Program - Society of Toxicology

50 th Anniversary Annual Meeting and ToxExpo
Program Description (Continued)
Tuesday
Abstract # Abstract #
and present the scientific background and challenges in the context of the
emerging regulatory landscape. Speakers will discuss the translational
aspects of nonclinical and clinical findings to regulatory and scheduling
processes. Emphasis will be placed on presentation and discussion of issues,
with specific examples, that bridge these areas of interest and enhance
overall awareness of the topic.
#1722 1:30 NONCLINICAL TO CLINICAL ABUSE
LIABILITY ASSESSMENT OF DRUGS:
CURRENT PRACTICES, CHALLENGES,
AND IMPACT OF RECENT REGULATORY
GUIDANCES. ​B. Gemzik. Discovery Toxicology,
Bristol-Myers Squibb Company, Princeton, NJ.
1:30 INTRODUCTION. ​Brian Gemzik
#1723 1:35 NEUROPHARMACOLOGY OF DRUGS
OF ABUSE AND IMPLICATIONS ACROSS
DIVERSE DRUG DISCOVERY PROGRAMS. ​
D. R. Compton. Preclinical Safety - Toxicology,
sanofi-aventis U.S. Inc., Bridgewater, NJ. Sponsor:
B. Gemzik.
#1724 2:05 ANIMAL MODELS FOR ASSESSMENT OF
ABUSE POTENTIAL: TRNSLATION TO
CLINICAL EVALUATION. ​M. J. Kallman.
Covance Inc., Greenfield, IN.
#1725 2:35 DESIGN AND INTERPRETATION OF
CLINICAL TRIALS EVALUATING ABUSE
POTENTIAL OF DRUGS: WHERE ARE
THE GAPS? ​M. Sokolowska. Grünenthal USA,
Bedminster, NJ. Sponsor: B. Gemzik.
#1726 3:05 CURRENT CHALLENGES IN ABUSE
LIABILITY ASSESSMENT: DRUGS WITH
NOVEL MECHANISMS OF ACTION. ​K. E.
Cannon. Global Safety Pharmacology CoE, Pfizer,
Inc., Groton, CT. Sponsor: T. Brabham.
#1727 3:35 REGULATORY AND SCHEDULING:
PROCESSES AND CURRENT CONCERNS. ​
M. Klein. CDER, U.S. FDA, Silver Spring, MD.
Sponsor: B. Gemzik.
4:05 PANEL DISCUSSION/Q&A.
Tuesday Afternoon, March 8
1:30 PM to 4:15 PM
Room 207
Emerging Global Public Health Issues
Workshop Session: Risk Assessment for Proteins Introduced
into Genetically Modified Crops
Chairperson(s): Bruce Hammond, Monsanto Company, St. Louis, MO,
and Joseph Jez, The Donald Danforth Plant Science Center, St. Louis,
MO.
safe use (HOSU) in food. For registration of GM crops in Europe, if there
is no reliable safety information, IP without a HOSU must be tested in a 28
day repeat dose toxicity study. Thus we will explore appropriate information
that might resolve safety concerns for IP without a HOSU. Advances in the
field of molecular biology over the last 30 years have increased our ability
to modify the structure, stability, and activity of proteins of interest. These
modified proteins may not have a HOSU. However, absence of HOSU
does not mean absence of safety. Protein engineering and evolution studies
suggest that changes in amino acid sequences of proteins not related to those
with known toxicological hazards (i.e., toxins or allergens) will not make a
protein potentially hazardous de novo. Modifications often exert little effect
on biological function, and some substitutions are deleterious to protein
structure and function. In regards to dietary risk assessment of proteins
introduced into GM crops, risk assessors have generally made the highly
conservative assumption that the IP remains functionally intact during the
processing of the crop into human food fractions. However for crops such
as corn or soy which are extensively processed, the IP that have been tested
do not survive processing functionally intact. This information could be
relevant to resolving concerns about the safety of IP that do not have a
HOSU. However, if the IP is related to known mammalian toxins, remains
functionally intact after processing or is not susceptible to digestion, then
further toxicology testing may be needed.
#1728 1:30 RISK ASSESSMENT FOR PROTEINS
INTRODUCED INTO GENETICALLY
MODIFIED (GM) CROPS. ​B. G. Hammond.
Product Safety Center, Monsanto Company, St.
Louis, MO.
1:30 INTRODUCTION. ​Bruce Hammond
#1729 1:35 NATURE’S BALANCING ACT:
EVOLUTIONARY CHANGES IN PROTEIN
FAMILIES. ​J. M. Jez. The Donald Danforth
Plant Science Center, St. Louis, MO. Sponsor: B.
Hammond.
#1730 2:07 ENGINEERING PROTEINS TO IMPROVE
BIOLOGICAL FUNCTION. ​S. J. Franklin.
Protein Technologies, Monsanto Company,
Cambridge, MA. Sponsor: B. Hammond.
#1731 2:39 SAFETY ASSESSMENT OF NOVEL
PROTEINS. ​J. L. Kough. Biopesticides and
Pollution Protection Division, Office of Pesticide
Programs, U.S. EPA, Washington, D.C. Sponsor: B.
Hammond.
#1732 3:11 EFSA’S UPDATED STRATEGY FOR THE
RISK ASSESSMENT OF GM PLANTS AND
DERIVED FOOD/FEED. ​H. A. Kuiper. Chair
EFSA GMO Panel, European Food Safety Agency
(EFSA), Parma, Italy. Sponsor: B. Hammond.
#1733 3:43 RISK ASSESSMENT RECOMMENDATIONS
FOR INTRODUCED PROTEINS. ​B. G.
Hammond. Product Safety Center, Monsanto
Company, Saint Louis, MO.
Sponsor:
Biotechnology Specialty Section
Endorsed by:
Food Safety Specialty Section
Risk Assessment Specialty Section
In 2009, there was 330 million acres of genetically modified (GM) crops
planted in 25 countries. Despite rapid adoption, planting of GM crops
remains controversial in some countries. GM crops undergo comprehensive
food safety assessment before commercialization. This includes proteins
introduced into the crop to achieve desired technical effects. One of the
safety questions asked is if the introduced proteins (IP) have a history of
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