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Workshop | In Person

Event Title
FDA/The Osteosarcoma Institute (OSI) Workshop: Advancing Osteosarcoma Drug Development – Connecting Research and Regulatory Pathways for Improved Outcomes
October 10, 2025

Date:
October 10, 2025
Time:
9:30 a.m. - 5:00 p.m. ET
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FDA/The Osteosarcoma Institute (OSI) Workshop

Organized By: FDA Oncology Center of Excellence and The Osteosarcoma InstituteExternal Link Disclaimer

Registration Information

Register for In-person Attendance: HEREExternal Link Disclaimer
Registration will close on September 24, 2025, at 5:00 p.m. Eastern Time.

Lincoln Square
555 Eleventh Street NW
Washington, DC 20004

In-person attendees are invited to arrive at 8:30 a.m. for coffee and conversation prior to the start of the workshop.

Register for Virtual Attendance: HEREExternal Link Disclaimer
Registration will remain open through the event.

Link to attend virtually will be provided upon registration via confirmation email from the OSI.

Background

The U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) and The Osteosarcoma Institute (OSI) have a shared interest in engaging with the osteosarcoma community to identify the major barriers to drug development for osteosarcoma and to discuss opportunities for collaboration to address these challenges.

The persistent unmet need for new therapies to treat patients with osteosarcoma requires expedient identification of promising drugs, consideration of molecular heterogeneity between osteosarcoma tumors, identification of suitable endpoints for clinical trials, and thoughtful incorporation of innovative study design elements, where appropriate. This workshop will promote robust scientific discussion on these topics by engaging speakers who represent patient advocacy organizations, the academic medical and cancer research communities, government regulators, and the biopharmaceutical industry. The workshop will provide an interdisciplinary forum to develop strategies to advance clinical development of therapies for osteosarcoma.

The intended audience for this event includes individuals and organizations engaged in the research and development of new therapies for patients with osteosarcoma. Participants may include patient advocacy groups, physicians, academic and clinical researchers, biopharmaceutical companies, regulatory agencies, non-profit organizations, and others involved in osteosarcoma.

Event Goals

  1. To convene key stakeholders to share perspectives on the challenges to, and identify opportunities for, advancing clinical development of therapies for osteosarcoma through collaboration and communication. 
  2. To identify opportunities to increase efficiency within osteosarcoma drug development. 
  3. To develop strategies to address the most significant challenges in clinical trials design and implementation in osteosarcoma.

Materials

  • Agenda (forthcoming)
  • Biographies (forthcoming)

Contacts

Erica Horodniceanu, MPH
Senior Health Scientist
Oncology Center of Excellence
U.S. Food and Drug Administration
Erica.Horodniceanu@fda.hhs.gov

Amy Lobner, MPH, CCRC
Director of Scientific Programs
The Osteosarcoma Institute
alobner@osinst.org

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