SBIA Education Events

Supporting Events from FDA CDER Small Business & Industry Assistance


Oncology Therapy Development Workshop 2021 Banner

Oncology Therapy Development Workshop:
Pivotal Steps and Avoiding Pitfalls for Start-ups
March 30 & 31, 2021
9:00 a.m. – 4:10 p.m. (EST, UTC-5)

View Start Time on World Clock

This event is FREE

Via Webcast

This workshop will provide guidance on the steps and potential pitfalls of early drug development for anticancer therapies.

REGISTER NOW

Topics Include:

  • The type and extent of scientific data necessary to acquire funding and potential sources of funding.
  • The formal and informal processes available at FDA to help in developing an IND application.
  • Efficient drug development in 2021 requires understanding the science—the molecular biology that is being treated—versus the specific cancer. Presentations will discuss FIH trial design, enrichment based on biology, and the necessity of homogenous patient populations to make early activity evaluations.

View the Full Agenda

Who Should Attend?

  • Academic entrepreneurs and founders of small start-up oncology companies.

Continuing Education Credit

Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations.  Certificates are only available during the two weeks post-event.

This Workshop:

  • has been pre-approved by RAPS as eligible for credits (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
  • has been pre-approved by SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area.
  • has been pre-approved by SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
  • has been approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

Agenda & Speaker Bios

PDF Download
Event Agenda

The agenda may be updated if scheduling changes occur. The current version is Version 4, updated on February 3, 2021.

PDF Download
Speaker Biographies

The speaker biographies document is being finalized and will be posted here as soon as it is ready.

REGISTER NOW

Virtual Attendance Information

The virtual conference will be hosted via Adobe Connect and is limited to 2,000 simultaneous attendees (1,000 each in Room One and Room Two). If a room is full when you attempt to enter, please try the other room. The recordings of each of the sessions will be posted below within 24 hours.

The links below to the Adobe Connect rooms will be activated shortly before the event begins.

Please select the correct room based on the first letter of your LAST NAME.

Last Name A – K

Last Name L – Z

The above rooms will open ~15 minutes before each day begins.

If you encounter any technical issues, visit the Technical Issues Support Page

The audio for the event will be provided through your computer speakers via Adobe Connect (there will NOT be a teleconference number to dial into). We recommend that you test your PC or mobile device prior to the event and you join the event a few minutes early to address any issues.

To test your PC, please visit:

https://concerted.adobeconnect.com/common/help/en/support/meeting_test.htm

Files, Certificate & Recordings

ZIP of Day One Session Slides

ZIP of Day Two Session Slides

The ZIP files above will be available for download 24 hours before the event.

Link to Final Evaluation & Certificate of Attendance

The above link will become active at the conclusion of the event.

Session Recordings:

Links to recordings will be added as they become available.

REGISTER NOW

Questions & More Information

Questions?

Please refer the FAQs page on this website. If you are not able to find your answer there, please email us at info@sbiaevents.com.

More Information

If you have questions regarding the content of the event or other CDER-specific information, please: