SOURCE: IBC Life Sciences

August 20, 2007 15:00 ET

IBC Announces the 4th Annual Early to Late Stage Bioprocess Development Summit

Featuring Keynote Presentations From Biogen Idec and Lilly Research Laboratories

WESTBOROUGH, MA--(Marketwire - August 20, 2007) - IBC Life Sciences today announced the fourth annual Early to Late Stage Bioprocess Development Summit, to be held November 5-7, 2007 in San Diego, California. This meeting offers delegates a strategic perspective on the planning for a full CMC development program, ranging from the discovery handoff all the way through to phase III clinical studies.

In contrast to past process and analytical development conferences, the Early to Late Stage Bioprocess Development Summit offers case examples and perspectives on treating these development activities as a continuum -- and how this approach can help preserve scarce resources, integrate information flows among different unit operations and implement timesaving platforming of key functions.

The meeting begins with a three-part keynote case study that reviews the full development program for Biogen Idec's antibody therapeutic Lumiliximab. These talks review lessons learned along the development path with comparability assessments, incorporating process and analytical improvements, and the effects of a change in clinical indication.

A second keynote presentation, "Pay Me Now or Pay Me Later: Managing the Transition from Early to Late Phase Product Development," will be given by Dr. William F. Heath, Jr., Executive Director of Bioproduct Research and Development for Lilly Research Laboratories. Dr. Heath describes Lilly's efforts to balance information and material generation across large molecule projects with a 'pay as you go' approach.

To help attendees customize their conference experience to the needs of their organizations, delegates may choose from six different small group problem-solving symposia:

--  Program and Project Management for Scientists: How to Effectively Work
    in Cross-Functional Program Teams
--  Improving the Product Handoff from the Discovery Function to
--  Balancing Product Yield and Quality in Clone Selection and Early Cell
    Culture Development
--  Optimizing Inter-function, Inter-site and Company-CMO Transfers in
    Biologics Development
--  Early Formulation and Dosage Form Development (High Concentration
    Proteins, Prefilled Syringes, Novel Delivery Methods)
--  How to Effectively Use and Validate Next-Generation Analytical Tools
    for Product Characterization

The conference will also offer a pre-conference workshop, "Increasing the Product Value of Biotherapeutics through Improved CMC Development" and fourteen new case studies demonstrating best practices in implementing the continuum approach to CMC planning.

Complete summit information can be found at

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