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Scientific Research and Development at Amgen Europe

Biologics Research and Development in Europe

Amgen Research Copenhagen (ARC)

In 2019 Amgen acquired Copenhagen-based biopharmaceutical company Nuevolution, now Amgen Research Copenhagen (ARC). This acquisition of Nuevolution and its world-class DNA-encoded library platform has dramatically expanded our small molecule screening capability.

Our new scientific team at ARC is a pioneer and leader in the field of DNA-encoded libraries (DEL), focused on synthesizing DNA-encoded small molecules and screening them for activity against targets.

This technology uses combinatorial chemistry to turn large collections of unique chemical fragments into enormous libraries of small molecules. In a DEL library, each compound is identified by a unique sequence of DNA, and mixtures containing billions of unique compounds can be screened in a single small test tube.

Screening technology plays a major role in small molecule drug discovery, where the general goal is to find “hits”—compounds that interact with drug targets. In conventional high-throughput screening systems, compounds are stored, tracked, and tested in microplates with 384 or 1536 wells per plate. Robots transfer compounds from storage plates to test plates that hold a drug target, and various technologies are used to read the strength of the resulting interactions and identify hits that chemists can then optimize to create investigational drugs.

A conventional library holds 0.5-2 million distinct compounds, but time and cost constraints make it difficult to go beyond that scale. Using DEL technology, those constraints don’t apply because each individual compound is linked to a unique strand of DNA, which functions like a barcode to identify that compound. The tagging allows diverse compounds to be stored and tested together as a mixture of compounds, with the ability to hold quadrillions of drug-like molecules in a single drop of liquid.

By focusing on building only high-quality libraries, the team at ARC aims to increase the probability of finding useful compounds with good properties and a tractable route forward for the medicinal chemists.

We believe our expanded screening platform will allow our chemists to tackle a wider range of “undruggable” targets known to drive serious diseases in multiple therapeutic areas.

 

Read the Amgen Science story on this exciting technology at AmgenScience.com:

Amgen Research Munich (ARM)

Amgen Research Munich GmbH (formerly Micromet GmbH) is located in Munich, Germany. It has been part of Amgen since March 2012 and is Amgen’s largest Research and Development site outside of the U.S. The site has about 200 staff who focus on the development of the "Bispecific Tcell Engager" (BiTE®) antibody constructs, with a specialization in the development of innovative cancer therapies.

Our Munich-based scientists are involved in many aspects of the work needed to develop innovative cancer medicines, from the concept stage, to the high-throughput screening used to identify lead molecules, to first-in-human studies

 

BiTE® Immuno-Oncology Platform: The Next Generation of Cancer Treatment

More than 30 years ago, researchers discovered that the body's own immune system is capable of curing certain types of cancer itself under certain conditions. This potential is being exploited in a targeted manner in the context of new types of immune therapies. The strongest weapon in this regard is certain defense cells of the immune system, the so-called T-cells.

T-cells fight off intruders such as bacteria and viruses in the body. In this way, they help to prevent and cure diseases. In addition, under certain circumstances, T cells can recognize and destroy modified cancer cells that are produced naturally in the body.

Malignant cancer cells very often develop mechanisms by which they can suppress an efficient immune response or remain undetected by the immune system. To close this loophole, our team at Amgen Research (Munich) GmbH has developed the "Bispecific T-cell Engager" BiTE® antibody constructs. Equipped with two different binding sites, BiTE® antibody constructs act as adapter molecules between certain defense cells of the body's own immune system, the T-cells, and cancer cells by binding to both cell types simultaneously. By binding to both cell types simultaneously, T cells are able to recognize and destroy previously unrecognized cancer cells.

 

 

The Investigational BiTE® Platform–Designed to Harness the Body’s Immune System to Help Fight Cancer

Translating this knowledge into a successful therapy for cancer patients took many years of research and development. Scientists at the Ludwig-Maximilian-Universität (LMU) Munich had initially researched the mechanism of BiTE® antibody constructs using a specific type of leukemia. As a spin-off from the university, the start-up company Micromet further developed this BiTE® antibody construct in clinical studies and demonstrated its efficacy before it was submitted for approval by Amgen in Europe in 2015.

Now Amgen is advancing nearly a dozen BiTE® molecules across a broad range of hematologic malignancies and solid tumors while the team in Munich is researching further BiTE® antibody constructs to fight more types of cancer.

 

We’re motivated by cancer patients like Annmarie and focused on pursuing potential therapies utilizing BiTE® technology to help blood cancer patients around the world. Watch as she shares her personal story.

Amgen Uxbridge (UKUX) and Amgen Cambridge (UKCA)

Cambridge and Uxbridge are home to Amgen's largest R&D investment outside the US, featuring a quantitative biology team that provides assay development, bioassay support and profiling.

Amgen Uxbridge opened in 2007, with Amgen Cambridge in 1989. Both sites are based in some of the fastest growing parts of the country and are important to the UK biotechnology sector. Today approximately 500 staff are based in the UK, with 340 staff dedicated to R&D.

Our teams in the UK are supporting the development of clinical trials which create a solid evidence base for our medicines, securing European regulatory approvals, as well as enabling patient access in the UK and Ireland. Our Irish affiliate is based in Dublin.

Our community works collaboratively across the sites to ensure our contribution that turns molecules to medicines is delivered with excellence and pride.

The UK research and development functions include Global Medical, Global Development, Global Regulatory Affairs and Safety, and Quality, Compliance, Audit, Learning and Performance.

  • Global Medical Organisation (GMO): This group’s focus is on educating the medical community on the evidence base for Amgen’s medicines and building confidence in the value Amgen’s medicines can offer. The team provides clinical input and support for publications, training and other scientific affairs activities. They also provide insights into our science and products by bridging the work of the Global Development and Commercial Organisation.
  • Global Development: The Global Development team in the UK consists of a number of Centers that work towards the overall vision of Amgen’s Global Development Organization to lead the development of breakthrough therapies that transform the lives of patients:
    • Centre for Observational Research (CfOR): supporting the design, conduct, analysis, interpretation and publication of observational research that inform the design of clinical trials using Real World Evidence (RWE).
    • Centre for Design & Analysis (CfDA): a team of statisticians with expertise in biostatistical science, helping to ensure Amgen’s future clinical trial data will be as robust and rigorous as ever.
    • Global Development Operations (GDO): delivering high quality data to advance Amgen’s pipeline through strong customer partnership and operational excellence in study execution.
  • Global Regulatory Affairs and Safety (GRAAS): GRAAS is a leader in benefit:risk assessment and communication and a trusted partner in providing regulatory and safety science expertise for the development, registration, and lifecycle management of all our molecules. In the UK, this group is concerned with collecting and analysing data from clinical trials and post-marketing use to predict and minimize risks for the safety of the patients. The group also drives Amgen’s Europe regulatory strategies throughout the product lifecycle. This includes the verification of nonclinical data and content, ensuring quality commercial labelling, developing strategies for manufacturing excellence and advancing policy strategies for an optimal regulatory environment.
  • Quality, Compliance, Audit, Learning and Performance (QCALP): This team drives quality and compliance to enable the delivery of vital medicines to patients. The team assures that all research, development, and pharmacovigilance activities are performed to the highest standards.

Watch this video from Madushi Dayalan our Strategic Planning and Operations Manager at the Center for Observational Research at the Uxbridge office.