1. VANESSA A. TASSO
4385 Camp 8 Road | Paso Robles, CA | 949-751-7039 | vatasso@yahoo.com
HEALTHCARE & AEROSPACE OPERATIONS EXECUTIVE
VALUE PROPOSITION
r 15+ years of experience creating the operational
infrastructures and marketing efforts to support
growing healthcare initiatives and gain funding.
r Expertise creating technical and consumer
marketing collateral and preparing clinical and
non-clinical presentations to raise awareness and
promote treatment options.
r Proven track record culling, analyzing, and
documenting processes and procedures to achieve
compliance with regulatory requirements.
Repeated success turning around programs that
have fallen behind schedule and delivering results
in a fraction of the time projected for the project.
r Experience in clinical trial environments in the US
and abroad and ability to navigate social, economic, and geo-political administrative and logistics concerns.
PROFESSIONAL EXPERIENCE
PresbiBio PLC/Presbia LLC, Presbia | Irvine, CA (medical device company) 2012 to Present
Vice President, Clinical Affairs (Regulatory Affairs)
Led the go-to-market strategy for this start up’s cornea inlay procedure. Brought operational rigor to venture and
built the funding strategy and business rationale necessary to go public in 2015. Directed all clinical evaluations;
analyzed data, prepared abstracts, wrote journal articles, and led presentations. Budget: $25M; Staff: 12
r Overhauled and organized company processes and documentation to position for IDE submission. Developed
critical clinical, regulatory, engineering, and operations protocols. Successfully met all criteria for IDE
submission on time.
r In less than one year, gained unprecedented FDA approval to begin pivotal trial without having to perform a
Phase II study. Compiled data, documents and annual reports, orchestrated competitive safety studies,
negotiated required testing, arranged FDA meetings, and trained staff on FDA processes.
r Achieved ambitious goal for patient enrollment in first stage pivotal trials in less than half the projected
time through an aggressive direct-to-consumer advertising and social media campaign. Accelerated
enrollment contributed to tremendous cost savings and generated high interest from investors. Expected to
treat 400+ patients by beginning of 4th
quarter 2015, significantly ahead of schedule.
r As part of a 4-person team, raised $44M to fund ongoing study and global operations. Created the
compelling collateral to show product effectiveness and return on investment used to take company public
in 2015 (Initial Public Offering – NASDAQ: LENS).
Glaukos Corporation | Laguna Hills, CA (glaucoma medical device company) 2008 to 2012
Director, Clinical Operations
Hired to conduct all phases of clinical studies to comply with FDA, CFRs, ISO and GCPs and provide management
oversight and support for clinical trials for glaucoma stent treatment product. Led more than 40 studies outside the
US and 5 IDE studies within the US. Managed programs and projects to budgets and schedules. Served as main
interface with FDA Bioresearch Monitoring (BIMO) auditors during Pre-Market Approval audits.
r Turned around an FDA approval process that was 9 months behind and completed 6 months ahead of schedule
by organizing and writing feasibility, pivotal, and pre/post-marketing support documentation.
r Recruited 500 patients for clinical trial 6 months ahead of schedule through direct-to-consumer advertising.
Continued…
AREAS OF EXPERTISE
Ü Business Process Optimization
Ü Program & Project Management & Logistics
Ü Cost Analysis
Ü Clinical Marketing Collateral Development
Ü Fundraising & Outreach
Ü Clinical Trials & Patient Retention
Ü Regulatory Compliance
Ü Product Commercialization
Ü IDE Submission/FDA, CFR, ISO, GCP Approvals
Ü Clinical Writing & Presentations
2. Vanessa A. Tasso | Page 2
r Brought clinical trial program to an in-need community in Armenia and secured strong enrollment population.
Navigated healthcare administrative and customs processes to ensure success of trial.
r Developed clinical study documentation for US and non-US studies including protocols, investigator
brochures, case report forms, informed consent, instructions for use, labeling, etc. to achieve clinical trial
compliance with FDA, CFRs, ISO, and GCPs.
SurModics, Inc. | Irvine, CA (ophthalmology-related medical device company) 2006 to 2008
Senior Manager Clinical Development and Communications
Provided management oversight and support for customer-related Phase I-III clinical trials for patients with diabetes-
related blindness. Managed clinical study programs, provided clinical research expertise and leadership, and
developed customer relationship and communications programs.
r Identified 500 patients for clinical trial and achieved a 100% retention rate throughout the study by creating
a systematized approach to patient follow up and developing an audible patient brochure advocating safety
of study and educating patients on impact their participation would have on the lives of others.
Bausch & Lomb | San Dimas, CA 2004 to 2006
Sr. Manager Strategic Communication and Clinical Marketing / Manager; Marketing & Strategic Communications
r Managed programs for Lasik surgical clinical marketing group; developed and implemented processes and
systems for electronically monitoring and conducting clinical studies and created protocols to ensure
continuous process improvement.
r Planned, organized, and managed efforts to develop scientific communications and supplementary research
on laboratory, clinical, and outcomes that supported product positioning; developed and executed strategic
plans for scientific presentations, podium presentations, and articles.
The Boeing Company | Anaheim, CA 1997 to 2004
Director Logistics Engineering -Support/ Deputy Chief Systems Engineer/ Manager Technical Publications Training
r Managed programs and projects supporting development of LES products; ensured ISO compliance and
supported government audits. Developed strategic marketing plans to position organization as a leader in
logistics innovation.
r Oversaw all aspects of systems engineering, deployment, sustainment, and product development related to
Sensors on the Ground-based Midcourse Defense program.
r Developed technical publications and training to support engineering projects.
Allergan Medical Optics | Irvine, CA 1992 to 1997
Manager Medical Research & Communications
Created communications collateral including presentations, scientific studies, and peer-reviewed scientific
publications. Conducted research and performed statistical analysis.
r Prepared and supported FDA Panel presentation on the AMO Array, delivered by Roger Steinert, MD.
r Co-created communications department short and long-term strategic plans; managed collaborative research
with outside investigators, in-house scientists, device engineers, and clinical researchers.
Rockwell International | Anaheim, CA 1984 to 1992
Hired as an Electrical Technician and progressed to Senior Data Analyst and Senior Logistic Support Analyst. Wrote
technical manuals related to aircraft and missile programs.
Served in United States Air Force as a Staff Sergeant for Missile Systems, 1980 to 1984
EDUCATION & CERTIFICATIONS
MBA, University of Redlands, Redlands, CA 2001
MA & BA, Physical/Cultural Anthropology, California State University, Fullerton, CA 1991 & 1989
Six Sigma Black Belt 2007