Robert E. Parson Resume

4523 Cather Avenue San Diego, CA 92122

ROBERT E. PARSON 858.357.6491robert.e.parson@gmail.

com

EXECUTIVE LEADERSHIP

A dedicated leader with a proven track record of guiding products from concept to commercialization. Experienced in developing and manufacturing products, ensuring quality and reliability. Played integral roles by holding key membership positions on corporate FDA and global regulatory submission teams, enabling clearance of hundreds of medical and IVD devices. Though leadership and decisiveness, implemented successful disease management programs. Adept at use of finance and actuarial techniques combined with excellent communication, team building, international business and program management skills.

CORE COMPETENCIES

Strategic Planning Consulting Project Leadership Program Management

Regulatory Affairs Pharmaco-economics Biometrics Process Engineering

International Business Quality Control Process Improvement Risk Management

Clinical Research Change Management Health Care Advocacy Disease Care Management

EDUCATION

UNIVERSITY OF CALIFORNIA, San Diego, CAMasters of Advanced Studies: Leadership of Healthcare OrganizationsIndependent Study Project: A Comprehensive Review of Diabetes Chronic Disease Management Programs for the Purpose of Identifying Features to Improving Outcomes, Reducing Cost and Maintaining QualityInternships: San Diego Hospice Center and Scripps Whittier Diabetes Program

ROCHESTER INSTITUTE OF TECHNOLOGY, Rochester, NYMasters of Science: Applied Statistics (Biostatistics)Thesis Topic: Evaluation of the Monroe County Healthcare Library Network Statistical Education and Information Systems Planning

PURDUE UNIVERSITY, West Lafayette, INBachelors of Science: Biochemistry Minor: Mathematics/Statistics

HIGHLIGHTS OF SKILLS & ACCOMPLISHMENTS

Pharmaco-economics & Outcomes Research Developed Markov Models for prostate cancer screening programs using Tandem tPSA and

fPSA/tPSA Ratio in support of Managed Care decision-making to provide tests in patient care protocols.

Authored cost-effectiveness/budget impact models and analyses for immunological fecal occult blood tests used in support of international, national healthcare system reimbursement and funding decision-making.

Coordinated and direction to a global staff of 30 marketing and sales professionals preparing national and regional healthcare system tender offers that incorporated budget impact analyses and comparative performance analysis with technology assessment assessments.

Regulatory Affairs Directed and partnered across R&D, Clincal, Marketing, Business Development and Sales

groups the integration of required regulatory guidance into product regulatory approval and registration strategy.

Enabled global cost analysis and reporting by implementing a budgeting/cost tracking system that resulted in improvements in tracking expenditures for international registration and labeling changes.

Facilitated introduction new product and product improvements by managing all aspects of approval process for large, diverse global organization.

ROBERT E. PARSON - PAGE 2 OF 4858.357.6491 - [email protected]

Clinical Operations Established Global Clinical Affairs organization for Inverness Medical Innovations to support

clinical programs. Transformed group of small, disjointed staffs with varying levels of education and experience into efficient global network.

Integrated Electronic Data Capture (EDC) with Clinical Study Information procedures and Clinical Information Management System (CIMS).

Successfully initiated international clinical study / trial programs for post-registration studies that allowed regional organizations access to clinical and EDC resources via Centers of Clinical Excellence.

Biostatistics Evaluated new medical diagnostic assays for FDA and global approvals, clinical trial protocols,

statistical plans, and detailed submissions for regulatory clearance. Oversaw completion of 300+ 510K and 4 PMA FDA submissions and supplements, plus

corresponding EU, Japanese, and Australian submissions. Presented PSA (prostate specific antigen) screening claim to FDA PMA panel meeting. Wrote

SAP and supported 6,770 patient studies with statistical analysis. Wrote CSR for study. Evaluated clinical designs for efficacy, statistical power, and assumption verification and

identify strengths and weaknesses of clinical study using simulation methods. Designed SAP for Tandem tPSA, fPSA, CA125, CA19.9, Ostase, AccuTnI Troponin assay, and many others (Hemoccult Sensa, ICT, NS-Plus, Blood Chemistries).

Clinical Data Management Performed strategic systems planning combining electronic data capture (EDC) and clinical

trial management system (CTMS) along with document management, registration dBase, on-line training systems, electronic medical device reporting (eMDR), and SharePoint systems implementation for international project management.

Devised and implemented organizational, procedural, and processing changes to achieve regulatory compliance.

PROFESSIONAL EXPERIENCE

ALERE INC. (formerly Inverness Medical Innovations), San Diego, CAAlere is comprised of 18 leading diagnostic and health management companies and is the second-largest health management provider in United States producing revenue of $2.1 billion. Employees span the globe. Vice President, Pharmacoeconomics & Outcomes Research 2010-2011

Managed generation of $50 million in revenue from oncology products (NMP22 (BladderChek, NS-Plus iFOBT joint distribution between Otsuka Electronics Corporation and Alfresa Pharmaceutical Corporation). Drove progress of new products and oversaw international tenders program, regulatory clinical studies in US, China, and Canada, and regulatory submissions.

Collaborated with leaders in global organization to devise strategy to obtain funding to implement new technology in countries with National Healthcare Systems.

Created strategy for global distribution of the NS-Plus i-FOBT assay system, obtaining agreement of all 3 distribution partners (Alere, Alfresa, and Otsuka).

Incorporated efficiency and cost effectiveness simulation models to compare costs in connection with staffing resources, laboratory space, reagent costs, laboratory data, and information processing into marketing and sales of new technology.

Planned and prepared for efficient integration of outcomes studies into analysis of laboratory technology under evaluation of international healthcare organizations.


INVERNESS MEDICAL INNOVATIONS (formerly Biosite and now Alere, Inc.), San Diego, CAInternational medical device manufacturer with product portfolio spanning cardiovascular, drugs of abuse, women's health, oncology, and infectious disease areas. Led market in rapid point-of-care diagnostic and clinical testing. With 11,900 employees worldwide, produced $2.1 billion in revenue.Vice President, Global Clinical & Regulatory Affairs 2008-2010

Directed global clinical and regulatory affairs for 55 companies and distributors for 1,600 products enabling detection and management of autoimmune diseases, infectious and enteric diseases, sexually-transmitted diseases, colorectal and bladder cancers, and cardiac risk. Supervised team of 15 senior-level managers and oversaw global clinical staff of 225. Managed annual budget of $24 million.

Established Global Clinical Affairs organization to support company’s clinical programs, which was comprised of 75 employees worldwide.

Standardized training programs and training schedules for all staff, transforming previously disorganized programs into unified and efficient programs.

Provided regional organizations with access to clinical and EDC resources by using Centers of Clinical Excellence.

Streamlined processes for effective and timely medical devise reporting, improving turnaround from 12 weeks to 4 weeks.

Formed Medical Affairs Team to handle off-label customer requests. Instituted additional regulatory guidance into product regulatory approval and registration

strategy, working in conjunction with regulatory management and clinical teams.

BIOSITE INC., San Diego, CA$300 million company renown for rapid, high-capacity antibody development, enabling high throughput screening of potential diagnostic markers and cost-efficient development of high affinity antibodies for use in commercialized products. Senior Director, Clinical & Medical Affairs Group 2006-2008

Advanced new product regulatory clinical studies, post approval studies, and pre-clinical studies and evaluations. Developed database, validation, and reporting systems for clinical and R&D. Supervised 2 biostatisticians and clinical data management staff of 4.

Revised standard operating procedures (SOPs) to maintain regulatory compliance and to increase focus on corporate objectives.

Successfully completed 9 clinical study statistical analysis plans, analyses, and reports that were integral to FDA and EU (CE marker) submissions.

Trained staff on statistical methodologies, sample size calculations, and preparation of statistical analysis plans used for pre-clinical, clinical, and post-clinical (outcomes) studies for cardiovascular point-of-care assays (Troponin, CKMP, BNP), pre-independent development evaluations, and production registration applications.

Developed multi-parameter (biomarkers, patient demographics, pathology) logistic regression models approach to evaluate various biomarker assays in plasma to be used on Triage point-of-care assay platform, which led to 3-biomarker panel for diagnosis of community-acquired sepsis in patients presenting in emergency rooms.

BECKMAN COULTER INC., San Diego, CACompany develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing performed in hospitals and critical care settings. Senior Staff Biostatistician, Regulatory & Clinical Affairs 1996-2006Supported product development, commercialization, troubleshooting and manufacturing of diagnostic assays, instrumentation and information systems. Assessed and mitigated risk.


HYBRITECH INCORPORATED (Eli Lilly & Co.), San Diego, CABiotechnology Company that developed and marketed monoclonal antibodies used to make diagnostic and medical monitoring tests to identify various infectious, viral and cancer-related diseases, infertility, allergies, and pregnancy.Director, Biostatistics, Clinical & Regulatory Affairs 1990-1996Oversaw biostatistics, clinical data management, and managed care planning. Supervised clinical and regulatory staffs. Managed manufacturing, quality control, research, and development. Created health economic models.

CERTIFICATIONS

ASQ Certified Reliability Engineer, ASQ Certified Quality Engineer and Certified Healthcare Executive

PROFESSIONAL AFFILIATIONS

International Society for Pharmaco-economics and Outcomes ResearchOrganization Memberships Drug Information AssociationAmerican Society for Quality – Senior Member StatusClinical Laboratory Management AssociationAmerican Association for Clinical ChemistryAmerican Statistical AssociationSociety for Controlled Clinical TrialsSociety for Medical Decision MakingClinical Data Management Association

COMPUTER SKILLS

Statistical Analysis System (SAS),RS-1, Data TreeAge Software, Medcalc, nQuery and PASS Sample Size Estimates, Microsoft Word, Excel, Project, Visio, SQL Database, Crystal Ball

Robert E. Parson Resume

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