of Kendig’s Disorders of the Respiratory Tract in Children, Sixth Edition. Chernick, V, Boat, T (editors). W.B. Saunders, Philadelphia, PA. Doody Review Service ( HYPERLINK http://www.doody.com) http://www.doody.com) . 1997. 2. Gibson, RL. Review of Pediatric Respiratory Medicine. Taussig, L and Landau, L (editors). Mosby, St. Louis, MO. Doody Review Service ( HYPERLINK http://www.doody.com http://www.doody.com ). 1999. 3. Drumm ML, Konstan MW, Schluchter MD, et al, and Knowles MR for the Gene Modifier Study Group (includes Gibson RL). Genetic modifiers of lung disease in cystic fibrosis. N Engl J Med 2005; 353:1443-53. 4. Vanscoy LL, Blackman SM, Collaco JM et al. (Gibson RL was a member of the CF Twin/Sibling Study Group). Heritability of lung disease severity in cystic fibrosis. Am J Respir Crit Care Med 175:1036, 2007. 5. Goss CH, McKone EF, Mathews D, Kerr D, Wanger JS, Millard SP; Cystic Fibrosis Therapeutics Development Network (Gibson RL was one of 14 collaborators). Experience using centralized spirometry in the phase 2 PAGE 10 Ronald L. Gibson, Jr., M.D., Ph.D. randomized, placebo-controlled, double-blind trial of denufosol in patients with mild to moderate cystic fibrosis. J Cystic Fibrosis 7(2):147-53, 2008. PAGE 10 Ronald L. Gibson, Jr., M.D., Ph.D. e) Submitted Manuscripts 1. McCoy K, Retsch-Bogart G, Gibson RL, Oermann C, Braff M, Montgomery AB. Relevance of established susceptibility breakpoints in predicting clinical efficacy of inhaled antibiotics therapies in cystic fibrosis. Re-submit to Antimicrobial Agents and Chemotherapy, February 2009. 2. Sanders DB, Hoffman LR, Emerson J, Gibson RL, Rosenfeld M, Redding GJ, Goss CH. Return of FEV1 after Pulmonary Exacerbation in Children with Cystic Fibrosis. Submitted, March 2009. 3. Rosenfeld M, Emerson J, McNamara S, Joubran K, Morgan W, and Gibson RL for the EPIC Study Group. Early Pseudomonas Infection Control Observational Study: Baseline Report. Submitted, March 2009. f) Abstracts 1. Zitomer, RS, Gibson, RL, and Hall, BD: In vitro translation of cytochrome mRNA. Presented. Cold Spring Harbor Symposium: The Molecular Biology of Yeast, page 28, 1975. 2. Gibson, RL, Schlesinger, S, and Kornfeld, S: The nonglycosylated glycoprotein of VSV is temperature-sensitive and undergoes aggregation at elevated temperatures. Presented 8th Annual ICN-UCLA Symposia on Molecular and Cellular Biology. Journal of Supermolecular Structure, supplement 3, page 96, 1979. 3. Redding, GJ, Gibson, R, Twiggs, G, Standaert, TA, and Truog, WE: Reduced pulmonary blood flow improves gas exchange in newborn piglets. Presented. American Thoracic Society, 1986. Am. Rev. Resp. Dis. 133(4), Part 2:A151, 1986. 4. Gibson, RL and Redding, GJ: Hypoxic pulmonary vasoconstriction persists following infusion of Group B streptococcus in neonatal piglets. J. Critical Care 1(1):32, 1987. 5. Gibson, RL, Truog, WE, and Redding, GJ: Nonspecific thromboxane-mediated pulmonary hypertension in neonatal gram-positive sepsis. Am. Rev. Resp. Dis., 135(4), Part 2:A124, 1987. 6. Redding, GJ, Gibson, RL, Standaert, TA, and Truog, WE: Lobar inflammation produced by zymosan-activated serum increases shunt fraction in piglets with lobar atelectasis. Am. Rev. Resp. Dis., 135(4), Part 2:A124, 1987. 7. Redding, GJ, Gibson, RL, and Truog, WE: Group B streptococcus (GBS) induced pulmonary hypertension does not alter shunt produced by atelectasis in piglets. Am. Rev. Resp. Dis., 135(4), Part 2:123, 1987. 8. Truog, WE, Gibson, RL, Juul, SE, Henderson, W, and Redding, GJ: Neonatal group B streptococcal (GBS) sepsis: Therapeutic implications of thromboxane synthetase (TxA2) inhibition. Pediatr. Res. 21(4), Part 2:468A, 1987. PAGE 10 Ronald L. Gibson, Jr., M.D., Ph.D. 9. Redding, GJ, Gibson, RL, Standaert, TA, and Truog, WE: Effects of hyperventilation upon pulmonary vasoconstriction induced by a thromboxane mimetic in piglets. Presented. American Thoracic Society, 1988. Am. Rev. Respir. Dis. 137(4) Part 2:105, 1988. 10. Standaert, TA, Willham, BE, Mayock, DE, Gibson, RL, and Woodrum, DE: Lung volume and pulmonary compliance of the piglet during the first month of life. Presented. American Thoracic Society, 1988. Am. Rev. Respir. Dis. 137(4) Part 2:382, 1988. 11. Redding, GJ, Davis, CB, Juul, SE, Gibson, RL, Truog, WE: Effects of angiotensin on pulmonary hemodynamics and gas exchange in piglets. Presented. American Thoracic Society. 1989. Am. Rev. Respir. Dis. 139(4), Part 2:A440, 1989. 12. Davis, CB, Gibson, RL, Truog, WE, Redding, GJ: Chronic hypoxia induced changes in the pulmonary hemodynamics of neonatal swine: pressure flow analysis. Presented. American Thoracic Society, 1989. Am. Rev. Respir. Dis. 139(4), Part 2:A437, 1989. PAGE 10 Ronald L. Gibson, Jr., M.D., Ph.D. 13. Gibson, RL, Redding, GJ, Truog, WE, Rubens, CE: A type III group B streptococcus (GBS) mutant devoid of capsular polysaccharide causes pulmonary hypertension and hypoxemia in piglets. Presented. American Thoracic Society, 1989. Am. Rev. Respir. Dis. 139(4), Part 2:A439, 1989. 14. Gibson, RL, Redding, GJ, Truog, WE: Tumor necrosis factor (TNF): potential mediator of neonatal group B streptococcal (GBS) sepsis. Presented. American Thoracic Society, 1989. Am. Rev. Respir. Dis. 139(4), Part 2:A439, 1989. 15. Truog, WE, Gibson, RL, Henderson, WR, Redding, GJ: Tumor necrosis factorinduced neonatal pulmonary hypertension: effects of dazmegrel pretreatment. Presented. Society for Pediatric Research, 1989. Pediatr. Res. 25(4), Part 2:329A, 1989. 16. Redding, GJ, Gibson, RL, Davis, CB, Standaert, TA, Truog, WE: Reduced cardiac output does not alter distribution of pulmonary blood flow to atelectatic lung regions in piglets. Presented. 1990 World Conference on Lung Health -American Thoracic Society. Am. Rev. Respir. Dis. 141(4), Part 2:A740, 1990. 17. Murphy, TD, Standaert, TA, Gibson, RL, Mayock, DE, Woodrum, DE: Group B streptococcal (GBS) sepsis impairs diaphragmatic function in the piglet. Presented. 1990 World Conference on Lung Health -- American Thoracic Society. Am. Rev. Respir. Dis. 141(4), Part 2:A549, 1990. 18. Gibson, RL, Redding, GJ, Henderson, WR, Truog, WE: Combined pentoxifylline and indomethacin pretreatment attenuates early and late features of group B streptococcal sepsis in piglets. Presented. 1990 World Conference on Lung Health -- American Thoracic Society. Am. Rev. Respir. Dis. 141(4), Part 2:A688, 1990. 19. Davis, CB, Gibson, RL, Redding, GJ, Standaert, TA, Truog, WE: Effects of acute and chronic alveolar hypoxia on gas exchange in neonatal swine. Presented. 1990 World Conference on Lung Health -- American Thoracic Society. Am. Rev. Respir. Dis. 141(4), Part 2:A852, 1990. 20. Gibson, RL, Redding, GJ, Truog, WE, Rubens, CE: Neonatal group B streptococcal (GBS) sepsis: the role of GBS capsular polysaccharide in tumor necrosis factor (TNF) production in piglets. Presented. Federation of American Societies for Experimental Biology, 1990. FASEB Journal 4:A355, 1990. 21. Truog, WE, Redding, GJ, Standaert, TA, Gibson, RL: Effect of pentoxifylline on tumor necrosis factor-induced pulmonary hypertension in piglets. Presented. Federation of American Societies for Experimental Biology, 1990. FASEB Journal 4:A573, 1990. 22. Redding, GJ, Gibson, RL, Standaert, TA, Truog, WE: Atelectasis does not inhibit pulmonary inflammation due to experimental streptococcal pneumonia. Am. Rev. Respir. Dis. 143(4), Part 2:A787, 1991. PAGE 10 Ronald L. Gibson, Jr., M.D., Ph.D. 23. Gibson, RL, Truog, WE, Standaert, TA, Redding, GJ, Rubens, CE: Endothelial cell invasion by group B streptococci. Presented. Society for Pediatric Research, 1991. Pediatr. Res. 29(4), Part 2:A281, 1991. PAGE 10 Ronald L. Gibson, Jr., M.D., Ph.D. 24. Murphy, TD, Standaert, TA, Gibson, RL, Mayock, DE, Woodrum, DE: Group B streptococcal shock impairs diaphragmatic contractility in the piglet. Am. Rev. Respir. Dis. 143(4), Part 2:A560, 1991. 25. Berger, JI, Clarke, WR, Gibson, RL, Standaert, TA, Redding, GJ, Truog, WE: Effects of amrinone on pulmonary vascular resistance and V/Q matching during group B streptococcal sepsis in piglets. Presented. Society for Pediatric Research, 1991. Pediatr. Res. 29(4), Part 2:A308, 1991. 26. Murphy, TD, Gibson, RL, Standaert, TA, Mayock, DE, Woodrum, DE: The thromboxane A2 mimetric, U46619, decreases piglet diaphragmatic contractility. Presented. American Thoracic Society, 1992. Am. Rev. Respir. Dis. 145(4) Part 2:A671, 1992. 27. Berger, JI, Gibson, RL, Standaert, TA, Redding, GJ, Clarke, WR, Truog, WE: Effect of inhaled nitric oxide on pulmonary vascular resistance (PVR) during group B streptococcal (GBS) sepsis in piglets. Presented. The Society for Pediatric Research, 1992. Pediatr. Res. 31(4), Part 2:301A, 1992. 28. Berger, JI, Gibson, RL, Redding, GJ, Standaert, TA, Truog, WE: Effect of NωNitro-L-Arginine Methyl Ester (L-NAME) on pulmonary hemodynamics during group B streptococcal (GBS) sepsis in piglets. Presented. Society for Pediatric Research, 1993. Pediatr. Res. 33(4):317A, 1993. 29. Gibson, RL, Soderland, C, Henderson, WR, Rubens, CE: Group B streptococci (GBS) invade lung endothelium in vitro: increased invasion and eicosanoid release from microvascular compared to pulmonary artery cells. Presented. American Thoracic Society, 1993. Amer. Rev. Respir. Dis. 147(4):A132, 1993. 30. Gibson, RL, Soderland, C, Rubens, CE: Specific transposon mutants of group B streptococcus (GBS) cause reduced lung microvascular endothelial cell injury in vitro. Am. J. Resp. Crit Care Med. 149:A294, 1994. 31. Nizet, V, Gibson, RL, Chi EY, Rubens CE. Expression of group B streptococcal hemolysin is associated with alveolar epithelial cell injury. Presented at the American Society of Microbiology, 1995. 32. Gibson, RL, Nizet, V, Rubens CE. Group B streptococcal β-hemolysin contributes to GBS-induced lung microvascular endothelial cell injury in vitro. Presented at the Society for Pediatric Research, 1995. Pediatr Res 37 (4): 291A, 1995. 33. Nizet, V, Gibson, RL , Framson, PE, Chi, EY, Rubens CE. Group B streptococcal hemolysin expression is correlated with epithelial cell injury. Presented at the Society for Pediatric Research 1995. Pediatr Res 37 (4): 296A, 1995. 34. Nizet, V, Gibson, RL, Rubens, CE. Group B β-hemolysin expression and injury of newborn lung. Presented at the Society for Pediatric Research May 1996 (abstract 15410). PAGE 10 Ronald L. Gibson, Jr., M.D., Ph.D. 35. Nizet, V, Gibson, RL, Rubens, CE. The role of GBS β-hemolysin expression in newborn lung injury. Presented at the XIIIth International Lancefield Society Meeting, Paris, France, Abstact # P109, 1996. 36. Ramsey, B., McNamara,S, Gibson, R, Emerson, J, Rosenfeld, M, Hiatt, P, McConnell, R, McKoy, K, Lawrence C, Olson, P. P. aeruginosa colonization in young children with cystic fibrosis. Pediatr Pulmonol, Supplement 17: page 320 (abstract #415), 1998. 37. Rosenfeld, M, Borowitz, D, Emerson, J, Gibson, R. Ingham, L, McCoy, K, McNamara, S. Montgomery, B, Ramsey, B, Vicini ,P, Wilmott, B. Safety and serum pharmacokinetics of inhaled tobramycin in very young CF patients. Presented at the 1999 North American Cystic Fibrosis Meeting. Pediatr Pulmonol, supplement 19, page 262 (abstract #346), 1999. 38. Lewis, TC, Rosenfeld M, Gibson, RL, Ramsey, BW. Urban/Rural differences in specialty health care utilization and health outcomes in cystic fibrosis. Presented at the 1999 North American Cystic Fibrosis Meeting. Pediatr Pulmonol, Supplement 19, page 337 (abstract #600), 1999. 39. Moss, R, Kylstra, J, Gibson, RL. Who benefits more? An analysis of FEV1 and weight in adolescent CF patients using inhaled tobramycin. Presented at the 1999 North American Cystic Fibrosis Meeting. Pediatr Pulmonol, Supplement 19, page 243 (abstract #279), 1999. 40. Noone, PG, Accurso FJ, Aitken M, Dovey M, Gibson, RL, Konstan M, Rodman, DM, Wilmott R, Zeitlin P, Gorden J, Shaffer C. Safety of aerosolized INS365 in patients with mild to moderate CF: results of a multi-center therapeutic development network study. Pediatr Pulmonol, Supplement 19, page 244 (abstract # 283), 1999. 41. Aitken, ML, Moss, RB, Waltz, DA, Dovey, ME, Tonelli, MR, Gibson, RL, Ramsey, BW, Carter, BJ, Reynolds, TC. A Phase I study of aerosolized administration of tgAAVCF to CF patients with mild lung disease. Pediatr Pulmonol, Supplement 20, page 236, abstract # 226, 2000. 42. Rosenfeld M, Gibson RL, McNamara S, Emerson J, Burns JL, Castille R, Hiatt P, McCoy K, Wilson CB, Smith AL, Ramsey BW. Early course of pulmonary infection, inflammation, and clinical outcomes in infants with cystic fibrosis. Pediatr Pulmonol, supplement 20, S5.4 pages 112-114, 2000. 43. Aitken ML, Tonelli MR, Pier MV, Burns JL, Emerson JC, Goss CH, McNamara SC, Gibson RL. Analysis of sequential aliquots of hypertonic saline induced sputum from stable patients with cystic fibrosis. Pediatr Pulmonol., Supplement 22, abstract # 381, page 302, 2001. 44. Gibson, RL, Emerson J, McNamara S, Burns JL, Rosenfeld M, Yunker A, Hamblett N, Accurso F, Dovey M, Hiatt P, Moss R, Konstan M, Retsch-Bogart G, Waltz D, Wilmott R, Wagener J, Zeitlin P, Ramsey B. A randomized controlled trial of inhaled tobramycin in young children with cystic fibrosis: eradication of Pseudomonas from the lower airway. PAGE 10 Ronald L. Gibson, Jr., M.D., Ph.D. Presented at the North American CF Conference in October 2002. Pediatr Pulmonol., Supplement 24, abstract #356, page 300, 2002. 45. Ordonez C, Gibson RL, Emerson J, McNamara S, Accurso F, Burns JL, Zeitlin P, Daines C, Retsch-Bogart G, Chmiel J, Henig N, Aitken M. Validation of sputum induction as an outcome measure for lower airway sampling in patients with cystic fibrosis. Presented at the North American CF Conference in October 2002. Pediatr Pulmonol., Supplement 24, abstract # 354, page 299, 2002. 46. Cassidy J, Gibson RL, Moskowitz S. Clinical pathway for cystic fibrosis pulmonary exacerbation. Pediatr Pulmonol., Supplement 24, abstract # 510, page 355, 2002. 47. Moss R, Wagener J, Daines C, Hale K, Ahrens R, Gibson R, Retsch-Bogart G, Nasr S, Noth I, Waltz D, Zeitlin P, Ramsey B, Hamblett N, Starko K. Randomized, double-blind, placebo-controlled, dose-escalating study of aerosolized interferon gamma-1b in patients with mild-moderate cystic fibrosis lung disease. Am J Resp Crit Care Med 2003; 167:A923. 48. Rosenfeld M, Emerson J, McNamara S, Castile R, McCoy K, Hiatt P, Burns JL, Gibson RL, Ramsey BW. Longitudinal follow-up of Pseudomonas aeruginosa infection in young children with cystic fibrosis. Am J Resp Crit Care Med 2003; 167:A164 49. Hoffman LR, Emerson JE, Gibson RL, Redding GJ. Frequency of return to best PFT baseline after CF cleanout: a pilot quality improvement project. Am J Respir Crit Care Med 2003;167:A923. 50. Moskowitz SM, Foster J, Emerson J, McNamara S, Gibson RL, Burns JL. Discordance of conventional and biofilm antibiotic susceptibilities of Pseudomonas aeruginosa isolated from cystic fibrosis airways. Am J Resp Crit Care Med 2003; 167:A322. 51. Clancy JP, Eubanks VL, Bebok Z, Franks K, Zeitlin P, Brass L, Aitken M, Gibson R, Gordon M, Davies Z, Sorscer EJ, Bedwell DM. A randomized double-blind trial of topical gentamicin and tobramycin to improve CFTR function in CF patients with and without premature stop mutations. Pediatr Pulmonol, Supplement 25, abstract # 193, 2003. 52. Sagel S, Emerson J, Rosenfeld M, McNamara S, Caron H, Ramsey B, Wagener J, Gibson R. Association of upper versus lower airway Pseudomonas aeruginosa infection with endobronchial inflammation and clinical status in young children with CF. Pediatr Pulmonol, supplement 25, abstract # 375, 2003. 53. Rosenfeld M, Caron H, Emerson J, Hamblett H, Burns JL, Gibson R, McNamara S, Hiatt P, McCoy K, Castile R, Ramsey B. What effect do anti-pseudomonal antibiotics have on serial upper airway cultures in infants with CF? Pediatr Pulmonol, supplement 25, abstract # 374, 2003. PAGE 10 Ronald L. Gibson, Jr., M.D., Ph.D. 54. Waltz DA, Gibson R, McNamara S, Campbell J, Hamblett N, Ramsey B. Safety and yield of clinical trial bronchoalveolar lavage procedures in young cystic fibrosis patients. Pediatr Pulmonol, supplement 25, abstract # 393, 2003. 55. Gibson RL, Emerson J, McNamara S et al. Duration of the anti-pseudomonal treatment effect of inhaled tobramycin in young children with cystic fibrosis. Pediatr Pulmonol, supplement 25, abstract # 323, 2003. 56. Moskowitz SM, Foster J, Emerson J, Gibson RL, McNamara S, Burns JL. Development of a numerical algorithm to select antibiotic regimens based on biofilm susceptibilities of CF P. aeruginosa isolates. Pediatr Pulmonol, supplement 25, abstract # 335, 2003. 57. Gibson, RL. Early CF lung disease: detection, pathogenesis, and treatment. Presented at Symposium at 2004 NACFC, October 15, 2004. Pediatr Pulmonol, supplement 27, S3.1, page 105, 2004. 58. Gibson, RL, Ahrens, R, Clancy JP et al. Safety and tolerability of aztreonam for inhalation (AI) in cystic fibrosis patients. Presented at 2004 NACFC Conference. Pediatr Pulmonol, supplement 27, abstract 189, 2004. 59. Dovey, M, Aitken ML, Emerson J, McNamara S, Dorman D, Gibson RL. A randomized, double-blind, placebo-controlled trial of oral corticosteroid therapy in cystic fibrosis patients hospitalized for pulmonary exacerbations. Presented at 2004 NACFC. Pediatr Pulmonol, supplement 27, abstract 327, 2004. 60. Retsch-Bogart G, Gibson RL for the AI Phase 2 Study Group. A phase 2 study of aztreonam lysinate for inhalation (AI) to treat cystic fibrosis patients with Pseudomonas aeruginosa infections. Presented at the American Thoracic Society, May 2005. Am J Resp Crit Care Med, 2005, Volume 2, Abstract Issue, page A576. 61. Stapleton KW, Gibson RL, Retsch-Bogart G et al. The effect of nominal dose and treatment duration alters the pulmonary deposition of inhaled antibiotics. Presented at the International Society for Aerosol Medicine, 2005. 62. McKone E, Rogers CE, Genatossio A, McNamara S, Gibson RL, Aitken ML. Candidate pathway approach to identifying genetic modifiers in cystic fibrosis. Pediatr Pulmonol, Suppl 28: Abstract 185, pg 252, 2005. 63. McKone EF, Rogers CE, Genatossio A, McNamara S, Gibson RL, Aitken ML. Environmental tobacco smoke exposure and lung function decline in cystic fibrosis. Pediatr Pulmonol, Suppl 28: Abstract 396, pg. 329, 2005. 64. McKone EF, O’Connor CM, Rogers CE, Genatossio A, McNamara S, Gibson RL, Elborn J, Gallagher CG, Kalsheker N, Aitken M. The influence of common genetic variants on the cystic fibrosis phenotype. Presented at the 2006 NACFC. Pediatr Pulmonol, Suppl 29: Abstract 207, p 280, 2006. 65. Rosenfeld M, Emerson J, Uh D, Anderson G, Genatossio A, McNamara S, Dunn C, Davies Z, Foster J, Kantor E, Moss R, Burns J, Aitken M, Gibson RL. Does PAGE 10 Ronald L. Gibson, Jr., M.D., Ph.D. tobramycin accumulate in respiratory secretions with repeated aerosol administration: a pilot study. Presented at the 2006 NACFC. Pediatr Pulmonol, Suppl 29: Abstract 342, pg 327, 2006. 66. McKone EF, O’Connor CM, Rodgers CE, Genatossio A, McNamara S, Gibson RL, Kalsheker N, Gallagher CG, Aitken M. TAGSNP evaluation of the endothelin pathway demonstrates genetic association between EDNRA and CF lung disease severity. Presented at the 2007 NACFC. Pediatr Pulmonol, Suppl 30, Abstract 202, pg 273, 2007. 67. Retsch-Bogart GZ, Montgomery B, Gibson R, McCoy K, Oermann CM, Cooper P. Phase 3 trial (AIR-CF 1) measuring improvement in respiratory symptoms in patients with cystic fibrosis following treatment with aztreonam lysine fro inhalation. Presented at the 2007 NACFC. Pediatr Pulmonol, Suppl 30, Abstract 308, pg 310, 2007. 68. Burns JL, Worrell K, Kuypers J, McNamara S, Emerson J, Gibson R, Englund JA. PCR diagnosis of respiratory viruses in children with cystic fibrosis. Presented at the 2007 NACFC. Pediatr Pulmonol, Suppl 30, Abstract 315, pg 313, 2007. 69. Rosenfeld M, Gibson R, Emerson J, McNamara S, Escobar DM, Andrina M, Chatfield B, Orenstein DM, Konstan MW, Rock M, Wall M, Ramsey BW. Large US cohort of young, Pseudomonas-negative CF patients: mild lung disease, heterogeneous management. Presented at 2007 NACFC. Pediatr Pulmonol, Suppl 30, Abstract 368, pg 332, 2007. 70. McCoy K, Retsch-Bogart G, Gibson R, Oermann C, Braff M, Montgomery AB. Microbiologic resistance and clinical efficacy of aztreonam lysine for inhalation (AZLI) in cystic fibrosis (CF). Presented at European CF Conference 2008. 71. Sanders DB, Emerson J, Hoffman L, Gibson R, Redding G, Goss CH. Return of FEV1 after pulmonary exacerbation in children with cystic fibrosis. Am J Resp Crit Care Med 177: A774, 2008. 72. Oermann CM, Retsch-Bogart G, McCoy KS, Gibson RL, Montgomery AB. Multiple courses of aztreonam lysine for inhalation to treat Pseudomonas aeruginosa airway infection in patients with cystic fibrosis: 6 month interim analysis of an open-label study. Am J Resp Crit Care Med 177: A460, 2008. 73. Kraynack NC, Chmiel JE, Xue W, Schluchter MD, Gibson RL, Kelley TJ, Hilliard JB, Konstan MW. Effect of simvastatin on exhaled nitric oxide and inflammatory markers in sputum in patients with cystic fibrosis. Pediatr Pulmonol, Supplement 31, Abstract # 281, page 300, 2008. 74. Retsch-Bogart GZ, McCoy KS, Gibson RL, Oermann CM, Braff MH, Montgomery AB. Sustained improvement in pulmonary function following a 28-day course of 75 mg AZLI TID therapy. Pediatr Pulmonol, Supplement 31, Abstract # 335, page 320, 2008. 75. Retsch-Bogart GZ, McCoy KS, Gibson RL, Oermann CM, Montgomery AB. Source of improvements in lung function in patients with CF following treatment PAGE 10 Ronald L. Gibson, Jr., M.D., Ph.D. with aztreonam lysine for inhalation (AZLI). Pediatr Pulmonol, Supplement 31, Abstract # 336, page 320, 2008. 76. McKoy KS, Retsch-Bogart GZ, Gibson R, Oermann C, Braff MH, Montgomery AB. Relevance of established susceptibility breakpoints to clinical efficacy of inhaled antibiotic therapies in CF. Pediatr Pulmonol, Supplement 31, Abstract # 418, page 351, 2008. PAGE 10
