The UK BioIndustry Association (BIA) and the Medicines and Healthcare products Regulatory Agency (MHRA) have published a report following their sixth annual joint conference, Accelerated Development and Access to Innovative Medicines for Patients. The conference took place on Wednesday 4 May 2016 at the Royal Society of Medicine and was attended by more than 170 delegates from across the life sciences sector.
MHRA and BIA brought together experts from across the sector to assess the state of play, discuss how the various schemes have performed, and how the National Health Service (NHS) might respond to current innovation challenges.
Products such as targeted cancer drugs, T-cell-based cancer immunotherapies, and cell and gene therapies, embody both significant health benefits and commercial opportunities for UK life sciences. However, the products are different in kind from the small molecules that went before, presenting challenges around how they are regulated, assessed and commissioned for use in the NHS.
This report summarizes the presentations and perspectives from senior experts and leading speakers from MHRA, the European Medicines Agency (EMA), the life science industry, National Institute for Health and Care Excellence (NICE), NHS England, academia, research charities, patient organisations and investment firms.
Commenting on the publication of the report, Alan Morrison, Chairman, BIA Regulatory Affairs Advisory Committee and Vice President, International Regulatory Affairs, MSD, said: “Many of the innovative products coming through the system start life in biotech SMEs, making it important that small companies understand the regulatory requirements. At the same time, the many novel constructs and new mechanisms of action, present challenges to a regulatory system that was developed on the back of small molecules.”
“The regulatory system needs to embrace innovation, while SMEs need information from the regulators and feedback from people in the industry who have put their products through the various accelerated access schemes,” he added.
Dr Ian Hudson, Chief Executive of the Medicines and Healthcare products Regulatory Agency, said: “It is an exciting time in the sector, with an explosion of science generating a range of new medicines, which need new approaches to bring safe and effective innovative products to patients. I appreciate the collaboration with the BIA on initiatives to support innovation, and the key focus must be to improve safe and timely access to new medicines and to support innovation.”
The full report can be downloaded from the conference website, where you can also find the full programme and slide presentations for this year.