(From the April 2015 issue of Research Now)
In an effort to increase customer service and consolidate the submissions to the U.S. Food and Drug Administration, all investigator-initiated Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications previously supported by Christine Hapanowicz in Clinical Research Services (CRS) will now be supported and managed by Drug Device and Development Services (DDDS), directed by Christopher Shilling, MS.
The DDDS was formed two years ago to assist pre-clinical activities/projects leading to an IND/IDE application. The DDDS services have been now expanded to include support for IND’s of repurposed products, expanded access, emergency IND’s, among others. Aligning the services under DDDS provides a streamlined approach to all IND/IDE services. Chris has been with NCH for 10 years and previously worked in the Center for Gene Therapy overseeing a number of INDs approved for first-in-human trials. The DDDS recently hired a new Program Coordinator, Sue Marting, MBA, who has extensive regulatory experience in the pharmaceutical industry. Like the CRS, the DDDS is also funded as a component of the Center for Clinical and Translational Services as part of the joint NIH CTSA award to NCH and OSU.
If you currently have an active IND or IDE regulated trial, the DDDS now maintains these records and will be contacting you to schedule a meeting to review your projects and understand how best to better support your needs. If you have an idea or trial that requires an IND or IDE application, you are encouraged to contact the DDDS for free support and guidance on how to obtain and maintain and IND or IDE. You can find more information regarding the DDDS and its services at http://www.nationwidechildrens.org/ddd or by contacting the staff below.
Christopher J. Shilling, MS
Director, Drug and Device Development Services
Office: (614) 722-6960
Sue K. Marting, MBA
Program Coordinator, Drug and Device Development Services
Office: (614) 355-2693
Lattice Biotech, a new Columbus-based company, won the Big IDEAs for Health competition at The Ohio State University for leveraging a discovery which disrupts bacterial biofilms to create a more effective environment for antibiotics to eradicate chronic infections. The research comes from Lauren Bakaletz, PhD, director of the Center for Microbial Pathogenesis at The Research Institute at Nationwide Children's, and Steve Goodman, PhD, principal investigator in the center.
Vidu Garg, MD, director of Translational Research for The Heart Center and the Center for Cardiovascular and Pulmonary Research at The Research Institute, was recently elected to the Society of Pediatric Research Council. This is a major distinction in the field of pediatric research and reflects highly on the caliber of research in child health that Dr. Garg has conducted throughout his tenure at Nationwide Children's.
Nicole O'Brien, MD, physician in the Division of Critical Care and director of the Global Health Certificate Program at Nationwide Children's, is the recipient of a prestigious Fulbright Scholarship. The Fulbright Scholarhip will allow Dr. O'Brien to further her clinical research and international health endeavors by studying the epidemiology, treatment and outcomes of pediatric traumatic brain injury in the Democratic Republic of Congo in Africa.
Jacob Olson, MD, postdoctoral scientist in the department of General Surgery at The Research Institute, recently received the American College of Surgeons Resident Research Fellowship for his project entitled, "Probiotics and HB-EGF: A Novel Therapy for Necrotizing Enterocolitis." This work comes from a joint collaborative mentorship by Steve Goodman, PhD, principal investigator in the Center for Microbial Pathogenesis, and Gail Besner, MD, chief of Pediatric Surgery and principal investigator in the Center for Perinatal Research. The highly prestigious award is given to six of the most promising young surgical investigators in the United States.
Joe Powell has joined The Research Institute at Nationwide Children's in the role of research accounting manager. He most recently served as Director of Finance and Grants for Homeport, a non-profit real estate developer. His non-profit experience also includes the role of business manager for the Columbus Jewish Day School. Joe is a graduate of Babson College with dual majors in Entrepreneurial Studies and Information Systems Management. Joe also serves as the board treasurer for Yay Bikes, a local bicycle advocacy member organization.
At Nationwide Children's, Joe supervises the Senior Accountants and Accountants who are responsible for monitoring payroll, cost transfers, financial reporting to sponsors and other related accounting functions and financial compliance. He can be reached directly at Joe.Powell@NationwideChildrens.org or (614) 722-2664.