Session Abstract – PMWC 2017 Silicon Valley
Session Synopsis: Pharma’s define the acquisition of human biospecimens as a very high-risk sourcing activity. This session looks at the risks and challenges, from an industry perspective, of acquiring samples and introduces a solution to remove the barriers, administrative burden, and reduce the cost for both Pharma’s and providers of samples.
Session Chair Profile
BSc (Hons), Senior Director Compliance, Scientist.com
Heading a cross industry team, Matt has led the development of a human biospecimen acquisition platform (COMPLI) that helps researchers quickly acquire the human samples they need for their research projects, but also ensures that all biosamples are treated in an ethically compliant way that respects the wishes of the sample donor. COMPLI establishes a rigorous compliance and governance framework that increases visibility, traceability and control for commercial and academic sources of human biospecimens. He has worked in the pharmaceutical industry for 16 years. For 15 years he worked within AstraZeneca (AZ), spending 12 years as a senior scientist working in R&D Genetics and Personalised Healthcare & Biomarkers. Then moving to Procurement to become the Global Category Manager for Human Biological Samples (HBS). Within this role he implemented a new category strategy that transformed the compliance, visibility, traceability and accessibility to HBS for scientists across the global AZ geographic footprint.
New Standard for Procuring Human Biospecimens
One of the biggest hurdles in pharmaceutical research is the acquisition of human biospecimens. With thousands of global providers, it’s become difficult for researchers to find high-quality samples that have been acquired in an ethically-compliant manner. This talk introduces a new way to address those risks and challenges.
MBA, Ph.D., Associate Director, Strategic Sourcing, Biogen
Shiva Krupa is the Associate Director for R&D Preclinical Strategic Souring at Biogen. In this role, Dr. Krupa is responsible for strategy and execution of outsourced preclinical services. She is also responsible for developing the procurement strategy for Human Biospecimens. In her previous roles, Dr. Krupa was the External Alliance and Project Manager at Novartis.
Risks of Human Biospecimen Acquisition – Industry Perspective
Biopharma’s define the acquisition of human biospecimens as a high-risk sourcing activity. We look at the risks, from an industry perspective, of acquiring biospecimens to increase awareness so that we begin to address the blockers of successful biopharma-provider relationships.
MSc. Organic Chemistry, Associate Director Global Sourcing R&D+M, BoehringerIngelheim Pharmaceuticals, Inc.
Brian Raudenbush is the Associate Director of Global Sourcing R&D+M at BoehringerIngelheim Pharmaceuticals. Mr. Raudenbush holds a MS in Organic Chemistry from The Pennsylvania State University and from 2001-2005 worked as a medicinal chemist at Bayer and Novartis. In 2005, Mr. Raudenbush joined BoehringerIngelheim as a medicinal chemist and in 2010 was a key contributor to the design and synthesis of Idarucizumab (Praxbind), a novel monoclonal antibody designed for the reversal of the anticoagulant effects of Dabigatran (Pradaxa). During his time as a medicinal chemist, Mr. Raudenbush was a contributor on 8 patents and 2 scientific papers. In 2011, Mr. Raudenbush moved into the Global Sourcing Department. In his current role, Mr. Raudenbush is a category manager for global preclinical R&D services, the US human biospecimen acquisition manager and supports the evaluation of emerging technologies, such as microbiome research and new antibody generation platforms.
Challenges of Human Biospecimen Acquisition – Industry Perspective
When identifying and acquiring human biospecimens, Biopharma’s have a number of complex challenges to overcome to enable successful relationships with external sources. We discuss some of these challenges to provide a transparency into the industry to enable us to identify efficient, cost effective, compliant solutions.