Regulatory Affairs Team

Audrey Perry
Regulatory Document Specialist

Email: audrey.perry@duke.edu
Phone: (919) 668-4623

Audrey Perry is the Regulatory Document Specialist in the Office of Regulatory Affairs and Quality (ORAQ) within the Duke University School of Medicine. She supports investigators, study teams, and the ORAQ staff/faculty in all aspects of regulatory technical document preparation, compilation, review, and submission to the Food and Drug Administration (FDA).  Audrey manages the office databases, all sponsor-investigator training, and compiles metrics and reports for all regulatory submissions.  Significantly, she maintains a database of regulatory applications within the institution and sends annual report reminders to study teams.  Audrey has worked at Duke for over 29 years and has spent most of her career supporting clinical research efforts. She has worked in regulatory since 2001 and has applied her advanced technical skills across the institution. Audrey has completed extensive coursework in nursing, participates in ongoing regulatory education, and holds a Technical Excellence Certification from Learning and Organization Development, all of which have contributed to her success in her specialized role.

 

Alysa Vereen, PharmD, RPh
Regulatory Affairs Scientist

Email: alysa.vereen@duke.edu
Phone: (919) 660-3788

Alysa Vereen, PharmD, RPh is a Regulatory Affairs Scientist in the Office of Regulatory Affairs and Quality (ORAQ) within the Duke University School of Medicine. In this role, Dr. Vereen is primarily responsible for providing support and guidance to investigators and regulatory study coordinators regarding the regulatory requirements relevant to their research study activities within the Pediatric Trials Network (PTN). Dr. Vereen is also involved in the implementation of educational initiatives within ORAQ and performs a number of extended services including regulatory education, regulatory consultation, and support for regulatory submissions.

Dr. Vereen completed her undergraduate studies and earned her PharmD from Hampton University. During her graduate training, she completed FDA’s experiential program where she had the opportunity to work within CDER Division of Drug Information. Prior to joining ORAQ, she worked as a pharmacist in both the hospital and community pharmacy settings and served as a National Executive Consultant for the Student National Pharmaceutical Association (SNPhA).

 

Daniel Tonkin, PhD, RAC
Senior Regulatory Affairs Scientist

Email: daniel.tonkin@duke.edu
Phone: (919) 681-2053

Daniel Tonkin, PhD, RAC is a Senior Regulatory Affairs Scientist in the Office of Regulatory Affairs and Quality (ORAQ) within the Duke University School of Medicine. In this role, Dr. Tonkin is responsible for providing support and guidance to investigators and regulatory study coordinators regarding the regulatory requirements relevant to their research study activities. His role is primarily focused on providing regulatory support to the Duke Human Vaccine Institute’s portfolio of clinical trials and GMP manufacturing.  Dr. Tonkin also performs a variety of extended services including regulatory education, regulatory consultation, and support for regulatory submissions.  In addition, Dr. Tonkin serves as an eCTD Publisher for ORAQ, with expertise in eCTD compliance, formatting, and submission.

Dr. Tonkin received his undergraduate degree from Duke University, and his PhD in Immunology from the University of Colorado. After his graduate studies, Dr. Tonkin worked as a staff scientist at Global Vaccines Inc. where he supported the preclinical development of a virus-based adjuvant. While at Global Vaccines, he was awarded a Ruth L. Kirschstein NRSA Postdoctoral Fellowship. Following his work at Global Vaccines Inc., he spent a year at the Preston Robert Tisch Brain Tumor Center at Duke University as a Regulatory Coordinator and Clinical Protocol Writer. Dr. Tonkin holds the Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professional Society.

 

David Jensen, PhD, RAC
Regulatory Affairs Scientist

Email: david.jensen@duke.edu
Phone: (919) 668-8914

David Jensen, Ph.D., RAC is a Regulatory Affairs Scientist in the office of Regulatory Affairs and Quality (ORAQ) within the Duke University School of Medicine. David uses his 15+ years of experience in US FDA-regulated medical product development to advise Duke Faculty and project teams, primarily at the Duke Clinical Research Institute (DCRI), on regulatory strategy, FDA meetings, regulatory submissions, project development, product manufacturing, and preclinical testing. He assists project teams with the development, coordination, and implementation of complex projects involving drugs, biologics, devices (including Software as a Medical Device), and dietary supplements. David is also involved in the implementation of operational initiatives within ORAQ (e.g. website, project database).

David is also a patent-holding cell & molecular biologist with broad experience in drug discovery and development and with significant scientific knowledge in a variety of therapeutic areas.

Prior to Duke, David held regulatory positions at a major CRO and at a biotechnology company (focused on nanotechnology) and he was a project leader for oncology, osteoarthritis, and virology programs at a major pharmaceutical company.

David has an undergraduate degree in Chemistry from California State University at Fullerton, a master’s degree in Medicinal Chemistry from Duquesne University, and a doctoral degree in Pharmacology from the University of Virginia. He also holds the US regulatory affairs certification (RAC) from the Regulatory Affairs Professional Society.

 

Jessica Chapman, PhD, RAC
Senior Regulatory Affairs Scientist

Email: jessica.chapman@duke.edu
Phone: (919) 668-7962

Jessica Chapman, PhD, RAC is a Senior Regulatory Affairs Scientist in the Office of Regulatory Affairs and Quality (ORAQ) within the Duke University School of Medicine. In this role, Dr. Chapman is responsible for providing support and guidance to investigators and regulatory study coordinators regarding the regulatory requirements relevant to their research study activities. Although her role is primarily focused on providing regulatory support to the Marcus Center for Cellular Cure’s portfolio of clinical trials and GMP manufacturing, Dr. Chapman also performs a variety of extended services including regulatory education, regulatory consultation, and support for regulatory submissions. Dr. Chapman is also involved in the implementation of operational initiatives within ORAQ.

Dr. Chapman received her undergraduate degree in biology from the University of Illinois, Champaign-Urbana. She conducted her graduate research at Wake Forest University, where she earned her PhD in Molecular Genetics and Genomics. Her research was focused on examining the role of adiposity loci recently identified in Europeans in multiple African American populations to elucidate the genetic differences between the two ethnicities. After her graduate studies, Dr. Chapman accepted a position with the Duke Translational Medicine Institute (DTMI) as a Quality Assurance Scientist. In this role, she spent two years providing quality and some regulatory support to the Carolinas Cord Blood Bank (CCBB) and the Marcus Center for Cellular Cures (formally, the Clinical and Translational Cellular Therapy Program). Dr. Chapman holds the Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professional Society.

 

Katherine Deland, PhD
Regulatory Affairs Scientist

Email: katherine.deland@duke.edu
Phone: (919) 613-1196

 Katherine Deland, PhD is a Regulatory Affairs Scientist in the Office of Regulatory Affairs and Quality (ORAQ) within the Duke University School of Medicine. In this role, Dr. Deland is responsible for providing support and guidance to investigators and regulatory study coordinators regarding the regulatory requirements relevant to their research study activities. In addition to her role providing regulatory support to the Pediatric Trials Network (PTN), Dr. Deland performs a variety of extended services including regulatory education, regulatory consultation, and support for regulatory submissions. Dr. Deland is also involved in the implementation of collaborative initiatives within ORAQ.

Dr. Deland received her undergraduate degree in biochemistry from Southern Methodist University. She conducted her graduate research at Duke University, where she earned her PhD in Molecular Cancer Biology. Her research focused on utilizing genetically engineered mouse models to study radiation biology. After her graduate studies, Dr. Deland worked as a postdoctoral associate in the Radiation Oncology Department at Duke University, where she developed a therapeutic strategy to improve the efficacy of radiation in pediatric brainstem gliomas and other adult cancers.

 

Kylie Opel, JD
Regulatory Affairs Scientist

Email: kylie.opel@duke.edu
Phone: (919) 668-0830

Kylie Opel, JD, is a Regulatory Affairs Scientist in the Office of Regulatory Affairs and Quality (ORAQ) within the Duke University School of Medicine.  In this role, Kylie is responsible for providing support and guidance to investigators and clinical research study teams regarding the regulatory requirements relevant to their research study activities within the Duke Clinical Research Institute (DCRI).  Kylie primarily serves as a lead regulatory scientist supporting the Pediatric Trials Network, an NICHD funded network that focuses on improving pediatric health, and pediatric drug labeling.  Kylie is also involved in education-related initiatives within ORAQ.  Kylie is interested in international research and collaborations, as well as the impacts of international privacy laws and regulations on clinical research.

Kylie received her undergraduate degrees in criminal justice and political science with a minor in international affairs from the University of North Carolina at Wilmington, and her Juris Doctor from Campbell University.

 

Rachel Johnson, PhD, RAC
Senior Regulatory Affairs Scientist

Email: rachel.h.johnson@duke.edu
Phone: (919) 668-4635

Rachel Johnson, PhD, RAC is a Senior Regulatory Affairs Scientist in the Office of Regulatory Affairs and Quality (ORAQ) within the Duke University School of Medicine.  In this role, Dr. Johnson is responsible for providing support and guidance to investigators and regulatory study coordinators regarding the regulatory requirements relevant to their research study activities. She performs a variety of services including regulatory education, regulatory consultation, and support for regulatory submissions. Dr. Johnson is also involved in the implementation of operational initiatives within ORAQ.

Dr. Johnson received her undergraduate degree in biochemistry from Clemson University.  She conducted her graduate research at Duke University, where she earned her PhD in Molecular Cancer Biology.    During her graduate training, Dr. Johnson was the recipient of a James B. Duke Fellowship, a Ruth L. Kirschstein-NRSA Predoctoral Fellowship, and a Robert J. Fitzgerald Scholar Award.  After her graduate studies, Dr. Johnson spent two years as a Regulatory Coordinator at the Preston Robert Tisch Brain Tumor Center at Duke University.  Dr. Johnson holds the Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professional Society.

 

Rose Beci
Regulatory Affairs Scientist

Email: rose.beci@duke.edu
Phone: (919) 668-8632

Rose Beci is a Regulatory Affairs Scientist in the office of Regulatory Affairs and Quality within the Duke University School of Medicine.  Rose serves as the regulatory lead for the Pediatric Trials Network, which was established by the Duke Clinical Research Institute (DCRI). Rose monitors and evaluates network activities, detects trends and opportunities, formulates and executes regulatory strategies and derives regulatory pathways essential to the successful management and outcome of clinical projects, including updates to product labels.  Rose has extensive experience arranging formal meetings with FDA, she supports a broad range of study designs, therapeutic areas, and patient populations, working closely with CRO, government and industry partners.  Rose is also involved in the implementation of collaborative initiatives within ORAQ. 

During Rose’s tenure at Duke she has worked as a Regulatory Associate, Sr., with  DCRI, a Regulatory Coordinator with the team of Duke GI oncologists, and a Research Coordinator with the Cancer and Leukemia Group B’s Statistical Center.

 

Stephanie PierceStephanie Fraser, PhD, RAC
Senior Regulatory Affairs Scientist

Email: stephanie.fraser@duke.edu
Phone: (919) 668-8685

Stephanie Fraser, PhD, RAC is a Senior Regulatory Affairs Scientist in the Office of Regulatory Affairs and Quality (ORAQ) within the Duke University School of Medicine. In this role, Dr. Fraser provides FDA regulatory support and guidance to investigators and study teams throughout the Duke clinical research community, with a primary focus of providing regulatory support to the Duke Human Vaccine Institute. She performs a variety of services including regulatory education, regulatory consultation, and support for regulatory submissions. In addition, Dr. Fraser serves as an eCTD Publisher for ORAQ, with expertise in eCTD compliance, formatting, and submission.

Dr. Fraser received her undergraduate degree in biology from Central Michigan University while also completing the McNair Scholar Program. She conducted her graduate research at the University of Iowa, where she earned her PhD in Molecular Physiology and Biophysics. Her research focused on the role and regulation of the SK3 Channel in the myometrium throughout pregnancy. During her graduate training, Dr. Fraser was the recipient of an American Heart Association Predoctoral Fellowship. Dr. Fraser then accepted a position as a Postdoctoral Research Assistant at the University of North Carolina in the Cell and Molecular Physiology Dept. and was awarded the NIH Contraception and Infertility LPR through the NICHD.  Dr. Fraser then went on to complete her postdoctoral training at Duke University studying the role of Adrenomedullin in cigarette smoke-mediated protection from preeclampsia. Dr. Fraser holds the Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professional Society.