Entries by Grace Furman

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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Use of two pathologists to read one 2-year rodent carcinogenicity study?

Hi RTC folks: I have a client who (of course) is looking to shave MONTHS off of reporting timelines for 2-year rat and mouse carci studies being conducted at CRL. CRL has indicated that the best way to approach this kind of challenge would be to have 2 pathologists read each study (one pathologist reading the males and the other pathologist reading the females). Both studies would also be formally peer reviewed. So that means there'll be 3 pathologists involved in each study. I see this being the head lamp of an oncoming train, but I'm willing to let previous experience influence my opinion of impending doom. Has anyone in the RTC ever resorted to this 2-pathologists option to expedite carci study readouts and, if so, did that approach ultimately work out in your client's favor? I'm also interested in hearing from the RTC pathologists about whether/not this approach is a good idea from a pathologist's perspective.  Thanks in advance for any input you can provide on this. Happy Friday!Grace Furman    
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Consulting Virologist?

Hello RTC folks! Does anyone know of a consulting virologist? This would be specifically for a COVID-related program. Thanks in advance for any suggestions/recommendations! Grace M. Furman, PhD DABTPresident & CEOParacelsus, Inc.Email:  Paracelsus.inc@cox.netPhone:  (760) 271-2858Website:  http://www.ParacelsusConsulting.com "All things are poison and nothing is without poison, only the dose permits something not to be poisonous."-Theophrastus Phillippus Aureolus Bombastus von Hohenheim (Paracelsus) 
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Ophthalmology Drug Product CMC Expertise?

Hi RTC folks: Can anyone recommend a CMC drug product consultant with experience/expertise with ophthalmology drug products? Thanks in advance for any recommendations! Grace M. Furman, PhD DABTPresident & CEOParacelsus, Inc.Email:  Paracelsus.inc@cox.netPhone:  (760) 271-2858Website:  http://www.ParacelsusConsulting.com "All things are poison and nothing is without poison, only the dose permits something not to be poisonous."-Theophrastus Phillippus Aureolus Bombastus von Hohenheim (Paracelsus) 
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Chinese tox data acceptable to ANSM (France)?

Hi RTC folks: Are any of you aware of tox data generated by a Chinese CRO being accepted by the French health authority (ANSM) to support clinical trials in France? Thanks in advance for any intelligence on this- Grace M. Furman, PhD DABTPresident & CEOEmail:  Paracelsus.inc@cox.netPhone:  (760) 271-2858Website:  http://www.ParacelsusConsulting.com "All things are poison and nothing is without poison, only the dose permits something not to be poisonous."-Theophrastus Phillippus Aureolus Bombastus von Hohenheim (Paracelsus) 
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RTC Speakers Needed for 2021 ACT Consulting Workshop

Hi RTC folks: As you may have read in the 2020 Summer Newsletter which was sent out yesterday, one of Peter Korytko's goals as 2020 RTC President is to increase RTC's visibility in the scientific community. One of the drivers behind this is that our Roundtable of very experienced consulting professionals has been (or shortly will be) losing key talent to well-deserved retirements. We need to find a way to ensure a supply of high-quality toxicology consultants to carry the RTC torch forward. To this end, the RTC will be submitting a proposal for a "So You Want to be a Consultant" workshop at the 2021 ACT Annual Meeting.  As RTC President next year, I'll be leading this effort and will be responsible for submitting the proposal to ACT's on-line proposal system (deadline:  31 December). The RTC Executive Committee (RTC EC) has drafted a preliminary outline for the workshop; the purpose of this this email is to solicit RTC speakers for the various topics to be covered in this workshop. Below is a strawman of the workshop; none of the session titles (or the title of the workshop itself, for that matter) are firm, but the concepts/topics outlined below is what the RTC EC envisions. There will be an interactive Q&A session after the presentations have been made; this Q&A session will be the highlight of the workshop. If you're interested in speaking on one of the following topics, please contact me directly for further information!Welcome & Introduction (10 min)Speaker:  Grace Furman, 2021 RTC PresidentWhy become an independent consultant and how to do it (20 min)Topics:  Why you? Why now? How to know when you're ready; what services to offer; differences between independent consulting and consulting groups; resources for independent consultants; key content from RTC Annual Survey; effect of COVID-19 on independent consulting Speaker:  Grace Furman (but I'll defer to other RTC members with strong interest in speaking on this topic!)How to set up a consulting practice (20 min)Topics:  Business model/legal structure; overhead (attorneys, CPAs, accountants); taxes and retirement planning; insurance; finance managementSpeaker:  ???Marketing and business development (20 min)Topics:  Developing your 'brand'; how to market your business; how to find (and keep) clientsSpeaker:  ???Break (30 min)Money (20 min)Topics:  Setting your hourly rate; full-time vs. part-time consulting; how to vet clients to determine if they have fundsSpeaker:  ???Q&A Session (1 hour)This will be the highlight of the workshopQuestions will be solicited from workshop registrants prior to the workshop, during the break and "live" during the Q&A session. Speakers will form the panel, but all RTC members attending the workshop will be encouraged to participate in the Q&A dialogue as we each have different experiences to share. For reference (from the ACT on-line proposal system):Workshops are intended to be interactive programs that engage attendees in discussion. Workshops may focus on areas of current controversy and on cutting-edge knowledge, techniques, and skills relative to a specific area of toxicology.Workshop sessions are three hours each (including a 30-minute break) and are held Monday through Wednesday, either in the morning or afternoon. Breaks are scheduled at the same time for all Symposia and Workshops (morning breaks 10:15 am–10:45 am; afternoon breaks 3:15 pm–3:45 pm).  Grace M. Furman, PhD DABTPresident & CEOParacelsus, Inc. Email:  Paracelsus.inc@cox.netPhone:  (760) 271-2858Website:  http://www.ParacelsusConsulting.com "All things are poison and nothing is without poison, only the dose permits something not to be poisonous."-Theophrastus Phillippus Aureolus Bombastus von Hohenheim (Paracelsus) 
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