10-12 October 2017
Boston, USA

Day One
Wednesday October 11, 2017

Day Two
Thursday October 12, 2017

08.20
Chairman’s Opening Remarks

  • Monica Luchi former CMO & Executive VP , Immune Pharmaceuticals

The Rise of Biologics in Dermatology

08.30
Panel Discussion: Pioneering Biological Therapies in Dermatology

  • Anne Parneix VP & Senior Head of Therapeutic Area, Dermatology, Novartis
  • Ernst Kriehuber Director Translational Medicine, Dermatology & Immune Mediated Diseases, Novartis Institutes for Biomedical Research
  • Frank Nestle Head of Immunology & Inflammation Therapeutic Research Area & CSO North America, Sanofi US

Synopsis

• Analyzing the explosion in new programs – the promise of more and more efficient therapies vs. the hurdles of a crowded development space
• Differentiating MOA that translate into actual benefit to the patient – is good efficacy enough?
• The growing investment – demonstrating value and understanding market share in advance

09.15
Advancing Dermatology Therapies with Biologics

  • Frank Nestle Head of Immunology & Inflammation Therapeutic Research Area & CSO North America, Sanofi US

Synopsis

• Addressing the flourishing of biologic therapies targeting dermatological conditions such as psoriasis and atopic dermatitis
• Dupilumab – analyzing the innovative mechanistic aspects and new pathways against type II inflammation
• Analyzing the current new chapter in the understanding and targeting of immunemediated diseases in the dermatology space

09.45
Beyond the Hype – Exploring the Application of Biologic Therapies to Tackle Unmet Needs in Dermatology

  • Anne Parneix VP & Senior Head of Therapeutic Area, Dermatology, Novartis

Synopsis

• Discussing how biologics hold great promise for other indications other than psoriasis and atopic dermatitis
• Addressing rare diseases – developing Ilaris (canakinumab)
• Exploring therapeutic approaches against Hidradenitis suppurativa

10.15
Dermtech Adhesive Patch Biopsies For Non-Invasive Molecular Dermatology – A Novel Platform To Guide Dermatology Drug Development, Target Discovery & Microbiome Studies

Synopsis

  • Overviewing the characteristics and performance of the adhesive patch biopsy platform to non-invasively harvest skin samples for RNA, DNA, microbiome and other studies
  • Outlining how this platform is currently used by more than 5 leading pharmaceutical companies to assess and predict treatment responses, stratify patient populations and identify targets for a variety of inflammatory skin conditions, and conditions where the skin serves as a surrogate target organ
  • Understanding how our gene expression assays may be used to monitor response to biologic drugs targeting specific cytokines, by identifying patients with a specific cytokine profile that may respond to a particular drug therapy, thus facilitating drug development
  • Analysing products for psoriasis, psoriatic arthritis, atopic dermatitis and other conditions

10.25
Morning Refreshments & Networking

11.00
Psoriasis: The Shift in Treatment Paradigm in the Last 25 Years

  • Marie Bernasconi Senior Director & Head of Dermatology Therapeutic Area R&D, Almirall

Synopsis

• Analyzing innovative approaches to the treatment of psoriasis: New biologics, new pathways, biosimilar space
• Is there still an unmet medical need? – addressing the need for new oral or topical treatment and what the R&D effort to develop them looks like
• What are the patients’ expectations?

Enhancing the Clinical Development of Dermatology Therapeutics

11.30
Clinical Development: Pathways to Success or Failure

Synopsis

  • Clinical Development Pathways: NCEs vs. Life Cycle Management
  • Listening to Your Brain vs. Your Belly: The Virtues of Driving Development using Data Driven “Go-NoGo” Criteria
  • Approval is Nice; Goal is a Commercially Viable Asset: Optimal Clinical Development Mandates Real Time Integration of Market, Regulatory, Reimbursement, CMC and Other Factors
  • Balancing Competing Aspects of Regulatory, Scientific, Development and Financial Requirements with Commercial Expectations

12.00
New Horizons in Dermatology – Rare & Orphan Disease Drug Development Opportunities & Challenges

Synopsis

• Analyzing the recent expansion of interest in rare, orphan and ultra-orphan diseases and how dermatology represents an important therapeutic area that has recently been a focus for rare and orphan drug development
• Outlining external stakeholder perspectives on drug development for orphan diseases – discussing how sponsors and investors accurately perceive orphan diseases as tremendous unmet medical needs that can generate value as well as create strong patient impact, how activist organizations have pressured regulators, and how many physicians welcome the chance to provide treatments to previously untreatable patients
• Exploring the landscape of unique challenges and opportunities in dermatology drug development in rare and orphan diseases – discussing clinical and regulatory strategies, trial design, patient selection and enrolment, and endpoint selection
• Presenting reflections on recent experiences and future challenges

12.30
Lunch & Networking

13.30
Can Molecular & Machine Learning Bring Efficiency to Clinical Trials in Dermatology?

Synopsis

• Discussing the “assessment gap” between the moment a patient’s response to treatment is biologically determined and when a response can actually be determined clinically
• Addressing statistical models that estimate disease improvement at the molecular level, showing smaller placebo effect and superiority of the treatment groups as early as one month of treatment
• Building precision medicine algorithms that use gene expression or blood protein biomarkers from the first month of treatment, to evaluate the long term treatment response
• Exploring how the highly promising and encouraging results we obtained with our prediction tool in psoriasis emphasize the potential of molecular profiling coupled with machine learning and statistical techniques to accelerate and optimize the conduction of clinical trials

14.00
Challenges with Dermatology Clinical Study Endpoints

  • Monica Luchi former CMO & Executive VP , Immune Pharmaceuticals

Synopsis

• Understanding what is a meaningful clinical change
• Getting regulatory consensus on endpoints in rare diseases
• Accounting for inter-observer differences and subjectivity (mitigation strategies include BSA and PGA values)
• Addressing how comparing between trials can be difficult due to variability in assessments
• Considering differences in aggressive vs. more cautious tendencies in medication administration/tapering

14.30
Collaborative Efforts to Harmonize the Endpoints & Outcome Measures in Dermatological Diseases

Synopsis

• Delving into dermatology specific issues in clinical trials
• Understanding difficulties in meta-analysis
• Underlying the necessity of international harmonization

The Evolution of the Regulatory Environment in Dermatology Drug Development

15.00
Panel Discussion: Dermatology Drug Development – A Regulatory Paradigm Shift

Synopsis

• Discussing the regulatory perspective on the changing landscape in the dermatology space – new delivery mechanisms, new therapeutic approaches and new targets
• Are regulatory guidelines in tune with current developments?
• Aligning regulation worldwide

15.45
Afternoon Refreshments & Networking

Commercial Decision-Making in Dermatology

16.15
How to Win in the Competitive Market Place?

  • Dogan Fidan Head of Global Strategic Franchise, Immunology & Inflammation, Galderma

Synopsis

• Overviewing the changing dynamics in the global dermatology market
• Analyzing the evolving payer environment for biologic treatments
• Raising awareness for unmet needs and importance of disease impact on patients’ lives
• Winning over key stakeholders through right value proposition
• Evolving towards more patient centric marketing

16.45
Panel Discussion: Addressing the Overall Concern of Rising Treatment Costs in Dermatology

Synopsis

• Evaluating the need for better tools to describe why prescribing biological treatments is valuable – patient reported outcome tools that effectively show the improved outcomes with treatment
• Is the cost worth it? The need for raising awareness among stakeholders
• Defining better market access strategies in dermatology

17.30
Chairman’s Closing Remarks

  • Monica Luchi former CMO & Executive VP , Immune Pharmaceuticals