US Agent Services
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 […]
Siobhan Gaynor: From Drug Developer to Patient
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 […]
Advanced therapies in the UK
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 […]
A brave new world for medical technologies
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, […]
Supporting the creation of new biotech companies from academia
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 […]
Programme management: the backbone of successful product development
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 […]
Supporting the development of treatments for rare diseases – it’s in our DNA
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 […]
Preventing fake medicines from reaching patients
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 […]
Overcoming the Barriers to the Development of Medicines for Ultra Rare Diseases
In the third and final article in the series on Orphan Drugs, Bryan Hurst discusses how to overcome the barriers to the development of medicines for the treatment of ultra-rare diseases. To read the first article on orphan drugs, click here, and for the second article, click here. The decision to invest in developing a […]
Orphan Drug Development
This is the first in a series of articles aiming to highlight the vital role that drug development consultants play in helping small pharma companies to bring new medicines to the market. To put this properly into context it is essential to understand the way drug development has changed. The big pharmaceutical companies that totally […]
