2022 Pre-Conference Workshop Day

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

Elevating Diversity and Inclusion to the Forefront of Clinical Design

Investing in Medical Dermatology: What to look for

Workshop A - 10:00am – 12:30pm

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.

Attend this workshop to:

  • Elevate knowhow in Early Development, Skin Biology, and Skin Permeation
  • Leverage 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 will be discussed as well as its limitations.
  • Utilize 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.
  • Enhance Product Development: Focusing on formulation development of topical drug products- early clinical candidates, late-stage formulations and generics with an emphasis on QbD.
  • Maximize Formulation Development: Formulation paradigm for topical drug development, skin delivery-pragmatic approaches for skin permeation enhancement, the impact of formulations on performance and safety, linking innovation with clinical derisking, generics (BA/BE waiver approaches).
  • Streamline 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)
  • Integrate 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

Workshop Leader

Vijendra

Dr. Vijendra Nalamothu
Chairman & CEO
Tergus Pharma

Workshop B - 13:00 – 15:30pm

Elevating Diversity and Inclusion to the Forefront of Clinical Design

Attend this workshop to:

  • Acquire a comprehensive overview of the disparities in clinical trial DEI representation across dermatology
  • Uncover the underlying reasons these disparities exist, drawing on conflicting evidence from vitiligo, AD, and blistering disease
  • Prepare for taking clinical trials abroad and overcome the challenges that come with marketing a drug in the trial destination, maintaining a comparable clinical trial standard

Workshop Leader

Ricardo rojo

Ricardo Rojo Cellas
Global Clinical Lead
Janssen

Workshop C - 16:00 – 18:30pm

Investing in Medical Dermatology: What to look for

Discuss the projected impact of different therapeutic modalities in dermatology: biosimilars, novel biologics, the microbiome, cell and gene therapy (CGT) and selective protein degraders – modalities that are changing the future activity of research in dermatology and immunology. Learn how the severe, rare disease space is making progress. Discover how novel molecular targets in moderate-to-severe inflammatory skin diseases have the potential to change health economics. Hear how capital market dynamics have changed in the last year and the implications of those market changes on exit strategies for dermatology start-ups.

Attend this workshop to:

  • Acquire a comprehensive understanding of dermatology market needs
  • Get one step ahead of the market through awareness of competitive activity
  • Gain an understanding of biotech investors involved at different levels, including seed financing, venture capital, private equity, growth capital, strategic investment, and public markets.
  • Explore future opportunities within the dermatological space for inflammatory skin conditions

Workshop Leaders

Humberto Antunes

Humberto Antunes
Partner Gore Range
Capital, Former Chief
Executive Officer
Galderma

john armstrong

John Armstrong
PhD, Managing Director,
Outcome Capital, Former
Head of Discovery &
Global Strategic Programs
Galderma

Chidi Nwankpa

Chidi Nwankpa
Healthcare & Life
Science Investor
Gore Range Capital