The appointment boosts Emyria’s global clinical trial and regulatory approval expertise to accelerate drug registration initiatives.
Smith has overseen more than 100 clinical trials and more than 20 regulatory approvals leading to product launches across diverse therapeutic areas including neuroscience, rare disease, oncology, cardiology, dermatology, oncology and anti-infective.
The news was welcomed by investors as shares have been as much as 14.5 per cent higher intra-day to A$0.235 cents.
“Highly acclaimed executive”
Emyria’s managing director Michael Winlo said: “We’re delighted to welcome Karen Smith to chair our Strategic Advisory Board.
“Dr Smith is a highly acclaimed and respected pharmaceutical executive, who has overseen multiple successful drug registrations.
“She has held key chief executive officer and chief medical officer roles at some of the most innovative biotech and pharmaceutical development companies in the world including holding the role of CMO and head of R&D at Jazz Pharmaceuticals, which recently acquired GW Pharma for $7.2 billion.
“GW’s FDA approved product is a formulation of CBD for a type of epilepsy.”
Drug development pipeline
Emyria’s Strategic Advisory Board will meet regularly to support Emyria’s drug development pipeline and its digital remote monitoring and Real-World Evidence (RWE) initiatives.
The appointment of Dr Smith is likely to support innovation across Emyria’s drug development programs and evidence-generating care models
Winlo said: “We believe Dr Smith’s background in successful product registration and strategic partnerships in biopharma will benefit Emyria’s globally-focused drug registration initiatives, including our EMD-003 product candidate for psychological distress and the symptoms of anxiety, depression and stress.”
Dr Smith holds multiple directorships with innovative pharmaceutical companies and was previously working as a chief medical officer and global head of research & development at Jazz Pharmaceuticals.
In addition to Emyria’s scientific advisory board, Dr Smith will also serve as chief medical officer of Emergent BioSolutions - a multinational speciality biopharmaceutical company developing and manufacturing therapeutics and devices for public health threats, including COVID-19.
She is also a director at Antares Pharmaceuticals - developing novel drug delivery technologies and Sangamo Therapeutics and Acceleron Pharmaceuticals - both developing novel treatments for rare diseases, and TeeFib – developing novel treatments for Fibrosis.
Previously, she served as executive vice president, global head R&D and chief medical officer of Jazz Pharmaceuticals and was also the founding chief executive officer of the Minderoo Foundation’s Eliminate Cancer Initiative supported by Andrew Forrest and remains an advisor to that program.
“Supporting innovative ways”
Dr Smith said: “I’m passionate about supporting innovative ways to accelerate drug development.
“Emyria has built a unique clinical service and evidence-generating model that has the potential to accelerate drug development for patients with unmet needs.
“I look forward to assisting the team make progress on its global drug registration goals.”
She has an MD from the University of Warwick (UK), PhD in Molecular Oncology from UCLA (USA) and University of Western Australia (Australia), an MBA from the University of New England in Australia and an LLM (Masters in Law) from the University of Salford (UK).