Monday, 28 March 201108:00 | Registration | 10:00 | The Biotech/CRO Relationship: Is the Niche CRO a Better Fit? Albert Agro, CEO & President, HNZ Strategic Holdings, Canada
Small virtual biotechs often don’t have the internal expertise to manage studies and depend heavily on their partners in making such an initiative come to fruition. This discussion will focus on: the needs of the small biotech, the role of the niche CRO, a case study comparing the use of a global CRO and niche local providers for a small biotech and the future. | 10:30 | Coffee Break and Networking in the Exhibition Hall | 11:15 | Selecting the Right CMO Partner David Downey, Vice President, Almac Group, United Kingdom
Choosing the most suitable CMO partner for your requirements can present challenges. Defining a selection criteria that captures your priorities will facilitate your choice and establish a level playing field that compares like with like. Secondly collating and providing a project information package that allows the CMO to assess the scope of work and quote accordingly will facilitate an initial screen. Direct supplier assessment over a range of considerations - technical, quality, operational and commercial, coupled to associated site visits will funnel choices further. Finally having chosen your preferred partner delivering on the project and managing the ongoing supply relationship becomes the means to move into a more strategic relationship. This presentation considers good practice in taking such decisions. | 11:45 | | Keynote Presentation Discovery Chemistry Outsourcing: Optimising the Process Luigi La Vecchia, Director, Novartis Institutes for BioMedical Research, Switzerland
The presentation will demonstrate how a small global network of preferred external suppliers was established, which criteria were applied to assess the various potential partners, the contracts set-up, which internal processes were implemented, and how the Prep Labs are collaborating with their current preferred suppliers. |
| 12:15 | Lunch and Networking in the Exhibition Hall | 13:30 | Poster Session | | Session: Selecting the Right Outsourcing Strategy |
| | 14:15 | In a Virtual World, Where Are the Walls of the House? The New Outsourcing Katya Tsaioun, President, Apredica, United States of America
Industry Dilemma - In house resources or outsource it? Outsourcing differences: R&D, late preclinical, clinical. In this presentation I shall cover strategic sourcing, drivers for outsourcing, failed approaches to outsourcing, partnership-type relationship or straightforward outsourcing, how can a true win-win be achieved and examples from R&D outsourcing. | 14:45 | How to Obtain a Solid Track Record in Medicinal Chemistry Research Services Bruno Giethlen, Chief Scientific Officer, Prestwick Chemicals, France
In this presentation, Dr. Giethlen will discuss the methods used by Prestwick Chemical, a successful medicinal chemistry research service provider, in order to reduce risks of failing in hit discovery, hit validation or lead optimization. In nine years of business, the company has been able to deliver six compounds that proceeded into clinical development. | 15:15 | Coffee Break and Networking in the Exhibition Hall | 16:00 | Preclinical Drug Safety: High Quality Data Obtained with a New Automated Patch Clamp Platform Olaf Scheel, Study Director, Cytocentrics Bioscience GmbH, Germany
| 16:30 | Drug Discovery Outsourcing: The Importance of Integration in the Selection of Higher Quality Clinical Candidates Simone Braggio, Director/Head, Aptuit Srl, Italy
Pharmaceutical and biotech industries are producing more drug candidates than ever before. Therefore the current need is not to increase the volume of drug candidates, but to improve drug discovery effectiveness advancing better candidates with greater frequency. In this context, the strategic outsourcing of lead optimization projects become challenging and the selection of a CRO partner that can guarantee the selection of higher quality clinical candidates is a key factor for success. | 17:00 | Drinks Reception |
Tuesday, 29 March 2011 | Session: Legal And Regulatory Issues |
| | 09:30 | U.S. Patent Law & Outsourcing: Things You Need to Know in Advance Thomas Saunders, Of Counsel, Rissman Hendricks & Oliverio, United States of America
This session will address major concerns and major pitfalls in accessing the U.S. chem/pharma market. Recent changes in the treatment of patents and patent licenses will be covered. We highlight IP disasters to (perhaps) avoid. | 10:00 | The Path from Transactional Buying to Strategic Alliance David Collins, Senior Manager, Key Strategic Accounts, Charles River Limited, United Kingdom
The advantages of different outsourcing models will be described, each being appropriate under different circumstances. Ultimately, a CRO should ‘add value’ by establishing a mutually beneficial partnership. We will explore the theme of ‘the closer you get to your outsourcing partner, the more you will benefit’. | 10:30 | Coffee and Networking in the Exhibition Hall | 11:15 | Drug Discovery Outsourcing: Managing IP Risks Hiroshi Sheraton, Partner, McDermott Will & Emery, United Kingdom
This presentation will address common areas of risk associated with outsourcing of R&D, from both the sponsor's and CRO's perspective. Beyond the simple allocation of IPRs to one party or another, key areas of concern will be illustrated by reference to case studies and practical steps to ensure that risks are minimised. | 11:45 | Outsourcing as a Vital Component of SBDD Strategy Arthur Oubrie, Chief Scientific Officer, Lead Pharma, Netherlands
The role of outsourcing specific elements of the X-ray/SBDD work flow will be discussed in relation to our overall SBDD strategy. Some case examples will be given. | 12:15 | Lunch and Networking in the Exhibition Hall | 13:30 | Poster Session | 14:30 | New Concepts for Addressing Ion Channel Targets in Drug Development and Safety Pharmacology Timm Danker, Team Leader, NMI TT, Germany
Ion Channels are promising targets requiring highly specific assays. We here present an overview about our assay systems which cover the range from secondary screening to safety pharmacology and from the single cell to the whole organ level. | 15:00 | The Enterprise Europe Network Rolf Pavert, Project Officer, Enterprise Europe, Netherlands
| 15:30 | Close of Conference |
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