Maria Marton is a Civil Engineer and has more than 30 years of experience in the road transport area and its steering mechanisms. She has strategic expertise in Tunnel Safety and ITS, Intelligent Transport Systems and long regulations expertise of tunnel design and ITS performance.
She has been working 16 years at the Swedish National Road administration in different positions, 10 years as consultant and head of an office in the field of transport related analyses. Since 2011 she works as an expert in the Swedish Transport Agency, at the Road and Rail department, a public authority, responsible for all transport related regulation for all modes of transport.
She is currently member of the PIARC Technical Committee on Road Tunnel Operations. Since 2011 she is Swedish Member State representative in the EU Commission, Tunnel Safety Committee and in the EU ITS Committee and participates in the regulation activities in the fields.
Tara Burt has more than 15 years of experience in clinical research including clinical study design, project management, new product development, and clinical evidence strategy in both the medical device and pharmaceutical sectors. She is currently responsible for overall clinical study operations and execution, and strategy for Procyrion.
Tara holds a B.A. from the University of Rochester and has held certifications in both clinical research and regulatory affairs.
Adina Pelusio brings more than 15 years of experience in drug development, most recently as the Vice President, Clinical Operations at SillaJen Biotherapeutics (formerly Jennerex, Inc), where she spent a decade advancing oncolytic viruses in clinical trials. In addition to overseeing the Clinical Operations department at SillaJen, she managed and pioneered the medical educator role to expand hospital personnel comfort and knowledge globally with working on these types of agents. Prior to Jennerex, Ms. Pelusio served as a SWAT Senior Clinical Research Associate at PPD, a large, global CRO, where she was tasked with study rescue and served on a technology committee assigned with developing training for CRAs and project teams on new technologies within the field.
As we discussed, a topic for the event is clinical trials are becoming increasingly complex and require an increase in the scope of site education. Strategies for engaging and ensuring protocol compliance amongst multiple stakeholders on site. Cancer therapies are increasing utilizing complex biologics such as live replicating viruses or bacteria and radioactive materials, but clinical sites remain uneasy or ill-suited to with the preparation, administration, or handling of these products and/or the patients receiving them. In these instances, designing and outsourcing education to clinical sites may a strategic plan between the Sponsor and the CRO, as well as specialized educators above and beyond the classic CRA model to increase patient enrollment and site interest in this and future studies
– Identifying stakeholders
– Designing a comprehensive education plan
– When and what activities can be outsourced, but which activities should remain in-house
– Benefits and budget impacts
Born in Foggia on July 23rd, 1960, he graduated at the University of Naples in Civil Engineering.
From 1987 he worked for an important private company operating in the public works sector, first as construction site director and supervisor for important infrastructure projects; later he became the director of the Sales Dept., working on infrastructure projects and project financing.
Starting in 2003 and until March of 2010, he directed the organizational unit ‘Procurement and General Services’ of ITALFERR S.p.A., the engineering company of Gruppo Ferrovie dello Stato S.p.A.
In 2008 he became a member of an expert consulting committee on tender procedures, for the Brenner Base Tunnel.
Since May of 2010 he has been the CEO for Italy of the European Public Limited Company “Galleria di Base del Brennero – Brenner Basistunnel BBT SE.
Catherine has over 20 years’ experience in clinical research with a focus on complex and early phase oncology trials, including oncolytic viruses. Prior to joining the newly founded Turnstone Biologics, in 2016, Catherine acquired invaluable experience on the site side of clinical research, including program management and serving as a reviewer for an oncology based ethics board for 5 years. In her new role as Clinical Site Education Manager at Turnstone Biologics, Catherine draws upon all of this experience to provide a unique level of support to sites.
Dr. Sofia de Achaval Wied is an epidemiologist with over 10 years of experience in clinical research. She began her career in Houston in psychosocial research and transitioned into research administration roles at leading academic research institutions in the Texas Medical Center. This year she expanded her clinical research and drug development experience by joining Tvardi Therapeutics, where she serves as the Executive Director of Research and Development.
Richie Cahill joined Tara Mines in 1982 and worked as a craftsman in the underground mobile equipment department. During this time he was a voluntary member of the mine rescue and underground ambulance services.
In 2008 Richie was elected by the Boliden Tara Mines workforce to the position of Full Time Safety Representative.
In 2011 Richie was appointed as a Health & Safety Officer at Boliden Tara Mines and is currently the trainer and mine rescue officer for the Boliden Tara Mine Rescue Organisation.
Janel joined Biogen’s Clinical Drug Supply group as an IRT Specialist in August 2017. As an IRT Specialist Janel worked on approximately 30 studies. As of July 2019, Janel took a new role as a clinical supply manager within Clinical Drug Supply, shifting her focus to drug supply forecasting and distribution. In this new role, Janel manages 6 clinical trials under 4 clinical assets, acting as an interface between clinical operations and the supply chain team. In addition to her Supply Manager responsibilities, Janel supports Biogen’s Clinical Drug Supply group by leading the inspection readiness team. Prior to Biogen Janel worked as a Project Manager at PAREXEL.
Samuel Bäckman started working for Boliden at the smelter Rönnskärsverket in 2010 after studying fire protection engineering at Luleå University of Technology. The first year was spent working on Seveso-related chemical risk analysis before switching organization to Boliden Mines.
Since 2011 he’s been working as a development engineer at Boliden Mines Health & Safety department with focus on fire safety and emergency preparedness both for underground operations as well as open pit mines. A recent area of interest with many challenges ahead is fire safety related to automation and battery vehicles.
During this period, he’s also been part of the fire safety group connected to the Swedish industry association of mines and mineral producers, Svemin.
