ESTP International Expert Workshop

Designed to stay yet do no harm: Safety assessment of Long-Acting Injectables and the evaluation of the injection site. The ESTP International Expert Workshop will take place on 29th September PM and 30th September AM. 

The main reason for the development of novel “long-acting injectable” (LAI) depot formulations, is to meet the needs of chronic or life-long disease therapy. The long-term treatment of diseases such as psychiatric conditions (e.g., schizophrenia) and infectious diseases (e.g., HIV), is often hampered by the fact that patients do not adhere to their daily (oral) medication.  In many instances, the slow drug-release provides steady plasma exposures, eliminating the “peak and trough” kinetics of repeated daily dosing.  Evaluation of LAI related injection site reactions in animal studies is a key component for risk assessment.

Currently, some important details of study designs, such as the collection and processing of injection sites, or the terminology and interpretation of injection site observations for these compounds are not well defined. This workshop will contain interactive elements, recommendations, and practical examples for the safety assessment of LAIs at the injection sites. In this workshop we aim to discuss and share our recommendations for the evaluation of LAI injection site reactions in local tolerance studies.

For the study design of in-life portion of the studies we will include species and administration site comparison for subcutaneous (SC) and intramuscular (IM) administration of long acting injectables. Currently the evaluation of clinical observations is often based on the “Draize score”, adopted from ocular/dermal evaluations.  Because the current Draize scoring scale might not be suitable for depot formulations, we will also provide recommendations for an adapted scoring system and terminology, including examples.  

Many long-acting injectables are formulated in a poorly soluble depot or a device, from which the active agent is slowly released over time. Assessment of these injection sites should include both the acute and chronic response to SC/IM injection of LAIs and their recovery. We will share our recommendations on the collection and trimming of SC/IM injection sites in different species. The available CDISC/SEND and INHAND nomenclature for histological description of these lesions will be reviewed, and proposed updates to the current INHAND nomenclature will be presented with examples.

We aim to provide criteria for pathologists to assess the local tolerance of LAIs, based on clinical observations and injection site histopathological findings. We will present case studies to discuss tolerability of LAIs, their translatability to the clinic and impact on drug label.

Finally we consider that the outcome of this workshop will also be useful to other studies using parenteral routes.

Registration fee
Expert Meeting € 150
Prices are incl. 7,7% Swiss VAT

The registration fee includes
• Admission to the Expert Meeting
• Coffee break
• Lunch 

How to register
In order to register for the Expert Meeting and / or the ESTP congress please register online and be sure to submit your registration. Upon receipt of your completed registration form and payment, you will receive an email confirmation of your registration.

Click here to register!