Long-Acting Injectables (LAIs) are rapidly growing across the pharmaceutical industry for the treatment of chronic conditions, infectious diseases (HIV, Malaria, TB, Hepatitis C, etc.), anti-psychiatric drugs, hormonal contraceptives, bone health, cancer, etc., because they offer the opportunity to reduce administration frequency, improve patience adherence and experience, and reduce healthcare costs. A recent example on the impact of LAI regimens to patients comes from the FDA approval of Cabenuva, an extended-release dosage of Cabotegravir and Rilpivirine for the treatment of HIV. Other key cross-pharma collaborations (e.g., Gilead and Merck) highlight the intense activity in the area. 

However, the path for design and development of LAIs is not as defined as it is for other dosage forms (e.g. oral solid dosage forms). At this stage, there is a need for experts in the field across the pharmaceutical, regulatory, and academic landscape to work together to identify gaps and defining strategies to accelerate the development of this game-changing class of drug products.

The LAI Drug Product Design and Development space should be brought to the same level as the oral solid dosage forms space, with clear regulatory guidelines (e.g. BCS classification, ICH M9), defined mechanistic understanding, predictive simulation tools (e.g., PBPK modeling), and biorelevant dissolution methods.

In this workshop participants will:

  1. Outline the current status of the three critical areas for the development of LAI Drug Products:
    1. In vitro biorelevant methods for dissolution/release
    2. In vivo preclinical models and mechanistic understanding for assessing performance
    3. In silico platforms for clinical translation and predicting performance
  2. Identify gaps and opportunities in each of these three areas
  3. Work in groups toward actionable solutions, including input from regulatory agencies
  4. Bring together their work by summarizing the key points from the discussions and defining proposals for strategic collaborations to bridge the gaps and solve specific challenges

Participants attending this workshop will:

  • Understand the current status of LAIs and develop a clear vision of the processes involved in the design and development of robust Long-Acting Injectable Drug Products for patients.
  • Work together to share different perspectives, identify gaps, and propose solutions for the effective and accelerated development of robust LAIs.
  • Explore proposals for collaborations post-workshop for interested parties.

Programming Committee

Simone Alidori, Ph.D., GSK (Chair)

Banu Zolnick, Ph.D., FDA (Vice Chair) 

Diane Burgess, Ph.D., UConn

Joe Polli, Ph.D., FAAPS, ViiV Healthcare

Chris Rhodes, Ph.D., Drug Delivery Experts



Full Event

Single Session







Student Member




All registrants will have access to the session slides and recordings 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 March 7,2021.  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 to [email protected] and will be honored as follows:

AAPS will issue a refund to any attendee who cancels at least two (3) business days in advance of the event:

  • If you cancel your registration on/before March 4, 2022 you will be refunded your registration fees minus an administrative fee of $50 for members/non-members or $25 for students.
  • In the case of a multi-day event, cancellation must be received no later than 3 business days before the first scheduled webinar date/start time.
  • Cancellations received less than 3 business days before the scheduled event date/start time will not be refunded.
  • In the rare event that AAPS must cancel due to circumstances beyond our control, we will make every effort to notify attendees as quickly as possible. Attendees will be given the opportunity to either transfer to another virtual event or obtain a full refund.

No refunds will be given for “no shows” or for attendee technology problems. It is the responsibility of the attendee to test their computer setup before the start of the webinar. If a technical failure at your home or workplace prevents access to the live event, you are not eligible for a refund. If the technical problem is due to our error, we will issue a refund.