General Internal Medicine Expert Witness

EXPERIENCE

MEDICAL GROUP
Medical Director and Principal Investigator, August 1998 to Present
Responsible for medical oversight, serve as Principal Investigator in clinical trials.

INTERNAL MEDICINE GROUP
Sole proprietor, 1982 to Present
Practice general Internal Medicine, serve as a Clinical Preceptor for Stanford University School of Medicine.

EDUCATION

COLLEGE OF MEDICINE AND DENTISTRY OF NEW JERSEY
Doctor of Medicine, 1979
Resident in Internal Medicine, 1979 to 1982

UNIVERSITY OF SOUTHERN CALIFORNIA

Bachelor of Science, 1974 CERTIFICATES AND LICENSES
Fellow of American College of Physicians, 1/2006 American Board of Internal Medicine, 1982
State of California Physician and Surgeon license, 1982 to present State of Washington Physician and Surgeon license , 2014 to present Nevada State Board of Medical Examiners Physician license, 2014 to present
State of Alaska Physician license, 5/2019 to present Basic Life Support Certification, 5/2014
Pre-Hospital Trauma Life Support Certification, 5/2014 Advanced Cardiovascular Life Support Certification, 5/2014 Neonatal Resuscitative Program Certification, 5/2014 Licensed Provider of Suboxone, 2008

PROFESSIONAL ACTIVITIES

Speaker for Lilly Pharmaceuticals 2018-Present

Medical Director at Villa Las Palmas Healthcare Center 2017-Present Medical Director at Somerset Subacute and Care 2016-Present Chief of Medicine at Alvarado Hospital, San Diego, CA 2016-2018 Sanofi Speaker Bureau 2015-2018
Medical Director at AC Global Medical Transports 2015-Present Medical Director at Parkway Hills Nursing and Rehabilitation 2015-2018 Medical Director at Country Hills Healthcare 2014-Present Medical Preceptor for Azusa Pacific University,
Nurse Practitioner Program 2013-Present Medical Director at Bella Vista Health Center 2013-2014 Southwest Regional Medical Director for REVA Air Ambulance 2013-2014 Vice Chief of Medicine at Alvarado Hospital, San Diego, CA 2013-2015 Medical Preceptor for the University of California, Davis 2012-Present Medical Preceptor for A.T. Still University, Arizona School of
Health Sciences Physician Assistant Program 2012-Present Medical Preceptor for Western University of Health Science
MSN/FNP Program 2012-Present
Medical Preceptor for Nova Southeastern University,
Physician Assistant Program 2010-Present Medical Director for Lemon Grove Care and Rehabilitation Center 2010-2014 Medical Director for American Care Air Ambulance 1994-2013 Member of Invasive Cardiology Committee at Alvarado Hospital 1993-1994 Member of Medical Supervisory Committee at Alvarado Hospital 1993-Present Member of Surgical Supervisory Committee at Alvarado Hospital 1993-Present Medical Preceptor for Stanford University School of Medicine 1992-2010 Director of Primary Care Medical Group Development at
Alvarado Hospital, San Diego 1992-2000 Member of the Board of Directors at Alvarado Hospital, Assoc 1992-1994 Director at Mission Bay Valley Home Health 1992-1993
Co-DRG Director at Alvarado Hospital, San Diego 1987-1995 Spokesperson for Southwest Regional Abbot Laboratory 1987-1992 President of San Diego Quality Care Medical Group, IPA 1986-1990 Clinical Instructor at the Department of Community and Family
Medicine at UCSD School of Medicine 1986-1990 Director at AMI Valley Hospital Medi-Van 1983-1989 DRG Director at AMI Valley Hospital, El Cajon, CA 1983-1989 Consultant for the Department of Social Security Disability
State of California 1982-2010
Chief of Medicine and Director of Medical Education at
College Park Hospital 1982-1983

HOSPITAL AFFILIATIONS

Alvarado Hospital, San Diego, CA Grossmont Hospital, La Mesa, CA

PROFESSIONAL AFFILIATIONS

San Diego County Medical Society 1982-Present
California Medical Society 1982-Present
American Medical Association 1982-Present
American College of Physicians 1982-Present

American Society of Internal Medicine 1982-Present RESEARCH
Bio-Technology General Corp. Protocol #M012: A Phase IV, open-label evaluation of the effect of Oxandrolone on body weight and composition and pulmonary function in patients with chronic obstructive pulmonary disease and associated involuntary weight loss. (1998)

Amgen, Inc. Protocol #NESP 980211: A Phase II, open-label, randomized study of Novel Erythropoiesis Stimulating Protein (NESP and recombinant human erythropoietin (r-HuEPO) for the treatment of anemia in patients with End-Stage Renal Disease (ESRD) receiving dialysis. (1998)

SmithKline Beecham Pharmaceuticals Protocol #BRL49653C/135: A 2 year randomized, double-blind, parallel group study to compare the efficacy, safety and tolerability of Rosiglitazone versus placebo in combination with glipizide in elderly patients with Type II diabetes mellitus who are inadequately controlled on maximum glipizide therapy. (1999)

SmithKline Beecham Pharmaceuticals Protocol #SB207499/039: A randomized, 24 week, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety and tolerability of Ariflo (15 mg BID) in patients with Chronic Obstructive Pulmonary Disease (COPD). (1999)

Knoll Pharmaceutical Company Protocol #P-85-AF: A double-blind, placebo- controlled, randomized clinical trial of slow release Propafenone (Rhythmol-SR) in the prevention of symptomatic recurrences of atrial fibrillation. (1999)

Shire Laboratories Inc. Protocol #LAM-IV-307: An open label, randomized, multi-center, Phase II, comparator controlled parallel group study to assess the long-term safety and efficacy of Lanthanum Carbonate in chronic renal failure patients receiving hemodialysis. (1999)

Shire Laboratories Inc. Protocol #LAM-IV-302: A Phase III, dose titration, randomized, double-blind, placebo controlled, parallel group study to assess efficacy and safety of Lanthanum Carbonate for reduction and maintenance of serum phosphorus levels in chronic renal failure patients receiving hemodialysis. (1999)

Takeda Pharmaceuticals America, Inc. Protocol #01-00-TL-OP1-506 A randomized comparator controlled, double-blind study of the liver safety of Pioglitazone HCL versus Glyburide with Metformin and Insulin as part of step therapy in subjects with Type 2 (Non-insulin dependent) diabetes. (2000)

Aventis Pharmaceuticals, Protocol #HMR3647A3014 (Treat Study) A randomized open-label, multicenter trial of the safety and effectiveness of Oral Telithromycin (Ketek ®) and Amoxicillin/Clavulanic Acid (Augmentin ®) in Outpatients with respiratory tract acute sinusitis in usual care settings. (2001)

SmithKline Beecham Pharmaceuticals. Protocol # SB207499/156 (Ariflo) A randomized 24 week, double-blinded, placebo controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of Ariflo 15 mg b.i.d. in patients with chronic obstructive pulmonary disease. (2001)

SmithKline Beecham Pharmaceuticals. Protocol #207499/041 A multicenter, open-label extension study to evaluate the safety, tolerability, and efficacy of oral Ariflo ™ (15 mg twice daily) in patients with chronic obstructive pulmonary disease. QR file #2244/2220 8/2001 – 3/2002

Sepracor Protocol #091-050 A double-blinded, double-dummy, randomized, placebo-and active-controlled multicenter, parallel-group study of (R, R) – Formoterol in the treatment of subjects with chronic obstructive pulmonary disease. 9/2001 – 9/2003

Sepracor Protocol #091-060 A multicenter, open-label, randomized, active- controlled, parallel group chronic safety study of (R, R)- Formoterol in the treatment of subjects with chronic obstructive pulmonary disease. 9/2002 – 9/2004

Genaissance Pharmaceutical Protocol #GNSC-02-SZ-01 A case control investigation exploring the relationship between gene variants (HAPTM Markers) and agranulocytosis or granulocytopenia in adult patients treated with Clozapine. 10/2002 – 10/2003

CardioDynamics Protocol #200202 Consideration of noninvasive hemodynamic monitoring to target reduction of blood pressure levels (CONTROL). 11/2002 – 8/2004

GlaxoSmithKline Protocol #NPP30005 A multicenter, double-blind, randomized study to evaluate the safety and efficacy of Lamotrigine 200mg/day, 300mg/day and 400mg/day compared with placebo in subjects with painful diabetic neuropathy. 2/2003 – 11/2003

Merck & Co., Inc. Protocol #066 A randomized, double-blind, active- comparator-controlled, parallel-group study to evaluate the safety of Etoricoxib in patients with Osteoarthritis or Rheumatoid Arthritis. 3/2003- 6/2006

GlaxoSmithKline Protocol #NPP30006 An Open-Label Study to Evaluate the Safety of Lamotrigine in Subjects with Painful Diabetic Neuropathy. 7/2003– 9/2004

Aventis Pharmaceuticals, Inc. Protocol #HOE901/4022 Substituting Lantus Glargine for a Thiazolidinedione vs. a third oral agent as add-on therapy in patients failing a Thiazolidinedione and Sulfonylurea or
Glucophage combination: A multicenter, controlled, randomized, open label study. 9/2003- 1/2005

GlaxoSmithKline Protocol #S3B30048 A 12-week, randomized, double- blind, placebo-controlled study of PRN BID and fixed dosing regimens of Alosetron in female subjects with severe diarrhea-predominant irritable bowel syndrome who have failed conventional therapy. 9/2003- 9/2005

Purdue Pharma L.P. Protocol BUP3019 A Randomized, Double-blind, Multicenter, Active Comparator Study to Determine the Efficacy and Safety of BTDS 20 or OXYIR® versus BTDS 5 in Subjects with Moderate to Severe Osteoarthritis (OA) Pain. 4/2004- 7/2005

Pain Therapeutics, Inc. Protocol PTI-801-XH A Multicenter, Randomized, Double-Blind, Active- and Placebo-Controlled, Phase III, Efficacy and Safety Study of Oxycodone HCl and Low-Dose Naltrexone HCl (PTI-801) in Patients with Moderate to Severe Chronic Pain Due to Osteoarthritis of the Hip or Knee. 6/2004- 5/2006

Schwarz Biosciences, Inc. Protocol SP768 A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Assess the Efficacy and Safety of SPM 927 (200, 400, and 600mg/day) in Subjects with Painful Distal Diabetic Neuropathy. 11/2004- 12/2005

GlaxoSmithKline Protocol CIL103657 A Randomized, 24-week, Double- blind, Parallel-group Study to Evaluate the Efficacy, Safety and Tolerability of Ariflo (15mg BID) in Patients with Chronic Obstructive Pulmonary Disease (COPD). 12/2004- 6/2006

GlaxoSmithKline Protocol ABD 104225 A Prospective Evaluation of the Burden of Illness Among Opioid-Naïve Subjects with Non-Surgical Pain Treated with Opioid Therapy. 3/2005-8/2005

GlaxoSmithKline protocol CXA30007 A Phase III, 12-Week, Multicenter, Double-blind, Double-dummy, Randomized, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381 1mg, 5mg, 10mg, 25mg, and 50mg Administered Orally Once Daily, in Adults With Osteoarthritis of the Knee. 6/2005- 11/2005

Schwarz Biosciences, Inc. Protocol SP745 A Multi-center, Open-label, Follow-on Trial to Assess the Long-term Safety and Efficacy of SPM 927 in Subjects with Painful Distal Diabetic Neuropathy. 11/2005- 1/2011

Pfizer Protocol A2171066 A US Randomized Questionnaire-Based Trial Assessing the Impact of the Availability of Inhaled Insulin on Therapeutic Choice in Patients With Suboptimally Controlled Type 2 Diabetes. 6/2005- 1/2006

Pain Therapeutics, Inc. Protocol PTI-821-CM A Long-Term, Open-Label, Safety Study of PTI-821 in Patients with Moderate to Severe Chronic Low Back Pain or with Moderate to Severe Chronic Pain Due to Osteoarthritis of the Hip or Knee. 5/2006- 5/2008

Pfizer Protocol A2171093 A Phase 3B, Randomized, Open-Label, Parallel Group, Multicenter Trial Assessing the Efficacy of Exubera vs. Lispro Introduced into a Lantus Based Regimen in Suboptimally Controlled Patients With Type 2 Diabetes Mellitus. 6/2006- 6/2008

Almirall Protocol M/34273/31 A 52-Week Randomized, Double-Blind, Parallel Group, Placebo Controlled, Multi-Centre Clinical Trial, to Assess the Efficacy and Safety of 200mcg of the Anticholinergic LAS34273 Compared to Placebo, Both Administered Once Daily by Inhalation, in the Maintenance Treatment of Patients with Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease. 6/2006- 6/2008

Novartis Protocol CLMF237A2302 A Randomized, Double-blind, Active- controlled, Multicenter Study to Compare the Effect of 24 Weeks Treatment with a Fixed Combination Therapy of Vildagliptin and Metformin to the Individual Monotherapy Components in Drug Naïve Patients with Type 2 Diabetes. 7/2006 – 8/2008

Pfizer Precision Protocol A3191172 A Randomized, Double-blind, Parallel- group Study of Cardiovascular Safety in Osteoarthritis or Rheumatoid Arthritis Patients With or at High Risk for Cardiovascular Disease Comparing Celecoxib with Naproxen and Ibuprofen. 10/2006- 10/2016

Sanofi aventis Protocol LTE6673 Efficacy and Safety of 2mg/day of M100907 on Sleep Maintenance Insomnia with a Sub-study of the Effect of M100907 on Stable Type II Diabetes Mellitus: a One Year, Multi-center, Randomized, Double-blind, Placebo-controlled Study. 5/2007- 05/2009

Pfizer Protocol A2171095 A Six Month, Open-Label, Randomized Parallel Group Trial Assessing the Impact of Dry Powder Inhaled Insulin (Exubera®) on Glycemic Control Compared to Insulin Glargine (Lantus®) in Patients With Type 2 Diabetes Mellitus Who Are Poorly Controlled on a Combination of Two or More Oral Agents. 8/2007- 6/2008

Sanofi aventis Protocol EFC5826 (CRESCENDO) Randomized, multinational, multicenter, double-blind, placebo controlled, two-arm parallel group trial of rimonabant 20mg OD for reducing the risk of major cardiovascular events in abdominally obese patients with clustering risk factors. 05/2008-05/2009

United BioSource Corporation for Pfizer Inc. Protocol A2171121 An observational follow-up study of patients previously enrolled in Exubera Controlled Clinical Trials. 9/2008-12/2010

Luitpold Protocol 1VIT08019 A multi-center, randomized, controlled study to investigate the safety and tolerability of intravenous ferric carboxymaltose (FCM) vs. standard medical care in treating iron deficiency anemia. 10/2008- 12/2009

Luitpold Protocol 1VIT08021 A multi-center, randomized, controlled study to investigate the safety and tolerability of a single dose of intravenous ferric carboxymaltose (FCM) vs. standard medical care in treating iron deficiency anemia in subjects who are not dialysis dependent. 10/2008-12/2009

GlaxoSmithKline Protocol GLP112753 A randomized, double blind, placebo and active controlled, parallel group, Multicenter study to determine the efficacy and safety of Albiglutide when used in combination with Metformin compared with Metformin plus Sitagliptin, Metformin plus Glimepiride, and Metformin plus placebo in subjects with type 2 Diabetes Mellitus. 12/2008- 6/2013

GlaxoSmithKline Protocol GLP112754 A randomized, open label, parallel group, multicenter study to determine the efficacy and long term safety of Albiglutide compared with Insulin in subjects with Type 2 Diabetes Mellitus. 12/2008-6/2013

GlaxoSmithKline Protocol GLP112755 A randomized, double blind, placebo controlled, parallel group, multicenter study to determine the efficacy and safety of Albiglutide when used in combination with Pioglitazone with or without Metformin in subjects with type 2 Diabetes Mellitus. 12/2008-1/2011

GlaxoSmithKline Protocol GLP112756 A randomized, double blind, placebo controlled parallel group, multicenter study to determine the efficacy and safety of two dose levels of Albiglutide compared with placebo in subjects with type 2 Diabetes Mellitus. 12/2008-6/2013

GlaxoSmithKline Protocol GLP112757 A randomized, double blind, placebo and active controlled, parallel group, multicenter study to determine the efficacy and safety of Albiglutide administered in combination with Metformin and Glimepiride compared with Metformin plus Glimepride and placebo and with Metformin plus Glimepride and Pioglitazone in subjects with type 2 Diabetes Mellitus. 12/2008-6/2013

Daiichi Sankyo Protocol DUI176b-C-U301 A phase 3, randomized, double blind, double dummy, parallel group, multicenter, multinational study for evaluation of efficacy and safety of DU-176B versus Warfarin in subjects with Atrial Fibrillation- Effective aNticoaGulation with factor xA next Generation in Atrial Fibrillation (ENGAGE AR-TIMI 48). 01/2009- 4/2013

Pfizer Protocol A4091012 A randomized, double-blind, multi-dose, active- and placebo-controlled, multi-center, parallel group study of the analgesic effects of Tanezumab in adult patients with chronic low back pain. 09/2009- 05/2010

Pfizer Protocol A4091039 A randomized, multicenter, long term study of the safety of Tanezumab in patients with chronic low back pain. 09/2009- Completed

Johnson & Johnson Protocol 28431754DIA3010; Phase III, A Randomized, Double-Blind, Placebo-controlled, parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin Compared with Placebo in the Treatment of Older Subjects with Type 2 Diabetes Mellitus Inadequately Controlled on Glucose Lowering Therapy. 04/2010- 4/2013

Takeda Protocol TMX-67_301 A multicenter, Randomized, Active-Control Phase 3B Study to Evaluate the Cardiovascular Safety of Febuxostat and Allopurinol in Subjects with Gout and Cardiovascular Comorbidities.
5/2010- 10/2017

AstraZeneca Protocol D1690C00019 A 24-week, multicenter, randomized, double-blind, age-stratified, placebo controlled phase III study with a 28- week extension period to evaluate the efficacy and safety of dapagliflozin 10 mg once daily in patients with type 2 diabetes and cardiovascular disease, who exhibit inadequate glycemic control on usual care. 07/2010-02/2013

Dey Pharma, LP Protocol 191-090 A 12-week randomized, multi-dose, double blind, placebo-controlled, parallel-group trial to assess the Pharmacodynamic Response of Fluticasone Propionate in Fixed-Dose combination with Formoter Fumarate in Subjects with COPD 08/2010-Completed

Johnson & Johnson Protocol 28431754DIA3004; Phase III, A randomized, double-blind, placebo-controlled, 3-arm parallel-group, 26-week, multicenter study with a 26-week extension, to evaluate the efficacy, safety, and tolerability of Canagliflozin in the treatment of subjects with type 2 Diabetes Mellitus who have moderate renal impairment. 09/2010-Completed

AstraZeneca Protocol D3820C00008- An Open-Label 52-week Study to Assess the Long-Term Safety of NKTR-118 in Opioid-Induced Constipation (OIC) in Patients with Non-Cancer-Related Pain 03/2011-12/2012

Bristol-Myers Squibb Protocol MB102-077: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Subjects with Type 2 Diabetes with inadequately controlled Hypertension treated with an Angiotensin- Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB) and an additional Antihypertensive medication 06/2011-4/2013

Bristol-Myers Squibb Protocol MB102073: A multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Subjects with Type 2 Diabetes with Inadequately Controlled Hypertension on an Angiotensin-Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB) 09/2011- 4/2013

Forest Research Inst., Inc. Protocol NAC-MD-01: A multicenter, Randomized, Double Blind, 8-week Study to Evaluate the Safety and Efficacy of Nebivolol and Valsartan Given as a Fixed-dose Combination in Patients with Stage 1 or Stage 2 Essential Hypertension 01/2012-Completed

Dey Pharma Protocol 201-085: A Randomized, Double-blind, Placebo- controlled Study to Evaluate the Safety of Long-Term Use of Perforomist® (formoterol fumarate) Inhalation Solution in Subjects with Chronic Obstructive Pulmonary Disease (COPD) 6/2012-Completed

Orexo Protocol OX219-006: Induction, Stabilization, Adherence and Retention Trial (ISTART) – A Randomized non-inferiority multicenter to assess early treatment efficacy of OX219 versus SUBOXONE® Film and to explore switching between treatments 6/2013-8/2014

Orexo Protocol OX219-008: A multicenter, open label, 24-week follow-up study to assess safety, efficacy and treatment adherence for maintenance of opioid dependence with OX219 9/2013-2/2015

Novo Nordisk Protocol EX1250-4080 DEVOTE: A trial comparing cardiovascular safety of insulin degludec versus insulin glargine in subjects with type 2 diabetes at high risk of cardiovascular events 3/2014 – 12/2016

Renaissance RX Protocol 2013-101: Diagnosing Adverse Drug ReacTions (DART) Registry: A multi-center registry to assess whether the use of pharmacogenomics data will result in a meaningful change in a subject’s drug regimen. 9/2014- 2/2015

Pfizer B1481022 SPIRE 1: A Phase 3 Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel Group Evaluation of the Efficacy, Safety, and Tolerability of Bococizumab (PF-04950615), in Reducing the Occurrence of Major Cardiovascular Events in High Risk Subjects 6/2015- 12/20

Pfizer B1481038 SPIRE 2: A Phase 3 Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel Group Evaluation of the Efficacy, Safety, and Tolerability of Bococizumab (PF-04950615), in Reducing the Occurrence of Major Cardiovascular Events in High Risk Subjects 6/2015- 12/2016

Egalet Protocol OC-EG-302: A Randomized Withdrawal, Double-blind, Placebo-controlled Phase 3 Trial to evaluate the safety and efficacy of Egalet-002, in patients with Moderate-to-Severe Chronic Low Back Pain 4/2016 – 2/2018

Pearl Therapeutics PT009003: A Randomized, Double-blind, Parallel Group, Multi-Center Study to Assess the Efficacy and Safety of PT009 compared to PT005 on COPD Exacerbations over a 52-Week Treatment Period in Subjects with Moderate to Very Severe COPD 5/2016 – 6/2018

Pearl Therapeutics PT010005: A Randomized, Double-blind, Multi-center, Parallel-group Study to Assess the Efficacy and Safety of PT010 Relative to PT003 and PT009 on COPD Exacerbations over a 52-Week Treatment Period in Subjects with Moderate to Very Severe COPD 4/2018- 10/2019