Boyds has announced the opening of its US office, based in the Philadelphia area, and welcomes Katy Rudnick who is appointed Vice President and Head of US Regulatory Affairs to head up the newly established US company.
Since Boyds was established in 2005, the company has worked with US companies seeking to develop and gain approval for their medicines in Europe and further afield. Boyds’ global reputation for its work in advanced therapies has led to a steady increase in the number of companies approaching Boyds for this expertise, with over 60% of the company’s client base now in the US.
The new office is based in Pennsylvania which is an ideal location for many of Boyds’ East Coast clients and provides a link between different time zones from Europe to the West Coast.
To coincide with the opening of the office, Katy Rudnick has joined to head up US Regulatory Affairs and run the newly established US office. She brings 20 years of regulatory and quality experience in the US, having worked across all therapeutic areas and dosage forms. Prior to joining Boyds, Katy was Director of Regulatory Affairs at Lupin Pharmaceuticals where she was responsible for a product portfolio of around 400 products at various stages. Katy has also held regulatory roles at Lannett Company, Teva Pharmaceuticals, and Mars Fishcare North America. Katy’s appointment will help support our clients who are based in the USA and facilitate our many interactions with the FDA.
President and Founder of Boyds, Professor Alan Boyd, says: “The US is the largest biotech market globally, and we have a strong and growing client base in the US. Opening the office in Pennsylvania is the natural next step for Boyds and having a presence on the ground will ensure we can work closely with US clients looking to develop and take their products forward for approval with regulators in the US, but also the UK and Europe, via our UK and Dublin offices.
“I am also delighted to welcome Katy to lead our US Regulatory Affairs activities and run the US office. She brings a strong scientific background and a wealth of regulatory experience including established links with the FDA and her wide network. We plan to grow the team further to extend our service offerings across programme management, medical monitoring, clinical operations, and consultancy directly from within the US, expanding and adding to our UK and Ireland-based teams.”
On joining Boyds, Katy says: “I am delighted to be joining Boyds. The team is a fantastic assemblage of experienced and educated experts in the global pharmaceutical industry. It is an honour to work alongside them and I am excited to be creating the US office and building on the reputation of Boyds across the US, particularly in cutting-edge advanced therapies.”
Katy has a Masters in Regulatory Affairs and Quality Assurance from Temple University and is currently enrolled on the regulatory doctorate program at USC where she is working on her thesis. This is an exclusive program accepting a small student cohort biennially.