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:
- Outline the current status of the three critical areas for the development of LAI Drug Products:
- In vitro biorelevant methods for dissolution/release
- In vivo preclinical models and mechanistic understanding for assessing performance
- In silico platforms for clinical translation and predicting performance
- Identify gaps and opportunities in each of these three areas
- Work in groups toward actionable solutions, including input from regulatory agencies
- 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.
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