Published: August 19, 2008
Forum to Help Emerging Biotechs Plan Development Timeline
IBC Life Sciences Presents the 5th Annual Early to Late Stage Bioprocess Development Summit

IBC Life Sciences announced today that its
5th Annual "Early to Late Stage Bioprocess Development Summit" will be held
on October 20-22, 2008 at the Hyatt Harborside Hotel in Boston, MA. The
meeting is designed to help managers and scientists from companies at
different stages of growth understand how to implement bioprocess
development processes treated as a continuum rather than a series of
distinct handoffs. This will help these organizations reduce costs, improve
product quality and streamline complex development steps.
The meeting begins with a pre-conference workshop, "Comparability
Strategies for CMC Development." Companies will share how they have
approached the critical steps involved in planning for the succession of
comparability studies required in preclinical and clinical development.
Three keynote presentations present examples of companies that have
benefited from successful process and analytical development strategies:
Mark Cunningham, Ph.D. of Centocor, will outline processes used to manage
the interface between discovery research and pharmaceutical development in
his case study presentation "PDAC: A Cross-Functional Team Driving the
Successful Transition of Biologics from Discovery Research to
Pharmaceutical Development and Beyond."
Sharon Ma, Ph.D. of Genentech, will show how new Quality by Design
approaches are being applied in the field in a talk entitled "Product
Quality Ownership throughout Clinical Product Development."
Richard Crowley of ImClone will share details of a new platform-based
approach to process development the company has recently adopted, as well
as the limitations they encountered during implementation.
Delegates may also choose from four small group problem-solving
discussions:
-- Timing and Strategies for Analytical Characterization (Moderated by
Wyeth Biopharma)
-- Process Development Strategies (Moderated by ImmunoGen Inc.)
-- Program and Project Management for Bench Scientists (Moderated by
Centocor, Inc.)
-- Optimizing Inter-function, Inter-site and Company-CMO Transfers
(Moderated by BioProcess Technology Consultants, Inc.)
For further information and to register for this event, please visit
www.IBCLifeSciences.com/ETL
To apply for a press pass, please contact gbroughton@ibcusa.com.
About IBC Life Sciences
IBC Life Sciences is the worldwide leader in scientific, technological and
business conferences and courses for the life science industry. To develop
its programs, IBC actively researches the advancements, technologies and
trends impacting and driving the race for new drugs and therapies. For more
information, visit: http://www.IBCLifeSciences.com.
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