Cell and Gene Therapy, Industrial Impact

The EU Clinical Trials Regulation − What You Need to Know

March 22, 2022

The EU Clinical
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. 

Spotlight

MolecularMD

MolecularMD Corporation develops and commercializes specialty molecular diagnostics for oncology applications. Its tests are designed to allow appropriate selection, monitoring and management of patients treated with molecularly targeted cancer therapies. MolecularMD’s assays incorporate both gold-standard and innovative technologies to provide highly sensitive, standardized, reliable results that support clinical development, regulatory approval, and commercialization of novel anticancer agents. A private company based in Portland, Oregon, MolecularMD was founded by Brian Druker, director of the Knight Cancer Center at Oregon Health & Science University and lead clinical investigator for Gleevec, and Sheridan G. Snyder, entrepreneur and founder of Genzyme Corporation and Upstate Biotechnology.

OTHER WHITEPAPERS
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Taking the Lead on Lab Cybersecurity

whitePaper | October 21, 2022

Just as thieves developed a new interest in explosives following the 1861 invention of the combination lock—and the concurrent rise in the popularity of bank vaults.

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6 Strategies to Stimulate Patient Engagementin Rehab Therapy

whitePaper | August 25, 2022

Patient engagement has become a measure of healthcare analytics that many in rehab therapy have sought to quantify.

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Connecting materials sciences with fungal biology: a sea of possibilities

whitePaper | March 1, 2022

The Special Issue “Connecting materials science with fungal biology” celebrates recent breakthroughs in the fabrication of fungal-based materials, all of which have been made possible by the interdisciplinary and transdisciplinary collaboration of fungal biologists and biotechnologists with artists, designers, materials scientists, and architects

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Lentivirus production study in the scale-X™ fixed-bed bioreactor

whitePaper | April 24, 2023

Implementation of a metabolite-based cell density<br /> estimation and evaluation of harvest strategies for<br /> Lentivirus production with HEK293T cells

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Biopharmaceutical Sector

whitePaper | May 29, 2023

tronger than expected US inflation and a bump in consumer spending have fuelled worldwide expectations that interest rates will go higher, as predictions about future monetary policy rapidly shift.

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Multi-Specific Monoclonal Antibodies

whitePaper | February 22, 2023

The reason for the rapid expansion and development of the therapeutic antibody sector is the capacity of monoclonal antibodies to precisely bind a target antigen and neutralise or promote its activity. The efficacy and safety.

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Spotlight

MolecularMD

MolecularMD Corporation develops and commercializes specialty molecular diagnostics for oncology applications. Its tests are designed to allow appropriate selection, monitoring and management of patients treated with molecularly targeted cancer therapies. MolecularMD’s assays incorporate both gold-standard and innovative technologies to provide highly sensitive, standardized, reliable results that support clinical development, regulatory approval, and commercialization of novel anticancer agents. A private company based in Portland, Oregon, MolecularMD was founded by Brian Druker, director of the Knight Cancer Center at Oregon Health & Science University and lead clinical investigator for Gleevec, and Sheridan G. Snyder, entrepreneur and founder of Genzyme Corporation and Upstate Biotechnology.

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