Diamond Pharma Services 2018 Update
Another standout year for Diamond Pharma Services
As we enter the final quarter of the calendar year, it leaves us contemplating a breakthrough period for regulatory science and our consultancy.
We have continued to support a broad range of clients across all product types throughout the product lifecycle. Our fascinating clients and our contribution to their programmes is an ongoing highlight for us. Here are a few of our memorable moments from 2018 so far:
In the summer we revealed that we had supported Kite Pharma in their CAR-T regulatory development programmes, supporting all EU regulatory activities leading to the MAA and subsequent market approval of YESCARTA®.
Outsourced Regulatory Support
We continued to grow our support to large pharmaceutical clients covering a broad range of development stage, and lifecycle regulatory programmes. In 2018 we added another two major outsourced FTE programmes to our portfolio for projects from top 20 pharma companies covering EU and International Regulatory Affairs.
Excellence in Development Stage Programmes
With a long track record of supporting pre-clinical and clinical stage biotechnology companies, Diamond continued to excel for clients. Through 2018 our teams have continued to support advanced biologics projects and next generation cell and gene therapies. We have provided ongoing support for IMPD and IB writing, Scientific Advice briefing documents, PIPs, Orphan Applications, multiple CTAs, and wide-ranging support for strategy documents including EU/US regulatory roadmaps and gap analyses. We have continued to be a trusted team player for our client’s development and regulatory teams.
- MAA Support
Not only have Diamond provided MAA support to Kite Pharma, our team are also supporting a number of clients in engaging with EMA for late stage licensing programmes and leading oral explanations at the EMA.
In addition to these client highlights, Diamond Pharma Services has also made significant progress in operational aspects including:
A rebrand and new website.
The opening of new global headquarters at our 10,000 ft2 facility in Harlow, north of London.
- The expansion of Diamond’s footprint in continental Europe with the opening of Diamond Pharma Services B.V. in Amsterdam and implementing our Brexit preparedness strategy to ensure business continuity for EU and UK based services.