Javier A. Alcalá Herrera, Ph.D.

College Station, TX 77845

(979) 255 - 8387

ad3tn7@r.postjobfree.com

PROFESSIONAL INTERESTS

• Assist in the process of selecting of large CROs for Clinical Trials - PPD, Quintiles, Syneos Health

• TMF design and review

• In house auditing, pre-FDA auditing, QC review, inspection readiness, international auditing

• Clinical Research Monitoring and Management – US and international

• International clinical trials placement

• CRO Management

EDUCATION

1989-1992 Post-Doctorate, Oceanography

Texas A&M University, College Station, Texas

1980-1989 Ph.D., Oceanography

Texas A&M University, College Station, Texas

1977-1980 M.S., Biology

Universidad Nacional Autónoma de México, México City, México 1973-1977 B.S., Biology (Special studied in Embryology, Cell Biology, Histology and Virology) Universidad Nacional Autónoma de México, México City, México SPECIAL SKILLS

Fluency in Spanish and English.

EDC SYSTEM EXPERIENCE:

• OMNICOMM TRIAL MASTER, PRISM-NEXTRIALS (ONCOLOGY), eCaseLink, Document Solution Group, Inc. (Urology/ Erectile dysfunction), ClinoPhone EDC (GI), Oracle Clinical (Diabetes), DataTrak, Phase Forward – InForm, EDC Solutions – BioPharma Systems, Inc, Cmed, Clinresearch,, Medrio-PRO, Medidata RAVE, MedQIA (Oncology), Clinreasearch (GI), ClinPlus, TrialStat, IBM, Axiom Real-Time metrics. EMR SYSTEM EXPERIENCE:

• FLORENCE, CRIO, REAL TIME, VEEVA SITE, VESTIGO, ADVARRA SYSTEM. EXPERIENCE

2010-Present President, Alcala-Herrera Pharmaceutical Consultants, LLC., College Station, TX. 1999-2010 President, Wilhelm Ibarra Analytical Services, Inc., College Station, TX. 1998-Present Clinical Research Consultant. Clinical Research Services as part of Wilhelm Ibarra Analytical Services, Inc. and Alcala-Herrera Pharmaceutical Consultants LLC. CRA experience

CLINICAL RESEARCH ASSOCIATE EXPERIENCE

1998- Present

Independent consultant since 1998. Duties have included general monitoring activities, maintaining Regulatory Binder, drug accountability, pre-study, monitoring and close out visits. Participated in over 50 trials, 13 of which have been bilingual placed in Mexico, Argentina, Brazil, Peru, Panama, Ecuador, Dominican Republic Honduras, Colombia, and Puerto Rico THERAPUETIC AREA EXPERIENCE

• Device (cardiology and hematology)

• Dermatology (acne, Rosacea)

• Pediatric (Viral/Influenza, diaper rash)

• Rare illnesses (Hereditary Angioedema)

• Oncology (Prostate, Breast, Colon, Leukemia, Bladder, Ovarian, non-Hodgkin’s, Pancreatic, Brain)

• GI (Bacterial Diarrhea-C. difficile, Constipation, Travel diarrhea, Diverticulitis, colon resection)

• Hematology (DVT)

• Diabetes Fibromyalgia, Diabetes related to the effect of vision

• Neurology (Alzheimer’s disease, depression, anxiety, restless legs, insomnia, schizophrenia)

• Gynecology

• Transplant/Stem cells

• Smoking cessation

• Pain (relief and management)

• Ophthalmology, Dry eye, Device, Lasik, Eye Lenses surgery

• Skin (Rosacea, acne)

• Fenom Pro device for uncontrolled asthma

AUDITING and CTM EXPERIENCE

(In house and onsite)

• Lymphoma Leukemia - Oncology

• Hematology

• Solid Tumors – Oncology

• Influenzas

• Cardiomyopathy

• Lupus

SPECIAL SKILLS

Fluency in Spanish and English.

EDC SYSTEM EXPERIENCE:

• OMNICOMM TRIAL MASTER, PRISM-NEXTRIALS (ONCOLOGY), eCaseLink, Document Solution Group, Inc. (Urology/ Erectile dysfunction), ClinoPhone EDC (GI), Oracle Clinical (Diabetes), DataTrak, Phase Forward – InForm, EDC Solutions – BioPharma Systems, Inc, Cmed, Clinresearch,, Medrio-PRO, Medidata RAVE, MedQIA (Oncology), Clinreasearch (GI)

EXPERIENCE

2010-Present President, Alcala-Herrera Pharmaceutical Consultants, LLC., College Station, TX. 1999-2010 President, Wilhelm Ibarra Analytical Services, Inc., College Station, TX. 1998-Present Clinical Research Consultant. Clinical Research Services as part of Wilhelm Ibarra Analytical Services, Inc. and Alcala-Herrera Pharmaceutical Consultants LLC. AUDITING EXPERIENCE

2007-Present

Independent consultant since 2013. Duties have included Auditing several studies in Latin America, Europe and USA. Reports were completed and review of the Regulatory Binder performed. CRA reports were summarized and SAEs and ICF verified for completeness. CRA reports were summarized and SAEs and ICF verified for completeness.

AUDITING and CTM

SUMMARY OF AUDITING/CTM EXPERIENCE

Therapeutic area Company Country

Years

Start- End

• Lupus • Idorsia Mexico 2021-2023

• Cardiomyopathy • Myokardia USA and Europe, 2020-2021 Influenza • Seqirus Latin America and USA 2019-2020 Oncology – Solid Tumors • EISAI/ CMF USA/Europe 2019-2019 Oncology/Lymphoma

Leukemia/Lymphoma

Society – Emericlin, LLC USA 2018-2020

Phase I – Opioid study

Egalet – MKR Clinical

Research Consultants,

Inc. USA/Canada 2016

ALS Veritas Clinical Consultant US/Europe 2013

Oncology Veritas Clinical Consultant USA 2013

Hematology Valiant Pharma

Argentina, Brazil and

Mexico 2009-2010

Oncology – Solid

Tumors Veritas Clinical Consultant USA and Europe 200*-****-****

Idorsia

CTM.

o Contact site in Mexico and Chile for an oncoming study Phase 3. Selection of over 60 sites in both countries.

o Contact sites and visit sites for Qualification visits. Idorsia

Oversight Monitor and CTM.

o Oversight pre-Auditing and resolution of issues prior to FDA audit and IP approval. o eTMF, Veeva Vault, review and verification of documents as well as quality. o Work will be performed in 23 sites located in Mexico. However, only Sponsor selectant sites will be reviewed.

2020-2021

Myokardia

CTA. Review of the eTMF for over 80 sites in USA and Europe. Identify issues and provide problems for resolution to PPD. Manger the pre- Sponsor Auditing and FDA auditing. o Oversight pre-Auditing and resolution of issues prior to FDA audit and IP approval. o Upload and review documents, quality of documents, naming convention, location, type of document in two studies for Myokardia. Identify problems. eTMF was Veeva Vault and the CRO was PPD.

o Study was over in March 2021.

2019-2020

Seqirus

Pre-auditing and CTM. Responsibilities included are Pre-visit - Review site reports and provide recommendations; review regulatory binder and verify all documents are updated, contact assigned CRA and verify that the site is informed of my visit and objectives. During Visit – Review all ICFs, verify the ISF, identify issues during monitoring, monitor a selected number of subjects. Post Visit – Complete report for the site and complete report for the CRA and CRO. Other obligations: Review annotated reports, and corresponding letters and provide recommendations for capturing all data required by the Sponsor. o Oversight of CROs for Latin America countries in multiple influenza studies. Travel to Central and South America and Caribbean areas. Spanish and Portuguese speaking countries

o Oversight of CROs for Clinical trials in USA. Multiple travel to sites in the USA to verify the CRO and CRA performance. Pre-auditing review.

o Contact with CRO (Syneos and Quintiles) for the discussion and co-managing of two Influenza studies. One in USA and one in Central and South America. 2019

EISAI

o Two studies of Solid Tumors. Sites were in Europe and USA. FDA audited two sites after performing this audit. No major findings were reported. o The Audit was performed prior to FDA audit. Sites in USA (including MSK and Boston General) and sites is Spain (Barcelona and Cordoba). Additional sites in Moscow, Italy, France and England were also audited during the study. 2018- 2020

The Leukemia & Lymphoma Society – Emericlin, LLC

o The study includes one Leukemia study and 16 sub-protocols of no-previously treated subjects. Sub-studies are defined based on the molecular risks. The CRA audits previously entered and monitored data and provides assessment to the Sponsor of resolution and problems identified during the audit review. Continuous supervision has been maintained.

o Remote review of data and producing Data Management queries after Monitoring by the assigned CRO.

o Also verify that data has been uploaded to Protocol First Service Data (Source) by the site staff and that complete verification is performed by the CRAs. 2016

EGALET – MKR Clinical Research Consultants, Inc.

o Phase I - Opioid study for the verification of Laboratory procedures. Auditing Laboratory procedures as a result of procedures being performed without following protocol. o International study. Two sites one is Salt Lake City and second in Toronto, Canada. o Completion of report and verifications. Unblinded Auditor work. 2013

KNOOP BIOSCIENCES, LLC. - VERITAS CLINICAL CONSULTANT, INC, FOGELSVILLE, PENNSYLVANIA

o Post Study – Sponsor – CRO/ Multi Site TMF review for a clinical trial Phase III ALS clinical trial pre-FDA audit.

o A study with 100 sites worldwide. The duties were to organize TMF, identify missing or incomplete documents. Request documents to the assigned CRO. Provide the sponsor with files that will be FDA audited and possible problems prior to the FDA audit. 2013

VERITAS CLINICAL CONSULTANT, INC, FOGELSVILLE, PENNSYLVANIA. o Oncology study – Home based auditing.

o A study with six sites were audited to identify deficiencies before an FDA Audit. The sites were in Brazil, Argentina, and Mexico. Relevant information was reported to the sponsor and training regarding FDA auditing was provided to the sites. All CRA visits occurred in 2009; however, additional visits took place with FDA auditors in 2013. 2009-2010

VALEANT PHARMA/GSK

o International Hematology study A study with six sites were audited to identify deficiencies before an FDA Audit. The sites were in Brazil, Argentina, and Mexico. Relevant information was reported to the sponsor and training regarding FDA auditing was provided to the sites. All visits occurred in 2009; however, additional visits took place with FDA auditors in 2010. 2007

VERITAS CLINICAL CONSULTANT, INC, CHALFONT, PENNSYLVANIA o Oncology Study - solid tumor

o A study with 200 sites worldwide. The Auditor duties were to organize regulatory binder, identify missing documents, request documents to the manager CROs. Provide the sponsor with documents that will be FDA audited. Advice the sponsor of possible problems during an FDA audit and provide solutions. Report was completed.

o Audit was home performed. No visits to the sites were done. CRA EXPERIENCE SUMMARY

Therapeutic area Company CRO Country

Yr.

Start- End Phase

Otomycosis Hill Dermaceutical USA

2022-

ongoing III

Urinary

Incontinence

Device. Nesuspera

Axiom/Monitor

for Hire USA 2022-2023 I and II

Diabetes Mellitus

(01) Oramed LDT Integrium USA 2021-2023 III

Diabetes Mellitus

(02) Oramed LDT Integrium USA 2021-2023 III

Oncology/ Acute

Myeloid Leukemia Morphosus CRAresources USA

2023-

Ongoing I and II

Ovarian Cancer VBL Therapeutics KCR

USA

2020-2022 III

Device Fenom Pro CAIRE Diagnostics

USA

2021-2022 IV

Pediatric 1401

study Windtree

MKR Clinical

Research

USA

2021-2022 II

Pediatric 1202

study Windtree

MKR Clinical

Research

USA

2021-2022 II

Neurological/

Alzheimer’s Disease Cassava Sciences USA 2021-2021 I Neurological/

Alzheimer’s Disease Cassava Sciences USA 2021-2021 II Oncology/Pre-

treatment

Coherus

Biosciences Randstad USA 2020-2021 I

Neurological/

Alzheimer’s Disease Cassava Sciences Emericlin USA 2020-2020 IIb Oncology/Solid Tumors MacroGenics Emericlin/KCR USA 2018-2019 I Ophthalmology/

Macula Edema AIVIVA Clindatrix USA

2022-

ongoing I-II

Ophthalmology/

Cataract surgery Zeiss Ora USA 2018-2019 II

Ophthalmology/

Eye Lenses Device Nidek, Ora USA 2018-2019 III

Ophthalmology/

Dry Eye Aldeyra, Ora USA 2018-2019 III

Oncology/Breast New Link Emericlin/KCR USA 2017-2019 II Oncology/

Pancreatic New Link Emericlin/KCR USA 2017-2019 II Ophthalmology/

Diabetes Kalvista Ora USA 2017-2019 III

Oncology/Brain New Link Emericlin/KCR USA 2017-2017 II Ophthalmology/

Dry Eyes ReGenTree Ora USA 2016-2017 III

Pediatric 1202

study Windtree

MKR Clinical

Research

United

States 2016-2017 II

Drug Management Egalet US, Inc USA 2016-2016 I

Drug Management Egalet US, Inc Canada 2016-2016 I

Oncology

Cao

Pharmaceuticals,

Inc.

Randstad

Pharma USA 2015-2021 I

Oncology

Alliance

Foundation Trials,

LLC, PrECOG

Quality Data

Services, Inc. USA 2015-2019 III

Oncology

Generon

Corporation Emeritus USA 2015-2019 IIa

Cardiovascular/

Device

Johnson &

Johnson/ Cardinal

Health Novella Clinical USA 2015-2019

Femoral Sten

System

Hepatic Fibrosis Nitto QDS

United

States 2015-2016 I

Liver Ambit Randstad

United

States 2015-2016 I

Liver Ambit Randstad

United

States 2015-2016 I

Oncology

Heron

Pharmaceuticals,

Inc.

Accelovance

Inc/Catalyst USA 2015-2015 III

Oncology/ Healthy subjects Ambit

Randstad

Pharma USA 2015-2015 I

Oncology/ Acute

Myeloid Leukemia Plexxikon Novella Clinical USA 2014-2015 II Pediatric/Influenza BioCryst INNO

United

States 2014-2015 III

Hereditary

Angioedema BioCryst INNO

United

State 2014-2015 III

Oncology/ Stem

cell transplant Ambit

Randstad

Pharma USA 2013-2015 I

Oncology/ Acute

Myeloid Leukemia Ambit

Randstad

Pharma USA 2013-2015 I

Oncology/ Prostate

Astellas

Pharmaceuticals

Randstad

Pharma USA 2013-2015 I

Cardiovascular/

Device

Johnson &

Johnson/ Cardinal

Health Novella Clinical USA 2013-2015

Pivotal and

post

marketing

Oncology/ Ovarian/

Ophthalmology Array Biopharma

Randstad

Pharma USA 2013-2014 III

Cardiovascular/

Device

Johnson &

Johnson/ Cardinal

Health Novella Clinical USA 2013-2014

Pivotal and

post

marketing

Acne, Dermatology

Taro

Pharmaceuticals Symbio LLC USA 2013-2014 III

Rosacea, Dermatology Tolmar, Inc Symbio LLC USA 2013-2014 III Oncology/ Acute

Myeloid Leukemia

Astellas

Pharmaceuticals

Randstad

Pharma USA 2013-2013 II

HN Registry Otsuka Registrat-MAPI USA 2013-2013 IV Oncology/ Acute

Myeloid Leukemia

Astellas

Pharmaceuticals

Randstad

Pharma USA 2012-2013 I

Oncology/ Stem

cell transplant

Astellas

Pharmaceuticals

Randstad

Pharma USA 2012-2013 I

Oncology/

Bladder Cancer

Endo

Pharmaceuticals Regisrat-Mapi USA 2011-2012 IV

Smoking Cessation

22nd Century

Limited, LLC

Trio Clinical

Research USA 2011-2012 I

Oncology/Pre-treatment

Coherus

Biosciences Randstad USA 2011-2012 I

Pain Management

Study

Nektar

Therapeutics None

United

Stated 2011-2011 I

Pain relief Trial

(Ileostomy, Open

Colectomy and

Lap Colectomy) Pacira Registrat-MAPI USA 2011-2011 IIIb Oncology/

Prostate, Ovarian/

Breast Cancers Exelixis Cmed USA 2010-2012 II

Hereditary Angioedema Pharming Cmed

USA,

Canada 2010-2012 IIIb

Diabetes XOMA Monitor for Hire Mexico 2010-2011 III GI/Diverticulitis/

Ulcerative colitis/

IBS Dr. Falk Pharma

TRIO Clinical

Research USA 2009-2013 III

Firbromyalgia Eli Lilly

Monitor For

Hire USA 2008-2011 IV

Urology/

Peyronie's Disease

Auxilium

Pharmaceutical ICON

United

States 2008-2010 II

Oncology/ non-

Hodgkin’s Lymphoma Pharma Mar

Worldwide

Clinial Research

Spain/

Argentina 2008-2010 III

GI/Colon resection/

Oncology/U colitis Helsinn

Bradstreet

Clinical

Research

Associates

United

States 2008-2010 II

Diabetes Tolerx

TRIO Clinical

Research

United

States 2008-2010 II

Cardiovascular/

Device Transoma Medical Monitor for Hire Panama 2008-2009 III Neurological/

Alzheimer’s Disease Elan

TRIO Clinical

Research

USA,

Canada 2007-2012 II, III

Oncology/ Prostate Novacea

Protrials

Research Inc. USA 2007-2008 II

Hematology/ Device BD Medical

Precept Life

Sciences Colombia 2007-2008 III

Neurological/

Alzheimer’s Disease Sepracor

TRIO Clinical

Research

United

States 2007-2007 II

Cardiovascular/

Device Transoma Medical Monitor for Hire Panama 2006-2009 II Pediatric Barrier

Veritas Clinical

Consultant Inc.

United

States 2006-2009 III

Hematology/ Pediatrics/ Kidney-Dialysis

Luitpold

Pharmaceuticals Mexico 2006-2009 II

GI/ Travel

diarrhea

Advance Biologics,

Inc. (Now part of

INC)

Advance

Biologics, Inc.

(Now part of

INC)

Peru,

Mexico 2006-2008 III

Diabetes Pfizer - Mexico

Kendle

International

Inc. Mexico 2006-2007 III

Transplant/Stem

cell

Bradstreet Clinical

Research

Associates.

USA,

Canada 2006-2006 III

Oncology/ GI ImmunoGen, Inc

Veritas Clinical

Consultant

Incorporated

United

States 2005-2008 I

GI/ Travel

Diarrhea

Salix

Pharmaceutical

TRIO Clinical

Research Mexico 2005-2007 III

GI/Constipation Inkine

Quality Data

Services, Inc. USA 2005-2005 III

Hematology

Luitpold

Pharmaceuticals, Mexico 2004-2007 III

Urology/

Overactive Bladder

Schwarz

Biosciences

Veritas Clinical

Consultant

Incorporated

United

States 2003-2007 II, III

Neurological/

Depression, Anxiety, Restless Cephalon legs, Insomnia, Schizophrenia Quality Data

Services, Inc.

United

States 2002-2006 II, III

Hematology/DVT

Bradstreet Clinical

Research

Associates, USA 1999-2000 III

Gynecology/Pap

smear

Bradstreet Clinical

Research

Associates Mexico 1998-1999 III

Cardiovascular/

Device Parke Davis USA 1993-1998 III

ONCOLOGY

2023-ONGOING

CRAResources

Morphosus

• A Phase I Study of XXXXX, a small molecule inhibitor of BET Protein in Patients with Acute Leukemia, Myelodysplastic Syndrome. or Myelodysplastic/Myeloproliferative Neoplasms Duties: The CRA performed the remote and on-site monitoring of the data. IP accountability and pharmacy contact during the study. The CRA has completed IMVs and is expecting to perform COV for two sites. 2020-2022

EMERICLIN

VBL Therapeutics, KCR

• The OVAL Study: A Randomized, Controlled, Double-Arm, Double-Blind, Multi-Center Study of XXXXX- YYYYYYY (VB-111) Combined with Paclitaxel vs. Paclitaxel Combined with Placebo for the Treatment of Recurrent Platinum-Resistant Ovarian Cancer. Phase III study Duties: Unblinded CRA. The CRA performed the IP accountability and pharmacy contact during the study. Most o the work was remote using different EMR systems, Vestigo, CRIO, etc, and performing the drug count via Team. Few on site visits were performed. The study was closed after an interim analysis showing that subjects were not responding to the medication as expected. 2017-2018

EMERICLIN

NEW LINK, KCR

• Study NLG2101: A Phase 2, Double-blinded, Randomized, Placebo-Controlled Study of xxxxxx in Combination with Texane Chemotherapy in Metastatic Breast Cancer. Duties included performing CRF development, SOPs development, SIVs, IMVs and COVs 2017-2019

EMERICLIN

NEW LINK, KCR

• NLG2102: A Phase 1/2 Study of the Combination of Indoximod and Temozolomide for Adult patients with Temozolomide-Refractory Primary Malignant Brain Tumors. Duties included performing CRF development, SOPs development, SIVs, IMVs and COVs 2017-2019

EMERICLIN

NEW LINK, KCR

• NLG2103: A Phase 1/2 Study of the Concomitant Administration of Indoximod plus Immune Checkpoint Inhibitors for Adult Patients with Advanced or Metastatic Melanoma. Duties included performing CRF development, SOPs development, SIVs, IMVs and COVs. 2017-2019

EMERICLIN

NEW LINK, KCR

• NLG-2104. A Phase 1/2 Study of Indoximod in Combination with Gemcitabine and Nab- Paclitaxel in Patients with Metastatic Adenocarcinoma of the Pancreas. Duties included performing CRF development, SOPs development, SIVs, IMVs and COVs 2015-2019

ALLIANCE FOUNATION TRIALS, LLC AND PRECOG,

• PALLAS: PALbociclib CoLlaborative Adjuvant Study: A randomized phase III trial of XXXXXX with standard adjuvant endocrine, therapy versus standard adjuvant endocrine therapy alone for hormone receptor positive (HR+) / human epidermal growth factor receptor 2 (HER2)-negative early breast cancer. Duties included performing CRF development, SOPs development, SIVs, IMVs and COVs 2015-2020

CAO PHARMACEUTICAL, HOUSTON, TX

• Phase I Clinical Trial of Camptothecin-20-o-Propionate Hydrate (CZ48).

• Duties included performing CRF development, SOPs development, SIVs, IMVs and COVs in one location in San Antonio Texas, USA locations. One CRA in Texas. 2015-2015

HERON THERAPEUTICS, INC. 123 Saginaw Drive, Redwood City, California 94063. ACCELOVANCE, INC. 2275 Research Boulevard, Suite 700, Rockville, Maryland 20850

• A Prospective, Randomized, Placebo-Controlled, Double-Blind, Multicenter, Phase 3 Study of XXXXX mg SC, YYYYYY 150 mg IV, and ZZZZZZZ vs. MMMMM 0.15 mg/kg IV, YYYYYY 150 mg IV, and ZZZZZZZ for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Subjects Receiving Highly Emetogenic Chemotherapy, including Pancreatic, Liver, Brain, Breast, Renal, and Ovarian cancers.

2014-2015

PLEXXIKON INC., 91 Bolivar Drive, Berkeley, CA 94710, USA

• A Randomized Multicenter Phase 2 Study of XXXXX Plus

• XXXXX Versus XXXXX Alone in Subjects with Newly Diagnosed FLT3-ITD-positive Acute Myeloid Leukemia who are 60 Years of Age or Older and Who Are Not Candidates for Intensive Chemotherapy.

2013-2014

ARRAY BIOPHARMA INC. 3200 Walnut Street, Boulder, CO 80301

• The MILO Study (MEK Inhibitor in Low-grade Serous Ovarian Cancer): A Multinational, Randomized, Open-label Phase 3 Study of XXXX vs. Physician’s Choice Chemotherapy in Patients with Recurrent or Persistent Low-grade Serous Carcinomas of the Ovary, Fallopian Tube or Primary Peritoneum.

2013- 2017

ASTELLAS PHARMA GLOBAL DEVELOPMENT, INC. RESEARCH & DEVELOPMENT, 1 Astellas Way, Northbrook, IL 60062

• A Phase 2 Study Determining Safety and Tolerability of XXXXXX (formerly YYYYY ) in Combination with Abiraterone Acetate in Bone Metastatic Castration-Resistant Prostate Cancer Patients.

2012-2013

ASTELLAS PHARMA GLOBAL DEVELOPMENT, INC. RESEARCH & DEVELOPMENT, 1 Astellas Way, Northbrook, IL 60062

• 2698-CL-2004 A Phase 2, Randomized, Open-Label Study of the Safety and Efficacy of Two Doses of Quizartinib (AC220; ASP2689) in Subjects with FLT3-ITD Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)

2012-2015

AMBIT BIOPHARMA, SAN DIEGO CA.

ASTELLAS PHARMA GLOBAL DEVELOPMENT, INC. Research & Development, 1 Astellas Way, Northbrook, IL 60062

• 2698-CL-0005 A Phase 1 Study of XXX (YYYY) in Combination with Induction and Consolidation Chemotherapy in Patients with Newly Diagnosed Acute Myeloid Leukemia. The study included escalation of study IP, 6 subjects, to identify the best dose. If 3 subjects discontinue as a result of SAEs/AEs related to study medication the prior dose (or two) will be used to randomize 50 additional subjects (Expanded Access Program). 2012-2015

AMBIT BIOPHARMA, SAN DIEGO, CA.

ASTELLAS PHARMA GLOBAL DEVELOPMENT, INC. Research & Development, 1 Astellas Way, Northbrook, IL 60062

• 2698-CL-0011. A Phase 1 Study of XXX (YYYY) as Maintenance Therapy in Subjects with Acute Myeloid Leukemia Who Have Been Treated with an Allogeneic Hematopoietic Stem Cell Transplant

2015-2015

AMBIT BIOPHARMA, SAN DIEGO, CA.

• AC220-019. a phase 1, open-label, randomized, single-dose, parallel-group study to evaluate the effect of food on the pharmacokinetics of xxxxxxx and its active metabolite, yyyyy, in healthy subjects

2011-2012

REGISTRAT-MAPI, 2343 ALEXANDRIA DRIVE SUITE 250, LEXINGTON, KY 40504-3276 ENDO PHARMACEUTICALS SOLUTIONS. INC. 100 Endo Boulevard Chadds Ford, PA 19317

• Valrubicin, valstar®EN3329-402 a prospective registry to assess the effectiveness and local tolerability of intravesical valrubicin in subjects with non-muscle invasive bladder cancer (nmibc) 2010-2012

CMED (CLINICAL RESEARCH SERVICES) LTD, HOLMWOOD, BROADLANDS BUSINESS CAMPUS, LANGHURSTWOOD ROAD, HORSHAM, WEST SUSSEX, RH12 4QP, UNITED KINGDOM SPONSOR: EXELIXIS

• A Phase 1/2 Drug-Drug Interaction Study of the Effects of XL184 on the Pharmacokinetics of a Single Oral Dose of Rosiglitazone in Subjects with Solid Tumors

• A randomized discontinuation study of xxxxx in subjects with advanced solid tumors. Thirty five subject were expected to be randomized 16 should complete study (Day 57) and then open to enrollment to 50 subjects. Five centers were selected to participate in the study (Expanded Access Program/Cohort expansion Study).

2008-2010

CRO: Worldwide Clinical Research;

SPONSOR: PharmaMar, Madrid, Spain.

• A Phase II Multicentre, Open-Label, Clinical And Pharmacokinetic Study of XXXX® as a 1-Hour Weekly IV Infusion, in Patients with Relapsed Or Refractory Aggressive non-Hodgkin’s Lymphoma. Pharmacogenomic tests associated to the clinical study APL-B-013-02. 2007-2008

CRO: Protrials Research Inc;

SPONSOR: Novacea, Inc., San Francisco, CA.

• A Phase 3, Randomized, Open-Label Study Evaluating XXXXX in Combination with Docetaxel in Androgen-Independent Prostate Cancer (AIPC) (XXXXXX). 2005-2006

VERITAS CLINICAL CONSULTANT, INC, CHALFONT, PENNSYLVANIA.

• “A Phase I Study to Assess the Safety and Pharmacokinetics of XXXXXXX Administrated as a Single Intravenous Infusion once every Three Weeks to Subjects with Solid Tumors.” Colon Cancer Project developed at CTRC, San Antonio Texas. Phase I study. CARDIOVASCULAR/DEVICE STUDY

1993

PARKE DAVIS

• Comparative study of a 24 hours Ambulatory Blood Pressure Monitoring System to cup measurements taken within 72 hours.

• Duties included: The 24 hours ambulatory systems took measurements at regular intervals and were captured in a small portable computer. Cup blood pressure measurements were taken 24 and 2 hours before the ABPM was installed, and 2 and 24 hours after removal. One Phase IV trial, one site 10 subjects in Texas.

2022-2023

Neuspera – Axiom – Monitor for Hire

• Clinical Study of Neuspera’s Implantable Sacral Nerve Stimulation (SNS) System in Patients with Symptoms of Urinary Urgency Incontinence (UUI)

• Duties included: Perform Monitoring duties for the Phase I and Phase II studies. The CRA was assigned 7 sites. SQVs, SIV, and IMVs were performed. 2006-2009

MONITOR FOR HIRE

SPONSOR: TRANSOMA MEDICAL

• Pilot Clinical Study of the XXXXXX Implantable XXXX Monitoring System. Phase II 2008-2009

MONITOR FOR HIRE

SPONSOR: TRANSOMA MEDICAL

• Pilot Clinical Study of the XXXXXX Implantable XXXX Monitoring System. Phase III 2013-2014

NOVELLA CLINICAL

SPONSOR: JOHNSON&JOHNSON

• A prospective, single-blind, randomized, multi-center study comparing the XXXX Elite to the XXXXX Velocity Sirolimus-Eluting Stent Systems. Phase Pivotal 2013-2015

NOVELLA CLINICAL

SPONSOR: JOHNSON&JOHNSON

• CYPRESS: A Prospective, Randomized, Multi-Center, Double-Blind Trial to Assess the Effectiveness and Safety of Different Durations of Dual Anti-Platelet Therapy (DAPT) in Subjects Undergoing Percutaneous Coronary Intervention with the XXXXX Sirolimus-eluting Coronary Stent (XXXXX Stent). Phase: Post marketing study

2015-2019

NOVELLA CLINICAL

SPONSOR: CARDINAL HEALTH (JOHNSON&JOHNSON)

• Cordis Study: Evaluation of Safety and Efficacy of the FlexStent Femoropopliteal Sel-Expanding Stent System Study.

OPHTHALMOLOGY

2022-ongoing

Clindatrix, 1 Ada Ste 250, Irvine, CA 92628

AiViva Biopharma, Inc., 1300 Bristol Street North, Suite 220, Newport Beach, CA 92660 SPONSOR: AiViva Biopharma, Inc., 1300 Bristol Street North, Suite 220, Newport Beach, CA 92660

A Phase 1 Study of the Safety, Pharmacokinetics, and Exploratory Efficacy of Periocular Administration of AIV007 Gel Suspension in Subjects with Macular Edema Secondary to Neovascular Age-Related Macular Degeneration (nAMD) or Diabetic Macular Edema (DME) 2018-2019

ORA, 300 Brickstone Square, 3rd Floor, Andover, MA 01810, USA SPONSOR: Carl Zeiss MediTec Production LLC, 1040 South Vintage Ave,m Bldg A, Ontario, CA 91761.

• A Multi-Center Prospective Clinical Trial to evaluate the safety and effectiveness of the CT LUCIA 611P Posterior Chamber Intraocular Lens for Correction of Aphakia Following Cataracts Removal. AIV007 (lenvatinib) Gel Suspension

2018-2019

ORA, 300 Brickstone Square, 3rd Floor, Andover, MA 01810, USA SPONSOR: Aldeyra Therapeutics, Inc.131 Hartwell Ave, Lexington, MA 020421, USA

• Protocol Title: ADX-102-AC-010 A Multi-Center, Double-Masked, Randomized, Parallel-Group, Vehicle-Controlled, Environmental Clinical Trial with Reproxalap Ophthalmic Solutions (0.25% and 0.5%) in Subjects with Seasonal Allergic Conjuntivitis 2017-2019

ORA, 300 Brickstone Square, 3rd Floor, Andover, MA 01810, USA SPONSOR: KalVista Pharmaceutical, Ltd., Tetricus Science Park, Building 227, Porto Down SP4 0JQ, United Kingdom

• Protocol Title: A randomized sham-controlled double-masked Phase 2a study of the efficacy, safety and tolerability of the intravitreal plasma kallikrein inhibitor, KVD001, in subjects with center-involving diabetic macular edema (ciDME) who have had prior anti vascular endothelial growth factor (VEGF) treatment

2017-2019

ORA, 300 Brickstone Square, 3rd Floor, Andover, MA 01810, USA SPONSOR: Aldeyra Therapeutics, Inc.131 Hartwell Ave, Lexington, MA 020421, USA

• Protocol Title: ADX-102-AC-008 A Multi-Center, Double-Masked, Randomized, Parallel-Group, Vehicle-Controlled, Phase 3 Clinical Trial to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solutions (0.25% and 0.5%) Compared to Vehicle in the Conjunctival Allergen Challenge (Ora-CAC®) Model of Acute Allergic treatment

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2017-2019

ORA, 300 Brickstone Square, 3rd Floor, Andover, MA 01810, USA SPONSOR: KalVista Pharmaceutical, Ltd., Tetricus Science Park, Building 227, Porto Down SP4 0JQ, United Kingdom

• Protocol Title: A multi-center, prospective clinical trial to evaluate the safety and effectiveness of the ct lucia 611p posterior chamber intraocular lens for correction of aphakia following cataract removal (ide 611 study)

2017-2019

ORA, 300 Brickstone Square, 3rd Floor, Andover, MA 01810, USA SPONSOR: NIDEK Co. LTD.cal, Ltd., Tetricus Science Park, Building 227, Porto Down SP4 0JQ, United Kingdom

• Protocol Title: Comparative study of NIDEK-TONOREF III and Hagg-Streit Goldmann Manual Tonometer (Predicate) to demonstrate conformance to ANSI Z80.10-2014 Ophthalmology Instruments – Tonometer, to the FDA Guidance for Industry and FDA Staff 2016-2017

ORA, 300 Brickstone Square, 3rd

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