Geron using The Medical Affairs Company (TMAC) in Europe for P3 IMpact Clinical Trial enrollment....

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kmall
Posts: 399
Joined: Thu Mar 21, 2019 3:57 pm

Geron using The Medical Affairs Company (TMAC) in Europe for P3 IMpact Clinical Trial enrollment....

Post by kmall » Thu Nov 24, 2022 2:31 am

Chiara Elia - Clinical Trial Liaison for Geron Corporation in Italy, Austria, Germany Switzerland and Denmark

The Medical Affairs Company (TMAC)
Modena, Emilia-Romagna, Italy


Chiara Elia:
"More than 15years of experience in clinical trial management.
Experience in various therapeutic areas.
Currently employed as Clinical Trail Liaison for Italy, Austria, Germany and Denmark for Geron (US).
Empathic with people with passionate commitment for work."

It appears that in the above 5 mentioned countries, each has at least one location "not yet recruiting":

Italy:
1. AOU San Luigi Gonzaga - Not yet recruiting
Orbassano, Torino, Italy, 10043

2. Arcispedale S Maria Nuova, AO di Reggio Emilia - Not yet recruiting
Reggio Calabria, Italy, 42123

Austria:
1. Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhügel - Not yet recruiting
Wein, Burgenland, Austria, 1130

Germany:
1. Universitätsklinikum Leipzig AöR - Not yet recruiting
Leipzig, Sachsen, Germany, 04103

Switzerland:
1. Universitaetsspital Zuerich - Not yet recruiting
Zurich, Switzerland, 8091

Denmark:
1. Aarhus University Hospital - Hematology - Not yet recruiting
Aarhus, Denmark, 8200

https://clinicaltrials.gov/ct2/show/NCT ... w=2&rank=4


*Interesting that Geron is using a 3rd party at this point to aid in recruitment goals.......

The Medical Affairs Company (TMAC):
https://www.themedicalaffairscompany.com/

My guess.....and it's only that, is that Geron needs to enroll IMpactMF at a pace that would enable an interim analysis in 2024 and a final analysis in 2025.

Take a look at the 4/13/2021 PR for the first patient dosed in the P3 IMpact Clinical Trial......

Use of Forward-Looking Statements (4/13/2021)....

"and (h) whether Geron is able to enroll IMpactMF at a pace that would enable an interim analysis in 2024 and a final analysis in 2025."

https://ir.geron.com/investors/press-re ... fault.aspx

Or perhaps it has something to do with filing an NDA in the EU ?

https://www.ema.europa.eu/en/human-regu ... -step-step

Something tells me it could lean more towards the latter since all 5 counties listed are in the EU......only time will tell, and something else to ponder as we digest our turkey and pumpkin pie while anticipating ASH and January's TLR. Happy Thanksgiving everyone! -Kmall

kmall
Posts: 399
Joined: Thu Mar 21, 2019 3:57 pm

Re: Geron using The Medical Affairs Company (TMAC) in Europe for P3 IMpact Clinical Trial enrollment....

Post by kmall » Tue Nov 29, 2022 7:05 pm

Belén Castillo - Clinical Trial Liaison at The Medical Affairs Company (TMAC) for Geron Corporation

Barcelona, Spain

Aug 2020 - Present 2 yrs 4 mos
Barcelona, Cataluña / Catalunya, España
Clinical Science Liaison responsible for the area of Hemato-oncology in Europe (Bulgaria, Georgia, Italy, Poland, Portugal, Spain, and Turkey), and LATAM (Argentina, Brazil and Colombia).
• Field-based representation of The Medical Affairs Company (TMAC) on behalf of Geron in Hemato-oncology in Europe Region.
• Field based liaison providing clinical support and optimization of enrollment process.
• Develop and enhance professional relationships with principal investigators and site study team.
• Provide medical information through scientific exchange in a fair-balanced manner.

*Geron focused on the EU -Kmall

biopearl123
Posts: 1105
Joined: Fri Jul 20, 2018 5:13 pm

Re: Geron using The Medical Affairs Company (TMAC) in Europe for P3 IMpact Clinical Trial enrollment....

Post by biopearl123 » Tue Nov 29, 2022 9:22 pm

Kmall, another good dig on another good day! Thank you.

kmall
Posts: 399
Joined: Thu Mar 21, 2019 3:57 pm

Re: Geron using The Medical Affairs Company (TMAC) in Europe for P3 IMpact Clinical Trial enrollment....

Post by kmall » Wed Nov 30, 2022 12:29 am

Bp - Two points of interest regarding The Medical Affairs Company (TMAC) and Geron's focus regarding Global Regulatory Agencies.

TMAC is utilized by Big Pharma and smaller Biotech alike. Big Pharma like Bayer, Pfizer, Teva and Beigene all have Clinical Trial Liaisons and Medical Advisor's who are contracted through TMAC. As well as up and coming Biotech like MorphoSys and Geron.

As far as the two TMAC employees contracted as Medical Affairs Liaisons for Geron, the listing of countries attached to their employment is interesting: Italy, Austria, Germany, Switzerland, Denmark, Bulgaria, Georgia, Poland, Portugal, Spain, and Turkey are all P3 IMpact (MF) Clinical Trial site locations for Geron.

https://clinicaltrials.gov/ct2/show/NCT ... w=2&rank=4

In the case of Belén Castillo, she also mentions the LATAM countries of Argentina, Brazil and Colombia, which all happen to have site locations for P3 IMpact.

http://www.tarius.com/?page_id=612


Speaking of Global Regulatory Agencies. Remember Murugappa Vedachalam, PhD ??, who is the EU MDR Biocompatibility / Pharma QA QC CMC and Process Validation Consultant for Geron?

I noticed this posted along with his profile recently:

"Consult and support with CMC for regulatory submissions for various regions (USA, Canada, UK, Spain, Czech Republic and Rest of the World)."

The Czech Republic stands out here. Although the Czech Republic is part of the EMA, they also have an independent Regulatory Agency: SKUL - State Institute for Drug Control....... maybe it's just me, but I find it intriguing that he singles out the Czech Republic here? -Kmall

kmall
Posts: 399
Joined: Thu Mar 21, 2019 3:57 pm

Re: Geron using The Medical Affairs Company (TMAC) in Europe for P3 IMpact Clinical Trial enrollment....

Post by kmall » Sat Jan 28, 2023 12:49 am

Update for TMAC recruitment of P3 IMpact in Europe 1/27/2023:

Italy-
Arcispedale S Maria Nuova, AO di Reggio Emilia -
Reggio Calabria, Italy, 42123 - Now Recruiting

Switzerland:
Universitaetsspital Zuerich
Zurich, Switzerland, 8091 - Suspended

https://clinicaltrials.gov/ct2/show/NCT ... w=2&rank=4

It appears that out of the 6 locations that TMAC has been contracted to help fulfill recruitment for, one is now Recruiting (Calabria, Italy) and the Zurich, Switzerland location is still Suspended. -Kmall

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