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Erika Stevens, MA: Interim Executive Director
Franco A. Barsanti, PharmD: Director, Trials Facilitation
Magaly Garcia, MD: Director, Hispanic Translation Center
Linda O'Neill: Manager of Finance, Operations Group
Mitchell Appleson, CPA: Manager of Finance, Post-Award Group
Lourdes Vasquez: Manager of Finance, Budgeting Group
Jean Robert Gabeau, JD: Manager, Contracts Group
Linda Busacca, BA: Manager, Clinical Trials Network
John F. Ennever MD, PhD: Medical Director
Richard Hlenski, MBA: Director of Strategic Planning and Finance
Robert B. MacArthur, PharmD: Director, Research Pharmacy
Table of organization
Erika Stevens, MA
Interim Executive Director, The Clinical Trials Office
Erika Stevens, MA, is the Interim Executive Director of the Clinical Trials Office at
Columbia University.
This position provides leadership in promoting, implementing, and
enhancing the strategic plans for clinical trials research at Columbia University's College
of Physicians and Surgeons and provides administrative resources and infrastructure to
build and sustain clinical research through close operation with New York Presbyterian
Hospital.
Ms. Stevens supervises 45 employees responsible for assisting investigators
in preparing applications, negotiating contracts, setting up sub-award agreements, and
maintaining certain post-award functions
Ms. Stevens completed masters' degrees from Case Western Reserve University and
Temple University in both Social Medicine and Social Research.
Her area of interest
has supported education and mentoring in her experience as an educator in clinical
research.
Ms. Stevens is a contributing author of the UPENN Manual for Clinical
Research©
and member of the development team for clinical research training and
certification at UPENN.
Ms. Stevens served as an oversight committee member to the
“Necessary Elements” Clinical Research Coordinator training curriculum under the
direction of the Associate Vice Chancellor for Research at Washington University School
of Medicine.
Ms. Stevens' previous experiences include Director of Clinical Research in the
Department of Surgery at Columbia University, Director of Research Operations in the
Department of Obstetrics and Gynecology at Washington University School of Medicine,
Senior Project Management in Maternal Fetal Medicine at the University of
Pennsylvania's School of Medicine, and Project Director at Case Western Reserve
University.
Ms. Stevens has served as adjunct faculty at many academic institutions on
the East Coast and the Midwest.
Ms. Stevens has co-authored and been published in a
variety of peer journals related to patient oriented research.
Ms. Stevens has over 14
years of clinical research experience, including over 11 years in clinical research
management.
Contact Ms. Stevens at ctodirector@columbiaclinicaltrials.org
Franco A. Barsanti, PharmD
Director, Trials Facilitation
Dr. Franco Barsanti is the
Trials Facilitation
Director of the Clinical Trials Office at
Columbia University.
This position provides leadership and expertise to drive the
successful implementation of the early clinical development initiative by expediting study
placement and providing regulatory and financial oversight.
After receiving his PharmD from Northeastern University Graduate
School of Pharmacy & Allied Health Professions in 1991,
Dr. Barsanti completed a two-year Postdoctoral Fellowship at the Rutgers College of
Pharmacy in 1996.
Later that year, he joined Hoffmann-La Roche as Clinical Science Specialist.
There, he was selected for the International Development Program as
Research Scientist within the Clinical Pharmacology Divisions in Welwyn, UK.
Dr. Barsanti served as a communication link between HLR Pharma Development and
Clinical Affairs for new drug discovery.
In 1998, he became Director for Clinical Research at Ortho Dermatological.
In 2002, Dr. Barsanti was recruited as the Director of the Clinical
Research Unit of the Department of Dermatology at Columbia University.
Dr. Barsanti joined the CTO in 2007.
Contact Dr. Barsanti at fb2025@columbia.edu
Magaly Garcia, MD
Director, Hispanic Translation Center
Magaly Garcia, MD, is the Director of the Hispanic Translation Center (HTC)
resource of the Clinical Trials Office.
Dr. Garcia coordinates all aspects of the
review and translation of documents at Columbia University, as well as outside
institutions to be used by Hispanic participants in research.
She manages
several off-site translation specialists and is the in-house contact for all research
personnel requiring Spanish translations.
After receiving her medical degree from University of Havana (Cuba) School of
Medicine, Dr. Garcia was Professor of Clinical Psychiatry there for 17 years.
As
Psychiatry Department Chair, she taught students, evaluated patients, and
collaborated in research and publications about child and adolescent mental
health.
Dr. Garcia then traveled to Venezuela, where she pursued a practice in
child and adolescent psychiatry.
Dr. Garcia
settled in the United States, came to Columbia University, and
began to work at the HTC in 1999.
In 2006, Dr. Garcia co-authored a paper describing the factors that influence how
members of the upper Manhattan Latin community self–prescribe antibiotics.
Contact Dr. Garcia at Hispanic-Translation@columbiaclinicaltrials.org
Linda O'Neill
Manager of Finance, Operations Group
Linda O'Neill is the Manager of Finance in the Operations Group of the Clinical Trials
Office (CTO).
Her principal roles are (1) to develop and manage the budgets for the
CTO and the Clinical Trials Network and (2) to prepare monthly and yearly financial
statements.
Ms. O'Neill works closely with the Controllers Office and clinical research
investigators and coordinators: troubleshooting problems with their studies, account
close-outs, and DAF requirements.
Ms. O'Neill also interacts regularly with industry
sponsors on issues related to their trials.
In her role as Finance Manager,
Ms. O'Neill maintains a professional and
smoothly-run office and solves administrative problems with staff, clients, and vendors.
Ms. O'Neill graduated from East Carolina University with a BSBA in Accounting. Ms.
O'Neill comes to Columbia with a prestigious accounting background having worked for
several Fortune 500 Companies.
Before joining the Clinical Trials Office, Ms. O’Neill
worked for 11 years at the entertainment conglomerate Ogden Corporation as a Senior
Financial Analyst, primarily with international mergers and acquisitions and various other
financial and accounting roles; for seven years at Viacom’s Showtime Networks as the
Business Manager for Marketing and Advertising; and with Madison Square Garden, a
subsidiary of Cablevision.
Ms. O’Neill also worked two years with Ingersoll Rand
Company, a worldwide manufacturing company, where traveled internationally as Audit
Supervisor.
Contact Ms. O'Neill at ctofinancemanager@columbiaclinicaltrials.org
Mitchell Appleson, CPA
Manager of Finance, Post-Award Group
Mitch Appleson is the Finance Manager of the Post-Award Group of
the Clinical Trials Office.
Post award activities include cash receipts, disbursements,
billing, accounts receivable and project account reconciliations.
Mr. Appleson is
responsible for the day-to-day management and activities of the post-award staff and
developing and enhancing processes to increase the efficiency and effectiveness of the
post-award group.
Mr. Appleson graduated from Yeshiva University in 2003 with a BS in Accounting
and earned his CPA license in 2005.
After nearly five years in public accounting, which included auditing healthcare institutions, Mr.
Appleson joined Columbia University Medical Center.
Contact Mr. Appleson at ctofinancemanager@columbiaclinicaltrials.org
Lourdes Vasquez
Manager of Finance, Budgeting Group
Lourdes Vasquez is the Finance Manager of the Budgeting Group of the Clinical Trials
Office.
Ms. Vasquez and the budget team review all industry sponsored projects to
ensure accuracy and completeness of budget plans, in order to gauge a project’s
financial feasibility.
If studies are deemed not financially viable, the budget team will
negotiate with sponsors to achieve this goal.
Ms. Vasquez and her budget team act as a liaison between investigators/coordinators
and sponsors to promote effective financial management in accordance with all
established Columbia University Medical Center policies and procedures.
Ms. Vasquez is a graduate of CUNY, Baruch College, where she earned a BBA in
Business Administration.
Prior to joining the Clinical Trials Office in 2005, Ms. Vasquez worked in both private
industry and the New York Health and Hospital Corporation-Elmhurst Hospital's Human
Resources Office.
Since joining the CTO, Ms. Vasquez received her Paralegal
Certificate from Hunter College in 2007.
Contact Ms. Vasquez at ctobudget@columbiaclinicaltrials.org
Jean Robert Gabeau, JD
Manager, Contracts Group
Jean R. Gabeau received his BA cum laude
with honors in Economics and Political
Science from Boston College in 1997 and
received his JD from Boston
College Law School in 2003.
He is admitted to practice law in New York State.
Before joining the Clinical Trials Office, Mr. Gabeau worked as a contract attorney for Hughes,
Hubbard & Reed LLP and Bank of America.
Mr. Gabeau joined the Contracts Department of the Clinical Trials Office in August, 2005
as a project officer.
He has extensive experience reviewing, drafting, and negotiating
clinical trial agreements, non-disclosure agreements, subcontracts, and material transfer
agreements.
Mr. Gabeau also manages several special projects at the CTO, including
serving as the primary project officer for all clinical trial agreements with Columbia
University’s Cancer Research Management Office as well as working closely with
Columbia University’s Office of General Counsel in developing new clinical trial
agreement provisions.
In 2007, Mr. Gabeau assumed the position of Manager of Contracts.
In this position, Mr. Gabeau is responsible for managing and training a staff of several attorneys and
paralegals, designing and implementing procedures and guidelines to facilitate the
contracting process.
In addition, Mr. Gabeau serves as a liaison among the CTO, the
Columbia University research community, and Columbia University’s Office of General
Counsel for to all contractual matters.
Contact Mr. Gabeau at ctocontractsmanager@columbiaclinicaltrials.org
Linda Busacca, BA
Manager, Clinical Trials Network
Linda Busacca is the Manager of the
Clinical Trials Network
(CTN) and acts as liaison between the Clinical Trials Office
(CTO) and the CTN. She is the primary contact for all CTN study
start-up, recruitment and regulatory documents, whether for
industry or government. The CTN was created by Columbia University
Medical Center, Weill-Cornell Medical Center, and New York-Presbyterian
Hospital, under the aegis of the CTO. Ms. Busacca coordinates
all activities between the Contract Research Organizations
(CROs), Site Management Organizations (SMOs), sponsors and
all participating network sites. Upon receiving her Bachelors
degree from the City University of New York and prior to joining
the CTO, she held positions in banking, pharmaceutical executive
recruiting, scientific publishing, and Columbia University's
legal department.
As encouraged by the NIH, Ms. Busacca will be participating
in the partnership between the academic medical centers and
private practices. The CTO will expand the CTN by incorporating
the Affiliated Hospitals of the New York-Presbyterian Health
Care System. Such partnerships reap the rewards of combining
clinical excellence and state-of-the-art research and education.
Contact Ms. Busacca at ctoCTN@columbiaclinicaltrials.org
John F. Ennever MD, PhD
Medical Director
Dr. John F. Ennever is the Medical Director of the Clinical
Trials Office. He has served as an Associate Clinical Professor
of Pediatrics in the Division of Pediatric Gastroenterology,
Hepatology and Nutrition at the Columbia University College
of Physicians and Surgeons since 1993. He is also the Associate
Medical Director of the Clinical Trials Network of the Clinical
Trials Office, a joint venture of Columbia University and the
New York-Presbyterian Hospital. Prior to the merger of the
Presbyterian Hospital and New York Hospital, Dr. Ennever served
in a number of administrative roles at the Presbyterian Hospital,
including Medical Director of the Allen Pavilion, Medical Director
of the Ambulatory Care Network Corporation and Medical Liaison
for Columbia-Presbyterian/Moscow. He was also the Hospital's
representative to the Executive Committee of the Clinical Trials
Advisory Committee during the time that the Clinical Trials
Network was conceived and initiated. He is a member of the
Columbia University Medical Center IRB and the Irving Center
GCRC Advisory Committee. Dr. Ennever received his Bachelors
and PhD in Biochemistry from Case Western Reserve University;
he also received his MD degree from Case Western Reserve University.
Prior to joining the administrative staff of the Presbyterian
Hospital, Dr. Ennever was at Case Western Reserve University
School of Medicine where he did basic research in bilirubin
photochemistry and clinical research in phototherapy for neonatal
jaundice. He helped to develop the BiliBlanket and led
the first international trial of this device in the treatment
of neonatal jaundice.
Contact Dr. Ennever at ctomedicaldirector@columbiaclinicaltrials.org
Richard Hlenski, MBA
Director of Strategic
Planning and Finance
Richard Hlenski assumed the leadership role of Director of
the Finance and Strategic Planning department in the fall of
2003. Upon graduating from Queen's College with a BA in Accounting;
he started his career in healthcare as an internal auditor
for New York Hospital. In 1988, he became the Chief Accountant
for the Westchester Division of New York Hospital, where he
was responsible for the Finance Department.
Over the next eleven years, Mr. Hlenski transferred to the
New York division of the Presbyterian Hospital system, earned
a Master's degree in Health Administration and became the Controller
of New York-Presbyterian Hospital. After briefly serving as
the Director of Grants, he joined the Clinical Trials Office,
bringing with him a vast knowledge of Finance and Strategic
Planning and a clear vision of developing a process that enables
the customer to work within the intricacies of the financial
systems of both the University and the Hospital and supports
the investigators in achieving their goals.
Contact Mr. Hlenski at ctofinance@columbiaclinicaltrials.org
Robert B. MacArthur, PharmD
Director, Research
Pharmacy
Dr. MacArthur received his degree of Pharm.D. from St. John's
University in New York, in 1988. He began his career working
for LAB, Inc., in Ridgefield, New Jersey as director of a 60-bed
Phase I unit and oversaw hundreds of Phase I and Bioequivalence
clinical trials from the initial proposal development to FDA
submission. In 1994, he worked for Sandoz Pharmaceuticals in
Drug Safety and Product labeling, and within the same year,
launched the opening of the Research Pharmacy at Columbia University.
The pharmacy presently has two locations and is involved in
hundreds of clinical trials.
As director of the CUMC Research Pharmacy, Dr. MacArthur
and his staff strive to provide the highest quality of investigational
drug pharmacy services to the University, NYPH, and its investigators.
Presently, the research pharmacy provides services to all divisions
and medical specialties. In the future, Dr. MacArthur looks
forward to expanding the capabilities of the existing solid
and sterile dosage forms for the convenience of the industry
and academic investigators, and to further develop the Englewood,
New Jersey site into a clinical trial packaging and investigational
and specialty drug distribution center for both the pharmaceutical
industry and academic sponsors.
Contact Dr. MacArthur at ctopharmacy@columbiaclinicaltrials.org
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