Cell and Gene Therapy, Industrial Impact

Best Practices for RIM Business Process Automation

December 15, 2022

Best Practices for RIM
Regulatory teams at life science companies are finding that
effective regulatory information management (RIM) has become critical to their operations.

Spotlight

ISA Pharmaceuticals

ISA Pharmaceuticals B.V. is an immunotherapy company developing rationally designed, fully synthetic immunotherapeutics against cancer and persistent viral infections.

OTHER WHITEPAPERS
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BIOTECHNOLOGY UPDATE

whitePaper | April 24, 2022

The Global Forum on Biotechnology, established in 2010, is one of 15 Global Fora created by OECD Committees. Global Fora are not official OECD bodiesbut are best described as broad.

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The US Bioeconomy

whitePaper | April 14, 2022

In the nearly 50 years since the first genetic engineering experiments, the United States has become the world’s biotechnology powerhouse,

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Growing a circular economy with fungal biotechnology

whitePaper | August 17, 2022

Fungi have the ability to transform organic materials into a rich and diverse set of useful products and provide distinct opportunities for tackling the urgent challenges before all humans.

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Accelerating the Biomanufacturing Revolution

whitePaper | February 11, 2022

The biomanufacturing revolution is here. Recent advancements in the field of synthetic biology have enabled significant cost reductions in foundational bioengineering unit operations such as DNA synthesis and sequencing.

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The EU Clinical Trials Regulation − What You Need to Know

whitePaper | March 22, 2022

The Clinical Trials Regulation has retained some definitions and refined others. For example the definition of “clinical study”: “Any investigation in relation to humans intended: (a) to discover or verify the clinical, pharmacological or other pharmacodynamic.

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Healthcare system readiness for the adoption of advanced therapies: learnings from the introduction of CAR T cell therapies in the UK

whitePaper | September 17, 2021

The adoption of CAR T therapies in the UK NHS is a success story, especially seen in relation to the experience in many other countries. The UK NHS showed itself to be agile, and responsive to addressing the unique challenges these therapies present, which facilitated access to patients earlier than in many other countries. (including delivery centre selection, development of service specifications, collaboration with manufacturers throughout the preparation phase for adoption, establishment of national multidisciplinary CAR T team to ensure equity of access and prioritization of resources (where needed)).

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Spotlight

ISA Pharmaceuticals

ISA Pharmaceuticals B.V. is an immunotherapy company developing rationally designed, fully synthetic immunotherapeutics against cancer and persistent viral infections.

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