SC4: Medical Dermatology Therapeutic R&D and Technical Innovation: Understanding Mechanisms, Novel Targets and Pathways & Industry Case Studies - Part 1 CLICK for full agenda Skin is the largest organ and dermatology is a very unique Therapeutic Area (TA) with a breadth of indications. Now is a dynamic time for the prescription dermatological drug industry due to consolidation, rising demand for therapies, and a deeper understanding of novel targets and disease pathways. This two-part short course provides a platform to discuss and learn about key challenges and special considerations of dermatology drug development. Instructors: Jack Leonard, Ph.D., Professor, Microbiology and Physiological Systems, UMASS Medical School Krishna Menon, Ph.D., President and Chief Scientific Officer, Cellceutix Corporation Anne Parneix, M.D., Vice President, Therapeutic Area Head, Dermatology, Novartis Yael Schwartz, Ph.D., CEO, Or-Genix Therapeutics, Inc. Michael Sierra, Ph.D., Vice President, Head, LEO Science & Tech Hub USA, LEO Pharma Thean Yeoh, Ph.D., Associate Research Fellow, Pfizer Meng Zhou, Head, R&D, Contract Pharmaceutical Limited Canada
SC8: Medical Dermatology Therapeutic R&D and Technical Innovation: Early Formulation Considerations, Utilizing New Tech for Med Derm R&D, CMC, Formulation Development and Late Stage Clinical - Part 2 CLICK for full agenda Skin is the largest organ and dermatology is a very unique Therapeutic Area (TA) with a breadth of indications. Now is a dynamic time for the prescription dermatological drug industry due to consolidation, rising demand for therapies, and a deeper understanding of novel targets and disease pathways. This two-part short course provides a platform to discuss and learn about key challenges and special considerations of dermatology drug development. Instructors: Jack Leonard, Ph.D., Professor, Microbiology and Physiological Systems, UMASS Medical School Krishna Menon, Ph.D., President and Chief Scientific Officer, Cellceutix Corporation Anne Parneix, M.D., Vice President, Therapeutic Area Head, Dermatology, Novartis Yael Schwartz, Ph.D., CEO, Or-Genix Therapeutics, Inc. Michael Sierra, Ph.D., Vice President, Head, LEO Science & Tech Hub USA, LEO Pharma Thean Yeoh, Ph.D., Associate Research Fellow, Pfizer Meng Zhou, Head, R&D, Contract Pharmaceutical Limited Canada
9:30 Prurisol, a New Small Molecule to Treat Psoriasis, Completed Phase 2 Trial and now Geared up for Phase 3 Krishna Menon, Ph.D., President and Chief Scientific Officer, Cellceutix Corporation • Strategy and science behind breakthrough oral small molecule, which is an immune-modulator affecting IL-20 and PRINS • Lessons from discovery and early development, opening up a new pathway to treat psoriasis • Obtaining a 505B(2) pathway; Key challenges and lessons on how this innovative small molecule was developed
INTERACTIVE PANEL DISCUSSION WITH PRESENTERS, PANELISTS AND ATTENDEES 10:05 Understanding Mechanisms, Novel Targets and Pathways to Further Novel Therapeutic Development in Dermatology Moderator: Michael Sierra, Ph.D., Vice President, Head, LEO Science & Tech Hub USA, LEO Pharma Panelists: Jack Leonard, Ph.D., Professor, Microbiology and Physiological Systems, UMASS Medical School Krishna Menon, Ph.D., President and Chief Scientific Officer, Cellceutix Corporation M. Joyce Rico, M.D., MBA, Chief Medical Officer, Novan, Inc. Yael Schwartz, Ph.D., CEO, Or-Genix Therapeutics, Inc. Thean Yeoh, Ph.D., Associate Research Fellow, Pfizer Meng Zhou, Head, R&D, Contract Pharmaceutical Limited Canada • The current and future treatments for skin diseases (e.g., psoriasis, eczema, AK/NMSC): Where will the opportunities be for innovation? • Understanding Mechanisms, Novel Targets and Pathways in: Inflammatory Skin Diseases (acne, rosacea, psoriasis, atopic dermatitis, eczema); Cancer and Pre-Cancers of the Skin (SCC, BCC, AK, non-melanoma); and Scleroderma and Other Orphan Skin Diseases • What are we learning about Autoimmune Diseases in Dermatology and what does this mean for new therapies? • What are some business models for this Therapeutic Area (biotech approach, big pharma approach, repurposing, out/in-licensing, public-private partnerships, managing a dual portfolio of Rx+Cosmeceuticals) and how do you evaluate them?
12:55 Utilizing New Tech for Med Derm Research and Development Krishna Menon, Ph.D., President and Chief Scientific Officer, Cellceutix Corporation • Biomarkers, Diagnostics, Imaging • Target Engagement • Skin Pharmacokinetics (PK)
INTERACTIVE PANEL DISCUSSION WITH PRESENTERS, PANELISTS AND ATTENDEES 2:10 Understanding Key Challenges and Special Considerations of Dermatology Drug Development Moderator: Yael Schwartz, Ph.D., CEO, Or-Genix Therapeutics, Inc. Panelists: Hans Hofland, Ph.D., Vice President Research and Nonclinical Development, Dermira, Inc. Krishna Menon, Ph.D., President and Chief Scientific Officer, Cellceutix Corporation Michael Sierra, Ph.D., Vice President, Head, LEO Science & Tech Hub USA, LEO Pharma Thean Yeoh, Ph.D., Associate Research Fellow, Pfizer Meng Zhou, Head, R&D, Contract Pharmaceutical Limited Canada • Understanding challenges specific to the disease and the application • Early formulation considerations & utilizing new tech for med derm R&D • CMC, formulation development and late stage clinical considerations • Choosing where to innovate: Making the decision in which programs and projects to invest
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