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.
Derrick L. Kearney – Supervisory Import Specialist – Pharmaceuticals, Health and Chemicals Center of Excellence and Expertise, Partnership Division, U.S. Customs and Border Protection (CBP). Mr. Kearney joined CBP in 2007, and is currently assigned to the Port of Philadelphia, PA. Previous positions within CBP include Import Specialist and Trade Operations Program Manager at the Port of JFK, New York. Prior to joining CBP, Mr. Kearney worked for the New York City Office of the Comptroller. Mr. Kearney is an Air Force veteran.
Educational accomplishments include numerous classes, seminars and workshops as a member of CBP, and a Master’s of Public Administration (MPA) Degree from Baruch College, City University of New York.
Stephen started his working career in the construction industry, undertaking different roles in carpentry, welding and engineering, before gravitating to a role in Health & Safety.
Having played an integral part on major projects, such as the Channel Tunnel Rail Link, M25 widening and Crossrail projects, Stephen studied in different Health and Safety qualifications to become a chartered Health & Safety professional with the Institute of Occupational Safety & Health.
Now employed by Eurotunnel as the Head of Health & Safety UK, has started to develop an understanding of the complexities of working for a bi-national company and varying approaches to legislation in both parent countries
Rana is Head of Profession – Highways and Traffic for TfL Engineering. TfL is London’s strategic transport authority responsible for all transport modes and their wide range of assets. Rana is responsible for Engineers supporting London’s strategic 580 km long road network including its vital infrastructure, as well as all of London’s traffic signals.
Rana is a civil engineer from Aachen University. In previous roles she has delivered Intelligent Transport Systems projects across Europe. As Chief Engineer Traffic Systems her team developed and maintained London’s traffic management and control systems and as a highlight she led the traffic systems readiness for the 2012 Games. More recently Rana oversaw the design of cycling and transformational schemes for TfL, and the Engineering support to asset operations.
