(December 12, 2017)
Personalization of medicine is driving the increase in demand for high-quality and well-annotated biospecimens. Biospecimen sourcing is becoming a challenge for many scientists (academic and private) who need to respect timelines for R&D plans as well as regulatory and ethical constraints. Industry has access to different biospecimen sourcing channels, each one has its pros and cons: are the scientists working with the samples aware of all the imperatives to obtain them; quality according to state-of-the-art procedures, respect of laws, ethics and regulations?
This webinar will discuss real cases of issues with the sourcing of biospecimens and how they can affect R&D projects. It will underline the need for traceability on biospecimen sourcing. The compliance with country-specific ethical and regulatory standards will also be discussed.
Upon completion of this Webinar, attendees should be able to:
- Understand the risks of not being able to trace human biospecimens (scientific conclusions drawn from studies, corporate risks)
- Better select their biospecimen providers by asking the right questions
Dr. Ann Cooreman, Ph.D.
Regulatory Affairs and Project Management
Dr. Cooreman holds an MA from Antwerp University (Antwerp, Belgium), and a PhD from the University of Oregon (Eugene, OR). Following on from various postdoctoral fellowships, she started her career in the Biobank field as a Project Manager for Scottish Biomedical with the primary responsibility of setting up a Tissue Bank. Afterwards Ann co-founded and led an international commercial biobank (UK) where she had a variety of corporate, business development, and operational responsibilities. While there, she supervised hundreds of projects for high profile clients, establishing privileged relationships with the most prestigious academic clinical sites and biobanks. In 2015, Ann became an independent consultant in ethics and regulatory affairs advising a number of academic and commercial entities or regulatory bodies. Ann joined Trans-Hit Bio ‘s multi-national team in January 2017. She is responsible for overseeing regulatory, ethical, and quality assurance issues and has supervised hundreds of biospecimen procurement projects for dozens of clients. She is instrumental in the development of THB’s European branch, partnering with key clients and biorepositories. Based on her actual experience, good and bad, she will present to the audience what can go wrong when sourcing biospecimens.