09.00-12.00 Workshop A: Planning and Implementing a Biorepository: maximising the use of samples by effectively planning a biorepository leading to effective future research.

Maximise sample use now and in the future through effective planning of your Biorepository. Learn how comprehensive planning can enhance the quality and utility of the samples you collect. Hear why comprehensive and detailed procedures managed through training and quality monitoring increase the value of the samples and data you collect. See how effective informed consent procedures allow enhanced sample use for future breakthroughs. All illustrated with case studies drawn from actual practice.

This workshop will provide three hours of interactive discussion and learning focussing on :

• Developing guidelines for sample collection and processing using best practices
• Setting good quality practices in an unregulated field
• Understanding and making effective material and method choices
• Creating effective and economical aliquoting schemes
• Capturing critical pre-analytical data parameters
• Incorporating information on future use in informed consents
• Developing utilization and culling strategies

Kathi Shea
Vice President BioServices Operations
SeraCare Life Sciences
(President Elect, ISBER)

Kathi Shea has over 20 years of leadership at SeraCare Life Sciences, working in BioServices and specializing in biorepository sciences. She is the Vice President of SeraCare’s BioServices Operations, which offers biorepository services from biological collection design through implementation, maintenance and closeout. Ms. Shea serves as the Principal Investigator on the US National Heart, Lung, and Blood Institute (NHLBI) National Biological Specimen Repository and acts as a lead on government, academic, and industry repository collections that range in size from a few hundred to over 5 million specimens. She has been an active member of the International Society of Biological and Environmental Repositories (ISBER) since its inception and is the 2012-2013 President. She has contributed to both the ISBER and NCI Best Practices documents, periodically serves the NIH as a scientific reviewer for repository related applications, advises on the design of research and clinical trial studies, and serves on the advisory working group for the recently initiated Biorepository Accreditation Program of the College of American Pathologists.

13.00-16.00Workshop B: Developing an Effective Consent Form

A hands-on interactive session gaining insight into different approaches for creating an effective consent form. Join this forum to openly discuss different consent forms and the best methods used to maximise sample usage.

To include:

• A case study from Sanofi highlighting the strategy for developing their new template
• A comparison between companies, taking apart consent forms to share and critically analyse different approaches
• An interactive Q & A session
• Top tips for maximising the use of samples by creating an effective consent form

Anne Bahr
Data Privacy Officer
Sanofi

Anne Bahr is the Deputy of the R&D Data Privacy Officer in charge of compliance with Personal Data Protection regulations. She is supporting international R&D projects and clinical studies worldwide. She is also in charge of ensuring the compliance with the French Data Protection regulation.

She has been involved in research and information systems for more than 12 years and holding her current position for 6 years, overseeing and assessing any new project. Projects cover all facets of sanofi-aventis R&D operations including biomedical and genetics-based research, safety surveillance, biobanking, drug discovery and medico-marketing. She has also been co-leading the preparation and the implementation of Sanofi Binding Corporate Rules which have been approved in 2009.

She joined the Sanofi group as a Hoechst-Marion-Roussel bioinformatician in 2000. She is an active member of the IPPC (International Pharmaceutical Privacy Consortium), the AFCDP (French Privacy Professionals Association) and the IAPP (International Privacy Professionals Association), from which she has been certified in December 2011 as a European Privacy Professional (CIPP/E).

She holds a PhD in Molecular Biology from Strasbourg University Louis Pasteur.