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How Potential Changes to the NIH Guidelines Could Impact IBC Review

WCG Clinical

At the time this change was implemented, methods used to deliver rsNA to cells or research participants typically involved the use of viral vectors that were subject to the NIH Guidelines. Since then, however, certain genetic engineering technologies (e.g.,

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Drug discovery in 2023: Five key predictions

Drug Discovery World

According to a survey of 150 biotech and biopharma leaders by clinical research company PPD , leveraging new technologies (including mRNA and drug discovery platforms) is one of the greatest opportunity areas in clinical trials for 2023. . Novel therapeutic platforms will drive innovation .

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Regulatory Trends in Cell and Gene Therapies

Advarra

Bottlenecks in the manufacturing process, supply chain issues such as accessibility of good manufacturing practice (GMP)-grade reagents, and shortages of qualified scientists and engineers have caused many therapies to fail at critical stages of the clinical development pipeline. Improving Communication Between FDA and Sponsors.

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Eight announcements to expect at AACR 2023   

Drug Discovery World

VAL-083 has completed Pre-Clinical, Phase I and II trials for the treatment of bevacizumab-refractory glioblastoma multiforme (GBM) and is currently being studied in two Phase II biomarker-driven clinical trials for unmethylated-MGMT GBM. Details of the poster presentation are as follows: Late-Breaking Research: Clinical Research 1 / Endocrinology (..)

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Who are the AACR Scientific Achievement Award winners?

Drug Discovery World

Carl H June, MD, FAACR – Lifetime Achievement in Cancer Research June, a Fellow of the AACR Academy, is the Richard W Vague Professor in Immunotherapy, Director of the Center for Cellular Immunotherapies, and Director of the Parker Institute for Cancer Immunotherapy in the Perelman School of Medicine at the University of Pennsylvania.

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Where is the drug discovery expertise happening in the UK?

Drug Discovery World

CellProthera selected the UK centres for their excellence in the conduct of clinical research with dedicated staff, equipment, availability of imaging platforms and high interest in cell therapy cardiovascular trials especially University Hospital of Birmingham equipped with a bi-plane Cathlab.

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Scaling up: The need for human cells to give better access to cell therapies

Drug Discovery World

These therapies, which utilise human cells to replace diseased or damaged cells or use engineered cells to act as therapies for a specific disease, have become more common in recent years, with approvals and clinical trials increasing.