HELEN M. CAMPANHA, MT (ASCP), Ph.D.

16 Hughes Place, Summit, NJ 07901 * (908) 273-1449 * (908) 347-0914

EXECUTIVE SUMMARY
Position Target: Team Lead
A Results Focused Professional with more than 20 years of combined experience in
clinical laboratory management and clinical and basic research. Experienced at
managing Phase I-III clinical trials for CROs and major Pharmaceutical companies
.
*Multilingual communicator with advanced verbal, written, and interpersonal
communication skills.
*Demonstrated track record as a high-quality participant and leader of multifunc
tional
teams
*Proven ability to manage and mentor staff
*Detailed understanding of regulatory requirements and impact on the development
of clinical trials
*Eight publications (two pending) on neurotoxicology and immunology.
KNOWLEDGE, SKILLS & ABILITIES
Study Start Up/Completion Project / Timeline Management
Clinical Trials Design Input Study Conduct Training
Clinical Site Audits Geographic Deplo
yment Plan
Pharmacokinetics/dynamics Animal Dosing/Biopsy testing
Flow Cytometry CLIA/GLP Guidelines
Immunology Neurotoxicology/ Risk Assessment
PROFESSIONAL PROFILE
Educational Background: PhD, Pharmacology / Toxicology, Dec 2006 Graduate Schoo
l of Biomedical Sciences, University of Medicine and Dentistry of New Jersey, Ne
wark, NJ
Dissertation: Acetylcholinesterase Mediated Toxicity of Paraoxon
MBA Program, Farleigh Dickinson University, Madison, NJ (not completed)
B.S., Medical Technology, Rutgers University, Newark, NJ
Core Competencies: Principles of pharmacology, pharmacokinetics, general toxic
ology, human pharmacology, neuropharmacology, human physiology, cell physiology,
biostatistics, molecular and cellular immunology; Good Clinical Practice (GCP)
and ICH guidelines; CLIA and GLP guidelines.
Effective Study Manager Knowledgeable in the area of developing and managing cli
nical studies from start-up through completion. Repeated successes driving down
costs and increasing trial efficiency. As a Clinical Scientist for Bristol-Myers
Squibb, decreased the length of a US Rheumatoid Arthritis trial by 12 weeks wit
h proven ability to get the needed data, and produce preliminary data analysis w
ith interpretation of results.
Protocol manager of high profile, complex, multinational Phase IIa study in diab
etes type 2. Lead team through launch of first East Indian Phase I study in com
pany history.
PhD EDUCATION EXPERIENCE
Strength in critical thinking, problem solving, scientific writing and data anal
ysis and presentation. Performed tissue culture to study cell growth kinetics,
pharmacodynamics and dose response relationships to test the effect of xenobioti
cs on acetylcholinesterase trophic function in neurodevelopment.
Specialized in the following:
*Biologically based dose/response kinetic model (ACSLXtreme software) utilized t
o
estimate rate of cell growth/death
*Principles and operation of HPLC, GC, and MS for drug identification.
*Enzyme kinetics; cell viability and adhesion assays.
*U.S.E.P.A. Benchmark Dose Model to estimate the benchmark dose and extrapolatio
n
techniques used to perform Risk Assessment Analysis.
*Laboratory rotation: neural regulation of obesity/diabetes (voltage clamp)
*Short term PhD thesis work in neuroimmunology (immunological assays)

PROFESSIONAL EXPERIENCE
AEROTEK, Piscataway, NJ 3/2010 - 5/2010
Clinical Project Scientist (Assoc Dir -contract / Johnson and Johnson)
Phase 3/Cardiovascular
*JnJ and Bayer joint venture mega trial for Rivaroxiban in Atrial Fibrillation-t
rial near
completion. Safety data review with appropriate queries. Initiated SAE review
.
Reviewed and collaborated with writing of patient narratives related to Liver
Cases.
Reconciled JnJ Expedited Safety Reports vs Bayer Case Overview.
BRISTOL-MYERS SQUIBB, Princeton, NJ
Clinical Scientist/Clinical Trial Manager 5/2007
- 3/2010
Phase 2a/Metabolics
*Assisted with protocol synopsis preparation and was primary protocol author for
11*-
HSD-1 Inhibitor in Diabetes Type 2.
*Protocol Manager in a matrix environment, for international study with multiple
PD
and exploratory biomarkers and in-home procedures; preparation of regulatory
documents for submission to Australia, Canada and Korea. Evaluated Geographica
l
Deployment Plan and country feasibility.
*Provided input to Ethics Committee/ Health Organization queries
*Interfaced with biomarker scientist, statistician, central lab, external data o
perations,
and data management.
*Lead international BMS-Hub team and prepared Investigator Meeting presentation
and interacted with Investigators
Phase 1/Immunology
*Provide leadership and expertise for the successful execution and management of
Phase 1 US/International, safety/efficacy of normal healthy volunteers and pa
tient
studies for p38 MAP Kinase Inhibitor and Abatacept (Orencia) in Rheumatoid
Arthritis. Primary authorship of documents includes protocols, informed consen
t, site
 monitoring plans.
*Provided safety sections of a Briefing Book and CSR. Reviewed data and collabor
ated
with presentation for Topline Results.
*Assisted with global queries from regulatory bodies.
Initiatives/Talent
*Involved in pilot study initiatives - provided consultation on best practices,
developing a strategy to improve productivity and data cleanup process.
*Provide leadership with vendor laboratory selection; input with
clinical/biomarker/pharmacokinetic data interpretation.
*Provide scientific perspectives into the design of study protocols. Prepared an
d
presented posters at internal scientific symposiums.
*Manage the ongoing review of available safety data with the Project Clinician a
nd
provide input into topline results and clinical study report.
UMDNJ-GSBS, Newark, NJ. 1999 - 2006
PhD Program (Pharmacology/Toxicology)
*Spent 1.5 years of PhD thesis work: "The effect of leptin on cytokine secretion

profile"in multiple sclerosis-crosstalk between neuro-immune systems (tissue c

ulture,
cell sorting assays, radio labeling, ELISA, RT-PCR, flow cytometry)- Neuroimmu
nology.
*Final Dissertation: Acetylcholinesterase Mediated Toxicity of Paraoxon
(Pharmacology/Toxicology), awarded 2006.
COVANCE, Princeton, NJ 1998 - 1999
Regulatory Affairs Associate
*Ensured quality assurance and FDA/GCP compliance of Phase III Clinical Trials o
n
cardiovascular, COPD, oncology, CNS and diabetes.
*Performed in-house and site audits of regulatory documents and source documents
followed with audit report.
SCHERING PLOUGH RESEARCH INSTITUTE, Kenilworth, NJ 1992 - 1998
Clinical Data Coordinator (10/1997 - 7/1998)
*Maintained database and developed CRFs in several phase III therapeutic areas
including CNS, Allergy, and Asthma; and in phase I, Clinical Pharmacology
*Point of contact for CRF design expertise.
*Updated and developed programs that identified queries, query resolution and
database finalization.
Clinical Research Associate (Anti-Infectives) (1/1997 - 10/1997)
*Responsible for initiation of phase III study start up activities and monitorin
g. Served
as point of contact for expertise in biology of Intron A/Ribavirin.
Associate Scientist (Immunology) (1/1992 - 1/1997)
*Operated and maintained a three-laser flow cytometer/cell sorter (BD-FACS Vanta
ge).
*Flow cytometry applications expert: independently modified a protocol to detect
intracellular cytokines by flow cytometry. Disease indications were Type I dia
betes
and Crohn's Disease.
*Performed immunophenotypic analysis of primate peripheral blood for pre-clinica
l
studies in IL-10 and IL-4 studies, according to GLP guidelines. Performed cel
l sorting
and cytokine detection assays (ELISA).
*Dosed animals and performed biopsies for biological testing.
NEWARK BETH ISRAEL MEDICAL CENTER, Newark, NJ 1979 - 1991
Supervisory Technologist (Flow Cytometry)
*Designed and set up a new flow cytometry laboratory according to CLIA-laborator
y
accreditation guidelines and other hospital accreditation agencies.
*Operated and maintained a BD-FacScan flow cytometer.
*Conducted training and evaluation for direct reports
*Diagnosed and differentiated leukemias and immunological disorders.
*Participated in panel discussion and case interpretation (with hospital-hired m
entor);
provided diagnostic reports with pathologist final sign off.
Senior Medical Technologist (Toxicology)
Maintained laboratory state certification by consistently passing New Jersey 'Pr
oficiency Tests' for determination of Lead and Erythrocyte Protoporphoryn levels
*Conducted in-service workshops for health-related employees.
*Consulted with physicians and medical residents on follow up of lead-contaminat
ed
patients.
*Facilitated staff training and evaluation for peers.
Medical Technologist (Chemistry)
Performed diagnostic tests including a patient population with kidney and heart
failure. Pre- and post transplant testing, including familiarity with HLA tissue
typing. Responsible for operation and troubleshooting of various Chemistry Ana
lyzers to perform tests such as renal, liver, and cardiac function; lipid metabo
lism, and immunological assays.
CERTIFICATIONS
Certified Medical Technologist
American Association of Clinical Pathologists-MT (ASCP)
Registrant: MT-132039
FOREIGN LANGUAGES
Portuguese: Fluent speaking, reading, and writing
Spanish: Speaking and reading
SOFTWARE PROGRAMS
ACSLXtreme (modeling and simulation), Sigma Plot, Sigma Stat, Kinetica, JumpIn (
SAS), E.P.A.-Benchmark Dose Model, MS Word, Excel, PowerPoint
AWARDS / OFFICES
Performance awards at BMS: 2007, 2008, and 2009
Honored member Global Directory of Who's Who, 2007
Vice-President of Graduate School Association, 2003
Secretary of Graduate School Association, 2001
Full six-year academic scholarship with student stipend- UMDNJ-GSBS. 1999
Full four-year academic scholarship to Rutgers University
PROFESSIONAL AFFILIATIONS
American Society of Pharmacology and Experimental Therapeutics (ASPET)
Society of Toxicology (SOT)
New York Academy of Sciences (NYAS)
American Association of Pharmaceutical Scientists (AAPS)
American Society of Clinical Pathologists (ASCP)
PUBLICATIONS
1. H. M. Campanha, P.A. Schlosser, F. Carvalho, 2010. Active and Peripheral An
ionic
Sites of Exogenous Acetylcholinesterase have differential modulation effects
on Cell
Proliferation, Adhesion and Neuritogenesis in the NG108-15 Cell Line. Brain
Research (submitted for publication-under review)
2. H. M. Campanha, P. Schlosser, 2009. Development of a Biologically Based Dos
e-
Response Model to Study the Effect of Thioflavin-T and Paraoxon on the Kinet
ics of
Cell Growth and Differentiation Patterns. (under construction).
3. J. Wang, S. Kaul, H. M. Campanha, G. Kollia, P. Ji, S. Galbraith, U. Thienel,
2008.
Multiple Ascending Dose Study of a Potent p38 MAPK Inhibitor BMS-582949 in
Patients with Rheumatoid Arthritis on Stable Doses of Methotrexate. Americ
an
College of Rheumatology annual meeting.
4. H. M. Campanha, 2006. Acetylcholinesterase Mediated Toxicity of Paraoxon. P
h.D.
Thesis Manuscript, University of Medicine and Dentistry of New Jersey-Gradu
ate
School of Biomedical Sciences, Newark, N.J
5. H. M. Campanha, E. J. Flynn, 2005. Thioflavin-T, an Acetylcholinesterase Peri
pheral
Site Ligand, Decreases NG108-15 Cell Proliferation. The Toxicologist, 84:19
48
6. H. M. Campanha, E. J. Flynn, 2004. The Effect of Thioflavin-T and Paroxon on
the
Growth Promoting Function of Acetylcholinesterase. The Toxicologist, 78: 20
69
7. C. Conroy, S. Cox, H. M. Styranec, R. Rubin, L. Pisarov, K. Dorko, 1997. FACS
Analysis of Human Hepatocytes Infected with HCV. National Hepatology Meeting
.
8. H. M. Styranec, K. Pennline, 1995. Detection of Intracellular Cytokines by Fl
ow
Cytometry. Cytometry Symposium, CA.
PRESENTATIONS
H. M. Campanha, E. J. Flynn. The Effect of Thioflavin-T on the Growth Promoting
Function of Acetylcholinesterase. Platform session, Society of Pharmacology/Tox
icology, December 2004, Portugal