Carlos Martinez has over 25 years of experience in clinical research, having worked as a clinical research consultant, clinical research associate, project administrator, and clinical research coordinator on various Phase I-IV clinical trials. His experience includes monitoring trials, ensuring regulatory compliance, resolving issues, maintaining relationships with investigators, and verifying drug accountability. He has extensive skills in computer systems used in clinical research and holds a degree in Biology from the University of Texas at Austin.

1. CARLOS MARTINEZ
2303 Ranch Rd. 620 South Suite 135-121
Lakeway, Texas 78734
512 293-4733 - carlosaustin@att.net
Experience
1997-Present Clinical Research Consultant
· Responsible for independently monitoring Phase I-IV clinical trials in accordance with Good Clinical Practice,
ICH guidelines and federal regulations
· Participate in identification an evaluation of Investigators
· Manage and report study site and overall program progress
· Monitor and or audit clinical studies to ensure data quality and integrity
· Verify investigational drug accountability and storage equipment
· PK sampling experience
· Conduct ongoing review of regulatory files and study supplies are maintained during the assigned project
· Resolve issues regarding enrollment
· Maintain relationships with Principal Investigators and study staff
· Ensure quality and deliverables are met across assigned clinical research institutions
· Trial Master File reconciliation
· Understanding of the assigned protocol(s) and trial specific manuals/plans to ensure quality
PPD/Pharmaco Inc. / Clinical Trials Management North America
1995-1997 Clinical Research Associate
· Independently monitored Phase II to IV clinical studies
· Conducted pre-study site selection, initiation, interim, and close-out visits
· Documented all findings, outcomes, and agreements reached during site visits
· Resolved discrepancies with EDC data
· Ensured proper maintenance of site's regulatory binder
· Verification of study drug accountability
· Contributed to the preparation and finalization of clinical study protocols and final reports
· Completion of Interim Analysis
1994-1995 Project Administrator
· Responsible for the management of multiple domestic and global projects
· Performed day to day tasks associated with the overall management of clinical research trials
· Tracked and managed fiscal aspects of studies, including yearly budget projections, actuals and study specific expenses
· Evaluated, selected, and implemented new clinical research technology according to GCPs, GLPs, cGMPs, FDA, DEA
and international guidelines
· Organized and scheduled multiple projects concurrently to meet deadlines
1991-1994 Clinical Research Coordinator
· Worked directly with physicians in the conduct of various in-patient and out-patient clinical trials
· Managed Schedule II and III controlled-substance studies
· Maintained accurate patient records, medication compliance and monitored for adverse events
· Presented protocols before research councils within hospitals for local IRB approvals
· Acted as liaison between pharmaceutical companies and clinical research institutions
Skills Computer – MAC OS X, XP 2011, Windows 8, ORACLE, CTMS, iMedidata, InForm, IRT - Fluent in Spanish
Education May 1990 University of Texas at Austin - Austin, Texas
Biology, Minor in Chemistry and Spanish

2. CLINICAL TRIAL EXPERIENCE
PHASE I
Pharmacokinetic and Pharmacodynamic Interactions of an Antiarrythmic and a Calcium Channel Antagonist.
The Oral Bioavailability /Bioequivalence of a New Beta Blocker Administered as 3 x 200mg Tablets and 600mg
Tablets Manufactured at different sites
Rising Dose Study to Determine the Tolerability and Pharmacokinetics of a New Antiarrhythmic Agent Using
Continuous Infusions in Normal Healthy Subjects
A Pharmacokinetic Comparison of a Calcium Channel Antagonist in Fed and Fasted Conditions
Multiple Dose Safety and Tolerance of a Cholesterol Absorption Inhibitor Administered in Ascending Doses and
Effect on Cholesterol Absorption in Volunteers with Mild to Moderate Hypercholesterolemia
Single Dose Safety and Tolerance of a Unique Cholesterol Lowering Agent in Man
A Randomized Four-Way Crossover Study to Evaluate the Pharmacokinetics, Dose Proportionality and
Bioavailability of an Anti-gout Agent Following Single Intravenous and Oral Administration in Healthy Male
Volunteers
At Risk for HIV Clinical Specimen Collection Study
Evaluation of the Pharmacokinetics of AMG 073 When Concomitantly Administered with Pantoprazole
Evaluation of the Pharmacokinetics of AMG 073 When Concomitantly Administered with Renagel
An Open-label, Single-dose Study of the Pharmacokinetics of AMG 073 Administered to Subjects with
End Stage Renal Disease Receiving Continuous Ambulatory Peritoneal Dialysis
Randomized, Double-blind, Placebo-controlled, Ascending, Single Oral Dose Study to Assess the Safety,
Tolerability, and Pharmacokinetics of BAG972 in Healthy Volunteers

3. PHASE II-IV
Preventive Relapse in Erosive or Ulcerative Gastroesophageal Reflux Disease
A Study of the Patient-Activated Reservoir in the Intrathecal Delivery of Morphine Sulfate as Management of
Pain due to Cancer and its Therapies
Long-Term Comparison on Growth Velocity and Tolerance of a Norditropin Human Growth Hormone
A Double-Blind, Randomized, Placebo-Controlled Study of Dose vs. Placebo in Sjogren's Syndrome Patients
with Xerostomia and Keratoconjunctivitis Sicca
An Open-Label Chronic Safety Study of a Dose in Sjogren's Syndrome Patients with Xerostomia and
Keratoconjunctivitis Sicca
A Comparison of the Onset of Action of Claritin-D and Semprex-D in Patients with Moderate to Severe Seasonal
Allergic Rhinitis
A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging study of CS-866 using Ambulatory Blood
Pressure Monitoring in Hypertensive Patients
A Phase II, Double-Blind, Double-Dummy, Optional Dose Titration, Cross-Over Comparison of Methylphenidate
Modified Release Formulation in Attention-Deficit Hyperactive Disorder Subjects Effectively Treated with
B.I.D. Immediate Release Methylphenidate
A Multicenter, Double-Blind, Parallel Group study comparing the Incidence of Gastroduodenal Ulcer associated
with SC-58635 bid with that of Diclofenac 75mg bid and lbuprofen 800mg tid, taken for 12 weeks in patients
with Osteoarthritis or Rheumatoid Arthritis
A Study of Long-Term Safety of SC-58635 in Treating and Signs and Symptoms of Osteoarthritis and
Rheumatoid Arthritis
A Comparative Study of the Efficacy and Safety of Clarithromycin Extended-Release Tablets and Loracarbef
Pulvules for the Treatment of Subjects with Secondary Bacterial Infectious of Acute Bronchitis
A Comparative Study of the Efficacy and Safety of Clarithromycin Extended-Release Tablets and Clarithromycin
Immediate Release Tablets for the Treatment of Subjects with Acute Exacerbation of Chronic Bronchitis
A Double-blind, Randomized, Stratified, Placebo-controlled Study of Ro64-0796 (also known as GS4104) in the
Treatment of Influenza
A Double-blind, Randomized, Stratified, Placebo-controlled Study of Ro64-0796 (also known as GS4104) in the
Treatment of Influenza in Children with Chronic Asthma
A Randomized, Double-blind, Placebo-Controlled Multicenter Study Measuring the Effects of Troglitazone in
Latino Patients with Type 2 Diabetes Mellitus

4. PHASE II-IV
A Comparative Study of the Safety, Efficacy and Effectiveness of Clarithromycin Extended-Release Tablets and
Augmentin Tablets for the Treatment of Subjects with Acute Exacerbation of Chronic Bronchitis
A Comparative Study of the Safety, Efficacy and Effectiveness of Clarithromycin Extended-Release Tablets and
Augmentin Tablets for the Treatment of Subjects with Acute Exacerbation of Chronic Bronchitis
A Phase II Double-Blind, Multi-Center, Vehicle-Controlled Feasibility Study of the Safety and Efficacy
of Intranasal Doxepin in the Prophylactic Treatment of Chronic Daily Headache
A Phase II Double-Blind, Multi-Center, Vehicle-Controlled, Dose Escalating Trial of the Safety and
Efficacy of Intranasal Doxepin in the Prophylactic Treatment of Chronic Daily
Headache
A Multinational, Randomized, Double-Blinded, Active-Controlled, Study for Evaluation of the Efficacy
and Safety of Oral HMR 3647 800mg Once a Day for 5 Days vs. Cefuroxime Axetil 250mg Twice a Day
for 10 Days in the Treatment of Acute Maxillary Sinusitis in Adults
A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety of the
Hormone Replacement Therapy Combination Drug Product Drospirenone/Estradiol in Postmenopausal
Women With Concomitant Disease and Medication Known to Potentiate the Risk of Hyperkalemia
A Randomized, Open Label, Parallel Design Study of Renagel Phosphate Binder Versus Calcium-Based
Phosphate Binders in Hemodialysis Patients
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled And Open-label Evaluation of the
Safety and Efficacy of Dual Therapy With Atorvastatin Plus Amlodipine When Compared To Either
Therapy Alone in the Treatment of Patients With Simultaneous Hyperlipidemia and Hypertension
Clinical Utility of Amlodipine/Atorvastatin To Improve Concomitant Cardiovascular Risk Factors of
Hypertension and Dyslipidemia
A Phase 3, Double-Blind, Multicenter, Multinational Randomized, Placebo-Controlled Trial Evaluating
Aztreonam Lysinate for Inhalation in Cystic Fibrosis Patients with Pulmonary P. aeruginosa (AIR-
CF1)
A Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial with Aztreonam Lysinate
for Inhalation in Cystic Fibrosis Patients with Pulmonary P. aeruginosa Requiring Frequent Antibiotics
(AIR-CF2)
A Phase 3, Open-label, Follow-on Study of Multiple Courses of Aztreonam Lysinate for Inhalation (AI)
in Cystic Fibrosis Patients (AIR-CF3)
A study of the irritation potential of 10% terbinafine hydrochloride nail solution for onychomycosis
(NSO) during repeated applications on the skin of healthy subjects

5. An open-label proof-of-concept study to assess the effects of two AIN457 doses (on Day 1 and Day 22)
in patients with noninfectious uveitis
PHASE II-IV
A Randomized, Double-Blind, Placebo-Controlled, Two Dose-Arm, Parallel study of the Safety and
Effectiveness of Immune Globulin Intravenous (Human), 10% (IGIV, 10%) for the Treatment of Mild-to-
Moderate Alzheimer’s Disease
A Phase 2B Double Blind, Randomized, Placebo-Controlled, Parallel group, Dose Ranging Study to
Assess the Efficacy, Safety, and Tolerability of PF-04950615 Following Monthly and Twice Monthly
Subcutaneous Dosing for Six Months in Hypercholesterolemic Subjects on a Statin
A Phase III, Stratified, Randomized, Double-Blind, Multicenter, Non-Inferiority Study to Evaluate Safety
and Immunogenicity of Cell-Based Quadrivalent Subunit Influenza Virus Vaccine and Cell-based
Trivalent Subunit Influenza Virus Vaccines in Subjects Ages ≥4 Years to 18 Years˂
A Phase III, Stratified, Randomized, Double-Blind, Multicenter, Non-Inferiority Study to Evaluate the
Safety and Immunogenicity of a Cell-based Quadrivalent Subunit Influenza Virus Vaccine and Cell-
based Trivalent Subunit Influenza Virus Vaccines in Adults Ages ≥18 Years of Age
Planned Transition to Sirolimus-based Therapy Versus Continued Tacrolimus-based Therapy in Renal
Allograft Recipients
An Open-label Extension Study of DS-5565 for 52 Weeks in Diabetic Peripheral Neuropathic Pain
A Randomized, Double-Blind, Placebo-Controlled, 13-Week Study of DS-5565 for Treatment of
Diabetic Peripheral Neuropathic Pain
A Randomized, Double-Blind, Placebo- and Active-Controlled study OF DS-5565 in subjects with Pain
Associated with Fibromyalgia
An Open-Label Extension Study of DS-5565 for 52 Weeks in Pain Associated with Fibromyalgia
A Phase III, Multicenter, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy
and Safety of K-103-IP Compared With Placebo for the Treatment of Mild to Moderate Acute Pain
Associated With Ankle Strain or Sprain
A 24-Week, Multicenter, Randomized, Double-blind, Placebo-Controlled, Add-on, Parallel-Group Study
to Assess the Effect of Rasagiline on Cognition in Patients with Parkinson’s Disease
A randomized, double-blind trial investigating the efficacy and safety of intravenous neridronic acid in
subjects with complex regional pain syndrome type I (CRPS-I)
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Investigating the Efficacy and Safety
of CVT-301 (Levodopa Inhalation Powder) in Parkinson’s Disease Patients With Motor Response

6. Fluctuations (OFF Phenomena)
PHASE II-IV
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of 2 Doses
of Tofacitinib (CP-690,550) in Subjects with Active Psoriatic Arthritis and an Inadequate Response to
at least One TNF Inhibitor
A Phase 3, Multi-Site, Open-Label Study of the Long Term Safety and Tolerability of 2 Doses of CP-
690,550 in Subjects with Moderate to Severe Chronic Plaque Psoriasis
A Phase 3 Efficacy and Safety Study of ALKS 5461 for the Adjunctive Treatment of Major Depressive
Disorder in Adults who have an Inadequate Response to Antidepressant Therapy (FORWARD-2 Study)
AC-1204 26-Week Long Term Efficacy Response Trial with Optional Open-Label Extension (NOURISH
AD) Alzheimer’s Disease
A Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active-Comparator Study
Evaluating the Efficacy and Safety of Liprotamase in Subjects with Cystic Fibrosis-Related Exocrine
Pancreatic Insufficiency
A Phase 3, Open-Label Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Cystic
Fibrosis Related Exocrine Pancreatic Insufficiency
An Open-Label Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Exocrine
Pancreatic Insufficiency due to Cystic Fibrosis
DERMATOLOGY
Safety and efficacy of test article cream, 1% compared to it’s vehicle and test article #2, 0.75% compared
to test article #3 in the treatment of Rosacea
An adrenal suppression trial of test article lotion, 0.05%compared to test article #2, 0.05% in subjects
with Psoriasis/Eczema.
Bilateral tolerance comparison study in subjects with Acne Vulgaris
A study of the contact sensitization potential of a 10% terbinafine hydrochloride nail solution for
Onychomycosis (NSO) following repeated applications onto the skin of healthy subjects
DENTAL STUDIES

7. A Randomized, Double-Blind, Placebo-Controlled Study to Compare the Analgesic Activity of RS138452,
an IP Receptor Antagonist, with lbuprofen 400mg and Placebo in a Post Surgical Dental Pain Model
in Male Patients, 18-40 Years of Age
IN-PATIENT STUDIES
A Multicenter, Randomized, Parallel, Double-Blind, Dose Ranging Study of Subcutaneous SR 90107A
/Org 31540 with an assessor blind, comparative control group of Subcutaneous LMWH in the prevention
of Deep Vein Thrombosis after Elective Total Hip Replacement
A Phase II, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Oral Food Challenge Trial of
Xolair (Omalizumab) with Children’s Peanut Allergy
A Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Control, Dose-Ranging Study to
Evaluate the Safety and Efficacy of a Single Administration of SKY0402 for Prolonged Postoperative
Analgesia in Subjects Undergoing Primary, Unilateral, Inguinal Hernia Repair
A Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Control, Dose-Ranging Study to
Evaluate the Safety, Efficacy, and Comparative Systemic Bioavailability of a Single Administration of
SKY0402 via Local Infiltration for Prolonged Postoperative Analgesia in Subjects Undergoing Total
Knee replacement
A Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Control, Dose-Ranging Study to
Evaluate the Safety and Efficacy of a Single Administration of SKY0402 for Prolonged Postoperative
Analgesia in Subjects Undergoing Hemorrhoidectomy
Clinical Evaluation of Efficacy and Safety of FS VH S/D 500 for Hemostasis in Subjects Undergoing
Vascular Surgery
INTERNATIONAL STUDIES
Edinburgh, Scotland
Phase I Disposition and Metabolic Study of Orally Administered EPG Drug in Normal Healthy Male
Volunteers
Ocho Rios, Jamaica & Guadalajara, Mexico
A Double-Blind, Randomized, Placebo-Controlled, Single Center, Multi-Site Study to Assess the Safety and
Efficacy of SP-303 in the Symptomatic Treatment of Acute Diarrhea Syndrome among Adult Residents of
Mexico Seeking Medical Care
A Double-Blind, Randomized, Placebo-Controlled, Multi-Site Study To Assess the Safety and Efficacy of SP-303
in the Symptomatic Treatment of Acute Diarrhea among Travelers to Mexico or Jamaica: Oral Administration of
125mg, or 500mg SP-303 Given Every 6 Hours for 48 Hours

8. INTERNATIONAL STUDIES (continued)
Panama City, Panama
Pharmacokinetics of Telithromycin (HMR 3647) in Infants and Children Suffering from Bacterial Lower
Respiratory Tract Infections after Single Oral Administration of 30mg/kg of a Telithromycin Suspension
(50mg/ml)
San Jose, Costa Rica, Guatemala City, Guatemala & Panama City, Panama
Multi-center, Phase II, Open-Label Study of the Efficacy, Safety, Acceptability, and Pharmacokinetics of
Telithromycin, after repeated oral administration of either of two doses, once daily, for 5 days or 7 to 10 days, in
the treatment of respiratory tract infections in children of 6 months to 12 years.
Mexico City, Mexico
Clinical Protocol for A Third Party Blind, Placebo Controlled, Comparison of the Analgesic Activity of Bextra
20mg, Bextra 40mg, Arcoxia 120mg, and Placebo in a Postsurgical Dental Pain Model
Mexico City, Mexico
Phase II, Double-Blind, Randomized, Exploratory Placebo-Controlled Study of the Efficacy, Safety and
Tolerability of MCC-135 Comparing QD vs. BID Doses in Subjects with Congestive Heart Failure, NYHA
Class II/III