PRE-CONFERENCE WORKSHOP DAY
TUESDAY, NOVEMBER 19, 2019

Workshop A- 8:00am – 10:45am

Novel Translational & Clinical Development Approaches For Topicals

An optimized early drug development program should meet the double challenge to correctly identify and predict target engagement in the patient and de-risk later stage clinical development for both efficacy and safety. By using a creative approach for topical product development which integrates innovative methods and translational models into early phase preclinical and clinical research, it is possible to increase efficiency and speed-up development time of dermatological products.

In this workshop, real-life data and hypothetical examples will be used to explore alternative strategies for early development of topical products. Cases will be shown illustrating how the measurement of real-time PK/PD, establishing proof-of-pharmacology in challenge models, or assessing safety via dermal PK can be applied to de-risk development and build confidence.

Development roadmaps will be presented to address the key challenges and pitfalls in new drug development scenarios, including:

• Drawing on systems dermatology: novel insight from pathophysiology and implications for drug developers
• Translating ex vivo and animal models to early human POC study designs
• NCE development: approaches for bridging of concept and final formulations
• Innovation in 505(b)2 or hybrid developments by bridging for safety and efficacy
• Add dermal PK/PD to your classic phase 1 study
• Efficient topical development of re- purposed APIs
• Place for novel methods and novel endpoints
• Understanding drug action and rapid dose selection in models
• The value of biomarkers
• Regulatory implications FDA vs. EMA

Workshop Leaders

Betsy Hughes Formella

Betsy Hughes-Formella
Independent Consultant,
Dermatology Drug Development

Frank Sinner

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

Robert Rissmann

Robert Rissman
Research Director, Dermatology
Center for Human Drug Research

Workshop B- 11:00am – 1:45pm

The Future of Drug Development in Dermatology: Indications & Implications

The spurt of innovation in dermatology drug development continues. Current and emerging drugs in development for skin diseases are moving boundaries of possible in efficacy, safety, and convenience for patients.

However, is there a correlation between development intensity and indication diversity? Are pharma/biotech companies in dermatology gravitating primarily towards several indications? What regulatory and commercial implications will that generate? What dermatological indications are crying for attention and how to prioritize areas of unmet needs based on the asset at hand?

This workshop is your opportunity to gain:

• Insights into pipeline optimization strategies and timely drug development
• New perspectives on recent occurrences in dermatology space
• Actionable learnings from instructive case studies

Key topics to be addressed include:

• Current and future dermatology drug landscape
• Differentiation strategies in the busy development space
• Unmet-need-driven innovation
• Building patients’ perspectives into the foundation of product strategy
• Acceleration of the drug development process

In this engaging workshop, Dr. Jasmina Jankicevic will deliver a discussion packed with relevant content and crisp-clear takeaways. This interactive session will enable you to strategically stimulate innovation in your organization, to optimize your pipeline, and to maximize the value of your development programs.

Workshop Leader

Jasmina Jankicevic

Jasmina Jankicevic
Dermatologist
Clinical Development & Medical Affairs Consulting

Workshop C- 2:00pm – 5:00pm

Formulation Development & Drug Delivery 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 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 for skin permeation enhancement, the impact of formulations on performance and safety, linking innovation with clinical derisking, 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 & 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 Leaders

Vijendra Nalamothu_Tergus Pharma

Vijendra Nalamothu
Chairman & CEO
Tergus Pharma

Tammy Payne_Tergus Pharma

Tammy Payne
Analytical R&D
Tergus Pharma

Tergus

Alon Mantel
Skin Biology
Tergus Pharma

Start-Up Focus Roundtable - 5:15pm – 7:00pm

Backing the Bet: Exploring the Challenges of Funding Development

How does a company maximize its ability to secure adequate funding for continued development of its asset(s)?

At a critical booming point in the dermatology drug development space, early stage start-ups exploring the opportunity to bring innovative programs to life face fierce competitive and financial pressures. This session will be an opportunity to discuss with peers and hear the perspectives of seasoned experts in investment and funding for life sciences companies on how to tackle key challenges to securing funding and investment for early stage development pipelines.

The session will explore key topics, including:

• Going public vs staying private
• Judging the macro environment
• The stories investors buy

Workshop Leaders

Sean Andrews

Sean Andrews
VP, Investor Relations
Sienna Biopharmaceuticals

Ken Cacciatore

Ken Cacciatore
Managing Director, Healthcare - Pharmaceuticals/Specialty
Cowen

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