TDM of Biologics

Co-sponsored by:


This workshop will explore the current state of the science in the field of therapeutic drug monitoring (TDM) for biologic products and current clinical practice in the United States and Europe. TDM of some small molecules is commonly performed to sustain target drug levels for efficacy and to minimize safety issues. TDM of large molecule biologics has been reported to improve clinical outcomes in some inflammatory diseases,  by ensuring sustained therapeutic levels and reducing the probability of immunogenicity.  The potential benefits, limitations, and future considerations for TDM of  large molecule therapeutics will be discussed. 

Conference Objectives:

  • Discuss the impact of TDM on patient outcomes in inflammatory and other diseases
  • Discuss the challenges and enabling factors and best practices in the implementation of TDM for biologics as an end-to-end  process from evidence generation to point-of-care implementation and evaluation (pre-analytical, analytical, clinical, regulatory, and health-economic considerations)
  • Explore possible ways all stakeholders could work collaboratively to address these challenges and actualize identified opportunities

Programming Committee 

Yow-Ming Wang, Ph.D., US FDA, Office of Translational Sciences, Office of
Clinical Pharmacology (Chair)
Tara Altepeter, M.D., US FDA, Office of New Drugs, Division of Gastroenterology
Daphne Guinn, Ph.D., US FDA, Office of Translational Sciences, Office of Clinical Pharmacology
Mohsen Rajabi, Ph.D.,  US FDA, Office of Translational Sciences, Office of Clinical Pharmacology
Sophie Shubow, Ph.D., US FDA, Office of Translational Sciences, Office of Clinical Pharmacology
Michele Gunsior, Ph.D., Astria Therapeutics (co-chair)
Michael Partridge, Ph.D., Regeneron (co-chair)
Amy Rosenberg, M.D., EpiVax (co-chair)



Early Bird
(On/Before January 25, 2024)

(On/After January 26, 2024)







Student Member



Member Virtual 



Non-Member Virtual



Student Member Virtual




Registration Fee Includes: 

  • Access to slides from available sessions, post-event
  • Continental breakfast
  • Lunch
  • Workshop recording post-event

Group Registration
Bring four or more paid full conference attendees from the same company and receive a 15% discount per full conference registration. This offer cannot be used with other discounted offers (e.g., speaker rate, complimentary sponsor passes, student rates, etc.). Please email [email protected] for your discount code. The deadline to redeem is February 1, 2024.  If your group does not meet the minimum requirement, AAPS reserves the right to alter your registration fee.

Cancellation & Refund Policy

Cancellations must be submitted to AAPS in writing by February 1, 2024, to [email protected]

Cancellation requests received by this date will be refunded less a $100 administrative fee for members and nonmembers, and $50 for student registrants. Refunds will not be issued for requests received after February 5, 2024.

Refunds will be credited back to the original credit card used for payment, or if paid by check, a refund check will be issued to the original payer within 30 days of submission. 

Travel Information

Getting to the FDA

Visitor parking is often limited. We recommend public transportation or a car service.


Several bus lines stop at the FDA White Oak campus and the FDA Shuttle runs between the White Oak campus and nearby Metrorail stations. Always check the status of public transit before leaving. Taxis and ridesharing services are usually available. Mapping apps and online trip planners can help find the best route for you.


Free FDA Shuttle

The FDA shuttle stops at the following local Metro stations and drops off or picks up in the traffic circle in front of Building 1. View details on the FDA Shuttle Bus. 

  • College Park Metro
  • Glenmont Metro
  • Medical Center Metro
  • Shady Grove Metro
  • Silver Spring Metro
  • Twinbrook Metro

Airport Information

There are 3 airports local to the FDA White Oak campus in the Washington, D.C. metro area:

Baltimore-Washington International (BWI) 
29 miles / 30-40 minutes

Ronald Reagan Washington National (DCA)
29 miles / 30-45 minutes

Washington Dulles International (IAD) 
33 miles / 45-60 minutes 

Recommended Hotels

AAPS does not have room block reserved for this event. However, below are a list of hotels close to the facility:


Home2 Suites by Hilton Silver Spring
1701 Elton Rd, Silver Spring, MD 20903
2 miles / 7 minutes

Hilton Garden Inn Silver Spring White Oak
2200 Broadbirch Dr, Silver Spring, MD 20904
4 miles / 10 minutes

Courtyard by Marriott Silver Spring North/White Oak
12521 Prosperity Dr, Silver Spring, MD 20904
4 miles / 10 minutes

Residence Inn by Marriott Silver Spring
12000 Plum Orchard Dr, Silver Spring, MD 20904
4 miles / 10 minutes