NEWSLETTER NO. 18

Upcoming Events

Zambon will have a booth at the upcoming AARC summer forum scheduled for June 29, July 1, 7, and 9, in a virtual environment. AARC Summer Forum Live! Event Summary

Frequently Asked Questions

In response to the positive feedback regarding the Frequently Asked Question section of Newsletter 15, we would like to share some additional questions we have had that may be useful to you.

Patient randomization outside of study protocol window

Q: If a site cannot randomize a patient within the window specified by the protocol, is there a possibility to randomize such patient with a waiver from the CRO or sponsor?

A: No; if a subject cannot be randomized in the 28-day screening window, the subject should be screen failed and formally/completely re-screening (new ICF, new subject number, etc). Per applicable regulations, sponsors are not allowed to approve “waivers” from requirements of the study protocol. This may result in serious findings in pre-approval inspections and put the approvability of L-CsA at risk. Many times, re-screening of a patient is feasible within a short period of time. Covance can provide advice and support on the most efficient ways.

Patient Lab Values for Inclusion

Q: A patient presents with exclusionary serum creatinine levels at the screening visit. However, the patient has historically healthy creatinine levels, and at a clinic visit right after the screening visits, the subject's creatinine levels were normal and meet exclusion criteria. Is such patient eligible?

A: In such case the patient can have an unscheduled study visit (the visit right after the screening visit in the example above). If lab values are normal and do not meet the exclusion criteria at this unscheduled visit, the patient will be eligible for randomization.

Kudos

Kudos for new randomizations go to the following sites:

• 112 Dr. Hays, Study Coordinator Reed Norris and team
• 106 Dr. Weigt, Study Coordinator Elman Punzalan, and team
• 119 Dr. Dr. Mooney, Study Coordinator Emerald Mann, and team
• 101 Dr. Griffith, Study Coordinator Maia Lee, and team
• 122 Dr Pelaez, Study Coordinator Vanessa Scheuble, and team
• 502 Dr. Gottlieb, Study Coordinator Ilona Olzik and team 
• 401 Dr. Kessler, Study Coordinator Julien Stauder and team
• 119 Dr. Dhillion, Study Coordinator Emerald Mann and team

How Do You Like the Newsletters?

Feedback (positive or constructive) is welcome at boston.sitesupport@zambongroup.com.

Help Needed, Questions or Suggestions?

The development program for inhaled L-CsA for the treatment of bronchiolitis obliterans is very important to Zambon.

LabCorp is responsible for the operational conduct of the studies and your LabCorp contact should be your first point of contact for questions.

However, please do not hesitate to get in touch with us directly if you’d like. Emails addressed to boston.sitesupport@zambongroup.com will reach the Zambon study team and will be answered promptly.

Newsletters are for BOSTON clinical site personnel only and not intended to be shared with patients, trial participants or any external audiences.