How Can Pharma Companies Boost Preclinical Trial Success?

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Interviews with Dr Torsten Hoffmann (Summit Chairman), Dr Bertil Lindmark and Herbie Newell, speakers at the marcus evans Discovery Summit 2014, taking place in Lisbon, Portugal, 31 March - 1 April 2014.

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How Can Pharma Companies Boost Preclinical Trial Success?

  1. 1. Discovery Summit 2014 31 March - 1 April 2014 executive perspectives speakers from the Discovery Summit 2014 discuss… How Can Pharma Companies Boost Preclinical Trial Success? Dr Torsten Hoffmann, Executive VP and CSO, Zealand Pharma In my view, three steps are imperative for successful pharmaceutical R&D; 1) Select the right target and identify the critical pathway, 2) Ensure access to fully translational disease models, and 3) Carefully design clinical Phase II PoC trials, including strong surrogate biomarkers for clinical outcomes. It is also important that human safety and tolerability are well predicted already preclinically. At Zealand, we have made the conscious decision to outsource the regulatory part of preclinical research and focus our competencies on innovative peptide design and drug development. Contrary to the R&D business models applied by larger pharmaceutical organisations, we believe “small is beautiful”. Via an agile organisational set-up, Zealand implements a dynamic feedback loop between research and development, enabling a fast and smooth route from target selection to clinical PoC. Post PoC, we pursue a partnering approach, and all activities are driven by our focus to provide better healthcare solutions for patients. Dr Bertil Lindmark, CSO & Executive Director R&D, Almirall Preclinical success is dependent upon target and pathway selection, and understanding how they relate to human beings. There is a big knowledge gap here as most of the data are from cellular or very limited in-vitro experiments. Very few studies have been done on man and are considered meaningful for the selection of targets and pathways. However, with the increasing use of systemic medicine and a better understanding of pathways, we can better identify the areas of redundancy where we can corner a biological action to get a clinical effect. With biomarkers, that further improves the chances of finding clinical effect in man. Our focus is on anti-inflammatory targets, where there are many unknowns. We prefer to focus in one area, to gain a good understanding of drug benefits and risks, and how to improve on them. Herbie Newell, Professor, Cancer Therapeutics, Northern Institute of Cancer Research (NICR) First and foremost is improving the understanding of the disease process at a cellular and molecular level. If you pick the wrong target the drug will not be effective in the clinic. Target selection depends upon the disease. If it has a genetic basis, then a genetic analysis of tumour material will help identify the best target. In some disease settings, the issue is incorrect signalling, therefore understanding the signalling pathways that lead to the disease is critical. We need to improve preclinical models of disease. Even if we have a very solid hypothesis, we must demonstrate activity in an appropriate preclinical disease model. We need to constantly strive to improve the quality of preclinical models, so that results are predictive of what is subsequently observed in patients.
  2. 2. The Pharma Network – marcus evans Summits group delivers peer-to-peer information strategic matters, trends and on professional breakthrough innovations. About the Discovery Summit 2014 This unique forum will take place at the Grande Real Villa Itália Hotel & Spa, Cascais, Lisbon, Europe, 31 March - 1 April 2014. Offering much more than any conference, exhibition or trade show, this exclusive meeting will bring together esteemed industry thought leaders and solution providers to a highly focused and interactive networking event. The Summit includes presentations on boosting pipeline productivity, understanding disease mechanism, finding promising targets, and reviewing economic and regulatory challenges. www.discovery-summit.com Please note that the Summit is a closed number business of event participants and the strictly limited. Contact Sarin Kouyoumdjian-Gurunlian, Press Manager, marcus evans, Summits Division Tel: Email: + 357 22 849 313 press@marcusevanscy.com For more information please send an email to info@marcusevanscy.com All rights reserved. The above content may be republished or reproduced. Kindly inform us by sending an email to press@marcusevanscy.com About marcus evans Summits marcus evans Summits are high level business forums for the world’s leading decision-makers to meet, learn and discuss strategies and solutions. Held at exclusive locations around the world, these events provide attendees with a unique opportunity to individually tailor their schedules of keynote presentations, case studies, roundtables and one-to-one business meetings. For more information, please visit: www.marcusevans.com Upcoming Events Evolution Summit (North America) - www.evolutionsummit.com Evolution Summit (Europe) - www.evolution-summit.com To view the web version of these interviews, please click here: www.discovery-summit.com/BertilLindmark-TorstenHoffmann-HerbieNewell

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