Ronald H. Saff, M.D. Curriculum Vitae

Transcription

1 Ronald H. Saff, M.D. Curriculum Vitae Address 2300 Centerville Road Tallahassee, FL (850) Certification Board Certified Internal Medicine, September 1992 Board Certified Allergy and Immunology, August 1997 Certified Clinical Research Investigator, April 2002 Certified Physician Investigator, November 2003 American Board of Independent Medical Examiners, 2010 Education 1981, B.S. University of Florida, Gainesville, Florida 1987, M.D. St. George s University, Grenada Postgraduate Training and Fellowship Appointments Intern, Internal Medicine Presbyterian University of Pennsylvania Medical Center Philadelphia, PA Resident, Internal Medicine Presbyterian University of Pennsylvania Medical Center Philadelphia, PA Fellow, Allergy-Immunology Medical College of Wisconsin Affiliated Hospitals Milwaukee, WI Employment Attending Physician MIHB Clinic Milwaukee, WI Attending Physician Allergy and Immunology Central New York Asthma and Allergic Disease Consultants Auburn, NY 1994-Present Attending Physician-Allergy and Immunology Allergy and Asthma Diagnostic Treatment Center 2300 Centerville Road Tallahassee, FL Journalism Health and Environment Columnist Tallahassee Democrat

2 Ronald H. Saff, MD Page 2 Revised 4/15/14 Faculty Appointments Assistant Instructor in Medicine University of Pennsylvania 2004-present Clinical Assistant Professor of Medicine Florida State University College of Medicine Publications Saff, R., Nahhas A., and Fink, J. Myocardial Infarction Induced by Coronary Vasospasm after Self-Administration of Epinephrine. Annals of Allergy 1993; 70: Saff, R., and Fink, J., Anaphylaxis to Chicken Soup: A Case Report and a Brief History of the Chicken in Medicine. Journal of Allergy and Clinical Immunology 1992; 89: Murali, P.S., Pathial, K., Saff, R. H., Splaingard, M.L., Atluru, D., Kurup, V.P., and Fink, J.N., Immune Responses to Aspergillus Fumigatus and Pseudomonas Aeruginosa Antigens in Cystic Fibrosis and Allergic Bronchopulmonary Aspergillosis. Chest 1994; Vol. 106: Presentations Saff, R. Myocardial Infarction After an Episode of Anaphylaxis: A Potential Use for Epi-Pen Jr. in Adults. State Medical Society of Wisconsin. Milwaukee, WI. April 25, Pathial K., Saff R., Kurup, V., Splaingard, M., Murali P. and Fink, J. Specific Immune Responses to Aspergillus in Patients with Cystic Fibrosis. American Academy of Allergy and Immunology Convention. March 7, Orlando, FL. Medicolegal 2010-Present File reviews, peer reviews, IME s 2014-Present Expert witness Community Service American Lung Association Council, Member Present Rotary 2001, 2004 Tallahassee Democrat Volunteer of the Year Nominee The Shelter, Board Member 2009 Volunteer of the Week from the American Lung Association s national office

3 Ronald H. Saff, MD Page 3 Revised 4/15/14 Community Service (con t) Feb 2012-Present - Board Member, Clean Water Network of Florida Hospital Privileges 1994-Present Tallahassee Memorial Regional Medical Center Magnolia Drive & Miccosukee Rd., Tallahassee, FL Present Capital Regional Medical Center 2626 Capital Medical Blvd., Tallahassee, FL Languages English (native) License Florida ME Georgia New York North Carolina Memberships in Professional Societies Clinical Trials 2001-Present Fellow, American Academy of Allergy, Asthma, and Immunology 1995-Present Member, American College of Allergy, Asthma, and Immunology 1995-Present Member, Joint Council of Allergy and Immunology 1995-Present Member, American Medical Association 1995-Present Member, Capital Medical Society 2002-Present Member, Association of Clinical Research Professionals 1995-Present Member, Florida Medical Association 9/97-12/98: (Phase IV) A Double-Blind, Randomized, Placebo- Controlled Surveillance Study of Asthma Event Outcomes in Subjects Receiving Either Usual Pharmacotherapy of Asthma or Usual Pharmacotherapy Plus Another Inhaler.

4 Ronald H. Saff, MD Page 4 Revised 4/15/14 5/98-11/98: (Phase III) A Comparative Study of the Efficacy and Safety of an Extended Release Antibiotic and another Antibiotic for the Treatment of Acute Bronchitis. 5/98-2/99: (Phase III) A Comparative Study of the Efficacy and Safety of an Extended Release Tab and an Immediate Release Tab for the Treatment of Subjects with Acute Exacerbation of Chronic Bronchitis. 5/98-3/99: (Phase IV) A Double Blind Placebo-Controlled Study to Evaluate the Effects of Treatment of SAR In Subjects with Comorbid Asthma and a History of Seasonal Exacerbation of Asthma on Medical Resources Utilization. 4/99-11/99: (Phase IV) A Randomized, Double-Blind, Parallel Group, Comparison Study of Inhaled Corticosteroid Versus a Leukotriene Modifier. 8/99-7/00: (Phase III) A Double-Blind, Placebo-Controlled, Parallel-Group Trial to Determine the Efficacy of a Leukotriene Modifier When Used on Asthma Subjects Using an Inhaled Beta Agonist Alone or Inhaled Beta Agonist in Combination with Inhaled Corticosteroids. 9/99-12/99: (Phase III) A Comparative Study of the Safety, Efficacy and Effectiveness of Two Antibiotics in the Treatment of Subjects with Acute Exacerbation of Chronic Bronchitis. 9/99-12/99: (Phase IV) A Double-Blind, Randomized, Placebo- Controlled Surveillance Study of Asthma Event Outcomes. 11/99-7/00: (Phase III) A Double-Blind Study to Determine the Efficacy of a Short Acting Beta Agonist in the Treatment Of African-American Patients with Asthma. 2/00-6/01: (Phase III) A Randomized, Double-Blind, Parallel Group Trial Assessing the Efficacy and Safety of an Inhaled Corticosteroid and Placebo in Subjects at least 12 Years of Age with Chronic Asthma Currently Treated with Inhaled Corticosteroids. 2/00-12/00: (Phase IV) A Randomized, Double-Blind, Parallel Group Comparative Trial of a Long Acting Bronchodilator/ Inhaled Corticosteroid versus an Inhaled Corticosteroid in Adolescents and Adults with Moderate Persistent Asthma.

5 Ronald H. Saff, MD Page 5 Revised 4/15/14 4/00-7/00: (Phase III) A Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Two Antihistamine Decongestants Versus Placebo in the Treatment of Subjects Twelve Years or Older with Seasonal Allergic Rhinitis. 8/00-10/00: (Phase III) Efficacy and Safety of Combination Antihistamine/ Leukotriene Modifier QD Vs. Its Components in the Treatment of Subjects with Seasonal Allergic Rhinitis. 8/00-12/00: (Phase II) A Randomized, Double-Blind, Parallel Group Comparison of the Safety and Efficacy of Three Once Daily Doses of a Phosphodiesterase- 4 Inhibitor with Placebo and a Leukotriene Modifier Daily in Patients with Symptomatic Asthma. 8/00-3/02: (Phase III) A Randomized Double-Blind, Double- Dummy, Parallel Group Comparison of an Inhaled Corticosteroid via a New Device with Oral Leukotriene Chewable Tablets in Children 6-12 years of Age with Persistent Asthma. 2/01-4/01: (Phase IV) "A Comparison of the Efficacy of a Once Daily Dose of Two Antihistamines in the Treatment of Subjects with Seasonal Allergic Rhinitis." 5/01-1/02: (Phase II) A Phase II Study Designed as a Double- Blind, Randomized, Parallel Group, Placebo Controlled Study of Three Different Maintenance Doses of Orally Administered Microencapsulated Pollen Extract. 7/01-9/02: (Phase III) A Phase III Double-Blind, Double-Dummy, Parallel-Group, Multicenter, Placebo-Controlled, Efficacy and Safety Study of Two Inhaled Corticosteroids Administered Twice Daily for 12-Weeks in the Treatment of Severe Persistent Asthma in Adolescents and Adults. 7/01-7/03: (Phase III) A Multicenter, Double-Blind, Randomized, One Year, Long-Term Safety Study of Inhaled Corticosteroid Metered Dose Inhaler Administered Twice Daily For the Treatment of Severe Persistent Asthma In Adolescents And Adults. 8/01-10/01: (Phase III) A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study Investigating the Clinical Effects of a Leukotriene Modifier in Patients With Seasonal Allergic Rhinitis.

6 Ronald H. Saff, MD Page 6 Revised 4/15/14 9/01-6/02: (Phase II) A Phase II Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Dose-Finding Study to Evaluate the Effectiveness of 28 days of Treatment with 5-LO Inhibitor in Adult Asthmatics. 10/01-1/02: (Phase IV) A Randomized, Open-Label, Cross Over Trial, Assessing Ease of Use, Correctness of Use and Patient Preference of a New Device Versus a Metered Dose Inhaler in Subjects at Least 12 Years of Age with Persistent Asthma Currently Receiving Short Acting Beta Agonists Alone. 11/01-2/02: (Phase III) A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study Investigating the Clinical Effects of a Leukotriene Modifier in Patients With Perennial Allergic Rhinitis. 11/01-05/03: (Phase III) A Randomized, Double-Blind, Placebo- Controlled, Parallel-Group, 12-Week Trial Evaluating the Safety and Efficacy of a Combination Inhaled Corticosteroid/Long Acting Beta-Agonist Product Once Daily Versus a Lower Strength Combination Product Twice a Day Versus an Inhaled Corticosteroid Once Daily Versus Placebo in Symptomatic Adolescent and Adult Subjects with Asthma that is not Controlled on Short Acting Beta 2 -Antagonist Alone. 11/01-05/03: (Phase IV) A Multicenter, Randomized, Double- Blind, Double-Dummy, Parallel Group, 16-Week Comparison of Asthma Control in Adolescents and Adults Receiving Either an Inhaled Corticosteroid/ Long Acting Beta-Agonist BID, Inhaled Corticosteroid BID, Long Acting Beta-Agonist BID, or Leukotriene Modifier QD. 12/01-8/02: (Phase III) A Multicenter, Randomized, Controlled, Open-Label Study to Evaluate the Safety of an Antibody in Moderate to Severe Persistent Asthma Subjects Already Treated with Other Therapies. 12/01-5/03: (Phase III) 12 Weeks Treatment with a PDE Inhibitor versus Placebo in Patients with Asthma. 12/01-3/02: (Phase III) A Double-Blind, Placebo Controlled, Parallel Group Study of the Efficacy and Safety of Once Daily Inhaled Corticosteroid in Patients with Asthma Currently Treated with Inhaled Steroids.

7 Ronald H. Saff, MD Page 7 Revised 4/15/14 1/02-11/02: (Phase IIA) A Phase II, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter, Pilot Efficacy and Safety Study of an Integrin Antagonist Administered by Inhalation Twice Daily for Twelve Weeks in Adults with Mild to Moderate Persistent Asthma. 2/02-6/02: (Phase III) A Double-Blind, Randomized, Parallel Group, Placebo Controlled Study Comparing the Efficacy and Safety of Generic Antihistamine in Aqueous Nasal Spray Versus Brand Name Nasal Spray and Placebo Nasal Spray in Subjects with Seasonal Allergic Rhinitis. 4/02-11/02: A Stratified, Randomized, Double-Blind, Parallel- Group, 12-Week Trial Evaluating the Safety and Efficacy of a Combination Product BID versus an ICS in Symptomatic Pediatric Subjects (4-11 Years) with Asthma. 6/02-12/03: A Twelve-Week, Randomized, Double-Blind, Double- Dummy Trial of a Combination ICS versus its Mono-Products in Asthmatic Children Aged Six to Fifteen Years. 6/02-10/03: A Stratified, Randomized, Double-Blind, Placebo- Controlled, Parallel-Group, 12 Week Trial Evaluating the Efficacy of an ICS Combination Product Once Daily Versus an ICS Once Daily and Placebo in Symptomatic Pediatric Subjects (4-11 Years) With Asthma. 8/02-12/02: (Phase II) A Placebo-Controlled, Double-Blind, Multicenter Study of a Nasal Spray Solution for the Treatment of Natural Rhinovirus Infection in Adults. 8/02-5/03: A multicenter, Randomized, Double-Blind, Crossover Study Comparing the Effect of PDE4 and Placebo in Adult Patients with Chronic Asthma. 9/02-5/03: A Multicenter, Double-Blind, Randomized, Parallel Groups Placebo Controlled Study To Assess The Efficacy and Safety of Antihistamine BID In Subjects With Mild to Moderate Persistent Asthma. 10/02-5/04: A Randomized, Multicenter, Placebo-Controlled Parallel Group Study of Four Months Duration Per Patient to Evaluate the Safety and Efficacy of Treatment With Two Doses of Long Acting Beta Agonist BID, Double-Blind, and Long Acting Beta Agonist BID, Open-Label, In Adolescent and Adult Patients With Persistent Stable Asthma.

8 Ronald H. Saff, MD Page 8 Revised 4/15/14 10/02-5/03: A Multicenter, Double-Blind, Randomized, Parallel Study Comparing the Efficacy and Safety of Antihistamine BID, Antihistamine QD, and Placebo in Subjects with Perennial Allergic Rhinitis. 10/02-5/04: (Phase II) Inhaled Corticosteroid Replacement Study- Efficacy and Safety of PDE4 in Moderate Persistent Asthma. 10/02-3/04: (Phase II) Dose-Ranging Study of PDE 4 in Patients with Persistent Asthma Not Treated With Inhaled Corticosteroids. 11/02-5/03: (Phase II) A Multi-Center, Randomized, Parallel- Group, Double-Blind, Efficacy and Safety Study of Nasal Spray versus Placebo in Subject with Perennial Allergic Rhinitis. 12/02-5/04: A Randomized, Double-Blind, Parallel-Group Multicenter Efficacy and Safety Phase IIB Pilot Study of PPI Twice Daily versus Placebo Twice Daily in Adult Asthmatics Treated for 4 Months. 1/03-7/03: (Phase IV) A Multicenter, Randomized, Single-Blind, Active-Controlled, Parallel Group Study Comparing the Efficacy of Corticosteroid Nasal Spray for One Week for the Treatment of Seasonal Allergic Rhinitis Symptoms in Patients Years of Age. 2/03-12/03: A Double-Blind Study of the Efficacy, Safety, and Pharmacoeconomics of ICS HFA Inhaler System as Compared to ICS Inhalation Aerosol in Patients with Asthma. 2/03-11/03: (Phase III) A Multicenter, Double-Blind, Randomized Study Investigating the Clinical Effect of Leukotriene Modifier on Allergic Rhinitis in Patients With Seasonal Allergic Rhinitis and Chronic Asthma. 3/03-7/03: A Multicenter, Randomized, Double-Blind, Double- Dummy, Placebo Controlled, Parallel Group, Four-Week Study Assessing the Efficacy of Corticosteroid Nasal Spray QD versus Leukotriene Modifier QD in Adolescent and Adult Subjects With Asthma and Seasonal Allergic Rhinitis Who are Receiving Concurrent Open-Label Combination ICS BID. 4/03-11/03: (Phase II) A Double-Blind, Randomized, Placebo- Controlled, Dose-Ranging Trial with Anesthetic Solution for Inhalation in Mild to Moderate Asthma Patients.

9 Ronald H. Saff, MD Page 9 Revised 4/15/14 7/03-12/03: (Phase III) A Multi-Center, Randomized, Double- Blind, Parallel-Group, Placebo-Controlled Study on the Efficacy and Safety of an Antihistamine Once Daily in Chronic Idiopathic Urticaria. 7/03-6/04: (Phase II) 12 Week Treatment with a selective PDE4 inhibitor versus placebo in Patients with Asthma. 8/03-11/03: (Phase II) A Multicenter, Double-Blind, Randomized, Parallel-Group Study Investigating the Clinical Effect of a DP and TP Antagonist in Patients With Seasonal Allergic Rhinitis. 10/03-6/04: (Phase III) A Multicenter, Double-Blind, randomized, Placebo-Controlled, Parallel-Group Study Investigating the clinical Effects of a Leukotriene Modifier in Patients With Perennial Allergic Rhinitis. 11/03-11/04: (Phase III) A Randomized, Double-Blind, Active- Controlled, Parallel-Group, Single-Dummy, Multicenter, 12 Week Study to Assess the Efficacy and Safety of a ICS/Long-acting Bronchodilator Compared to a ICS in Asthmatic Subjects 12 Years of Age and Older." 1/04-11/04: (Phase III) "A two-stage randomized, open-label, parallel group, multicenter, 7-month study to assess the efficacy and safety of ICS/B-Dilator Combination administered either as fixed or as an adjustable regimen versus a fixed regimen of ICS/long-acting B-Dilator combination." 2/04-11/04: "A Four-Week, Double-Blind, Placebo-Controlled Exploratory Evaluation of FEV 1.0 Changes and Safety PDE4 Inhibitor with Chronic Obstructive Pulmonary Disease (COPD)." 2/04-9/05: "A Stratified, Multicenter, Randomized, Double-Blind, Parallel Group, 4-Week Comparison of ICS/B-Dilator Combination Product versus ICS in Pediatric Subjects with Activity Induced Bronchospasm." 3/04-5/05: "A randomized, controlled study of PDE4 inhibitor versus placebo in patients with asthma." 3/04-8/05: "A Multi-Center, Multinational, Randomized, Double- Blind, Parallel Group Study of the Effects of ICS HFA-MDI and ICS HFA-MDI on Lens Opacification in Adult Subjects with Moderate to Severe Persistent Asthma."

10 Ronald H. Saff, MD Page 10 Revised 4/15/14 3/04-7/04: "A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group Study to Evaluate the Clinical Effect of Oral Leukotriene Modifier Versus Placebo During the Allergy Season in Patients With Seasonal Aeroallergen Sensitivity and Chronic Asthma Which is Also Active During Allergy Season." 6/04-04/05: A randomized, double-blind, placebo-controlled, parallel group, multi-center, multiple dose ( 7days) dose-ranging study, to assess the efficacy and safety of 4 doses of a long-acting bronchodilator, delivered via a multiple dose inhaler and 1 dose of a long-acting bronchodilator delivered via a single dose inhaler, in adult and adolescent patients (12-75 years old inclusive) with stable persistent asthma. 9/04-10/04: (Phase IV) A Placebo Controlled Study of the Efficacy and Safety of Antihistamine vs Antihistamine in the Treatment of Subjects with Symptomatic Seasonal Allergic Rhinitis. 9/04-6/05: (Phase III) Safety and Efficacy of Two Doses of HFA- Propelled ICS Versus Placebo by Breath Operated and MDI in Moderate Asthmatic Adolescents and Adults on a Stable Regimen of ICS. 11/04-7/05: (Phase II) A Multicenter, Randomized Double-Blind, Crossover Study Comparing the Effect of DP Receptor Antagonist With Placebo Plus Leukotriene Modifier in Adult Patients With Chronic Asthma. 11/ : (Phase III) A Randomized, Parallel Group, Double- Blind, Comparative Trial Assessing Lung Function in Adults and Adolescents at Least 12 Years of Age With Persistent Asthma Who Have a Specific Genotype and are Treated With ICS or Long- Acting Bronchodilator. 11/ : (Phase III) A Randomized, Parallel Group, Double- Blind, 52 Week Comparison of Asthma Control in Subjects of African Descent Receiving ICS or ICS/Long-acting Combination. 11/04-5/04: (Phase III) A Comparative Double-Blind, Double- Dummy Clinical Study of Antihistamine, and Placebo Once Daily in Patients with Chronic Idiopathic Urticaria. 11/04-12/05: (Phase II) A Placebo and Active controlled ICS, Randomized, Parallel Group, Dose range finding of ICS Administered by Dry Powder Inhaler in Adult and Adolescent Patients With Persistent Asthma.

11 Ronald H. Saff, MD Page 11 Revised 4/15/14 3/05-6/05: A randomized, double-blind, placebo-controlled, parallel-group, multicenter, study to evaluate the efficacy and safety of once-daily, intranasal administration of a nasal spray for 4 weeks in adult and adolescent subjects (12 years of age) with perennial allergic rhinitis (PAR.) 4/05-11/05: An investigator-blind, randomized, placebo-controlled, parallel-group study to demonstrate the safety and bioequivalence of a nasal steroid compared with a nasal spray in the relief of the signs and symptoms of seasonal allergic rhinitis (SAR.) 9/05-2/07: (Phase III) A multinational, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy of ICS metered-dose inhaler at a daily dose of 160mcg either in a once-daily in the morning regimen for 16 weeks or in a 160mcg qd AM regime for 12 weeks preceded by a twice-daily regime for 4 weeks, or in an 80mcg bid regime for 16 weeks, in adults and adolescents with mild to moderate persistent asthma not treated with steroids. 9/05-1/07: A multicenter, randomized, double-blind, tripledummy, placebo-controlled, parallel group, four-week study assessing the efficacy of a nasal steroid QD versus montelukast QD in adolescent and adult subjects with asthma and seasonal allergic rhinitis who are receiving ICS/long-acting bronchodilator BID or placebo BID. 10/05-11/06: (Phase II) A randomized, double-blind, placebocontrolled trial evaluating the safety and efficacy of an antiheumatic agent twice weekly in subjects with moderate to severe persistent asthma. 11/ : A randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of once-daily, intranasal administration of a nasal spray for 4 weeks in adult and adolescent subjects (12 years of age and older) with vasomotor rhinitis. 03/ : (Phase IV) A 26-week, randomized, double-blind, parallel-group, placebo-controlled, multi-center study to evaluate the effect of an anti-ige recombinant humanized monoclonal antibody (omalizumab) on improving the tolerability of specific immunotherapy in patients with persistent allergic asthma inadequately controlled with inhaled corticosteroids

12 Ronald H. Saff, MD Page 12 Revised 4/15/14 03/06-07/06: (Phase III) Randomized, double-blind, placebocontrolled trial of the safety and efficacy of an intranasal antihistamine in patients with seasonal allergic rhinitis. 07/06-11/06: (Phase III) A multicenter, randomized, double-blind, placebo-controlled parallel group 8 week study to evaluate the efficacy of chewable montelukast when initiated at the start of school year in pediatric patients with chronic asthma 08/06-10/06: (Phase II) A randomized, double-blind, parallelgroup, multicenter, placebo-controlled dose-ranging study of Erdosteine for the treatment of stable chronic bronchitis associated with chronic obstructive pulmonary disease 09/06-06/07: (Phase II) A placebo-controlled study of the effects of Pleconaril nasal spray on common cold symptoms and asthma exacerbations following rhinovirus exposure 10/ : (Phase III) A randomized, double-blind, placebocontrolled, parallel group, stratified, multi-center, 12 week study comparing the safety and efficacy of Fluticasone and Formoterol combination (Flutiform 100/10mcg twice daily) in a single inhaler (SkyePharma HFA pmdi) with the administration of placebo or Fluticasone (100mcg twice daily) and Formoterol (10mcg twice daily) alone in adolescent and adult patients with mild to moderate asthma 10/06-04/07: (Phase IV) A comparative study of the efficacy and tolerability of maintenance treatment of patients with mild/moderate persistent asthma with Inhaled Corticosteriod QD PM versus Inhaled Corticosteriod Placebo QD PM 12/ : (Phase III) Safety study of an antihistamine nasal spray 04/ : (Phase III) A 52-Week Efficacy and Safety Non- Inferiority Study of Fluticasone Propionate/Salmeterol 250/50 mcg BID Delivered by Dry Powder Inhaler (Diskus ) Versus Mometasone Furoate/Formoterol Fumarate 200/10 mcg BID Delivered by Pressurized Metered-Dose Inhaler in Persistent Asthmatics Previously Treated with Medium Doses of Inhaled Glucocorticosteroids.

13 Ronald H. Saff, MD Page 13 Revised 4/15/14 04/ : (Phase IV) A 52-week, Randomized, Double-Blind, Parallel-Group Study of Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 mcg BID and Fluticasone Propionate (FP) DISKUS 250 mcg BID in Treatment of Subjects with Asthma 3/ : (Phase III): Active-Controlled Trial of the Safety and Tolerability of MP03-36 in Patients with Perennial Allergic Rhinitis 8/07-12/07: (Phase IV) A Randomized, Double-Blind, Placebo Controlled, Active Comparator, One Week, Cross-Over, Multicenter Study to Evaluate the Efficacy and Patient Preference of Nasal Spray Characteristics of Once-Daily, Intranasal Administration of 110mcg Fluticasone Furoate Nasal Spray and 200 mcg Fluticasone Propionate Nasal Spray in Adult Subjects with Seasonal Allergic Rhinitis 10/07-11/08: (Phase II) A double-blind placebo-controlled study to evaluate the efficacy (measured by clinic FEV1, bronchodilator response to salbutamol/albuterol, daily PEF, symptoms, rescue salbutamol/albuterol use and withdrawals due to lack of efficacy), safety (assessed by adverse events, clinical laboratory evaluations, ECGs and vital signs) and pharmacokinetics of five doses (3mcg, 6.25mcg, 12.5 mcg, 25 mcg, and 50 mcg) of GW642444M administered once daily compared with placebo over a 28 day treatment period in subjects with persistent asthma. 6/08 8/09: (Phase IV) A 12-week, randomized, double-blind, double dummy, multi-center, phase IV study comparing the efficacy and safety of inhaled corticosteroid/long acting beta agonist pmdi 160/4.5 µ x 2 actuations twice daily versus budesonide inhalation powder DPI 180µ X 2 inhalations twice daily, in adult and adolescent (> 12 years) African American subjects with asthma. 9/08 2/11: (Phase IV) A Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter, Two-Year Study to Evaluate the Ocular Safety of Once-Daily, Fluticasone Furoate Nasal Spray 110mcg in Adults and Adolescents 12 Years of Age and Older with Perennial Allergic Rhinitis.

14 Ronald H. Saff, MD Page 14 Revised 4/15/14 10/08 3/10: (Phase IV) A Double-Blind, Placebo-Controlled, Multicenter, Crossover Study to Evaluate the Effects of a Single Oral Dose of Montelukast, Compared with Placebo, on Exercise- Induced Bronchoconstrition (EIB) in Pediatric Patients Aged 4 to 14 Years. 10/08 3/09: (Phase IIb) A Multi-Centre, Randomized, Double-Blind Cross-over study to assess the non-inferiority of GW mcg Once Daily in the Evening and 100mcg Twice Daily in Adult and Adolescent Patients with Asthma. 03/09 2/11: (Phase IIIb) Safety of Olopatadine Hydrochloride Nasal Spray in Patients with Perennial Allergic Rhinitis 03/09 02/10: (Phase IIb) A Phase IIb Study to Investigate the Treatment-Sparing Effects of the IL-4 and IL-13 Receptor Antagonist in Asthma Patients Not Fully Controlled on Current Therapy 09/09 2/11 (Phase IV) A prospective, Randomized, Double- Blind Study of the Efficacy of Xolair in Atopic Asthmatics with Good Lung Capacity Who Remain Difficult to Treat (Exact). 11/09 11/11 (Phase III) A Phase III randomized, double-blind, placebo-controlled, parallel-group trial to evaluate efficacy and safety of tiotropium inhalation solution delivered via Respimat inhaler (5 µg/day) over 48 weeks as add-on controller therapy on top of usual care in patients with severe persistent asthma. 06/10 11/10 (Phase III) A Randomized, Double-Blind, Placebo- Controlled, Parallel-Group, Phase 3 Clinical Study to Assess the Efficacy and Safety of BDP HFA Nasal Aerosol (320 mcg, once daily) in the Treatment of Perennial Allergic Rhinitis (PAR) in Adult and Adolescent Subjects (12 Years of Age and Older) 08/10 12/10 (Phase II) A randomized, double-masked, placebo-controlled, parallel group, confirmatory natural exposure study of the safety and effectiveness of Bepreve (bepotastine besilate ophthalmic solution) 1/5% for the treatment of seasonal allergic conjunctivitis associated with nasal allergy symptoms

15 Ronald H. Saff, MD Page 15 Revised 4/15/14 08/10 8/11 A multi-center, randomized, double-blind, fiveway crossover pharmacodynamic study comparing Perrigo s albuterol inhalation aerosol to Teva s ProAir HFA inhalation aerosol using a methacholine challenge design in asthmatic subjects 09/10 3/11 (Phase III) A randomized, double-blind, doubledummy, parallel-group, placebo controlled (on inhaled corticosteroid medication), multicenter study to evaluate the efficacy and safety of vilanterol inhalation powder (GW642444) and salmeterol, compared with placebo in the treatment of persistent asthma in adults and adolescents uncontrolled on inhaled corticosteroids. 12/10 5/12 (Phase IIB) A multi-center, double-blind, placebo controlled, parallel-group study to establish proof-of-concept and explore the efficacy of different doses of ACT in adult patients with partly controlled asthma 3/11-11/11 A Randomized Double-Blind, Double-Dummy, Placebo-Controlled, Stratified, Parallel-Group, Multicenter, Dose Ranging Study to Evaluate the Efficacy and Safety of GSK Tablets Administered Once Daily, Fluticasone Propionate Inhalation Powder 100 mcg Twice Daily Montelukast 10mg Once Daily compared with Placebo for 8 Weeks in Adolescent and Adult Subjects with Persistent Asthma while Treated with Short Acting Beta2-agonist 3/11-present (Phase III) A 16-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Reslizumab (0.3 or 3.0 mg/kg) as Treatment for Patients (12-75) Years of Age) With Eosinophilic Asthma 8/11-present (Phase III) An Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Reslizumab (3.0 mg/kg) as Treatment for Patients With Eosinophillic Asthma Who Completed a Prior Cephalon-Sponsored Study in Eosinophillic Asthma. 4/11-9/11 (Phase II) A Randomized, Dose-Ranging, Placebo- Controlled Trial to Evaluate the Effects of Phenylephrine HCL Immediate Release Tablets on Nasal Congestion In Subjects With Seasonal Allergic Rhinitis

16 Ronald H. Saff, MD Page 16 Revised 4/15/14 4/11-2/13 (Phase II) A randomized, double-blind, placebocontrolled, parallel group study to assess the efficacy, safety, and tolerability of SAR231893/REGN668 administered subcutaneously (SC) once weekly for 12 weeks in patients with persistent moderate to severe eosinophilic asthma who are partially controlled/uncontrolled by inhaled corticosteroid (ICS) plus longacting beta 2 agonist (LABA) therapy. 7/11-8/12 (Phase III) A phase II, multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of Xolair (Omalizumab) in patients with chronic idiopathic urticaria (CIU) who remain symptomatic despite antihistamine treatment (H1) 8/11-6/12 (Phase III) A randomized, placebo-controlled trial to evaluate the effects of Phenylephrine HCI 30 mg extended release tablets on nasal congestion in subjects with allergic rhinitis. 12/11-12/12 (Phase III) A 12-week, double-blind, randomized, multi-centre, parallel-group study evaluating the efficacy, safety and patient use (User Study) of Symbicort (budesonide/formoterol) Breath Actuated Metered Dose Inhaler (BA MDI) 2x µg twice daily compared with Symbicort (budesonide/formoterol) AC (actuation counter) pmdi 2 x µg twice daily and budesonide AC pmdi 2x160µg twice daily in adult and adolescent asthmatics. 4/12-8/13 (Phase III) A 12-Week Dose-ranging Study to Evaluate the Efficacy and Safety of Fp Spriomax (Fluticasone Propionate Inhalation Powder) Administered Twice Daily compared with Placebo in Adolescent and Adult Subjects with Persistent Asthma Uncontrolled on Non-steroidal Therapy. 4/12-7/13 (Phase II) Randomized, Double-blind, Placebocontrolled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of ARRAY-502 in Adults with Persistent Asthma. 5/12-10/13 (Phase III) Randomized, Double-blind, Placebocontrolled study to assess the efficacy and safety of Lebikizumab in Patients with Uncontrolled Asthma who are on Inhalled Corticosteroids and a Second Controller Medication.

17 Ronald H. Saff, MD Page 17 Revised 4/15/14 5/12-present (Phase IV) A Safety and Efficacy Study of Inhaled Fluticasone Propionate/Salmeterol Combination versus Inhaled Fluticasone Propionate in the Treatment of Adolescent and Adult Subjects with Asthma. 11/12-3/13 (Phase IV) Investigation of the Real World Effectiveness of Beclomethasone Dipropionate (BDP) Nasal Aerosol in Perennial Allergic Rhinitis (PAR) Patients. BALANCE 11/12-9/13 (Phase III) A Randomized, Double-Blind, Parallel Group, Multicenter Study of Fluticasone Furoate/Vilanterol 200/25 mcg Inhalation Powder, Fluticasone Furoate/Vilanterol 100/25 mcg Inhalation Powder, and Fluticasone Furoate 100 mcg Inhalation Powder in the Treatment of Persistent Asthma in Adults and Adolescents. 1/13-9/13 (Phase III) A 12-week Comparison of the Efficacy and Safety and steady-state Pharmacokinetics of Albuterol Spiromax and Placebo in Subjects12 years and older with Persistent Asthma with steady state Pharmacokinetics Assessments 4/13-9/13 A 12-Week Dose-ranging Study to Evaluate the Efficacy and Safety of Fp Spiromax (Fluticasone Propionate Inhalation Powder) Administered Twice Daily compared with Placebo in Adolescent and Adult Subjects with Severe Persistent Asthma Uncontrolled on High dose Inhaled Corticosteroid Therapy. 6/13-1/14 (Phase II) A 12-week Randomized, Multiple-Dose, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Nebulized Fluticasone Propionate (FP) Dose Response in Adult Subjects with Partly Controlled and Uncontrolled Asthma 6/13-Present (Phase IIb) A Randomized, Placebo-Controlled, Phase IIb Dose-Finding Study of CYT003-QbG10, a TLR9- Agonist, in Patients with Moderate to Severe Allergic Asthma not Sufficiently Controlled on Current Standard Therapy (GINA Steps 3+4) 7/13-Present (Phase II) A Randomized, Double-blind, Placebocontrolled Study to Evaluate the Safety and Efficacy of Brodalumab in Subjects with inadequately Controlled Asthma and High Bronchodilator Reversibility.

18 Ronald H. Saff, MD Page 18 Revised 4/15/14 8/13-Present (Phase IIb) A Phase IIb, Randomized, double-blind, placebo-controlled study to assess the efficacy and safety of Lebrikizumab in patients with uncontrolled asthma who are on inhaled corticosteroids and a second controller medication 9/13-Present A Randomized, Double-Blind, Multiple-Dose Trial of Mometasone Nasal Spray, 50 µg (Mylan), Nasonex Nasal Spray, 50 µg (MSD-EU) and Placebo for the Treatment of the Signs and Symptoms of Seasonal Allergic Rhinitis in 1,520 Male and Female Volunteers 1/14-Present (Phase IIb) A Double-Blind, Randomized, Placebo- Controlled, Multicenter, Parallel-Group, Adaptive-Design, Dose Ranging Study of MK-1029 in Adult Subjects with Persistent Asthma 2/14-Present (Phase III) A Randomized, Double-Blind, Double- Dummy, Placebo-Controlled, Parallel-Group, 12-Week Clinical Study to Assess the Efficacy and Safety of 32- or 640 mcg/day of Beclomethasone Dipropionate Delivered via Breath-Actuated Inhaler (BAI) or Metered-Dose Inhaler (MDI) in Adolescent and Adult Patients 12 Years of Age or Older with Persistent Asthma 2/14-Present (Phase III) A Randomized, Double-Blind, Placebo- Controlled, Parallel-Group, 12-Week Clinical Study to Assess the Efficacy and Safety of Beclomethasone Dipropionate (80 and 160 mcg/day) Delivered via Breath-Actuated Inhaler (BAI) in Adolescent and Adult Patients 12 Years of Age and Older with Persistent Asthma