|
TELECONFERENCE DESCRIPTION |
This presentation begins with an overview of the biological self
versus non-self mechanism resulting in the anti-drug response of
biopharmaceuticals. The next section describes how to
differentiate the risk associated with internal attributes of
the drug from the risk derived from external factors. That
guideline in conjunction with the latest industry
recommendations and regulatory guidelines provides a logical
approach to the risk strategy.
The second-half of the presentation demonstrates how to use
pre-clinical results to further characterize (but not predict)
the immunogenicity response and utilize this information to be
ready for adverse effects during clinical trials. The
presentation finishes with recommendations on a sampling
strategy and a representative clinical case study describing the
importance of immunogenicity testing not only during clinical
trials but also after the drug is commercialized. |
| AREAS
COVERED IN THE SEMINAR |
|
This presentation reviews the following important topics to
understand immunogenicity and analyzing risk factors to
strategically develop biopharmaceuticals:
-
Self versus non-self.
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Risk factors associated with immunogenicity.
-
Regulatory expectations on immunogenicity
testing .
-
How to use immunogenicity results from
pre-clinical studies.
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Minimizing immunogenicity risk.
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Phase specific sampling plan.
-
Case study and commercialization strategy.
|
|
WHO WILL BENEFIT |
|
This webinar will provide valuable assistance to all companies
that are developing biopharmaceuticals that are NOT
being used as vaccines. The employees who will benefit
include:
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Pharmacologists
-
Toxicologists
-
Clinicians
-
Project Managers
-
Regulatory personnel
-
Consultants
|
|
INSTRUCTOR PROFILE |
|
Dr. Menendez, is currently
an independent consultant and international instructor on
GMP/GLP Bioassay Method Development. In her previous position as
Senior Director of Biotechnology at Catalent Pharma Solutions
she implemented various laboratories to verify the functionality
and safety of biotechnology products using cellular molecular
and immunological procedures.
Her expertise covers potency
bioassays, PK and immunogenicity testing. Her latest industry
paper provides recommendations for preparing and storing
non-manufacturing cell banks used in GMP and GLP analysis.
Dr Menendez joined Catalent from Bristol-Myers Squibb, where as
Associate Director of Regulatory Sciences, she transitioned
Oncology and Infectious Diseases candidates from the lab bench
to the clinic. Dr. Menendez obtained her Ph.D. in
Microbiology/Immunology and she pioneered monoclonal antibody
technology at Wyeth from 1982 to 1995.
Topic Background:
Biopharmaceutical products hold great promise in therapeutics
because of their excellent targeting ability. This advantage is
tempered with the danger of inducing an unwanted immune response
in patients. All biopharmaceutical development programs need to
quickly identify and characterize antibodies that can affect the
potency and safety of the drug. Intrinsic drug specific
attributes plus several external and internal factors can have a
tremendous impact on the immunogenic response of a
biopharmaceutical.
In addition, lack of understanding of
industry expectations and regulatory documents regarding
immunogenicity can needlessly jeopardize a development program.
A clear strategic path to evaluate risk and manage
immunogenicity issues is essential to not only be successful in
the clinic but also throughout the entire life cycle of a drug.
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| REGISTER |
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Registration - Session Only: $249.00
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