A meeting of Southern Research’s Institutional Biosafety Committee convened on Thursday, 13 Nov 2025, in Birmingham, Alabama 35205.
The following participants were present:
Participant, Voting Status
Rebecca Boohaker, Voting
Enatra Hale, Voting
Mark Jackson (by phone), Voting
Lamar Jones, Voting
Steven Orr, Voting
La’Wanda Parker, Voting
Carson Sakamoto, Voting
James Toomey, Voting
Christina Humphries, Ex-Officio
Erin Luea, Visitor
Miranda Nebane, Visitor
1. Review and Approval of Meeting Agenda
The Chairperson called the meeting to order. The Chairperson asked the committee to
review the agenda. A motion was made to approve. A second was made and by voice vote
the agenda was approved.
2. Review and Approval of Previous Meeting Minutes
• 09 Oct 2025 – A motion was made to approve. A second was made, and by voice
vote the minutes were approved.
3. New Business
• BSO Notes/OSP Reportable Incidents Report – None to report.
4. Review and Approval of BPRs and Amendments
R24-03-007NS Amendment 7
Title: Core Non-Infectious HTS Assays
RS: Miranda Nebane-Ngwa
IBC reviewed, no comments or contingencies were received. A motion was made to
approve as submitted, a second was made, and by voice vote the BPR amendment was
approved.
• Agent Name: human FGFR4 and PLCg cDNA Inserts
• Agent Characteristics: No change from core
• Containment Conditions: BSL-2INSTITUTIONAL BIOSAFETY COMMITTEE Minutes, Page 2 of 4
• Sources of the Inserted DNA Sequences: commercially supplied
• Foreign Gene Expression: Hek293t cells express fusion protein
• Protein Expressed: fusion proteins
• Applicable Section(s) of the NIH Guidelines: Section III D 3
• Types of Manipulations Planned: Same as Core
24-03-007NS Amendment 8
Title: Core Non-Infectious HTS Assays
RS: Miranda Nebane-Ngwa
IBC reviewed, no comments or contingencies were received. A motion was made to
approve as submitted, a second was made, and by voice vote the BPR amendment was
approved.
• Agent Name: human FGFR4 and PLCg cDNA Inserts
• Agent Characteristics: No change from core
• Containment Conditions: BSL-2
• Sources of the Inserted DNA Sequences: commercially supplied
• Foreign Gene Expression: Hek293t cells express fusion protein
• Protein Expressed: fusion proteins
• Applicable Section(s) of the NIH Guidelines: Section III D 3
• Types of Manipulations Planned: Same as Core
R25-10-019NS
Title: Maximum Tolerated Dose Study in Sprague Dawley Rats via an Escalating Dose of
an Implanted SymphNode Formulation Disk
RS: Erin Luea
IBC reviewed, comments and contingencies were received. A motion was made to approve
with additions, a second was made, and by voice vote the BPR amendment was approved.
• Agent Name: SymphNode
• Agent Characteristics: A small injectable test material disk that is designed to target
and activate tumor-experienced immune cells, particularly T cells, to support their anti-
tumor activities.
• Containment Conditions: BSL-2, ABSL-2
• Sources of the Inserted DNA Sequences: Study sponsor
• Foreign Gene Expression: n/a
• Protein Expressed: n/a
• Applicable Section(s) of the NIH Guidelines: III-D-4-b
• Types of Manipulations Planned: Animals will be implanted with a formulation disc at
increasing concentrations and tumor growth monitored.
Contingency 1: Check BSL-2 in Section 5.13a for in-vitro work.
Response: The column mark for BSL-2 surveillance has been added for this section.
Contingency 2: Since this does not have a biological agent or virus, the decontamination section
was not required to be completed. What are the decontamination procedures for this study or
appropriate disinfectants since it is ABSL-2?
Response: Correct, there is not a biological agent or virus in the test material or study. ThereINSTITUTIONAL BIOSAFETY COMMITTEE Minutes, Page 3 of 4
should not be any specific decontamination procedures for the IL-2 component of the test
material. Appropriate disinfectants for this study will include Lysol and Coverage.
Contingency 3: Should section 6.4e be checked since it stated there was no vector previously?
Response: I read this section as identification of the material source. I have removed these
check marks as Section 6.4b is appropriately marked as no.
Contingency 4: Both yes and no are checked for 8.3a.
Response: Section 8.3a has been updated to only indicate ‘yes’. The material has a human
IL-2 component.
Contingency 5: Section 4.2: States No, has training been conducted? Recommend it for all
staff handling this study.
Response: Will request training materials for the IL-2 component as suggested.
Contingency 6: Section 5.9 states: Intraperitoneal injection of disk, however, I believe it is
planned to be surgically implanted between the shoulder blades of the animal.
Response: The dose implantation site has been updated recently in other meetings. This
document was submitted prior to the updates. The Section has been updated accordingly to
indicate intrascapular implantation site throughout the document.
Contingency 7: 5.9 (e) just states CCP, there is not a room number. Recommend CCP 138 IF
a BSC is needed. If not, the surgical suite
Response: Implant room has been updated to CCP surgical suite with the intention that a BSC
will not be required.
Contingency 8: 5.9 (f) Animals will be housed in CCP 243/244.
Response: Animal study room has been updated as indicated; CCP 243/244.
Contingency 9: 5.9 (g): Is a BSC required? States it is required in section 5.11.
Response: Section 5.9g has been updated to include that due to the nature of the surgical
procedure, animals will be appropriately anesthetized which will reduce potential safety risk at
time of implantation.
Contingency 10: Section 5.11: Is this a A/BSL2? Recombinant human IL-2 (aldesleukin,
Proleukin equivalent) itself is a protein, right? Is it an infectious biological agent or pathogen?
Response: Recombinant human IL-2 is not infectious agent or pathogen, it is a protein.
Contingency 11: 5.11 (d) same as above. Is a BSC needed for blood collection?
Response: In Section 5.11d, I removed the requirement of BSC for blood collection. I do
not think there is a risk to the technical team that would require the use of the BSC for
this project.
Contingency 12: 5.11 (e): If it does not shed, then does the bedding need to be
disinfected/decontaminated prior to leaving the room? Is it only needed for animals that have
been surgically implanted with the disc?
Response: The bedding should not need to be disinfected prior to leaving the room. All animals
in treated groups will have discs implanted that contain the IL-2 protein.INSTITUTIONAL BIOSAFETY COMMITTEE Minutes, Page 4 of 4
Contingency 13: 5.14 (a) does not look completed.
Response: Section 5.14a has been updated to include comments for animal waste/cages that
indicate additional disinfecting is not required.
BPR Amendments Approved Via Biosafety Officer Review:
• R23-04-003SA Amendment 6
o Title: High Throughput Screening of Broad-Spectrum Viruses at BSL2 and BSL3
o RS: Miranda Nebane-Ngwa
o BPR amendment was approved 05Nov2025.
Amendment Summary: All HTS laboratories in the Southern Research NRB (New
Research Building) were added to the core BPR.
• R24-03-008NS Amendment 1
o Title: General Protocol for Cancer Model Use and Drug Evaluation in the Cancer
Therapeutics Group
o RS: Rebecca Boohaker
o BPR amendment was approved 10Nov2025
Amendment Summary: Section 1.4 of the original BPR was amended to add additional key
personnel.Section 5.8 of the original BRP was amended to update the BPR reference
relating to cell cultures.
5. Next Meeting
The next Institutional Biosafety Committee meeting is scheduled for Thursday,
11 December 2025 at 11:15 in Birmingham.
6. Adjourn