Bruce Burnett, PhD, RAC
Director of Regulatory Affairs, DTMI
E-mail: Bruce.Burnett@duke.edu
Phone: 919.688.7178

Dr. Burnett is responsible for overseeing a variety of services designed to support investigators in determining the regulatory requirements that apply to their research endeavors and in meeting their obligations. These services include regulatory education, regulatory consultation, and support for regulatory submissions.

Dr. Burnett received his undergraduate degree in chemistry from the University of California, San Diego and his PhD in biochemistry from MIT. He completed an NIH postdoctoral fellowship in genetics at Harvard Medical School.

Dr. Burnett brings over 20 years of experience in the pharmaceutical industry involving research and development, scientific affairs, quality control/assurance, and regulatory affairs. He came to Duke from AlphaVax, a local vaccine biotech company where he served as Vice President of Quality and Regulatory Affairs (and previously as Director of Regulatory Affairs and Quality Control). He has also held positions with Biogen (Associate Director of Quality Control and Bioassay, Manager of Regulatory Affairs, and Associate Director of Regulatory Affairs), Genetics Institute (Manager of Clinical Quality Control), and Serono Laboratories (Manager of Scientific and Clinical Affairs).

Dr. Burnett’s regulatory experience includes working on license applications that have resulted in the US approval of Tysabri (natalizumab), Amevive (alefacept), Neumega (oprevelkin, IL-11) and Benefix (coagulation Factor IX). He has also been responsible for preparing and submitting multiple initial INDs to CBER or CDER, preparing for many pre-IND and End of Phase 2 meetings, and leading numerous teleconferences with the Agency reviewers. His responsibilities have included defining regulatory strategies that have resulted in Phase 1, 2 and 3 clinical studies both in the US and Europe. Dr. Burnett also brings extensive experience with and knowledge of Good Laboratory Practice and Current Good Manufacturing Practice and their respective requirements for early drug development and clinical studies. Dr. Burnett holds the Regulatory Affairs Certification (RAC) in both US and European regulations from the Regulatory Affairs Professionals Society.

Regulatory Education Services

Sue Avery, MSN, CCRA
Manager, Regulatory Education and Training
E-mail: Sue.Avery@duke.edu
Phone: 919.668.8685

Ms. Avery has a BS in Nursing from the State University of New York at Buffalo and an MSN in Nursing Administration from the Duke University School of Nursing. She has worked in clinical research for the past 15 years and brings a wealth of experience and expertise in the area of education and training.

Ms. Avery joined the DCRI in 2002 in the role of Education and Training Coordinator. She has also served as the Interim Director of Quality Assurance and Regulatory Compliance at the DCRI since April 2005.

Ms. Avery is responsible for developing and managing education and training programs related to regulatory requirements and institutional standards for investigators, study coordinators, and other research staff involved in the conduct of translational and clinical research (including preclinical research, research in which a Duke faculty member serves as a sponsor-investigator, and site-based research).

Erin O’Reilly, PhD, RAC
Regulatory Affairs Associate
E-mail: Erin.OReilly@duke.edu
Phone: 919.668.4635

Dr. O’Reilly is responsible for performing a variety of services designed to support investigators and regulatory study coordinators in determining the requirements that apply to their research study activities. These services include regulatory education, regulatory consultation, and support for regulatory submissions.

Dr. O’Reilly received her undergraduate degree in molecular genetics from the State University of New York, Fredonia, and her PhD in molecular, cellular, and developmental biology from Indiana University. She completed an NIH- and DOD- supported postdoctoral fellowship here at Duke in the Department of Microbiology.

Dr. O’Reilly comes to the DTMI from the Duke’s Department of Medicine here at Duke where she has served as regulatory coordinator for the Phase I Oncology team. Her regulatory experience includes IRB submissions, informed consent preparation, and IND submissions to the Food and Drug Administration.

Dr. O’Reilly also brings 3 years of prior experience from the pharmaceutical industry from positions involving diagnostics, manufacturing technologies, validation sciences, and quality control/assurance. She has held positions with bioMerieux (Senior Process Engineer and Quality Control Scientist) and PharmaSys (Senior Scientist). These positions have given her experience with GLP and, GMP, as well as her six-sigma green belt. She has also held numerous adjunct teaching positions at Indiana University, Kaplan Test Prep, and Durham Technical Community College.

Jelena Petrovic Berglund, PhD, RAC
Regulatory Affairs Associate
E-mail: jelena.petrovic@duke.edu
Phone: 919.668.4639

Dr. Berglund is responsible for providing guidance and support to investigators and regulatory study coordinators in determining requirements and meeting obligations that apply to investigator research study activities. Additional responsibilities include regulatory education and consultation, and support for regulatory submission.

Dr. Berglund received her undergraduate degree in molecular biology and physiology from the University of Belgrade, Serbia. She conducted her graduate research studies in at the Pasteur Institute, Paris, and also at the Karolinska Institute in Stockholm, Sweden, where she received her PhD in immunology for her studies in autoimmune mechanisms associated with type 1 diabetes. She held the position of postdoctoral fellow at the Karolinska Institute, and conducted a second postdoctoral fellowship here at Duke University, in the department of cell biology, focusing on mechanisms related to aging and type 2 diabetes.

Dr. Berglund brings a broad scientific experience in cell biology, immunology, microbiology, and molecular biology.  As a regulatory affairs associate, she has completed various Investigational New Drug (IND) applications, prepared annual reports and briefing documents, and participated in pre-IND meetings with the FDA.  She provides guidance and support to Duke sponsor-investigators in different aspects of regulatory affairs including IND/IDE submission and maintenance. Dr. Berglund holds the Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professional Society.

Judith M. Kramer, MD, MS
Regulatory Consultant

Dr. Kramer is trained in clinical pharmacy (BS, MS) and is board certified in general internal medicine, having practiced internal medicine in the community for 5 years. For the past 21 years, she has been involved in clinical research. She worked for 10 years at Burroughs Wellcome Co. where she was Vice-President and Director of U.S. Clinical Research. In that capacity, she oversaw 220 employees and was responsible for the scientific administration of antiviral, oncology, neurology/psychiatry, cardiovascular, and pulmonary/critical care clinical research. During that time she supervised the preparation of 7 full original new drug applications (NDAs) and 14 INDs.

From 1997 to 2006 Dr. Kramer was Chief Medical Officer at DCRI and in that role provided guidance and consultation on the formation of the regulatory affairs and quality assurance functions at DCRI.

Dr. Kramer is currently the Executive Director of a public–private partnership, the Clinical Trials Transformation Initiative (CTTI). She oversees all activities and operations of the partnership under the direction of the Chair and Co-Chair, 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. The goal of CTTI is to improve and modernize the operational performance of the clinical research enterprise by convening experts in the field and undertaking projects to identify existing issues related to current practice, design models for improvement, test the new procedures and compare them to previously existing systems, and develop recommendations to inform policy makers.

Dr. Kramer’s office is located in 7024 North Pavilion. She can be reached at 919-668-8501 (office). Her email address is Judith.Kramer@duke.edu.

Lawrence H. ("Doc") Muhlbaier, PhD
Regulatory Consultant

Dr. Muhlbaier is available to consult with faculty who are participating in research projects.

Faculty may consider contacting Dr. Muhlbaier to discuss topics such as the following:

• Consultation on maintaining privacy and confidentiality in research, particularly as it relates to HIPAA and the Common Rule.
• Consultation on health services research and privacy regulations when there is no consent or authorization
• Consultation on disclosures and making NIH study data available for public use
• Consultation on Community Based Research

Dr. Muhlbaier is trained in biostatistics and has a PhD from UNC. For the past 21 years, he has been involved in clinical research. He has worked for 35 years at Duke, in positions ranging from Computer Programmer to Managing Director of the Duke Databank for Cardiovascular Diseases and is currently an Assistant Professor of Biostatistics.

Dr. Muhlbaier is part of the registry research team in the DCRI and the project statistician for the African American Health Improvement Partnership (an NIH grant for Community Based Research). Dr. Muhlbaier is the Privacy Director for the DCRI and the (Interim) Security Director for the Duke University School of Medicine. He is a member of the DUHS IRB.

Dr. Muhlbaier’s office is located in 7065 North Pavilion. He can be reached at 919-668-8774 (office). His email address is lawrence.muhlbaier@duke.edu.