Joint Site and Sponsor Perspectives on Innovative Solutions Addressing Sites Challenges

Kristin Herman is the Executive Director of the Clinical Trials Office (CTO) at the Sidney Kimmel Comprehensive Cancer Center at Jefferson. Herman is responsible for the integration and standardization of all operations, policies, regulations, and finances of the CTO and oversight of all research support personnel. Herman serves a key role in expanding SKCCC clinical trial availability across the Delaware Valley. Prior to joining Jefferson in 2022, Herman spent 5 years at Tallahassee Memorial HealthCare (TMH) in Florida as Director of the Office of Research. There she oversaw the TMH IRB, and clinical research administration across all disease areas. She worked to establish an academic research collaboration with Florida State University, culminating in state funding and approval to develop an FSU academic health center on the TMH campus. She also collaborated closely with the University of Florida to advance population and rural health research via the OneFlorida Clinical Research Consortium where she served on the Executive Committee. Previously, Herman spent 14 years at Memorial Sloan Kettering Cancer Center, working as a clinical research coordinator, and then in operations and project management roles. There she gained experience in clinical trial budget and contract negotiation, research privacy and compliance regulations, and other facets of clinical trials administration. She contributed to the launch of the MSK Cancer Alliance initiative in 2013. Herman has an MBA from FSU, and a BA from the University of Rochester.

Eileen Hughes is a Senior Manager in Site Partnerships at CSL Behring, a registered nurse who has worked in research at a clinical site, as a CRA, at a CRO as well as the sponsor. With her experience as a study coordinator and clinical trial educator, she is intimately familiar with challenges faced by our site partners in clinical research. As a site partnership representative, she is working to bring innovative ideas and solutions to facilitate a more streamlined process for study start-up.

Lisa Kiehne is the Senior Vice President for Clinical Operations at The START Center for Cancer Research. By way of background, Ms Kiehne holds a Masters in Healthcare Administration from Trinity University, with a 16 year career in cancer service line leadership and research operations. Prior to her role at START, Ms Kiehne worked for Houston Methodist and HCA/ Sarah Cannon, leading the cancer service line in strategy, operations, and program-building for comprehensive cancer programs including early-phase research programs, preclinical research programs, and hematological malignancy research programs. Ms Kiehne has led the development and implementation of essential systems, such as an ERP system in the Research Institute and an EMR and CTMS system in the Cancer Center. Additionally, Ms Kiehne spearheaded a significant recruitment and development plan to deepen research infrastructure and expand clinical capabilities towards NCI designation. She has a proven track record of fostering growth and global partnerships, representing the organization by opening new START sites and building collaborative relationships with pharmaceutical and biotech companies.

Dr Christopher McNair is an Associate Professor in the Department of Medical Oncology and serves as the Director of Cancer Informatics and the Enterprise Associate Director for Data Science at the Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University. Dr McNair provides informatics leadership and oversees the development of technologies and applications for use by the SKCCC research population. These include data capture software, bio-specimen collection tools, research data warehouse and associated applications, catchment area tools, and those to support genomic research. Dr McNair also serves as the co-director for the SKCCC’s precision medicine program which aims to standardize molecular testing across the center, decrease disparities in testing, and increase genomic-driven research studies and state of the art clinical trials at SKCCC.

Currently, as the Head of Patient & Site Engagement Capabilities, Tracey leads a team that is responsible for the development the global solutions and processes supporting all aspects patient and site engagement including the use of decentralized technologies in trials. She started her career in consulting working for Coopers & Lybrand / PricewaterhouseCoopers on projects across a broad cross-section of pharmaceutical clients. Prior to her current role at Boehringer she has worked across Medicine leading the business activities for global systems implementations, in IT heading support for Regulatory Submissions Management, and in Biostatistics & Data Science as the Digital Trials team lead. Her career to date has taken her from the UK to US, Germany and back to the US. Typically, she is responsible for strategy development, leadership, project management, process harmonization, innovation, and organizational change management. She has a Bachelor of Science (Hons) in Technology & Business Studies (Production Engineering and Economics) from Strathclyde University, and an MBA Information Management from Robert Gordon University (Scotland, UK). She is Project Management Professional (PMP) and Certified Scrum Master (CSM). 

Dennis Salotti is an accomplished executive with two decades of experience in clinical research. Currently serving as the Executive Director & Head of Clinical Outsourcing & Innovation at Jazz Pharmaceuticals, he oversees strategic initiatives within sourcing that foster innovation in clinical trial management. His leadership has been instrumental in driving efficiency and quality in outsourcing practices, ensuring external relationships and solutions drive value for the business. Prior to his role at Jazz Pharmaceuticals, Mr Salotti held several senior positions at notable organizations including serving as Chief Operating Officer for The Avoca Group, where he spearheaded operational strategies, contributing to the company's growth and success. His tenure saw significant advancements in various areas of quality and compliance, including innovative approaches to vendor qualification processes, and the creation of the Diligent Pharma platform. Mr Salotti’s commitment to advancing clinical research extends beyond his corporate roles. He serves as Adjunct Faculty at Drexel University College of Medicine, where he shares his expertise with future industry professionals. With a Master of Business Administration from NJIT and a Master of Science in Clinical Research Organization Management from Drexel University, Mr Salotti combines academic rigor with practical experience to drive innovation and excellence in the pharmaceutical industry. Throughout his career, Mr Salotti has demonstrated exceptional leadership and strategic vision, earning him recognition such as Drexel University's 40 under 40 award and the Professor's Excellence Award from New Jersey Institute of Technology