Monday, September 19 | 8:00 - 11:00 am
Medical Dermatology Therapeutic R&D and Technical Innovation: Understanding Mechanisms, Novel Targets and Pathways & Industry Case Studies – Part 1
Monday, September 19 | 12:00 - 3:00 pm
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
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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, a deeper understanding of novel targets and disease pathways, genetic discoveries, antibody drug development, advanced delivery technologies, and new predictive and diagnostic technologies being utilized both in the clinic and for translational research.
Despite the scientific opportunities, continued burden to patients with unmet medical needs, and growing market demand, there are hurdles for developing new therapies. So, where should companies focus their resources in order to bring new therapies to market and to the patients who need them? And, what are key challenges and special considerations of dermatological drug development?
Cambridge Healthtech Institute’s two-part “Medical Dermatology Therapeutic R&D and Technical Innovation” provides a platform to discuss and learn about novel targets, disease pathways and the most promising emerging therapies, and to then understand key challenges and special considerations of dermatology drug development.
Who Should Attend:
- Directors, Managers, Researchers, and Scientists from Pharma, Biotech, Academia, Regulatory, Government and Healthcare Organizations working in the area of Dermatology
- Researchers and Companies whose research and drug development in Oncology, Rheumatoid Arthritis, System inflammation, Inflammatory Disease, Immunology and Opthamology crosses over into Dermatology
- Physicians and Clinicians involved in clinical and translational research in Dermatology
- CROs and CMOs with a focus on Dermatology, skin characterization techniques providers, formulation and manufacturing vendors, consultants
- Innovator Companies from Biotech-Pharma-Diagnostic, 505b2 Companies, and Small-Virtual Pharma Working in Dermatological Drug Development
- Companies and individuals responsible for Partnering, licensing, investment and business development in dermatology
Presenters and Panelists:
- Hans Hofland, Ph.D., Vice President Research and Nonclinical Development, Dermira, Inc.
- 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.
- 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
Monday, September 19 | 8:00 - 11:00 am
Medical Dermatology Therapeutic R&D and Technical Innovation: Understanding Mechanisms, Novel Targets and Pathways & Industry Case Studies – Part 1
8:00 Chairperson’s Opening Remarks and Welcome
8:05 Lay of the Land: Novel Drug Development for Dermatology and Some Promising Pathways
Michael Sierra, Ph.D., Vice President, Head, LEO Science & Tech Hub USA, LEO Pharma
- The current and future treatments for skin diseases (e.g., psoriasis, eczema, AK/NMSC)
- The direction diagnostics are moving for predicting, monitoring and diagnosing skin disease
- Integrating data into the digital universe to empower patients
8:30 Biology of Skin Disease Mechanisms: Promising Pathways
M. Joyce Rico, M.D., MBA, Chief Medical Officer, Novan, Inc.
- 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
8:50 A New Therapeutic Approach to Control Aberrant Beta Catenin Signaling in Hyperproliferative Skin Disorders
Jack Leonard, Ph.D., Professor, Microbiology and Physiological Systems, UMASS Medical School
- The biology behind Psoriasis and inflammatory skin disease
- Identification of a novel and untapped therapeutic target for silencing the dys-regulated β-catenin signaling that drives hyperproliferation in skin disease
9:10 Topical Treatment of Hormonal Skin Aging: The 3rd Wave of Innovation
Yael Schwartz, Ph.D., CEO, Or-Genix Therapeutics, Inc.
- After the onset of menopause, women lose more than 30% of skin collagen rendering skin to become wrinkled and thin
- There has been nothing new and scientifically-validated to improve aging skin since the retinoids and alpha-hydroxy acids
- Smart chemical engineering can replace the estrogen that declined during menopause without risk of systemic exposure
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
9:50 Coffee Break
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?
10:55 Closing Comments
11:00 Part 1 of Course Ends, Part 2 Begins at 12:00 pm
Monday, September 19 | 12:00 - 3:00 pm
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
12:00 Chairperson’s Opening Remarks and Welcome
12:05 Biology of Skin Disease: Exploring New Mechanisms of Action & Understanding Internal/External Development Challenges
Hans Hofland, Ph.D., Vice President Research and Nonclinical Development, Dermira, Inc.
- Understanding the pathophysiology of inflammatory skin disease (acne, rosacea, psoriasis, atopic dermatitis)
- Exploring new pathways and mechanisms of action to treat these skin diseases
- Using new preclinical models to provide proof of mechanism in development of novel therapies
- Beyond the science, understanding internal (optimizing resources) and external challenges (payers and medical need, planning for regulatory hurdles) of dermatology drug development
- Choosing where to innovate: Some tips on making the decision in which programs and projects to invest
12:30 Drug Delivery into Skin: Early Formulation Considerations
Thean Yeoh, Ph.D., Associate Research Fellow, Pfizer
- Molecular properties for topical delivery and integration of topical delivery into compound selection funneling
- Research formulation versus commercial formulation: design consideration
- When to trigger commercial formulation development?
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)
1:25 Coffee Break
1:40 CMC, Formulation Development and Late Stage Clinical
Meng Zhou, Head, R&D, Contract Pharmaceutical Limited Canada
- You get your molecule, now what? API sourcing, Formulation Development, Tox batch/POC CTM supply, Non-clinical and POC study
- Phase I/II: CTM supply, Formulation Development to enhance penetration and delivery, building manufacturing process knowledge, tech transfer
- Phase III: Final formulation, CTM supply, tech transfer for future commercialization
- Special CMC consideration regarding 505(b)2
- Bioequivalence for topical generics
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
2:55 Closing Comments
3:00 Part 2 of Course Ends, CHI’s 14th Annual Discovery on Target continues through September 22
INSTRUCTORS:
Hans Hofland, Ph.D., Vice President Research and Nonclinical Development, Dermira, Inc.
Dr. Hans Hofland has over 20 years of experience in skin biology, drug discovery and medicines development in industry. Prior to joining Dermira as head of research and nonclinical development, Dr. Hofland was leading the Center for Skin Biology at Stiefel, a GSK company, where he was responsible for target identification and validation, and for the early development of novel compounds in the dermatology portfolio for a wide variety of indications. He has held leadership positions at various other companies, including Aventis, Optime Therapeutics, and Connetics. Over his career, Dr. Hofland was involved with 10 IND- and 8 NDA-filings. He earned his PhD in Pharmaceutical Sciences from the University of Leiden in the Netherlands, where he studied the interactions between topical drug delivery systems and human skin.
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Jack Leonard, Ph.D., Professor, Microbiology and Physiological Systems, UMASS Medical School
Dr. Jack Leonard is a senior scientist who, as a Principal Investigator, combined his expertise in Physiology, Biochemistry and Molecular Biology to develop a unique set of tools to explore the role of a newly discovered, key component of the Wnt/β-catenin Pathway in hyperproliferative skin disorders and cancer. This key regulator (β-catenin Regulatory Protein, BRP)controls β-catenin entry into the nucleus and is essential for early embryonic development. He formed a team of accomplished scientists to explore the therapeutic potential of BMP to treat hyperproliferative disorders using a family of BRP molecules capable of entering the cell (cell penetrating, cpBRP).
Krishna Menon, Ph.D., President and Chief Scientific Officer, Cellceutix Corporation
Dr. Krishna Menon has more than 25 years of experience in drug development with academia and industry. Dr. Menon is a co-founder of Cellceutix and has served as President and Director since inception in June 2007. Prior to Cellceutix, Dr. Menon served at Eli Lilly as Group Leader, Cancer In Vivo Research and Clinical Development. At Lilly, Dr. Menon played a key role in lead selection and pre-clinical development of Gemzar and Alimta, two anti-cancer drugs which have generated billions of dollars in yearly revenue. In addition, Lilly honored Dr. Menon with the prestigious President’s Recognition Award. Prior to Eli Lilly, Dr. Menon operated his own veterinary oncology and drug development consultancy practice. Earlier in his career, he held research scientist positions at Miles Laboratories and Dana Farber Cancer Research Institute, where he worked under the direction of Dr. Emil Frei, one of the world’s leader in medical research. Dr. Menon is a trained veterinary surgeon and holds a PhD in Pharmacology from Kerala University. His PhD work focused on anti-folate therapy.
M. Joyce Rico, M.D., MBA, Chief Medical Officer, Novan, Inc.
M. Joyce Rico, MD, MBA, is the Chief Medical Officer at Novan, Inc. located in Research Triangle Park, North Carolina. As the Chief Medical Officer, she leads the company’s clinical development programs. She received her MD from the University of Florida, and her MBA from DePaul University’s Charles H. Kellstandt Graduate School of Business. Dr. Rico is a board-certified dermatologist who has served on the faculty at the University of Miami, Duke University, New York University, and Northwestern University. She is a Fellow of the American Academy of Dermatology (FAAD), and serves on the Board of Directors for the American Dermatologic Association.
Yael Schwartz, Ph.D., CEO, Or-Genix Therapeutics, Inc.
Dr. Schwartz is President and CEO of Or-Genix Therapeutics, Inc., a private company focused on non-prescription and prescription dermatology products. She has more than 25 years of experience as a pharmaceutical scientist/manager/educator with advanced training in pharmacology, toxicology, human physiology and immunology. She has a proven track record of advancing small molecule therapeutics from discovery through NDA submission in multiple therapeutic areas. She has identified and in-licensed drug candidates in dermatology and women's health. She has identified and worked closely with thought leaders in respiratory, CNS, dermatology and women's health. As a founder and entrepreneur of multiple companies, she has raised private placement financing and Series A venture capital to initiate preclinical development of novel topical therapeutics in women's health and dermatology.
Michael Sierra, Ph.D., Vice President, Head, LEO Science & Tech Hub USA, LEO Pharma
Dr. Michael Sierra has more than 24 years of experience in drug discovery with industry. Dr. Sierra is head of LEO Pharma's newly created LEO Sience & Tech Hub in Boston. Prior to this position, Dr. Sierra headed the Translational Research and External Discovery functions at LEO Pharma where he built their extrernalization platform. Dr. Sierra also worked 10yrs at GSK's French Research Center outside of Paris. During Dr. Sierra's career, he has participated in identifying 21 clinical candidates. Dr. Sierra did his post doc with Francois Mathey at Ecole Polytechnique in France and earned his PhD in Chemistry from Wayne State University.
Thean Yeoh, Ph.D., Associate Research Fellow, Pfizer
Thean Yeoh, Ph.D. currently leads topical and transdermal product design and development for small molecules at Pfizer global R&D. He oversees topical formulation strategies to guide early compound selection through commercial formulation selection for development. He manages both external and internal scientific resources to support all phases of formulation related activities for topical NME’s. He is the company subject matter expert for topical and transdermal delivery.
Meng Zhou, Head, R&D, Contract Pharmaceutical Limited Canada
At CPL, Dr. Zhou leads a team of 35 scientists supporting numerous NDAs, ANDAs, and 505(b)2 development. He spent 15 years in the pharmaceutical industry in various research and development roles. He has extensive experience in drug delivery and formulation development, analytical development and validation, clinical trial supply manufacturing, process scale-up and commercialization. Prior to CPL, he worked at Patheon Inc., Endo Pharmaceuticals, and ALZA Corporation. Dr. Zhou earned his PhD in Pharmaceutical Science from University of Georgia and MS in Technology Management from Stevens Institute of Technology.
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