Entries by Peter Korytko

Bridging study to support new CMC process

Hi RTC, I have a team that is convinced that a "bridging strategy" will save the timeline for their IND-enabling small molecule program (small molecule, not oncology). They want to proceed quickly with IND-enabling GLP toxicology program with a current lot of drug. In parallel, they want to develop and optimize the CMC process, and then produce clinical supplies using the new GMP process.  Then, they propose to run a 2-week rat toxicology study with the GMP clinical batch to "bridge" the toxicology program (previously done with lot from old process) to the clinical lot (with the final CMC process). I am against this because most of the program would be done with a lot of material that is not representative of the clinical lot (genetic toxicology included).  Also, I am having a hard time seeing the savings in time because we still would need to run that 2-week "bridging" study. That 2 week study will take almost as much time as a standard 4-week toxicology program. In short, I want the IND-enabling toxicology program to use a toxicology lot that used the same manufacturing process as the clinical lot.  This team is hard to convince.   Has anyone heard of a bridging study like this? Or is my team brilliant with ideas that are not thought of elsewhere?   Thanks,   Peter
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RTC – external recognition within tox community

Hi RTC, Here is good news for RTC: The RTC is included within list of well-established toxicology-related organizations on the SOT website for the Triennial Salary Survey. That is really nice external recognition of RTC as an organization. Others will see us on this list also. That is all good for RTC.   Academy of Toxicological Sciences American Board of Toxicology American College of Toxicology Environmental Mutagenesis and Genomics Society Roundtable of Toxicology Consultants Society for Risk Analysis Society of Environmental Toxicology and Chemistry Safety Pharmacology Society Society of Toxicological Pathology Society of Toxicology The Society for Birth Defects Research and Prevention The Society of Toxicology of Canada The Toxicology Forum  
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CRO Rebranding and Transformation – (re)new kid on block

RTC, Please see transformation of Battelle, below, as sent to me by sales person at Amplify Bio.   "I wanted to provide a quick heads up that today Battelle will announce the creation of a new, for profit, company: Amplify Bio.  This new preclinical CRO will have over $200 million in combined assets and cash.  The former Battelle toxicology facility (room map attached) along with the entire staff of >125 people have transitioned over to Amplify Bio.  This transition is now complete, and we are ready to do business.  All studies that were in house have already been transitioned over with the sponsors informed.  I believe this new CRO will offer the market a much-needed choice in preclinical outsourcing.  By shedding all the government procedures and restraints, Amplify Bio will be more competitive in both pricing and process."   Peter
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RTC Salary and Marketing Survey – Any new questions?

Hi RTC, We are about to release the annual Salary and Marketing Survey. If you have any questions that you would like to add to the survey, please send them directly to me or comment in this thread on the Talklist.  Deadline is Monday noon Pacific Time to add new questions to the Survey. Thanks, Peter Vaccines save lives.  
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SC to sublingual switching

Hi RTC, I have a client that has completed an entire toxicology program up to 4 weeks in rat and dog using a peptide dosed once daily by SC injection. Client wants to switch to sublingual dosing – daily for up to 4 weeks. For the toxicology program to support sublingual switching, do we need to repeat toxicology studies in 2 species? Or is one species enough since subcutaneous dosing was already completed using 2 species. Also, how many doses would be needed to support 4 weeks of sublingual dosing in humans. Can we just do a single dose sublingual assessment for local tolerance and rely upon SC dosing studies for up to 4 weeks (complete in past)?  Or do we need to do a full 4-week study by sublingual dosing? Thanks, Peter   Vaccines save lives.   Scheduled out of office: April 16, 2021; July 16 to July 24; August 30 to Sept 11 (Tentative); November 13 to 19 (ACT & RTC Meeting/Training).   Peter Korytko, PhD, MBA Preclinical GPS 206/842-1004 office or 206/473-2913 mobile 00-1-206-473-2913  or +-1-206-473-2913 http://www.linkedin.com/in/peterkorytko ; http://www.preclinicalgps.com/  
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RTC Annual Business Meeting – Reminder for meeting today – Zoom details below – 3 PM Eastern, 2 PM Central, 1 PM Mountain, Noon Pacific

Dear RTC, Please join us for the Annual Roundtable of Toxicology Consultants Meeting via Zoom.   Participants will be admitted into the meeting by the host. Please note participants will be muted upon entry into meeting. Chat will be available for question or comments. Slides will be shared during the meeting. Join Zoom Meeting https://zoom.us/j/93072100542?from=addon Meeting ID: 930 7210 0542 One tap mobile +12532158782,,93072100542# US (Tacoma) +13462487799,,93072100542# US (Houston) Dial by your location +1 253 215 8782 US (Tacoma) +1 346 248 7799 US (Houston) +1 669 900 9128 US (San Jose) +1 301 715 8592 US (Washington DC) +1 312 626 6799 US (Chicago) +1 646 558 8656 US (New York) +1 204 272 7920 Canada +1 438 809 7799 Canada +1 587 328 1099 Canada +1 647 374 4685 Canada +1 647 558 0588 Canada +1 778 907 2071 Canada Meeting ID: 930 7210 0542 Find your local number: https://zoom.us/u/ad1R35TrbU    
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RTC – 2021 Annual Business Meeting – Zoom Meeting on Wednesday March 10 at 3 PM Eastern, 2 PM Central, 1 PM Mountain, 12 PM Pacific Details below – see also Eblast email.

Please join us for the Annual Roundtable of Toxicology Consultants Business Meeting via Zoom.   Participants will be admitted into the meeting by the host. Please note participants will be muted upon entry into meeting. Chat will be available for question or comments. Slides will be shared during the meeting. Join Zoom Meeting https://zoom.us/j/93072100542?from=addon Meeting ID: 930 7210 0542 One tap mobile +12532158782,,93072100542# US (Tacoma) +13462487799,,93072100542# US (Houston) Dial by your location +1 253 215 8782 US (Tacoma) +1 346 248 7799 US (Houston) +1 669 900 9128 US (San Jose) +1 301 715 8592 US (Washington DC) +1 312 626 6799 US (Chicago) +1 646 558 8656 US (New York) +1 204 272 7920 Canada +1 438 809 7799 Canada +1 587 328 1099 Canada +1 647 374 4685 Canada +1 647 558 0588 Canada +1 778 907 2071 Canada Meeting ID: 930 7210 0542 Find your local number: https://zoom.us/u/ad1R35TrbU  
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RTC Elections – vote today

Hi RTC, If you voted for RTC EC elections already, Thank You! If you have not yet voted, please vote!   https://www.toxconsultants.com/eforms/2021-rtc-ballot-copy/23/              
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