Susan Marlin is the President and CEO of Clinical Trials Ontario (CTO), an organization established by the Province of Ontario in 2012 to make Ontario a preferred location for global clinical trials while maintaining the highest ethical standards. Prior to joining CTO served as the Associate Vice-Principal at Queen’s University. Susan worked with the Canadian Cancer Trials Group for many years coordinating cancer clinical trials and leading the development and implementation of the Ethics, Regulatory, and International Office.
Susan has actively engaged in research ethics for many years. She served as President of the Canadian Association of Research Ethics Boards, as a member of the Canadian Institutes of Health Research (CIHR) Research Integrity Committee, the Ontario Cancer Research Ethics Board and the Tri-Agency Panel on the Responsible Conduct of Research. Susan is on the Board of Directors and Executive Committee of Life Sciences Ontario and the Management Team for the Ontario SPOR (Strategy for Patient-Oriented Research) Support Unit. She is an Adjunct Lecturer at Queen’s University in Kingston, Ontario and is the nominated principal investigator on the CHEER Project, a Canadian Institutes of Health Research funded project to streamline research ethics review for child health research across Canada.
Susan was born and raised in Halifax, Nova Scotia. She holds a BSc (Hons) from Dalhousie University and an MSc in Community Health and Epidemiology from Queen’s University. She was awarded the Queen’s Elizabeth II Diamond Jubilee medal in 2012 in recognition of her work in support of military and veteran health research.
As President and CEO, James lead the development team of Asymmetrex® LLC. Asymmetrex® is a for-profit limited liability company with a mission of developing innovative tissue stem cell biotechnologies for applications in cellular medicine and drug development.
Asymmetrex’s lead tissue stem cell biotechnology is the first-in-kind method for specific and accurate counting of tissue stem cells. Asymmetrex’s TORTOISE Test^TM kinetic stem cell (KSC) counting technology is freely available to the stem cell research, biomanufacturing, medical, and pharmaceutical communities. By providing early and easy access to the new technology (https://lnkd.in/dGru6Tc), Asymmetrex® is achieving its vision of accelerating progress in tissue stem cell science and medicine by enabling, for the first time in the 60+ year history of stem cell science and medicine, the routine determination of tissue stem cell number and treatment dosage.
Kaitlin is working on the NIBR CQA team to manage quality issues by supporting clinical operations teams with root cause analysis and CAPA management to ensure patient safety and data integrity. She is also, actively involved in cross-divisional quality improvement projects focused on informed consent, inspection readiness, and quality culture.
Dr. Cunningham has over 15 years’ experience in clinical leadership position in medical device industry, overseeing a full spectrum of clinical development programs ranging from FIM to pivotal to post-market phases. She has a unique perspective in leading clinical programs in a dynamic startup environment. She also has a special interest in innovations that can improve the quality and efficiency of clinical trial execution. She currently serves as Vice President of Clinical Affairs at Endogenex, a medical device company developing innovative solutions for the treatment of Type 2 diabetes. Dr. Cunningham came from academic background. She was an assistant professor at Loyola University Chicago and a practicing vascular surgeon in Shanghai, China.
Nina is an experienced executive director of clinical services with over 25 years in the pharmaceutical/biotechnology and clinical research organization industry. She oversees US and EU Project Services teams including project management, client partnerships, team and portfolio management. She has demonstrated success in managing first-in-human through large, international clinical programs with multiple protocols in Phase I-III drug development resulting in several NDAs/BLAs. Before joining ICON, Nina served as Project Director focusing on Neuroscience, Immunology & Infectious Disease at Covance and held several PM roles at Takeda, TAP Pharmaceuticals, Gilead and Genentech. Nina holds a BS in Cellular Molecular Biology and a Masters in Biomedical Laboratory Science.
Misha holds a Bachelor of Science in Electronics Engineering and has worked in the capacitor field for 10 years in both engineering and sales. Prior to working at Evans Capacitor Company, Misha worked at Aerovox (now known as CD Aero) where he specialized in film capacitors.
James J. Krupa, Pharm.D., Director, Clinical Supply Team Lead, Operations at Takeda in Lexington, MA. In this position, I am responsible for providing the leadership and strategic direction in terms of planning, budget, coordination, scheduling, resources and tracking of global clinical trial materials. I have over 42 years of industrial pharmaceutical experience in multiple dosage form drug development. Building upon experience as a bench pharmacist in clinical and non-clinical supplies, formulations, process development, and technical services, I have contributed to the success of early and late stage development programs intended for regulatory approvals in women’s health, pain, oncology, CNS disorders, anti-inflammatory diseases, metabolic disorders, anti-infectives, cardiovascular, gastroenterology, gene therapy, and rare disease therapeutic areas.
David Sokoloff is the Director of Global Logistics & Materials Management for Novavax, Inc. He manages the storage and transportation of Novavax’s products through its global network. David founded For Granted, Inc. in 2006, a nonprofit supporting community driven programming in education, water and sanitation, micro-finance, and child health.
David has managed supply chains for emergency relief efforts across the Globe. He ran operations in the field for several years with Doctors Without Borders, prior to working in Washington, D.C., leading logistics operations for the U.S. Office of Foreign Disaster Assistance. At the onset of the COVID-19 outbreak, David joined Novavax, Inc. He supports their global supply chain to deliver products preventing a broad range of infectious diseases. Novavax produces vaccine candidates in response to both known and emerging disease threats, including the company’s CoVID-19 vaccine.
