Pre-Conference Workshop Day
Tuesday, November 16, 2021

A Positive Clinical Study

What Makes a Dermatology Investment Most Successful?

Topical Product Development: An End-to-End Approach of Concept to Commercialization

Biomarkers, Technology & (Novel) Endpoints in Clinical Development

Workshop A - 8:00am – 10:00am

A Positive Clinical Study

The new strategic and operational interventions are in order to achieve genuine innovation in dermatology drug development. The promising therapies in development for common and rare skin diseases are to move the boundaries forever. If there is a recipe for successful clinical development, let’s discuss the key ingredients.

This workshop is your opportunity to tackle:

  • Competitive clinical trial designs for 2022 and beyond
  • Innovation and timelines and budgets – making it a win-win-win
  • Clinical trial implementation know-how for dermatology drug developers

Dr. Jasmina Jankicevic is known for her engaging style of leading workshops that are packed with relevant content and crisp-clear takeaways. This interactive session will enable you to maximize the value of your development programs.

Workshop Leader

Jasmina Jankicevic Headshot

Jasmina Jankicevic
Dermatologist, Clinical Development & Medical Affairs
JJ Consulting

Workshop B - 10:15am – 12:15pm

What Makes a Dermatology Investment Most Successful?

How does dermatology drug development fit into the evolving prism of mental models through which investors view suitable programs for funding?
There are universal rules about making wise investment decisions in general. There are specific rules about making drug development investments successful. There are patterns in successful dermatology investments. But rule-following inhibits innovation and creates templates that repeat themselves creating outcomes that fall short of their original expectations. Companies and investors often fall into “the good data trap” and miss out on the drug’s full value potential. The steps towards successful dermatology investments start very early in the drug development process. No situation is exactly like the prior one.

What can one do to make sure an investment in dermatology is successful?

  • We will speak about investments in dermatology through venture, private equity, academia, government, strategic sponsor, or public markets.
  • We will discuss basic elements that one cannot circumvent and discuss how one can increase the chances that your investment in dermatology is a successful one.
  • We will have a chance to interact with each other to formulate what one can do to make investments in auto-immune skin diseases successful.

Workshop Leader

Humberto Artunes Headshot

Humberto Antunes
Partner
Gore Range Capital
Former Chief Executive Officer
Galderma

Workshop C - 12:45pm – 3:45pm

Topical Product Development: An End-to-End Approach of Concept to Commercialization

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 areas to be discussed include:

  • Early Development, Skin Biology and Skin Permeation
  • Leveraging Skin Biology in Dermal Drug Development: The use and the application of different variations of human skin equivalents or human ex vivo skin culture models (which have become of particular interest in the pharmaceutical industry to de-risk topical drug development of new drugs and optimize formulation development) will be discussed as well as its
    limitations.
  • Utilizing in Vitro Permeation Testing (IVPT) as a tool for developing topical drug products: Discussing IVPT as a tool in the screening study of new molecules, evaluation of formulations prior to a regulatory filing, post-approval claims support studies, and as a BE/BE approval tool for generics, etc.
  • Product Development: Focusing on formulation development of topical drug products- early clinical candidates, late-stage formulations and generics with an emphasis on QbD.
  • Formulation Development: Formulation paradigm for topical drug development, skin delivery-pragmatic approaches forskin permeation enhancement, the impact of formulations on performance and safety, linking innovation with clinical derisking, generics (BA/BE waiver approaches).
  • Manufacturing Process Development: Scaleup and commercialization, quality by Design (QbD), novel packaging approaches, phase appropriate Clinical Trial Material (CTM), Scale Up and Post Approval Changes (SUPAC)
  • Analytical Research & Development: This interactive and comprehensive session will allow you to streamline and boost innovative delivery and formulation approaches that match the potential of your drug candidates

Workshop Leader

Vijendra Nalamothu

Vijendra Nalamothu
Chief Executive Officer
Tergus Pharma

Workshop D - 4:00pm – 6:00pm

Biomarkers, Technology & (Novel) Endpoints in Clinical Development

One of the biggest challenges in dermatological research today remains the development of meaningful methodologies to determine the rate and extent to which a topically or systemically applied drug 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 quantify dermal pharmacokinetic (PK) and pharmacodynamic (PD) measurements in model and patient settings, and explore their role in dose finding and product differentiation. Further, we will focus on biomarker guided drug development, the role of innovative technology and discuss appropriateness of (novel) endpoints throughout early and late clinical development.

Key topics to be discussed include:

  • Challenges with dermal PK – did the API reach the site of action?
  • Stratum corneum (tape-stripping and role as drug depot)
  • Epidermis (Raman spectroscopy)
  • Dermis (open flow microperfusion)
  • Transdermal (systemic absorption)

Biomarkers

  • Classical wet biomarkers
  • Skin tissue vs. systemic
  • Classical vs. modern

Technology

  • -omics
  • Non-invasive imaging
  • Devices
  • Modular toolbox

Endpoints

  • Classical physician-based
  • Patient-centric
  • Digital (trial@home) // 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, implementation of novel endpoints throughout development, and how these methodologies can provide value and de-risk clinical development of dermatological drugs.

Workshop Leaders

Robert Rissmann Headshot

Robert Rissmann
Research Director,
Dermatology
Center for Human
Drug Research

Betsy Hughes-Formella Headshot

Betsy Hughes-
Formella

Independent Consultant
Dermatology Drug
Development

Frank Sinner Headshot

Frank Sinner
Director, Institute for
Biomedicine & Health Sciences
Joanneum Research