AGAH e. V.

7th AGAH Dermatological Product Development Workshop
May 11 – 12, 2017 – Bethesda, Maryland, USA

Day 1 · Thursday, May 11, morning track

Candidate Selection

The development of new medicines starts with the selection of a druggable target, which have been  enzymes, nuclear receptors or G-protein-coupled receptors. With the advent of Bioinformatics, “big data” and  “omics” technologies, new opportunities of finding targets have emerged for all therapeutic areas. More recently the use of global transcriptomic profiling has been used to improve the understanding of disease molecular mechanisms and discovery of new targets.

Once a target is selected and validated, drug discovery programs start the design and evaluation of new chemical entities with adequate potency, safety and physicochemical properties. While dermatology has recently benefited from drug repurposing, the synthesis of molecules with properties more suitable for topical treatment is an area of growing interest. In addition to the key properties for topical drug candidates, the demonstration of target engagement can de-risk projects in early stages. In the past years a few in vitro and in vivo models have been developed to provide proof of concept in skin inflammatory diseases such as psoriasis and atopic dermatitis, thus enabling the selection of development candidates. Additionally, 3D skin models are being used for better understanding of drug metabolism and toxicity. After target engagement has been proven, the next stages of candidate selection generally include pre-formulation, skin irritation and penetration, and early safety assessment.

  • Rational design and selection of drug development candidates for dermatology
  • Immune-mediated dermatological indications:  Lessons from clinical transcriptomics
  • Bioprinted three-dimensional (3D) Human Tissues for Toxicology and Disease Modeling
  • Topical drug delivery of new chemical entities: physicochemical properties, skin penetration, and formulation development
  • Clinical and tissue biomarkers as predictors of therapeutic response
     

Day 1 · Thursday, May 11, afternoon track

Dermal Dosage Form development and characterization: Impact of vehicle and emerging New technologies

With FDA emphasizing incorporation of Quality by Design (QbD) principles very early on in development of drug product development, it is critical to approach formulation development in a strategic way using Critical Material Attributes (CMAs) with defined Critical Quality Attributes (CQAs) of the drug product. In this session, discussion will be focused on strategic development of topically administered dosage forms with a focus on impact of vehicle and raw materials on product performance & safety and techniques used to characterize topical formulations.

Various strategies to develop topical semisolid formulations targeting desired permeation/drug delivery profiles will be discussed from a vehicle composition point of view. Novel models for in vitro evaluation of functional efficacy to understand the importance of vehicle composition will be presented.

Overview on classes of chemical penetration enhancers – routes of permeation enhancement - what to look out for from a reversible/irreversible effects point of view. Special considerations for specific skin diseases will be given.

While selecting excipients, consideration should also be given to the irritation potential and sensory effects. Overview of ways to screen formulations for these attributes and importance of incorporating these screening tools early on as a stage gate approach to formulation development. Case studies will be presented to discuss the impact of specific excipients on permeation/release profiles and irritation potential. Practical considerations about excipient selection from a global regulatory standpoint will also be discussed.

Once a formulation is made, characterization of a topical formulation can be done using variety of techniques. Recent advancement in this field with challenges faced while using different techniques and their relative importance to drug product stability will be showcased.

  • Nanotechnology in topicals: Screening and identification of nanoemulsion formulations as an effective topical therapy
  • Microneedle technologies to enhance drug delivery targeted to the skin
  • Strategies for de-risking dermal formulation development
  • Characterization of topical dosage forms: The utility of predictive data to identify potential risks during and post clinical development
  • Impact of vehicle on performance and safety: Usage of the early development data to de-risk clinical formulations

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Dates to remember
  • December 15, 2016
    Opening registration
    • March 15, 2017
  • End of early registration
      • May 11, 2017
    • End of mid registration
      •  
    • May 11–12, 2017
    • 7th AGAH e.V. Workshop Dermatological Product Development
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