People

Management Team                                                              Printable Roster

Ellen Kelso, CIP
Managing Member and CEO

Administrative Vice Chair



Review Board Members

Jeffrey R. Botkin, MD, MPH
Salt Lake City, Utah
Professor of Pediatrics- Division of Pediatrics, Professor of Internal Medicine and Medical Ethics - University of Utah School of Medicine, Associate Vice President for research Integrity, University of Utah

Jennifer Bradley, MSN
Cincinnati, Ohio
Pediatric Nurse Practitioner
Clinical Research Associate

Lynne Calloway
Cincinnati, Ohio
Individual and Family Liaison
Hamilton County Board of Mental Retardation & Developmental Disabilities

James Cheever, DMD
Tucson, Arizona
Former Associate Director for Regulatory Programs & Policy, Division of Medical Imaging and Radiopharmaceutical Drug Products
Center for Drug Evaluation and Research
Food and Drug Administration

Donald Denson, PhD, FCP
Atlanta, Georgia
Associate Professor of Anesthesiology
Director, Anesthesiology Research Laboratories
Core Faculty, Center for Cell and Molecular Signaling Emory University School of Medicine

Angela Green, BSN
Indianapolis, Indiana
Hospital, Occupational Health and School
Corporation Nurse

Ruth Sara Hart-Schneider
Cincinnati, Ohio
Non-science/community representative

Timothy Hester
Cincinnati, Ohio
Non-science/community representative

Sheila Kinney
Indianapolis, Indiana
Non-science/community representative

Judith Lapp
Cincinnati, Ohio
Non-science/community representative

Donna Littrell, BSN
Indianapolis, Indiana

Clinical Research Consultant
Clinical Research Administrator

Maurice Mueller, M.D. PhD
Fort Mitchell, Kentucky
Obstetrician-Gynecologist
Chair, Ethics Committee
St. Elizabeth Medical Center


Robert Olick, JD, PhD
Syracuse, New York

Associate Professor in the Center for Bioethics and Humanities

SUNY Upstate Medical University

Robin Levin Penslar, JD
Vice-Chair
Toronto, Ontario, Canada
Legal Researcher
Ogilvy Renault, Barristers and Solicitors
Principal Author and Editor
NIH Institutional Review Board Guidebook

John C. Pezzullo, PhD
Acting Chair
Washington, D.C.
former Informatics Core Director and Biostatistician, Associate Professor, Pharmacology and Biostatistics
General Clinical Research Center
Georgetown University Medical Center

Ward Rice, MD, PhD
Edgewood, Kentucky
Director, Neonatology Fellowship Training Program
Division of Neonatology and Pulmonary Biology
Children’s Hospital and University of Cincinnati

Edward H. Saeks, MD
Cincinnati, Ohio
Director, Division of General Surgery
Former President of the Medical Staff
Jewish Hospital, Cincinnati

Albert William Schreiner, lll, MD, FACP
Cincinnati, Ohio
former Director, Internal Medicine/Residency Program and Chair of Intensive Care and Clinical Review Committees
former Chair, Institutional Review Board The Christ Hospital

Laura A. Siminoff, PhD
Cleveland, Ohio
Associate Professor of Medicine
Medical Anthropology
School of Medicine
Case Western Reserve University

Robert M. Veatch, PhD
Washington, D.C.
Professor of Medical Ethics
Senior Research Scholar and former Director
Kennedy Institute of Ethics
Georgetown University

Jürgen Venitz, MD, PhD
Richmond, Virginia
Associate Professor,
Department of Pharmaceutics
School of Pharmacy
Medical College of Virginia Campus of Virginia Commonwealth University

Kurt Weingand, PhD, DVM
Mason, Ohio
President, SciComPro, LLC
Consultant, biomedical research and optimization of innovation
(for James Cheever, DMD)



Profiles

Ellen Kelso

For over twenty-five years, Ellen Kelso has provided consultation and services to the Pharmaceutical industry supporting clinical research and worldwide regulatory submissions and strategies. Before Goodwyn IRB, she served Kendle International (a Cincinnati-based clinical research organization) as Director of Regulatory Affairs responsible for clinical research site selection, coordination of documents for initiation and execution of large-scale clinical trials, document quality assurance and regulatory support for clinical monitors.

Prior to Kendle, Ms. Kelso served Procter & Gamble Pharmaceuticals as Regulatory Affairs and Standards Manager. While at P&G she led project teams through production and approval of New Drug Applications (NDAs), managed international submissions and strategies, and established electronic submission publication, document management and regulatory compliance systems.

Ms. Kelso began her career as a microbiologist and subsequently, during thirteen years of service at  Eli Lilly and Company, planned and administered clinical trials, managed drug safety assessments, and prepared worldwide regulatory submissions.  Ms. Kelso also served as the company’s worldwide regulatory point-person for human insulin products.

Jeffrey R. Botkin, MD, MPH

Professor of Pediatrics and Adjunct Professor of Internal Medicine in the Division of Biomedical Ethics at the University of Utah School of Medicine and Associate Vice President for Research Integrity, University of Utah.. Director of the "Genetic Science in Society" Program (ELSI Core) at the Utah Center for Human Genome Research. Chair of the Committee on Bioethics for the American Academy of Pediatrics (effective July 1st, 2001).  Dr. Botkin's primary research interests are ethical issues in human genetics and ethical issues in pediatrics.

Graduate Education:

M.D., M.P.H., Johns Hopkins, Baltimore MD
Postdoctoral Fellowship (Law, Ethics, and Health): Johns Hopkins in affiliation with the Kennedy Institute of Ethics.

Teaching Activities:

Medical Ethics
Social Medicine
Human Genetics
Department of Pediatrics Resident Ethics Seminar series
Attending service on general pediatric wards
Pediatric clerkship case seminars

Research/Other Activities:

Member, Huntsman Cancer Institute, Clinical Research Executive Committee.  This work is focused on behavioral and psychological responses to genetic testing for cancer susceptibility, and on issues in informed consent, privacy, and confidentiality.

Primary Investigator: National Cancer Institute grant providing genetic testing for the BRCA1 gene in a large Utah kindred
Chair, Bioethics Committee, Primary Children's Medical Center
Member, Institutional Review Board, University of Utah Health Science Center
Study Section Member, NIH Ad Hoc Study Section on Ethics and Genetics
American Academy of Pediatrics Member, Committee on Bioethics, District VIII Representative
Chair, Genetics Advisory Committee, Department of Health , State of Utah
Co-leader, Informed consent working group, NIH (NCI/NHGRI) Cancer Genetic Studies Consortium
Co-Chair, Ethics Committee, NIH Cancer Genetics Network

Dr. Botkin is also an award-winning photographer of Utah’s wilderness.


Jennifer M. Bradley, MSN

Independent consultant/contractor supporting clinical, safety and regulatory activities in pharmaceutical research.

Graduate Education:

M.S.N., University of Cincinnati

Past work includes serving as a hospital staff nurse, nurse educator and pediatric nurse practitioner as well as a Clinical Research Associate/Project Coordinator focused on large-scale multicenter trials for a large pharmaceutical company.

Teaching Experience:

Well Child Supervision
Health Assessment
Management of Minor Illness
Advanced Parent Child Health Nursing Assessment
Reviewing and Participating in Clinical Research Projects


Lynne Calloway

Ms. Calloway is a married, mother of two children. She devotes her time to home, family and helping individuals and families achieve what is important to them through the Hamilton County (Ohio) Board of Mental Retardation and Developmental Disabilities (MR/DD).  Hamilton County Board of MR/DD offers services and programs to benefit adults and children with mental retardation and developmental disabilities. 

Education:

B.S., Special Education, Ashland University, Ohio

Graduate Education:

M.Ed. University of Cincinnati


James R. Cheever, DMD

Principal, Coyote Consultants, providing guidance on drug development and regulatory strategies to pharmaceutical companies.

United States Navy:

Naval aviator and advanced jet flight instructor

Graduate Education:

D.M.D., Medical College of Georgia

Past work includes serving as a regulatory management officer in the Center for Drug Evaluation and Research (CDER) and Associate Director of the Division of Medical Imaging and Radiopharmaceutical Drug Products (DMIRDP) in the Food and Drug Administration (FDA).

Focus/Interests:

Investigational New Drug Applications (INDs)
New Drug Applications, including Phase IV (NDAs)
Clinical Trial Design


N. Angela Green, BSN

An nurse experienced in hospital and intensive care units, occupational health and in working for a school corporation.

Education:

B.S.N, DePauw University
Graduate Certificate (Elementary Education): University of Kansas

Activities:

School and Girl Scout Volunteer
The Eiteljorg Museum: American Indian and Western Art, Culture
The Farnsworth Group (research-based market consulting) -- marketing concepts
Devonshire Civic Association


Ruth Sara Hart-Schneider

Community advocate with a background in business management of physician practices.

Education (Mechanical Engineering):

University of Virginia

Past work includes serving as an engineer for Procter and Gamble and as a principal partner in a firm specializing in medical billing, electronic medical records and consulting.

Activities:

Winners Walk Tall – character development program for inner city children
Reading Program volunteer, Englewood Rotary
Project work, Ohio Valley Voices (school for hearing-impaired children)
Board member and Waterfront Chairman, Englewood Isles Association I

Travel and fitness


Timothy Hester

Independent Licensed Medical Massage Therapist

Education:

Self-Health Institute of Medical Massage
Therapy and Psycho-Physiological Studies

Activities:

American Whole Health Networks
American Massage Therapy Association
Race Across America Sports Therapy Team
Scoutmaster-BSA

Music, Family and the Great Outdoors


Sheila Elliott Kinney, JD

Attorney and community advocate focused on education and environmental issues.

Education (French and Theater):

Indiana University

Graduate Education:

J.D., Indiana University School of Law

Past work includes practicing law in the areas of contract, property, and employment and
representation of various governmental agencies. ( Prior volunteer work included serving as an ESL teacher for French-speaking immigrant students.)

Activities:

Parent Teacher Organization (Past President)
School District Planning
Languages and Cultures


Judith A. Lapp, JD

Ms. Lapp is an assistant prosecuting attorney in the appellate division, Hamilton County Prosecutor's Office, Ohio.  She is the mother of three with a background in Journalism.

Education (Journalism):

Ohio State University

Graduate Education:

J.D., University of Cincinnati
Mediation Internship: American Bar Association, Special Committee on Dispute Resolution, Washington DC

Past work includes serving as a general assignment reporter for a newspaper and as assistant prosecutor in the criminal appellate and trial divisions in Hamilton County, Ohio.


Donna Littrell, BSN

Independent consultant/contractor supporting clinical, safety and regulatory activities in pharmaceutical research. 

Education:

B.S.N, Indiana University School of Nursing
Graduate Certificate (Elementary Education): University of Kansas

Past and current work includes coordination, implementation and data management of both publicly and privately funded Phase I-IV clinical trials.

Activities:

Founding member and Treasurer (1998) of local chapter (Circle City, Indianapolis) of Association of Clinical Research Professionals (ACRP)
Junior League of Indianapolis, Inc., sustaining member
United Way National Leadership Conference – volunteer
 


Maurice J. Mueller, MD, PhD

Volunteer Associate Professor of Obstetrics-Gynecology at the University of Cincinnati College of Medicine.

Graduate Education:

M.D., Ohio State University. Visiting Scholar, The Hastings Center, Briarcliff NY.
Residency (OB/GYN): Naval Medical Center, San Diego CA
Ph.D. (Bioethics), Union Institute, Cincinnati, OH

Board Certification:

American College of Obstetricians and Gynecologists

Past work includes 20 years clinical practice and serving as a member of the American College of Obstetrics and Gynecology Committee on Ethics.

Activities:

Chair, Medical Ethics Committee at St. Elizabeth Medical Center, Edgewood, KY
Family Practice Residency and Medical Student Teaching Faculty, St. Elizabeth Medical Center

Facilitator, University of Cincinnati College of Medicine course in "Health Care Ethics"

Visiting Lecturer, Xavier University Philosophy Department

Visiting Lecturer, Wood Hudson Cancer Research Laboratory

Selected Publications:

"Ethical Considerations in Research Involving Pregnant Women", American College of Obstetricians and Gynecologists Committee on Ethics, November, 1998.


Robert S. Olick, JD, PhD

Associate Professor in the Center for Bioethics and Humanities, SUNY Upstate Medical University.  Dr Olick directs the Ethical, Legal and Social Issues in Medicine component of the Medical Unveristy's Practice of Medicine course.

Graduate Education:

J.D., Duke University School of Law
Ph.D. (philosophy and bioethics), Georgetown University and the Kennedy Institute of Ethics

Past work includes serving as Executive Director of the New Jersey Bioethics Commission and chief consultant to the New Jersey Governor’s Advisory Council on AIDS.

Teaching Activities:

Health Law
Biomedical Ethics

Research Interests:

legal, ethical and policy issues involving the physician-patient relationship
advance directives and decisions near the end of life
ethics committees and consultants
confidentiality
genetics.

Selected Publications:

Dr. Olick is the author of the book Taking Advance Directives Seriously: Prospective Autonomy and Decisions Near the End of Life (Georgetown Univ. Press, 2001). He is currently working with two colleagues on a book to be titled, The Tissue Issue: Stored Human Tissue in the Era of Molecular Genetics, to be published with Oxford University Press in June 2004.


Robin Levin Penslar, JD

Legal Researcher at Ogilvy Renault, Barristers and Solicitors.

Graduate Education:

J.D., Boalt Hall, University of California-Berkeley

Past work includes serving as Special Assistant on issues of research ethics to the Vice President for Research at Indiana University, and as a Research Associate at the Poynter Center for the Study of Ethics and American Institutions. Her work in research ethics was preceded by legal practice at the law firm of Ballard, Spahr, Andrews and Ingersoll in Philadelphia.

Selected Publications:

Principal author and editor of OPRR’s Protecting Human Research Subjects: Institutional Review Board Guidebook (GPO, 1993).
Editor of Research Ethics: Cases and Materials (Indiana University Press, 1995).


John C. Pezzullo, PhD

Former Associate Professor in the Departments of Pharmacology and Biostatistics at Georgetown University. Informatics Core Director and Biostatistician for the General Clinical Research Center (GCRC).  Dr. Pezzullo retired only recently from these positions and looks forward to a Georgetown University adjunct faculty appointment.

Graduate Education:

Ph.D. Providence College, Providence RI

Past work includes serving as a member of GCRC's advisory committee (reviewing all proposed research protocols) and the Statistical Consultant to the GUMC Internal Review Board.  Dr. Pezzullo was the primary scientific programmer for the Pathology Department, Senior Management Engineer, Information Services Director, and Director of the Information Technology Center of Rhode Island Hospital (RIH). He was also the hospital's primary biostatistician, assisting researchers in the acquisition, management, and analysis of their data. He served on the RIH Institutional Review Board until moving to the GUMC in 1993.

Research/Other Activities:

Principal informatics / biostatistical consultant to the National Perinatal Information Center since its inception in 1986
Head, Informatics Section, Perinatal Research Branch of the National Institutes of Child Health and Human Development.
Consultant for a number of healthcare-related companies and organizations, including the Degge Group Ltd., of Alexandria VA, which specializes in providing drug safety research, consulting & information services to the pharmaceutical industry.

As a result of his lifelong interest in computational statistics, he maintains the Interactive Statistical Pages web site (http://StatPages.net), which provides an organized collection of hundreds of online statistical analysis pages, as well as links to statistical software, textbooks, tutorials, interactive demonstrations, and other statistics-related resources. This web site is accessed thousands of times per week by researchers, teachers and students worldwide, and has been cited by the Applied Mathematics Society and Science Magazine.


Ward R. Rice, MD, PhD

Director of Graduate Medical Education in the Division of Neonatology at the University of Cincinnati College of Medicine and Professor of Pediatrics in the Divisions of Neonatology and Pulmonary Biology in the Department of Pediatrics at the Cincinnati Children's Hospital Medical Center (CCHMC).

Graduate Education:

M.D., Ph.D. (Biochemistry), University of Chicago, Chicago IL
Internship and Residency: Duke University, Durham, NC
Postgraduate Fellowship (Neonatology): University of Cincinnati College of Medicine, Cincinnati OH

Research/Activities:

In addition to his clinical responsibilities, Dr. Rice heads a research laboratory investigating factors regulating lung development.
He has served for 10 years on an NIH study section, 3 of those years as chairperson.
He is an active participant in the monthly Ethics Seminars sponsored by the CCHMC and has served as a scientific advisor to the Clinical Research Center of the CCHMC.

Edward H. Saeks, MD

Former President of the Medical Staff and Director of the Division of General Surgery at The Jewish Hospital, Cincinnati, Ohio.

Graduate Education:

M.D., University of Cincinnati College of Medicine
Internship and Residency (General Surgery): The Jewish Hospital

Past work includes serving in the United States Air Force from 1958-1960 as the Chief of Surgery at the 6510th U.S.A.F Hospital and private practice for almost 40 years. Dr. Saeks served on the Medical Staff Executive Board of The Jewish Hospital and on the Executive Committee of the board of Trustees for several years.

Other Activities: Board Member of several community organizations, including:

National Conference of Christians and Jews
The Wellness Community
Playhouse in the Park


Laura A. Siminoff, PhD

Associate Professor of Internal Medicine and Health Care Research and Bioethics (with tenure) at the Case Western School of Medicine.

Graduate Education:

Ph.D., Johns Hopkins University School of Hygiene and Public Health, Baltimore MD

Research Interests: Dr. Siminoff has been the recipient of numerous research grants and specializes in conducting empirical research in bioethical issues. Her research Interests include:

treatment decision-making and informed consent for phase III randomized controlled trials
organ procurement policy
ethnic variation in provision of health care services.


Robert M. Veatch, PhD

Professor of Medical Ethics and the former Director of the Kennedy Institute of Ethics at Georgetown University. He also holds appointments as Professor of Philosophy and Adjunct Professor in the Department of Community and Family Medicine at Georgetown's Medical Center. Senior Editor of the Kennedy Institute of Ethics Journal and former member of the Editorial Board of the Journal of the American Medical Association.

Graduate Education:

M.S. (Pharmacology), University of California Medical Center
Ph.D. (Medical Ethics), Harvard University

Past work includes serving as an ethics consultant in the preparation of the legal case of Karen Ann Quinlan, the woman whose parents won the right to forgo life-support (1975-76) and testifying in the case of Baby K, the anencephalic infant whose mother insisted on the right of access to ventilatory support.

Selected Publications:

Dr. Veatch is the author of several books in medical ethics including The Patient as Partner: A Theory of Human Experimentation Ethics and A Theory of Medical Ethics. The second edition of his edited textbook entitled Medical Ethics was published in 1997.

Among his recent publications are:

The Basics of Bioethics (second edition), Prentice Hall 2000

Transplantation Ethics, Georgetown University Press, 2000

Consent, Confidentiality, and Research. The New England Journal of Medicine 336 (March 20, 1997):869-870.
From Nuremburg Through the 1990s: The Priority of Autonomy. In The Ethics of Research Involving Human Subjects: Facing the 21st Century. Edited by Harold Y. Vanderpool. Frederick, MD: University Publishing Group, 1996, 45-82.
"Abandoning Informed Consent." Hastings Center Report 25 (March-April 1995, No. 2): 5-12.


Jürgen Venitz, MD, PhD

Associate Professor of Pharmaceutics, Medicinal Chemistry and Pharmacy, Director of the Pharmacokinetic-Pharmacodynamic (PK/PD) Laboratory in the School of Pharmacy, Campus of the Medical College of Virginia Commonwealth University, Richmond, VA.   Dr. Venitz also serves as Chair of the Clinical Pharmacology Subcommittee, Center for Drug Evaluation and Research, United States Food and Drug Administration.

Graduate Education:

M.D., Ph.D. (Physiology), Universität des Saarlandes in Saarbrücken, Germany
Postdoctoral Fellowship: Beehive School of Pharmacy, University of Florida, Gainesville, FL.

Past work includes serving as Director of Clinical Research and Development at the Institut für Klinische Pharmakologie Bobenheim in Grünstadt, Germany; where he was in charge of a Phase I, Clinical Unit and responsible for design, implementation and data analysis of phase I, PK/PD clinical pharmacology studies.

Teaching Activities:

Pharmaceutics

Clinical Pharmacology
Medicinal Chemistry
Nurse anesthesia

Research/Interests:

Design and analysis of safety, pharmacokinetic and pharmacodynamic studies in early clinical drug development

PK/PD modeling in dosing regimen optimization
Multiple university, AAPS, ACCP, ASCPT and NIH committees
Scientific expert consultant in clinical pharmacology with various pharmaceutical companies, as well as the FDA (Office of Clinical Pharmacology and Biopharmaceutics)

   
 
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