51st Annual Meeting & ToxExpo - Society of Toxicology

Society of Toxicology 2012
Scientific
Symposia
• Systems Biology to Inform Cross-Species Extrapolation.
Lyle Burgoon, US EPA, Research Triangle Park, NC.
Regulatory Science: Bridging the
Gap between Discovery and Product
Availability
Development of Biosimilar Products: Overview of
Standards and Regulations
Tuesday, March 13, 9:00 AM to 11:45 AM
Chairperson(s): Gregory Finch, Pfizer, Inc., Groton, CT, and
Barbara Mounho, Amgen, Thousand Oaks, CA.
Sponsor:
Biotechnology Specialty Section
Endorsed by:
Regulatory and Safety Evaluation Specialty Section
Biosimilar products are follow-on versions of approved, innovative
biopharmaceuticals derived from recombinant DNA technology. As
innovator biopharmaceuticals are reaching the end of their patent
protection period, there is an increased interest globally in the pharmaceutical
industry in the opportunity for the development and
registration of biosimilar products. A number of biosimilar products
are now approved in certain regions (e.g., Europe), and numerous
regulatory authorities around the world have either finalized or are
in the process of developing guidance documents for the approval
biosimilars. This symposium will provide an overview of the history
and development of the regional guidelines for biosimilars, as well
as some of the unique challenges in developing biosimilars such as
CMC, nonclinical, and clinical issues. Currently approved biosimilar
products will be reviewed, including a more in-depth outline of the
nonclinical and clinical studies conducted to support the approval
of certain biosimilar products to illustrate selected challenges in the
development process. The session will also include an overview of the
US Biologics Price Competition and Innovation Act and regulatory
perspective on requirements for biosimilar development, as well as
an update and review on the US FDA’s regulatory guidance on the
nonclinical and clinical approval requirements for biosimilars.
• Overview of the History and Development of Regional
Guidelines for the Approval of Biosimilar Products.
Barbara Mounho, Amgen Inc., Thousand Oaks, CA.
• Biosimilar Drug Development—Approaches to Toxicity
Evaluation. Danuta Herzyk, Merck & Co Inc., West Point, PA.
• Industry Perspective on Biosimilar Drug Development and
Registration. Kelly Lai, Biotechnology Industry Organization,
Washington, DC.
The Thematic Track information can be found on pages 8–9.
• Challenges and Regulatory Approach for the Approval of
Subsequent Entry Biologics in Canada. Anthony Ridgway, Health
Canada, Ottawa, Ontario, Canada.
• US FDA’s Overview of the Regulatory Guidance for the Approval
of Biosimilar Products in the United States. David Jacobson Kram,
US FDA, Silver Spring, MD.
The Role of Danger Signals in the Development
of Chemical Sensitization by Environmental and
Occupational Agents
Tuesday, March 13, 9:00 AM to 11:45 AM
Chairperson(s): Marc Pallardy, Université Paris-Sud-INSERM,
Chatenay-Malabry, France, and Raymond Pieters, Utrecht University
of Applied Sciences—Institute for Risk Assessment Sciences, Utrecht,
Netherlands.
Sponsor:
Immunotoxicology Specialty Section
The adaptive immune response to a foreign antigen needs both the
recognition of the specific antigen and the presence of a specific cellular
microenvironment at the place of antigen entrance. This specific
cellular microenvironment provides signals to antigen-presenting
cells allowing the elicitation of the immune response instead of
immune tolerance to the foreign antigen. To this extent danger signals
(e.g., proinflammatory cytokines, specific molecules from pathogens,
necrosis products) play a crucial role in the immune adaptive
response to pathogens. Triggering the innate immune system with
danger signals, for instance through specific receptors termed PRR
(pattern recognition receptors) including TLR (toll-like receptors), is
a prerequisite for the immune system to react to pathogens as well as
environmental antigens. These danger signals can be considered as
adjuvants of immunity and indeed this concept has been extensively
used for vaccination by adding chemicals (aluminium hydroxide) or
pathogen products in vaccines. By analogy to the immune response to
pathogens, the hypothesis that chemical allergens need the presence
of danger signals or provide this danger signal to induce chemical
hypersensitivity reactions has been developed during the past five to
ten years. In this case, the chemical will play the role of an adjuvant.
Recent evidence suggests that particulate matters and nanoparticles
(SiO2, TiO2) can also mimic the presence of danger signals and thus
have adjuvant potential on immune responses. Recently, several in
vitro models have been developed to address the adjuvant effect of
chemical sensitizers as tools to predict chemical sensitizer potential.
• Chemicals Modify the Cellular Microenvironment in the Skin
Providing Endogenous Danger Signals. Stefan Martin, University
of Freiburg, Freiburg, Germany.
• Chemical Sensitizers Can Play the Role of Danger Signals.
Marc Pallardy, Université Paris-Sud-INSERM, Chatenay-Malabry,
France.
Thematic Session
76
SOT’s 51 st Annual Meeting