Kite announces new worldwide facilities, including one in the Netherlands 

Kite, a Gilead Company announced it has leased a new facility in the Netherlands to engineer cell therapies in Europe. The 117,000 square-foot site in Hoofddorp (SEGRO Park Amsterdam Airport) will enable Kite to efficiently manufacture and deliver its cell therapies to people living with cancer in Europe and will provide more than 300 new jobs when fully operational in 2020.

The facility will engineer and produce innovative cell therapies, including axicabtagene ciloleucel, a Chimeric Antigen Receptor T cell (CAR T) therapy that is currently under review by the European Medicines Agency and which is approved in the United States as Yescarta.

“We are pleased to be leading a new frontier of cancer innovation that is bringing hope for people living with cancer,” commented John F. Milligan, PhD, Gilead’s President and Chief Executive Officer. “This new European manufacturing facility will enable personalized cell therapies to be manufactured in closer geographic proximity to the patients who will receive them, potentially shortening the turnaround time for people who urgently need care.”

In addition to the Netherlands facility, Kite has recently purchased a new building in Santa Monica from Astellas Pharma Inc. that will be used for cell therapy research, development and the expansion of clinical manufacturing capabilities, and has leased a 26,000 square-foot facility in Gaithersburg, Maryland. The Maryland site will support the work of a new Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) to develop adoptive cell therapies targeting patient-specific tumor neoantigens. Neoantigens are mutations found on the surface of cancer cells that are unique to each person and tumor, offering the potential for more targeted antitumor activity.

“We are proud to be at the forefront of advancing cell therapy, which we believe has the potential to transform cancer treatment,” said Alessandro Riva, MD, Gilead’s Executive Vice President, Oncology Therapeutics & Head, Cell Therapy. “The addition of these three new facilities and the expanded CRADA with our research collaborators at the NCI will help us bring cell therapies to more people with cancer around the world.”

Source: Gilead

The Netherlands and EMA take major steps forward in relocation to Amsterdam

Since 20 November 2017, the day it was announced that the European Medicines Agency (EMA) will relocate to the Netherlands, all parties involved have been working hard to achieve a seamless transition for the agency.

It all starts with the construction

Step by step much is being accomplished. On 1 May 2018, the construction of the new EMA building started, one month ahead of the initial schedule. On 28 May this fact was celebrated with an official ceremony. Together with Gea van Craaikamp, Deputy-Secretary General of the Ministry of Health, Welfare and Sport, the Amsterdam alderman Eric van der Burg and the Executive Director of EMA Guido Rasi placed a time capsule containing good wishes for the construction and for the building in a borehole of one of the foundation piles.

Next up: signing a seat agreement

On 1 June another important event took place. On that day EMA and the Netherlands signed a seat agreement which describes the relationship between the Netherlands and the Agency, its bodies and its employees once they start operating in the Netherlands. This is an important step in the relocation of EMA from London to Amsterdam as a result of Brexit. The seat agreement allows EMA to prepare for a smooth transition of the work of its scientific committees and delegates. EMA staff and their families now have clarity on their treatment and can settle in the Netherlands without delay. For patients throughout the EU, a smooth transition of the agency is also crucial. With the signing of the seat agreement, a crucial step has been taken on time. The Dutch Government is committed to having EMA fully operational in Amsterdam as of 30 March 2019. The seat agreement was signed by Executive Director of EMA Guido Rasi and the chair of the Management Board Christa Wirthumer-Hoche and by Ambassador Johan van der Werff on behalf of the Dutch Government.

Signing of the seat agreement, from left to right: Christa Wirthumer-Hoche (chair of the Management Board EMA), Guido Rasi (Executive Director EMA) and Johan van der Werff (Ambassador on behalf of the Dutch Government).

Stay up-to-date with the EMA tracking tool: relocation to Amsterdam main milestones.

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