Stayble Therapeutics recruits VP CMC and Regulatory Affairs
Stayble Therapeutics strengthens the organization by appointing Dr Sara Richardson in the new role of VP CMC and Regulatory Affairs. Dr Richardson’s expertise and experience in manufacturing issues (CMC) and regulatory applications will be very valuable for the company’s future plans and the clinical development of the drug candidate STA363. BioStock reached out to Dr Richardson for a comment.
Stayble Therapeutics is a Gothenburg-based company that has developed an injectable drug candidate called STA363 for chronic disc-related back pain. The candidate’s efficacy is currently being evaluated in a phase II clinical study in the Netherlands, Russia and Spain.
Strengthening the team
Last week, the company announced that it is strengthening its team by recruiting Dr Sara Richardson in the newly created role VP CMC and Regulatory Affairs. Dr. Richardson will take up her position on July 1 and her main duties will be to address manufacturing issues (CMC), regulatory matters and interactions with authorities during the continued clinical development of candidate STA363.
»Dr Richardson will play a central role in the company, especially in the continued clinical development of our drug candidate STA363. It feels great to welcome Dr. Richardson to the team where her expertise and experience will be very valuable to our plans going forward« — Andreas Gerward, CEO of Stayble Therapeutics
Dr Sara Richardson
Dr Richardson received her PhD in Analytical Chemistry from Lund University in 2001. Since then, she has had a long career at AstraZeneca in several positions in research, development and management. Her most recent position involved responsibility for manufacturing issues (CMC) in drug development in the clinical phase. The role also included strategy development, outsourcing of clinical manufacturing and regulatory applications to the European Medicines Agency (EMA) and the US FDA.
Dr Richardson has also held several leadership roles in groups responsible for formulation and analysis development in clinical phase as well as various research roles in pharmaceutical projects throughout clinical development from phase I to phase III.
BioStock got in touch with Dr Richardson to find out more about why she chose to accept the job offer in Stayble Therapeutics.
Sara, what attracted you to the role of VP CMC and Regulatory Affairs in Stayble Therapeutics?
– On the one hand, it was the area of CMC and Regulatory Affairs, which is the background I come from, butabove all it was the concept of a smaller company that also has succeeded very well so far that attracted me to the role. I am both inspired and impressed by how Stayble Therapeutics has managed to take an idea for a drug product to clinical phase IIb in short time.
»I am both inspired and impressed by how Stayble Therapeutics has managed to take an idea for a drug product to clinical phase IIb in short time«
How do your previous experiences prepare you to take on this role?
– I bring with me a long and broad experience in the development of pharmaceutical products throughout the clinical phase, with a focus on CMC, an experience I hope will be an important contribution to successfully driving STA363 through the clinical development phase, all the way to market launch to make it available to patients. I also bring a large network from my years at AstraZeneca, which I think can be important in my rolein Stayble.
How do you see the company and its future?
– I am very positive about the company, its innovation and the future. Disk-related, chronic lumbar pain affectsa very large patient population that today are offered very few treatment options. I believe STA363 has great potential to reach the market and thus be offered as a relatively simple therapy to help a large part of the millions of people who today suffer from chronic pain in the lumbar spine. And I am very much looking forward to taking part in the journey to that goal.
»I am very positive about the company, its innovation and the future.«
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