6/28/23 Updates

Written By PIcc Alliance

Because we hosted our in-person, annual meeting this month, there was no virtual updates meeting. To view an overview of the annual meeting, view this page, PIcc23: Unlocking the Potential of Digital Pathology and AI Through Regulatory Science.

Though not presented, please find relevant updates from June below.

FDA

  • News release: FDA Launches Pilot Program to Help Reduce Risks Associated with Using Laboratory Developed Tests to Identify Cancer Biomarkers (link)

  • Update on In-Person Face-to-Face Formal Meetings with FDA (link)

  • CDRH: CDRH Seeks Public Comment: Increasing Patient Access to At-Home Use Medical Technologies (link)

  • Publications:

    • 1. Dosage optimization in drug development: An FDA Project Optimus analysis of postmarketing requirements issued to repair the cracks.
      Brian Heiss, Lili Pan, Alemayehu Akalu, Jonathon Vallejo, Joyce Cheng, Pamela Balcazar, Nam Atiqur Rahman, Stacy Shord, Mirat Shah, Richard Pazdur, Marc Theoret.
      DOI: 10.1200/JCO.2023.41.16_suppl.1598

      2. Bridging the gap: FDA diversity-related postmarketing requirements.
      Natasha Kormanik, Theresa Carioti, Kayla Crai, Bindu Kanapuru, Nicholas Richardson, Nicole Gormley.
      DOI: 10.1200/JCO.2023.41.16_suppl.e13608

      3. Project facilitate: Innovation and advancement in FDA’s oncology expanded access program.
      Mitchell Chan, Ramya Antony, FNP, Jessica B., Tamy Kim, Richard Pazdur.
      DOI: 10.1200/JCO.2022.40.16_suppl.e18556

      4. Clinical evidence and benefit of special FDA designations in anti-cancer drugs.
      Daniel Tobias Michaeli, Julia Caroline Michaeli, Sebastian Albers, Tobias Boch, Boris Winterhoff, Thomas Michaeli
      DOI: 10.1200/JCO.2023.41.16_suppl.e13655

      5. Trends in FDA approval of solid tumor therapies with analysis of single-agent vs. combination therapies.
      Manoj P. Rai, Akshit Chitkara, Rajat Thawani, Emerson Yu-sheng Chen
      DOI: 10.1200/JCO.2023.41.16_suppl.e13659 

  • 2022 Annual Report ORA Ombudsman Program (download .pdf)

  • Report to Congress - Drug Shortages CY 2022 (download .pdf)

  • Accelerating Rare disease Cures (ARC) Program Anniversary Update (download .pdf)

  • Discussion Paper and Request for Feedback: Using Artificial Intelligence & Machine Learning in the Development of Drug & Biological Products (download .pdf)

  • CDER

    • Office of Surveillance and Epidemiology 2022 Annual Report (download .pdf)

  • Study Data Technical Conformance Guide (download .pdf)

  • Guidance

    • Severely Debilitating of life-threatening hematologic disorders nonclinical development of pharmaceuticals (download .pdf)

    • Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot Program (download .pdf)

NYS CLEP

DEI

  • Kim et al. Racial disparity in tumor microenvironment and distant recurrence in residual breast cancer after neoadjuvant chemotherapy

    (download .pdf)

  • Ethan Mollick and Lilach Mollick. ASSIGNING AI: SEVEN APPROACHES FOR STUDENTS WITH PROMPTS (download .pdf)

  • Liang et al. GPT detectors are biased against non-native English writers (link)

HHS

  • Proposed Rule: Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (download .pdf)

Resources

  • Responsible AI at Google Research: AI for Social Good (link)

  • CAP Opposes Proposal to Change Profession Name ‘Cytotechnologist’ to ‘Cytologist’ (link)

  • CIOMS Working Group XIII – Real-World Data and Real-World Evidence in Regulatory Decision Making (link)

  • CPT Editorial Summary of Panel Actions, May 2023 (download .pdf)

  • American Cancer Society CAN: Equitable Discovery and Implementation of Pharmacogenomic (PGx) Testing in Cancer Care: Recommendations (download .pdf)

  • Roche: Evolving Conversations with U.S. Payers about Comprehensive Genomic Profiling (download .pdf)

  • Uncocska et al. Rating analysis and BERTopic modeling of consumer versus regulated mHealth app reviews in Germany (download .pdf)

  • Robust. Resilient. Sustainable. Integrated Security for Germany (download .pdf)

  • FACT SHEET: White House Cancer Moonshot Announces Public and Private Sector Commitments to Reduce the Burden of Cancer in India (link)

  • IARC researchers identify early blood protein markers of lung cancer that may improve early detection (link)

  • Article from Manhattan Institute: Slow, Costly Clinical Trials Drag Down Biomedical Breakthroughs (link)

  • Article from Healthcare Economist: ICER’s proposed changes to their value framework (link)

  • ASCO: Trastuzumab Deruxtecan Effectively Treats HER2-Expressing Cancers Regardless of Tumor Location (link)

Missed the in-person meeting? Catch up on what you missed on the summary page.

Publications

  • Tarantino et al. ESMO expert consensus statements (ECS) on the definition, diagnosis, and management of HER2-low breast cancer (link)

    #HER2 #cancer #breast tumors #metastatic breast cancer

  • Koyuncu et al. Machine learning driven index of tumor multinucleation correlates with survival and suppressed anti-tumor immunity in head and neck squamous cell carcinoma patients (download .pdf)

  • Fink et al. Minimizing Sample Failure Rates for Challenging Clinical Tumor Samples (download .pdf)

  • Davis et al. Detection of calibration drift in clinical prediction models to inform model updating (download .pdf)

  • Vermeulen et al. Ultra-fast deep-learned pediatric CNS tumor classification during surgery (download .pdf)

  • Darbandsari et al. Artificial intelligence-based histopathology image analysis identifies a novel subset of endometrial cancers with distinct genomic features and unfavourable outcome (download .pdf)

  • Hajighasemi et al. Multimodal Pathology Image Search Between H&E Slides and Multiplexed Immunofluorescent Images (download .pdf)

  • Sun et al. CARs: a new approach for the treatment of autoimmune diseases (download .pdf)

  • Manas Dave and Neil Patel. Artifcial intelligence in healthcare and education (download .pdf)

  • Wang et al. Accelerating the integration of ChatGPT and other large‐scale AI models into biomedical research and healthcare (download .pdf)

  • Ardon et al. Digital pathology operations at a tertiary cancer center: Infrastructure requirements and operational cost (download .pdf)

  • Purwanto et al. MicroRNA-223 is Associated with Resistance Towards Platinum-based Chemotherapy and Worse Prognosis in Indonesian Triple-negative Breast Cancer Patients (download .pdf)

  • Bhin et al. Multi-omics analysis reveals distinct non-reversion mechanisms of PARPi resistance in BRCA1- versus BRCA2-deficient mammary tumors (download .pdf)

  • Chen et al. The impact of rare protein coding genetic variation on adult cognitive function (download .pdf)

  • Chan Kwon Jung, Andrey Bychkov & Kennichi Kakudo. Update from the 2022 World Health Organization Classification of Thyroid Tumors: A Standardized Diagnostic Approach (download .pdf)

  • Don Eugene Detmer & Andrew Gettinger. Essential Electronic Health Record Reforms for This Decade (download .pdf)

  • Ezratty et al. Racial/ethnic diferences in supplemental imaging for breast cancer screening in women with dense breasts (download .pdf)

  • Keerthi Kurma & Catherine Alix-Panabières. Mechanobiology and survival strategies of circulating tumor cells: a process towards the invasive and metastatic phenotype (download .pdf)

  • Gordhandas et al. Comprehensive analysis of germline drivers in endometrial cancer (download .pdf)

  • Harada et al. Rare molecular subtypes of lung cancer (download .pdf)

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