Radiopharm Theranostics has appointed Rama Abu Shmeis as Senior Vice President Chemistry, Manufacturing and Controls, or “CMC” as the latest in a line of top-shelf appointments at the ASX-listed radiopharmaceuticals specialist.
Dr Shmeis brings to the Melbourne-based radiopharmaceuticals specialist a 23-year record of achievements in leading strategic, operational and scientific aspects of CMC development and manufacturing across all stages from pre-clinical through all clinical stages to commercialisation.
Most recently she held the role of Vice President CMC and Manufacturing Operations at TG Therapeutics and immunotherapy developer Checkpoint Therapeutics, serving at the NASDAQ-listed companies for more than five years.
Her experience covers a wide variety of dose forms, products and technologies.
Radiopharm’s Chief Executive Officer and Managing Director, Riccardo Canevari, said: “Dr Shmeis is known for developing creative solutions to complex problems in the sector, in addition to a strong ability to anticipate risk and therefore establish appropriate strategies to manage this. With a big picture focus and high-level attention to detail, we’re looking forward to her contribution to our vision at Radiopharm.”
Radiopharm has made multiple top-level appointments since listing on the ASX in November 2021 with the goal of developing radiopharmaceutical products for both diagnostic and therapeutic uses in areas of unmet medical needs.
Most recently, the company appointed a new Chief Operating Officer, a VP of Clinical Development, a VP Clinical Operations, an SVP Regulatory and two new board members.
Canevari said Radiopharm was thrilled to add another excellent senior team member with top-shelf experience in the USA.
As with most listings and private companies in the life sciences sector like Radiopharm, cracking the American market can be a game changer because of the sheer size of the market and the prestige generated by being cleared by the powerful US Food and Drug Administration, or “FDA”.
The announcement of Dr Shmeis’ appointment comes less than a fortnight after it was revealed Radiopharm would begin clinical trials of its pancreatic cancer-finding peptide in a New York institute as soon as March 2023 following the green light it received from the powerful US FDA granting the company investigational new drug approval. The approval means Radiopharm can now test its patented RAD301 integrin technology in the real world to determine its efficacy in the early detection of one of the world’s deadliest cancers.
Radiopharm says Dr Shmeis has an outstanding record in building and leading teams of scientists and engineers. Her work has regularly been subject to the demands of aggressive timelines and includes managing both external partners and Contract Development and Manufacturing Organisations to advance more than 25 new molecular entities on a speed-to-market timeline.
This has resulted in a number of successful global regulatory CMC submissions, approvals and market launches across multiple therapeutic areas including oncology, virology, neuroscience and pain management. She has also headed CMC due diligence evaluations leading to several acquisitions, in-licensing, out-licensing and strategic alliances.
Dr Shmeis attended Columbia University’s Graduate School of Business in New York, was awarded a PhD in Pharmaceutics at the University of Iowa and a Bachelor of Science in Pharmacy from the University of Jordan.
She also has a record of invited presentations at national and international conferences, publications in peer-reviewed journals as well as several patents.
It is estimated about 10 million people die annually from cancer, the most common of which are lung, breast, bowel and prostate and attempting to ease this devastating human toll has become a mega business. Globally, Radiopharm’s products are seeking entry into the US$284 billion worldwide oncology market which Precedence Research expects to grow to grow to US$581 billion by 2030.
Radiopharm’s listing on the ASX followed a $50 million IPO to enable it to focus on developing radiopharmaceutical products to diagnose or image tumours and then destroy them by delivering low-level radiation precisely to cancer cells.
With Radiopharm Theranostics planning several clinical trials in 2023, Dr Shmeis will be kept busy as the company works to fulfil its lofty ambition of being the recognised leader in fighting cancer through innovative radiopharmaceutical therapies.
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