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You have previously been provided access to the C6081001 study portal which was created to help you to conduct the C6081001 Study and to ensure compliance to regulatory requirements.
We have noticed that you haven't yet completed C6081001 Study, Protocol-Specific Training (Amendment 1) training module. It is recommended that you log in to the C6081001 Study Portal to complete this training module. On completion of this module, a certificate will be made available for your records.
R5458-HM-24145 (LINKER-SMM2) Training Dear Elnaz Enjom,
You have previously been provided access to the R5458-HM-24145 (LINKER-SMM2) study portal which was created to help you to conduct the R5458-HM-24145 (LINKER-SMM2) study and to ensure compliance to regulatory requirements.
We have noticed that you have not yet completed Mandatory R5458-HM-24145 (LINKER-SMM2) Amendment 1, 19 Feb 2026 Protocol Overview training module. It is recommended that you log in to the R5458-HM-24145 (LINKER-SMM2) Study Portal to complete this training module. On completion of this module, a certificate will be made available for your records.
Regards Jennifer Rojas Research Pharmacy Coordinator Vagelos College of Physicians and Surgeons at Columbia University Milstein Hospital (CUIMC Research Pharmacy) 177 Fort Washington Avenue MHB-LL1-001 New York, NY 10032 (office) 212-305-6888 (fax) 212-305-0068 Email: [log in to unmask]
Aidan Holmes Clinical Research Coordinator, Thoracic Oncology Columbia University Irving Medical Center Clinical Protocol and Data Management Office 161 Fort Washington Avenue Herbert Irving Pavilion, Mezzanine New York, NY 10032 Phone: 212-304-5548
The monitor for V3982, cc'd, is scheduled for a monitoring visit on October 29th and has requested to review pharmacy documents. Can you please confirm your availability on that date for a visit? I've included the monitors information below:
Kim Taylor (formerly Muller) Senior CRA Clinical Operations Mobile: 910-431-2135 Regionally based in Wilmington, NC [log in to unmask]<mailto:[log in to unmask]>
I am reaching out to request a RMV if available on either November 30th, 2026 or December 1st, 2026 for study AAAV5215. Below is the CRA's information. Thank you for your assistance!
Justin Reynolds, BS, CCRP Senior Clinical Research Associate Oncology & Canada Global Site Activation & Monitoring Global Clinical Development, Research & Development Solutions
Gina Coviello Data Coordinator I, GI Oncology Columbia University Irving Medical Center Clinical Protocol and Data Management Office 161 Fort Washington Avenue Herbert Irving Pavilion, Mezzanine New York, NY 10032 Phone: 212-304-6346 http://cancer.columbia.edu<http://cancer.columbia.edu/> [New Columbia Logo_]
From: Vasquez, Ariana <[log in to unmask]> Sent: Monday, September 14, 2026 1:22 PM To: Coviello, Gina M. <[log in to unmask]>; [log in to unmask] Subject: Re: RMV AAAV5215 Pharmacy Visit Request (CRA JUSTIN REYNOLDS)
I noticed that Justin had the incorrect email address in his signature block. He had a gmail account instead of @iqvia.
This should be the one used for contact: [log in to unmask]<mailto:[log in to unmask]>
Thank you!
Gina
Gina Coviello Data Coordinator I, GI Oncology Columbia University Irving Medical Center Clinical Protocol and Data Management Office 161 Fort Washington Avenue Herbert Irving Pavilion, Mezzanine New York, NY 10032 Phone: 212-304-6346 http://cancer.columbia.edu<http://cancer.columbia.edu/> [New Columbia Logo_]
The study closure is currently submitted to our IRB for review. Once they provide the final approval, I will be able to send over the final delegation log and IRB determination letter.
The next IRB meeting dates and submission deadlines are
In the meantime, I'll keep an eye out for the drug destruction confirmation and kit destruction confirmation.
Thanks!
Melissa deLaFe Toterhi Sr. Project Lead Parexel International Morrisville, NC, United States t +1 984-284-0916 [log in to unmask]<mailto:[log in to unmask]> www.parexelbiotech.com<https://urldefense.com/v3/__http:/www.parexelbiotech.com/__;!!GfteaDio!c6vMYocHg9Hg3Au7mbTIcVEwROVsj9pLbSz1tkzCrkmVaOO0AslGI7dVOhuWweWLhdcFNvnUG5FAAeXsXwNgJ-Pj9rM$>
Join me in bringing light to the darkness of cancer: Melissa's Light The Night Fundraiser<https://pages.lls.org/ltn/nc/Triangle26/mdelafetot>
From: Kanzlemar, Christina N. <[log in to unmask]> Sent: Monday, September 14, 2026 1:03 PM To: deLaFe Toterhi, Melissa <[log in to unmask]>; Zhu, Julia H. <[log in to unmask]>; Zanelli, Nicholas J. <[log in to unmask]>; Andrea Martins (Contact) <[log in to unmask]>; ChemoRX (Contact) <[log in to unmask]> Subject: RE: Stemline Trillium (281582) - Site 00116/PI: Iyer - Final Study
The attached Dara drug order has been processed and is expected to ship today (Sep 14) and delivery on Tuesday (Sep 15). Also, the attached Teclistamab (30mg and 150mg) drug order has been processed and is expected to be delivered in 3-5 business days.
Please let me know if the shipments are received in good condition or if there are any issues, delays, or concerns.
According to IRT, it seems that a drug shipment was received today. Is it possible for you to forward me that IP shipment receipt documentation for that?
Kind regards,
Blake C. Barrington, M.Sc. (he/him) Senior Clinical Research Associate Parexel International Durham, NC, United States (Eastern Time) w +1 919 519 4190 m +1 919 360 3013 [log in to unmask]<mailto:[log in to unmask]> www.parexel.com<http://www.parexel.com/> [Parexel logo]<http://www.parexel.com/>
We are pleased to inform you that the R5458-HM-24145 (LINKER-SMM2) Firecrest study portal is now available to you. On this portal you will find a range of training, guidance, support materials and key documentation, all designed to support you in your study role.
Use the easy-access details below to see how this portal, hosted by Firecrest, can enhance your study and place important information at your fingertips: Firecrest Portal URL: https://www.firecrestclinical.com/login Your Firecrest Username: [log in to unmask] If you are new to Firecrest or you have forgotten your password, to retrieve please click: https://services.firecrestclinical.com/identity-ui/ui/login/#/forgot/true and
Please note this email address should only be utilized for non-urgent clinical questions. If you are experiencing a medical emergency, please call 911 or go to the nearest emergency room. If you have an urgent medical inquiry,
Nicholas Zanelli, PharmD Lead Research Pharmacist Vagelos College of Physicians and Surgeons Columbia University Milstein Hospital 177 Fort Washington Avenue Suite MHB-LL1-001 New York, NY 10032 Phone: 212-305-8684 Fax: 212-305-0397 Email: [log in to unmask]<mailto:[log in to unmask]>
I am looping in my colleagues individually as we are currently experiencing some issues receiving emails on our chemorx listserv address.
Please respond to this email chain instead.
Thank you,
Zara Imtiaz, PharmD Research Pharmacist Vagelos College of Physicians & Surgeons at Columbia University Milstein Hospital | CUIMC Research Pharmacy 177 Fort Washington Avenue Suite MHB-LL1-001 New York, NY 10032 Office: 212-305-8684 Fax: 212-305-0397 Email: [log in to unmask]
Zara Imtiaz, PharmD Research Pharmacist Vagelos College of Physicians & Surgeons at Columbia University Milstein Hospital | CUIMC Research Pharmacy 177 Fort Washington Avenue Suite MHB-LL1-001 New York, NY 10032 Office: 212-305-8684 Fax: 212-305-0397 Email: [log in to unmask]
From: Imtiaz, Zara <[log in to unmask]> Date: Friday, September 11, 2026 at 2:52 PM To: Mai, Ly <[log in to unmask]> Cc: ([log in to unmask]) <[log in to unmask]>; Zanelli, Nicholas J. <[log in to unmask]>; Elia, Sarah-Belle <[log in to unmask]>; Martins, Andrea <[log in to unmask]>; Bukauskaite, Indre <[log in to unmask]> Subject: RMC-9805-305 | ACYY2694 | Post SIV Follow up
Could you please provide guidance on what we should do with delivered IP that has not been used for the patient it was requested for? Are we able to use it for other patients if needed?
If you are referring to EAP drug and all EAP patients you should be able to reassign in the system. See attached portal guidance. If you need help with that let me know and I’ll get you to the RevMed EAP team.
If the other patient is not an EAP patient then no you cannot use it for someone else.
Please note this email address should only be utilized for non-urgent clinical questions. If you are experiencing a medical emergency, please call 911 or go to the nearest emergency room. If you have an urgent medical inquiry, please contact your Oncologist’s office.
Attached are our SOPs including destruction, accountability, and temperature management as requested. I have also included a list of our pharmacy staff where you can find our pharmacy address and hours of operation. A video of our research pharmacy can be viewed using this link: CUIMC Research Pharmacy Video Tour<http://bit.ly/respharmvideotour>
Nicholas Zanelli, PharmD Lead Research Pharmacist Vagelos College of Physicians and Surgeons Columbia University Milstein Hospital 177 Fort Washington Avenue Suite MHB-LL1-001 New York, NY 10032 Phone: 212-305-8684 Fax: 212-305-0397 Email: [log in to unmask]<mailto:[log in to unmask]>
Hi Dr. Manji and team: Attached is the confirmation letter for our IMV next week. Please try to address all pending actions and have missing source documents uploaded to the EMR in advance of this visit.
Tracy Didinger Principal CRA PPD Clinical Research Services Thermo Fisher Scientific Mobile (610) 823-0445 or (484) 332-9820 [log in to unmask]<mailto:[log in to unmask]> | thermofisher.com/ppd [cid:image001.png@01DD41DF.F26D1350]
We have a pickup scheduled for 9AM-10AM today and the driver has not arrived yet. We called dispatch about 20 minutes ago and they notified us that the driver is 10minutes away, but he has not arrived. This pick up is time sensitive, can you please let me know if there is an updated ETA for the driver and how we can prevent this from reoccurring?
Margaret Wyza, MSc CRA Located in Cleveland, OH/Eastern time zone Stiris Research Inc. www.stirisresearch.com<http://www.stirisresearch.com/> Mobile: 216-346-9855 | [log in to unmask]<mailto:[log in to unmask]>
Collaborating in life sciences to improve the lives of others This e-mail communication (including any attachments) contains information from Stiris Research Inc./Stiris Research USA Inc. or its affiliates that is confidential and may be privileged. The information contained herein is intended only for the use of the addressee(s) named above. If you are not the intended recipient (or
Please note this email address should only be utilized for non-urgent clinical questions. If you are experiencing a medical emergency, please call 911 or go to the nearest emergency room. If you have an urgent medical inquiry, please contact your Oncologist’s office.
Nicholas Zanelli, PharmD Lead Research Pharmacist Vagelos College of Physicians and Surgeons Columbia University Milstein Hospital 177 Fort Washington Avenue Suite MHB-LL1-001 New York, NY 10032 Phone: 212-305-8684 Fax: 212-305-0397 Email: [log in to unmask]<mailto:[log in to unmask]>
Aidan Holmes Clinical Research Coordinator, Thoracic Oncology Columbia University Irving Medical Center Clinical Protocol and Data Management Office 161 Fort Washington Avenue Herbert Irving Pavilion, Mezzanine New York, NY 10032 Phone: 212-304-5548
Aidan Holmes Clinical Research Coordinator, Thoracic Oncology Columbia University Irving Medical Center Clinical Protocol and Data Management Office 161 Fort Washington Avenue Herbert Irving Pavilion, Mezzanine New York, NY 10032 Phone: 212-304-5548
Nicholas Zanelli, PharmD Lead Research Pharmacist Vagelos College of Physicians and Surgeons Columbia University Milstein Hospital 177 Fort Washington Avenue Suite MHB-LL1-001 New York, NY 10032 Phone: 212-305-8684 Fax: 212-305-0397 Email: [log in to unmask]<mailto:[log in to unmask]>
Dear Zanzalintinib (XL092) Investigators and Site Staff,
Please find attached the updated XL092 IST Zanzalintinib Pharmacy Manual V6, dated 09Sept2026 in both tracked changes and clean versions.
The most notable revisions include a correction to the Exelixis Clinical Supplies email address ([log in to unmask]<mailto:[log in to unmask]>) as well as additional information regarding WebEZ access and submission of drug shipment requests.
Nicholas Zanelli, PharmD Lead Research Pharmacist Vagelos College of Physicians and Surgeons Columbia University Milstein Hospital 177 Fort Washington Avenue Suite MHB-LL1-001 New York, NY 10032 Phone: 212-305-8684 Fax: 212-305-0397 Email: [log in to unmask]<mailto:[log in to unmask]>
Thank you, the attached drug order has been processed and is expected to be delivered in 3-5 business days.
Please let me know if the shipment is received in good condition or if there are any issues, delays, or concerns.
Kind regards,
Kaique Henrique dos Santos ICON plc Performing Global Clinical Trial services for: J&J Post Approval Delivery Unit Phone: +55 11 93490 7425 E-mail: [log in to unmask]<mailto:[log in to unmask]>
For research and development teams seeking expert analysis of existing data—from QC and statistics to visualization, interpretation, and reporting. --- mkt-sys unsubscribe:ja --- 配信停止について 今後のご案内メールの配信停止をご希望の場合は、以下のURLからお手続きください。 https://life--analytics.net/mkt-sys/auth/unsubscribe?email=chemorx%40lists.cumc.columbia.edu&campaign_id=46&t=9312e1aacb7044125b3caf36b456066ba42b0b5e2e29012c4dba8c18cb330f46&lang=ja リンクを利用できない場合は [log in to unmask] 宛に「配信停止」とご連絡ください。 会社Webサイト: https://life--analytics.net/top/
Hello, I am writing regarding our upcoming industry-sponsored study, BED-FAP-121 (A Phase 1/2 Study of [18F]FPyQCP for PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications), sponsored by Blue Earth Diagnostics.
For this study, the investigational medicinal product, [18F]FPyQCP, is a radioactive PET tracer that will be manufactured and supplied directly by the Sponsor and delivered by courier from an external radiopharmacy directly to our imaging site, the Kreitchman PET Center (722 West 168th Street, Suite R1, New York, NY 10032). As the drug product will be received, stored, and administered entirely within the PET Center under their standard
Hi Jennifer and Lucy, Please see below, we would like to request a letter confirming the Research Pharmacy will not be utilized for this study. The investigational agent is a radioactive PET tracer and as such will be received and dispensed through the Radiopharmacy at the PET Center.
If a quick call would be helpful, please let us know.
The order has been placed and tracking information will be provided when available.
Thanks, Carolyn
From: Martins, Andrea <[log in to unmask]> Sent: Thursday, September 10, 2026 4:28 PM To: Carolyn Szczerba <[log in to unmask]> Cc: ChemoRx <[log in to unmask]> Subject: [EXTERNAL] I-RUX-24-04 | AAAV7563 | Drug Order Request
CAUTION: EXTERNAL EMAIL Hi,
Please see the attached drug order request and let us know once processed and shipped.
Could you please request final drug resupply for the below patients? They only received C1 supply so resupply should be allowed on the portal.
Name MRN EAP Subject ID Jie Pang 1402185470 6236-84912 Robert Alini 1401837823 6236-43201 Roberto Ibasan 1007959256 6236-11543
Additionally, has sponsor provided guidance on drug that was delivered but not used? i.e. Steven Krebs' drug was delivered, however, his commercial supply was delivered and he opted to use that supply, and withdraw from EAP. Would we be able to use his supply for another patient?
I can place these resupply orders today. Can you confirm that they will all be continuing on the 300mg daily dosing and will not require dose reduction?
Thank you,
Sarah-Belle Elia, PharmD
Research Pharmacy
Vagelos College of Physicians and Surgeons
Columbia University
Milstein Hospital
177 Fort Washington Avenue
Suite MHB-LL1-001
New York, NY 10032
Phone: 212-305-8684
Fax: 212-305-0397
Email: [log in to unmask]<mailto:[log in to unmask]>
I can place these resupply orders today. Can you confirm that they will all be continuing on the 300mg daily dosing and will not require dose reduction?
Thank you,
Sarah-Belle Elia, PharmD
Research Pharmacy
Vagelos College of Physicians and Surgeons
Columbia University
Milstein Hospital
177 Fort Washington Avenue
Suite MHB-LL1-001
New York, NY 10032
Phone: 212-305-8684
Fax: 212-305-0397
Email: [log in to unmask]<mailto:[log in to unmask]>
Thank you for confirming. All three resupply requests have been submitted.
@Kuriakose, Nadine<mailto:[log in to unmask]>We haven't received guidance on what to do with delivered IP that has not been used. We'd have to reach out to sponsor to find out if we would be able to use for another patient. Please let me know if you'd like me to reach out or if you have a direct contact that you can reach out to.
The monitor for ACYY1604, cc'd, is scheduled to perform the first monitoring visit of the study on September 25th and has requested to review pharmacy documents. Can you please confirm your availability on that date? I've included the monitors information below:
Melissa Banuelos, BSN, RN, CCRP, CCRC Principal Clinical Research Associate Medpace 5375 Medpace Way Cincinnati, Ohio 45227 Cell: +1.513.316.2031 Fax: +1.513.579.0444 E-mail: [log in to unmask]<mailto:[log in to unmask]>
Megan (Morrison) Nieman Data Specialist, Lead Hematologic Malignancies Columbia University Irving Medical Center Clinical Protocol and Data Management Office Parker Plaza, Floor 7 400 Kelby Street Fort Lee, NJ 07024 Phone: 212.305.8272 http://cancer.columbia.edu<http://cancer.columbia.edu/> [New Columbia Logo_]
This electronic message is intended to be for the use only of the named recipient and may contain information that is confidential or privileged. If you are not the intended recipient, you are hereby notified that any disclosure, copying, distribution or use of the contents of this message is
Can someone please assist with confirming availability for this requested visit?
Best, Megan
Megan (Morrison) Nieman Data Specialist, Lead Hematologic Malignancies Columbia University Irving Medical Center Clinical Protocol and Data Management Office Parker Plaza, Floor 7 400 Kelby Street Fort Lee, NJ 07024 Phone: 212.305.8272 http://cancer.columbia.edu<http://cancer.columbia.edu/> [New Columbia Logo_]
This electronic message is intended to be for the use only of the named recipient and may contain information that is confidential or privileged. If you are not the intended recipient, you are hereby notified that any disclosure, copying, distribution or use of the contents of this message is
Megan (Morrison) Nieman Data Specialist, Lead Hematologic Malignancies Columbia University Irving Medical Center Clinical Protocol and Data Management Office Parker Plaza, Floor 7 400 Kelby Street Fort Lee, NJ 07024 Phone: 212.305.8272 http://cancer.columbia.edu<http://cancer.columbia.edu/> [New Columbia Logo_]
This electronic message is intended to be for the use only of the named recipient and may contain information that is confidential or privileged. If you are not the intended recipient, you are hereby notified that any disclosure, copying, distribution or use of the contents of this message is strictly prohibited. If you
Thank you for your recent order. I’m happy to confirm that it has been received and is currently being processed.
Best wishes, Tiffanie
Tiffanie Moore-Washington
Sr. Research Pharmacy Technician, Clinical Research Services
800.693.4906 Ext 0080
www.covermymeds.com<http://www.covermymeds.com/>
[cid:6a6e3972-e2e7-4211-a68d-50cf734c9805]
This electronic transmission is confidential and intended solely for the addressee(s). If you are not the intended addressee, do not disclose, copy, or take any other action in reliance on this transmission. If you have received this transmission in error, please delete it from your system and notify CoverMyMeds at [log in to unmask]<mailto:[log in to unmask]>. Thank you.
Can you please add the following remote pharmacy visits for U0765?
10/26 12/15
Monitor: Chinwe Anyamele, MD CRA II, Clinical Operations-Americas Syneos Health Regionally Based in Wisconsin, USA (CST) Mobile: +1 781-552-2073 Email: [log in to unmask] Syneoshealth.com
Thank you,
Marina Peterson
Data Coordinator, Melanoma/Sarcoma & Thoracic Oncology
Columbia University Irving Medical Center
Clinical Protocol and Data Management Office
161 Fort Washington Avenue
Herbert Irving Pavilion, Mezzanine New York, NY 10032 Phone: 212-304-6328
Please see the attached drug order request and let us know once processed and shipped.
Thank you,
Nicholas Zanelli, PharmD Lead Research Pharmacist Vagelos College of Physicians and Surgeons Columbia University Milstein Hospital 177 Fort Washington Avenue Suite MHB-LL1-001 New York, NY 10032 Phone: 212-305-8684 Fax: 212-305-0397 Email: [log in to unmask]<mailto:[log in to unmask]>
Karen Thompson, RPh Research Pharmacist, Clinical Research Services 800.693.4906 Extension 0097 www.covermymeds.com<http://www.covermymeds.com/>
[cid:6334e108-aed1-46c7-b961-4cc78f0b9b6b]
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Hi! Would you be able to schedule a pharmacy visit for Y1732 with the monitor below on or after 9/15?
Thank you!
Vee Sido Snr. Clinical Research Associate Phone: (214) 500 -1243 Email: [log in to unmask]<mailto:[log in to unmask]> 9640 Medical Center Dr. Rockville, MD 20850
Thank you so much for your time today. I have attached our site SOPs, a list of pharmacy staff who will need IQVIA access and pharmacy information.
As discussed, please share the most updated pharmacy manual version that is currently in use and confirm if the use of Equashield is acceptable for IP preparation and administration.
Aidan Holmes Clinical Research Coordinator, Thoracic Oncology Columbia University Irving Medical Center Clinical Protocol and Data Management Office 161 Fort Washington Avenue Herbert Irving Pavilion, Mezzanine New York, NY 10032 Phone: 212-304-5548
Hello! Yes, the sponsor is eager to get your site prepared. I would like to conduct an eval visit to review the feasibility report and a high overview of the study. I was told you could provide a virtual tour as well. What do you need from me to have a remote visit scheduled? Thank you! Andrea
We are primarily interested in the HCB301 trial (NCT06487624). Could you kindly confirm whether our site may be considered for participation in this study? If so, we would be happy to discuss our site's capabilities and interest in opening the trial. Thank you!
Alyssa Schumpp, M.S. Clinical Research Manager, Phase 1 Oncology Clinical Protocol and Data Management Office 161 Fort Washington Avenue Herbert Irving Pavilion, Mezzanine New York, NY 10032 Phone: 212-342-3970 http://cancer.columbia.edu<http://cancer.columbia.edu/>
Are you able to provide the pharmacy manual as well? We need to know how the investigational product needs to be stored.
In regards to relabeling, our pharmacy does not relabel vials. We use Vestigo as our accountability system which captures information such as updated expiration dates. All updated expiration memos our uploaded to our electronic pharmacy binder for review. If relabeling is absolutely mandatory by the sponsor we would have to arrange for a CRA to come on site to relabel.
Hope this is of some help. I will notify the sponsor of your replies regarding relabeling. Thanks so much!!
From: Zanelli, Nicholas J. <[log in to unmask]> Sent: Thursday, September 10, 2026 11:06 AM To: Andrea,Hunter <[log in to unmask]>; Schumpp, Alyssa <[log in to unmask]>; ChemoRX (Contact) <[log in to unmask]>; Dreher, Nickolas P. <[log in to unmask]>; Henick, Brian S. <[log in to unmask]>; Irizarry, Luis <[log in to unmask]> Subject: RE: HCB303-ONC-101 Product Questions
HI Nicholas, Please confirm you received my response. Thank you!
From: Zanelli, Nicholas J. <[log in to unmask]> Sent: Thursday, September 10, 2026 11:06 AM To: Andrea,Hunter <[log in to unmask]>; Schumpp, Alyssa <[log in to unmask]>; ChemoRX (Contact) <[log in to unmask]>; Dreher, Nickolas P. <[log in to unmask]>; Henick, Brian S. <[log in to unmask]>; Irizarry, Luis <[log in to unmask]> Subject: RE: HCB303-ONC-101 Product Questions
Good morning Andrea,
Are you able to provide the pharmacy manual as well? We need to know how the investigational product needs to be stored.
Please find attached the SRC Decision Letter for Dose Level 4 and a QW dosing Memo, and ensure these are filed into your site's ISF Binder. Kindly disseminate to additional team members as needed.
Thank you,
Arianna Chaitkin Project Coordinator
Medpace 5400 Medpace Way Cincinnati, Ohio 45227
Tel: +1.283.227.6186 E-mail: [log in to unmask]<mailto:[log in to unmask]> [cid:image001.png@01DD4116.CD923520]
Please find attached the corrected SRC Decision Letter, as a typo was noted and therefore corrected.
Thank you for your patience,
Arianna Chaitkin Project Coordinator
Medpace 5400 Medpace Way Cincinnati, Ohio 45227
Tel: +1.283.227.6186 E-mail: [log in to unmask]<mailto:[log in to unmask]> [cid:image001.png@01DD413F.34E60DA0]
From: Chaitkin, Arianna Sent: Thursday, September 10, 2026 11:37 AM Cc: EIU104101 <[log in to unmask]>; Roehrs, Philip <[log in to unmask]>; Hess, Lisa <[log in to unmask]> Subject: EvolveImmune | EIU 104-101 | DL 4 SRC Decision Letter & QW Dosing Memo | 10Sep2026 Importance: High
I don't see that we had a dispensation on 07/08/2026 but we did dispense on 08/07/2026. Can you confirm if you're looking for a return from the August 7th dispensation ?
Apologies, I am a bit confused. Are you saying the patient return was dropped off on August 7th or are you checking to see if the medication we dispensed to the patient on August 7th has been returned?
Ok, thank you for confirming. If drug was dispensed to the patient on August 7th then the return would have been dropped off last week, right? According to our records, we dispensed the patients next cycle on 8/28/26.
Let me know if you require any additional information
Kind regards, Mariana Molero Zambrano Sr. Clinical Research Coordinator Department of Clinical Protocol and Data Management Herbert Irving Comprehensive Cancer Center New York-Presbyterian/Columbia University Irving Medical Center http://cancer.columbia.edu<http://cancer.columbia.edu/>
Name: Aina Acosta MRN: 1010964811 Visit Type: Month 12 - IP Administration
Visit Date: 11 Sep 2026
Please let me know if you need any additional information.
Kind regards, Mariana Molero Zambrano Sr. Clinical Research Coordinator Department of Clinical Protocol and Data Management Herbert Irving Comprehensive Cancer Center New York-Presbyterian/Columbia University Irving Medical Center http://cancer.columbia.edu<http://cancer.columbia.edu/>
You are scheduled for a remote close out visit, I have attached the following documents:
1. Final Accountability Logs 2. Certificate of Destruction for what was recently destroyed 3. Certificate of Destruction for everything that has been destroyed 4. Temperature Report from 10/23/2025 (last visit) to date
Now that we have no IP on hand, can we close the pharmacy portion of this study?
Can you please also send over the following IP shipment receipts (these should also include temptale reports) 200001599 Received 2203-20-07 Joseph Jurcic Columbia University Medical Center United States of America 5 28 Feb 2020 3/2/2020 12:00:00 AM +00:00 3-Mar-20 UPS 1ZE2565F2499708502 200003291 Received 2203-20-07
1. Requested PS 2. Temperature Report from 09/11/2019-06/26/2020 (previous pharmacy) 3. Temperature Report from 06/26/2020-01/25/2022 (requested dates) 4. Temperature Report from 07/08/2022-09/08/2022 (requested dates) 5. Temperature Report from 10/05/2022-05/09/2023 (requested dates) 6. Temperature Report from 07/28/2023-01/01/2024 (requested dates) 7. Temperature Report from 03/28/2024-10/10/2024 (requested dates) 8. Temperature Report from 03/07/2025-10/22/2025 (requested dates)
Please provide confirmation for closure if these are the last documents needed.
Thank you, Ariana! I will review and reach out if anything is needed.
Best,
Tedra Hughes, BS Lead Site Manager, US Early Development-Oncology Oncology Delivery Unit J&J Innovative Medicine
[log in to unmask]<mailto:[log in to unmask]> Mobile: 943-210-7265 Jnj.com
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Attached is a listing of IP drug in IRT noted as expired but the study team indicates that shipment was not acknowledged as received at the site. Can you please confirm shipment the medication numbers listed in attached report was never received at the site?
Thanks!
Tedra Hughes, BS Lead Site Manager, US Early Development-Oncology Oncology Delivery Unit J&J Innovative Medicine
Thank you for this confirmation. I will pass this information to our study team.
Tedra Hughes, BS Lead Site Manager, US Early Development-Oncology Oncology Delivery Unit J&J Innovative Medicine
[log in to unmask]<mailto:[log in to unmask]> Mobile: 943-210-7265 Jnj.com
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To correct the subject line, HCB303 not 301. Thank you
From: Andrea,Hunter Sent: Wednesday, September 9, 2026 7:24 PM To: 'Schumpp, Alyssa' <[log in to unmask]>; ChemoRX (Contact) <[log in to unmask]>; Dreher, Nickolas P. <[log in to unmask]>; Henick, Brian S. <[log in to unmask]>; Irizarry, Luis <[log in to unmask]> Subject: RE: HCB301-ONC-101 Product Questions
Thanks for your follow up! Andrea
From: Schumpp, Alyssa <[log in to unmask]<mailto:[log in to unmask]>> Sent: Wednesday, September 9, 2026 5:48 PM To: Andrea,Hunter <[log in to unmask]<mailto:[log in to unmask]>>; ChemoRX (Contact) <[log in to unmask]<mailto:[log in to unmask]>>; Dreher, Nickolas P. <[log in to unmask]<mailto:[log in to unmask]>>; Henick, Brian S. <[log in to unmask]<mailto:[log in to unmask]>>; Irizarry, Luis <[log in to unmask]<mailto:[log in to unmask]>> Subject: RE: HCB301-ONC-101 Product Questions
Can you please schedule 2 pharmacy reviews for V1270 for 15Oct2026 and 10Dec2026? I have the monitor's info below. Thank you!
Madison Watts Clinical Research Associate II
Sarah Cannon Development Innovations
1100 Dr. Martin Luther King Jr. Blvd., Suite 800, Nashville, TN 37203
D 720-621-4556
E [log in to unmask]
Best, Shikha
Shikha Puri Clinical Data Coordinator II, Multiple Myeloma & GI Oncology Columbia University Irving Medical Center Clinical Protocol and Data Management Office Parker Plaza, Floor 7 400 Kelby Street Fort Lee, NJ 07024 e: [log in to unmask]<mailto:[log in to unmask]> phone: 212-305-3616 http://cancer.columbia.edu<http://www.cancer.columbia.edu>
A Platform Study of RAS(ON) Inhibitors in Patients with RAS-Mutated Non-Small Cell Lung Cancer (NSCLC)
Dear Dr. Benjamin Orie Herzberg, MD, This is to confirm my monitoring visit scheduled from 15-Sep-2026 -17-Sep-2026. I plan to utilize each full workday to complete my review, and I estimate that the visit will last approximately 24 hours in total. I would appreciate it if all outstanding Monitoring Findings and Deviations outlined in the attached confirmation letter could be addressed before the visit begins. At the conclusion of the visit, I would like to meet with your team to discuss any findings, answer any
Please note this email address should only be utilized for non-urgent clinical questions. If you are experiencing a medical emergency, please call 911 or go to the nearest emergency room. If you have an urgent medical inquiry, please contact your Oncologist’s office.
Please note this email address should only be utilized for non-urgent clinical questions. If you are experiencing a medical emergency, please call 911 or go to the nearest emergency room. If you have an urgent medical inquiry, please contact your Oncologist’s office.
Investigator Name: Bhutani, Divaya Institution: Columbia University Medical Center - Herbert Irving Pavilion Location Site Number: 0020 Country: United States
Shipment Address: Columbia University Medical Center - Herbert Irving Pavilion Location
177 Fort Washington Ave
Suite MHB-LL1-001
New York, NY 10032-3729
United States Phone: (212) 305-8684 Contact Email: [log in to unmask]
Shipment Number: 11902498 Shipment Status: Received Shipment Complete: Yes
Investigator Name: Bhutani, Divaya Institution: Columbia University Medical Center - Herbert Irving Pavilion Location Site Number: 0020 Country: United States
Shipment Address: Columbia University Medical Center - Herbert Irving Pavilion Location
177 Fort Washington Ave
Suite MHB-LL1-001
New York, NY 10032-3729
United States Phone: (212) 305-8684 Contact Email: [log in to unmask]
Shipment Number: 11902500 Shipment Status: Received Shipment Complete: Yes
Please note this email address should only be utilized for non-urgent clinical questions. If you are experiencing a medical emergency, please call 911 or go to the nearest emergency room. If you have an urgent medical inquiry, please contact your Oncologist’s office.
Aidan Holmes Clinical Research Coordinator, Thoracic Oncology Columbia University Irving Medical Center Clinical Protocol and Data Management Office 161 Fort Washington Avenue Herbert Irving Pavilion, Mezzanine New York, NY 10032 Phone: 212-304-5548
Please note this email address should only be utilized for non-urgent clinical questions. If you are experiencing a medical emergency, please call 911 or go to the nearest emergency room. If you have an urgent medical inquiry, please contact your Oncologist’s office.
Please note this email address should only be utilized for non-urgent clinical questions. If you are experiencing a medical emergency, please call 911 or go to the nearest emergency room. If you have an urgent medical inquiry, please contact your Oncologist’s office.
Please note this email address should only be utilized for non-urgent clinical questions. If you are experiencing a medical emergency, please call 911 or go to the nearest emergency room. If you have an urgent medical inquiry, please contact your Oncologist’s office.
Yes, you can manually dispsense and then Suvoda can be updated when back online to capture this dispensation.
Justin Reynolds, BS, CCRP Senior Clinical Research Associate Oncology & Canada Global Site Activation & Monitoring Global Clinical Development, Research & Development Solutions
[cid:image001.png@01DD404D.79CC6240] Learn more<http://www.iqvia.com/> about IQVIA
Columbia, SC M: +803-445-9001 | F: +1 803-667-3464 | E: [log in to unmask]<mailto:[log in to unmask]>
Upcoming OOO: IQVIA US Closed: 25May2026 Personal Leave: 29Jun-03Jul2026
[cid:image002.jpg@01DD407B.CC8DC0E0] 09-Sep-2026 Dear Investigators and Site Staff, [cid:image004.jpg@01DD407B.CC8DC0E0] The Search Continues - We are seeking participants to enroll in Cohorts 5 (UC) and 14(RCC) at all sites that have received approval under Protocol Amendment 5. Additionally we are seeking for 6 participants to enroll in Cohort 15 for sites that have received approval under Protocol Amendment 6.
The study team has confirmed that the study is now closed and won't be opening up for enrollment. We'd like to destroy the IP we have on hand to be able to close the pharmacy portion of the study. Please see the report attached that details everything that will be destroyed once approved.
Hello Vasquez, Thank you for your inquiry regarding the destruction of the onsite IP. Yes, your site may proceed with the destruction of the IP. Once completed, please provide a copy of the Certificate of Destruction for our records. In addition, could you please provide the maintenance records for the IP storage unit during the period the IP was stored at your site? Thank you for your assistance. Please let me know if you have any questions.
Hello Ariana, I noticed that some information appears to be missing from the site's Site Facilities and Equipment Checklist form. Could you please provide the following details?
* What are the site's procedures for managing temperature excursions? * Is the storage unit equipped with a temperature alarm system? * Is a backup freezer available in the event of equipment failure?
1. We followed our SOP, please see attached 2. Yes, all pharmacy staff are notified before an excursion occurs and if it occurs during non-business hours, an on-call pharmacist is paged. 3. Yes a backup freezer is available
Regards,
Ariana Vasquez
Research Pharmacy Assistant
Vagelos College of Physicians and Surgeons at Columbia University
Upcoming Office Closures: • Thursday, November 26, 2026 • Friday, November 27, 2026 • Thursday, December 24, 2026 • Friday, December 25, 2026
From: Vasquez, Ariana <[log in to unmask]> Sent: Wednesday, September 9, 2026 8:50 AM To: Batze, Candi <[log in to unmask]> Cc: ChemoRx <[log in to unmask]> Subject: [EXTERNAL] Remote Pharmacy Visit ELA026-CP002 | ACYY0125
Hi Sites, In continuation of last week's reminder regarding 580 mg dose cap, we are writing to ask you to please acknowledge about this urgent update to GSK arms that introduces a dose cap for GSK5733584 agent In appendix AM and AN. There is a new 580 mg dose cap immediately in place ( this dose cap applies to all dose levels). This is based on current weight, not baseline. Please ensure weight is checked at each visit. The memo is attached and documents are updated on Pharmacy MOP as well. (A44 Pharmacy MOP<https://quantumleaphealthcarecollab.box.com/s/axp3hutjo5uif159p0oig3h9urwciegm>) Of note, this is provisional and
Best Practice in Dangerous Goods Regulations (DGR) Training Dear Elnaz Enjom,
You have previously been assigned to Best Practice in Dangerous Goods Regulations (DGR) training on the Firecrest Site Portal.
We have noticed that you have not yet completed Mandatory Best Practice in Dangerous Goods Regulations (DGR) training module. It is recommended that you log into the Firecrest Site Portal and complete this training module in the My Training tab. On completion of this module, a certificate will be made available in your training plan for all Regeneron studies which have this module assigned.
A Platform Study of RAS(ON) Inhibitors in Patients with RAS-Mutated Non-Small Cell Lung Cancer (NSCLC)
Dear Dr. Benjamin Orie Herzberg, MD,
It was a pleasure speaking with your site team during my monitoring visit call. This communication serves as a summary of the findings noted during the visit. Please review and address all outstanding Monitoring Findings and Deviations as outlined in the attached follow-up letter. I appreciate the readiness of the study documentation for review and your availability during the ME. It is a pleasure working with you and your staff. Please file a copy of the attached follow-up letter
We received a shipment on 9/3 with an alarmed temptale. I have acknowledged this shipment in IRT, and it was quarantined. I have also quarantined it physically. Let me know how I should proceed.
Thanks
Jennifer Rojas
Research Pharmacy Coordinator
Vagelos College of Physicians and Surgeons at Columbia University
Hi Jennifer- Thanks for the update. I will be in touch by EOB today with instructions on what to do next.
Best,
Jan Strack, BSN, RN Senior Clinical Research Associate Clinical Operations GCO Americas
BeOne Medicines USA, Inc. New York (EST) - Remote
Email: [log in to unmask]<mailto:[log in to unmask]> Mobile: (917) 415-4860
[A red and blue logo AI-generated content may be incorrect.]
From: Rojas, Jennifer <[log in to unmask]> Sent: Tuesday, September 8, 2026 3:19 PM To: Jan Strack <[log in to unmask]> Cc: [log in to unmask]; Chemorx <[log in to unmask]> Subject: BGB-16673-104 | ACYY0017 - Alarmed Temptale - Shipment # 10582 Site# 001198
Hi Jennifer- I don't have an official response from our team. Please keep it quarantined until you hear back from me.
Best,
Jan Strack, BSN, RN Senior Clinical Research Associate Clinical Operations GCO Americas
BeOne Medicines USA, Inc. New York (EST) - Remote
Email: [log in to unmask]<mailto:[log in to unmask]> Mobile: (917) 415-4860
[A red and blue logo AI-generated content may be incorrect.]
From: Rojas, Jennifer <[log in to unmask]> Sent: Tuesday, September 8, 2026 3:36 PM To: Jan Strack <[log in to unmask]> Cc: [log in to unmask]; Chemorx <[log in to unmask]> Subject: Re: BGB-16673-104 | ACYY0017 - Alarmed Temptale - Shipment # 10582 Site# 001198
Hi Jennifer- While we wait to hear back from our TE team please complete the temperature excursion form. It will help to determine our next steps. On the first page is a helpful process flow diagram.
Thank you!
Best,
Jan Strack, BSN, RN Senior Clinical Research Associate Clinical Operations GCO Americas
For study BGB-16673-104 site 0011198 shipment order 10582, the impacted IPs (Sonrotoclax and BGB-16673 ) exposed to 25.9°C for 9 hours and 40 minutes. Based on the TE category 1, the IP is deemed Fit For Use and classified as a non-reportable case.
Best,
Jan Strack, BSN, RN Senior Clinical Research Associate Clinical Operations GCO Americas
Please find attached a memo from the Nested Team regarding updates to the IP dispensing frequency for NST-628, 0.1 mg, and 0.2 mg tablets. Effective immediately, sites may dispense one bottle of NST-628 to provide sufficient supply for two treatment cycles.
Additional details can be found in the attached memo, but please do not hesitate to reach out to the Nested Team and your site-assigned CRA with any questions or concerns.
From: Vasquez, Ariana <[log in to unmask]> Sent: Tuesday, September 8, 2026 2:05 PM To: Wahlay, Natalie <[log in to unmask]> Cc: ChemoRx <[log in to unmask]> Subject: Remote Pharmacy Visit GII-102-P101 | AAAV9349
You don't often get email from [log in to unmask]<mailto:[log in to unmask]>. Learn why this is important<https://aka.ms/LearnAboutSenderIdentification> Hi Natalie,
You are scheduled for a remote pharmacy visit, I have attached the following documents:
Hello, I am following up on this request of confirmation of IP destruction. My pharmacy visit is scheduled for 10Sep2026, though I have not received any invitation /account credentials. Does your site use Vestigo for Pharmacy? If so, will access be granted to my email tomorrow morning?
I am waiting for it to be witnessed by a pharmacist and then destruction will be completed. Yes, we use vestigo but all documents will be sent via email.
You should expect to receive documents by this afternoon.
Regards,
Ariana Vasquez
Research Pharmacy Assistant
Vagelos College of Physicians and Surgeons at Columbia University
Thank you for your presentation today. As mentioned during the SIV, I am forwarding the SOPs, the document listing the Pharmacy staff who will need access to the IRT System, and our shipping address.
Please also forward the SIV slides and confirm whether the most updated Pharmacy Manual is Version 3.0 [2025.11.28], which is the version we currently have on file.
The current manual is v3. Slides attached and I will follow up regarding Equashield. May I ask regarding VESTIGO, will I have access to the system to update my review of accountability? It was mentioned during the SIV that the IMP records would be gathered and sent to myself. Usually, I can access a site's VESTIGO and click a box to indicate monitor review. Thanks!
We do not grant access to Vestigo. However, all documents you will need will be provided via email or through Lab Archives.
Once again, to schedule monitor visits, please email the ChemRx email to check availability. Please try to schedule visits at least 4–6 weeks in advance.
Please note this email address should only be utilized for non-urgent clinical questions. If you are experiencing a medical emergency, please call 911 or go to the nearest emergency room. If you have an urgent medical inquiry, please contact your Oncologist’s office.
We are fully booked Oct 6th, does the 7th work? Also, all of our visits are remote unless there is a specific need to be on-site. Can you ask the monitor for the reason to be on-site?
Regards,
Ariana Vasquez
Research Pharmacy Assistant
Vagelos College of Physicians and Surgeons at Columbia University
Please note this email address should only be utilized for non-urgent clinical questions. If you are experiencing a medical emergency, please call 911 or go to the nearest emergency room. If you have an urgent medical inquiry, please contact your Oncologist’s office.
Please note this email address should only be utilized for non-urgent clinical questions. If you are experiencing a medical emergency, please call 911 or go to the nearest emergency room. If you have an urgent medical inquiry, please contact your Oncologist’s office.
We have the 2023 PSs in our system. The last date in 2023 was shipment number 01-0569 printed on 28 Dec2023. I haven't really checked but it looks like that may be the last one for 2023.
Please note this email address should only be utilized for non-urgent clinical questions. If you are experiencing a medical emergency, please call 911 or go to the nearest emergency room. If you have an urgent medical inquiry, please contact your Oncologist’s office.
We have been asked to schedule visits every 8-12 weeks. Please let me know if the following dates would work for a one day remote visit: 10/20, 10/21 or 10/22. I will need EMR access, LabArchives and pharmacy records. Thanks for your assistance!
Charli E. Gore, BS, CCRA [log in to unmask] 919 617 7609
Attached is the follow up letter from our last IMV. Please address pending items and file this letter in Lab Archives
Please let me know if you have any questions.
Thanks!
Tracy Didinger Principal CRA PPD Clinical Research Services Thermo Fisher Scientific Mobile (610) 823-0445 or (484) 332-9820 [log in to unmask]<mailto:[log in to unmask]> | thermofisher.com/ppd [cid:image001.png@01DD3F69.51B5D550]
I do not have access to this study; I have not acknowledged this shipment. I do have access to the system https://beigene2.4gclinical.com/login. If possible , Can this study be added to my access?
Thanks Jennifer
From: Mackenzie Myers (EXT.) <[log in to unmask]> Sent: Monday, September 14, 2026 3:51 PM To: Rojas, Jennifer <[log in to unmask]>; Mackenzie Myers (EXT.) <[log in to unmask]>; Martins, Andrea <[log in to unmask]>; Aby Oommen <[log in to unmask]>; Jassira Gomes <[log in to unmask]> Cc: Chemorx <[log in to unmask]> Subject: [EXTERNAL] RE: BGB-11417-304 | ACYY2535 - SIV Follow up
Apologies for the misunderstanding. When you had acknowledged drug, I was under the impression you had access to the study/site. Can you clarify how you were able to perform this action?
@Jassira Gomes<mailto:[log in to unmask]> - may you please assist in provisioning study access for the below individual in IRT?
Rojas, Jennifer User name: [log in to unmask]<mailto:[log in to unmask]>
Following up on my IRT request. I do have access to the system, just need this study to be added. My user name is my email.
Regards Jennifer
From: Mackenzie Myers (EXT.) <[log in to unmask]> Sent: Friday, September 4, 2026 3:11 PM To: Rojas, Jennifer <[log in to unmask]>; Mackenzie Myers (EXT.) <[log in to unmask]>; Martins, Andrea <[log in to unmask]>; Aby Oommen <[log in to unmask]> Cc: Chemorx <[log in to unmask]> Subject: [EXTERNAL] RE: BGB-11417-304 | ACYY2535 - SIV Follow up
Herbert Irving Pavilion, Mezzanine New York, NY 10032 Phone: 212-304-5570 http://cancer.columbia.edu<http://cancer.columbia.edu/>
[New Columbia Logo_]
Please note this email address should only be utilized for non-urgent clinical questions. If you are experiencing a medical emergency, please call 911 or go to the nearest emergency room. If you have an urgent medical inquiry, please contact your Oncologist’s office.
Nice to meet you. Thank you for connecting us, Ly.
I am following up for Suvoda IRT approval as we have requested access.
Best,
Zara Imtiaz, PharmD Research Pharmacist Vagelos College of Physicians & Surgeons at Columbia University Milstein Hospital | CUIMC Research Pharmacy 177 Fort Washington Avenue Suite MHB-LL1-001 New York, NY 10032 Office: 212-305-8684 Fax: 212-305-0397 Email: [log in to unmask]
Herbert Irving Pavilion, Mezzanine New York, NY 10032 Phone: 212-304-5570 http://cancer.columbia.edu<http://cancer.columbia.edu/>
[New Columbia Logo_]
Please note this email address should only be utilized for non-urgent clinical questions. If you are experiencing a medical emergency, please call 911 or go to the nearest emergency room. If you have an urgent medical inquiry, please contact your Oncologist’s office.
Thanks for getting back so quickly. I believe we use the CADD legacy plus pump and I have attached images of the tubing below (both the one with the filter and without, based on the bag size).
Would your team like/prefer to do the larger bags (72 or 96 hr bag) while he is inpatient? We can discuss and plan the schedule so the study team can enter the INV orders accordingly.
Confirming the Pharmacy SIV at 12PM on 09/23/26. Please send invites to : @Zanelli, Nicholas J.<mailto:[log in to unmask]> @Elia, Sarah-Belle<mailto:[log in to unmask]> @Martins, Andrea<mailto:[log in to unmask]> @Imtiaz, Zara<mailto:[log in to unmask]> @Bukauskaite, Indre<mailto:[log in to unmask]>
Thank you for providing the pharmacy team’s availability.
I would like to confirm the separate pharmacy-focused SIV/training for AL46650 EAP, Site 517592, PI Dr. Benjamin Herzberg, on Wednesday, September 23, 2026, at 12:00 PM ET.
We will keep the session focused on the applicable investigational product receipt, storage and handling, dispensing, accountability, temperature excursions, returns/destruction, and related pharmacy requirements, as previously discussed.
We have dispensed investigational Blina in the past and have prepared 72-hour and 96-hour bags at that time. Our most recent patient was admitted for the full Blina cycle and we dispensed longer duration bags with the Nitroglycerin IV sets. Elaine, can you please confirm which CADD tubing the inpatient pharmacy is currently using for Blina? Orders should be place within a treatment plan in EPIC which will lay out the dates of each bag exchange. You will have to work with the study team to create the calendar as they will be entering the orders within the
Please note this email address should only be utilized for non-urgent clinical questions. If you are experiencing a medical emergency, please call 911 or go to the nearest emergency room. If you have an urgent medical inquiry, please contact your Oncologist’s office.
Can you please schedule a remote pharmacy visit for T0903 on 12/9-12/10?
Monitor: Ariadna Alvarado Avila Sr. Clinical Research Associate Clinical Operations Learn more about IQVIA Biotech Formerly based in Florida, currently based in Houston, TX (CST, CDT) M: +1 954 309 7062 | E: [log in to unmask]
Thank you,
Marina Peterson
Data Coordinator, Melanoma/Sarcoma & Thoracic Oncology
The sponsor just sent us the agenda for the SIV for Dr. Chakraborty's ACYY1491 study this Thursday 9/17. The pharmacy portion is scheduled for 3-3:30. Would someone be available to attend? If not we'll reach out and schedule a separate section.
Warmly,
Kaitlyn Campbell, MPH
Clinical Research Manager, Breast and Multiple Myeloma Oncology
Please see the cart details below and let us know the expected ETA. Thank you!
Thank you, Your Cart #196772268 has been Submitted Login to SupplyManager<https://mms.mckesson.com/>
PO Order # Created By Submitted Total CU00214474 84717624 Punchout User 9/14/26 1:09:43 PM EDT $202.83 Account #54637591 COLUMBIA UNIVERSITY Shipping To #64682808 COLUMBIA UNIVERSITY RESEARCH PHARMAC MHB LL1 RM 001 177 FORT WASHINGTON AVE NEW YORK, NY 10032 This order has been submitted for processing. Item status is subject to change. If you have questions or your order needs special handling, contact Customer Service @ 866-625-2679 and refer to Order #
Dear all, Following up again here. Thanks so much, Bridget
From: Yates, Bridget R. Sent: Tuesday, September 8, 2026 10:22 AM To: Elia, Sarah-Belle <[log in to unmask]>; Zanelli, Nicholas J. <[log in to unmask]>; Holgate, Tanja S. <[log in to unmask]> Cc: [log in to unmask] <[log in to unmask]>; Lee, Jaimie <[log in to unmask]> Subject: RE: ACYY2551 - George (SymBio) - Contact Info?
Dear all, I wanted to follow on the request below. Please let me know if you have any questions or if you prefer to talk through these on a call, I'm happy to set something up with whoever is available from the pharmacy! Best, Bridget
Thank you for your time during the remote SIV for TYR300-203 conducted on 27 Aug and 31 Aug 2026. Please find the follow-up letter attached. Within the letter are follow-up actions for your sites review and response.
Lastly, a copy of the attached letter will need to be filed within the ISF. Should you have any questions, please reach out.
Can you tell me the order number? I have inventory I can pull from another warehouse.
Thank you,
Maureen Morin Field Account Representative 860 268-3827 | [log in to unmask]<mailto:[log in to unmask]> Health Systems| McKesson Medical-Surgical McKesson | 9954 Mayland Drive, Richmond, VA 23233 | www.mckesson.com<http://www.mckesson.com/> [cid:image001.png@01DD443F.AB46B870] McKesson Medical-Surgical is becoming Wellverse.
Confidentiality Notice: This e-mail message, including any attachments, is for the sole use of the intended recipient(s) and may contain confidential and privileged information. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail and destroy all copies of
1401429839 AAAV3425 Genmab GCT1184-02 PRO1184-002 GOG-3107 ENGOT-ov86 RAINFOL-OV2 14Sep2026 Rina-S or Gemcitabine Orders will be placed and signed in EPIC, will release, complete day and practice clear on visit date (Cycle 10 Day 1)
From: Vattakalam, Reena M. Sent: Wednesday, September 9, 2026 3:41 PM To: Martins, Andrea <[log in to unmask]>; Zanelli, Nicholas J. <[log in to unmask]>; [log in to unmask] <[log in to unmask]> Subject: RE: Upcoming visits: OBGYN ---- GYN ONC
Hi Zara Currently no pending for the pharmacy that I am aware of. I included Tania, your site primary CRA to this communication. Please contact her moving forward for any issues/concerns. It was nice talking to you and the team. Good luck with the study. 🙂
Thanks and Regards
Ly Mai
Sr. Clinical Research Associate
Oncology/Canada Global Site Activation & Monitoring Global Clinical Development, Research & Development Solutions
Please see communications with Vestgio accountability logs attached at each monitor visit and audit prep.
Thanks,
Nicholas Zanelli, PharmD Lead Research Pharmacist Vagelos College of Physicians and Surgeons Columbia University Milstein Hospital 177 Fort Washington Avenue Suite MHB-LL1-001 New York, NY 10032 Phone: 212-305-8684 Fax: 212-305-0397 Email: [log in to unmask]<mailto:[log in to unmask]>
From: Mersereau, Cole A. <[log in to unmask]> Sent: Monday, September 14, 2026 9:20 AM To: Elia, Sarah-Belle <[log in to unmask]>; Martins, Andrea <[log in to unmask]>; Zanelli, Nicholas J. <[log in to unmask]>; Bukauskaite, Indre <[log in to unmask]>; Imtiaz, Zara <[log in to unmask]> Cc: Minhaz, Moury <[log in to unmask]>; Buchanan, Diana L. <[log in to unmask]>; Peterson, Marina A. <[log in to unmask]>; Rivera, Caroline Y. <[log in to unmask]>; [log in to unmask] <[log in to unmask]> Subject: Re: Vestigo
Nicholas Zanelli, PharmD Lead Research Pharmacist Vagelos College of Physicians and Surgeons Columbia University Milstein Hospital 177 Fort Washington Avenue Suite MHB-LL1-001 New York, NY 10032 Phone: 212-305-8684 Fax: 212-305-0397 Email: [log in to unmask]<mailto:[log in to unmask]>
From: [log in to unmask] <[log in to unmask]> On Behalf Of Kuriakose, Nadine Sent: Friday, September 11, 2026 6:06 PM To: [log in to unmask] <[log in to unmask]> Cc: Roven, Una R. <[log in to unmask]> Subject: Fw: RASolute 305 | 110/Dr Manji | TSIV Pharmacy Portion
The pharmacy has availability next week 9/21, 9/23, 9/24 or 9/25 from 11AM - 2PM EST. Please let us know what time works best for you.
Thanks,
Nicholas Zanelli, PharmD Lead Research Pharmacist Vagelos College of Physicians and Surgeons Columbia University Milstein Hospital 177 Fort Washington Avenue Suite MHB-LL1-001 New York, NY 10032 Phone: 212-305-8684 Fax: 212-305-0397 Email: [log in to unmask]<mailto:[log in to unmask]>
From: [log in to unmask] <[log in to unmask]> On Behalf Of Smith, Emme Sent: Monday, September 14, 2026 9:22 AM To: Guidry, Leo <[log in to unmask]>; Minhaz, Moury <[log in to unmask]>; Herzberg, Benjamin O. <[log in to unmask]>; Vasquez, Ariana <[log in to unmask]>; Rojas, Jennifer <[log in to unmask]>; ([log in to unmask]) <[log in to unmask]> Cc: Carter, Tunja <[log in to unmask]>; Prosper,
From: Khuu, Victor Sent: Monday, August 31, 2026 5:29 PM To: 'Elia, Sarah-Belle' <[log in to unmask]>; Rojas, Jennifer <[log in to unmask]>; Vasquez, Ariana <[log in to unmask]> Cc: ChemoRx <[log in to unmask]> Subject: RE: PRISM-1 Dr. Manji IDMV5 102085 Remote Pharmacy Visit by Unblinded Monitor
Thank you for letting me know. Looping in @Vasquez, Ariana<mailto:[log in to unmask]> and @Rojas, Jennifer<mailto:[log in to unmask]> to help with scheduling and @ ([log in to unmask])<mailto:[log in to unmask]> for awareness.
Thanks,
Emme Smith
Clinical Research Coordinator II, Thoracic Oncology
We are finalizing our responses for the Aura audit we had on July 15-16th, 2026 and we wanted to check if you had ever provided the Vestigo records during or before the audit during a previous monitoring visit to the sponsor. Please let me know ASAP! Much appreciated.
This is for Aura AU-011-301, AAAV7661. I know that sometimes the CRAs ask for Vestigo records at monitoring visits.
Please let us know if there is anything else you need from our end.
Looking forward to working with you!
Best,
Zara Imtiaz, PharmD Research Pharmacist Vagelos College of Physicians & Surgeons at Columbia University Milstein Hospital | CUIMC Research Pharmacy 177 Fort Washington Avenue Suite MHB-LL1-001 New York, NY 10032 Office: 212-305-8684 Fax: 212-305-0397
The use of 24-hour bags inpatient is specific to our inpatient pharmacy due to cost-saving initiatives and to minimize drug waste in the event of a disconnect. If the research pharmacy team is comfortable using longer-duration bags while the patient is admitted and the day of discharge, that is fine.
Thank you for working on this and apologies for including the Sobi Order email address. Removed it now. Could you please advise on the current status of the shipment?
This electronic message is intended to be for the use only of the named recipient and may contain information that is confidential or privileged. If you are not the intended recipient, you are hereby notified that any disclosure, copying, distribution or use of the contents of this message is strictly prohibited. If you
We only use 24 hour bags while the patients are admitted and then transition to a combination of 48 hour, 72 hour, and 96 hour bags for outpatient follow up.
Kate Phinney, DNP, CPNP-PC Pediatric Nurse Practitioner Division of Pediatric Hematology, Oncology, & Stem Cell Transplantation New York-Presbyterian Columbia University Medical Center Herbert Irving Pavilion 161 Fort Washington Avenue, 7th Floor New York, NY 10032 (212)305-9770
Hi Justine, Nuclear medicine is working on providing the answers on the questionnaire. Would you have a draft copy of the protocol so that they may assist in providing informed answers here? We can discuss setting up a meeting once we have the protocol accordingly. Thanks Kriti
We are fully supportive of streamlining this wherever possible. That said, our SOPs require this assessment for all non-company sourced IMPs. I have pre-filled some questions that are not applicable for Pluvicto (relating to sourcing, as Novartis is the sole supplier), see attached.
To make this as efficient as possible, can we schedule a call and assist the Nuclear Medicine team in completing the remaining questions to ensure we understand your site's workflows and capabilities to prevent future questions once patients enroll and monitoring begins?
We normally keep them for the first 3-7 days depanding on the course and the tumor load and the rest is outpatient. From: Zanelli, Nicholas J. <[log in to unmask]> Sent: Friday, September 11, 2026 2:57 PM To: Phinney, Kate [NYP] <[log in to unmask]>; Patel, Shrushti <[log in to unmask]>; Elia, Sarah-Belle <[log in to unmask]>; chemorx <[log in to unmask]>; Augustine, Elaine [NYP] <[log in to unmask]> Cc: Sookraj, Karishma S. <[log in to unmask]>; Medrano, Karla Y. <[log in to unmask]>; Chanatry, Claire E. <[log in to unmask]>; Hijiya, Nobuko <[log in to unmask]> Subject: RE: Potential study patient enrollment- AALL1821 (AAAT6268)
Hope you are doing well. Please kindly provide a copy of Acknowledgement of Computerized System Validation Form (ACSV) for Vestigo.
Thank you for all your help and continued support.
KR, Christopher
CAUTION: When replying, please ensure not to include any of patient's personal information/details in your response or in any attached document. Any patient's personal information must be completely removed/redacted to avoid Data Privacy Breach. Thanks for your attention to this important matter.
From the research pharmacy perspective, we can give our expected Blina bag exchange schedule. The research pharmacy's hours of operations are Monday - Friday 8AM - 4PM, closed on holidays. We typically try to plan the bag exchange during our business hours. For example, if the patient were to start Blina on 9/17 we would prepare a 96-hour bag so that the next bag would be due on Monday 9/14. We would then prep a 72-hour bag so the patient would maintain a Monday/Thursday schedule. Do you know if the patient will be admitted for the full 28-day
I just chatted with Dr. Hijiya regarding tentative planning for next steps for Cai. I have scheduled him to return to clinic next Thurs 9/17 for LP/IT and admission for Blina +/- Nivo depending on randomization. This will be my first time dealing with on study Blina so I wanted to reach out to see how best to make sure all of the checklist items are taken care of.
Since Nicole is rolling off the study and I will be the new US PM, please allow me to take the discussion from here.
We did receive a few additional questions from the Sponsor below. Could you please provide the further needed information:
* What is the distance between the parent site and this proposed satellite site location? * Since we are not expecting to have a separate site number for this satellite location as lab kits/IP can be transferred from the main site, then we need to also ensure there are proper procedures in place
We are working on getting nuclear medicine input for the questions
At the same time, the questions are a potential barrier for a problem that just doesn’t exist. We have been stably giving Pluvicto here for at least 2 years without any supply issues and plan to use SOC Pluvicto.
Please note this email address should only be utilized for non-urgent clinical questions. If you are experiencing a medical emergency, please call 911 or go to the nearest emergency room. If you have an urgent medical inquiry, please contact your Oncologist’s office.
Hi All I just sent the invitation for the pharmacy portion at 11am today. Our company mailbox moved all emails from the pharmacy team to the junk email. Our apologies for the oversight. Talk to you later.
Thanks and Regards
Ly Mai
Sr. Clinical Research Associate
Oncology/Canada Global Site Activation & Monitoring Global Clinical Development, Research & Development Solutions
Medpace 5400 Medpace Way Cincinnati, Ohio 45227 Mobile: +1.283.227.6871 Fax: +1.513.579.0444 E-mail: [log in to unmask]<mailto:[log in to unmask]>
From: Irizarry, Luis <[log in to unmask]> Sent: Friday, September 11, 2026 8:44 AM To: Abraham, Lloyd M. <[log in to unmask]>; Stricker, Abby <[log in to unmask]>; Banuelos, Melissa <[log in to unmask]>; ChemoRx <[log in to unmask]>; Kim, Alyssa <[log in to unmask]> Cc: Conwell, Nicole <[log in to unmask]>; Zanelli, Nicholas J. <[log in to unmask]>; Anjom, Elnaz <[log in to unmask]> Subject: Re: Lilly BCL6 | J6Y-OX-JBFA | Combination Drug Sourcing 13000
Apologies for the back-and-forth, as the question below will need to be addressed by @ChemoRX (Contact)<mailto:[log in to unmask]> given I am unaware of their physical limitations of IP storage for the moment.
@ChemoRX (Contact)<mailto:[log in to unmask]> can you please address the question highlighted in the below thread?
Following up on the invite for the pharmacy SIV. Please send to:
@Elia, Sarah-Belle<mailto:[log in to unmask]> @Imtiaz, Zara<mailto:[log in to unmask]> @Zanelli, Nicholas J.<mailto:[log in to unmask]> @Martins, Andrea<mailto:[log in to unmask]> @Bukauskaite, Indre<mailto:[log in to unmask]>
Thanks,
Sarah-Belle Elia, PharmD
Research Pharmacy
Vagelos College of Physicians and Surgeons
Columbia University
Milstein Hospital
177 Fort Washington Avenue
Suite MHB-LL1-001
New York, NY 10032
Phone: 212-305-8684
Fax: 212-305-0397
Email: [log in to unmask]<mailto:[log in to unmask]>
I wanted to follow up on the below questions and IRT access for my colleagues and myself. I see that our site has officially been activated, but I don't see that we have IRT access yet.
CONFIDENTIALITY NOTICE: The contents of this email message and any attachments are intended solely for the addressee(s) and may contain confidential and/or privileged information and may be legally protected from disclosure. If you are not the intended recipient of this message or their agent, or if this message has been addressed to you in error, please immediately alert the sender by
You can list me as the recipient of drug shipment with the delivery address of:
Columbia University Medical Center 177 Fort Washington Avenue Suite MHB-LL1-001 New York, NY 10032
We ask that you do NOT ship out any investigational drug to our site until the pharmacy SIV has been scheduled and completed with the research pharmacy.
Can you please forward the invite for tomorrow's meeting with pharmacy and we can provide all of our SOPs at the conclusion of the meeting.
Thanks,
Nicholas Zanelli, PharmD Lead Research Pharmacist Vagelos College of Physicians and Surgeons Columbia University Milstein Hospital 177 Fort Washington Avenue Suite MHB-LL1-001 New York, NY 10032 Phone: 212-305-8684 Fax: 212-305-0397 Email: [log in to unmask]<mailto:[log in to unmask]>
From: [log in to unmask] <[log in to unmask]> On Behalf Of Jelski, Alexis Sent: Thursday, September 10, 2026 3:24 PM To: Roven, Una R. <[log in to unmask]>; [log in to unmask] <[log in to unmask]> Cc: Kuriakose, Nadine <[log in to unmask]>; Mai, Ly <[log in to unmask]>; Kevorkian, María Laura <[log in to unmask]> Subject: RE: ACYY2694 RMC-9805-305 pharmacy SIV scheduling
Hope you're doing well. The invite has now been forwarded to the individuals listed below.
Thanks, and please let me know if there's anything else you need.
Best, Laura
[cid:image002.png@01DD4139.175A0620] Laura Jalava Senior Clinical Research Associate TEL +1(518)227-6495
Email [log in to unmask]<mailto:[log in to unmask]> Web www.linical.com<http://www.linical.com> Time Zone EST
[A blue background with white text AI-generated content may be incorrect.]<https://www.linical.com/news-and-events/linical-celebrates-20-years-of-innovation>
From: Elia, Sarah-Belle <[log in to unmask]> Sent: Thursday, September 10, 2026 10:52 AM To: Kuriakose, Nadine <[log in to unmask]>; Laura Jalava <[log in to unmask]>; Ali, Sara <[log in to unmask]>; He, Aiwu R. <[log in to unmask]>; Qun Zeng <[log in to unmask]>; [log in to unmask] <[log in to unmask]>; Elia, Sarah-Belle <[log in to unmask]>; Martins, Andrea <[log in to unmask]>; Zanelli, Nicholas J. <[log in to unmask]>; Imtiaz, Zara
Would you be able to provide us with your IP transport SOP (specifically for transport from Pharmacy to main site?)
Kind regards,
Alexis Jelski, MS, RD Senior Site Activation Coordinator Country Site Activation - R&D Solutions [cid:image001.png@01DD4138.5B66CA20] Learn more<http://www.iqvia.com/> about IQVIA Home based in PA United States O/M: +1 267 382 7619 | E: [log in to unmask]<mailto:[log in to unmask]>
I just wanted to ensure that you have received the updated pharmacy manual v12. Here it is attached.
Jared Bradshaw Clinical Research Associate
Medpace 5375 Medpace Way Cincinnati, Ohio 45227 Mobile: +1.513.814.0694 E-mail: [log in to unmask]<mailto:[log in to unmask]>
[cid:image001.png@01DD4127.3F7B2D30]
From: Gruber, Lily <[log in to unmask]> Sent: Friday, August 14, 2026 12:52 PM Cc: RLY2608 <[log in to unmask]> Subject: RLY-2608-101 | Updated Pharmacy Manual V12.0 Importance: High
Thank you for accommodating my pharmacy monitoring visit today. Looking at your records, it looks like you currently have 4 kits of fulvestrant that recently expired and is in quarantine status. I wanted to make sure that you saw the email below and confirmation from sponsor that you can proceed with IP destruction.
Following up to provide the monitor's email and phone number:
Jin Azizpour, CCRP Senior Clinical Research Associate Therapeutic Delivery Unit – Oncology Global Site Activation & Monitoring Global Clinical Development, Research & Development Solutions Homebased – FL (EST) Learn more about IQVIA M: +1 904 312 3317 | F: +1 407 279 3416 | E: [log in to unmask]
Marina Peterson
Data Coordinator, Melanoma/Sarcoma & Thoracic Oncology
Can you please add a remote pharmacy visit for 10/2 for T7686?
Monitor: Jin Azizpour, CCRP Senior Clinical Research Associate Therapeutic Delivery Unit – Oncology Global Site Activation & Monitoring Global Clinical Development, Research & Development Solutions Homebased – FL (EST)
Thank you,
Marina Peterson
Data Coordinator, Melanoma/Sarcoma & Thoracic Oncology
Thank you! Only two documents remain outstanding. Sponsor will not provide greenlight without them.
FD for Stein
GCP for Brian Marr has expired so we need his updated GCP Certificate
Cindy Meyers, MS Clinical Team Manager Hematology Oncology PPD Clinical Research Services
Thermo Fisher Scientific 929 North Front Street | Wilmington, NC, 28401-3331, USA Tel: 910-558-7699 | [log in to unmask]<mailto:[log in to unmask]> | thermofisher.com/ppd Please Note - My normal working hours are 7:30 am until 4:00 pm EST.
There is no need to return the completed form. It can just be completed and filed in your records.
Thank you, Mira
[cid:image001.png@01DD4111.0518BE20] Mira Patel Biochemical Engineer | Greenwich LifeSciences, Inc. | NASDAQ: GLSI [log in to unmask] | (203) 434-3392
From: Vasquez, Ariana <[log in to unmask]> Sent: Thursday, September 10, 2026 10:06 AM To: Mira Patel <[log in to unmask]>; Rojas, Jennifer <[log in to unmask]>; Elia, Sarah-Belle <[log in to unmask]> Cc: [log in to unmask] <[log in to unmask]> Subject: Re: GLSI-21-01 | AAAU0138 | GM-CSF Shipment Update
Apologies if there was any confusion. There was another instance of PHI from 05AUG2026, that is the date I need confirmation of. This email confirmed the deletion of the 27MAY26 correspondence.
Thank you,
Aidan Holmes Clinical Research Coordinator, Thoracic Oncology Columbia University Irving Medical Center Clinical Protocol and Data Management Office 161 Fort Washington Avenue Herbert Irving Pavilion, Mezzanine New York, NY 10032 Phone: 212-304-5548
The previous email does not include your confirmation of deletion of PHI instance from 05AUG2026. Could you please confirm the deletion of PHI breach correspondence from this date?
Thank you,
Aidan Holmes Clinical Research Coordinator, Thoracic Oncology Columbia University Irving Medical Center Clinical Protocol and Data Management Office 161 Fort Washington Avenue Herbert Irving Pavilion, Mezzanine New York, NY 10032 Phone: 212-304-5548
Please forward the pharmacy SIV invite scheduled for 9/22 at 1PM to the following personnel:
@Elia, Sarah-Belle<mailto:[log in to unmask]> @Martins, Andrea<mailto:[log in to unmask]> @Zanelli, Nicholas J.<mailto:[log in to unmask]> @Imtiaz, Zara<mailto:[log in to unmask]> @Bukauskaite, Indre<mailto:[log in to unmask]>
Thank you,
Sarah-Belle Elia, PharmD
Research Pharmacy
Vagelos College of Physicians and Surgeons
Columbia University
Milstein Hospital
177 Fort Washington Avenue
Suite MHB-LL1-001
New York, NY 10032
Phone: 212-305-8684
Fax: 212-305-0397
Email: [log in to unmask]<mailto:[log in to unmask]>
[cid:image001.png@01DD4108.447EFE20] Mira Patel Biochemical Engineer | Greenwich LifeSciences, Inc. | NASDAQ: GLSI [log in to unmask] | (203) 434-3392
From: Vasquez, Ariana <[log in to unmask]> Sent: Thursday, September 10, 2026 9:04 AM To: Mira Patel <[log in to unmask]>; Mira Patel <[log in to unmask]>; Rojas, Jennifer <[log in to unmask]>; Elia, Sarah-Belle <[log in to unmask]> Cc: [log in to unmask] <[log in to unmask]> Subject: Re: GLSI-21-01 | AAAU0138 | GM-CSF Shipment Update
Is there a more updated version of the manual than Version 1.0 dated 03/23/2026 that you can share with us?
Thank you,
Zara Imtiaz, PharmD Research Pharmacist Vagelos College of Physicians & Surgeons at Columbia University Milstein Hospital | CUIMC Research Pharmacy 177 Fort Washington Avenue Suite MHB-LL1-001 New York, NY 10032 Office: 212-305-8684 Fax: 212-305-0397
Please make sure it's the price corresponding to the correct PS for which these vials were purchased.
Thanks, Elnaz
From: Martins, Andrea <[log in to unmask]> Sent: Thursday, September 10, 2026 10:09 AM To: Anjom, Elnaz <[log in to unmask]> Cc: Irizarry, Luis <[log in to unmask]>; Rojas, Jennifer <[log in to unmask]>; Vasquez, Ariana <[log in to unmask]>; Holgate, Tanja S. <[log in to unmask]>; ChemoRx <[log in to unmask]> Subject: Re: Approval to Transfer Fludarabine (AAAV0196 to AAAV5525)
I'm sorry-I must have missed the emails. Feel free to always ping me if there's anything I haven't responded to.
Approved!
Please make sure you follow all required steps in the attached instructions for transferring the vial, and confirm once the transfer is complete so Luis can make the appropriate billing updates.
Thank you, Ariana. I just approved the vials for use in the system.
Mira
[cid:image001.png@01DD4103.15DCEB90] Mira Patel Biochemical Engineer | Greenwich LifeSciences, Inc. | NASDAQ: GLSI [log in to unmask] | (203) 434-3392
From: Vasquez, Ariana <[log in to unmask]> Sent: Thursday, September 10, 2026 8:50 AM To: Mira Patel <[log in to unmask]>; Mira Patel <[log in to unmask]>; Rojas, Jennifer <[log in to unmask]>; Elia, Sarah-Belle <[log in to unmask]> Cc: [log in to unmask] <[log in to unmask]> Subject: Re: GLSI-21-01 | AAAU0138 | GM-CSF Shipment Update
We will review and provide you with a pharmacy training log once completed.
I would like to confirm if we should close the pharmacy portion of the study? We currently have drug on hand, so we will need to reach out to the CRA to get approval to destroy before we can close the study.
My apologies, we accidentally used an old form. I will work with Cryogene to get this corrected and to get you an updated one for your records. The correct shipment number is 1960.
Thank you, Mira
[cid:image001.png@01DD40FE.011299D0] Mira Patel Biochemical Engineer | Greenwich LifeSciences, Inc. | NASDAQ: GLSI [log in to unmask] | (203) 434-3392
From: Vasquez, Ariana <[log in to unmask]> Sent: Thursday, September 10, 2026 7:48 AM To: Mira Patel <[log in to unmask]>; Rojas, Jennifer <[log in to unmask]>; Elia, Sarah-Belle <[log in to unmask]> Cc: [log in to unmask] <[log in to unmask]> Subject: Re: GLSI-21-01 | AAAU0138 | GM-CSF Shipment Update
Thank you for having me this morning! It was nice seeing the facility, but I didn't catch the woman's name who gave me the tour. Could you please let me know? Thank you in advanced!
Stein-FD Treatment Beyond Progression IRB Approved ICF GCP for Brian Marr has expired so we need his updated GCP Certificate
Cindy Meyers, MS Clinical Team Manager Hematology Oncology PPD Clinical Research Services
Thermo Fisher Scientific 929 North Front Street | Wilmington, NC, 28401-3331, USA Tel: 910-558-7699 | [log in to unmask]<mailto:[log in to unmask]> | thermofisher.com/ppd Please Note - My normal working hours are 7:30 am until 4:00 pm EST.
The shipment number on the PS (shipment # 1710) does not match the shipment number that is showing on RTSM (shipment # 1960). I did notice that the tracking number found on RTSM linked to shipment #1960 does match the tracking number written on the PS. Can you please confirm that these are the same shipments? Once I have confirmation, I can move forward with acknowledging.
I'll wait for Luis, Lloyd, and Nicole to confirm availability.
Thanks, Elnaz
From: Stricker, Abby <[log in to unmask]> Sent: Wednesday, September 9, 2026 3:03 PM To: Anjom, Elnaz <[log in to unmask]>; Banuelos, Melissa <[log in to unmask]>; Conwell, Nicole <[log in to unmask]>; ChemoRx <[log in to unmask]>; Zanelli, Nicholas J. <[log in to unmask]> Cc: Irizarry, Luis <[log in to unmask]>; Abraham, Lloyd M. <[log in to unmask]> Subject: [EXTERNAL] RE: Lilly BCL6 | J6Y-OX-JBFA | Combination Drug Sourcing 13000
From: Schumpp, Alyssa <[log in to unmask]> Sent: Wednesday, September 9, 2026 5:48 PM To: Andrea,Hunter <[log in to unmask]>; ChemoRX (Contact) <[log in to unmask]>; Dreher, Nickolas P. <[log in to unmask]>; Henick, Brian S. <[log in to unmask]>; Irizarry, Luis <[log in to unmask]> Subject: RE: HCB301-ONC-101 Product Questions
HI Andrea, Can you kindly send the protocol for this trial? Thanks! Looping in @Dreher, Nickolas P.<mailto:[log in to unmask]> and @Henick, Brian S.<mailto:[log in to unmask]> for awareness. @Irizarry, Luis<mailto:[log in to unmask]> are you able to assist with the below questions?
HI Andrea, Can you kindly send the protocol for this trial? Thanks! Looping in @Dreher, Nickolas P.<mailto:[log in to unmask]> and @Henick, Brian S.<mailto:[log in to unmask]> for awareness. @Irizarry, Luis<mailto:[log in to unmask]> are you able to assist with the below questions?
Alyssa Schumpp, M.S. Clinical Research Manager, Phase 1 Oncology Clinical Protocol and Data Management Office 161 Fort Washington Avenue Herbert Irving Pavilion, Mezzanine New York, NY 10032 Phone: 212-342-3970 http://cancer.columbia.edu<http://cancer.columbia.edu/>
Can you please record receipt of the shipment in the RTSM system as soon as possible? 103B is unable to record an upcoming visit because there is no inventory available in the system.
Thank you, Mira
[cid:image001.png@01DD4072.16576AA0] Mira Patel Biochemical Engineer | Greenwich LifeSciences, Inc. | NASDAQ: GLSI [log in to unmask] | (203) 434-3392
From: Mira Patel <[log in to unmask]> Sent: Thursday, September 3, 2026 10:31 AM To: Rojas, Jennifer <[log in to unmask]>; Mira Patel <[log in to unmask]>; Elia, Sarah-Belle <[log in to unmask]> Cc: [log in to unmask] <[log in to unmask]> Subject: RE: GLSI-21-01 | AAAU0138 | GM-CSF Shipment Update
Could you please send over the IRB Approved Treatment Beyond Progression ICF as well as the two FDFs-Dr. Stein and Dr. Yeager.
Cindy Meyers, MS Clinical Team Manager Hematology Oncology PPD Clinical Research Services
Thermo Fisher Scientific 929 North Front Street | Wilmington, NC, 28401-3331, USA Tel: 910-558-7699 | [log in to unmask]<mailto:[log in to unmask]> | thermofisher.com/ppd Please Note - My normal working hours are 7:30 am until 4:00 pm EST.
Hi Sehar and Team, We are still missing two FDFs and cannot activate your site without them.
Yeager Stein
Cindy Meyers, MS Clinical Team Manager Hematology Oncology PPD Clinical Research Services
Thermo Fisher Scientific 929 North Front Street | Wilmington, NC, 28401-3331, USA Tel: 910-558-7699 | [log in to unmask]<mailto:[log in to unmask]> | thermofisher.com/ppd Please Note - My normal working hours are 7:30 am until 4:00 pm EST.
Transportation to the new regional site has not occurred yet. Please reach out to the study team for additional information, they should have been in touch when they updated the 1572.
A White Plains address is listed on the 1572 dated 18Mar2026. Confirming that while this was listed on the March 1572, transportation to regional site did not occur until August?
Alyssa Schumpp, M.S. Clinical Research Manager, Phase 1 Oncology Clinical Protocol and Data Management Office 161 Fort Washington Avenue Herbert Irving Pavilion, Mezzanine New York, NY 10032 Phone: 212-342-3970 http://cancer.columbia.edu<http://cancer.columbia.edu/>
From: Anjom, Elnaz <[log in to unmask]> Sent: Wednesday, September 9, 2026 1:18 PM To: Kunjukutty, Shiney <[log in to unmask]>; Herzberg, Benjamin O. <[log in to unmask]>; Schumpp, Alyssa <[log in to unmask]>; Irizarry, Luis <[log in to unmask]>; Brogan, Frances L. <[log in to unmask]>; Fernandez, Lourdes <[log in to unmask]> Cc: Calloway, Keith A. <[log in to unmask]>; Khan, Sehar <[log in to unmask]>; [log in to unmask] Subject: RE: Important Update: 3263-001 | Protocol Amendment (PA) V5.0; Cost Estimate Revision - Midazolam?
From: Martins, Andrea <[log in to unmask]> Sent: Wednesday, September 9, 2026 3:40 PM To: Vattakalam, Reena M. <[log in to unmask]>; Zanelli, Nicholas J. <[log in to unmask]>; [log in to unmask] <[log in to unmask]> Subject: Re: Upcoming visits: OBGYN ---- GYN ONC
Hi Reena,
Just wanted to confirm if patient C-C will be coming in next week for treatment?
Friday 11Sep, anytime between 12PM-2PM EST Tuesday 15Sep, anytime between 2-3:30PM EST Thursday 17Sep, anytime between 12-1PM EST Friday 18Sep, anytime between 12-3PM EST
Medpace 5400 Medpace Way Cincinnati, Ohio 45227 Mobile: +1.283.227.6871 Fax: +1.513.579.0444 E-mail: [log in to unmask]<mailto:[log in to unmask]>
From: Anjom, Elnaz <[log in to unmask]> Sent: Wednesday, September 9, 2026 12:03 PM To: Stricker, Abby <[log in to unmask]>; Banuelos, Melissa <[log in to unmask]>; Conwell, Nicole <[log in to unmask]>; ChemoRx <[log in to unmask]>; Zanelli, Nicholas J. <[log in to unmask]> Cc: Irizarry, Luis <[log in to unmask]>; Abraham, Lloyd M. <[log in to unmask]> Subject: RE: Lilly BCL6 | J6Y-OX-JBFA
Please note this email address should only be utilized for non-urgent clinical questions. If you are experiencing a medical emergency, please call 911 or go to the nearest emergency room. If you have an urgent medical inquiry, please contact your Oncologist’s office.
This is for U2483. Can this document be reviewed and just let me know once that has been done:) They are closing this study, so I am unsure why they are asking but I just need to document training.
Attached is the revised Cost Estimate, to reflect Pembrolizumab, Pemetrexed, Carboplatin, Cisplatin, Gemcitabine, Nab-Paclitaxel, mFOLFOX6, mFOLFIRINOX (Fluorouracil, Leucovorin, Irinotecan, Oxaliplatin), premeds and supportive meds for Cohorts F - K are to be sourced via standard of care.
Thanks, Elnaz
Elnaz Anjom, PharmD, MBA Senior Director of Research Pharmacy Vagelos College of Physicians and Surgeons at Columbia University Milstein Hospital 177 Fort Washington Avenue Suite MHB-LL1-001 New York, NY 10032 Phone: 212 305 7746 Cell: 347 947 0016 Fax: 212 305 0068 Email: [log in to unmask]<mailto:[log in to unmask]>
Excellent thank you! I was working with CUMC on the Amgen 20220127 study. However, this visit is for the sponsor, Amgen, as a whole, and is not study specific.
Kind regards,
Bridget McGuigan Sr. CRA
Upcoming Out of Office 20Oct
Global Strategic Solutions Contracted Partner of Amgen Mobile: +1 302 267 5892 [log in to unmask]<mailto:[log in to unmask]> www.ICONplc.com<http://www.iconplc.com/>
[cid:image001.png@01DD405B.3D1AC8B0] This communication contains Amgen Confidential Information and is only being shared because you have been identified as an individual with a business need to know and require this information for the purposes of supporting this program. If you do not have a business
Adding Lloyd Abraham, the assigned budget analyst for this trial.
Given the number of potential standard-of-care products included in the request and the complexity of the associated sourcing requirements, it's best to schedule a meeting to discuss.
Based on our preliminary review, several of the specialty products listed will be difficult or impossible to source through our usual channels since they require manufacturer approval before they can be purchased. Availability can also change over time; therefore, even if we are able to identify a potential source today, Research Pharmacy cannot guarantee that the product will be available when
Hi all, I was wondering if you could provide the following information for patient US-07-010, who is participating in the U9708 trial, related to the treatment administered on 09/08/2026: Could you please provide the chemotherapy lot number and the ultrasound resonator lot number used during that treatment? Thank you,
Herbert Irving Pavilion, Mezzanine New York, NY 10032 Phone: 212-342-4743 http://cancer.columbia.edu<http://cancer.columbia.edu/>
[New Columbia Logo_]
Please note this email address should only be utilized for non-urgent clinical questions. If you are experiencing a medical emergency, please call 911 or go to the nearest emergency room. If you have an urgent medical inquiry, please contact your Oncologist’s office.
Hi Alyssa, I need to follow up on the questions below as I have not received any response from Chemo RX. Thank you lots! Andrea
From: Schumpp, Alyssa <[log in to unmask]> Sent: Thursday, September 3, 2026 12:17 PM To: Andrea,Hunter <[log in to unmask]>; ChemoRX (Contact) <[log in to unmask]> Subject: RE: HCB301-ONC-101 Product Questions
Hi Andrea, Looping in research pharmacy team to help with question 1 @ChemoRX (Contact)<mailto:[log in to unmask]>. Please see my responses below in red.
Please note this email address should only be utilized for non-urgent clinical questions. If you are experiencing a medical emergency, please call 911 or go to the nearest emergency room. If you have an urgent medical inquiry, please contact your Oncologist’s office.
Please see both accountability logs attached. I am working on destroying the vials and as soon as it is witnessed I will send you all documents needed.
Regards,
Ariana Vasquez
Research Pharmacy Assistant
Vagelos College of Physicians and Surgeons at Columbia University
Hello, Correct - patient was supposed to start radiation back up on 8/14 but refused to get treated so drug was held and not administered (per protocol, if radiation is held, injection must be held). Same for 8/18. We did not know if patient would refuse radiation treatment for 8/14 and 8/18 . Patient withdrew on 9/08 after the syringe was prepared and picked up.
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We just received 3 syringes to discard for the patient. Syringes dated 08/14, 08/18 and 9/8. Can you confirm that those were the only dates that we prepared the syringes and the patient did not get dosed? I don't see that we were informed of this and we need to update our records.
Alyssa Schumpp, M.S. Clinical Research Manager, Phase 1 Oncology Clinical Protocol and Data Management Office 161 Fort Washington Avenue Herbert Irving Pavilion, Mezzanine New York, NY 10032 Phone: 212-342-3970 http://cancer.columbia.edu<http://cancer.columbia.edu/>
From: Irizarry, Luis <[log in to unmask]> Sent: Wednesday, September 9, 2026 10:35 AM To: Schumpp, Alyssa <[log in to unmask]> Cc: Anjom, Elnaz <[log in to unmask]>; [log in to unmask]; Elia, Sarah-Belle <[log in to unmask]>; Calloway, Keith A. <[log in to unmask]> Subject: Re: AAAV4605 Cost Estimate PART A ONLY- Drug Procurement; INTERNAL DISCUSSION
Hi Janice, We are waiting on the CTA to be signed by sponsor for Full Execution. We are also pending Greenlight from sponsor. For clinical questions, @Chiza, Pearl<mailto:[log in to unmask]> can assist
Cindy Meyers, MS Clinical Team Manager Hematology Oncology PPD Clinical Research Services
Thermo Fisher Scientific 929 North Front Street | Wilmington, NC, 28401-3331, USA Tel: 910-558-7699 | [log in to unmask]<mailto:[log in to unmask]> | thermofisher.com/ppd Please Note - My normal working hours are 7:30 am until 4:00 pm EST.
We just want to confirm you received everything needed for activation at our site for IDE-034. Including @Schumpp, Alyssa<mailto:[log in to unmask]>
We also emailed separately regarding the below, but would like to confirm :
* Whether the available slots are for dose escalation or expansion? There is a line-of-therapy restriction, so this will be important when reviewing potential patients. * Which tumor types are currently being enrolled? * How many slots will be allocated to our site once activated?
You do not need to provide any documentation to discard.
Thanks,
Zara Imtiaz, PharmD Research Pharmacist Vagelos College of Physicians & Surgeons at Columbia University Milstein Hospital | CUIMC Research Pharmacy 177 Fort Washington Avenue Suite MHB-LL1-001 New York, NY 10032 Office: 212-305-8684 Fax: 212-305-0397
Thank you, we do not have a black bin in the clinic or our office, so I will discard the unused syringes in the research pharmacy black bin. Do I need to bring any documentation to discard?
We do not accept returns for unused syringes; however, we can discard in our black bin if you do not have one available.
Thank you,
Zara Imtiaz, PharmD Research Pharmacist Vagelos College of Physicians & Surgeons at Columbia University Milstein Hospital | CUIMC Research Pharmacy 177 Fort Washington Avenue Suite MHB-LL1-001 New York, NY 10032 Office: 212-305-8684 Fax: 212-305-0397
Apologies for the late notice, but I will be on-site tomorrow only (10Sep), as that is when the facility tour for the rest of the hospital is scheduled. However, I do not think an office space will be needed, I will only need to walk through the pharmacy space to review the facility.
Good morning, Our patient withdrew from the study yesterday and we were not able to administer the syringe. May you please advise if unused syringes need to be returned to research pharmacy?
Ariana, Yes. Thank you so much. This is what I was looking for. Heather
Heather Ferretti Site Manager ICON Strategic Solutions Performing Site Management Services for Johnson & Johnson Innovative Medicine Mobile: 724.691.6803 Email: [log in to unmask] [log in to unmask]<mailto:[log in to unmask]>
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From: Vasquez, Ariana <[log in to unmask]> Sent: Wednesday, September 9, 2026 8:26 AM To: Ferretti, Heather [JRDUS Non J&J] <[log in to unmask]>; Peterson, Marina A. <[log in to unmask]>; ([log in to unmask]) <[log in to unmask]> Cc: Smith, Emme <[log in to unmask]> Subject: [EXTERNAL] Re: T2776 Pharmacy Remote COV
Medpace 5400 Medpace Way Cincinnati, Ohio 45227 Mobile: +1.283.227.6871 Fax: +1.513.579.0444 E-mail: [log in to unmask]<mailto:[log in to unmask]>
From: Stricker, Abby Sent: Tuesday, September 1, 2026 5:17 PM To: 'Anjom, Elnaz' <[log in to unmask]>; Banuelos, Melissa <[log in to unmask]>; Conwell, Nicole <[log in to unmask]>; ChemoRx <[log in to unmask]>; Zanelli, Nicholas J. <[log in to unmask]>; Elia, Sarah-Belle <[log in to unmask]> Cc: Irizarry, Luis <[log in to unmask]> Subject: RE: Lilly BCL6 | J6Y-OX-JBFA | Combination Drug Sourcing 13000
Can you confirm if the expired Glofit has been destroyed per your SOP? If so, could you be able to send me the certificate of destruction? Thank you! Kim
Kim Taylor (formerly Muller) Senior CRA Clinical Operations
Mobile: 910-431-2135 Regionally based in Wilmington, NC [log in to unmask] www.ICONplc.com/clinical [cid:image001.png@01DD3FAB.EF112A60]<https://www.surveymonkey.com/r/ICONPulseSiteSurvey>
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From: Taylor, Kim Sent: Monday, July 6, 2026 3:06 PM To: 'Vasquez, Ariana' <[log in to unmask]> Cc: ChemoRx <[log in to unmask]> Subject: RE: Approval for Destruction ADCT-402-105 | AAAV3982 | Site 204
Herbert Irving Pavilion, Mezzanine New York, NY 10032 Phone: 212-304-5570 http://cancer.columbia.edu<http://cancer.columbia.edu/>
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Please note this email address should only be utilized for non-urgent clinical questions. If you are experiencing a medical emergency, please call 911 or go to the nearest emergency room. If you have an urgent medical inquiry, please contact your Oncologist’s office.
Hello Ariana, I wanted to ask if there is a way to run the drug accountability reports for both subjects with the subject initials showing? If not, I'll try to redact on my end, but I thought I would check with you. Heather
Heather Ferretti Site Manager ICON Strategic Solutions Performing Site Management Services for Johnson & Johnson Innovative Medicine Mobile: 724.691.6803 Email: [log in to unmask] [log in to unmask]<mailto:[log in to unmask]>
From: Schumpp, Alyssa <[log in to unmask]> Sent: Tuesday, September 8, 2026 3:28 PM To: Herzberg, Benjamin O. <[log in to unmask]>; Irizarry, Luis <[log in to unmask]>; Anjom, Elnaz <[log in to unmask]> Cc: Calloway, Keith A. <[log in to unmask]>; Khan, Sehar <[log in to unmask]>; [log in to unmask] Subject: RE: 3263-001 | Protocol Amendment (PA) V5.0; Cost Estimate Revision - Midazolam?
Hi Dr. @Herzberg, Benjamin O.<mailto:[log in to unmask]> Research pharmacy needs to have clear communication that the below drugs in yellow will be considered SOC – Can you kindly respond to this email to confirm so Luis can proceed with finalizing the CE? Thank you!!
Hi Dr. @Herzberg, Benjamin O.<mailto:[log in to unmask]> Research pharmacy needs to have clear communication that the below drugs in yellow will be considered SOC – Can you kindly respond to this email to confirm so Luis can proceed with finalizing the CE? Thank you!!
Also I want to confirm again that Pembrolizumab, Pemetrexed, Gemcitabine, Nab-Paclitaxel, Carboplatin, Cisplatin, and the components of mFOLFOX and mFOLFIRINOX (Oxaliplatin, Leucovorin, 5-FU, and Irinotecan) + premeds are SOC
Herbert Irving Pavilion, Mezzanine New York, NY 10032 Phone: 212-304-5480 http://cancer.columbia.edu<http://cancer.columbia.edu/>
[New Columbia Logo_]
Please note this email address should only be utilized for non-urgent clinical questions. If you are experiencing a medical emergency, please call 911 or go to the nearest emergency room. If you have an urgent medical inquiry, please contact your Oncologist’s office.
Thank you! In Atreo, if you scroll over to the right, there will be a pencil icon in the last column. If you click the pencil icon, it should let you add to the conversation. I’ve responded to DCF 940 and let them know about the information in DCF 956 that you’ve submitted. If any additional action is required on your part, I will let you know.
I tried to respond to the query in Atreo but it would not allow me to type anything in or edit the DCF I originally submitted. I created a new DCF submission with the requested information. The updated Data Change Number is 956.
Cindy Meyers, MS Clinical Team Manager Hematology Oncology PPD Clinical Research Services
Thermo Fisher Scientific 929 North Front Street | Wilmington, NC, 28401-3331, USA Tel: 910-558-7699 | [log in to unmask]<mailto:[log in to unmask]> | thermofisher.com/ppd Please Note - My normal working hours are 7:30 am until 4:00 pm EST.
From: Schumpp, Alyssa <[log in to unmask]> Sent: Tuesday, September 8, 2026 11:43 AM To: Meyers, Cindy <[log in to unmask]>; Khan, Sehar <[log in to unmask]>; Janice George <[log in to unmask]>; Chiza, Pearl <[log in to unmask]>; Martins, Andrea <[log in to unmask]>; Biran Henick <[log in to unmask]>; Ly, Cat T. <[log in to unmask]>; chemorx <[log in to unmask]>; Nicholas Zanelli <[log in to unmask]>; Alia Garcia <[log in to unmask]>; Jennifer White <[log in to unmask]>; Keith Calloway <[log in to unmask]>; Jonathan
Alyssa Schumpp, M.S. Clinical Research Manager, Phase 1 Oncology Clinical Protocol and Data Management Office 161 Fort Washington Avenue Herbert Irving Pavilion, Mezzanine New York, NY 10032 Phone: 212-342-3970 http://cancer.columbia.edu<http://cancer.columbia.edu/>
From: Meyers, Cindy <[log in to unmask]> Sent: Tuesday, September 8, 2026 9:54 AM To: Khan, Sehar <[log in to unmask]>; George, Janice <[log in to unmask]>; Schumpp, Alyssa <[log in to unmask]>; Chiza, Pearl <[log in to unmask]>; Martins, Andrea <[log in to unmask]>; Henick, Brian S. <[log in to unmask]>; Ly, Cat T. <[log in to unmask]>; chemorx <[log in to unmask]>; Zanelli, Nicholas J. <[log in to unmask]>; Garcia, Alia V. <[log in to unmask]>; White, Jennifer F. <[log in to unmask]>; Calloway, Keith A. <[log in to unmask]>; Cho, Jonathan C. <[log in to unmask]>; Kim, Joy T. <[log in to unmask]>;
Sorry for the delay. I am attaching our drug transport SOP here. We do not have a video tour link yet, I can provide some photos of the facility if needed.
Thanks,
Nicholas Zanelli, PharmD Lead Research Pharmacist Vagelos College of Physicians and Surgeons Columbia University Milstein Hospital 177 Fort Washington Avenue Suite MHB-LL1-001 New York, NY 10032 Phone: 212-305-8684 Fax: 212-305-0397 Email: [log in to unmask]<mailto:[log in to unmask]>
Herbert Irving Pavilion, Mezzanine New York, NY 10032 Phone: 212-342-4743 http://cancer.columbia.edu<http://cancer.columbia.edu/>
[New Columbia Logo_]
Please note this email address should only be utilized for non-urgent clinical questions. If you are experiencing a medical emergency, please call 911 or go to the nearest emergency room. If you have an urgent medical inquiry, please contact your Oncologist’s office.
I hope you are doing well. Please go into IRT and provide a response to the query noted below for the DCF that was submitted. If you have any questions, please let Sarah and I know.
Atreo<https://login.atreo.io/#/>
[cid:image001.png@01DD3F84.FDA00AA0]
Thank you, Amanda Nicholl, RN, BSN Assistant Clinical Research Associate PPD Clinical Research Services
Thermo Fisher Scientific 929 North Front Street ꞁ Wilmington, NC, 28401-3331, USA Tel: +1 (910) 558 2265 [log in to unmask]<mailto:[log in to unmask]> | thermofisher.com/ppd<http://www.thermofisher.com/ppd>
Apologies for the delay getting back to you. Sponsor needs the temperature log from 24APR2026 to present.
Thank you, Camila Barrios Clinical Research Coordinator I, Bone Marrow Transplant and Cell Therapy Columbia University Irving Medical Center Clinical Protocol and Data Management Office 161 Fort Washington Avenue Herbert Irving Pavilion, Mezzanine New York, NY 10032 Phone: 212-342-3884 http://cancer.columbia.edu<http://cancer.columbia.edu/> [New Columbia Logo_] Please note this email address should only be utilized for non-urgent clinical questions. If you are experiencing a medical emergency, please call 911 or go to the nearest emergency room. If you have an urgent medical inquiry, please
Zara Imtiaz, PharmD Research Pharmacist Vagelos College of Physicians & Surgeons at Columbia University Milstein Hospital | CUIMC Research Pharmacy 177 Fort Washington Avenue Suite MHB-LL1-001 New York, NY 10032 Office: 212-305-8684 Fax: 212-305-0397
We have processed the order for shipment today and will inform you when we have the relevant tracking details.
Kindly note that all study drug order requests should be sent directly to Marianna Tampere or me. Please do not send these requests to [log in to unmask], as was done in the example below.
Please note this email address should only be utilized for non-urgent clinical questions. If you are experiencing a medical emergency, please call 911 or go to the nearest emergency room. If you have an urgent medical inquiry, please contact your Oncologist’s office.
Jen/Ari- please coordinate with Tanja and Luis to book the office space if needed and put this on the calendar.
Thanks,
Elnaz
Elnaz Anjom, PharmD, MBA Senior Director of Research Pharmacy Vagelos College of Physicians and Surgeons at Columbia University Milstein Hospital 177 Fort Washington Avenue Suite MHB-LL1-001 New York, NY 10032 Phone: 212 305 7746 Cell: 347 947 0016 Fax: 212 305 0068 Email: [log in to unmask]<mailto:[log in to unmask]>
Hi Bridget, Please see SOPs attached. Will defer to @Zanelli, Nicholas J.<mailto:[log in to unmask]> and @Anjom, Elnaz<mailto:[log in to unmask]> re: pharmacy visit and SOPs.
* Reg 002-13 External AE Safety Report Processing- attached * Reg 004-13 DoA – attached * Reg 018-14 Deviations, Violations, Unanticipated Problems- attached * Reg 024-15 Protocol Training- attached * Reg 028-21 Record Maintenance and Retention- attached * Reg 032-22 Electronic Signatures- attached * SMO 003-13 Research Nursing Documentation- attached * SMO 004-13 Informed Consent Process- attached * SMO 005-13 Re-Consent Process- attached * SMO 008-15 Clinical Assessment Worksheet- attached * SMO 009-15 Tissue Sampling and Processing- attached * SMO
Dear all, I wanted to follow on the request below. Please let me know if you have any questions or if you prefer to talk through these on a call, I'm happy to set something up with whoever is available from the pharmacy! Best, Bridget
From: Yates, Bridget R. Sent: Wednesday, September 2, 2026 12:50 PM To: Elia, Sarah-Belle <[log in to unmask]>; Zanelli, Nicholas J. <[log in to unmask]>; Holgate, Tanja S. <[log in to unmask]> Cc: [log in to unmask] <[log in to unmask]> Subject: RE: ACYY2551 - George (SymBio) - Contact Info?
Thanks for your help - please let me know if you have any questions while completing the questionnaire. It would be great to have this completed by the end of this week.
We would also like to set up a call to discuss some details related to Pluvicto ordering, storage, and documentation once we have the completed questionnaire. Is there a day this week that we could set up a 30 min call with you or someone else from Nuc Med? Thank you!
@Khan, Sehar<mailto:[log in to unmask]> we still need FDFs for the below: Mark Stein,Linda Wu, Lauren Yeager
Cindy Meyers, MS Clinical Team Manager Hematology Oncology PPD Clinical Research Services
Thermo Fisher Scientific 929 North Front Street | Wilmington, NC, 28401-3331, USA Tel: 910-558-7699 | [log in to unmask]<mailto:[log in to unmask]> | thermofisher.com/ppd Please Note - My normal working hours are 7:30 am until 4:00 pm EST.
From: Khan, Sehar <[log in to unmask]> Sent: Tuesday, September 8, 2026 9:32 AM To: Meyers, Cindy <[log in to unmask]>; Janice George <[log in to unmask]>; Alyssa Schumpp <[log in to unmask]>; Chiza, Pearl <[log in to unmask]>; Martins, Andrea <[log in to unmask]>; Biran Henick <[log in to unmask]>; Ly, Cat T. <[log in to unmask]>; chemorx <[log in to unmask]>; Nicholas Zanelli <[log in to unmask]>; Alia Garcia <[log in to unmask]>;
I trust that the day finds you well. If you don't mind, could you kindly assist URGENTLY with the Financial Disclosure Forms for the following: Mark Stein,Linda Wu, Lauren Yeager
I would greatly appreciate your assistance.
Adanne
From: Meyers, Cindy <[log in to unmask]> Sent: Tuesday, September 8, 2026 9:39 AM To: Khan, Sehar <[log in to unmask]>; Janice George <[log in to unmask]>; Alyssa Schumpp <[log in to unmask]>; Chiza, Pearl <[log in to unmask]>; Martins, Andrea <[log in to unmask]>; Biran Henick <[log in to unmask]>; Ly, Cat T. <[log in to unmask]>; chemorx <[log in to unmask]>; Nicholas Zanelli <[log in to unmask]>; Alia Garcia <[log in to unmask]>; Jennifer White <[log in to unmask]>; Keith Calloway <[log in to unmask]>; Jonathan Cho <[log in to unmask]>; Joy Kim <[log in to unmask]>; Emmett Wechsler <[log in to unmask]>; Okeke, Adanne Kelechi Okeke
I was informed that the pharmacists will be taking the SIV for this study soon. At earliest convenience, would you be able to review the provided cost estimate - and, if no concerns or questions, sign off and send back to me.
I hope you had a good holiday weekend! Please send over the requested SOPs by noon today. As a reminder, I will also require pharmacy and equipment maintenance SOPs that are maintained by the hospital. Additionally, have you received further confirmation from the pharmacy team regarding the on-site tour?
IRB Approval and associated documents are still pending from your site.
Cindy Meyers, MS Clinical Team Manager Hematology Oncology PPD Clinical Research Services
Thermo Fisher Scientific 929 North Front Street | Wilmington, NC, 28401-3331, USA Tel: 910-558-7699 | [log in to unmask]<mailto:[log in to unmask]> | thermofisher.com/ppd Please Note - My normal working hours are 7:30 am until 4:00 pm EST.
From: George, Janice <[log in to unmask]> Sent: Friday, September 4, 2026 4:25 PM To: Alyssa Schumpp <[log in to unmask]>; Meyers, Cindy <[log in to unmask]>; Chiza, Pearl <[log in to unmask]>; Martins, Andrea <[log in to unmask]>; Biran Henick <[log in to unmask]>; Ly, Cat T. <[log in to unmask]>; chemorx <[log in to unmask]>; Khan, Sehar <[log in to unmask]>; Nicholas Zanelli <[log in to unmask]>; Alia Garcia <[log in to unmask]>; Jennifer White <[log in to unmask]>;
