(SC 1) THE INS & OUTS OF WORKING WITH
CROS* • 2:00-5:00pm
Outsourcing has become an integral part of creating
pharmaceutical and biological products.
Deciding which part of a project to outsource, and how to establish
and maintain positive
CRO/CMO relationships may not be as self-evident.
This workshop has been designed to provide helpful and practical
information about working
with contract research and contract manufacturing organizations,
including a focus on how CROs 'handle' the science that lies at the
heart of the work.
Topics to be discussed include:
• Choosing a CRO/CMO
• Sight Inspections
• IP Issues
• Project Management
• Communication
• Contracts
• Regulatory Issues
• Process Planning and Management (Including Process Changes)
This workshop will provide you with essential information that will
help you avoid unnecessary complications that lead to lost time –
and lost revenue.
Peter Silvera, Ph.D., Senior Project Leader, Vaccine Research
Program, Department of InfectiousDisease Research, Southern Research
Institute
* separate registration required
(SC 2)
ANTIBODY ENGINEERING* • 2:00-5:00pm
Using Antibodies and especially monoclonal antibodies as targeted
therapeutics presents numerous challenges and opportunities to the
pharmaceutical industry. In order to use Mab’s in the clinic, topics
such as pharmacokinetic, pharmacotoxicity and stability need to be
addressed. This short course will provide in depth interactive
lectures with time given for discussing actual problems.
New Advances in Cancer
Radioimmunotherapy
David Goldenberg, Ph.D., President, Lab Science, Garden State Cancer
Center
- Review of past experience with radiolabeled antibodies in cancer therapy
- Two approved products for therapy of non-Hodgkin lymphoma
- Therapy of solid tumors locoregionally or in adjuvant setting
- Prospects of pretargeted radimmunotherapy as new paradigm for improved radioimmunotherapy
(SC 3)
MANUFACTURING VACCINES COLLOQUIUM* • 10:00am-5:00pm
A one-day colloquium focused on the myriad concerns
related to the manufacture of vaccines, including regulatory issues.
Indepth presentations from vaccine manufacturers and experts in
managing processes such as scaling up and cGMP compliant processing
for the manufacture of viral vectors and vaccines.
Biologics – From Bench Top to Bedside
Nicholas Obiri, Ph.D., Acting Director, Division of Microbiology
and Infectious Diseases, National Institute of Allergy and Infectious
Diseases, National Institutes of Health
Phase 3 Manufacturing of a Japanese Encephalitis Vaccine
Daniel Vellom, Ph.D., Associate Director, Purification Development,
Acambis plc
Building and Validating a Commercial-Scale Plasmid DNA
Vaccine Manufacturing Facility
Rick Hancock, Chief Operating Officer, Althea Technologies, Inc.
Vaccine Manufacturing Compliance for Clinical Trials: cGMP's
are still the cGMP's
R. Barry Holtz, Ph.D., President & CEO, InterveXion
Therapeutics
Overcoming the Engineering Challenges with Rapid Development
of Robust and Scalable Processes for Manufacture of Viral Vectors and
Vaccines
Madhusudan Peshwa, Ph.D., Vice President, Research &
Development, MaxCyte, Inc.
Technology for Aiding the Manufacture of Vaccines
Scott Geller, President & Chief Executive Officer, Invistics
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