CURRICULUM VITAE KEITH D. FORWITH, Ph.D., M.D.
EMPLOYMENT HISTORY:
Advanced ENT and Allergy
Commonwealth Ear, Nose & Throat
PLACE OF BIRTH: Mansfield, OH
MARITAL STATUS: Married: Susan Forwith - 30 years
Children: 4 daughters
EDUCATION: Xavier University 1986 B.S. Chemistry
University Scholar
Purdue University 1992 Ph.D.
Case Western Reserve University 1996 M.D.
Alpha Omega Alpha honor society, Mastin Scholar
INTERNSHIP: University of Cincinnati 1996-1997
General Surgery
RESIDENCY: University of Cincinnati Hospital 1997-2001
Children's Hospital of Cincinnati
Otolaryngology—Head & Neck Surgery
LICENSURE: Kentucky 36650
Indiana 01054405
Ohio 35073389
BOARD CERTIFIED: American Board of Otolaryngology 2002, 2010
Head and Neck Surgery
PROFESSIONAL SOCIETIES: Alpha Omega Alpha
American Academy of Otolaryngology
American Thyroid Association
American Association of Clinical Endocrinologists
PUBLICATIONS:
Han JK, Forwith KD, Smith TL, et al. RESOLVE: a randomized, controlled, blinded study of bioabsorbable steroid-eluting sinus implants for in-office treatment of recurrent sinonasal polyposis. Int Forum Allergy Rhinol. 2014; 4:861-870.
Forwith KD, Chandra RK, Yun PT, et al. ADVANCE: A multi-site trial of bioabsorbable steroid-eluting sinus implants. Laryngoscope 2011; 121:2473-2480
Murr AH, Smith TL, Hwang PH, et al. Safety and Efficacy of A Novel Bioabsorbable, Steroid-eluting Sinus Stent. Int Forum Allergy Rhinol [2042-6984]. January/February 2011; 1:23-32.
Forwith, K. and Tami, T. Carotidynia: Symptom or Diagnosis? Current Opinion in Otolaryngology1999, 7: 150-154.
PRESENTATIONS: Kinetic Studies on Ovomucoid Inhibitors. PhD thesis. Purdue University, West Lafayette, IN. 1992.
Effects of Charge Changes on Association Rates of Serine Protease Inhibitors. Keith Forwith and Michael Laskowski, Jr. The Fourth Symposium of the Protein Society, San Diego, CA, August 1990.
Correlations of Ovomucoid Third Domain Inhibitory Activity Towards Several Serial Proteinases. R. Wynn, S.J. Park, M. Tashiro, K. Forwith, and M. Laskowski, Jr. The Third Symposium of the Protein Society, Seattle, WA, July 1989.
Emphysema and Ovomucoid: A Rational Approach to Designing Protein Inhibitors. Department of Chemistry, Xavier University, Cincinnati, OH, March 1991.
Protein Targeting: Import of Mitochondrial Proteins. Seminars in Biochemical Research, Purdue University, West Lafayette, IN, March 1988.
Effect of Bilirubin on Mitochondrial Asparate Aminotransferase. Undergraduate Research Thesis, D. McLoughlin, PhD, Research Director, Xavier University, Cincinnati, OH, May 1986
RESEARCH EXPERIENCE: Director of Clinical Research, Advanced ENT & Allergy (1/06 present)
“Human Participants Protection Education for Research Teams” online course sponsored by the National Institutes of Health 4/14/03
Duke University Health System Online Course for Human Subjects Protection 5/15/07
Completion of online course for Good Clinical Practice and Human Subjects Protection 5/13/09
Sub-investigator: “Randomized, Double-Blind, Placebo-Controlled Trial of XXX, XXX, and XXX plus XXX in Patients with Seasonal Allergic Rhinitis”
Sub-investigator: “A Multicenter, Randomized, Double-Blind study to Evaluate the Safety and Efficacy of XXX once daily for 5 days versus XXX once daily for 10 days in the Treatment of Acute Bacterial Sinusitis in Adults”
Sub-investigator: “A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of XXX in the Treatment of Xerostomia Secondary to Radiation Therapy for Cancer in the Head and Neck Region”
Sub-investigator: “A Pilot, Multicenter, Open-Label, Non-Comparative Study of the Safety and Efficacy of XXX in the Treatment of Acute Otitis Media Twice Daily for Seven Days in Children with Tympanostomy tubes”
Sub-investigator: “Nasal Obstruction and Septoplasty Effectiveness Trial”
Principal Investigator: “A Multicenter, Randomized, Comparative Study to Evaluate the Efficacy and Safety of XXX in the Treatment of Children Who Have Recurrent and/or Persistent Acute Otitis Media”
Principal Investigator: “A Multicenter, Long-Term, Active-Surveillance Study of Musculoskeletal Disorders That Occur After Initiating a Course of XXX or XXX Therapy for Acute Infectious Diseases in Children Who Were Enrolled in Phase 3 Clinical Trials Involving XXX”
Sub-investigator: “A Phase III, Open Label, Long-Term Safety Surveillance Study of XXX in Patients with Xerostomia Secondary to Radiation Therapy for Cancer in the Head and Neck Region”
Sub-investigator: “A Randomized, Double-Blind, Placebo-Controlled Trial of XXX and XXX plus XXX in Patients with Seasonal Allergic Rhinitis”
Sub-investigator: “A Randomized, Double-Blind, Placebo-Controlled Trial of XXX at a Dosage of One Spray per Nostril Twice Daily in Patients With Seasonal Allergic Rhinitis”
Sub-investigator: “A Phase II, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study of the Effects of XXX on Oral Mucositis in Patients Receiving Radiation Therapy for Carcinoma of the Oral Cavity, Oropharynx, or Nasopharynx”
Sub-investigator: “A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial if XXX versus XXX for the Treatment of Acute Bacterial Maxillary Sinusitis in Adults Undergoing Diagnostic Sinus Aspiration”
Sub-investigator: “Bioequivalence Study of XXX versus XXX in Patients with Seasonal Allergic Rhinitis”
Sub-investigator: “A Phase 2, Double-Blind, Placebo-Controlled, Multi-Center, Randomized Study Evaluating the Safety and Efficacy of XXX in Post-Surgical Subjects with Chronic Rhinosinusitis”
Sub-investigator: “A Phase II, Multicenter, Double-Blind, Randomized Trial Comparing XXXXXX at XXmg orally BID for 7 Days and XX mg orally BID for 5 Days in Subjects with Acute Maxillary Sinusitis Diagnosed by Antral Tap”
Sub-investigator: “An Investigator-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Demonstrate the Safety and Bioequivalence of XXXXXX Nasal Spray compared with XXXX Nasal Spray in the Relief of Signs and Symptoms of Seasonal Allergic Rhinitis (SAR).”
Principal Investigator: “Prospective, Multicenter, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of XXXXXX QD for 5 Days versus Placebo in the Treatment of Acute Bacterial Sinusitis.”
Sub-investigator: “Bioequivalence study of XXX vs XXX Nasal Spray in Patients with Seasonal Allergic Rhinitis”
Principal Investigator: “A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of XXX for 4 weeks in Adult and Adolescent Subjects with Vasomotor Rhinitis”
Sub-investigator: “A Comparison of XXX plus Lifestyle Modifications versus Lifestyle Modifications Alone for the Treatment of Laryngopharyngeal Reflux (LPR) in Adults”
Principal Investigator: “Safety and Efficacy of XXX in the treatment of Acute Otitis Media with Otorrhea through Tympanostomy Tubes (AOMT)”
Sub-investigator: “Safety and Efficacy Evaluation of XXX Compared to XXXX in the Treatment of Acute Otitis Media with Otorrhea through Tympanostomy Tubes (AOMT)”
Sub-investigator: “Safety and Efficacy Evaluation of XXX in the treatment of Acute Otitis Externa”
Sub-investigator: “An Open-Label Study of XXX Pharmacokinetics in Sinus Mucosal Tissue and Plasma in Subjects with Chronic Rhinosinusitis Following XXX or XXX”
Sub-investigator: “Double-Blind, Multi-Centre, Placebo-Controlled study to Evaluate the Equivalence of XXX vs. XXX for the Indication of Seasonal Allergic Rhinitis”
Sub-investigator: “Phase 2 Double-Blind, Placebo-Controlled, Multi-Center, Randomized study Evaluating the Safety and Efficacy of XXX in Post-Surgical Subjects with Chronic Sinusitis”
Sub-investigator: “Safety Study of XXX Nasal Spray (in subjects with perennial allergic rhinitis)”
Sub-investigator: “A prospective, randomized, double-blind, placebo-controlled, multicenter, parallel-group, study of intranasal XXX in patients with refractory, postsurgical chronic sinusitis”
Sub-investigator: “A randomized, double-blind, placebo-controlled design study to assess the effectiveness of XXX to improve oral health in patients with xerostomia secondary to radiation therapy for treatment of head and neck squamous cell carcinoma”
Sub-investigator: “Prospective, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of XXX in the treatment of acute bacterial sinusitis”
Sub-Investigator: “Safety and Efficacy of XXXX in 6-11 Year Old Patients”
Sub-Investigator: “Safety and Efficacy of XXXX in the Treatment of Peri-Operative Tube Otorrhea”
Sub-Investigator: “Safety and Efficacy Evaluation of XXXX in the Treatment of Acute Otitis Externa”
Sub-Investigator: “A Clinical Evaluation of XXXX When Used in Post-Sinus Surgery Patients with Recurrent Nasal Polyps”
Sub-Investigator: “A Clinical Evaluation of XXXX Used Following Functional Endoscopic Sinus Surgery (FESS) in Patients with Chronic Rhinosinusitis (CRS)”
Principal Investigator: “A Multi-Center, Prospective, Observational Study to Assess the Psychometric Properties of the XXX in Tinnitus Patients”
Co-Investigator: “Parental Response to Ear Disease in Children with and without Tubes”
Principal Investigator: “A Randomized, Double-Blind, Placebo-Controlled, Clinical Evaluation of the Efficacy, Safety and Tolerability of XXX in Patients with Subjective Tinnitus”
Sub-Investigator: “Safety of XXX in Patients with Perennial Allergic Rhinitis”
Sub-Investigator: “A Clinical Evaluation of XXX When Used Following Endoscopic Sinus Surgery in Patients with Chronic Sinusitis”
Principal Investigator: “Healthcare Utilization and Outcomes of XXX Treatment in the Office”
Sub-Investigator: “Natural History of Post Tympanostomy Tube Otorrhea,” Alcon C-09-041
Sub-Investigator: “Topical Treatment of Acute Otitis Media through Tympanostomy Tube (AOMT) and its Effect on Microbial Flora Distal to the Site of Infection,” Alcon C-09-017
Principle Investigator: “A Randomized, Double-Blind, Placebo-Controlled, Clinical Evaluation of the Efficacy, Safety and Tolerability of Neramexane in Patients with Subjective Tinnitus,” Protocol Number: MRZ 92579/TI/3003
Principle Investigator: “An Open-Label, Long-Term Treatment Study to assess the Long-Term Safety and Tolerability and Efficacy of Neramexane in Patients with Subjective Tinnitus,” Protocol Number: MRZ 92579/TI/3004
Sub-Investigator: “A Clinical Study of the Acclarent Tympanostomy Tube Delivery System In-Office (inVENT-IO Study)” Acclarent Protocol CPR005016 Rev. A
Principle Investigator: “Surgical Reduction of the Inferior Turbinate using a Coblation® Device for Treatment of Nasal Obstruction in a Pediatric Population: A Prospective, Multi-center Clinical Study.”
Sub-Investigator: “Clinical Protocol MQT10-01: Determination of Modified Quantitative Testing (MQT) Conditions Using Skintestor OMNI Skin Test Device,” Greer Pharmaceuticals
Sub-Investigator: “A Multi-Center, Randomized, Double-blind Placebo-Controlled, Single-Dose Trial of the Safety and Efficacy of Intravenous XXXXXX for Treatment of Pain in Pediatric Patients Undergoing Tonsillectomy,” Cumberland Pharmaceuticals Inc. Protocol# CPICL014
Sub- Investigator: “A Clinical Study of the Acclarent Tympanostomy Tube Delivery and Iontophoresis Systems In Office (inVENT-visIOn study),” Acclarent, Protocol CPR005022 Rev. C
Sub-Investigator: “A Clinical Evaluation of the Steroid-Releasing S8 Sinus Implant Used in Post-Sinus Surgery Patients with Recurrent Sinus Obstruction,” S8 Sinus Implant Pilot Study,” Intersect ENT
Sub-Investigator: “A prospective, randomized, double-blind, placebo-controlled, multicenter, 16-week Phase 2 study of OTO-104 given as a single intratympanic injection in subjects with unilateral Meniere’s disease.” Otonomy Inc.
Principle Investigator: “ A Prospective, Randomized, Multi-Center Evaluation of XXXXMiddle Turbinate Implant versus XXXX, a Bioresorbable Nasal Dressing / Sinus Stent after Endoscopic Sinus Surgery,” ENTrigue Surgical, Inc. Protocol# CSA 2011-01
Sub-Investigator: A Multicenter, Randomized, Double-Blind Clinical Trial to Assess the Efficacy and Safety of XXXXX% plus XXXXX % Otic Solution Compared to XXXX% Otic solution and to XXXXX% Otic Solution in the Treatment of Acute Otitis Media with Tympanostomy Tubes (AOMT) in Pediatric Patients, Laboratorios SALVAT, S.A. Protocol# CIFLOTIII/10IA04
Sub-Investigator: “Comparison of Single versus Repeat Doses of XXXX in the Treatment of Acute Inner Ear Tinnitus (TACTT1),” Auris Medical Inc.
Sub- Investigator: “Safety and Efficacy Evaluation of Topical XXXXXX Otic Suspension, XXX% in the Treatment of Acute Otitis Externa,” Alcon Research, Ltd. Protocol# C-10-018
Sub-Investigator: “A 16-Week RaNdomized, Double-Blind, Placebo-Controlled, PArallel-Group, Multicenter Study EValuatInG the Efficacy and Safety of Intranasal Administration of XXX, XXX and XXX μg of XXXXXX XXXX Twice a Day (BID) Using a Novel Bi-DirecTional DEvice in Subjects with Bilateral Nasal Polyposis Followed by an 8-Week Open-Label Extension Phase to Assess Safety,” OptiNose US, Inc. Protocol# OPN-FLU-NP-3102
Sub- Investigator: “Medical ThErapy veRsus BaLloon Sinus Dilation for Patients with ChrOnic RhinosinusiTis (MERLOT) Acclarent, Protocol #: CPR005028
Sub-Investigator: “A Prospective, Randomized, Double-blind, Placebo and Sham-Controlled Multicenter, Phase 1B Study of XXX-XXX given as a Single Intratympanic Injection for Intra-operative Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement” Otonomy Protocol # : 201-201101
Principle Investigator: “A Clinical Evaluation of the Safety and Efficacy of the Steroid-Releasing S8 Sinus Implant Used in Post-Sinus Surgery Patients with Recurrent Sinus Obstruction (RESOLVE STUDY)” Intersect ENT Protocol#: P500-1012
Sub-Investigator: “A 3-Month Open-Label Multicenter Study Evaluating the Safety of Intranasal Administration of xxx μg of xxxxxxxxxxx Propionate Twice a Day (BID) Using a Novel Bi-Directional Device in Subjects with Chronic Sinusitis With or Without Nasal Polyps OptiNose Protocol#: OPN-FLU-CS-3204
Sub-Investigator: “A prospective randomized, double-blind, sham-controlled, multicenter, Phase 3 study of OTO-201 given as a single intratympanic injection for intra-operative treatment of middle ear effusion in pediatric subjects requiring tympanostomy tube placement. Otonomy Otonomy Protocol #: 201-201303
Sub-Investigator: “Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Otitis Media in Subjects at the Time of Tympanostomy Tube Insertion
Alcon Research, Ltd. Protocol#: C-13-008
Sub-Investigator: “Study title: Efficacy and Safety of AM-101 in the Treatment of Acute Peripheral Tinnitus 2 (TACTT2). Auris Medical Inc.
Protocol #: AM-101-CL-12-01
Sub-Investigator “AM-101 in the Post-Acute Treatment of Peripheral Tinnitus 1 (AMPACT1) – An open-label extension to the TACTT2 study. Auris Medical Inc. Protocol #: AM-101-CL-12-03
Sub-Investigator “Safety and Efficacy of the Propel Mini Steroid-Eluting Sinus Implant Following Surgical Opening of the Frontal Sinus for Chronic Sinusitis: A Randomized Blinded Controlled Study.” Intersect ENT Protocol#: P500-0514
Sub-Investigator “The RESOLVE II StudyA Clinical Evaluation of the Safety and Efficacy of the Steroid-Releasing S8 Sinus Implant in Chronic Sinusitis Patients with Recurrent Sinus ObstructionIntersect ENT Protocol#: P500-1113