CLINICAL TRIAL STRATEGY AND REGULATORY APPROVAL. SIMS Biotech Executive Programme Module IV Barcelona, July 3-5, 2008

Transcription

1 CLINICAL TRIAL STRATEGY AND REGULATORY APPROVAL SIMS Biotech Executive Programme Module IV Barcelona, July 3-5, 2008

2 Presentation Science and Innovation Management Studies (SIMS) is promoted by Biocat (the BioRegion of Catalonia) in collaboration with the Barcelona Biomedical Research Park (PRBB) and the Continuing Education Institute (IDEC-UPF) of the Pompeu Fabra University. The objective of SIMS is to create a world-class framework in Barcelona for a learning and knowledge centre for entrepreneurship and innovation of new emerging technologies, with special emphasis on biotechnologies. SIMS offers an executive biotechnology business programme targeted at the biotechnology industry. SIMS facilitates a co-operative industry approach to professional education and development. These targeted executive modules will serve to improve and update overall skills and knowledge levels, and to encourage entrepreneurship and innovation. During three days the participants will learn about the road map for clinical trials and regulatory approvals. Case studies and practical tips reach from preclinical issues and clinical quality standards up to budgeting and relationships with CROs and public administrations. The programme content consists of 4 focused curses of three days each and the topics include: Basic Business Essentials of Biotechnology IP, Licensing and the Pipeline for Value Creation Biotech Financing, Partnering,M&As and Strategic Alliances Clinical Trial Strategy and Regulatory Approval All course contents are aimed at the life cycle of a biotech company. The module IV of the intensive Executive Biotech Programme will take place in Barcelona on July 3-5, Best practise faculty from across Europe and the USA exposes participating scientists and companies to new research and business opportunities, giving them a better understanding of the technology markets and the technological value chains. There is a critical need for scientists with business skills that can drive innovation and entrepreneurship in the biotechnology sector. SIMS is an educational framework that can help scientists, tech transfer experts and junior biotech managers to understand the key business success factors in this complex sector. José Carlos Gutiérrez-Ramos, PhD SIMS Programme director SVP Inflammation Research GSK, Stevenage, UK.

3 Programme of Lectures Thursday 3 July to 9.30 Welcome speeches 9.30 to The road map for clinical trials and regulatory approvals Jennie Sykes, VP and Head of Medicines Development Center, GSK London, UK to Break to Preclinical / clinical homework: safety, biomarkers and exposure Piet Wiegerinck, SVP Drug Development at Galapagos, Mechelen Belgium to Trip to the Barcelona Biomedical Research Park - PRBB 13:30 to Lunch to Best practices: Good Clinical Practices (GCP), Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) Tacye Connolly, Director at Regulatory Resources Group, UK to Break to Case studies: First in human trials and phase 0 Jackie Parkin, VP Immune Mediated Diseases GSK, UK to Visit of the PRBB building Welcome dinner (Sponsored by Trial Form Support) Friday 4 July to Forecasting clinical trial requirements: stage planning & budgeting Christian E. Elling, Vice President of Biology & Development at 7TM Pharmaceuticals, Denmark to Break to Case studies: Calendar and costs of different drug developments Carlo Zanotti, Director of Marketing and Product Development at Cellerix, Spain to Lunch to Clinical trial strategies and regulatory approvals Remy Luthringer, CEO of Forenap Pharma, France to Break to Case studies: Drug development options and value creation through commercial and regulatory positioning Göran Tornling*, Executive VP Research & Development at Orexo Pharmaceuticals, Sweden Saturday 5 July to Case studies: Relationships with corresponding public administration Federico Plaza, Orphamed Spain to Break to Outsourcing, partnering and involvement of CROs Jean-Pierre Isal*, Consultant and former Vice President of Quintiles Europe to Break to Lessons learned: Round table discussion José Carlos Gutiérrez, SVP Inflammation Research GSK, Stevenage, UK to Lunch *(speaker to be confirmed)

4 The Venue Barcelona is a major European city, forming the centre of an extensive metropolitan region with 4.6 million inhabitants and is the economic, cultural and administrative capital of Catalonia, situated in the north-east of Spain, on the shores of themediterranean. The city is particularly noted for its climate and high standard of living, as well as its architecture and cultural activities. Catalonia has around 250 companies related to the biotechnological and biomedical sector. Approximately 60 of them are biotechnological and 60 pharmaceutical. The rest, around 120, are companies related to the sector providing services to the biotechnological companies. According to Asebio (Spanish Association of Biotech Companies), Catalonia was the most dynamic region in 2006 and 2007 in terms of biotechnological company creation. The classeswill take place at IDEC-Universitat Pompeu Fabra (Balmes, , Barcelona) and at the Barcelona Biomedical Research Park PRBB (Doctor Aiguader, 88, Barcelona). Photos by Ferran Mateo.

5 GENERAL INFORMATION Language This programme is conducted entirely in English. Course fee 1500 Discounts Members of the IDEC-Universitat Pompeu Fabra Alumni Association are eligible to a 10% discount. For registration and payments completed before 13 June 2008, the reduced course fee is 1,350. For registration or payments made after this date, the course fee is 1, Those applicants who have attended the previous modules will receive a discount of 20% on the cost of subsequent SIMS modules. If payment is made before 13 June 2008, they will receive a total discount of 30%. Financing IDEC-Universitat Pompeu Fabra has established agreements with Banco Bilbao Vizcaya Argentaria, Caixa Catalunya, la Caixa and SabadellAtlántico for the granting of loans for course fees. Please consult conditions on the website s registration/ financing section. Registration procedure 1.Complete the online admissions form ww.idec.upf.edu/sims4 2.Send your curriculum vitae and university qualification to documentacion@idec.upf.edu 3. Payment of fees. You can pay fees in the following ways: By cash By cheque By credit card By bank draft, in which case you must send a copy as proof of payment by fax to , indicating the code number of the course and the name of the participant. Information and registration IDEC-Universitat Pompeu Fabra info@idec.upf.edu Balmes, Barcelona Phone: Fax: * The data in this document are for information only and must be confirmed at registration. Location IDEC-Universitat Pompeu Fabra, Balmes , Barcelona.

6 IDEC-UNIVERSITAT POMPEU FABRA Pompeu Fabra University (UPF) is a public institution founded in 1990, and is part of the urban network that contributes to the dynamics of Barcelona as a cosmopolitan city. With all its entrepreneurial activity, UPF has established a new learning model which integrates the highest level of national and international teaching staff. Pompeu Fabra University (UPF) is a public institution founded in 1990, and is part of the urban network that contributes to the dynamics of Barcelona as a cosmopolitan city. With all its entrepreneurial activity, UPF has established a new learning model which integrates the highest level of national and international teaching staff. IDEC acts as a link between the Universidad Pompeu Fabra and society and is instrumental in relations with the world of business, professionals and society in the field of specialisation, updating of knowledge and professional re-cycling. In line with UPF s own objectives as a public university in terms of teaching and research, IDEC offers lifetime training services in accordance with social needs in the required form, place and time. BARCELONA BIOMEDICAL RESEARCH PARK PRBB At PRBB science and diversity are connected in one creative space. The park is one of the largest biomedical research clusters in Southern Europe and stands out because of its critical mass of people and the scientific diversity of 100 research groups within the biomedical field. The PRBB, an initiative of the Government of Catalonia, the City Council of Barcelona and the Pompeu Fabra University (UPF), is a large scientific infrastructure that is physically connected to the Hospital del Mar de Barcelona and that gathers together six public research centres closely coordinated amongst them. PRBB is member of the European Technology Transfer Club (ETTC). The club is composed of the five directors of technology transfer of INSERM in France, Medical Research Council (MRC) en UK, the Karolinska Institute in Sweden, the Flanders Institute of Biotechnology VIB in Belgium and the PRBB in Barcelona. The aim of the club is to facilitate the exchange of experiences and to promote new projects between the different research organizations. BIOCAT, THE BIOREGION OF CATALONIA Biocat is the organization that promotes biotechnology and biomedicine in the Catalan biomedical cluster (the Bio- Region of Catalonia). It is fostered by the Government of Catalonia and composed of companies and public research institutions. Biocat s goals are facilitating networking among the different stakeholders, fostering biotechnology as a key economic driver for the country, promoting Catalonia biotechnology at the world stage and informing and contribute to a better understanding and perception of biotechnology. Among Biocat s strategic projects there is the creation of experienced pools of biotech industry managers, by means of specific training programs like SIMS. Sponsored by: DL B