Pharma in Focus
Email Address Sign-Up

Australia's most trusted source of pharma news

News

Mesoblast preps for US launch

Posted 14 August 2019

ASX-listed Mesoblast is preparing to file its first new drug application in the US with the appointment of a top pharma industry executive who brings more than 20 years global experience to the homegrown company.

Dr Fred Grossman will take on the role of Chief Medical Officer (CMO) for Mesoblast, based in New York. Dr Grossman has held numerous leadership roles at global pharmaceutical companies, including Eli Lilly, J&J and BMS.

"Fred brings to Mesoblast extensive industry experience which is extremely valuable to the strategic and execution phases of our commercial transition as we prepare for our first FDA Biologics License Application (BLA) and commercial product launch in the United States market," Mesoblast CEO Dr Silviu Itescu said.

"His strong track record of building high-performing teams and setting corporate culture make him ideally suited to lead our late-stage product development strategies and commercial execution."

Dr Grossman has led teams in the US, Europe and Japan with responsibility for global medical affairs, global clinical development, health economics and outcomes research and global drug safety.

"I am very excited to have the opportunity of working at Mesoblast, a very innovative company with a mature pipeline of cellular medicines that have the potential to address some of the most severe diseases affecting people worldwide," Dr Grossman said.

"I look forward to utilizing the experience gained from many product launches to ensure that Mesoblast successfully transitions to a commercial organisation with the planned launch of its first product in the United States."

Mesoblast recently announced it had secured Orphan Drug designation for off-the-shelf cell therapy product Revascor.

Ex-PBAC member gets cardio first

A recently retired member of the PBAC has been appointed first female president of the Cardiac Society of Australia and New Zealand (CSANZ).

Professor Clara Chow has been named President-elect, with her term in office commencing August 2020.

Professor of the Faculty of Medicine and Health at the University of Sydney, Academic Director of the Westmead Applied Medical Research Centre and Program Director, Community Based Cardiac Services and Cardiologist, at Westmead Hospital, Professor Chow stepped down from her PBAC committee role in June.

Professor Chow will likely still have ties to PBAC through her new role, representing cardiologists and those working in the area of cardiology including researchers, scientists, cardiovascular nurses, allied health professionals and other healthcare workers.

"I think this shows the strong commitment of our society to change and addressing the challenges of diversity for our members as well as our patients," Professor Chow said.

Megan Brodie

Pipeline Monitor
BMS I-Os target liver
Combo under priority review for HCC in US.
Top of the Hill
The pill or the cure
New gene therapies a challenge for payers.
Approvals Action
Novartis' newest drug
First-ever oral SPMS drug Mayzent arrives.