Khoshini

June 2017

CURRICULUM VITAE

Reza Khoshini, M.D.

San Diego Digestive Disease Consultants, Inc.

Medical Associates Research Group, Inc.

Diplomate American Board of Gastroenterology

Board Certified

8008 Frost Street, Suite 200

San Diego, CA 92123

San Diego Digestive Disease Consultants, Inc.Medical Associates Research Group, Inc.

(858) 292-7527 24-hour(858) 277-5678

(858) 292-7804 Fax(858) 277-2317 Fax

E-Mail:

CALIFORNIA MEDICAL LICENSE NUMBER: A77202

EDUCATION:

1991 – 1995Bachelor of Science, Microbiology and Molecular Genetics

University of California, Los Angeles

1995 – 1996Master of Science, Applied Physiology

The Chicago Medical School, North Chicago, IL

1996 – 2000Doctor of Medicine

The Chicago Medical School, North Chicago, IL

POSTGRADUATE TRAINING:

2000 – 2003Internal Medicine Residency

Los Angeles County Harbor UCLA Medical Center, Torrance CA

2003 – 2004Perioperative Fellowship, Chief Resident

Los Angeles County Harbor UCLA Medical Center, Torrance, CA

2005 – 2008UCLA Affiliated Training Programs in Gastroenterology

University of California, Los Angeles

2008 – 2009Interventional Endoscopy Fellowship Program (EUS and ERCP)

Los Angeles County Harbor UCLA Medical Center, Torrance, CA

EMPLOYMENT:

2009 – presentSan Diego Digestive Disease Consultants, Inc.

San Diego, CA

2013 – presentMedical Associates Research Group, Inc.

San Diego, CA

2009 – presentSan Diego Endoscopy Center

4033 Third Ave., San Diego, CA

CERTIFICATION:

2001Medical Board of California

2002DEA Registration

Registration number FK1124647

2008American Board of Internal Medicine, Gastroenterology

Number 221781

2013National Institutes of Health (NIH) “Protecting Human Research Participants”

Certification Number: 1214692

BLS Certified

NPI number: 1184772014

UPIN number: H87120

2014, 2016Good Clinical Practice Course - CITI

PROFESSIONAL MEMBERSHP/LEADERSHIP:

2005 – presentAmerican Society for Gastrointestinal Endoscopy

2009 – presentSharp Memorial Hospital Medical Director of Endoscopy

PUBLICATIONS:

1.Khoshini R, Garrett B, Sial S, Eysselein VE. The role of radiologic studies in the diagnosis of mesenteric ischemia. MedGenMed. 2004 Jan 5;6(1):23.

2.F. Tsai, M. Vosoghi, R. Khoshini, S. Reicher, D. Chung, S. French, V. Eysselein. Preliminary Results of BÂRRX Ablation Trial in Patients with Non-Dysplastic Intestinal Metaplasia versus Low or High Grade Dysplasia. DDW 2006 Abstract AB142.

3.Khoshini R, Dai SC, Lezcano S, Pimentel M. A Systematic Review of Diagnostic Tests for Small Intestinal Bacterial Overgrowth. Dig Dis Sci. 2007 Nov 8 (Epub ahead of print).

4.S. Jee, W. Morales, K Low, C Chang, R Khoshini, J Conklin, M. Pimentel. Antibiotics and Cdt Expression in Campylobacter Jejuni Contribute to Duration of Colonization in Rats. DDW 2008 abstract W1283.

CLINICAL RESEARCH:

  1. A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of AZD1722 for the Treatment of Constipation-Predominant Irritable Bowel Syndrome (IBS-C). Principal Investigator Michael Bennett, MD, Sub-investigator Reza Khoshini, MD, Medical Associates Research Group, Inc. 2013. Ardelyx, Inc.
  1. A Phase 3 Evaluation of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination in Non-cirrhotic Subjects with Genotype 1 Chronic Hepatitis C. Principal Investigator Michael Bennett, MD, Sub-investigator Reza Khoshini, MD, Medical Associates Research Group, Inc. 2013. Bristol-Myers Squibb.
  1. A Phase 3 Evaluation of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination in Subjects with Genotype 1 Chronic Hepatitis C and Compensated Cirrhosis. Principal Investigator Michael Bennett, MD, Sub-investigator Reza Khoshini, MD, Medical Associates Research Group, Inc. 2013. Bristol-Myers Squibb.
  1. A Phase 3B Randomized, Open-Label, Multi-Center Trial Assessing Sofosbuvir + Ribavirin for 16 or 24 Weeks and Sofosbuvir + Pegylated Interferon + Ribavirin for 12 Weeks in Subjects with Genotype 2 or 3 Chronic HCV Infection. Principal Investigator Michael Bennett, MD, Sub-investigator Reza Khoshini, MD, Medical Associates Research Group, Inc. 2013. Gilead Sciences, Inc.
  1. A Phase II Clinical Trial to Evaluate the Efficacy and Safety of a Combination Regimen of MK-5172 with/without MK-8742 and/or Ribavirin (RBV) in Treatment-naïve Subjects with Chronic Hepatitis C Genotype 2, 4, 5 and 6 Infection. Principal Investigator Michael Bennett, MD, Sub-investigator Reza Khoshini, MD, Medical Associates Research Group, Inc. 2013. Merck Sharp & Dohme Corp. (PPD).
  1. A Phase 3 Evaluation of Daclatasvir and Sofosburiv in Treatment Naïve and Treatment Experienced Subjects with Genotype 3 Chronic Hepatitis C Infection. Principal Investigator Michael Bennett, MD, Sub-investigator Reza Khoshini, MD, Medical Associates Research Group, Inc. 2014. Bristol-Myers Squibb.
  1. A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of a 12- or 8-Week Treatment Regimen of Simeprevir in Combination with Sofosbuvir in Treatment-Naïve and –Experienced Subjects with Chronic Genotype 1 Hepatitis C Virus Infection Without Cirrhosis. Principal Investigator Michael Bennett, MD, Sub-investigator Reza Khoshini, MD, Medical Associates Research Group, Inc. 2014. Janssen Research & Development.
  1. A Phase 3, Multicenter, Open-Label, Single-Arm Study to Investigate the Efficacy and Safety of a 12-Week Regimen of Simeprevir in Combination with Sofosbuvir in Treatment-Naïve or-Experienced Subjects with Chronic Genotype 1 Hepatitis C Virus Infection and Cirrhosis. Principal InvestigatorMichael Bennett, MD, Sub-investigator Reza Khoshini, MD, Medical Associates Research Group, Inc. 2014. Janssen Research & Development.
  1. A Phase III Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172/MK-8742 in Subjects who have Failed Prior Treatment with Pegylated Interferon and Ribavirin (P/R) with Chronic HCV GT1, GT4, GT5, and GT6 Infection. Principal Investigator Michael Bennett, MD, Sub-investigator Reza Khoshini, MD, Medical Associates Research Group, Inc. 2014. Merck Sharp & Dohme Corp. (PPD).
  1. An Open-Label Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Ombitasvir/ABT-450/Ritonavir (Ombitasvir/ABT-450/r) and Dasabuvir Co-administered with Sofosbuvir (SOF) With and Without Ribavirin (RBV) in Direct-Acting Antiviral Agent (DAA) Treatment-Experienced Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection. Principal Investigator Michael Bennett, MD, Sub-investigator Reza Khoshini, MD, Medical Associates Research Group, Inc. 2014. AbbVie.
  1. An Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir and Dasabuvir with or without Ribavirin (RBV) in Treatment-Naïve Adults with Genotype 1 Chronic Hepatitis C Virus (HCV) Infection, with Severe Renal Impairment or End-Stage Renal Disease (RUBY-I). Principal Investigator Michael Bennett, MD, Sub-investigator Reza Khoshini, MD, Medical Associates Research Group, Inc. 2014. AbbVie.
  1. An Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 in Subjects with Chronic Hepatitis C Virus (HCV) Genotype 1 Infection. Principal Investigator Michael Bennett, MD, Sub-investigator Reza Khoshini, MD, Medical Associates Research Group, Inc. 2014. AbbVie (Covance).
  1. A Randomized, Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 With and Without RBV in Subjects with Chronic Hepatitis C Virus (HCV) Genotype 2 or Genotype 3 Infection. Principal Investigator Michael Bennett, MD, Sub-investigator Reza Khoshini, MD, Medical Associates Research Group, Inc. 2014. AbbVie (Covance).
  1. A Phase 3, Multicenter, Randomized, Double-Blind Placebo-Controlled Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks in Subjects with Chronic HCV Infection. Principal Investigator Michael Bennett, MD, Sub-investigator Reza Khoshini, MD, Medical Associates Research Group, Inc. 2014. Gilead Sciences, Inc. (PRA).
  1. A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks with Sofosbuvir and Ribavirin for 12 Weeks in Subjects with Chronic Genotype 2 HCV Infection. Principal Investigator Michael Bennett, MD, Sub-investigator Reza Khoshini, MD, Medical Associates Research Group, Inc. 2014. Gilead Sciences, Inc. (PRA).
  1. A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks with Sofosbuvir and Ribavirin for 24 Weeks in Subjects with Chronic Genotype 3 HCV Infection. Principal Investigator Michael Bennett, MD, Sub-investigator Reza Khoshini, MD, Medical Associates Research Group, Inc. 2014. Gilead Sciences, Inc. (PRA).
  1. An Open Label Study of Sofosbuvir/GS-5816 Fixed-Dose Combination in Subjects with Chronic HCV Infection. Principal Investigator Michael Bennett, MD, Sub-investigator Reza Khoshini, MD, Medical Associates Research Group, Inc. 2015. Gilead Sciences, Inc. (PRA).
  1. A Phase 2, Global, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of GS-9857 Plus Sofosbuvir/GS-5816 Fixed Dose Combination in Subjects with Chronic Genotype 1 HCV Infection. Principal Investigator Michael Bennett, MD, Sub-investigator Reza Khoshini, MD, Medical Associates Research Group, Inc. 2015. Gilead Sciences, Inc. (PRA).
  1. A Phase 2, Global, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of GS-9857 Plus Sofosbuvir/GS-5816 Fixed Dose Combination in Subjects with Chronic Non-Genotype 1 HCV Infection. Principal Investigator Michael Bennett, MD, Sub-investigator Reza Khoshini, MD, Medical Associates Research Group, Inc. 2015. Gilead Sciences, Inc. (PRA).
  1. A Registry for Subjects with Cirrhosis Who Achieve a Sustained Virologic Response Following Treatment With a Sofosbuvir-Based Regimen Without Interferon for Chronic Hepatitis C Infection in Gilead Sponsored Trials. Principal Investigator Michael Bennett, MD, Sub-investigator Reza Khoshini, MD, Medical Associates Research Group, Inc. 2015. Gilead Sciences, Inc. (Duke Clinical Research Institute).
  1. A Phase 2, Double-blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Crohn’s Disease. Principal Investigator Michael Bennett, MD, Sub-investigator Reza Khoshini, MD, Medical Associates Research Group, Inc. 2015. Gilead Sciences, Inc. (ICON).
  1. A Long-term Follow-up Study to Evaluate the Durability of Virologic Response and/or Viral Resistance Patterns of Subjects with Chronic Hepatitis C Who Have Been Previously Treated with MK5172 in a Prior Clinical Trial. Principal Investigator Michael Bennett, MD, Sub-investigator Reza Khoshini, MD, Medical Associates Research Group, Inc. 2015. Merck Sharp & Dohme Corp.
  1. A Phase II, Randomized, Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172 and MK-3682 with Either MK-8742 or MK-8408 in Subjects with Chronic HCV GT3 Infection. Principal Investigator Michael Bennett, MD, Sub-investigator Reza Khoshini, MD, Medical Associates Research Group, Inc. 2015. Merck Sharp & Dohme Corp.
  1. A Randomized, Open-Label, Active-Controlled, Multicenter Study to Compare Efficacy and Safety of ABT-493/ABT-530 to Sofosbuvir Co-Administered with Ribavirin in Adults with Chronic Hepatitis C Virus Genotype 3 Infection (ENDURANCE-3). Principal Investigator Michael Bennett, MD, Sub-investigator Reza Khoshini, MD, Medical Associates Research Group, Inc. 2015. AbbVie
  1. A Phase 2a Study Evaluating the Safety, Efficacy, and Pharmacodynamic Effects of ABT-981 in Patients with Knee Osteoarthritis. Principal Investigator Michael Bennett, MD, Sub-investigator Reza Khoshini, MD, Medical Associates Research Group, Inc. 2015. AbbVie.
  1. A Randomized, Double-Blind, Multicenter Study to Explore the Effect of GED-0301 on Endoscopic and Clinical Outcomes in Subjects with Active Crohn’s Disease. Principal Investigator Michael Bennett, MD, Sub-investigator Reza Khoshini, MD, Medical Associates Research Group, Inc. 2015. Celgene (PPDI).
  1. A Phase 2, Open-label, Multicenter Study to Explore the Efficacy and Safety of Mongersen (GED-0301) in Subjects with Active Ulcerative Colitis. Principal Investigator Michael Bennett, MD, Sub-investigator Reza Khoshini, MD, Medical Associates Research Group, Inc. 2015. Celgene (PPDI).
  1. A Phase 3, Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 12 Weeks in Direct-Acting Antiviral-Experienced Subjects with Chronic HCV Infection. Principal Investigator Michael Bennett, MD, Sub-investigator Reza Khoshini, MD, Medical Associates Research Group, Inc. 2015. Gilead Sciences, Inc. (PRAHS).
  1. A Phase 3, Global, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 8 Weeks Compared to Sofosbuvir/Velpatasvir for 12 Weeks in Direct-Acting Antiviral-Naïve Subjects with Chronic HCV Infection. Principal Investigator Michael Bennett, MD, Sub-investigator Reza Khoshini, MD, Medical Associates Research Group, Inc. 2015. Gilead Sciences, Inc. (PRAHS).
  1. A Phase 3, Double-Blind, Randomized, Long-Term, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Obeticholic Acid in Subjects with Nonalcoholic Steatohepatitis. Principal Investigator Michael Bennett, MD, Sub-investigator Reza Khoshini, MD, Medical Associates Research Group, Inc. 2015. Intercept Pharmaceuticals, Inc.
  1. A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis. Principal Investigator Michael Bennett, MD, Sub-investigator Reza Khoshini, MD, Medical Associates Research Group, Inc. 2015. Receptos, Inc. (Quintiles).
  1. A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis. Principal Investigator Michael Bennett, MD, Sub-investigator Reza Khoshini, MD, Medical Associates Research Group, Inc. 2015. Receptos, Inc. (Quintiles).
  1. A Phase 3, Global, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 8 Weeks and Sofosbuvir/Velpatasvir for 12 Weeks in Subjects with Chronic Genotype 3 HCV Infection and Cirrhosis. Principal Investigator Michael Bennett, MD, Sub-investigator Reza Khoshini, MD, Medical Associates Research Group, Inc. 2016. Gilead Sciences, Inc. (PRAHS).
  1. A Phase 3, Global, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 12 Weeks and Sofosbuvir/Velpatasvir for 12 Weeks in Direct-Acting Antiviral-Experienced Subjects with Chronic HCV Infection Who Have Not Received an NS5A Inhibitor. Principal Investigator Michael Bennett, MD, Sub-investigator Reza Khoshini, MD, Medical Associates Research Group, Inc. 2016. Gilead Sciences, Inc. (PRAHS).
  1. A Phase 2, Multi-Center, Open-Label Induction Trial with Extension Period to Assess Endoscopic Improvement and Changes in Intestinal and Serum Biomarkers in Patients with Moderately to Severely Active Crohn’s Disease Receiving Oral RPC1063 as Induction Therapy. Principal Investigator Michael Bennett, MD, Sub-investigator Reza Khoshini, MD, Medical Associates Research Group, Inc. 2016. Receptos, Inc. (Quintiles).
  1. A 12-Week, Randomized, Double Blind, Placebo-Controlled Study with a 4-Week Randomized Withdrawal Period to Evaluate the Efficacy and Safety of Tenapanor for the Treatment of Constipation-Predominant Irritable Bowel Syndrome (IBS-C). Principal Investigator: Michael Bennett, MD, Sub-investigator Reza Khoshini, MD, Medical Associates Research Group, Inc. 2016. Ardelyx, Inc. (ICON).
  1. Collection of Blood Specimens from Subjects Infected with Chronic Hepatitis C Treated with Regimens Containing Sofosbuvir. Principal Investigator: Michael Bennett, MD, Sub-investigator Reza Khoshini, MD, Medical Associates Research Group, Inc. 2016. Roche Molecular Systems, Inc.
  1. A Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-range-finding Trial of IW-3718 Administered Orally for 8 Weeks to Patients with Symptomatic Gastroesophageal Reflux Disease Not Completely Responsive to Proton Pump Inhibitors. Principal Investigator: Michael Bennett, MD, Sub-investigator Reza Khoshini, MD, Medical Associates Research Group, Inc. 2016. Ironwood Pharmaceuticals, Inc. (PPDI).
  1. An Open Label Long-Term Safety Study of Tenapanor for the Treatment of Constipation-Predominant Irritable Bowel Syndrome (IBS-C). Principal Investigator Michael Bennett, MD, Sub-investigator Reza Khoshini, MD, Medical Associates Research Group, Inc. 2016. Ardelyx, Inc. (ICON).
  1. A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-0976 in Subjects with Nonalcoholic Steatohepatitis. Principal Investigator Michael Bennett, MD, Sub-investigator Reza Khoshini, MD, Medical Associates Research Group, Inc. 2016. Gilead Sciences, Inc. (PRAHS).
  1. A Randomized, Double-Blind, Placebo-Controlled, Titration-to-Effect Study of Orally Administered CR845 in Patients with Osteoarthritis of the Hip or Knee. Principal Investigator Michael Bennett, MD, Sub-investigator Reza Khoshini, MD, Medical Associates Research Group, Inc. 2016. Cara Therapeutics, Inc. (INC Research).
  1. A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Investigate the Efficacy and Safety of Mongersen (GED-0301) for the Treatment of Subjects With Active Crohn’s Disease. Principal Investigator Michael Bennett, MD, Sub-investigator Reza Khoshini, MD, Medical Associates Research Group, Inc. 2016. Celgene Corporation (Quintiles).
  1. A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects with Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis. Principal Investigator Michael Bennett, MD, Sub-investigator Reza Khoshini, MD, Medical Associates Research Group, Inc. 2017. Gilead Sciences, Inc. (PRAHS).
  1. A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects with Compensated Cirrhosis due to Nonalcoholic Steatohepatitis (NASH). Principal Investigator Michael Bennett, MD, Sub-investigator Reza Khoshini, MD, Medical Associates Research Group, Inc. 2017. Gilead Sciences, Inc. (PRAHS).
  1. A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Subjects with Nonalcoholic Steatohepatitis (NASH). Principal Investigator Michael Bennett, MD, Sub-investigator Reza Khoshini, MD, Medical Associates Research Group, Inc. 2017. Gilead Sciences, Inc. (PRAHS).

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