Scott Evan Eder, M.D., F.A.C.O.G., F.A.C.S
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CURRICULUM VITAE
1982 1983 1984 1985 Scott Evan Eder, M.D., F.A.C.O.G., F.A.C.S.
OFFICE ADDRESS: 666 Plainsboro Rd., Bldg. 100, Suite D Plainsboro, New Jersey 08536 (609) 799-5010 Fax: (609) 799-0819
E-MAIL: [email protected]
1. EDUCATION
A. Undergraduate
1970.1974 B.A., History Boston University Boston, Massachusetts
B. Graduate and Professional
1974-1976 M.S., Physiology Rutgers University New Brunswick, New Jersey
1976-1982 Doctor of Medicine Universite Catholique de Louvain Brussels, Belgium
1998-2000 M.S., Administrative Medicine/Preventative Health University of Wisconsin Medical School Madison, Wisconsin
1 2. POSTDOCTORAL TRAINING
a. Internship and Residency
1982.1983 Department of Internal Medicine St. Louis University Group Hospitals St. Louis, Missouri
1983-1987 Department of Obstetrics & Gynecology UMDNJ-New Jersey Medical School Newark, New Jersey
3. LICENSURE
a. New Jersey MA43626 Missouri 36473 Pennsylvania MD-041421E Florida ME 99513 New York 163424 (inactive)
4. CERTIFICATION
American Board of Obstetrics & Gynecology Diplomat 1989 Recertified 1997 Recertified 2007 Voluntary Recertification, 2012, 2013, 2014, 2015, 2016, 2017
Certifying Commission in Medical Management Certified Physician Executive 2001 Association of Pharmaceutical Physicians and Certified Physician Investigator Investigators 2015
National Certification Corporation Certificate of Added Qualification in
Electronic Fetal Monitoring 2012 5. NARCOTICS CERTIFICATION
a. Federal DEA AE2488460
b. New Jersey CDS D060991 6. UNIVERSITY APPOINTMENTS
1983.1987 Clinical Instructor II UMDNJ-New Jersey Medical School Newark, New Jersey
1988.1992 Clinical Instructor UMDNJ-New Jersey Medical School Newark, New Jersey
1992-2005, Clinical Assistant Professor 2008-present Department of Obstetrics/Gynecology UMDNJ-New Jersey Medical School Newark, New Jersey
2016-present Instructor (Gynecology) Internal Medicine Residency Program Capital Health System Trenton, New Jersey
7. HOSPITAL APPOINTMENTS
July 1987-December 1987 St. Mary’s Hospital Good Samaritan Hospital Humana Hospital Wellington Regional Medical Center Palms West Hospital West Palm Beach, Florida
February 1988-present Capital Health System Trenton, New Jersey
October 1988-2005 UMDNJ-University Hospital Newark, New Jersey
July 1989-present University Medical Center of Princeton Plainsboro, New Jersey
September 1994-2003 Robert Wood Johnson Medical Center At Hamilton Trenton, New Jersey
3 8. OTHER PROFESSIONAL POSITIONS
1988-1990 Clinician Planned Parenthood of Mercer County Trenton, New Jersey
1989.1991 Clinician Rutgers Community Health Plan Lawrenceville, New Jersey
1989.1991 Medical Director 1995.1996 Familyborn Birth Center Princeton, New Jersey
1994-1997 Host, “Healthcare Radio Show” New Jersey Network Trenton, New Jersey
2006-present Physician-Medical Missions to Niger and Rwanda International Organization for Women & Development, Inc. Rockville Centre, New York
2011-present Medical Consultant Exeltis USA, Inc. 180 Park Avenue Florham Park, New Jersey 07932
2015-present Medical Consultant Prima-Temp, Inc. 2820 Wilderness Place, Unit C Boulder, CO 80027
2015-present Medical Consultant Reckitt Benckiser LLC One Phillips Parkway Montvale, NJ 07645
2016-present Medical Monitor (ContraMed CMDOC-0022) SynteractHCR, Inc. 5759 Fleet Street Suite 100 Carlsbad, California 9200 9. AWARDS AND HONORS 1974 B.A. with distinction 1986 M.D. cum laude 1992, 1995, 1998, 2001, AMA Physician’s Recognition Award 2004, 2007 2015 Medical Society of NJ Quality Recognition Award
10. BOARD OF DIRECTOR/TRUSTEES
1992-2001 Associate Board of Governors Capital Health System Trenton, New Jersey
1993-present Board of Trustees Mercer County Medical Society Trenton, New Jersey
11. MAJOR COMMITTEE ASSIGNMENTS
a. National and Regional
One Health Plan of NJ, Inc Southern Physician Advisory One Centennial Avenue Committee Piscataway, NJ 08855 2001-2008
Empire Blue Cross/BS Practice Guidelines Subcommittee Wellchoice, Inc. 2000-2001 11 West 42nd Street Clinical Quality Committee New York, NY 10036 2003-2007
Physician’s Healthcare Plan of NJ Credentials Committee Lawrenceville, New Jersey 1995-1997
Clover Health LLC Credentials Committee Harborside Financial Center Plaza 10 2014-present Jersey City, NJ 07311
5 b. Hospital
Helene Fuld Medical Center Chairman, Medical Records (Capital Health System) 1991-1996
Continuing Medical Education 1989-1990
Credentials 1992-2000
Operations and Other Procedures 2000-2003. Chairman, 2002
Medical Center at Princeton Credentials 2000-2009
c. Departmental
Helene Fuld Medical Center Secretary, Ob/Gyn 1991-1992
Vice Chairman, Ob/Gyn 1994-1995
Chairman, Ob/Gyn 1995-1997
12. MEMBERSHIP IN PROFESSIONAL SOCIETIES
American College of Obstetricians & Gynecologists- Fellow American College of Surgeons- Fellow American Medical Association New Jersey Medical Society Mercer County Medical Society- President, 2004-2005 Association of Clinical Research Professionals 13. MAJOR RESEARCH INTERESTS
Obstetrics & Gynecology, Women’s Health
14. GRANT HISTORY
Rhone-Poulenc Rorer (RPR 106522-201) Principal Investigator, “A Randomized, Double-blind, Multi-Center Progestin Efficacy Study of Thee Doses of RPR Estradiol/Norethisterone Acetate (NETA) Patches in Sequential Wear HRT Regimen Compared to an Estradiol 50 Patch” 1994
Ortho-McNeil Pharmaceutical, Inc. (CAPSS-062) Principal Investigator, “Effect of an Extended Pill-Free Interval on Follicular Activity, Ortho Tricyclin and Alesse,” 1997- 1998
Ortho-McNeil Pharmaceutical, Inc. (CAPSS-053) Principal Investigator, “Time to Symptomatic Relief: Terazol 3 Vaginal Cream vs. Diflucan,” 1998
Berlex (Protocol 96043) Principal Investigator, “A Multicenter, Double-Blind Randomized Study of Continuous Transdermal Estradiol-Levonorgesterol Combination, Compared to Continuous Transdermal Estradiol to Examine the Safety and Effects on Endometrium, Symptoms, and Bleeding Patterns in Post Menopausal Women,” 1998- 1999
Searle (N6S-97-02-001) Principal Investigator, “Dosing Optimization with Intranasal Synarel (Naferelin Acetate) for Patients with Endometriosis,” 1999
Ortho-McNeil Pharmaceutical, Inc. (CAPSS-153) Principal Investigator, “A Multicenter, Randomized, Open-Label, Parallel Group Study to Evaluate the Endometrial Safety Following Treatment with Ortho-Prefest Compared to Prempro in Postmenopausal Women,” 2001
Ortho-McNeil Pharmaceutical, Inc. (CAPSS-320) Principal Investigator, “Comparison of the Safety and Efficacy of Patient Controlled Analgesia Delivered by Fentanyl HCl Transdermal System Versus Morphine IV Pump for Pain Management after Non- emergent Lower Abdominal or Pelvic Surgery,” 2004-2005
Novo Nordisk Pharmaceuticals, Inc. (VAG-2195) Principal Investigator, “A 12 month double-blind, randomized, parallel-group, placebo controlled, multicenter trial to investigate the efficacy and safety of Vagifem Low Dose (10microgram 17 beta estradiol vaginal tablet) for the treatment of postmenopausal atrophic vaginitis symptoms,” 2005
7 Duramed Research Inc. (DR-MPG-201) Principal Investigator, “A Phase II, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate Induction of Withdrawal Bleeding After Administration of Oral Micronized Progesterone in Women with Secondary Amenorrhea” 2005
Duramed Research Inc. (DR-PSE-309) Principal Investigator, “A Multicenter, Open- Label Study to Evaluate the Efficacy and Safety of an Extended Cycle, Low Dose, Combination Oral Contraceptive Regimen, DP3-Lo84/10, Which Utilizes Ethinyl Estradiol During the Seven Day Interval Between Each 84-day Cycle of Combination Therapy For the Prevention of Pregnancy in Women” 2005
Luitpold Pharmaceuticals, Inc. (1 VIT 03001) Principal Investigator, “Comparison of the Safety and Efficacy of a Unique Intravenous Iron Preparation (Vit 45) versus Oral Iron in Subjects Who Display Post Partum Anemia” 2005
Church & Dwight Co. Inc. (ST-6981) Principal Investigator, “Analytical Accuracy Test to Evaluate Percent Agreement Between a Male Fertility Diagnostic Device and Manual Sperm Analysis” 2006
Wyeth Pharmaceuticals Inc. (3115A1-304-WW) Principal Investigator, “A Double-Blind, Randomized, Placebo and Active Controlled Efficacy and Safety Study of Bazedoxifene/Conjugated Estrogens Combinations for Prevention of Endometrial Hyperplasia and Prevention of Osteoporosis in Postmenopausal Women” 2006
Organon USA Inc. (292002) Principal Investigator, “A Randomized, Open Label, Comparative, Multi-Center Trial To Evaluate Contraceptive Efficacy, Cycle Control, Safety And Acceptability Of A Monophasic Combined Oral Contraceptive (COC) Containing 2.5 Mg Nomegestrol Acetate (NOMAC) and 1.5 Mg Estradiol (E2), Compared To A Monophasic COC Containing 3 MG Drospirenone (DRSP) and 30 Micrograms Ethinyl Estradiol (EE)” 2006
Church & Dwight Co. Inc. (ST-7005) Principal Investigator, “ An Observational Study to Evaluate the Safety and Ease of Self-vaginal Specimen Collection by Untrained Consumers for Intended OTC Diagnosis of Bacterial Vaginosis (BV) and Yeast Infection (YI)” 2006
Duramed Research Inc. (DR-CEN-302) Principal Investigator, “A Randomized, Multicenter, Double-blind, Placebo-Controlled Trial to Compare the Effects of 12 Weeks of Treatment with Cenestin Vaginal Cream vs. Placebo Vaginal Cream on Vulvovaginal Atrophy in Healthy Postmenopausal Women,” 2006
Xanodyne Pharmaceutical Inc. (XP12B-MR-303) Principal Investigator, “A Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Study to Evaluate Efficacy And Safety of 1.3g Oral Doses of XP12B-MR TID During Menstruation For The Treatment of Menorrhagia,” 2006 Symbollon Pharmaceuticals, Inc., (Protocol 005) Principal Investigator, “A Phase III, Multicenter, Randomized, Double Blind, Placebo-Controlled Study of IoGen for the Treatment of Moderate or Severe, Periodic Breast Pain Associated with Symptomatic Fibrocystic Breast Disease in Otherwise Healthy, Euthyroid, Premenopausal Women,” 2006
Hormos Medical Ltd. (Protocol 15-50310) Principal Investigator, “Efficacy and Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women: A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing Oral Ospemifene 30 mg and 60 mg Daily Doses With Placebo,” 2006
Medicis Pharmaceutical Corporation (MP-0104-18) Principal Investigator, “A Randomized, Double-Blind, Placebo-Controlled Study to Examine the Effects of Minocycline Extended-Release Tablets on Spermatogenesis in Human Males,” 2007
Duramed Research Inc. (Protocol DR-DSG-302) Principal Investigator, “ A Prospective, Multicenter, Randomized, Double-blind Study to Evaluate Hormone Patterns and Ovarian Follicular Activity with the Oral Contraceptive Regimen DR-1021,” 2007
TriPath Imaging, Inc. (Protocol MP-3-01) Principal Investigator, “Intended Use Study of the SurePath Molecular Pap,” 2007
Xanodyne Pharmaceutical Inc. (Protocol XP12B-MR-301) Principal Investigator, “A Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Study to Evaluate Efficacy and Safety of 0.65g and 1.3g Oral Doses of XP12B-MR TID Administered During Menstruation for the Treatment of Menorrhagia,” 2007
Warner Chilcott (Protocol PR-05806) Principal Investigator, “An Open Label Study of the Safety and Efficacy of a New Low Dose Oral Contraceptive Containing Norethindrone Acetate and Ethinyl Estradiol,” 2007
Repros Therapeutics, Inc. (Protocol ZPE-201) Principal Investigator, “A Phase II, Three- Arm, Parallel Design, Dose-Ranging, Placebo-Controlled, Randomized, Double-Blind, Multicenter Study Evaluating the Safety and Efficacy of the Selective Progesterone Receptor Modulator Proellex (CDB-4124) in the Treatment of Premenopausal Women with Symptomatic Endometriosis,” 2007
TriPath Imaging Inc., (Protocol TriPath 2007-2009) Principal Investigator, “Pre-Clinical Evaluation of a Panel of Biomarkers in the Differential Diagnosis of Ovarian Cancer in Patients with Abnormal Pelvic Mass,” 2008
FemmePharma Global Healthcare, Inc., (Protocol FP1198-001) Principal Investigator, “A Randomized , Double-Blind, Placebo-Controlled, Dose-Ranging, Multicenter Evaluation of the Use of Topically Administered Danazol versus Placebo in Subjects with pain associated with Fibrocystic Breast Disease,” 2008
9 Bayer Healthcare Pharmaceuticals Inc., (Protocol 310184) Principal Investigator, “A multicenter, double-blind, randomized, placebo-controlled study to determine the lowest effective dose of oral Angeliq (drospirenone 0.5 mg/17 beta estradiol 0.5mg, drospirenone 0.25mg/17 beta estradiol 0.3mg) for the relief of moderate to severe vasomotor symptoms in postmenopausal women over a treatment period of 12 weeks,” 2008
Roche Molecular Systems, Inc., (Protocol MWP-HPV-159) Principal Investigator, “Evaluation of the Amplicor HPV Test and the Linear Array High Risk HPV Genotyping Test for the Detection of High-Grade Cervical Disease in Women Undergoing Routine Cervical Cancer Screening Using Cervical Samples Prepared with the cobas x421 Instrument,” 2008
Graceway Pharmaceuticals LLC., (Protocol GW01-0805) Principal Investigator, “A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter, Efficacy and Safety Study of Imiquimod Creams in the Treatment of External Genital Warts,” 2008
KV Pharmaceutical Company, (Protocol CBC-303-603-622467) Principal Investigator, “A Randomized, Double-Blind, Parallel-Group Study to Compare the Safety and Efficacy of Clindamycin/Butoconazole Vaginal Cream with Butoconazole Alone in the Treatment of Mixed Bacterial Vaginosis/Vulvovaginal Candidiasis Infections,” 2008
QuatRx Pharmaceuticals Company, (Protocol 15-50821) Principal Investigator, “Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated with Sexual Activity, Symptoms of Vulvar and Vaginal Atrophy (VVA), Associated with Menopause: A 12-Week, Randomized, Double-Blind, Placebo- Controlled, Parallel Group Study Comparing Oral Ospemifene 60mg Daily Dose With Placebo in Post Menopausal Women,” 2008
OraSure Technologies, Inc., (Protocol OQ-HCV-F-8) Principal Investigator, “Clinical Investigation to Evaluate the Performance of the OraQuick Rapid HCV Antibody Test,” 2008
Ferring Pharmaceuticals, (Protocol FPI GNRH 2008-03) Principal Investigator, “A Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo Controlled Study to Assess the Efficacy and Safety of Three Dosage Strengths of Pulsatile GnRH Delivered from a Iontophoretic Patch (Lutrepatch) Compared to Oral Treatment with Clomiphene Citrate or Placebo in Anovulatory or Oligoovulatory Infertile Females,” 2009
Bayer HealthCare Pharmaceuticals, Inc., (Protocol 91555) Principal Investigator, “Multicenter, Open-label, Uncontrolled Study to Investigate the Efficacy and Safety of the Transdermal Contraceptive Patch Containing 0.55mg Ethinyl Estradiol and 2.1mg Gestodene in a 21-day Regimen for 13 Cycles in 1650 Healthy Female Subjects” 2009 Church and Dwight Co. Inc., (Protocol #246) Principal Investigator, “Collection of Urine Samples From Pregnant Women with Defined Prenatal Gender,” 2009
Church and Dwight Co. Inc., (Protocol #270) Principal Investigator, “Collection of Early Pregnancy Urine Samples,” 2009
Church and Dwight Co., Inc., (Protocol #279) Principal Investigator, “Collection of Urine Samples from Non-Pregnant Females of Reproductive Age Around Time of Expected Period.” 2009
Duramed Research, Inc., (Protocol #DR-103-301) Principal Investigator, “A Multicenter, Open-Label Study to Evaluate The Efficacy and Safety of A Combination Oral Contraceptive Regimen For The Prevention Of Pregnancy In Women,” 2009
Graceway Pharmaceuticals, LLC, (Protocol # GW05-0904) Principal Investigator, “ A Multicenter, Randomized, Investigator-Blinded, Phase 2, Dose Ranging Study of Metronidazole Vaginal Gel in the Treatment of Bacterial Vaginosis,” 2010
Church and Dwight Co., Inc., (Protocol ST-7329) Principal Investigator, “Analytical Accuracy Test to Evaluate Percent Agreement Between a Male Fertility Diagnostic Test Device and Manuel Semen Analysis,” 2010
Church and Dwight Co., Inc., (Diagnostics Protocol 318) Principal Investigator, “Preliminary Evaluation of Various Optical Measurement Methodologies for Semen Analysis,” 2010
Boehringer-Ingelheim Pharmaceuticals, Inc., (Protocol 511.156) Principal Investigator, “A Twenty-four Week, Randomized, Double-blind, Placebo Controlled, Safety and Efficacy Trial of Flibanserin, with Up-titration, 100 Milligrams Administered Orally Once Daily in Naturally Postmenopausal Women with Hypoactive Sexual Desire Disorder in North America,” 2010
Warner Chilcott Company LLC, (Protocol PR-00110.0) Principal Investigator, “Effect of Udenafil on Spermatogenesis: A Double-blind, Randomized, Placebo-controlled, Parallel-group Study,” 2010
Church & Dwight Co. Inc, (Protocol ST-7356) Principal Investigator, “Accelerated Aging of the First Response Male Fertility Test,” 2010
Vermillion, Inc., (Protocol OVA2-001-C03) Principal Investigator, “Marker Discovery and Clinical Trial Testing for OVA2 using Serum From Women with a Documented Ovarian Adnexal Mass,” 2010
Gynuity Health Projects, Principal Investigator, “Vaginal and Rectal Clostridial Carriage Among Women of Reproductive Age In The United States,” 2011
Teva Branded Pharmaceutical Products R & D, Inc., (Protocol PSE-HSP-203) Principal Investigator, “A Multinational, Multicenter, Randomized, Open-Label Study to Evaluate
11 the Impact of a 91-day Extended Cycle Oral contraceptive Regimen, Compared to Two 28-day Standard Oral Contraceptive Regimens, on Hemostatic Parameters in Healthy Women,” 2011
Warner Chilcott (US), LLC, (Protocol PR-04409) Principal Investigator, “A Randomized, Double-Blind, Placebo-Controlled Comparison of Two Dosing Regimens of a Low Dose Estradiol Vaginal Cream With Regard to Their Safety and Efficacy in the Treatment of Symptoms of Vaginal Atrophy in Postmenopausal Women,” 2011
Emotional Brain New York LLC, (Protocol EB 82) Principal Investigator, “Lybrido At Home: A Double Blind, Randomized, Placebo-Controlled Dose-Finding Study to Investigate the Efficacy of Lybrido in Healthy Female Subjects with Hypoactive Sexual Desire Disorder (HSDD) and Low Sensitivity for Sexual Cues,’ 2011
Abbott Laboratories, (Protocol M12-663) Principal Investigator, “A Phase 2a Proof of Concept Study to Evaluate the Safety and Efficacy of Elagolix in Pre-Menopausal Women with Heavy Uterine Bleeding and Uterine Fibroids,” 2011
Amneal Pharmaceuticals, LLC, (Protocol AM-ESD-001) Principal Investigator, “A Double-Blind, Randomized, Parallel-Group, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Bioequivalence of a Generic Estradiol Vaginal Tablet and Reference Listen Vagifem (Estradiol Vaginal Tablets) and Compare Both Active Treatments to a Placebo Control in the Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy Associated with Menopause,” 2012
Merck Sharp & Dohme Corporation, (Protocol MK-8175A-022-019) Principal Investigator, “A Phase III, Randomized, Open-Label, Active-Control, Multicenter Trial to Study the Contraceptive Efficacy and Safety of the Commercial Batch of Oral Tablets of MK-8175A (Nomegestrol Acetate-17B-estradiol) in Health, Sexually-Active Women Aged 18-50 Years,” 2012
Medicis Global Services Corporation, (Protocol MMP-1601-01) Principal Investigator, “A Phase 3, Multicenter, Randomized, Double-blind, Vehicle-controlled Study to Evaluate the Safety and Efficacy of Product 55394 in the Treatment of Bacterial Vaginosis,” 2012
Novum Pharmaceutical Research Services, (Protocol 71036006) Principal Investigator, “A Randomized, Investigator-Blind, Placebo-Controlled, Parallel Design, Multiple-Site Study Comparing Teva Pharmaceuticals Estradiol Vaginal Tablets with Vagifem (Estradiol) Vaginal Tablets (Novo Nordisk) in the Treatment of Atrophic Vaginitis,” 2012
AbbVie Inc., (Protocol M12-665) Principal Investigator, “A Randomized, Double Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Elagolix in Subjects with Moderate to Severe Endometriosis Associated Pain,” 2013
Church & Dwight Co. Inc., (Protocol 421) Principal Investigator,” Collection of Daily AM & PM Urine Samples From Ovulating Women,” 2014 Endoceutics, Inc., (Protocol ERC-238) Principal Investigator, “ Intravaginal Prasterone (DHEA) Against Vulvovaginal Atrophy Associated With Menopause (Placebo- Controlled, Double Blind and Randomized Phase III Study,)” 2014
Church & Dwight Co. Inc. (Protocol ST 7485) Principal Investigator, “Clinical Evaluation of Effects of Four Personal Lubricants on Vaginal pH Among Asymptomatic Women 18 to 40 Years of Age’” 2014
Symbiomix Therapeutics, LLC (Protocol SYM-1219) Principal Investigator, “A Phase 2, Multi-center, Prospective, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effectiveness and Safety of SYM-1219 for the Treatment of Bacterial Vaginosis,” 2014
Mylan Pharmaceuticals, Inc. (Protocol EVCR-11196) Principal Investigator, “Clinical Endpoint Therapeutic Equivalence Multi-Site Study Comparing Estradiol Vaginal Cream (0.01%; Mylan) to Estrace Cream (0.01%; Warner Chilcott) in Postmenopausal Females with Atrophic Vaginitis,” 2014
Bayer HealthCare Pharmaceuticals (Protocol BAY 98-7196/15832) Principal Investigator, “A Randomized, Double Blind, Double Dummy, Parallel Group, Multi- Center Phase IIb Study to Assess the Efficacy and Safety of Different Dose Combinations of an Aromatase Inhibitor and a Progestin in a Vaginal Ring Versus Active Comparator and Placebo in Women with Symptomatic Endometriosis (moderate to severe pain) over a 12 Week Treatment Period,” 2014
Pharmacosmos A/S (Protocol P-Monofer-IDA-01) Principal Investigator, “A Phase III, Randomized, Open Label, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer) and Iron Sucrose in Subjects with Iron Deficiency Anemia and Who Are Intolerant or Unresponsive to Oral Iron Therapy or Who Need Iron Rapidly,” 2014
TherapeuticsMD (Protocol TXV 14-01) Principal Investigator, “A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Trial to Evaluate the Safety and Efficacy of TX-004HR in Postmenopausal Women with Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy,” 2014
Laboratorios Leon Farma, S. A. (Protocol CF111/303) Principal Investigator, “ A Pivotal, Multicenter, Non-Comparative Trial on the Contraceptive Efficacy, Safety, Tolerability and Pharmacokinetics of LF111 (Drospirenone 4.0 mg) During 13 Cycles,” 2014
Palatin Technologies (Protocol BMT-301) Principal Investigator, “A Phase 3, Multicenter, Randomized, Double Blind, Placebo-Controlled, Parallel-Group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Subcutaneously Administered Bremelanotide in Premenopausal Women with Hypoactive Sexual Desire Disorder (HSDD)”2015
Viamet Pharmaceuticals, Inc (Protocol VT-1161) Principal Investigator, “A Phase 2, Randomized, Placebo-Controlled, Double-Blind, Dose-Ranging Study to Evaluate the
13 Efficacy and Safety of VT-1161 Oral Tablets in the Treatment of Patients with Recurrent Vulvovaginal Candidiasis,” 2015
Symbiomix Therapeutics, LLC (Protocol SYM-1219) Principal Investigator, “A Phase 3, Multi-center, Prospective, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effectiveness and Safety of SYM-1219 2 Grams for the Treatment of Women and Post-menarchal Adolescent Girls with Bacterial Vaginosis” 2015
Agile Therapeutics, Inc (Protocol ATI-CL23) Principal Investigator, “ A Single-arm, Open label, Multi-center Phase 3 Study of the Contraceptive Efficacy, Safety and Tolerability of the AG200-15 Transdermal Contraceptive Delivery System TCDS) 2015
Curatek Pharmaceuticals, LLC (Protocol MTC-001) Principal Investigator, “Solubilized Metronidazole And/or Terconazole Gels Intra-Vaginal Efficacy and Safety (SMART GIVES,”) 2016
Novum Pharmaceutical Research Services, Inc (Protocol 71462901) Principal Investigator “A Randomized, Double-Blind, Placebo-Controlled, Parallel Design, Multiple-Site Study to Evaluate the Therapeutic Equivalence of Estradiol Vaginal Cream USP, 0.01% (Alvogen Pine Brooke LLC) to Estrace Estradiol Vaginal Cream USP, 0.01% (Warner Chilcott) in the Treatment of Atrophic Vaginitis,” 2016
Lumenis (Protocol LUM-ABU-AP-16-01 VVA) Principal Investigator, The Safety and Efficacy of the FemTouch laser for the Treatment of Vulvovaginal Atrophy in Post- Menopausal Women.” 2016
Estetra SPRL (Protocol MIT-Es0001-C302) Principal Investigator, “ A Multicenter, Open-label, Single-Arm Study to Evaluate the Contraceptive Efficacy and Safety of a Combined Oral Contraceptive Containing 15mg Estetrol and 3 mg Drospirenone,” 2016
Pharmacosmos (Protocol P-Monofer-IDA-03) Principal Investigator, “A phase III, randomized, open-label, comparative safety and efficacy trial of intravenous iron isomaltoside (Monofer) and iron sucrose in subjects with iron deficiency anemia who are intolerant or unresponsive to oral iron therapy or in whom the hemoglobin measurement in Investigators opinion were sufficiently low as to require rapid repletion of iron stores to minimize the risk of receiving a blood transfusion,” 2016 15. MAJOR TEACHING EXPERIENCE
Instruction to residents and medical students in obstetrics and gynecology and family practice. Volunteer faculty, Clinical Assistant Professor, Department of Obstetrics, Gynecology and Women’s Health, New Jersey Medical School
Gynecology instructor, Internal Medicine Residency Program, Capital Health System, Trenton, NJ.
Lecturer and trainer to physician audiences for major pharmaceutical companies including Organon, Warner Chilcot, Ortho-McNeil, Lilly, Merck, and Rhone-Poulenc- Rorer.
Producer and Host, “Healthcare Radio Show,” New Jersey Network, New Jersey’s state sponsored public broadcasting station, offering the public a weekly half hour call in, drive time healthcare show highlighting the latest developments in medicine.
16. PRINCIPAL CLINICAL AND HOSPITAL SERVICE RESPONSIBILITIES
Inpatient and outpatient care, Capital Health System and Medical Center of Princeton Principal Investigator, Women’s Health Research Center
17. MAJOR ADMINISTRATIVE RESPONSIBILITIES
1986.1987 Chief Resident Department of Ob/Gyn UMDNJ-New Jersey Medical School Newark, New Jersey
1991-2009 Founder and C.E.O. Delaware Valley Ob/Gyn and Infertility Group, P.C. Lawrenceville, New Jersey
1995-1997 Chairman Department of Obstetrics & Gynecology Helene Fuld Medical Center Trenton, New Jersey
1998-present Owner Women’s Health Research Center/The Center for Women’s Health & Wellness, L.L.C. Plainsboro, New Jersey
15 2004-2005 President Mercer County Medical Society Ewing, New Jersey
18. PRIVATE PRACTICE
July 1987-December 1987 1897 Palm Beach Lakes Blvd. West Palm Beach, Florida
February 1988-Sept. 2009 2 Princess Road, Suite C Lawrenceville, New Jersey
September 2009-present 666 Plainsboro Road Plainsboro, New Jersey
3100 Princeton Pike Bldg. 1 Lawrenceville, New Jersey BIBLIOGRAPHY
19. ARTICLES
1. Eder S., Chatterjee M., Salvio C.: “Evaluation of Meteneprost Potassium (A PGE2 Analogue) for Cervical Dilation and Side Effects in Non-Pregnant Women,” Prostaglandin 32:19 (1986) 2. Eder S., Apuzzio J., Weiss, G.: “Varicella Pneumonia During Pregnancy: Treatment of Two Cases with Acyclovir,” American Journal of Perinatology 5:16 (1988) 3. Lippman, Joel, Creinin, Mitchell D., Eder, Scott E., Mellon, Richard W., Godwin, Amy, and Olson, William: “The Effect of Extending the Pill-Free Interval on Follicular Activity: Triphasic Norgestimate/35 microgram ethinyl estradiol (EE) versus Monophasic Levonorgestral/20 microgram,” Contraception 66:147-152 (2002) 4. Lukes, Andrea S., Moore, Keith A., Muse, Ken N., Gersten, Janet K., Hecht, Bryan R., Edlund, Mans, Richter, Holly E., Eder, Scott E., Attia, George R., Patrick, Donald L., Rubin, Arkady, and Shangold, Gary A.: “Tranexamic Acid Treatment for Heavy Menstrual Bleeding,” Obstetrics & Gynecology 116:865- 875 (2010) 5. Lee, Stephen R., Kardos, Keith W., Schiff, Eugene, Berne, Cheryl A., Mounzer, Karam, Banks, Alpha T., Tatum, Harvey A., Friel, Timothy J., DeMicco, Michael P., Lee, William M., Eder, Scott E., Monto, Alexander, Yearwood, Graham D., Guillon, Geraldine B., Kurtz, Lisa A., Fischl, Mark, Unangst, Jay Lynn, Kriebel, Feiss, Gary. Roehler, Michele: “Evaluation of a New, Rapid Test for Detecting HCV Infection, Suitable for Use with Blood or Oral Fluid,” Journal of Virological Methods 172: 27-31 (2011) 6. Lukes, AS, Baker, J., Eder, S., Adomako, TL: “Daily Menstrual Blood Loss and Quality of Life in women with Heavy Menstrual Bleeding,” Women’s Health (Lond Engl.) 8 (5):503-11 (2012) 7. Portman, DJ, Bachmann GA, Simon JA; Ospemifene Study Group: “Ospemifene, a Novel Selective Estrogen Receptor Modulator for Treating Dyspareunia Associated with Postmenopausal Vulvar and Vaginal Atrophy,” Menopause, 2013 June; 20 (6): 623-30 8. Eder, S., Baker, J., Gersten J., Mabey RG, Adomako TL.: “Efficacy and Safety of Oral Tranexamic Acid in Women with Heavy Menstrual Bleeding and Fibroids,” Women’s Health (Lond Engl.) 2013 Jul; 9 (4): 397-403 9. Eder, SE “Evaluation of the EmbaGYN Pelvic Floor Muscle Stimulator in Addition to Kegel Exercises for the Treatment of Female Stress Urinary
17 Incontinence: a Prospective, Open-Label, Multicenter, Single-Arm Study,” Women’s Health (Lond, Engl.)2014 Jan; 10 (1):17-27 10. Eder, SE, “Ospemifene: A Novel Selective Estrogen Receptor Modulator for Treatment of Dyspareunia,” Women’s Health ( Lond.Engl.) 2014 Sept;10(5):499- 503 11. Chavoustie SE, Eder SE, Koltun WD, Lemont TR, Mitchell C, Nyirjesy P, Sobel JD, Sobel R, Villanueva R, “Experts Explore the State of Bacterial Vaginosis and the Unmet Needs Facing Women and Providers,” Int J Gynaecol Obstet. 2017 Mar 6. Doi: 10.1002/ijgo.12114 (Epub ahead of print)
20. BOOKS, MONOGRAPHS, PAPERS, AND CHAPTERS
Eder S, Chatterjee M., Salvio C.: “Evaluation of a PGE2 Analogue for Pre-Operative Cervical Dilation” in Proceedings of the XI World Congress of Gynecology and Obstetrics in Gynecology and Obstetrics, Edited by H. Ludwig and K. Thomsen, Springer-Verlag, New York (1986)
Lukes, Andrea, Hecht, Bryan, Eder, Scott, Attia, George, Shangold, Gary, Moore, Keith,“Reduced Impact of Heavy Menstrual Bleeding on Physical and Social Activity of Women Using XP12B-MR,” Papers on Current Clinical and Basic Investigation, American College of Obstetrics & Gynecology Annual Clinical Meeting, May 4, 2009, San Francisco
Lukes, A., Waldbaum, A., Eder, S., Moore, K., Shangold, G., “Novel Tranexamic Acid (TA) Product (XP12B-MR) For Heavy Menstrual Bleeding: Dose-Response Analysis.” Abstract for Poster Presented at American College of Obstetricians and Gynecologists Annual Meeting, San Francisco May 15-19, 2010
Eder, Scott, Hecht, Bryan, Attia, George, Trott, Ed, “Improvement in the Frequency of Sleep Interruptions for Women with Heavy Menstrual Bleeding Treated with Tranexamic Acid” Abstract for Poster Presented at National Medical Association Meeting, July 23, 2011, Washington, DC
Eder, Scott, “Responder Analysis and Durability of Tranexamic Acid Treatment Response in Heavy Menstrual Bleeding,” Abstract Presented at National Medical Association Meeting, July 24, 2011, Washington, DC
Eder, Scott, “New Uses for CO2 Laser,” Talk Presented at New Zealand Society of Cosmetic Medicine, August 13,2016, Queensland, New Zealand
(Revised March 19, 2017)