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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

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