27 – 29 November 2018
Boston

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AGENDA

Conference Day One – Wednesday, November 28, 2018

08.15 Chair’s Opening Remarks

Christian Antoni, Senior VP & Head of Development, LEO Pharma A/S D. 


08.30  Opening Keynote Panel Discussion: Innovating Dermatology Drug Development

  • Establishing the current landscape and state-of-the art in dermatology drug development – latest advances, study failures, and challenges
  • Analyzing the end-to-end pain points that accompany dermatology programs – from improving preclinical translation, to tackling late regulatory and commercial challenges
  • Identifying and addressing unmet needs – defining the strategic driver for companies involved in drug development for rare dermatological diseases or moderate skin conditions (vs. standard of care)
  • Outlining where we are and what’s next – important learnings to date and perspectives on future directions

Panelists:
Frank Nestle Global Head, Immunology Therapeutic Research Area & CSO North
America, Sanofi
Hans Hofland
,VP – Research & Nonclinical Development, Dermira
Christian Antoni,
Senior VP & Head of Development, LEO Pharma A/S D.


09.15 Precision Dermatology: Targeting Atopic Disease & Beyond

  • Understanding how new technologies drive insights into molecular disease mechanisms and innovative therapies
  • Exploring atopic disease as the next frontier in inflammatory disease
  • Addressing the future landscape of Precision Dermatology

Frank Nestle, Global Head, Immunology Therapeutic Research Area & CSO North America, Sanofi


Latest Advances in Dermatology Translational Research


09.45 Understanding the Advantages & Limitations of Ex Vivo/In Vitro
Human Skin Target Engagement Models

  • Addressing the misconception that human ex vivo skin models for target engagement will help to predict clinical efficacy – even though these models recapitulate major signalling pathways involved in the pathogenesis of the disease, they don’t necessary recapitulate all of them
  • Understanding the purpose of these models, which is to help select:
    • The API and/or formulations that will lead to the best activity for their respective target(s) based on the API release from the formulation
    • The API delivery/pharmacokinetic into skin layers
    • Its activity/bioavailability

Jean-Philippe Therrien, Head, Skin Biology Tergus Pharma


10.15 Speed Networking Session: Brought to you by CPL 


10.45 Morning Refreshments


11.15 From Serendipity to Precision Medicine

  • Establishing deep disease pathways understanding as a prerequisite vs. “designer drugs” approaches
  • Translating pathway targets to precise human efficacy
  • Tackling practicalities – right first time:
    • GDPR – creating the optimal informed consent
    • Minimal invasive methods to harvest biologic material
    • Machine learning vs. hypothesis testing
    • Precision Medicines – payer acceptance

Christian Antoni, Senior VP & Head of Development, LEO Pharma A/S


11.45 Translational Approaches to Personalized Medicine in Dermatology

  • Using Omics approaches to understand disease heterogeneity and pathogenesis
  • Integrating precision medicine approaches in clinical trials
  • Defining innovative approaches to predictive medicine

Michael Howell, Senior Director – Translational Research, Incyte Corporation


12.15 GBR830 – A Novel OX40 Antagonistic mAb Inducing Progressive & Sustained Improvement in Moderate to Severe Atopic Dermatitis Skin & Inflammatory Biomarkers as well as Disease Activity

  • Detailing on how GBR 830 is a safe and well tolerated mAb, with a similar TEAE profile to placebo
  • Inhibiting the OX40/OX40L pathway, as shown through reduced expression of OX40 and OX40L in lesional skin
  • Reducing epidermal hyperplasia, and lesional biomarkers of disease activity with GBR 830
  • Inducing clinical improvement in AD scores

Venkat Reddy, Senior VP & Global Head of Translational Sciences, Glenmark Pharmaceuticals


12.45 Cell Printing & Interrogation For Optimized Drug Development

  • Introducing Fluicell’s approach to cell biology and drug development, which enables cell functionalities to reveal at a level of details unavailable with currently technologies
  • Showcasing the product family, highlighting a key application of each tailored towards drug development
  • Introducing Biopixlar bioprinter, a product able to generate advanced cell-based disease models and drug development applications

Gavin Jeffries, CTO, Fluicell AB

Tatsiana Lobovkina, CSO, Fluicell AB


12.55 Lunch & Networking


Enhancing Preclinical Development in Dermatology


13.55 Finding New Targets & Molecules: An Overview from an External Innovation Perspective

  • Addressing external innovation as the key to sustainability of R&D
  • Harnessing innovation at different stages of development with different external innovation models
  • Understanding how academic collaborations are a key source of innovation

Edward Hsia, VP, External Research & Innovation, Almirall


14.25 Melanocortin Therapeutics for Rare & Prevalent Diseases

  • Understanding how melanocortin receptor biology offers unique therapeutic opportunities
  • Demonstrating utility in erythropoietic protoporphyria with a MC1R agonist
  • Analyzing how melanocortin interventions may offer benefit in both rare and prevalent diseases

Lee Koetzner, Senior Manager, Preclinical Pharmacology, Castle Creek Pharmaceuticals


14.55 Integrative Preclinical Research Strategies to Identify New Therapeutic Opportunities in Dermatology

  • Highlighting potential in vivo/ex vivo/in vitro skin models
  • Exploring preclinical strategies to de-risk dermatology drug development
  • Highlighting case studies that transitioned from preclinical research to clinical trial development

Paul Smith, Senior Director – Preclinical Pharmacology, Incyte Corporation


Developments in Topical Drug Development & Formulation Approaches


15.25 Advances in Dermatology Development – Systems and Models for Topicals

  • Analyzing historical topical product development and its limitations
  • Delving into the use of Performance Testing in topical product development - exploring old and new Performance Testing Systems and Models
  • Describing a multimodal approach for de-risking development

Jon Lenn, Senior VP, US Operations, MedPharm


15.55 Afternoon Refreshments & Poster Session


16.40 De-risking Topical Product Development

  • Selecting the best molecules for topical delivery
  • Developing and selecting the best topical formulation
  • De-risking clinical development

Hans Hofland, VP – Research & Nonclinical Development, Dermira


17.10 Overviewing the Latest Developments in Strategies for Topical Drug Delivery

  • Exploring challenges in topical drug delivery
  • Describing recent technological advances that have enabled delivery of small and large molecules into skin
  • Current status and future potential of new strategies for topical drug delivery

Samir Mitragotri, Hiller Professor of Bioengineering & Hansjorg Wyss Professor of Biologically Inspired Engineering, Harvard University


17.40 SNA-Based Therapeutics to Treat Diseases with Great Unmet Medical Need

  • Addressing the drug discovery and development efforts by Exicure, revolving around the use of spherical nucleic acid (SNA) constructs
  • Exploring the distinct skin penetration properties and increased cellular uptake of SNAs
  • Developing XCUR17 (a topical antisense oligonucleotide in the SNA format), which is targeted to interleukin 17 receptor alpha mRNA for the treatment of chronic plaque psoriasis
  • Analyzing recent Phase 1 clinical data from XCUR17

Weston Daniel, Senior Director – Program Management, Exicure Inc.


18.10 Chair’s Closing Remarks

Christian Antoni, Senior VP & Head of Development, LEO Pharma A/S

Conference Day Two – Thursday, November 29, 2018


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