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  1. Article

    Open Access

    Recommendations for Method Development and Validation of qPCR and dPCR Assays in Support of Cell and Gene Therapy Drug Development

    The emerging use of qPCR and dPCR in regulated bioanalysis and absence of regulatory guidance on assay validations for these platforms has resulted in discussions on lack of harmonization on assay design and a...

    Amanda Hays, Mark Wissel, Kelly Colletti, Russell Soon, Mitra Azadeh… in The AAPS Journal (2024)

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  2. Article

    Open Access

    A platform trial of neoadjuvant and adjuvant antitumor vaccination alone or in combination with PD-1 antagonist and CD137 agonist antibodies in patients with resectable pancreatic adenocarcinoma

    A neoadjuvant immunotherapy platform clinical trial allows for rapid evaluation of treatment-related changes in tumors and identifying targets to optimize treatment responses. We enrolled patients with resecta...

    Thatcher Heumann, Carol Judkins, Keyu Li, Su ** Lim… in Nature Communications (2023)

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  3. No Access

    Article

    Neoadjuvant cabozantinib and nivolumab convert locally advanced hepatocellular carcinoma into resectable disease with enhanced antitumor immunity

    A potentially curative hepatic resection is the optimal treatment for hepatocellular carcinoma (HCC) but most patients are not candidates for resection and most resected HCCs eventually recur. Until recently, ...

    Won ** Ho, Qingfeng Zhu, Jennifer Durham, Aleksandra Popovic… in Nature Cancer (2021)