As President of Theradex for over 20 years, Ms. Valnoski has led Theradex operations including full service trial support throughout the US, EU and Asia. Ms. Valnoski oversees regulatory affairs in the US collaborating with Theradex's lead clinical scientists and EU regulatory experts to provide clients global development strategies for oncology drug products ranging from standard cytotoxic approaches to targeted combinations. She works closely with the diverse team of experts within Theradex to support the ongoing efforts to increase knowledge and the technical tools necessary to ensure the successful execution of your clinical trial. She facilitates communication between the clinical trial management staff and systems developers to ensure that clients have both the knowledge and the tools available to manage all phases of oncology trials across regions. Ms. Valnoski draws upon extensive experience interacting with clients and the regulatory authorities in the development to help clients navigate through the changing regulatory environment driven by the evolution of personalized treatment approaches.
Ms. Valnoski works with the company senior leadership to support collaborations that provide clients with combined benefit of long term clinical development and project execution experience.
At Theradex, Dr. Anderson acts as the medical and safety monitor for commercial phase I, II and III trials. He supervises the Clinical Operations teams and helps sponsors devise strategies for new agent evaluation and protocol development. Additionally, Dr. Anderson supervises Theradex's Clinical Trial Monitoring Service team that reviews and audits early phase studies conducted by the National Cancer Institute. In the CTMS role, Dr. Anderson interacts with staff at the NCI Clinical Trials Monitoring Branch and Cancer Therapy Evaluation Program.
Dr. Anderson joined Theradex in 2007, after serving as a Senior Investigator at the Clinical Investigations Branch of the NCI Cancer Therapy Evaluation Program for eight years. While at NCI he worked closely with extramural NCI-supported investigators in the design, conduct and oversight of phase I, II and III cancer clinical trials conducted by the NCI Cooperative Groups. He served on numerous Data Safety Monitoring Boards for national cancer trials and was a leader in the development of the NCI-supported Pediatric Central IRB. Dr. Anderson was also an assistant professor and clinical attending in the Division of Pediatric Hematology, Oncology and Stem Cell Transplant at the Lombardi Cancer Center of Georgetown University for five years prior to joining the NCI. His experience with clinical patient care and the design and implementation of large, multi-institutional cancer treatment studies has provided Dr. Anderson with significant exposure to the scientific, regulatory and clinical aspects of contemporary cancer clinical trial conduct. Dr. Anderson received a Bachelor of Science in Biology from Lehigh University, a Ph.D. in Immunology from Duke University Medical Center and his medical degree from the University of Virginia. He trained in pediatric medicine at Northwestern University and completed a fellowship in Pediatric Hematology/Oncology and HIV research at the National Cancer Institute Pediatric Branch.
Dr. Ungerleider provides expert advice in the design and conduct of phase I, phase 2, and large-scale pivotal oncology clinical trials, and participates in developing the research plans for pilot and laboratory-translational studies. He provides scientific leadership and medical guidance to clinical operations personnel at Theradex. Prior to joining Theradex in 2001, Dr. Ungerleider had been Chief of the Clinical Investigations Branch at the NCI for over a decade in which role he was responsible for the Clinical Trials Cooperative Group Program. His career in the U.S. Public Health Service spanned twenty-seven years, the last twenty-five of which were spent at the NCI. Dr. Ungerleider's involvement in policy development to improve the conduct of oncology clinical trials provided him with extensive exposure to the scientific, regulatory, and industrial communities and familiarized him with the different interests of each.
Dr. Ungerleider received a Bachelor of Arts in Biology from the State University of New York at Binghamton's Harpur College, and his medical degree from New York University. He trained in pediatric medicine at the Albert Einstien College of Medicine and at Stanford University, and underwent fellowship training in Pediatric Hematology/Oncology at Stanford and the National Cancer Institute Pediatric Branch. He is a Diplomate of the American Board of Pediatrics and the Sub-Board of Pediatric Hematology-Oncology.
Sean Hannan joined Theradex (Europe) Ltd. as Managing Director in September 2014. He oversees all aspects of the European operations, having previously worked successfully at a senior level in a number of commercial businesses. He has extensive international experience, including over a decade working in the Asian market.
His focus at Theradex is on supporting the clinical professionals who deliver our services, using his strategic and business planning skills to identify and pursue business appropriate strategies.
With a extensive background in general management, experience with start-up and mergers, he has a strong implementation focus which fits well with the disciplines of our business.
He has a strong customer focus and is using his business development experience to ensure we provide excellent service at every level.
As Director, Clinical and Regulatory Operations, Marie Moores oversees the Clinical and Regulatory Operations of Theradex (Europe), drawing on her experience in the industry of over 19 years. She manages and provides strategic direction to a seasoned group of oncology project managers, regulatory affairs and drug safety professionals. She has overall responsibility for ensuring overall clinical program timelines and deliverables are met across our clients' trials portfolios. She provides European regulatory strategies to our clients and is regularly involved in organizing and attending scientific advice meetings with national Competent Authorities and the EMA across a range of issues. She is actively involved in the acquisition of new business and is responsible for contract administration with vendors who provide complimentary services for our clients' oncology studies.
Dr. Austin Smith, Medical Director, is trained in medical oncology and is currently undertaking pharmaceutical medicine training. A graduate of the Royal College of Surgeons in Ireland, Dr. Smith has over fourteen years of experience in the clinical practice of hematology and oncology and eight years within clinical development in the pharmaceutical industry. Dr. Smith provides medical expertise and strategic input into the clinical development programs of our European clients. He also represents clients at national Competent Authorities and the European Medicines Agency for both scientific and regulatory advice meetings. Dr. Smith provides clinical training, support and expertise to project teams working on hematology/oncology/immunology studies primarily in the EU. Dr. Smith also plays a pivotal role in study feasibility assessments and selection of sites and investigators for upcoming studies. Dr. Smith regularly attends and presents at scientific and industry meetings. Dr. Smith also explores and maintains dialogue with pharma and biotechs to establish working collaborations and opportunities for new and innovative development of cancer therapeutics.
Dr. Durivage oversees and manages all aspects of Theradex pharmacovigilance and regulatory affairs operations. Dr. Durivage provides direct oversight of Theradex pharmacovigilance and regulatory affairs staff, implementation and operation of the Oracle Argus drug safety database and development of pharmacovigilance and regulatory services training curriculum. Dr. Durivage also leads and manages all of Theradex's research integrity projects, which have included conducting and reporting of "for-cause" or requested clinical oncology research compliance audits, providing advice on hospital and academic center clinical oncology research operations, assisting cancer centers prepare for NCI cooperative group audits and leading the conduct and reporting of National Cancer Institute-requested study monitoring, auditing and response verification projects. In his 12 years of experience at Theradex, Dr. Durivage has also led quality assurance audits at most of the NCI-designated cancer centers, served as project manager for two industry-sponsored pivotal trials and several phase I first-in-man clinical trials.
In addition to his experience at Theradex, Dr. Durivage brings an additional 11 years of experience as the director of clinical trial operations at two NCI-designated cancer centers and 12 years of experience as an oncology pharmacist. Dr. Durivage managed many components of institutional oncology clinical research including, but not limited to, determining feasibility of research projects, allocation of resources, budgeting resource needs with pharmaceutical sponsors, and establishing performance benchmarks to measure the impact of improvement initiatives. Dr. Durivage has also served as a member of cancer center scientific review committees, medical school institutional review board and chairman of a cancer center data and safety monitoring committee.
Pat Mancini joined Theradex in December 2014 to serve as director of finance. In this role, he provides management, control and administration of fiscal and business operations. Key responsibilities include partnering with operational and administrative groups to define processes resulting in improved efficiencies, consistent monitoring and measuring of project profitability and production of action oriented financial and operational analysis.
Pat came to Theradex with over a decade of CRO experience. In his most recent position, he was Controller/Director of Finance for North America for one of the world's largest privately held CROs. Previously, Pat demonstrated progressive experience helping small and large private organizations achieve financial and operational goals including acquisition. He earned a bachelor's degree in Economics from Moravian College and a M.B.A. from Centenary College.