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Program - Society of Toxicology

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44 th Annual Meeting<br />

and ToxExpo<br />

<strong>Program</strong> Description<br />

Monday Morning<br />

Monday Morning, March 7<br />

9:30 AM to 11:30 AM<br />

Exhibit Hall A<br />

Monday Morning, March 7<br />

7:30 AM to 3:00 PM<br />

Room 214<br />

UNDERGRADUATE EDUCATION PROGRAM FOR MINORITY<br />

STUDENTS<br />

Chairperson(s): Rosita Proteau, SCMI Chair, Oregon State University,<br />

Corvallis, OR.<br />

Sponsored by:<br />

Education Committee<br />

Education Subcommittee for Minority Initiatives<br />

7:30 AM–8:00 AM Breakfast for Students, Advisors, Peer Mentors,<br />

and SOT Hosts<br />

8:15 AM–9:15 AM Plenary Lecture: Science, Policy, and Regulation<br />

at the White House Office <strong>of</strong> Information and<br />

Regulatory Affairs, John D. Graham, Office <strong>of</strong><br />

Information and Regulatory Affairs, OIRA<br />

9:30 AM–11:30 AM Special Poster Session for Visiting Students<br />

POSTER SESSION FOR VISITING STUDENTS<br />

Chairperson(s): Rosita Proteau, SCMI Chair, Oregon State University,<br />

Corvallis, OR and Javier Avalos, TopTox, Sacramento, CA.<br />

Sponsored by:<br />

Education Committee<br />

Education Subcommittee for Minority Initiatives<br />

This poster session is part <strong>of</strong> the Undergraduate Education <strong>Program</strong> for<br />

Minority Students. All are welcome to view the specially selected presentations<br />

which provide an overview <strong>of</strong> research in toxicology and demonstrate the diversity<br />

within the discipline.<br />

Monday Morning, March 7<br />

9:30 AM to 12:00 NOON<br />

Room RO4<br />

SYMPOSIUM SESSION: THE FUTURE OF MOLECULAR GENETIC<br />

THERAPEUTICS<br />

Chairperson(s): David Monteith, Lilly Research Laboratories, Greenfield, IN<br />

and Vijay Reddy, Lilly Research Laboratories, Greenfield, IN.<br />

MONDAY<br />

11:45 AM–1:00 PM Closing Session<br />

1:00 PM–3:00 PM Evaluation Focus Groups<br />

Monday Morning, March 7<br />

8:30 AM to 9:15 AM<br />

La Louisiane Ballroom<br />

PLENARY LECTURE: SCIENCE, POLICY, AND REGULATION AT<br />

THE WHITE HOUSE OFFICE OF INFORMATION AND<br />

REGULATORY AFFAIRS<br />

Lecturer: John D. Graham, Administrator, Office <strong>of</strong> Management and Budget,<br />

OIRA.<br />

John D. Graham, PhD, is Administrator <strong>of</strong> the Office <strong>of</strong> Information and<br />

Regulatory Affairs within the White House Office <strong>of</strong> Management and Budget.<br />

As OIRA Administrator, Dr. Graham has pursued an agenda <strong>of</strong> “smarter regulation.”<br />

This means that the <strong>of</strong>fice is neither pro-regulation nor anti-regulation.<br />

OIRA seeks to accelerate the adoption <strong>of</strong> sensible rules, modify existing rules<br />

to make them more effective and less costly, and rescind outdated rules whose<br />

benefits do not justify their costs. Under Dr. Graham’s leadership, OIRA has<br />

made changes in many areas to increase the reliance on sound science. These<br />

initiatives include government-wide Information Quality Guidelines, guidance<br />

on Peer Review, and a revised circular on Regulatory Analysis for benefits and<br />

costs <strong>of</strong> regulations. Dr. Graham will talk about these initiatives, other OIRA<br />

activities, and also share with SOT ways in which members <strong>of</strong> the public can<br />

constructively engage in the process <strong>of</strong> bringing sound science to the policy<br />

arena.<br />

Endorsed by:<br />

Comparative and Veterinary SS<br />

Regulatory and Safety Evaluation SS*<br />

Student Advisory Committee<br />

During the last decade the decoding <strong>of</strong> the human genome has provided exciting<br />

possibilities for the treatment <strong>of</strong> human disease. The promise <strong>of</strong> gene therapy<br />

and antisense have stirred the imagination to the potential <strong>of</strong> redirecting<br />

abnormal cellular processes. These therapies provide potential advantages in<br />

specificity to gene targets and selectivity for protein intervention in some<br />

disease targets that are <strong>of</strong>ten considered ‘undruggable’ with traditional<br />

chemotherapies. To date, these technologies have provided interesting technologies<br />

as research tools to gain perspective with respect to effects <strong>of</strong> various<br />

targets; in particular antisense strategies using single-strand and siRNA provide<br />

tools to validate molecular targets in disease pathways. These antisense<br />

approaches utilize different mechanisms (i.e., RISK complex and RNase H) to<br />

reduce a target protein in a manner not achievable with a small molecule<br />

approach. Gene therapy has posed the potential to treat and possibly cure disease<br />

by replacing lost function with the insertion <strong>of</strong> a normal gene. Currently, there<br />

are numerous antisense and gene therapy clinical candidates in development by<br />

corporate sponsors as well as academic centers and investigators. The selection<br />

<strong>of</strong> disease candidates and targets is complex. The administration, delivery, cell<br />

permeability, and pharmacokinetic and pharmacodynamic attributes have<br />

played a critical role in the development <strong>of</strong> these therapies. This symposium will<br />

cover the biologic and safety hurdles these therapies have faced and the solutions<br />

that have been developed to evaluate these molecules in patients. The<br />

symposium will consist <strong>of</strong> an expert panel <strong>of</strong> presenters involved in the science<br />

and development issues surrounding molecular genetic therapies.<br />

#13 9:30 THE FUTURE OF MOLECULAR GENETIC<br />

THERAPEUTICS. D. Monteith and V. Reddy. Eli Lilly<br />

and Company, Greenfield, IN.<br />

#14 9:40 GENE THERAPY: A SIMPLE CONCEPT WITH<br />

COMPLEX CHALLENGES. R. M. Lyons. Self-<br />

Employed, Gaithersburg, MD.<br />

up-to-date information at www.toxicology.org 49

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