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The Code of Federal Regulations, specifically 21 CFR § 207.69, requires all domestic and foreign companies to have an official contact located in the US in order to act as the primary contact with the FDA and liaise between the FDA and the sponsor company for all communications. Specifically for non-US (foreign) entities, any company that wishes to register a new medicine or device with the FDA must appoint a US agent, as must foreign companies that wish to import

For Siobhan Gaynor, a love of science, and the workings of the body, medicine and the disease process, has underpinned a 30-year career in drug development. But earlier this year, this knowledge and experience informed the very toughest of personal decisions for Siobhan following her diagnosis of metastatic breast cancer. Siobhan Gaynor’s love of biology was inspired by a schoolteacher who had worked in industry herself, who highlighted the opportunities that lay ahead and helped to crystalise her passion and

Across the UK, and indeed the world, there is significant growth and clinical progress being made in the field of advanced therapy medicinal products (ATMPs). In this article, Ian Hollingsworth, Associate Director of Product Development at Boyds explores the changing landscape of ATMPs in the UK. ATMPs comprise of gene therapies, somatic cell therapies and tissue engineered products. This class of treatments offers the potential to address significant unmet medical needs for patients, offering the promise of treating diseases currently

Boyds’ Vice President of Regulatory Affairs, Julie Warner, has co-edited an article in the October issue of the TOPRA journal, Regulatory Rapporteur, which focuses on medical technologies. The following article, A brave new world for medical technologies, was published in Regulatory Rapporteur, Volume 18, issue 10, October 2021. By Julie Warner, Vice President of Regulatory Affairs, Alan Boyd Consultants Ltd, UK, and Steve Dew, Executive Director, Organon & Co, UK Change. As a word, it generally either fills us with dread

With the launch of Axovia Therapeutics, a biotech company in the gene therapy space, Dr. Nick Meyers, VP and Head of Product Development & Programme Management at Boyds reflects on the team’s involvement in the company’s formation. With recent advances in bioengineering and genetics, the therapeutic options for treating genetic diseases, especially monogenic diseases have broadened and are it seems, expanding exponentially.  The delivery of gene therapy requires the use of viral vector (e.g., adenoviruses, adeno-associated viruses, lentiviruses) or nanoparticle

An increasing number of academic groups, new start-ups, biotechs and small pharma companies are turning to Boyds for professional programme management support and guidance to help them progress their ideas into medicines for patients. Dr. Nick Meyers, Vice President of Product Development at Boyds, reflects on the benefits of putting a credible development plan in place from an early stage to help navigate the pathway, overcome challenges and improve efficiencies. One indirect effect of the COVID pandemic, and the successful

To mark Rare Disease Day 2021, Professor Alan Boyd reflects on the work that he and his colleagues carry out to support the development of advanced cell and gene therapies to treat orphan diseases. Rare Disease Day aims to raise awareness of the 300 million people across the globe that are living with a rare disease. In Europe, a disease is considered to be rare when it affects fewer than 1 in 2000 people, and there are approximately 6,000 rare

Boyds’ Director of Regulatory Affairs, Julie Warner, has co-edited an article in the October issue of the TOPRA journal, Regulatory Rapporteur, which focuses on falsified medicines. The following article was published in Regulatory Rapporteur, Volume 16, No 10, October 2019.   Preventing fake medicines from reaching patients By Julie Warner, Director Regulatory Affairs, Alan Boyd Consultants, UK Andrew Germain, Associate Director Regulatory Affairs CMC, GW Pharmaceuticals, UK   Safety feature requirements for prescription and some over-the-counter medicines have now been