Not sure this post made it to talk list

All, I Wanted to let folks know I won’t be renewing my membership for this coming year as I recently accepted a position (part time) with Alumis Inc. I joined a management team I was familiar with as many of them had formerly been with Principia Biopharma, a company I had consulted with for the past 10 years. It has certainly been a pleasure being part of the RTC, and hoping to refresh my membership before too long! All the best in the New Year, MikeMichael J. Taylor, PhDNonClinical Safety AssessmentOffice hours: 9 am - 4 pm (PT) - M, W, Th micjtay@gmail.com650-796-2683www.nonclin.comThis email and any attachments thereto may contain private, confidential, and privileged material for the sole use of the intended recipient. Any review, copying, or distribution of this email (or any attachments thereto) by others is strictly prohibited. If you are not the intended recipient, please contact the sender immediately and permanently delete the original and any copies of this email and any attachments thereto....

 

Consulting Opportunity – Small Molecule Oncology

Hi RTC folks: I'm hoping to connect MAIA Biotechnology with an experienced consulting toxicologist with expertise in small molecule oncology development programs. The ideal consultant will have experience conducting tox studies in India (specifically, Eurofins); studies are scheduled to begin in January. If you have interest in/availability for a new client and you think you'd be a good fit for this client, please contact Vlad Vitoc directly at vvitoc@maiabiotech.com. Cheers!Grace  
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Client needs expert to respond to FDA queries on environmental assessment portion of an NDA under review

Urgent - an RTC member or a recommndation Regards,  Shayne C. Gad, Ph.D., DABT Principal Gad Consulting Services 4008 Barrett Drive, Suite 201 Raleigh, NC 27609 Phone: (919) 233-2926 Fax: (919) 233-2927 www.gadconsulting.com NOTICE:  The information contained in this email and any document attached hereto is intended only for the named recipient(s). If you are not the intended recipient, nor the employee or agent responsible for delivering this message in confidence to the intended recipient(s), you are hereby notified that you have received this transmittal in error, and any review, dissemination, distribution or copying of this transmittal or its attachments is strictly prohibited. If you have received this transmittal and/or attachments in error, please notify me immediately by reply e-mail and then delete this message, including any attachments.
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7-Day toxicology studies to support Phase 1 studies in Europe

Hello all:  I have a client with a small molecule intravenous drug for stroke.  The anticipated duration of therapy in patients has been projected for one but no more than three administrations.  Based upon ICH M3 (R2) we did 7-Day repeated IV studies in rats and dogs (Footnote "a" of Table 1 indicating acceptability in the USA).  Our clinical site was then changed to Hungary for the Phase 1 SAD and MAD (was going to be at least 3 days).  But the Hungarian Regulatory Authority has indicated they want 14-Day repeat dose toxicology studies apparently to even support a single administration SAD.  We've pushed back once and they've not moved.  Does anyone have any real or anecdotal evidence for using 7-Day studies to support this type of clinical program in Europe?     Thanks, in advance, for any time and help on this.  BTW – if you'd prefer a direct chat, feel free to call me on my mobile of 847-530-3684).  And wishing you and yours the happiest and safest of holidays.   Stan  
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In Vitro Toxicology Assays – Adrenal Glands

Dear Colleagues, Can someone recommend an academic lab or boutique CRO that conducts in vitro toxicity assays? I am primarily interested in assays which utilize adrenal gland cell culture systems; rats, dogs, and human cell lines would be best. I am aware of the EPA/OECD steroidogenesis assay which uses the human H295R adreno-carcinoma cell line to detect potential perturbation of estradiol and testosterone synthesis, but am interested in other in vitro systems.  Thanks in advance. Regards, Barry___________________________________Barry S. Levine, DScDiplomate, American Board of ToxicologyLevine Tox ConsultingConsultants in Toxicology   and Nonclinical Development2440 N. Lakeview Ave.Suite 7EFChicago, IL 60614Tel (773) 697-4846Fax (312) 546-6334Cell (312) 550-0100email bslevine@LevineToxConsulting.comwebsite www.LevineToxConsulting.com 
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Attentive Science

Dear Colleagues, Does anyone have experience with Attentive Science in Kansas?  Thanks. Regards, Barry___________________________________Barry S. Levine, DScDiplomate, American Board of ToxicologyLevine Tox ConsultingConsultants in Toxicology   and Nonclinical Development2440 N. Lakeview Ave.Suite 7EFChicago, IL 60614Tel (773) 697-4846Fax (312) 546-6334Cell (312) 550-0100email bslevine@LevineToxConsulting.comwebsite www.LevineToxConsulting.com 
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RTC at ACT

First, great job Grace, Chris, Robin and Dave, and appreciate RTC’s support of ACT.   It would be great if RTC could provide another symposium, workshop or Continue Ed course next year as we continue to forge a closer alliance with the College. In particular, we are looking for interactive type course (talk with an expert, problem/case study learning).   However, proposals are due by Dec. 31!  They don’t have to be complete, but the more complete the better chance of being accepted. If interested, there is a separate system for logging in proposals. Use this link: https://flame.firebird.systems/ACT/ACTSessions2022/MySubmissions   Love to have another great contribution from the RTC,  Jeff (2022 ACT Education Committee Chair)   Jeff Tepper, PhD, DABT, DSP Tepper Nonclinical Consulting San Carlos, CA  94070 (510) 717-1413 TepperTox@gmail.com www.TepperTox.com   From: Roundtable of Toxicology Consultants <admin@toxconsultants.com> Sent: Tuesday, November 16, 2021 2:06 PM To: Jeff Tepper <Jeff@teppertox.com> Subject: RTC at ACT   webversion | unsubscribe | update profile   ‌ RTC at ACT ‌   ‌ RTC at ACT Hey RTC, Today was a good day. Last year, we set the goal of increasing visibility of RTC. Today, the RTC cosponsored the ACT workshop “So, you want to be a consultant.” This was a 3-hour work shop with brief presentations and lots of Q&A. Thank you to Grace for her leadership in this program, and to Chris Chengelis, Robin Guy and Dave Serota for presentations plus all of the work it takes to put together a workshop at ACT. I thought it was very informative and fun. We already received positive feedback from participants. If you would like to help promote RTC by organizing a future workshop at an international conference, please contact Grace or me to discuss. Thanks again to the RTC members that helped get RTC on stage at ACT. Best Regards, Peter Korytko Past President, RTC Read More ‌   ‌ You have received this email because you have subscribed to Roundtable of Toxicology Consultants as jeff@teppertox.com. If you no longer wish to receive emails please unsubscribe © 2021 Roundtable of Toxicology Consultants, All rights reserved ‌  
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CROs that can work with Schedule 1 drugs?

Hi RTC folks: I'm looking to identify a list of reputable tox CRO (other than CRL) that can work with a Schedule 1 test article. If you have experience in this area and can recommend a particular CRO, can you please let me know? Thanks! Grace 
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Just had a CRL lab state thta the have to have a sponsor protocol number on protocols. Never heard this one before

Anyone else? Regards,  Shayne C. Gad, Ph.D., DABT Principal Gad Consulting Services 4008 Barrett Drive, Suite 201 Raleigh, NC 27609 Phone: (919) 233-2926 Fax: (919) 233-2927 www.gadconsulting.com NOTICE:  The information contained in this email and any document attached hereto is intended only for the named recipient(s). If you are not the intended recipient, nor the employee or agent responsible for delivering this message in confidence to the intended recipient(s), you are hereby notified that you have received this transmittal in error, and any review, dissemination, distribution or copying of this transmittal or its attachments is strictly prohibited. If you have received this transmittal and/or attachments in error, please notify me immediately by reply e-mail and then delete this message, including any attachments.
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Who would like to do an dusit of a full program of studies to support an IND application at Wuxi in the next month?

Client has a good payment record Regards,  Shayne C. Gad, Ph.D., DABT Principal Gad Consulting Services 4008 Barrett Drive, Suite 201 Raleigh, NC 27609 Phone: (919) 233-2926 Fax: (919) 233-2927 www.gadconsulting.com NOTICE:  The information contained in this email and any document attached hereto is intended only for the named recipient(s). If you are not the intended recipient, nor the employee or agent responsible for delivering this message in confidence to the intended recipient(s), you are hereby notified that you have received this transmittal in error, and any review, dissemination, distribution or copying of this transmittal or its attachments is strictly prohibited. If you have received this transmittal and/or attachments in error, please notify me immediately by reply e-mail and then delete this message, including any attachments.
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