Laboratory Director

Curriculum Vitae

Guido Daniel Pollevick, Ph.D.

Mobile 315-***-****

E-mail: **************@*****.***

EXECUTIVE SUMMARY

• Pharmaceutical/Biotech experience:

• Clinical operations management and strategic development in pharma/biotech

• Monitors workflow, turnaround time, quality control/assurance programs

• Expertise in personalized medicine: Familion® test development and scale up

• Experience in pharmacogenetics test development, clinical validation, and implementation (genetic tests to predict response to clopidogrel [Plavix®], rituximab, and warfarin)

• Certified Laboratory Director (CLIA/CLEP New York State Department of Health) in a regulated clinical laboratory

• Experience in developing, implementing, and maintaining service standards to meet client’s expectations

• Strong background in Laboratory Finance/data collection

• More than 10 years of management experience, including staff development and team building

CAREER HISTORY

Transgenomic Inc. New Haven, CT

Director of Operations. 2010- 2012

Roles and Responsibilities:

• Daily operation of the CLIA/CLEP high complexity genetic diagnostic, DNA sequencing, and pharmacogenetic testing laboratory/Budgeting, cost analysis and capacity planning

• Oversight of QA and QC groups: Improvement standard operating procedures, document management systems and equipment qualification

• Management of 11 direct reports and 3 teams of indirect reports (non-exempt)

Accomplishments:

• Market launch of the pharmacogenetic test to predict response to clopidogrel [Plavix®] including implementation of SNP analysis tools/software and prioritized targets for validation.

• Development and validation of seven neurology DNA sequencing tests

• Accomplishment of quarterly and annual financial goals, service and marketing targets, in collaboration with Sales, Marketing, and Customer Service teams

PGxHealth, a Division of Clinical Data. New Haven, CT

Laboratory Director. 2007- 2010

Roles and Responsibilities:

• Daily operation of the CLIA/CLEP high complexity DNA sequencing, and companion diagnostic laboratory/Budgeting, cost analysis, and capacity planning

• Management of 5 direct reports and 3 teams of indirect reports (non-exempt): Improved employee integration by implementing HR training

Accomplishments:

• QC: Improved quality and process capacity (test efficiency went from 80% to 96%)

• Implementation of Six Sigma projects: Reduced test turnaround time 65%

• Oversight of the test development group: Development and implementation of 14 new cardiovascular DNA sequencing tests into the CLIA laboratory

• Increased gross margins

• Familion® test development and scale up

• Working with sales and marketing on the launch of pharmacogenetic tests to predict response to warfarin, clozapine, and rituximab

PGxHealth, a Division of Clinical Data. New Haven, CT

Research Scientist II. 2007

• Responsible for the implementation of the CPVT (Catecholaminergic polymorphic ventricular tachycardia) genetic test into the CLIA laboratory and the development of the Master Variant Database in Access Database

Masonic Medical Research Laboratory. Utica, NY

Laboratory Director. 2005-2007

Roles and Responsibilities:

• Set up of the DNA sequencing laboratory for the diagnosis of cardiac diseases in compliance with CLIA/CLEP and HIPAA regulations

• Academic/hospital collaborations (USA and international)

• Management of 2 undergraduate students and 4 research assistants

Accomplishments:

• Identification of three new genes and mutations associated with sudden cardiac death (Cell 2005; Circulation 2007)

Masonic Medical Research Laboratory. Utica, NY

Research Scientist I. 2002- 2005

Roles and Responsibilities:

• Gene expression and preclinical studies of antiarrhythmic drugs in a canine model, genetic engineered mouse model, and mammalian cell culture

• Management of one research assistant

Accomplishments:

• Development of a new therapeutic adenovirus-based antisense technology for arrhythmias using canine and “in vitro” models/ion channels expression

Laboratorios Gentronic SA. Buenos Aires, Argentina

Laboratory Director. 1999- 2002

Roles and Responsibilities:

• Managed operations of genetic testing collaborations with Quest Diagnostics (USA), Athena

Diagnostics (USA), and Institute for Molecular Medicine (IMMD, Germany)

Accomplishments:

• Developed in house high complexity genetic tests (in collaboration with the University of General San Martin): Hemophilia A, Hereditary Breast and Ovarian Cancer (BRCA 1 and BRCA 2 Test), Hereditary Non-Polyposis Colon Cancer, Familial Hypercholesterolemia, Abnormal Drug Metabolism (P450), Canavan Disease, Cystic Fibrosis (31 Mutations), Gaucher Disease, Hereditary Hemochromatosis, Tay Sachs Disease, Alzheimer's disease, and Fragile X Syndrome

ADDITIONAL RELATED EXPERIENCE

University of San Martin, Preclinical studies for an antidepressant drug in a tree shrew (Tupaia belangeri) animal model and neuron cell culture

Fundacion Campomar, University of Buenos Aires, Identified new Trypanosoma cruzi specific antigens; developed and implemented the first commercially available ELISA test for Chagas Disease using recombinant antigens

Tecnologia Genetica S.A: Developed the first technique in the world for sex determination of bovine embryos; transferred this technology to different livestock companies (Nature/Biotechnology, 1992)

TECHNICAL SKILLS

• Genetics, molecular genetics, molecular biology, molecular diagnostics (cardiovascular, neurology), companion diagnostic, pharmacogenetics, platform analysis and selection, diagnostics technologies implementation ad clinical validation, biomarker identification, service laboratory management, regulated clinical laboratory set-up

• DNA sequencing, PCR, Real Time PCR, genotyping, genetic engineering, animal model (mouse, dog, and tupaia), mammalian cell culture, Elisa, Western blot, bidimensional gels

• Consistent success in biomedical scientific research and writing (see Addendum)

• Active involvement in business planning and transactions working with CEO/CFO management level (asset sale of Familion® and pharmacogenomics biomarkers in December 2010)

EDUCATION

Ph.D. Chemical Sciences, School of Science, University of Buenos Aires, Argentina*

Bachelor of Science in Biological Sciences, School of Biology, University of Buenos Aires,

Argentina*

*Accredited in the United States by the International Education Research Foundation, Inc.

CERTIFICATIONS

1-Certificate of Qualification as Laboratory Director in Genetic Testing (Molecular) from New York State Department of Health. 2006-Present

2- Human Participants Protection Education for Research Teams, NIH, 2002

3- Ethics in Behavioral Genetics Research. Duke University School of Medicine, 2005

4- Ethics and Genetics Research in Populations. Duke University School of Medicine, 2005

5- Ethical Issues in Research on Gene-Environment Interactions. Duke University School of

Medicine, 2005

6- Leadership Essentials Series: Employers Association of the North East, 2009

PATENTS AND PUBLICATIONS

1- Loss of function mutation in calcium channel polypeptides associated with sudden cardiac death. Inventors: Charles Antzelevitch and Guido D. Pollevick. App Number 11983005 Pub Number 200******** May, 2008.

2- Cacnb2 nucleic acid mutations as indicators of shorter than normal QT interval and ST segment elevation associated with sudden cardiac death. Inventors: Charles Antzelevitch and Guido D. Pollevick. App Number 12901070 Pub Number20110053165 March, 2011.

39 PUBLICATIONS IN PEER-REVIEWED SCIENTIFIC JOURNALS (provided upon request)

REFERENCES

Excellent professional and personal references provided upon request

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