Kevin Bosse, PhD, RAC
Kevin Bosse joined Drug and Device Development Services in 2017 focusing on cellular therapy. As a RAC-certified regulatory professional, he advises the development and regulatory strategy of novel drugs, biologics and devices under the Cellular Therapy and Cancer Immunology Program, as well as with other researchers both here and at The Ohio State University. With extensive project management, scientific and communications experience, Kevin assists through the full spectrum of regulatory submissions from preliminary FDA meeting requests to IND/IDE filings and CMS coverage.
Prior to joining DDDS, Kevin was assistant director of communications for Nationwide Children’s Hospital Foundation, helping to raise critical funds for the advancement of research and clinical programs at Nationwide Children’s. He holds a bachelor’s of science degree in biology from Xavier University and a doctoral degree in molecular, cellular and developmental biology from The Ohio State University. Kevin completed a postdoctoral research fellowship at Nationwide Children’s Center for Cardiovascular Research.
Sue Marting, MBA
Sue Marting brings over 25 years’ experience in regulatory affairs in the pharmaceutical, biopharmaceutical, device, food and personal care industries to Nationwide Children’s Hospital. She manages a wide ranging portfolio of regulatory filings for drugs and devices being developed for off-label or expanded access use at Nationwide Children’s Hospital and The Ohio State University.
Sue holds an associate of science degree in medical laboratory science from Mount St. Joseph University and is certified by the American Society of Clinical Pathology, a bachelor’s of science degree in business administration from Franklin University and a master’s of science degree in business administration with a concentration in finance and tax from Xavier University, and is Lean Six Sigma Black Belt Certified.
Rachel Manthe-Gross, PhD
Rachel Manthe-Gross joined Drug and Device Development Services as a regulatory specialist in 2018. In her role, Rachel provides regulatory support and guidance for gene therapy products during preclinical development through initiation and conduct of early phase clinical trials. She also provides CMC regulatory consulting and writing services for gene therapy products manufactured for external clients by the Clinical Manufacturing Facility at Nationwide Children’s Hospital.
Prior to joining the team, Rachel was a postdoctoral scientist in the Center for Gene Therapy at Nationwide Children’s Hospital. She holds a bachelor’s of science degree in biomedical engineering from The University of Akron and a doctoral degree in bioengineering from the University of Maryland, College Park.
Nil Patel, a Regulatory Specialist, is one of the newest additions to our team. Prior to joining DDDS, Nil has held several internship positions with pharmaceutical industries in regulatory affairs, quality assurance and quality control. In addition, Nil was previously a research assistant in the Cardiovascular Stem Cell Therapeutics Laboratory at the Davis Heart & Lung Research Institute at The Ohio State University. His research focused on investigating the therapeutic potential of cardiac progenitor cells (CPCs) and their derived exosomes in response to hypoxic microenvironments.
Nil holds a bachelor’s of science degree with research distinction in neuroscience from The Ohio State University. He is currently a student in the Master of Clinical Research program, specializing in regulatory affairs for drugs, biologics and medical devices, at The Ohio State University.
Administrative Support III
Cristina joined the Abigail Wexner Research Institute at Nationwide Children's Hospital in May 2019. She supports both Drug and Device Development Services and the Office for Technology Commercialization. Cristina has 15 years of experience in administration, sales and customer service.