NEWSLETTER NO. 6

New People to Know & Clinical Trials Participation Webinar

This edition of the newsletter is dedicated to the introduction of new study team members at Breath/Zambon. You may meet some of them “online” during one of the upcoming study meetings or even in person when the COVID-19 pandemic will allow for travel or scientific meetings again. In addition, there will be a webinar on clinical trials participation on 20 October – see below for more details.

Paola Castellani, MD – Chief Medical Officer

Paola is Zambon’s Global Chief Medical Officer and Patient’s Access Head and part of the company’s senior management. Before moving to the pharmaceutical industry, she trained as a physician in the area of infectious diseases. In the meantime, she has accumulated more than 25 years of experience in pre-clinical and clinical research and development, medical and regulatory affairs, patient’s advocacy and market access worldwide. In her role, she also likes to network with the medical community and patient organizations. After Noreen Henig left the company, Paola also assumed the role of Clinical Development Program Leader for the BOSTON clinical development program.

“We look forward to working together to achieve our common goal of developing a safe and effective treatment for people with bronchiolitis obliterans syndrome. Together with your enthusiasm and commitment, we believe we are well-positioned to accomplish this critical mission. The BOSTON clinical team extends our sincere gratitude to you for ensuring patients’ safety and well-being despite the challenges of managing healthcare and conducting clinical research during the current Covid-19 pandemic environment.”

Dario Cuomo, MD – Clinical Program Physician

Dario is Zambon’s Global Head of Medical Affairs for Respiratory and Established Drugs and he is now covering the role of Clinical Research Physician for the BOSTON studies.

“A passion for putting patients first” and “In Science we trust” are his preferred inspirational quotes. He is a neurologist by training with a solid background in clinical research for respiratory diseases, where he has led many clinical trials, from phase I to IV. Dario has accumulated more than 10 years of experience in the pharmaceutical industry in various roles both in Research and Development and in Medical Affairs within different multinational companies. When he is not working, you can find him training in a gym or walking along the sea.

Stefanie Prante, MSc – Clinical Operations Leader

Stefanie is a microbiologist by education and started her clinical operations career at two different CROs with ten years working in various positions within the CROs.

Subsequently, as Clinical Operations Manager at PARI Pharma, she coordinated the L-CsA studies and other studies in cystic fibrosis and ear, nose and throat indications for almost ten years. During the last four years at PARI Pharma, she was head of the pharmacovigilance group as QPPV.

For more than two years, Stefanie has been part of the clinical operations team at Breath Therapeutics, and earlier this year, she was appointed as head of the clinical operations department.

Stephan Witte, PhD – Clinical Site Liaison

Stephan studied molecular immunology and pharmaceutical medicine in Germany and underwent postdoctoral training in the US. He is an experienced drug development professional and supported small and large drug development programs from first-in-human to registration.

He joined the Breath/Zambon Team earlier this year to establish a clinical site liaison group in order to improve and foster the relationships with clinical sites. You may meet him soon either “online” or in person.

When not busy with the clinical development of drugs you may find him outdoors – either with hiking boots or on a sailing boat.

Upcoming Clinical Trials Participation Event

On October 20th at 12 pm EST, Breath Therapeutics, in conjunction with The Lung Transplant Foundation, will present a conversation about clinical trials and the importance of patient participation. The target audience is lung transplant recipients. Invitations have been shared with several patient organizations. The discussion will cover three segments including an overview of clinical trials and how they work, hearing from a lung transplant recipient who has participated in a BOS clinical trial, and a discussion on the BOSTON studies. For additional information and to register, visit here or by following Lung Transplant Foundation’s Facebook page here. A replay will also be available following the event.

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.