Boyds expands Regulatory Affairs team to support growing demand

Global drug development consultancy Boyds has strengthened its award-winning Regulatory Affairs team with the appointment of two senior specialists, further expanding its ability to support life sciences companies as they navigate increasingly complex regulatory pathways.

Established in 2005, Boyds works with an international client base to help translate scientific innovation into medicines and medical devices for patient benefit.

Vicki Hayes joins Boyds as Vice President of Regulatory Affairs and Jan Ohotski joins as Director of Regulatory Affairs. Together, they bring senior expertise spanning global regulatory strategy, clinical development, small molecules, biotechnology therapeutics, and cell and gene therapies.

Vicki brings more than 20 years’ experience in regulatory affairs and joins Boyds from a US biotechnology company, where she was Vice President of Global Regulatory Affairs and Policy. She was previously a Board Director at a regulatory affairs consultancy, where she held several senior regulatory affairs roles, and has also worked at Amgen and Eli Lilly and Company.

She has created and led regulatory strategies from first-in-human studies through to post-licensing across therapeutic areas including oncology, neuroscience, anti-infectives and rare diseases, and across modalities including small molecules, biologics and advanced therapies. In 2022, Vicki was awarded the TOPRA Regulatory Affairs Contribution Award.

At Boyds, Vicki will lead the regulatory consulting function, working closely with clients to design robust, pragmatic regulatory strategies that support product development decisions.

Commenting on her appointment, Vicki said: “Boyds thinks outside the box and provides a bespoke, tailored service that supports the development of novel, emerging and cutting-edge technologies. As Vice President of Regulatory Affairs, I look forward to developing creative and pragmatic regulatory strategies that accelerate development and maximise product value, as well as working with the award-winning Regulatory Affairs team, many of whom I have had the pleasure of working with previously.”

Jan joins Boyds from CRO Medpace, where he led the Cell and Gene Therapy team. He began his career as a scientist focused on drug discovery and pharmacology for oncological indications, working in both academia and industry, before moving into regulatory affairs more than ten years ago. He specialises in the clinical development of cell and gene therapies and, at Boyds, will support regulatory affairs activities alongside clinical operations.

Jan commented: “Boyds is known in the industry for its impactful work on cutting-edge medicines, including cell and gene therapies. My interest in these therapies, along with my desire to further develop my expertise in regulatory consulting, attracted me to Boyds. I look forward to bringing practical operational knowledge across the non-clinical, clinical and CMC development of cell and gene therapies, including global expertise in biosafety risk assessments and associated submissions.”

Dr Katherine Bowen, Chief Regulatory Affairs Officer at Boyds, said: “We are delighted to welcome Vicki and Jan to Boyds. Their combined experience further strengthens our ability to provide strategic and practical regulatory support to clients developing innovative medicinal products.

“Demand is rising as clients face complex regulatory challenges and need expert support to keep programmes moving efficiently. Our Regulatory Affairs team has built long-standing, trusted relationships with leading regulators, founded on decades of regulatory experience and constructive engagement. The appointment of Vicki and Jan further solidifies these relationships, enabling productive, solution-focused discussions that help clients anticipate requirements, address regulatory questions and move development programmes forward.”

For more information, visit www.boydconsultants.com.