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CTTI Staff
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Judith Kramer, MD, MS, Executive Director
Dr. Kramer brings over two decades of leadership experience in the field of clinical research, as well as the perspective of someone who has worked across multiple sectors including private medical practice, the medical products industry, and academia. She also brings experience in leading another major public-private partnership and serving in an advisory capacity to regulatory authorities.
Dr. Kramer is an Associate Professor of Medicine in the Division of General Internal Medicine at the Duke University School of Medicine. She received her MD from the University of North Carolina, Chapel Hill, in addition to a BS and MS in Pharmacy. She completed her internship and residency at Massachusetts General Hospital. She is board certified in internal medicine and practiced internal medicine in the community for 5 years. For the past 25 years, she has been involved in clinical research. She worked for 10 years at Burroughs Wellcome Co., where she was Vice President, Medical and U.S. Director of Clinical Research. In that capacity, she was responsible for the scientific administration of antiviral, oncology, neurology/psychiatry, cardiovascular, and pulmonary/critical care clinical research and supervised the preparation of 7 full original NDAs and 14 INDs.
From 1997 to 2006, Dr. Kramer served as the Chief Medical Officer of the DCRI, and in that role she provided guidance and consultation on the formation of the regulatory services, regulatory compliance, and quality assurance functions. Dr. Kramer previously served as Professor of Pharmaceutical Sciences and Director of Clinical Research Programs at Campbell University, where she was responsible for developing the initial curriculum for the BS and MS degrees in clinical research. She also served as the Principal Investigator of the Agency for Healthcare Research and Quality (AHRQ)-sponsored Duke Center for Education and Research on Therapeutics, focused on cardiovascular drugs and devices. She currently serves as a member of several national panels related to regulatory reform and policy development. In 2004, she served as a member of the FDA’s Medical Product Surveillance Network (MedSun) Expert Working Group with the Center for Devices and Radiological Health. Since 2006, she has served as a member of the FDA’s Drug Safety and Risk Management Advisory Committee, and since 2009 has served as chair of the advisory committee. She has published over 40 manuscripts in the peer-reviewed literature and 2 book chapters.
In her role as Executive Director of CTTI, Dr. Kramer oversees all activities and operations of the partnership under the direction of the Co-Chairs, Dr. Robert M. Califf, Vice Chancellor for Clinical Research at Duke University, and Dr. Rachel Behrman, Director of the FDA’s Office of Critical Path Programs.
Leanne Madre, JD, MHA, Director of Strategy
Ms. Madre advises and supports the Executive Director and other CTTI leaders in setting and carrying out organizational strategies in support of CTTI's mission. She is also responsible for maintaining awareness and assessing related efforts of government and private sector organizations. Ms. Madre develops and implements appropriate strategies for CTTI in light of those initiatives.
Ms. Madre previously served as Program Director, Centers for Education and Research on Therapeutics (CERTs) Coordinating Center, where she played an instrumental role in developing the CERTs program organization, including the creation of a model for public-private partnership. While at Duke University, Ms. Madre also served as Manager of Strategic Relations and Client Services for the Duke Clinical Research Institute (DCRI). Prior to joining Duke, she served as an attorney for Sentara Health System. Ms. Madre received her JD from the University of Richmond, her MHA from the Medical College of Virginia/Virginia Commonwealth University, and her BS (biochemistry) from North Carolina State University.
Cheri D. Janning, BSN, RN, MS, Senior Clinical Project Manager
Ms. Janning is responsible for managing the development and implementation of CTTI projects. In collaboration with team leaders, she leads the creation of study plans and budgets, and the implementation of those plans. Ms. Janning works with the Executive Director of CTTI and regularly reports project status.
Prior to joining CTTI, Ms. Janning was Associate Director of Clinical Operations for the cardiovascular therapeutic area at the Duke Clinical Research Institute (DCRI). She has 14 years experience in clinical trials at DCRI, including ten years of program and project management experience. Her therapeutic experience includes cardiology (drug and device), orthopedics, rheumatology, oncology, trauma and pediatrics. Ms. Janning has a background in clinical nursing (BSN, Wright State University) with clinical and teaching experience working at academic institutions in Ohio, Michigan, Tennessee, South Carolina, and North Carolina. She received a Master’s degree in Clinical Research from Campbell University. As part of her graduate work, Ms. Janning examined the degree of monitoring in a large international multi-center clinical trial and its relationship to primary analysis of the protocol. Ms. Janning has experience with other large collaborative research initiatives including the Cardiac Safety Research Consortium (CSRC), and Harmonization By Doing (HBD).
Sara Bristol Calvert, PharmD, Senior Clinical Project Manager
Dr. Calvert is responsible for managing the development and implementation of CTTI projects. In collaboration with team leaders, she leads the creation of study plans and budgets, and the implementation of those plans.
Prior to joining CTTI, Dr. Calvert was a Clinical Pharmacist and Project Leader in the Outcomes Group at the Duke Clinical Research Institute. She has eight years of clinical research experience at the DCRI which included project management, conducting a randomized intervention to improve medication adherence, and serving as the anticoagulation monitor for a multi-center clinical trial. Her therapeutic experience includes cardiology, diabetes, hypertension, and anticoagulation. She continues to practice as a clinical pharmacist at the Duke Outpatient Clinic. Dr. Calvert received her Doctor of Pharmacy from the University of Pittsburgh and completed an Ambulatory Care Pharmacy Residency at Duke University Medical Center and Health System.
Cheryl Grandinetti, PharmD, FDA Health Science Policy Analyst
Dr. Grandinetti joined the Food and Drug Administration’s (FDA) Office of Medical Policy within the Center for Drug Evaluation and Research (CDER) in October 2010. She is the Agency lead responsible for supporting the Clinical Trials Transformation Initiative (CTTI). In addition, she is responsible for coordinating a number of program and policy initiatives involving human subject protection and good clinical practices within the Office of Medical Policy and for development of guidance documents related to labeling for human prescription drugs.
Prior to joining FDA, Dr. Grandinetti was a senior clinical research pharmacist for the Cancer Therapy Evaluation Program (CTEP) at the National Cancer Institute. At CTEP, she managed several investigational agents in support of NCI-sponsored cancer treatment trials, as well as a variety of activities related to international trials.
Dr. Grandinetti is a registered pharmacist and received her B.S. in pharmacy from West Virginia University and her Doctor of Pharmacy from Virginia Commonwealth University. She began her pharmacy career as a hospital pharmacist at the University of Virginia Health System and served as their investigational drug pharmacist for the last 7 of her 14 years there.
Rhonda Bartley, Assistant to the Executive Director
Rhonda Bartley began her Duke career in 1991 as Assistant to the Chairman of the Department of Anesthesiology at Duke University Medical Center. In 1999, she joined the Duke Clinical Research Institute as Assistant to Dr. Judith Kramer, and has supported Dr. Kramer in her various roles as Chief Medical Officer of DCRI, founding Director of the Clinical Research Training Program at Campbell University, Principal Investigator for the Research Center of the Duke Center for Education and Research on Therapeutics (CERTs), and now as Executive Director of CTTI in the Duke Translational Medicine Institute. Rhonda has over 25 years of administrative experience in the healthcare field. For CTTI, Rhonda provides administrative support to the Executive Committee, and is the primary contact for new member organizations.
Rhonda is active in the DCRI’s annual United Way campaign and was a 2007 Susan B. Clark Administrative Leadership Award Honoree at Duke University Medical Center. She and her husband, Kent, have one daughter, Lauren.
MariJo Mencini, Staff Specialist
Ms. Mencini provides administrative support for the Senior Clinical Project Managers and the project teams. Her responsibilities include arranging multi-stakeholder meetings used by project teams to gain input or consensus on important issues being addressed by CTTI projects.
Ms. Mencini brings more than 12 years of administrative experience to her position. For over 10 years, she was employed by a privately-held engineering software company, providing support to the executive team, as well as the Sales and Marketing groups. She was involved in the coordination of quarterly board meetings, customer meetings, online training courses and user meetings.
Ms. Mencini enjoys spending her spare time with family and friends.
Rene Hamilton, Staff Assistant
Ms. Hamilton provides administrative support for the Steering Committee and its subcommittees. She also supports CTTI’s internal and external dissemination activities including maintenance of the website.
Ms. Hamilton has been with Duke University Medical Center for 10 years, working initially with the Centers for Education and Research on Therapeutics (CERTs) Coordinating Center and most recently with the Division of Cardiology. She has over 25 years of administrative experience in the health care field.
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