Mast Cell Degranulation – Seek Expert Toxicologist

Hi RTC,
I have a past client that is keen on meeting experts in mast cell degranulation. Specifically, they seek an expert that can guide them through a potential screening process in discovery. They want to ensure that they are not picking a bad molecule to move into later development. Also, they are looking for someone that can help them use nonclinical data to predict clinical responses. Finally, they would also like to learn more about study designs for in vitro screening, ex vivo screening, and in vivo assessment.
Drug is a cationic peptide, probably with one or more thiols. Dose route is SC.

They are a great group with a solid very busy toxicologist on staff. If I knew more about mast cell degranulation, I would keep this project for myself. But, I am too busy right now to take on a project that is outside of core business.

Please contact me directly by Friday 5 PM Pacific if interested in introduction.

Peter

Scheduled out of office:
July 18 to July 26: no access to email or phone.
November 3: Office closed for US elections.

Peter Korytko, PhD, MBA
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Medicilon / MPI – Does anyone have experience with this CRO doing NHP studies?

Medicilon is a CRO in China that a client wants to consider using for NHP studies. Does anyone have experience doing GLP studies for FDA submission using NHP at this CRO. I see from our CRO database that they have been associated with MPI in the past. Is this still the case? Thanks and have a safe, healthy and wonderful weekend!...

 

Use of Minipigs to support an oncology program

Has anyone had experience using minipigs as the nonrodent species to support an oncology program for a monoclonal or bispecific antibody? I'm reviewing a development plan for a project out of a university laboratory and I'm told that NHPs aren't available to them for pilot work and early stage work but pigs are so they'd like to proceed with them. While I know minipigs are an acceptable nonrodent I don't recall ever seeing them being used for an oncology program and this leaves me uncertain about the reception at FDA if this project moves forward. Any thoughts on this will be appreciated.

Thanks,
Bill...

 

Client suggested using Slack; bad idea?

Hi RTC experts - I imagine someone will have crossed this bridge (or decided not to cross it) before me.

A smaller client has "invited" me to join a shared Slack channel for the program we're collaborating on. I think of Slack (perhaps naively - correct me please) as an always-on instant messenger service.

People who are employees in my client company are using Slack. But, here's the thing, they're EMPLOYEES: Pretty much whatever they're doing at their computer during the day is company-focused (and if it's not....here's looking at you Amazon Prime....maybe a pop-up reminder isn't a bad idea).

I'm happy to keep current with all clients' communications (by checking email between tasks or meetings, time permitting, and responding to [rare] urgent texts), and this has worked well to date. So I'm not sure - on a day that might include teleconferences with a couple of different clients and will absolutely include project work (protocols, reports) for a couple of different clients, not sure that I want to have something pop up in the middle of other work "ANDY IS THE RAT STUDY STARTING NEXT WEEK OR THE WEEK AFTER THAT? THANKS." (This is a smaller client, remember.)

OK, you get it.

Have you been asked to join a Slack channel, and (if so and you agreed) how has it worked for you?

I'm thinking of politely declining, and saying (1) I'm unsure this will increase my ability to meet (client) expectations, and (2) I don't wish to seem unresponsive if I'm on a teleconference with another client for 2 hours.

I read this in an article on Inc., "There's a different expectation of immediacy with real-time communication, so it's crucial your employees and your customers understand how quickly you have committed to respond. And then do it. "Unless you're really committing to responding to every channel within a very short period of time, or you're able to set specific ground rules about when people are going to be available on the channel and stick to them, you're not really able to keep that customer's experience high,"

What do RTCers advise? Thanks!
Andy

Andrew J Sonderfan, PhD, DABT
Nonclinical Strategies, LLC
asonderfan@gmail.com
+1.978.505.7138
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Desperately Seeking’ Recent Member Publications for RTC Summer 2020 Newsletter

RTCers,

As RTC Councilor, it is my duty to request your recent citations by July 24 to be included in the next RTC newsletter.

How to Submit 2020 Citations for Member Publications:

If you have a recent journal article, book chapter or book (no presentations) that was published as advance online or in hard print (no past publications, in press or in preparation) since the last call for publications in January 2020, please submit a copy of the full citation (include doi, online link or ISBN and underline your name) to me.

For a journal article, the correct format for the newsletter is found on PubMed. Just click on your article on PubMed and then click on ‘Cite’ under Actions in upper right corner of page and the citation pops up for you to copy. If you don’t do this, then I have to do it, which takes time.

Example:
Kirkland D, Levy DD, LeBaron MJ, Aardema MJ, et al. A comparison of transgenic rodent mutation and in vivo comet assay responses for 91 chemicals. Mutat Res Genet Toxicol Environ Mutagen. 2019;839:21-35. doi: 10.1016/j.mrgentox.2019.01.007.

If your article is not on PubMed, the complete citation information should be acquired from the journal website, Google Scholar or a similar reference aggregator and the DOI or ISBN number appended if applicable

Thanks in advance,
Brian
dr.brianshort@gmail.com.
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Environmental Assessment

I got a request from Tyra Miles at DJA Global Pharmaceuticals. They are looking for someone to conduct an Environmental Analysis calculation. I do not have the bandwidth at this time to take this on and hope that someone at RTC might be able to help on this. Please contact Tyra directly at tlm@djaglobalpharma.com.
Hope everyone is well. We are happy to have left Florida and are up in Kingston, NY quarantining with our daughter. Never thought in April that I would say I want to get out of Florida and go to NY!
Ed...

 

American Preclinical Services, MN

Hello all:

Does anyone have any experience or opinions on American Preclinical Services in MN? I have a client that wants to use them for GLP studies for a medical device, but I have had no experience with them. Honestly I had note heard of them before the client asked.

Thanks in advance for any help

Andrew...

 

Voting for ACT

Dear RTC colleagues
I have the honor of being nominated for the Vice President and the presidential chain for the ACT.
Our profession is being challenged because of the pandemic that has led to cancelled meetings requiring new ways of bringing people together through virtual meetings and educational courses. In addition, the field continues to be challenged to ensure the next generation of toxicologists are mentored and are given opportunities to participate in our professional societies and activities.
I ask you to support my nomination to ACT so that these and other challenges are met head-on to the benefit of toxicological sciences and the ACT. Thank you for your vote and support.
Bill
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Interesting Case Study with EPA and AD division

Interesting Case Study with a client this week to share with you all.

Client sells a sanitizing product, to clean cosmetics...

Client has been told by downstream customers / online distributiors,... You are not FIFRA compliant

I organized a pre-application meeting for client with EPA AD division, preparing to ask about Efficacy, labeling, etc..
EPA said "This is a cosmetic,... we don't regulate it"

We said "Nope, not a cosmetic, doesn't go on human body,...and we looked at your definitions of FIFRA regulation and sanitization for use,... so you regulate it."

EPA says,... "Yeah,...well, I talked to our lawyer and we quote this vague FDA rule and thus we don't regulate it, so we aren't gonna have a call with you."

Client asked EPA "Well can we have an official letter of exemption to show our clients so we can sell the product?"

EPA says "No, but you can submit the product for review and pay the $2500 fee and after 4 months, we can send a letter for exclusion of regulation if we make that determination."

Client is at least happy they have a path forward. This is your federal tax dollars at work and the level of coordination / understanding we have between the EPA and FDA, I might send a letter to my congress and senate representatives and see what they think about it. Hope you find this information helpful.

Sol Bobst
ToxSci Advisors LLC...

 

Background Check and Drug Screen

Hello all: We have all undergone a background check and drug screen as a new employee. Not unusual. Now, I have been requested to have these done for a new client. The client is a rather large corporation. Currently, I am pushing back on this particularly the drug screen given the pandemic. In the years doing consulting, this is a first. I wonder whether anyone has been requested to undergo a drug screen and background check for a new consulting project. Thanks. ...