AGAH e. V.

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

Day 2 · Friday, May 12, morning track

Dermal Pharmacokinetics and Pharmacodynamics: Key role For effective development of dermally acting drugs

For systemically delivered drugs, pharmacokinetic (PK) as well as pharmacodynamic (PD) approaches based on drug and biomarker concentrations in whole blood, serum or plasma are standard in New Chemical Entity (NCE) and formulation development as well as pivotal endpoints for generic product development. In these development programs, systemic levels are assumed to accurately reflect drug bioavailability (BA) at the target site of action. Clinical PK and PD studies are recognized as an ideal tool to investigate (1) active drug concentration profiles after drug administration, (2) bioequivalence studies for generic drugs, (3) proof-of-mechanism, (4) dose response in the case of NCE, and (5) toxicity.

In contrast, over the last decades PK and PD data have been generally ignored in the case of topically administered drugs which exert a local effect in skin. For these drugs only a small fraction of the topically applied drug reaches the systemic blood circulation and active drug concentrations in the skin are many times higher. In the absence of reliable, validated methodologies to quantitate PK and biomarkers in the skin, these important indicators have not been routinely integrated into early development programs. Further, for topical generic products it is not possible to use PK endpoints as alternatives to expensive, less reliable clinical therapeutic endpoint studies. The development and validation of appropriate in vitro and in vivo methodologies to determine the rate and extent to which a topically applied drug reaches it site of action and engages its target in the skin remains one of the biggest challenges in dermatological research today, including topical generic drugs.

In this session the strengths and weaknesses of available in vitro and in vivo dermal PK and PD approaches will be discussed. Further, we will highlight the risks and pitfalls of omission of dermal PK and PD in NCE and generic drug development programs. This session aims to give critical insights into dermal drug development strategy and when inclusion of validated in vitro and in vivo dermal PK and PD models in the drug development process can save time, resources and reduce, refine and in some instances replace clinical trials.

Presentations:

  • How dermal drug development would look like today if reliable dermal PK and PD methods could be used
  • Innovative dermal PK and PD: Approaches using ex-vivo human skin
  • Innovative dermal PK and PD: In vivo Proof-of-Mechanism to clinical dermal bioequivalence using Open Flow Microperfusion
  • Cutaneous pharmacokinetics and pharmacodynamics for the 21st century

Day 2 · Friday, May 12, afternoon track

Strategies for de-risking topical product development

Whether developing a topical product of an NCE to clinical POC or all the way to marketing authorization, or a generic drug through formulation screening and bioequivalence testing to marketing authorization, there are many different paths that can be taken. This session will consider the approaches taken by both big and small pharma, evaluate the risks and potential pitfalls, and discuss the risk mitigation that should be considered and the contingencies that can be put in place.  The three previous themes of the meeting: candidate selection, formulation development and manufacturing, and PK and PD studies, will be brought together along with preclinical, clinical and regulatory aspects of the development process.  In addition, practical advice will be given on criteria for choice of region for early clinical development, how best to interact with the regulatory authorities, and how the topical product approval process may change in the future. The session will conclude with case studies of success provided by representatives from both big and small pharma innovators (GSK and Dermira) and from a generics company (Dr. Reddy’s).

Presentations:

  • Opinions on the current status of the field: What big pharma does best, the obstacles, how things could be improved
  • Case studies of success from a small pharma innovator (Dermira)
  • Case studies of success from a generics company (Dr. Reddy’s)
  • Strategic placement of clinical trials through proof-of-concept: Comparison of key factors across regions  including ease of approval, recruitment, and incentives
  • Regulatory strategy: Building the plan to include innovation

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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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