Entries by Grace Furman

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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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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RTC Co-Sponsored Workshop at ACT Annual Meeting – Please Participate!

Hi RTC Members:

The RTC will be co-sponsoring a workshop entitled "So, You Want To Be A
Consultant" at the upcoming virtual ACT Annual Meeting. The Workshop is
scheduled for Tuesday, November 16th from noon-3:30 PM EST. The agenda
details are provided at the end of this email.

The format of the workshop is a series of 4 high-level presentations, a
30-minute break, and then a 1.75-hour interactive Q&A session, which will be
the heart of this workshop. During this Q&A session, questions (which can be
submitted via the on-line chat function any time during the workshop) will
be addressed by the 4 speakers AND/OR RTC MEMBERS WHO WILL BE PARTICIPATING
IN THE WORKSHOP. As a member of the RTC, your participation in this workshop
would be greatly appreciated! The workshop is free to all meeting
registrants - no pre-registration required. Please plan on attending the
workshop and helping the 4 panelists address questions submitted by aspiring
independent consultants. Every one of us has unique and valuable experiences
and insights that can be shared during the Q&A session!

I hope to "see" you at the workshop on the 16th!

Grace (2021 RTC President)

AGENDA DETAILS

12:00 Noon-12:10 PM Welcome and Introduction
Grace Furman, Paracelsus, Inc., Leucadia, CA

12:00 Noon-12:10 PM Would Independent Consulting Be a Good Fit for You?
Grace Furman, Paracelsus, Inc., Leucadia, CA

12:25 PM-12:40 PM How to Set Up a Consulting Practice
Robin Guy, Robin Guy Consulting, LLC, Lake Forest, IL

12:40 PM-12:55 PM Marketing and Business Development
Christopher P. Chengelis, Chengelis Scientific Consulting Services, Ashland,
OH

12:55 PM-1:15 PM Business Models and Financial Considerations
Peter Korytko, Preclinical GPS, Bainbridge Island, WA

1:15 PM-1:45 PM Break

1:45 PM-3:30 PM Interactive Discussion...

 

Inotiv Acquires Genetox Assets From BioReliance

Hello, RTC folks: For those who haven't seen it yet:  Inotiv Acquires Genetic Toxicology Assets from MilliporeSigma's BioReliance® portfolio (https://ca.finance.yahoo.com/news/inotiv-acquires-genetic-toxicology-assets-123300087.html) Have a great week!Grace 
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Otic pathology expertise?

Hi RTC folks: Can anyone recommend a pathologist with expertise in evaluating otic (intra-tympanic) studies? This would be for a peer review. Thanks in advance for any suggestions/recommendations! Grace
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Please take a moment to complete the RTC 2020 Business Practices Survey

Hi RTC folks: We need a bit more participation for the RTC 2020 Business Practices Survey, so we're keeping the survey open until Friday June 11th. The Survey was opened on May 10th, and in the 15 days thereafter, 41 (of approximately 120) RTC members completed the survey. It would be great if we could get some more involvement to ensure that this survey reflects the diversity of our membership. For those members who may be experiencing "survey hesitancy", rest assured that the Survey is secure and completely anonymous. Survey results will be shared with RTC members only. To complete the Survey, lease (1) log in to the RTC website and then (2) follow this link to access the survey: www.toxconsultants.com/eforms/2020-rtc-business-practices-revenue-survey/25/ Thanks for your participation! Grace 
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PPAR agonist/antagonist binding assays?

HI RTC folks: Do any of you have experience/expertise in interpreting PPAR agonist/antagonist binding assays? One of my clients is developing a molecule that has "hit" on PPAR alpha and gamma receptor subtypes in a screening nuclear receptor assay run in agonist and antagonist modes. Figuring out what these screening data mean is beyond my expertise. Is there anyone in the RTC that can walk my client through these data ASAP (with a Consulting Agreement in place, of course)? Thanks in advance! Grace 
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Pathologist traveling to China?

Hi everyone: Is anyone aware of any ACVP-boarded consulting pathologists who are either based in China or would consider traveling to China to read slides? Yes, I'm aware of WuXi's DACVP pathologist, but she's currently not an option (apparently she's not in China right now and is "expected" to return in September). This isn't an urgent matter – I'm looking for options for the end of this year or next year.  Thanks in advance for any suggestions- Grace
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FDA SEND Technical Rejection Criteria: 90-Day Notice

Hi RTC colleagues: FYI below regarding pending requirements relating to FDA Technical Rejection Criteria (SEND). If you have any questions, please feel free to contact Pete Dugan at PDS directly. GraceHi Grace, The FDA has been busy. On March 18, 2021, the FDA released an update to the FDA Technical Rejection Criteria.  The document is attached, and also the link to download is provided here:https://www.fda.gov/media/100743/downloadThe FDA Technical Rejection Criteria has been around for some time, always stipulating that this automated check at the FDA will one day be activated and the industry would receive 90 days' notice.March 18, 2021 is the start of the 90 days' notice.  Effective September 15, 2021 the automated check/rejection will be active.  This applies to studies submitted in the following folders on the FDA structure4.2.3.1 Single Dose Toxicity Studies4.2.3.2 Repeat Dose Toxicity Studies4.2.3.4 Carcinogenicity studies (This includes all carcinogenicity studies including subfolders 4.2.3.4.1 Long Term and 4.2.3.4.2 Short or Medium Term studies and 4.2.3.4.3 Other studies)What does this mean for PDS' clients and the industry?Prior to this announcement, the FDA was not rejecting study submissions that did not include SEND or a TS domain, despite being required by the FDA Technical Conformance Guide.  Now submissions will be automatically rejected if a TS at minimum is not provided.  If the study is after the FDA required SEND dates, and SEND is not provided, the study will automatically be rejected.  Thus clients/sponsors will have to build time and budget in for SEND or TS domains.  The excuse or rationale of we didn't have time for SEND will no longer be acceptable.  Even if the sponsor is submitting a draft report, they will need SEND or TS domains to accompany the draft report submission.  Then they will need an updated SEND dataset to accompany the final report, should anything have changed.What does this mean for PDS and our clients?Currently PDS already complies with this mandate and creates full SEND datasets or TS only domains for studies which predate SEND.  Thus PDS is already positioned to meet our clients' needs.Please reach out if you have any questions or if you would like to discuss our SEND Express service. Pete...

 

Discovery tox support?

Hi RTC folks: A startup company is looking for a consulting toxicologist to help them develop an early screening tox "platform" for their library of compounds. This company is developing new approaches to target known signaling pathways in oncology with known safety profiles. The consultant would help this client set up in vitro screens to deploy in conjunction with chemistry, pharmacology and DMPK screening to maximize "TI" potential as early as possible in the discovery process. If you're interested, please contact Kim Stickland directly at kim.stickland@gmail.com. Cheers! Grace M. Furman, PhD DABTPresident & CEOParacelsus, Inc. 
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