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  4. FDA-AACR Workshop: Non-Clinical Models for Safety Assessment of Immuno-Oncology Products - 09/06/2018
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Meeting

Event Title
FDA-AACR Workshop: Non-Clinical Models for Safety Assessment of Immuno-Oncology Products
September 6, 2018

Date:
September 6, 2018

Date:           September 6, 2018

Time:           8:00 am to 5:00 pm

Location:  

Marriott Wardman Park Hotel
2660 Woodley Rd. NW
Washington, DC 20008

Registration:

For in-person or webcast participation in this public workshop, please register at the following link: https://www.surveymonkey.com/r/NonClinWS18 

Background:

The development of non-clinical models that can predict toxicities of immune checkpoint inhibitors and stimulators in patients is an extremely important and timely issue for the cancer community. There are 50 agents targeting PD-1 or PD-L1 in clinical development, and more than 1100 trials combining anti-PD-1/L1 agents with other therapies (Tang et al 2017), yet retrospective analyses indicate that animal toxicity for many of these agents is minimal and does not predict adverse effects in patients (Saber et al. 2016). In addition, the recent observation of worse overall survival in two randomized trials that evaluated anti-PD-1/L1 agents in combination with immunomodulatory drugs underscores the need for cross-sector collaboration in this area. With advances in nonclinical models to study the pharmacodynamics of immune checkpoint inhibitors and stimulators, the question remains whether any of these models could be adapted to assess the safety of immune-oncology products.

Workshop Objectives:

  • Discuss current challenges and opportunities for non-clinical models to predict toxicities of immune checkpoint inhibitors and stimulators in patients
  • Provide a forum for academic, industry and regulatory experts to discuss developing non-clinical models that are both predictive and practical for human safety assessment
  • Brainstorm ways that academia, industry, NCI and FDA can work together to advance the science in this area

Who Should Attend
This workshop will be open to the public. The primary audience will be academic and pharmaceutical company scientists working on non-clinical models in immune-oncology, NCI program staff who oversee funding opportunities in this area, and FDA representatives.

Contacts:
FDA/CDER

American Association for Cancer Research (AACR)

  • Sarah Martin, MS, PhD: sarah.martin@aacr.org
    Senior Regulatory Science and Policy Analyst
    Office of Science Policy and Government Affairs
  • Trevan Locke, PhD: trevan.locke@aacr.org
    Scientific Program Administrator, Regulatory Science and Policy
    Office of Science Policy and Government Affairs
     
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