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Amanda Martell Panos, BSME, MBA, CCRA

250 La Paloma, Suite 4, San Clemente, CA 92672 * Cell: 949.632.2217 * apcd03f4@


westpost.net
Consultant, Clinical Affairs
Strategic and process oriented with proven ability to independently develop, ana
lyze, execute, and manage scientifically valid human research studies, feasibili
ty through post-market, in multiple therapeutic areas.
Key competencies include:
* Streamlining Clinical Operations/Processes * Cardiovascular, Neurovascular, Pe
ripheral, Pulmonary Vascular Devices
* Investigator & Site Relationship Development
* Budget & Contract Negotiations * Case Support & Product Field Training/Educati
on
* EDC / CDMS / CTMS / Safety Systems * US, EU & Japanese Regulations (GCP, ICH)
* Thought Partner Identification & Collaboration * Clinical Investigation Plan,
CRF & SOP Creation
* Functional Expert Identification & Collaboration * Statistical data analysis f
or FDA/TUV approval
* Investigator, field sales, distributor training * Design Dossier and Phase/Pro
duct Review

EXPERIENCE
Consultant, Sept 2003 - Present
* Clients - CliniQual, RX Solutions, ROX Medical, Inc.
Sr. Director, Clinical Affairs, ROX Medical, San Clemente, CA Sept 2009- Octob
er 2010
* Report to Vice President of CA/RA/QA
* Plan, author, direct and/or execute multiple concurrent clinical studies
* One IDE pilot clinical trial for class III medical device (US)
- ICR/Fax Data Management System
* One OUS pivotal trial for class III medical device (EU)
- Internally developed and validated ACCESS database
* One Post-market study/registry for CE Marked class III medical device (EU)
- Combination of paper & EDC
* Provide strategic direction, management and development of the clinical staff
(Data Management, In-house CRAs, Field CRAs, Clinical Safety, Interns, Project C
oordinators, Consultants, Contractors)
* Perform product training and support cases in the field
* Subject Recruitment Strategy identification & implementation (incl. local IRBs
for site level recruitment, WIRB for study level recruitment campaigns, interne
t advertising, website SEO, SEO, call centers, patient support group collaborati
ons & presentations)
* Resource modeling for right balance of clinical staff (functionally & in-sourc
e v. outsource) during study phases
* Efficacy data review and analysis
* Safety data review, narrative writing and analysis
* Develop and maintain multi-million dollar budgets
* Vendor management (core labs, data management, translations)
* Develop & update departmental processes & SOPs, flowcharting
* Implemented quantitative goals, metrics and dashboards to bring transparency t
o the activities in Clinical Operations to Executive staff and Board of Director
s
* Quarterly presentations to Board of Directors
Director, Global Clinical Operations, Medtronic CardioVascular, Santa Rosa, CA
June 2005- Sept 2009
* Report to Vice President of Global Clinical Affairs in support of Coronary Vas
cular, Peripheral Vascular and Endovascular therapies.
* Provide strategic direction, management and development of the clinical operat
ions departments and it's employees (Clinical Payments, Clinical Contracts, Alli
ance Management, Field Operations, Clinical Safety, Clinical Quality, Clinical L
earning & Development and Clinical Systems)
* Develop internal processes to streamline department activities including imple
menting and/or developing software, communication centers, intranets, databases
* Developed capacity models for clin ops departments for determining required re
sources and mix of insourcing and outsourcing to support on-going and proposed s
tudies
* Develop and maintain multi-million dollar budgets
* Implemented EDC / CDMS and currently implementing a CTMS software solution for
CV Clinical Affairs globally
* Implemented CFR Part 11 compliant safety system (Oracle AERS)
* Wrote DOPs describing internal and external clinical research activities
* Implemented quantitative goals, metrics and dashboards to bring transparency t
o the activities in Clinical Operations to strategic partners

Assoc. Director, Clinical Affairs, 3F Therapeutics, Lake Forest, CA Sept. 2003


- June 2005
* Plan, author, direct and execute multiple concurrent clinical studies (aortic
valves)
* Two IDE pivotal clinical trials for class III medical devices (EU & US)
* Three Feasibility trials for class III medical devices (EU)
* Compassionate Use investigation for class III medical device (EU)
* Post-market study for CE Marked class III medical device (EU)
* Assure successful conduct of clinical programs consistent with business strate
gy and applicable regulations and policies
* Create and monitor project timelines and budgets
* Direct report to Vice President regarding operations, scheduling, contracts an
d resources
* Hire and manage in-house and regional CRAs and multiple European CROs
* Obtain device export approvals and country insurance
* Train Investigators and nurses on devices and provide case support (US and EU)
* Meet with regulatory agencies to discuss clinical and regulatory strategies (F
DA, TUV)
* Develop internal processes to streamline department activities including imple
menting and/or developing software, communication centers, intranets, databases
* Write SOPs and Work Instructions describing internal and external clinical res
earch activities
* Present data and new projects to key opinion leaders and Investigators
* Write clinical trial protocols, investigator brochures and Instructions For Us
e
* Research and write clinical / no clinical rationals
* Identify and ensure the qualifications of current and potential clinical inves
tigators
* Select and initiate investigative sites (US and EU)
* Organize and participate in investigator meetings and presentations
* Manage monitoring activities to ensure data discrepancies are resolved timely
* Manage clinical inventory, generate investigator payments and approve contract
invoices
* Perform statistical analysis and interpret investigation results in preparatio
n for submissions
* Interface with representatives from key functional groups including R&D, Manuf
acturing, Sales, Marketing, Executive Management, and Regulatory Affairs
* Develop employees and evaluate performance
* Audit Highlights: - FDA Investigational Site Bimo Audit - No observations/find
ings
- FDA Sponsor Bimo Audit - No observations/findings
Sr. Clinical Research Specialist/CRA, Edwards Lifesciences, Irvine, CA Jan 200
3 - Aug 2003
* Execute multiple concurrent clinical studies (AAA, Laser Ablation for Afib, He
art Valves)
* One IDE pivotal clinical trial for class III medical device (US)
* Two 510(k) equivalence trials (US)
* Protocol, case report form, and informed consent creation
* Identification, selection, and initiation of clinical sites
* Development and negotiation of contracts and budgets with research sites
* Protocol and device training of investigators and site staff
* Management of timeline, budget, and resources for study
* Conduct studies using paper and Electronic Data Capture systems (EDCs)
* In-house monitoring, query resolution, database management support
* Identification, report and follow-up of serious adverse events
* Case support
* Motivate sites to enroll and complete study in line with timelines
* Study results interpretation and interim and final report generation
* Disbursement of study payments, including grant payments and IRB payments
* Provide technical and clinical support to Marketing
* Modify and create internal clinical research SOPs and Work Instructions
* Sales support and collaboration with key opinion leaders on journal articles,
abstracts and conference presentations
* Identification of operator hazards, determination of clinical significance of
product malfunctions, assessment of accuracy and adequacy of product labeling
Sr. R&D Engineer, Micro Therapeutics, Irvine, CA April 2000 - Nov 2002
* Develop rapport with key opinion leaders and investigators
* Develop and perform product and protocol training for physicians and site staf
f; including:
* In-service training materials
* In-vitro training on portable wetlab
* In-vivo training on canine and swine at animal labs
* Proficient in fluoroscopic imaging
* Cath lab/angio suite case support during trial and pre-market evaluations
* Analyze clinical data for trends and statistical significance
* Identification, report and follow-up of device related serious adverse events
* Support regulatory submissions to domestic and foreign governing bodies
* Sales support
* Design product demo fixtures for marketing, sales, and physician training
* Develop project plans, timelines, market and product requirements, risk analys
is for nuerovascular products and surgical techniques
* Managed design dossier and product/phase reviews for multiple products (brain
aneurysm occlusion systems, arteriovenous malformations)
* Write protocols and reports, perform testing
* Designed the following devices/techniques (see patents):
* Mirage, 0.008in guidewire for arteriovenous malformation AVM access
* UltraFlow, next generation flow-directed catheter for the treatment of AVMs
* Next generation liquid embolic and procedure for the treatment of aneurysms
* Procedure to treat bifurcated aneurysms with a liquid embolic

Wrote and Defended Thesis, Kettering University, Michigan, January 1999 - March
2000
Mechanical Engineer & Documentation Services Manager, Aetrium Inc., San Diego, C
A
April 1997- Dec. 1998
* Develop assembly guides, procedures, and engineering drawings
* Determine manufacturing costs, time standards, tooling and processing requirem
ents, cause of rejected parts and disposition
* Determine maximum utilization of production facilities and personnel
* Provide cost studies and equipment recommendations
* Target potential failures and fatigue problems
* Manage the activities of Documentation Services personnel
* Developed a semiconductor contactor to measure temperature which resulted in a
n increase in accuracy from 74% to 99.2% -time of product in final test went fro
m 8 to 1 hours

Mechanical Engineer Intern, Guidant (formerly EVT), Menlo Park, CA July 1995 -
Sept. 1996
* Statistical data analysis
* Perform failure analysis and implement manufacturing modifications to increase
product yield
* Material Review Board lead, production trainer, process validation
* Designed renal artery markerboard used during AAA endovascular surgery
* Developed surgical procedure for Ancure AAA catheter deployed graft.

Other Engineering Internships, General Motors Corporation, Warren, MI July 199


3 - March 1995
* Co-op for Corvette Platform, Detroit, Michigan. Responsible for plant layout.
Applied Best-Fit and FIFO methods to material routing and bulk storage.
* Co-op at Corvette Assembly Plant, Bowling Green, Kentucky. Implemented Assembl
y Line Balancing software for indirect labor. Ergonomics, Time Motion and manpow
er studies.
* Co-op on Core Industrial Engineering Platform, Detroit, Michigan. Design for M
anufacturability and Assembly.

PRESENTATIONS / PUBLICATIONS
Collaboration with Michael Argenziano, M.D., Columbia Presbyterian Medical Cente
r, New York, NY, on Laser Technology for Atrial Fibrillation Ablation presentati
on at the Third Annual Conference on the Surgical Treatment of Atrial Fibrillati
on in San Francisco, CA, hosted by Ralph Damiano, M.D., June 18th 2003.
Conner, A., Canton, G., Lasheras, PhD, J., Levy, MD, D., "Comparative Measuremen
t of the Hemodynamic Stresses in Embolized and Non-embolized A-Com Aneurysms: Ne
ck Remnant Effect", to be published in neuroradiology/ surgery journal, and pres
ented at industry conference.
Conner, A., "Onyx Delivery Techniques", Thesis under Professor M. Tavakoli. Anal
ysis of Micro Therapeutics, Inc Onyx liquid embolic for the treatment of arterio
venous malformations. Portions presented at WIN/ABC, January 2001, Val d'Isere,
France.

Conner, A., "Less Invasive Approach to Treating AAA". Under cooperation with Gui
dant Cardio & Vascular Surgery Group, presented to new Kettering University Medi
cal Device Design specialty students as introduction to industry, 2000.
PATENTS
Patent 7,018,365, "Threaded Syringe with Quick Stop"
Patent 7,374,568: "Methods for Embolizing Aneurysms with a High Viscosity Emboli
zing Composition"
Patent 6,527,732: "Torsionally Compensated Guidewire"
CERTIFICATIONS
Operating Room Protocol for the Healthcare Representative; Sponsored by HealthSt
ream - Recognized by AORN.
Exposure to Bloodborne Pathogens in the Surgical Environment; Sponsored by Healt
hStream.
Certified Clinical Research Associate (CCRA) by Association of Clinical Research
Professionals (ACRP), 2003.
Medtronic Director Development Program, Wharton, University of Pennsylvania, Dec
2007-May 2008.

EDUCATION
CALIFORNIA STATE UNIVERSITY, FULLERTON Irvine, CA
Master of Business Administration (MBA), 2003
KETTERING UNIVERSITY (formerly GMI) Flint, MI
Bachelor of Science, Mechanical Engineering (BSME), Thesis Defended, 2000.
Biomedical specialty.

OTHER SKILLS
* Experienced with FDA/ISO/QSR standards for Design Control/Project Planning, St
atistical Analysis, Risk Analysis, DOE
* Advanced AutoCAD skills
* Advanced FMEA skills (software: IDEAS)
* Intermediate Solidworks 2000 skills
* Basic Pro-E skills
* Programming Languages: C++, FORTRAN
* Engineering Software: LABView, MATLAB, Simulink
* Proficient with MS Office tools (MS Word/Excel/Access/Project/PowerPoint)
* Proficient with MAC iLife tools
* Proficient in web design including intranet solutions (i.e., SharePoint)

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