Diamond Pharma a jewel in the UK’s life science crown
Since launching nearly 13 years ago, Diamond Pharma Services in Cambridge and Harlow has proved an increasingly influential enabler for UK pharmaceutical and biotechnology companies scaling internationally.
The technical services and consulting group helps clients pick their way through what can often be regulatory minefields in the commercialisation of life science.
Diamond clients are advancing treatments for illnesses for which patients have few therapeutic options. The company famously supported the activities leading to the approval of the first gene therapy in Europe. And it works on a significant array of products for rare diseases where it is essential to inject some creativity into the regulatory strategy.
Its broad portfolio ranges from virtual biotechnology companies to global multinationals. In recent years it has been active in supporting immunotherapy products which are now very high profile.
Through analysis, interpretation and distillation of data, Diamond Pharma Services is able to help clients obtain and maintain medicinal product licences across all stages of a product’s life cycle.
Its ‘power behind the throne’ profile has enabled the company to grow to a headcount of 55 people with combined experience spanning more than 250 years.
Harlow is the company’s global HQ and Diamond has satellite operations at Cambridge Science Park and in London. It now has two offices in Europe having recently opened a base in Amsterdam to ensure business continuity through the Brexit process and increase its presence in continental Europe.
Further afield, the company has a collaborative network of United States providers to help companies navigate between EU and US regulatory pathways. Heady days indeed since comparatively modest origins in 2005 as Diamond BioPharm Ltd to provide end-to-end regulatory affairs consulting services. The regulatory landscape has evolved rapidly and consistently in the intervening years.
Managing director Dr Maureen Graham says: “As European pharmaceutical companies invest in new areas of gene and cell therapy, the regulations surrounding these medicinal areas are becoming more and more complex and evolving at a rapid rate.
“These industry developments add to an ever-changing regulatory landscape, which has led to pharmaceutical regulatory consultancies being increasingly brought in to help these companies navigate the highly technical challenges.
“As guidelines are changing all the time, it is critical that pharma companies stay up-to-date in order to progress new products as quickly and smoothly as possible.
“When you work in cutting-edge arenas that have hundreds of guidelines, ensuring rigorous regulatory support and pharmacovigilance when it comes to strategy, development and clinical trials, for example, is obviously extremely important.
“This means that pharma companies need support over the full regulatory spectrum, from regulatory services through to pharmacovigilance and compliance.
“We’ve recently moved to a new state-of-the-art office in order to better facilitate that kind of integration, offer a thorough, joined-up view of regulatory developments, and stay at the forefront of this sector. Such services are going to be even more valued moving forward due to events like Brexit.”
Dr Graham says the pharmaceutical industry is at a particularly exciting stage, with the increasing prevalence of cutting-edge gene and cell therapies as well as new biologic and biotech products.
“But the reality is that with this comes added regulatory complexity. For example, even established US companies can find the transition to the European frameworks very challenging,” she says.
“The Regulatory Authorities within Europe have a different focus which requires a careful and rigorous translation of development plans and regulatory interactions.
“There are also new schemes, such as the European Medical Agency’s PRIME Scheme, which bring great opportunities that we like to be involved in. Our vigilance in staying on top of external changes meant we were able to help a company become one of the first to be accepted onto this scheme.”
The impending impact of Brexit could further increase this complexity, but Dr Graham is optimistic that, while the shift will have a considerable effect, pharmaceutical regulatory consultancies with the right specialist knowledge are well-positioned to facilitate operations in the new regulatory dynamics of a post-Brexit pharma world.
“If you have experience in European regulatory affairs, that won’t become obsolete overnight. Pharma companies will still need support in European markets – that’s why we’ve invested in maintaining a strong presence in the region, with offices in the Netherlands, Spain and Central Europe.
“They may have to take actions such as extracting their marketing authorisations from Europe and submitting as UK nationals instead. If they don’t have the resource or expertise internally, then consultancies will continue to have their part to play.”
Dr Graham says the regulatory landscape is always changing: “Twenty years ago, the advance of antibody therapies led to a series of new regulations and the expansion of regulatory science.
“During this time companies like Cambridge Antibody Technology developed blockbuster biological drugs such as Humira. Since Diamond was formed, the progress of gene and cell therapies has advanced significantly; regulations in this area are still emerging and the companies involved are continually developing groundbreaking technologies.
“At Diamond we have assisted more than 35 different cell and gene therapy clinical development programmes – an achievement we’re immensely proud of.”
Cross-border commercialisation of drugs and therapies can add complexity, as Dr Graham explains. “One of the major advances with the formation of the European Medicines Agency was the evolution of legislation and regulations to provide common rules for the approval of medicines in the EU.
“The UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), was a major influence on the European regulatory landscape.
“Obviously Brexit has had a significant impact in this area and soon after the triggering of Article 50 we stated our business plan and how we would help support our clients in navigating the uncertainties of Brexit.
“All other territories, including the US, have their own regulatory pathways, their own approaches to product development and their own nuances when it comes to data requirements.
“We help clients to build robust regulatory solutions to meet regional EU related and global regulatory expectations. The best scenario is to always be prepared.
“We build regulatory considerations into all product development programmes and provide bespoke solutions to deliver regulatory excellence. Without a robust and cohesive regulatory strategy, no medicinal product will reach the market.”
• PHOTOGRAPH SHOWS: Dr Maureen Graham, managing director, Diamond Pharma Services