27 – 29 November 2018
Boston

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PRE CONFERENCE WORKSHOPS - TUESDAY, NOVEMBER 27, 2018

Workshop A (8.30 AM – 11.30 AM)

Innovative Approaches to Early Clinical Development & Dose-finding: Integration of Dermal Pharmacokinetics (PK) & Pharmacodynamics (PD) in Dermal Drug Development

One of the biggest challenges in dermatological research today remains the development of meaningful methodologies to determine the rate and extent to which topically or systemically applied drugs reaches its site of action and engages its target in the skin.

In this workshop learn how to make the most of early clinical development by integrating advances in techniques to quantitate dermal PK and PD measurements in model and patient settings and their role in dose finding.

Key topics to be discussed include:

  • Challenges with dermal PK – did the API reach the site of action?
    • Stratum corneum (tape-stripping)
    • Epidermis (raman spectroscopy)
    • Dermis (open flow microperfusion)
    • Transdermal (systemic absorption)
  • Challenge models in healthy volunteers
    • Imiquimod
    • Wound healing after skin punch biopsies
    • Lipopolysaccharide intradermal and intravenous
    • UVB irradiation
    • Histamine
    • Capsaicin
  • Models in patients
    • Psoriasis
    • Atopic dermatitis / contact dermatitis
    • Wound healing in ulcers, atopic dermatitis
    • Hidradenitis suppurativa, vitiligo, acne
  • The role of samples
    • Biopsy
    • Skin surface
    • Non-invasive sampling: dry blood spot, swabs
  • Dose response relationship: Intended vs. unintended effects
  • Toolbox
    • Biochemistry (e.g. biomarkers in biopsy, non-invasive measurements)
    • Next generation biophysical measurements
    • Non-invasive imaging
    • Clinical assessments
    • Lipidomics
    • Patient reported assessments
    • Mobile apps

Join us in this interactive session that will bring practical insights into the inclusion of PK and PD measurements and clinical models in early clinical development programs and how these can provide value and de-risk clinical development of dermatological drugs.

Workshop Leaders:

Betsy Hughes-Formella, Independent Consultant - Dermatology Drug Development

Robert Rissmann, Research Director Dermatology, Center for Human Drug Research

Workshop B (12.00 PM – 3.00 PM)

Innovating Drug Delivery & Formulation of Dermatological Drugs

A key area of focus for drug developers working in dermatology is to ensure the optimization of drug delivery platforms and formulation approaches. In this workshop, you will have the opportunity to gain in-depth insights from leading experts in this space that will help you advance your topical development.

Key topics to be discussed include:

  • Skin Biology
    • Leveraging Skin Biology in Dermal Drug Development: The development of new and innovative dermatological products can be very expensive. Having good science and models before getting into a significant development program can be extremely valuable to maximize the return on investment (ROI). Since its conception more than 30 years ago, tissue engineering has made significant progress, especially in the field of human skin. Tissue engineering of the human skin was initially developed for clinical/treatment purposes, but quickly recognized as a powerful tool for the different phases of research and development of dermatological products. Different variations of human skin equivalents or human ex vivo skin culture models have been developed to test safety, delivery, and efficacy of active ingredients and topical products. In the over-the-counter/cosmetic industry, these models have been validated to test the product safety to avoid animal use. In the pharmaceutical industry, these models have become of particular interest to de-risk topical drug development of new drugs and optimize formulation development. The use and the application of these different models will be discussed as well as limitations.
  • Product Development
    • Formulation Development: formulation paradigm for topical drug development, skin delivery-pragmatic approaches for skin permeation enhancement, impact of formulations on performance and safety, linking innovation with clinical de-risking, generics (BA/BE waiver approaches)
    • Manufacturing Process Development – scale up and commercialization, quality by Design (QbD), novel packaging approaches, phase appropriate Clinical Trial Material (CTM), Scale Up and Post Approval Changes (SUPAC)
  • Analytical Research and Development

Phase specific method development to support early drug development through selection of a lead formulation.  The typical approaches to method development vary for new chemical entities versus known molecules.  For known molecules, compendia or literature searches generally provide starting point conditions and any known impurities/related substances are commonly established.  New chemical entities present a unique set of challenges as the method development process is undefined, requiring studies to gain adequate knowledge and understanding of impurity profiles/degradation pathways.  In addition to gaining understanding on API stability; drug excipient compatibility studies are utilized to identify incompatible excipients by combining the drug substance with penetration enhancers, viscosity modifiers, emollients, preservatives, oils, etc. in which the data generated can be used to assist in predicting product stability.  To support product stability, suitable extraction procedures must be developed.  Implementation of suitable “topical” extraction procedures present significant challenges as development is two-fold:  ensuring that the solvent/technique used is sufficient to 1) penetrate the formulation matrix and 2) extract and solubilize the drug substance.  Once the lead formulation has been selected, phase appropriate validation to support varying clinical development stages will be executed.  A life-cycle approach to method validation is applied as differences exist in requirements between early development and late-stage development (Phase IIb and beyond).  For technology transfer activities, streamlining the method transfer process is critical to avoid common pitfalls and challenges which could cause unnecessary and timeline-impacting delays.

  • In Vitro Testing

In Vitro Release Test (IVRT) is a test to measure the release of active ingredient from a formulation matrix into an appropriate receiving medium.  It is based on Fick’s laws on diffusion.  Release of active ingredient is a complicated process, and it depends upon the properties of the drug, the formulation matrix and the barrier.  Specifically, for IVRT, the barrier is an inert, synthetic membrane that acts as a holding surface for the dosage form in a diffusion apparatus, thereby limiting the dependence of release rate onto the properties of the dosage form and the active ingredient.  Most commonly used apparatus for IVRT is the vertical Diffusion cell.  USP chapter <1724> describes the apparatus and the use procedure in detail. IVRT has several applications during development of a topical dosage form.  During early stage of development, it serves to characterize and understand the release properties of the active ingredient and the dosage form, allowing formulators to make appropriate changes in excipients/process to optimize a formulation prototype.  When Quality by Design approach is used, as it should and desired by the agency, IVRT remains to be an important parameter to evaluate when changes are made in excipients, excipient supplier or grad and process of manufacturing.

Join this interactive and comprehensive session that will allow you to streamline and boost innovative delivery and formulation approaches that match the potential of your drug candidates.

Workshop Leaders:

Vijendra Nalamothu, CEO, Tergus Pharma

Jean-Philippe Therrien, Head, Skin Biology, Tergus Pharma

Tammy Payne, Head, Analytical R&D, Tergus Pharma

Kailas Thakker, (Co-Founder Emeritus), In Vitro Sciences, Tergus Pharma

 

 

Workshop C (3.30 PM – 6.30 PM)

Patient-Centricity Know-How – For Perpetual Innovation, Optimized Development & Successful Commercialization of Dermatologic Drugs

Pharma/biotech companies in dermatology and medical esthetics will maximize the value of development programs and prevent multiple missteps with significant financial ramifications when genuine paradigm shift from product-centricity to patient-centricity finally occurs. The paradigm shift is already happening within regulatory agencies, among healthcare industry stakeholders, in scientific journals and at medical conferences.

This workshop is your opportunity to gain:

  • Systematic knowledge of current patient-centric strategies and tools in drug development and commercialization
  • Actionable insights from instructive patient engagement case studies

Key topics being addressed include:

  • Patient-focused innovation incubators
  • Patients’ perspectives built into the foundation of product strategy
  • Impact of the patient involvement on clinical development:
    • Making the study design more relevant and clinical trial more feasible
    • Endpoints that make sense and will make a difference
    • Getting study completed with time and budget savings
    • Data interpretation that speaks value for the patient
    • Assets for regulatory approval
  • Putting patient in the center of the medical affairs and commercial strategy
    • Advisors, panelists, speakers, co-authors, evidence generators
  • Influence of patient preferences on decisions of healthcare stakeholders including payers and providers
  • Overcoming barriers to increased patient involvement in clinical/medical/commercial decisions including tight deadlines, limited resources, compliance/regulations, flawed methodologies, and organizational resistance.

 

This interactive session, packed with relevant content and crisp-clear takeaways, will enable you to stimulate innovation in your organization, maximize the value of your development programs and see ROI for patient engagement.

Workshop Leader:

Jasmina Jankicevic, Dermatologist, Clinical Development & Medical Affairs Consulting