Recombinant DNA Advisory Committee - 06/7-8/93 
Dr. Ilan responded that the cells will be selected in hygromycin; therefore, the remaining 
cells will be 100% transduced. Dr. Miller asked about the IGF-1 efficiency of inhibition 
in these transfected human cells. Dr. Ilan answered that IGF-1 production is completely 
inhibited; however, he stated that he did not have data demonstrating this inhibition. 
Dr. Miller stated that he had requested these data several weeks before the meeting. 
Critical data have not been submitted for review. Drs. Miller and Geiduschek stated 
that they could only recommend approval of this protocol contingent on the submission 
and review of IGF-1 inhibition data. 
A lengthy discussion ensued about the inappropriateness of investigators withholding 
critical data prior to a RAC meeting. The RAC members said that this practice is an 
ongoing procedural problem that must be addressed. Dr. Parkman suggested that data 
not included in the written proposal should not be allowed to be presented at the RAC 
meeting. Dr. Krogstad said that the Points to Consider states that written responses from 
the PI are due to ORDA 2 weeks before the meeting. Dr. Parkman requested that the 
Points to Consider should be amended to prevent the submission of data immediately 
prior ( < 2 weeks before meeting) and during the committee meeting. 
Committee Motion 
A motion was made by Dr. Miller and seconded by Dr. DeLeon to approve the protocol 
contingent on the submission of the following: (1) data demonstrating inhibition of IGF- 
1 expression by the antisense construct in human tumor cells, (2) data demonstrating 
repeated success in establishing primary cultures from fresh human tumors, and (3) data 
demonstrating efficiency of the transduction procedure. This document must be 
reviewed and approved by Drs. Straus, Post, Miller, Geiduschek, and Ms. Grossman. 
The motion to approve the protocol passed by a vote of 19 in favor, 0 opposed, and no 
abstentions. 
XXIV. ADDITION TO APPENDIX D OF THE NIH GUIDELINES REGARDING A SEMLIKI 
FOREST VIRUS (SFV) VECTOR EXPRESSION SYSTEM-REDUCTION OF 
PHYSICAL CONTAINMENT FROM BL3 to BL2/DR TEMPLE 
Review-Dr. Krogstad 
Dr. Walters called on Dr. Krogstad to present his primary review of the proposal 
submitted by Dr. Gary F. Temple of Life Technologies, Inc., Gaithersburg, Maryland. 
This request is a resubmission that was previously reviewed at the September 1992 RAC 
meeting. The investigators are requesting a reduction in the physical containment level 
from Biosafety Level (BL) 3 to BL2 for their Semliki Forest virus (SFV) cloning vector. 
Dr. Krogstad stated that this reclassification would make Life Technologies' SFV cloning 
kit more widely available and marketable. Since there is no jurisdiction in this area by 
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