EuroMEEting - Genetic Alliance UK
EuroMEEting - Genetic Alliance UK
EuroMEEting - Genetic Alliance UK
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26<br />
THEME 6<br />
This is the advance programme. New speakers and sessions will be added. Visit www.diahome.org for the most recent additions to the programme.<br />
Theme 6 | Engaging the Research World!<br />
Non-Clinical Research and Development<br />
Per Spindler, Director, Biopeople, University of Copenhagen, Denmark<br />
Nancy Claude, Director of Drug Safety, IRIS, France<br />
Pre-clinical research and development is central to product innovation in<br />
the healthcare business. The stakeholders involved are academics, contract<br />
research, regulators and industry. They need in many cases to work together to<br />
leverage on synergies enabling smarter and faster early product development.<br />
Product innovation in our sector is massively embedded in regulatory and<br />
streamlined processes; however to do the early steps smarter and faster<br />
the research world must be engaged. A pallet of contemporary topics have<br />
been selected that will guide and inspire you in the pre-clinical research and<br />
development of novel healthcare products.<br />
Tuesday, 29 March 2011<br />
09:00-10:30 Session 0601<br />
INTERNATIONAL STRATEGY FOR NON-CLINICAL CONSULTANTS<br />
Session Chair:<br />
Elisabeth C. Goodman, Principal Consultant, RiverRhee Consulting, <strong>UK</strong><br />
This session presents three case studies which address respectively: The<br />
challenges of building a non-clinical drug safety business in an international<br />
context; how using an organised global network of expert level consultants can<br />
facilitate successful navigation of the regulatory requirements for entry into Phase<br />
1; and how a CRO can engage its whole organisation in creating greater value<br />
for its customers, streamlining its processes and building a stronger people and<br />
culture infrastructure.<br />
International Strategy: Experience of a Non-clinical CRO<br />
Roy Forster, Scientific Director, CIT, France<br />
Using an Organised Global Network of Experts to Address Regulatory<br />
Requirements for Entry into Phase 1<br />
Maurice G. Cary, CEO and founder, Pathology Experts LLP, Switzerland<br />
Building Quality in a Time of Change<br />
Mark S. Duxon, Chief Executive Officer, Porsolt and Partners Pharmacology, France<br />
11:00-12:30 Session 0602<br />
NON-CLINICAL EVALUATION OF DRUG-INDUCED HEPATOTOXICITY<br />
Session Chair:<br />
Beatriz Silva Lima, Chair SWP; Professor, Pharmacology, iMED-UL, Lisbon<br />
University and INFARMED, Portugal<br />
Hepatotoxicity constitutes one of the major causes for late attrition during the<br />
development process of pharmaceuticals. In addition, many drugs have been<br />
withdrawn from market due to liver toxicity. The need for earlier and better<br />
prediction is needed. Recently, the EMA/CHMP/SWP issued a discussion paper<br />
where the approaches and strategies for prediction of hepatotoxicity in animal<br />
studies are discussed. The session will address current discussions and progress in<br />
the area. The views of industry and regulatory scientists will be explained<br />
Impact of Hepatotoxicity on the Attrition of Drug Development - Lessons<br />
learned in the Post-marketing Setting<br />
Marku Pasanen, Professor, University of Eastern Finland, Finland<br />
Reinforcing the Predictive Role of the Non-Clinical Testing: The CHMP/SWP<br />
discussion paper on hepatotoxicity<br />
Klaus Olejniczak, Scientific Director, Department of Drug Toxicology, BfArM,<br />
Germany<br />
The Joint Efforts of Industry and Academia to Reinforce Hepatotoxicy<br />
Prediction Including the Value of Regulatory Measures<br />
Speaker to be confirmed<br />
14:00-15:30 Session 0603/1303<br />
SAFETY ASPECTS IN THE DEVELOPMENT OF VACCINES (JOINT WITH<br />
THEME 13)<br />
Session Chair:<br />
Jan Willem van der Laan, Senior Assessor Section on Safety of Medicines and<br />
Teratology Centre, National Institute for Public Health and the Environment<br />
(RIVM), The Netherlands<br />
There is an increasing awareness that vaccines have their own characteristics<br />
in safety aspects. The recent introduction of adjuvants in marketed products<br />
has underlined this. The risk of an increase in autoimmune phenomena and the<br />
safe use of vaccines during pregnancy are hot topics. The WHO will present its<br />
perspective on the use of adjuvants.<br />
WHO Perspective on Adjuvants in Vaccines<br />
Martin Howell Friede, Technical Officer, Initiative for Vaccine Research, WHO,<br />
Switzerland<br />
Adjuvants and the Potential Risk of Autoimmunity<br />
Sarah Gould, Non Clinical Safety Division, Sanofi Pasteur, France<br />
Vaccines and Pregnancy<br />
Jan Willem van der Laan, Senior Assessor Section on Safety of Medicines and<br />
Teratology Centre, National Institute for Public Health and the Environment<br />
(RIVM), The Netherlands<br />
16:00-17:30 Session 0604<br />
BIOBANKING: LOGISTICS AND SAMPLES HANDLING<br />
Session Chair:<br />
Hermann Schulz, Chief Executive Officer, INTERLAB Central Lab Services<br />
GmbH, Germany<br />
Handling frozen specimens is of increasing importance in clinical research.<br />
This session willo present strategies and solutions in order to ensure both that<br />
frozen specimens are correctly collected, shipped and stored and that these<br />
samples arrive in stable condition at the laboratory where reliable lab results<br />
are expected.<br />
A Biopharmaceutical Company Perspective: Strategies for improving the<br />
management of global samples<br />
Julie Corfield, Biobank Head, AstraZeneca R&D, <strong>UK</strong><br />
A Biorepository Perspective: How the development of global standards for<br />
sample management could improve clinical trial outcomes<br />
Lori Ball, Chief Operating Officer, BioStorage Technologies, USA<br />
A Central Laboratory Perspective: How to successfully handle pre-analytical<br />
factors such as logistics and frozen storage to achieve reliable laboratory<br />
results<br />
Hermann Schulz, Chief Executive Officer, INTERLAB Central Lab Services<br />
GmbH, Germany