Pharma Outsourcing Congress Agenda

Registration

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.

Coffee Break and Networking in the Exhibition Hall

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.

Lunch and Networking in the Exhibition Hall

Poster Session

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.

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.

Coffee Break and Networking in the Exhibition Hall

Preclinical Drug Safety: High Quality Data Obtained with a New Automated Patch Clamp Platform
Olaf Scheel, Study Director, Cytocentrics Bioscience GmbH, Germany

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.

Drinks Reception

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.

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’.

Coffee and Networking in the Exhibition Hall

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.

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.

Lunch and Networking in the Exhibition Hall

Poster Session

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.

The Enterprise Europe Network
Rolf Pavert, Project Officer, Enterprise Europe, Netherlands

Close of Conference