Margaret Rosenfeld, MD, MPH

Page 10

January, 2008

Margaret Rosenfeld, M.D., M.P.H.

Curriculum Vitae

CONTACT INFORMATION:

Division of Pulmonary Medicine, A-5937

Children’s Hospital and Regional Medical Center

4800 Sandpoint Way NE, Seattle, WA 98105

EDUCATION

l983 B.S., Molecular Biophysics and Biochemistry, Yale University,

New Haven, CT. Magna cum laude, Distinction in the Major

l988 M.D., Harvard Medical School, Boston, MA

1995 M.P.H., Department of Epidemiology, University of Washington

School of Public Health, Seattle, WA

POSTGRADUATE TRAINING

l988-91 Internship/Residency in Pediatrics, University of Washington School of Medicine/Children's Hospital and Medical Center, Seattle, WA

l992-95 Fellowship, Pediatric Pulmonology, University of Washington

School of Medicine, Seattle, WA

FACULTY POSITIONS HELD

1995-1998 Acting Instructor, Department of Pediatrics, University of

Washington School of Medicine, Seattle, WA

1999-2000 Acting Assistant Professor, Department of Pediatrics, University of

Washington School of Medicine, Seattle, WA

2000-2005 Assistant Professor, Department of Pediatrics, University of

Washington School of Medicine, Seattle, WA

2005- Associate Professor, Department of Pediatrics, University of

Washington School of Medicine, Seattle, WA

HOSPITAL POSITIONS HELD

1995-  Attending Physician, Children’s Hospital and Regional Medical Center

2000-  Medical Director, Pulmonary Function Laboratory, CHRMC

2003-  Co-Director, Fellows’ College

2007- Medical Director, General Clinical Research Center, and Associate Director, Center for Clinical and Translational Research, Children's Hospital and Regional Medical Center

HONORS

1992-98 Leroy Matthews Physician Scientist Award, Cystic Fibrosis Foundation

1993 Physician Scientist Fellowship Award, Glaxo Corporation

BOARD CERTIFICATION

l993, 2000 Diplomate, General Pediatrics, American Board of Pediatrics (expired as of 1/31/2006)

1998, 2005 Diplomate, Pediatric Pulmonology, American Board of Pediatrics

LICENSURE

l988- State of Washington, # 00027801

PROFESSIONAL ORGANIZATIONS

American Academy of Pediatrics

American Thoracic Society

Society for Pediatric Research

Western Society for Pediatric Research

Association for Patient Oriented Research

Association of Pediatric Program Directors

TEACHING RESPONSIBILITIES

Courses:

1991-  Housestaff noon conference didactic sessions on chronic cough, obstructive sleep apnea, and common airway disorders (each given annually)

1992- Visiting lecturer, NURS 517 (Pediatric Nurse Practitioner graduate course), University of Washington School of Nursing (annually)

1995- Attending rounds didactic sessions to resident ward team on various relevant topics in pediatric pulmonary medicine (cystic fibrosis, pulmonary physiology, asthma, bronchiolitis)

1995-2002 Visiting lecturer, Core Pediatrics Clerkship,

University of Washington School of Medicine (~ 6 times annually)

2002- 2007 Lecturer, Core Pediatrics Clerkship, ethics session (9 times annually)

2004- Lecturer, HuBio 512 course to 1st year medical students (lectures on cystic fibrosis)

2007 Lecturer and panel discussant, UW Educational Outreach 88597-Intro to Clinical Trials

Trainees:

1997-1999  Graduate thesis preceptor for Toby Lewis, M.D., M.P.H., former fellow, Division of Pulmonary Medicine. Advised her in design, conduct and analysis of her study assessing outcomes associated with urban vs. rural residence among cystic fibrosis patients in the U.S. CF Foundation National Registry. Dr. Lewis is currently an Assistant Professor in the Division of Pulmonary Medicine, Department of Pediatrics, University of Michigan School of Medicine.

2000  Research mentor for Victoria Cartwright, MD, former fellow in Division of Rheumatology, “A Randomized, Controlled Trial of Pain Management Methods for Intraarticular Steriod Injections in Patients with Juvenile Rheumatoid Arthritis.” Dr. Cartwright is currently on faculty in the Department of Pediatrics at Madigan Army Medical Center in Tacoma, WA.

2001 Research mentor to Chris Goss, MD, MSc, now Assistant Professor, Division of Pulmonary and Critical Care Medicine, Department of Medicine, University of Washington School of Medicine. Assisted him in preparation of his successful grant applications to the Cystic Fibrosis Foundation for a LeRoy Matthews Physician Scientist Award and to the NIH for a K23 award. His proposals assess the quality of life in cystic fibrosis patients with end-stage lung disease.

2001- Research mentor to Jason Debley, MD, Assistant Professor, Division of Pulmonary Medicine. Assisted him in preparing three successful grant applications and currently serve as one of his mentors on his NIH K23 career development award assessing predictors of asthma among wheezy infants utilizing infant pulmonary function tests.

2002- 2004 Advisor to Doris Uh, Pharm.D., postdoctoral fellow, Department of Pharmaceutics. Mentored her in investigation of pharmacokinetics of inhaled antibiotics and supervising her role as consulting clinical pharmacist in the Division of Pediatric Pulmonary Medicine.

2003 Research mentor to Martha McKinney, MD, MPH, former fellow, Division of Pulmonary Medicine. Assisted her in her preparing her thesis in fulfillment of the Masters in Public Health degree, assessing the prevalence of smoking among Canadian asthmatics. Sat on her thesis committee. Dr. McKinney is currently an Assistant Professor, Department of Paediatrics, Queen's University, Kingston, Ontario.

2006- Research Mentor to Maida Chen, Acting Assistant Professor, Division of Pulmonary Medicine, on her submitted grant application to University of Washington. Alcohol and Drug Abuse Institute, ”Sleep in Fetal Alcohol Spectrum Disorders,” and for her planned application for an NIH K12 career development award, “Sleep Disordered Breathing in Special Needs Pediatric Populations.”

2007-08 Biology project advisor to Paramita Saha, doctoral candidate in Biostatistics

2007- Member, Scholarship Oversight Committee of Don “DB” Sanders, fellow in Pulmonary Medicine

EDITORIAL RESPONSIBILITIES

Regular reviewer for Pediatric Pulmonology, Journal of Pediatrics, Annals of Epidemiology, Thorax, European Respiratory Journal, Pediatric Infectious Diseases, Journal of Antimicrobial Chemotherapy, Journal of Cystic Fibrosis, Chest, JAMA

2006 Guest Editor, Proceedings of the American Thoracic Society, “Imaging Endpoints in Cystic Fibrosis”

SPECIAL NATIONAL RESPONSIBILITIES

1999-2000  Participant in development of Pulmonology subspecialty examination, American Board of Pediatrics

1999  Correspondent Reviewer, NIDDKM K01 grant application

2002-2003 Member, Nominating Committee, Pediatric Assembly, American Thoracic Society

2002-2004 Member, American Thoracic Society Health Care Policy Committee

2002-2004 Member, Cystic Fibrosis Foundation Therapeutics Development Network Protocol Review Committee

2004- Member, Cystic Fibrosis Foundation Therapeutics Development Network Publication and Presentations Committee

2003 Manuscript judge, 2003 Uniformed Services Scientific Award Competition

2003-  Member, Cystic Fibrosis Foundation National Patient Registry Committee

2003-2007  Member, American Thoracic Society Pediatric Assembly Planning Committee

2003-2004  Member, Writing Committee, “The Clinical Utility of Newborn Screening for Cystic Fibrosis” report published in Morbidity and Mortality Weekly Reports in 2004

2005-2006 Chair, U.S. Cystic Fibrosis Foundation task force On Updating Spirometry Reference Equations for the CFF National Patient Registry

2005- Vice-Chair, EPIC (Early Pseudomonas Infection Control) Steering Committee

2005-2007 Member, American Thoracic Society Pediatric Assembly Program Committee

2006 Co-Chair, U.S. Cystic Fibrosis Foundation workshop on Defining a Pulmonary Exacerbation, held Sept 17-18, 2006, Bethesda, MD

2007 Faculty Member, Cystic Fibrosis Foundation Learning and Leadership Collaborative V

2008- Chair, American Thoracic Society Working Group on Infant / Preschool Lung Function

SPECIAL LOCAL RESPONSIBILITIES

1997-2000 Subspecialty Teaching Ad Hoc Subcommittee of the Residency Committee, Children’s Hospital and Regional Medical Center

1997-  Residency Program Liaison, Division of Pulmonary Medicine, Children’s Hospital and Regional Medical Center

2002, 2005 Reviewer, Cystic Fibrosis Critical Elements of Care Community Provider Guidelines, Center for Children with Special Needs and Chronic Health Conditions, CHRMC

1998-  Member, Scientific Advisory Committee to the Clinical Research Center, UW and CHRMC.

2000-2003 Member, UW Clinical Research Training Grant K-30 Steering Committee – Training Grant Program Track

2001-2002 Member, Newborn Screening Advisory Committee to Washington State Board of Health regarding additional universal newborn screening tests.

2001- Member, CHRMC Pharmacy and Therapeutics Committee

2000-  Member, Medical Advisory Board, World Bike for Breath

2003-  Member, Faculty Council on Academic Affairs, UW School of Medicine

2004-  Member, Education Committee, University of Washington School of Medicine General Clinical Research Center

2005-2006 Member, Institutional Resident/Fellow Advisory Committee (IR/FAC), University of Washington School of Medicine

2006 Member, CHRMC Strategic Plan Task Force on Education

2006 Leader, Workgroup on Family Support Services for Symposium on Creating Institutional Change for Work-Life Balance in Pediatric Careers, CHRMC, October 11, 2006

2007- Member, University of Washington Department of Pediatrics Recognition Committee

2007 Member, Seattle Children’s Hospital Research Institute Center for Health Services and Behavioral Research Strategic Planning Committee

2007 Member, Seattle Children’s Hospital Research Institute Center for Clinical and Translational Research Strategic Planning Committee

2007- Member, Steering Committee, Seattle Children’s Hospital Research Institute Center for Clinical and Translational Research

RESEARCH FUNDING

ACTIVE

OBSERV04K0 (Rosenfeld – PI) 2/1/04 – 3/31/09 3.0 calendar

Cystic Fibrosis Foundation $1,290,917

EPIC Observational Study

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

1 U54 FF019480 (Knowles – PI) 8/4/04 – 7/31/09 1.6 calendar

NIH (NCRR) (Subcontract from University of $324,692

North Carolina at Chapel Hill) (Rosenfeld – Site PI)

Genetic Disorders of Mucociliary Clearance

Four-center prospective, longitudinal study to define the onset and progression of lung disease in a cohort of patients with primary ciliary dyskinesia (PCD) using standardized procedures.

KERBY04A0 (Kerby-PI) 2/01/05 – 1/31/08 (NCE 1/31/09) .60 calendar

Cystic Fibrosis Foundation $130, 522

Spirometry as an outcome measure in preschool children with CF

Longitudinal 8-center study of three methods of assessing lung funciotn in CF patients 3 to 5 years of age. Dr. Rosenfeld is Seattle site PI, well as study co-PI with Dr Kerby and Dr. Stephanie Davis (UNC).

UL1RR025014-01 (Disis – PI) 9/17/07 – 5/31/08 2.40 calendar

University of Washington (UW), Institute of $947,328

Translational Health Science

Institutional Clinical and Translational Health Science Award CTSA

Dr. Rosenfeld is the Medical Director of the Pediatric Clinical Research Center, overseeing program and infrastructure to conduct clinical research in the Pediatric Clinical Research Center located at Children’s Hospital and Regional Medical Center.

ISIS07K1 (Rosenfeld – PI) 10/1/07 – 9/30/08 2.4 calendar

Cystic Fibrosis Foundation $640,312

Infant Study of Inhaled Saline

A large multicenter randomized controlled trial of inhale 7% hypertonic saline in infants with cystic fibrosis.

ROSENF03AO (Rosenfeld – PI) 2/1/03 – 1/31/08 (NCE to 1/31/09) 0 calendar

Cystic Fibrosis Foundation Therapeutics, Inc. Direct Costs: $910,024

Evaluation of pulmonary function from raised lung volumes as outcome measures for clinical trails in infants with cystic fibrosis. Dr. Rosenfeld has 0 effort during the NCE.

.

ISIS07K1P (Rosenfeld – PI) 10/1/107 – 9/30/08 0 calendar

Cystic Fibrosis Foundation $112,745

A Pilot Study to Evaluate Inhaled 7% Hypertonic Saline in CF Infants

Open-label pilot study to assess the safety and tolerability of exposure to 14 days of 7% HS twice daily in infants with CF who are 12 to 30 months of age at enrollment. Dr. Rosenfeld’s effort on this project is paid under ISIS07K1.

PENDING

Rosenfeld – PI 10/1/08 – 09/30/12 2.4 calendar

NIH (Score 146 – 12th percentile) $1,601,967

Infant Study of Inhaled Saline in Cystic Fibrosis (ISIS) – CCC – Lead Application

A multicenter, randomized controlled trial of 7% inhaled hypertonic saline in infants with cystic fibrosis. If funded, Dr. Rosenfeld will receive funding for her effort on this project under this award rather than ISIS07K1.

Completed

1.  K23 RR15529 (PI, Margaret Rosenfeld). Source: NCRR, NIH. Dates: 5/01/2000– 11/30/2005. Annual Direct Costs: $96,333. Percent Effort: 75%. Title: Mentored Patient Oriented Research Career Development Award

2.  HR 597004 (PI: Margaret Rosenfeld). Source: Research Endowment Fund, Childrens Hospital and Regional Medical Center. Dates: 1/01/2002– 3/31/2004. Annual Direct Costs: $24,780. Percent Effort: 0%. Title: A pilot study of sputum induction as a non-invasive means to measure serial airway antibiotic concentration in cystic fibrosis.

3.  Cystic Fibrosis Foundation, Leroy Matthew Physician Scientist Award (Bonnie Ramsey, MD PI, 1992-95 for my fellowship funding; M. Rosenfeld, PI, 1996-98). Dates: 1992-1998. 1997-98 direct costs: $65,250.

4.  Pari Respiratory Equipment, for Study of Efficacy of Cleaning Methods for Small-Volume Nebulizers (M. Rosenfeld, PI). Date: 1997. Direct costs: $1,847.

5.  PathoGenesis Corp., Safety Study of Aerosolized Tobramycin in Young Children with Cystic Fibrosis (M. Rosenfeld, PI). Dates: 4/98 – 10/98. Total direct costs: $90,591.

6.  PathoGenesis Corp. and Cystic Fibrosis Foundation. A Pilot Study of the Deposition of Inhaled Tobramycin in Young Children with Cystic Fibrosis (M. Rosenfeld, PI). Dates: 4/99-5/00. Total award: $81,968.

BIBLIOGRAPHY

Manuscripts in Refereed Journals

1. Rosenfeld M, Ramsey B. Evolution of airway microbiology in the infant with cystic fibrosis: role of pseudomonal and non-pseudomonal pathogens. Semin Respir Infect 1992;7(3):158-67.

2. Rosenfeld M, Cohen M, Ramsey B. Aerosolized antibiotics for bacterial lower airway infections: principles, efficacy and pitfalls. Clinical Pulmonary Medicine 1997;4(2):101-12. (Also appeared in Infectious Diseases in Clinical Practice 1998:7;66-79)

3. Rosenfeld M, Davis R, Fitzsimmons S, Pepe M, Ramsey B. The gender gap in cystic fibrosis mortality. American Journal of Epidemiology 1997;145(9):794-803.

4.  Rosenfeld M, Emerson J, Astley S, Joy P, Williams-Warren J, Standaert T, Yim DL, Crist D, Thykkuttathil J, Torrence M, FitzSimmons S, Ramsey B. Home nebulizer usage among patients with cystic fibrosis. Journal of Pediatrics 1998;132:125-31.

5.  Rosenfeld M, Casey S, Pepe M, Ramsey B. Nutritional effects of long term gastrostomy feedings in children with cystic fibrosis. Journal of the American Dietetic Association 1999;99:191-4.

6.  Rosenfeld M, Emerson J, Accurso F, Armstrong D, Castile R, Grimwood K, Hiatt P, McCoy K, McNamara S, Ramsey B, Wagener J. Diagnostic accuracy of oropharyngeal cultures in infants and young children with cystic fibrosis. Pediatric Pulmonology, 1999;28:321-328.

7.  Rosenfeld M, Pepe MS, Emerson J, Longton G, FitzSimmons S. Effect of different reference equations on the analysis of pulmonary function data in cystic fibrosis. Pediatric Pulmonology 2001;31:227-37.

8.  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 young children with cystic fibrosis. Journal of Infectious Disease 2001;183(3):444-452.

9.  Rosenfeld M, Emerson J, Willians-Warren J, Pepe M, Smith A, Montgomery AB, Ramsey BW. Defining a pulmonary exacerbation in cystic fibrosis. J Pediatr 2001;139(3):359-365.

10.  Rosenfeld M, Gibson RL, McNamara S, Emerson J, Burns JL, Castile R, Hiatt P, McCoy K, Wilson CB, Inglis A, Smith A, Martin TR, Ramsey BW. Early pulmonary infection, inflammation, and clinical outcomes in infants with cystic fibrosis. Pediatric Pulmonology 2001;32:356-366.