2021 Pre-Conference Workshop Day

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

john armstrong

John M. Armstrong
Managing Director
Outcome Capital, LLC

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

Numerous new and innovative drugs are currently entering the dermatological market space. The dermatologist of the 20th century used to have a limited amount of pharmacological treatment options comprising mainly nonspecific drugs such as (topical) corticosteroids and methotrexate. This has changed tremendously in the last two decades when novel, targeted therapies became the new hallmark for the treatment of moderate to severe skin diseases. Risankizumab, for instance, is a monoclonal antibody selectively targeting interleukin 23 in chronic plaque psoriasis and is the 12th unique biologic drug that is registered in Europe and in the United States. Having these multiple, targeted treatment options available has greatly improved the flexibility and personalization of psoriasis care in clinical practice. However, such targeted treatment options are still under development for various other indications including atopic dermatitis, chronic urticaria, hidradenitis suppurativa, vitiligo, and alopecia areata.

By definition, the early exploratory phase in clinical drug development is performed without clinical information on the drug, e.g., unknown active dose, unclear regimen, and uncertain pharmacological activity. This uncertainty leads to a probability of success as low as 13.8% from phase 1 to market registration across all therapeutic areas and 6.3% for auto-immune/inflammation treatments in particular. Therefore, more rational approaches for drug development are needed such as question-based drug development with biomarkers included 2 of the quantitative model-based approach. However, there is no clear guidance on how to perform early phase clinical trials with innovative topical or systemic drugs at the cross-road of dermatology and clinical pharmacology.

Hence, with this workshop, we aim to illustrate the various aspects of recent examples to enable rational dermatological drug development for mostly nonmalignant skin diseases in the early clinical phase, i.e., human pharmacology and exploratory therapeutic setting.

Importantly, biomarkers and drug development tools described in this manuscript need to be qualified or validated to enable reliability of the observations as described in more detail in the FDA guidances.

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