Alisa Danielyan

***** **** ***** *******

Boca Raton, FL 33433

Tel (cell): +1-714-***-****

Email: ad3unp@r.postjobfree.com

PROFESSIONAL EXPERIENCE

Project Manager / Lead CRA Nov 2010 – present

Clinartis LLC / Hollywood, FL

Main Duties:

Responsible for the management of designated clinical studies including investigator selection, analysis of potential patient recruitment, preparation of study related documentation (protocols, Case report forms, investigators brochures, consent documents, letters of agreement, confidentiality agreements), organizing IRB/Ethics committee submissions with follow through to ensure successful outcome.

Organize investigator’s start-up meeting and study site initiation meetings.

On-site and remote monitoring the assigned clinical study following Company SOPs and in accordance with GCP.

Point of first contact when investigators/site personnel enquire about patient inclusion/exclusion criteria for ongoing studies.

Manage patient recruitment strategies to increase patient enrollment into clinical studies

Planning the requirements for Investigational Products and other clinical study supplies, maintaining procedures for accountability of Investigational Products and other clinical study supplies, checking the expiration of Investigational Products and other clinical study supplies and requesting extensions if necessary.

Review AEs and SAEs, ensure Medical Director sign-off, that sites are notified and that all applicable procedures are complied with.

Coordinate the movement of laboratory samples and the resulting data when central laboratory facilities are used.

Tracking completed CRFs and setting up systems whereby completed CRFs are rapidly entered into the database. Ensure that queries generated during cleaning are responded to in a timely fashion.

Maintain project files including ethics committee approvals; curricula vitae of investigators and study personnel; clinical investigators brochure; protocols; case report forms instructions; consent documents; clinical study material shipping orders; kick-off and initiation meeting attendance documentation; lab reference ranges; all investigator and site correspondence; and schedules of payments, and others.

Participate in global conference calls and meetings to review progress of ongoing clinical studies.

Participating in development of clinical protocols.

Participating in designing Case Report Forms and other study specific forms and logs

Manage the vendors – initial identification of a suitable partner, definition of vendor responsibilities, communication plan, review deliverables, milestones, and status reports.

Participate in SOP development.

Perform cross-functional duties and responsibilities and participate in delivery of Company services in various project roles according to the qualification and training

Senior Chemist Jan 2008 – Jan 2010

Azopharma LLC / Miramar, FL

Main Duties:

Perform a large variety of analytical tasks associated with method development and validation for the analysis of pharmaceutical drug products, raw materials and medical devices; ability to perform different types of techniques used including HPLC, GC, UV, dissolution.

Reviews data for accuracy and completeness.

Develops Standard Operating Procedures (SOPs).

Conducts experimental work on projects; sets up the procedures and performs the experiment based on established protocols, developed procedures, or experimental designs; keeps records of experiments performed and all data collected.

Modify and adjust of existing methods.

Perform multiple tasks simultaneously, keep accurate records, transcribe data, write reports, act with a positive attitude toward quality control and safety procedures, work in an organized manner, and follow instructions and comply with company policies.

Quality Control Lead May 2006 – Jan 2008

bioRASI LLC / Aventura, FL

Main Duties:

Design and develop Protocols and Standard Operational Procedures (SOP)

Set up procedures for GLP implementation in laboratories performing analytical testing in patients involved in clinical trials;

Establish and develop operating policies and procedures for the analytical laboratories;

Direct clinical laboratories personnel in performing HPLC, GC/MS, LC-MS/MS and drug dissolution analysis for pharmacokinetics and bioavailability studies in patients involved in clinical trials;

Audit bioRASI subcontractors to ensure compliance to GMP and GLP and post-audit remediation work;

Analyze reports to determine areas of improvement and determine appropriate plan of action; regarding performance against quality indicators, as appropriate to the individual position;

Train and consult subcontracts clinical laboratories personnel in analytical/bioanalytical method development and validation.

Analytical Laboratory Supervisor Aug 2005 – May 2006

Westar Nutrition Corp. / Costa Mesa, CA

Main Duties:

Analytical testing of raw material, final pharmaceutical products and stability samples using various separation and detection techniques (HPLC, GC/MS, GC, AA, FTIR, UV/Vis), and drug dissolution methods

Developing and validation of new methods to assay raw materials and finished products

Modifying and adjusting of existing methods

Writing SOPs for new methods, revising and updating old SOPs

Training personnel in new or revised SOP.

Organizing and reviewing of routine test results and QC report sheets

Inspection of Analytical lab areas and monitoring general lab practices for correctness, safety and hazardous waste storage

Calibration and troubleshooting of analytical instruments

Short-Long term stability checking for Dietary Supplements

Ordering of chemicals and supplies for the Analytical lab

Participating in the designing of new products

Implementing of GMP and GLP standards for Analytical lab

Improving of Good report and SOPs writing procedures

Continuous training of assigned staff

Analytical Chemist Jan 1998 - May 2005

Drug Control Laboratory of Armenian Drug

and Medical Technology Administration / Yerevan, Armenia

Main Duties:

Operating general analytical instruments during drugs testing (i.e., HPLC, GC, UV, automatic titrator, IR and TLC).

Conducting calibration, qualification and maintenance of laboratory instrumentation (i.e., pH meter, HPLC, dissolution equipment, etc).

Performing wet Chemistry tests of drugs (i.e., pH, titration, etc.).

Preparing standard and sample solutions as required by the test methods (according to SOPs, testing protocols, or compendia (USP, BP or EP).

Maintaining appropriate documentation (records and lab notebooks) as required by SOP's.

Assisting in reviewing test methods.

QC Analyst, Researcher Sep 1993 – Dec 1997 Institute of Organic Chemistry / Yerevan, Armenia

Main Duties:

Conducting routine and non-routine analysis of raw materials, finished formulations and stability samples according to standard operating procedures

Performing HPLC, TLC, GC analysis and methods optimization.

Preparing and labeling of all laboratory reagents, reference standards and solutions.

Column chromatography

EDUCATION

1987 - 1992 Master of Science, Chemistry

National Polytechnic University of Armenia

LANGUAGES

Fluent in English, Russian and Armenian.

CERTIFICATES

2022. CITI-Collaborative Institutional Training Initiative. Good Clinical Practice Certification.

MAYO CLINIC "Dangerous Goods Shipping" Training & certificate

SELECTED PUBLICATIONS

Panossian A,H, Danielyan A, Mamikonyan G, Wikman G. “Methods of phytochemical standardisation of rhizoma Cimicifugae racemosae” Phytochem Anal. 2004, 15(2):100-8

Sh.O. Badanyan, Zh.A. Chobanyan, M.R. Tirakyan, A.H. Danielyan “Regiospecific functionalization of terminal acetylene compounds with CH-acids” Institute of Organic Chemistry Bull., Yerevan,1997, p 17.

Sh.O. Badanyan, Zh.A. Chobanyan, M.R. Tirakyan, A.H. Danielyan “Specific Futures of Reactions Butyl- and Phenylacetylens with CH-acids” Russian Journal of Organic Chemistry,1997, Vol.33, No1, pp 27-33.

Sh.O. Badanyan, Zh.A. Chobanyan, M.R. Tirakyan, A.H. Danielyan “Propargyl Acetate in Reaction of Heterocyclization with beta-dicarbonyl Compounds” Chemistry of Heterocyclic Compounds,1998, No8, pp 904-907.

COMPUTER SKILLS

Microsoft Office (Excel, Word, PowerPoint and others)

Working knowledge of statistics (GraphPad Prism, Excel Datasheet and others)

EDC (OmniComm, Medrio, OpenClinica)

SELECTED CLINICAL TRIAL EXPERIENCE

A Randomized, Double-Blind, Multi-country, Multi-center, Vehicle-Controlled Study to Compare the Safety and Efficacy of XXX in Treatment of Chronic Stable Mild to Moderate Plaque Psoriasis.

An Open-Label, Balanced, Randomized, Two-Treatment, Two-Period, Two-Sequence, Single-Dose, Two-Way Crossover Relative Bioavailability Study Comparing XXX and XXX® Vaginal Tablets in Healthy, Adult, Human Postmenopausal Female Subjects.

A Randomized, Multi-Dose, Two-Way Crossover, Steady-State Bioequivalence Study of XXX Orally Disintegrating Tablets in Severe Schizophrenic Patients.

A Randomized, Controlled, Parallel Group, Multicenter Phase 3 Study to Evaluate the Efficacy and Safety of XXX Using SPECT Myocardial Perfusion Imaging in Patients with Stable Angina Pectoris.

A Randomized, Open Label, Two Treatment, Two Sequence, Steady-State Crossover Bioequivalence Study of XXX Tablet and YYY Tablets in Schizophrenic Patients Receiving XXX in a Stable Regimen, Under Fasting Conditions.

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of XXX Patients with Stable Angina Pectoris who are not Optimal Candidates for Revascularization.

Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Effectiveness of XXX Administered by Intramuscular Injection for the Treatment of Lumbar Ischemia.

Clinical Study Protocol a Randomized, Multi-country, Multi-center, Placebo-Controlled, Double Dummy, Blinded, Parallel-Group Study Comparing the Safety and Efficacy of XXXX vs YYYY in Subjects with Active Mild to Moderate Ulcerative Colitis.

A Phase 3, Double-Blind, Placebo-Controlled, Randomized, Multi-Center Study to Evaluate the Safety and Efficacy of XXX in Postmenopausal Women with an Intact Uterus in Reducing the Frequency and Severity of Vasomotor Symptoms and Managing the Incidence of Endometrial Hyperplasia

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability, and Pharmacokinetic Study of Single-Ascending Doses of Intravenous XXX in Healthy Adult Subjects

The Relative Bioavailability of Two XXX Estradiol Transdermal Systems to XXX® ETS.

Comparative Evaluation of the Adhesion, Cumulative Irritation and Contact Sensitization Potential of XXX Transdermal System in Healthy Post-Menopausal Women.

Safety, Tolerability, and Pharmacokinetics of XXX after Single Ascending Oral Doses in Healthy Subjects.

A Randomized, Three-Cycle, Double-Blind, Placebo-Controlled Study to Evaluate Induction of Secretory Conversion of Endometrium and Withdrawal Bleeding After Administration of XXX in Estrogen-Primed Women with Secondary Amenorrhea.

Clinical Endpoint Bioequivalence Multi-Country Study Comparing XXX Vaginal Tablets to XXX in Postmenopausal Females with Atrophic Vaginitis

A Multi-Center, Randomized, Double-Blind Vehicle-controlled Study to Demonstrate the Bioequivalence of XXX and XXX® Nasal Spray in the Treatment of Allergic Rhinitis.

A randomized, single dose, open-label, two-treatment, two-period, two-sequence, crossover, comparative bioavailability study of a new formulation of XXX tablets and YYY tablets in healthy, adult, human subjects under fasting and fed conditions

A Phase I, Open Label, Single Dose Study to Evaluate the Pharmacokinetics of XXX Tablets in Patients with Hepatic Impairment.

A Phase 1, Multiple-Dose, Open-Label Study to Determine and Compare Plasma and Intrapulmonary Concentrations of XXX in Healthy Adult Human Subjects

A Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Multicenter Study to Compare XXX to XXX® Cream and Both Active Treatments with a Vehicle Control in Treatment of Vulvar And Vaginal Atrophy.

A Study to Assess the Safety, Tolerability and Effects of Single and Multiple Ascending Doses of XXX in Healthy Male and Female Subjects Under Fasted and Fed Conditions.

A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous XXX in Healthy Volunteers.

A Phase 1, Multiple-Dose Open-Label Study to Determine and Compare Plasma and Intrapulmonary Pharmacokinetics of XXX in Healthy Adult Human Subjects.

A Randomized, 2 Part, Double-Blind, Double-Dummy, Placebo- and Positive-Controlled, Crossover Study to Evaluate the Effect of XXX on the QT/QTc Interval in Healthy Volunteers

An Open-Label, Randomized, Single-Dose, Four-Way Crossover Relative Bioavailability Study Comparing XXX Inhalation Aerosol and YYY Inhalation Aerosol

A Phase I, Open-Label, Single-Dose Study to Investigate the Pharmacokinetics of Intravenous XXX in Patients with Renal Impairment

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Escalating Doses of Intravenous XXX in Healthy Adult Human Subjects

A Phase I, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of XXX PR Tablets in Patients with Mild, Moderate and Severe Hepatic Impairment Compared to Matched Healthy Subjects

A Phase I, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of XXX PR Tablets in Patients with Mild, Moderate and Severe Renal Impairment Compared to Matched Healthy Subjects

2022. Site Coordinator: Adverum Biotechnologies Protocol ADVM-022-11 A Multi-center, randomized, double-masked phase 2 study to assess safety and efficacy of ADVM-022 (AAV.7m8-aflibercept) in Anti-VEGF treatment-experienced patients with neovascular (Wet) Age Related Macular Degeneration (LUNA).

2022. Site Coordinator: Adverum Biotechnologies Protocol ADVM-022-07: A Long-term Study of ADVM-022 in Neovascular (Wet) AMD - OPTIC Extension

2022. Site Coordinator: F. Hoffmann-La Roche Ltd Protocol GE43220: A multicenter, prospective, observational study of the progression of intermediate age-related macular degeneration (HONU).

2021. Site Coordinator: REGENXBIO Inc. Protocol RGX-314-3101: A Randomized, Partially Masked, Controlled, Phase 3 Clinical Study to Evaluate the Efficacy and Safety of RGX-314 Gene Therapy in Participants with nAMD (ASCENT).

2021. Site Coordinator: UNITY Biotechnology, Inc. Protocol UBX1325-03A Phase 2, Prospective, Multicenter, Randomized, Double-Masked, Active-Controlled Study to Assess the Safety, Tolerability, and Evidence of Activity of a Repeat Intravitreal Injection of UBX1325 in Patients with Neovascular Age-Related Macular Degeneration (ENVISION)

2021. Site Coordinator: F. Hoffmann-La Roche Ltd Protocol GR41986: A phase III, multicenter, randomized, double-masked, active comparator-controlled study to evaluate the efficacy and safety of Faricimab in patients with macular edema secondary to central retinal or hemi-retinal vein occlusion (COMINO).

2021. Site Coordinator: Alexion Pharmaceuticals, Inc. Protocol ALXN2040-GA-201: A Phase 2, Double-Masked, Placebo-Controlled, Dose Range Finding Study of Danicopan (ALXN2040) in Patients with Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)

2021. Site Coordinator: AimMax Therapeutics, Inc. Protocol CPN-302: A Multicenter, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of APP13007 for the Treatment of Inflammation and pain after Cataract Surgery, Including a Corneal Endothelial Cell Sub-study.

2021. Site Coordinator: F. Hoffmann-La Roche Ltd Protocol BP43445: A phase II, multicenter, randomized, double masked, active comparator-controlled study to investigate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of RO7200220 administered intravitreally in patients with diabetic macular edema

2021. Site Coordinator: Kodiak Sciences Inc. Protocol KS301P107, A Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center, Two-arm, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared with Intravitreal Aflibercept in Participants with Neovascular (Wet) Age-related Macular Degeneration (wAMD) DAYLIGHT.

2021. Site Coordinator: Gyroscope Therapeutics Ltd. Protocol GT005-03: A phase II, open-label, outcomes-assessor masked, multicenter, randomized, controlled study to evaluate the safety and efficacy of two doses of GT005 administered as a single subretinal injection in subjects with geographic atrophy secondary to dry Age-Related Macular Degeneration. (HORIZON)

2021. Site Coordinator: Bayer AG and Regeneron Pharmaceuticals Inc. Protocol 20968: A randomized, double-masked, active-controlled, Phase 3 study of the efficacy and safety of high dose Aflibercept in patients with neovascular Age-Related Macular Degeneration. (PULSAR)

2021. Site Coordinator: IVERIC bio, Inc. Protocol ISEE2008: A phase 3 multicenter, randomized, double-masked, sham-controlled clinical trial to assess the safety and efficacy of intravitreal administration of Zimura™ (complement c5 inhibitor) in patients with geographic atrophy secondary to Age-Related Macular Degeneration (GATHER-2) 2021.

2021. Site Coordinator: Adverum Biotechnologies Protocol ADVM-022-06: Analysis of Aqueous Humor and Matching Serum Samples.

2021. Site Coordinator: F. Hoffmann-La Roche Protocol GR42691: A multicenter, open-label extension study to evaluate the long-term safety and tolerability of Faricimab in patients with neovascular Age-Related Macular Degeneration (AVONELLE-X)

2020. Site Coordinator: F. Hoffmann-La Roche Ltd Protocol GR42558: multicenter, open-label extension study to evaluate the long-term safety and tolerability of intravitreal injections of FHTR2163 in patients with Geographic Atrophy secondary to Age-Related Macular Degeneration (GallegOLE).

2020. Site Coordinator: KODIAK Protocol KS301P105, A Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center, Two-arm, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared with Intravitreal Aflibercept in Participants with Visual Impairment Secondary to Treatment-naïve Diabetic Macular Edema (GLIMMER)

2020. Collaborative Institutional Training Initiative (CITI) Research Ethics Course – Good Clinical Practice. Certification obtained. Sponsored by Advarra IRB.

2020. IATA Re-certification – Mayo Clinic Laboratories Online Course.

2020. Site Coordinator: KODIAK Protocol KS301P103, A Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center, Two-arm, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared with Intravitreal Aflibercept in Participants with Visual Impairment Due to Treatment-naïve Macular Edema Secondary to Retinal Vein Occlusion (BEACON)

2020. Site Coordinator: F. Hoffmann-La Roche Ltd Protocol GR42558: multicenter, open-label extension study to evaluate the long-term safety and tolerability of intravitreal injections of FHTR2163 in patients with Geographic Atrophy secondary to Age-Related Macular Degeneration (GallegOLE).

2020. Site Coordinator: Novartis Protocol CBASICHR0049. Age-Related Macular degeneration Blood Collection Study.

2020. Site Coordinator: F. Hoffmann-La Roche Ltd Protocol GR41986: A phase III, multicenter, randomized, double-masked, active comparator-controlled study to evaluate the efficacy and safety of Faricimab in patients with macular edema secondary to central retinal or hemiretinal vein occlusion [COMINO]

2020. Site Coordinator: F. Hoffmann-La Roche Ltd Protocol GR41987: A multicenter, open-label extension study to evaluate the long-term safety and tolerability of faricimab in patients with diabetic macular edema Rhone-X= nAMD [RHONE-X]

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