Paul Edward Wylie, M.D.
Phone:(501) 661-9191 Fax: (501) 661-1991
PERSONAL Date of Birth: March 25, 1962
Citizen: United States Office: Paul E. Wylie, M.D., P.A. 11219 Financial Center Parkway
Little Rock, AR 72211 Phone: (501) 661-9191 Fax: (501) 661-1991 Arkansas Center for Sleep Medicine
Doctors Building 500 South University, Suite 506 Little Rock, AR 72205 Phone: (501) 661-9191 Fax: (501) 661-1991 Preferred Research Partners, Inc. 11219 Financial Centre Parkway, Suite 260 Little Rock, AR 72211 Phone: (501) 553-9987 Fax: (501) 553-9986
The Arkansas Center for Sleep Medicine (ARCSM) is a private independently owned and operated sleep-testing facility that is not affiliated with or located within a hospital. The ARCSM facility is accredited by the American Academy of Sleep Medicine. Education 1980-84: University of Oklahoma Norman, Oklahoma Bachelor of Science - Microbiology 1984-88: University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma-
1988-92: University of Arkansas for Medical Sciences, Little Rock, Arkansas-
1993-95: Training in Sleep Medicine under supervision of Robert Galbraith, M.D., ABSM and Virgil Wooten, M.D., ABSM Medical Licensure 10-23-89 Arkansas N-7808 Current Employment 10/1997 – Present: Paul E. Wylie, MD, PA – Little Rock, AR – President, Physician & owner of Sleep Disorder Private Practice 10/1997 – Present: Arkansas Center for Sleep Medicine, PLLC – Little Rock, AR – President, Medical Director, owner & Clinical Investigator for polysomnography lab January 2009 – Present: Preferred Research Partners, Inc.- Little Rock, AR – President, Medical Director, Clinical Investigator & co-owner Professional Memberships 1984-88: Oklahoma State Medical Association 1988-PR: Pulaski County Medical Society, Arkansas State Medical Association, American Medical Association 1993-PR: American Academy of Sleep Medicine 1997-PR: National Sleep Foundation, American Sleep Apnea Association, Restless Leg Syndrome Foundation, Narcolepsy Network 2004-PR: Association of Clinical Research Professionals Sleep Research Society Honors and Awards 1992: Sandoz Award in Recognition of Superior Academic Achievement and Contribution to Healthcare 1992: UpJohn Achievement Award for Excellence in Clinical Care and Teaching Abilities 6/94: Certified - American Board of Psychiatry and Neurology 4/95: Certified - American Board of Sleep Medicine Staff Positions 8/92-PR: Active Medical Staff - St. Vincent Infirmary Little Rock, Arkansas 4/93-97: Medical Director - St. Vincent Infirmary Sleep Disorders Center 6/97-03: Active Medical Staff - Arkansas Heart Hospital Little Rock, Arkansas 4/94-03: Consultant Staff - Baptist Health Sleep Center Little Rock, Arkansas Publications 2003: “An Evaluation of a New Automatically Adjusting Continuous Positive Airway Pressure (CPAP) Device” 2004: “An Evaluation of a New Bi-level Mode for the Treatment of Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS)”
6/2006 Poster Presentation & article for APSS: “A Multi-center, Randomized, Controlled Trial of the First Automatically Titrating Bi-Level Positive Airway Pressure Device during Polysomnography” 2007: World Sleep Congress – “AFlex vs. CFlex: A Randomized, Blinded, Cross-Over Comparison Study”. 2007: APSS – “Evaluation of the BiPAP Auto M-Series with Biflex Device for the Treatment of OSA”. 2009: “The Treatment of Complex Central Sleep Apnea (CompCSA) Including Cheyne-Stokes Breathing (CSB), with Respironics’ BiPAP autoSV Advanced Therapy System”. 2009: “Randomized Placebo-Controlled Study of the Pillar Palatal Implant System with CPAP: Clinical Report for Clinical Protocol 845”. Published in Journal of Clinical Sleep Medicine. 2010: “Sham controlled trial of the effect of Pillar implant on adherence to CPAP therapy in Obstructive Sleep Apnea/Hypopnea Syndrome”.
Research Projects Device: 2/2000: Respironics Inc. - Comparison of Profile Lite Gel Mask to Gold Seal Gel Mask - Patient Preference 3/2000: Respironics Inc.- Simplicity Mask and Headgear - Design Consultation and Effectiveness in Patient Care 9/2000: Respironics Inc.- Simplicity Mask - Comparison of Patient Preference for Prototypes 1/2001: Respironics Inc.- Comparison of Effectiveness in Treatment of Obstructive Sleep Apnea-BiPAP versus BiFLEX 5/2001: Respironics Inc.- Comparison of Simplicity Deluxe Mask Prototype to Simplicity Original Mask 5/2001: Respironics Inc.- Evaluation of the REMSTAR AutoPAP Performance in the Treatment of Obstructive Sleep Apnea 9/2001: Respironics Inc.- Patient In-Home Comparison / Preference Study - BiPAP versus BiFlex 9/2001: Respironics Inc. - Evaluation of a new device (Synchrony) for the treatment of Cheyne- Stokes respiration in patients with congestive heart failure. 1/2002: Respironics Inc.- Comparison of Standard CPAP versus REMStar AutoPAP device versus RESMED AutoSet-T
4/2002: Respironics Inc. – User Validation Testing of the REMstar Pro with C-Flex. 6/2002: Respironics Inc.- Validation of feasibility of Average Volume Assured Pressure Support Software when Used with BiPAP Synchrony on Patients with Respiratory Insufficiency. 10/2002: Respironics Inc. - Validation of feasibility of an Auto-Adjusting Bi-Level PAP device for the treatment of OSA. 1/2003: Respironics Inc. – Validation of software upgrades to the Therapy Algorithm of an Auto-Adjusting REMstar CPAP device. 3/2004: Respironics Inc. – Evaluation of a new device – Heart PAP – for the treatment of patients with sleep disordered breathing.
05/2005: Respironics Inc. – Efficacy of an Auto-Adjusting Bi-Level PAP Device for the Treatment of OSA. 11/2005: Respironics Inc. – Evaluation of the M-Series REMStar Auto C-Flex Device for the Treatment of OSA. 05/2006:Respironics Inc.- Evaluation of the BIPAP Auto M-Series with Bi-flex Device for the Treatment of OSA 07/2006: Respironics Inc. – The Impact of BIPAP Auto SV on OSA and Complex Sleep Apnea 12/2006: Respironics Inc.- Comparison of Auto A-Flex to Auto C-flex
01/2007: Respironics Inc.- Encore Anywhere User Preference Beta Test 01/2007: Respironics Inc. – The Impact of BIPAP Auto SV on OSA and Complex Sleep Apnea. 10/2007: Respironics Inc. – The Impact of BiPAP AutoSVTM on Central Disregulated Breathing & Chronic Pain Patients 10/2007: Restore Medical, Inc. – A Randomized, Placebo-Controlled Study of the Pillar Palatal Implant System with CPAP 01/2008: Respironics Inc. – Stardust Screening Study 02/2008: Respironics Inc. – Evaluation of a Positive Air Pressure Delivery Systems on Adherence & Outcomes (System One versus Better Together)
08/2008: Respironics Inc. – Evaluation of Software Enhancements to the Respironics BiPAP AutoSV device 04/2009: Respironics Inc. – User Preference & Validation Evaluation of the New BiPAP autoSV3 device 07/2009: Philips Respironics – Evaluation of the Q-Series Auto Device for the Treatment of OSA 10/2009: Philips Respironics – Engineering Evaluation of the Next Generation of autoSV Devices 6/2010: Philips Respironics – Evaluation of the Philips Respironics BiPAP autoSV devices in subjects with Sleep Disorders 12/2010: Philips Respironics – Philips Respironics BiPAP autoSV4 User Preference Trial Other: 2009: Development of a Sleep Measure in Restless Legs Syndrome Pharmaceutical: 1/2002: A Double-Blind, Randomized, Placebo Controlled, Parallel Group Study to Investigate the Tolerability of a Dose-Escalating Regimen of XXX in Patients Suffering from Restless Legs Syndrome. 2003: A Phase III, Open-Label, Fixed Dose Study to Determine the Safety of Long-Term Administration of XXX in Subjects with Chronic Insomnia. 2003: A Phase III, randomized, double blind, placebo-controlled outpatient study to assess the efficacy and safety of two dose levels of XXX in elderly patients with primary insomnia 2003: A 12-Week, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of XXX in Patients Suffering from Restless Leg Syndrome. 2003: A Phase III, Double-Blind, Outpatient, Extension Study to Assess the Long-Term Safety of Two Dose Levels of XXX in Elderly Patients with Primary Insomnia. 2004: A 12-month, Open-Label, Flexible-Dosage (100 to 250mg/day) Study of the Safety and Efficacy of XXX in the Treatment of Patients with Excessive Sleepiness Associated with Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder 2004: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Outpatient Study to Assess the Efficacy and Safety of a Modified Release Formulation of XXX in Elderly Primary Insomnia Patients with Sleep Maintenance Difficulties
2005: A Double-Blind, Randomized, Placebo-Controlled, Multicenter, 30-Night Polysomnographic Study of XXX in Adult Patients with Primary Insomnia. 2005: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Assess the Long Term Efficacy and Safety of XXX in Primary Elderly Insomnia Patients with Sleep Maintenance Difficulties. 2006: A 28-day, Polysomnographic and Subjective Assessment of XXX, 10 and 30 mg, for the Treatment of Primary Insomnia: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial. 2006: A Long-Term Study of XXX versus Placebo Treatment Assessing Maintenance of Efficacy & Safety in Patients with Restless Legs Syndrome. 2006: A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Proof-of-Concept Study to Evaluate the Safety and Efficacy of XXX Taken in Combination with XXX for the Treatment of Subjects with Chronic Insomnia 2006: A 12-Week, Multi-Center, Double-Blind, Placebo-Controlled, Parallel Group, Flexible Dose Polysomnography Study of XXX Controlled Release for Restless Legs Syndrome (RLS) in RLS Patients with Sleep Disturbance and Periodic Limb Movements (PLM) During Sleep. 2006: An Open-Label Clinical Study to Investigate Pharmacokinetics (PK) of Different Doses (0.125 mt, 0.25 mg, 0.5 mg) of XXX Administered Once Daily in Pediatric Patients who are Individually Optimized to Stable XXX Doses for the Treatment of Idiopathic Restless Legs Syndrome (RLS). 2007: A Randomized, Double-Blind, Placebo-Controlled, Dose-Response Study to Assess the Efficacy, Safety, and Pharmacokinetics of XXX in Patients with Restless Legs Syndrome. 2007: A Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Demonstrate the Subjective Treatment Effects of XXX on Sleep Using a Post Sleep Questionnaire- Interactive Voice Response System (PSQ-IVRS) in an “At-Home Setting” in and Adult Population with Chronic Insomnia. 2007: An Open-Label, 52-week Extension Study Assessing XXX Safety and Efficacy in Patient with Restless Legs Syndrome. 2007: A Randomized, Double-Blind, Placebo-Controlled, Parallel, Proof of Concept Study to Evaluate the Effectiveness of XXX to Advance the Timing of Sleep in Individuals with Delayed Sleep Phase Syndrome (DSPS). 2007: Efficacy and Safety of 2 mg/day of XXX on Sleep Maintenance Insomnia with a Sub-Study of the Effect of XXX on Stable Type II Diabetes Mellitus: a One Year, Mult-Center, Randomized, Double-Blind, Placebo-Controlled Study.
2007: A Six-Week, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Efficacy and Safety, Sleep Lab Trial with XXX in Patients with Chronic Primary Insomnia. 2007: A Randomized, Double-Blind, Placebo-Controlled, Dose-Response Study to Assess the Efficacy and Safety of XXX in Patients with Restless Legs Syndrome. 2007: Fifty-Two Weeks, Open Label Extension Trial to Evaluate Safety and Efficacy of XXX in Outpatients with Chronic Primary Insomnia who Completed the Clinical Trial Protocol 176001 or 176002. 2007: A Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Multicenter Outpatient Trial of XXX in Adults with Primary Insomnia. 2008: XXX Dose-Ranging Trial: A Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Multicenter Outpatient Trial of XXX in Adults with Nonrestorative Sleep. 2008: A Phase 2, Randomized, Double-Blind, Placebo-and Active-Comparator-Controlled Study of the Safety and Efficacy of XXX in Outpatients with Insomnia. 2009: Randomized, Double-Blind, 12-Month Study of XXX in Subjects With Restless Legs Syndrome. 2009: A Randomized, Double-Blind, Placebo-Controlled, 3-Way Crossover, Multicenter Polysomnography Study of Pregabalin and Pramipexole in Adults with Restless Legs Syndrome. 2009: Effects of Pregabalin on Sleep Maintenance in Subjects with Fibromyalgia Syndrome and Sleep Maintenance Disturbance: A Randomized, Placebo-Controlled, 2-Way Crossover, Polysomnography Study 2010: A Randomized, Placebo-Controlled, Double-Blind, Fixed-Dose Study of the Efficacy and Safety of Eszopiclone in Children (6 to 11 years) and Adolescents (12 to 17 years) with Attention-Deficit/Hyperactivity Disorder-Associated Insomnia. 2010: A Long-Term, Open-Label, Safety Study of Eszopiclone in Children (6 to 11 years) and Adolescents (12 to 17 years) with Attention-Deficit/Hyperactivity Disorder-Associated Insomnia. 2010: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of Nitazoxanide in Adults with Acute Uncomplicated Influenza. (Sub-Investigator) 2010: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-27018966 in the Treatment of Patients With Irritable Bowel Syndrome With Diarrhea. (Sub-Investigator) 2010: A Double-Blind, Randomized, Multicenter Study of Prasugrel Compared to Placebo in Adult Patients with Sickle Cell Disease. (Sub-Investigator)
2010: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Intravenous Peramivir in Subjects with Uncomplicated Influenza. The RELIEF Study. (Sub-Investigator) 2011: A Randomized, Double-Blind, Placebo-Controlled Study of Nitazoxanide in Adults and Adolescents with Acute Uncomplicated Influenza. (Sub-investigator) 2011: A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Phase III, Efficacy & Safety Study of 3 Fixed Dose Groups of TC-5214 (S-mecamylamine) as an Adjunct to an Antidepressant in Patients with Major Depressive Disorder Who Exhibit an Inadequate Response to Antidepressant Therapy. 2011: A Multicenter, Open Label, 2-Group, Dose Escalation Study of Monotherapy Administration of Rotigotine in Pediatric Subjects with Idiopathic Restless Legs Syndrome. Phase IIA 2011: An Open Label, Long-Term Follow-Up Study to Determine the Safety, Tolerability, & Efficacy of Rotigotine Transdermal System as Monotherapy in Pediatric Subjects with Restless Legs Syndrome. Phase IIA
Beth D. Jacob Beth Jacob is a partner in the firm's New York office. Her practice focuses on complex civil litigation, trial practice and intellectual property, in particular representing generic pharmaceutical companies in Hatch-Waxman Ms. Jacob's experience includes primary responsibility for major litigation matters and trials, including mass tort product
Bundle of Misery The Diagnosis for an Inconsolable Infant Might Be Reflux, Not Colic Kim Fernandez Special to The Washington Post August 27, 2002; Page F1 this year in the Archives of Pediatrics & Adolescent Medicine, GERD "is a common weeks later. If Joseph was awake and not disease of infancy, with a prevalence as high as 18 percent in [otherwise] healthy constantly, he was