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Speakers

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Anton Stuetz
Founder and CEO
Pharma R&D Consulting Stuetz GmbH & Akribes Biomedical GmbH

Dr. Stuetz is Founder and CEO of Pharma R&D Consulting Stuetz GmbH since 2014 and Co-Founder and Co-CEO of Akribes Biomedical GmbH since 2015. He has been Executive Director Dermatology within the Novartis Institutes for BioMedical Research, located in Vienna, Austria, until July 2013. Dr. Stuetz studied chemistry and physics at the University of Vienna 1965 –1972 and has a PhD in Organic Synthesis. After a post-doctoral fellowship in molecular biology at the Max Planck Institute for Biophysical Chemistry, Goettingen, Germany, he joined the Sandoz Research Institute Vienna, Austria, as head of laboratory in 1974. Dr.Stuetz invented terbinafine (Lamisil®) in 1980, which after development and worldwide launch 1991-1997 has become the global standard for the oral and topical treatment of fungal infections of the skin and nail. 1986 Dr.Stuetz took over responsibility to establish dermatology research within Sandoz. In his department the topical calcineurin inhibitors, including the use of topical tacrolimus (Protopic®) for treatment of skin diseases were pioneered, pimecrolimus (Elidel®) invented and its pharmacological profile established. Protopic and Elidel have become the first therapeutically effective and registered topical non-steroids for treatment of atopic dermatitis. 1994 Dr.Stuetz was appointed professor of pharmaceutical chemistry at the University of Vienna. He is the author/coauthor of 93 publications, 180 abstracts and 40 patents in the fields of synthetic and medicinal chemistry, antifungal chemotherapy, immunology, inflammation, dermatology and translational research. He is frequently invited speaker at international congresses and at universities. 2004 Dr.Stuetz received the Erwin Schroedinger Preis by Austria´s Academy of Sciences. Dr.Stuetz served as member of the Board of Directors of the Society for Investigative Dermatology 2005-2010. 2011 Dr.Stuetz received the Eugene J.Van Scott Award for Innovative Therapy of the Skin and Philipp Frost Leadership Lecture by the American Academy of Dermatology.

Betsy Hughes-Formella
Independent Consultant, Dermatological Drug Development

Dr. Betsy Hughes-Formella is a strategic and clinical consultant for dermatological product development of NMEs, known or re-purposed molecules, and generics. She has more than 25 years of experience in clinical development of topical products and transdermals over a wide range of indications including psoriasis, atopic dermatitis, acne, rosacea, fungal and viral infections, pain, wound healing, and aesthetic products. Prior to providing independent consulting services to the global pharmaceutical and CRO industry, Dr. Hughes-Formella held a management position in a niche CRO specialized in conduct of early phase dermatological studies. There she had hands-on experience with the design and conduct of dermal safety and efficacy studies in all phases and played a key role in consultation of clients in early clinical development. She now concentrates on advice for developing and executing the most efficient pathway for dermal products through early development to proof-of-concept or licensing, helping companies to reach critical milestones while mitigating risks. Dr. Hughes-Formella received her PhD in physiology from the University of Georgia in Athens, GA. She spent nearly a decade in basic research in the areas neuromuscular physiology/steroid biochemistry and then melanoma research before shifting her focus to skin physiology and clinical research.

Bill Bosch
Executive Director & CSO
Botanix Pharmaceuticals

Bill Bosch is an executive board director and Chief Scientific Officer at Botanix Pharmaceuticals, a clinical stage dermatology company listed on the Australian stock exchange. Bill has also held the role of CSO at Churchill Pharmaceuticals and iCeutica Inc, both based in suburban Philadelphia, USA. Much of his career has focused on the development novel fine particle technologies for oral delivery of poorly water-soluble drugs, including SoluMatrix Fine Particle Technology™ and NanoCrystal® Technology. He is an inventor of eight prescription drug products approved by the U.S.F.D.A. Bill received his Ph.D. degree in chemistry from the University of Pennsylvania.

Day Two

Thursday 13th December 2018

10:00 am | Topical Formulations of Cannabidiol for the Treatment of Acne, Atopic Dermatitis, & Psoriasis

Carlo Pincelli
Professor of Dermatology & CEO
University of Modena and Reggio Emilia, PinCell

Carlo Pincelli is Professor of Dermatology at the School of Medicine and Biotechnology, and Director of Research at the Laboratory of Cutaneous Biology, University of Modena and Reggio Emilia, Italy. He has been President of the European Society for Dermatological Research (ESDR), and is currently President of the European Dermatology Forum (EDF). He has published in areas including keratinocyte biology, skin neurobiology and autoimmune skin diseases. Professor Pincelli is Faculty member in the course “Entrepreneurs in Clinical Academia” (Insead, Fontainebleu). He is the inventor of four international patents, and founder of PinCell srl, which aims to research and develop novel treatments for skin diseases.

Day One

Thursday 13th December 2018

2:05 pm | Addressing The Medical Need for Pemphigus: A New Biologic

Charles Evans
Vice President of Pharmaceutical Development
MedPharm

Charles Evans has been with MedPharm for over 10 years as part of the formulation and analytical development teams and leads MedPharm’s rigorous approach to developing formulations from proof of concept to robust commercial products. He has many years expertise in all types of topical, inhalation and transdermal formulations and played a key role in the development of MedPharm’s proprietary MedSpray® technology currently under license to customers to enhance their products' performance.

Day One

Thursday 13th December 2018

9:45 am | Topical Formulation Development: Boosting Your Success

Dhaval Patel
Executive Vice President & CSO
UCB

Dhaval Patel leads UCB’s research organization with the main goal of bringing scientific innovation to patients and helping them live the life they choose. Dhaval Patel is a medical doctor and holds a PhD in Microbiology and Immunology. He comes to UCB from Novartis, based in their headquarters in Basel, Switzerland, where for 11 years he led various biomedical research teams in areas of neurology, autoimmunity, transplantation and inflammation. In 2010, he became the Head of Research for the Novartis Institutes for BioMedical Research (NIBR) Europe. For 12 years prior to crossing into industry, Dhaval made a strong mark in the halls of academia and research, specifically at Duke University Medical Center and the University of North Carolina (UNC) at Chapel Hill in North Carolina in the US. He authored and co-authored over 100 thought-leading publications and presentations. He is a member of UCB’s Executive Committee.

Day One

Thursday 13th December 2018

9:00 am | Opening Keynote Panel Discussion: What’s Next in Dermatology Drug Development?

Deborah Ramsdell
Head of Regulatory & Clinical Operations
Wings Therapeutics

Deborah Ramsdell has 30 years of experience in executive management and consulting roles in early and mid-stage biopharmaceutical companies. Over the course of her career, she has been responsible for the strategic design, leadership and operational oversight of multiple drug candidates in the fields of oncology, rare metabolic diseases, dermatology, pain, infectious diseases, transplantation, cardiology, renal diseases, and endocrinology. She is currently working with Wings Therapeutics to transition the operational aspects of their lead program from ProQR.

Day One

Thursday 13th December 2018

3:05 pm | Treating Epidermolysis Bullosa by Removing Mutations from The RNA

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

Dogan Fidan is currently the Head of Global Strategic Franchise Immunology and Inflammation at Galderma. He has over 20 years of experience in pharma, public agencies & academia. Prior to joining Galderma, he spent 13 years in Sanofi holding senior corporate roles in commercial, market access, and medical affairs organizations. He also spent four years at NICE in the UK, where he acted as a technical lead in health technology appraisals. He is a Doctor of Medicine (MD), holds a PhD in Public Health, MSc in Health Economics, and MBA.

Day Two

Thursday 13th December 2018

1:30 pm | Panel Discussion: The Evolving Clinical, Regulatory & Commercial Paradigm in Dermatology

Elena Rizova
Vice President & Head of Medical Affairs Immuno Inflammation
Sanofi

Dr Rizova is a Physician and holds a PhD in Immunology and Diploma in Pharmacoeconomy. She has a 24 years of experience in biopharmaceutical industry mainly in international drug development from early clinical development to launch on a background of clinical medicine & basic science research. This experience stemmed from a broad-based role in several Pharma Companies, in which she developed the capabilities of working and leading multi-disciplinary team integrating Research and Development, Medical Affairs, Clinical operations, Regulatory affairs, Pharmacovigilance etc. Through her career, Elena has hold variety of positions with increasing responsibility in R&D and Medical Affairs in Galderma, Biogen, 3M Pharmaceuticals, Johnson & Johnson and Sanofi Genzyme. During her career, Dr Rizova worked in various regions of the Globe such as Europe, Asia, USA Her main focus was the development of the company Medical Affairs strategy across several therapeutic areas. While being in Asia, Dr Rizova was heading the Asia Pacific Innovation Center Johnson & Johnson. Dr Rizova joined Sanofi in 2015 as Head of Global Medical Affairs for Immunology Franchise and still work in this capacity based in Cambridge, MA, US.

Day Two

Thursday 13th December 2018

2:15 pm | Overviewing The Latest Advances in Biologic Therapies in Dermatology

Ernst Kriehuber
Vice President - Translational Sciences
Glenmark Pharmaceuticals

Ernst Kriehuber received his MD degree from Medical University Vienna. He worked with Peter Elias (UCSF) on the permeability barrier of the skin and with Georg Stingl (Medical University Vienna) and Giulio Superti-Furga (CeMM) on immunemechanisms in skin inflammation. Ernst has joined Glenmark Pharmaceuticals in September 2018 and is currently Vice President of Translational Sciences. Before, Ernst has held different positions in discovery and translational research within Novartis. Among others, Ernst has led a Novartis Institutes for BioMedical Research site dedicated to dermatologic drug discovery in Vienna, Austria, before joining the companies’ headquarters in Basel, Switzerland. In Basel, Ernst has contributed to strategic outlines of NIBR’s dermatology and respiratory TA and DA strategies and was part of leadership teams and decision boards. In addition, Ernst was leading teams of translational and computational biologists to explore novel indications and druggable nodes in dermatology and other therapeutic areas.

Day One

Thursday 13th December 2018

11:15 am | Translational Data to Guide Clinical Development & Target Discovery

9:00 am | Opening Keynote Panel Discussion: What’s Next in Dermatology Drug Development?

Felicitas Thom
Director, Project Management in Autoimmunity,
Transplantation & Inflammation
NIBR

Working for more than 20 years in clinical and pre-clinical development. Starting her carrier in the operational field of clinical studies as field monitor, continuing with managing clinical studies from phase I- IV in the fields of dermatology, gynecology and pain, but also autoimmune diseases such as IBD and respiratory. From 2016 – 2018 she was the Clinical Science and Operations Head being responsible for all NIBR studies in the field of Dermatology, Celltherapy and muscoskeletal diseases. She recently joined the Disease Area Autoimmunity, Transplantation and Inflammation, where she co-leads the Project Management group, focusing on early drug development projects within ATI, portfolio management tasks and the liaison to program and portfolio management groups in NIBR. Felicitas holds a master degree in biology and a Ph.D. in biochemistry from the University of Cologne, Germany.

Day One

Thursday 13th December 2018

5:20 pm | Innovative Trial Design to Determine Early Efficacy of Drugs in Translational Medicine at Novartis

Gavin Jeffries
Chief Technology Officer
Fluicell AB

Founder and CTO of Fluicell AB, Gavin D. M. Jeffries has a PhD in Chemistry from the University of Washington (Seattle, USA) on control & manipulation of femtoliter droplets for the study of single cell reactions & nanochemistry. Before joining Fluicell as a CTO in 2017, Gavin was Assistant Professor at Chalmers University of Technology (Gothenburg, Sweden) for 4 years and has published over forty peer reviewed scientific publications, with a total citation count of over a thousand. Entrepreneur/founder of two biotech and optics companies, inventor of multiple patents and technologies, Gavin has a strong background in microfluidics, single-cell analysis and optical platform integration.

Day One

Thursday 13th December 2018

1:55 pm | Advancing Bioprinting to the Level of Individual Cells

Isabella Andreini
Senior Scientist, Expert in Immunology & Biomarkers
RTC

Isabella is a Senior Scientist, Expert in Immunotoxicology at RTC. She’s a registered Toxicologist (ERT), a Veterinary Doctor with specialization in Animal Health and PhD in Toxicology. She has worked for 9 years in basic research in Italy, US, Germany Academia. In 1997 she joined RTC where presently assists Sponsors to design the preclinical development of biologics, supervises all bioanalytical activities of large molecules and acts as Project leader of projects of biologicals. Isabella is the author of >70 presentations, posters, publications.

Day One

Thursday 13th December 2018

12:45 pm | Preclinical Toxicology for Wound Healing Therapies: Animal Models & Analysis

Jakob Felding
Director, Skin Research
LEO Pharma A/S

Dr. Felding has 20 years of drug discovery experience. During this time he has worked in both midsize pharma companies and biotech. He has been involved in a variety of research topics such as target identification, target validation, hit identification technologies, medchem design, drug candidate selection, pipeline management and open innovation. Currently he is director of Skin Research at LEO pharma, which is a biology function responsible for providing expert biology input across the pipeline projects and pre-clinical biology support from the early idea phase up to proof-of-concept in man. In addition, he is member of the management team in the Research organization at LEO Pharma. Dr. Felding has co-authored 44 publications and is a co-inventor of 32 patents.

Day One

Thursday 13th December 2018

11:45 am | Application of a Translational in Vitro Assay Platform for Selection of a Highly Selective JAK1 Inhibitor

Jean-François Ginglinger
CSO
Temisis Therapeutics

With a PhD in cell and molecular biology, Dr. Jean-François Ginglinger has worked as a scientist at the CNRS in Strasbourg for 6 years elucidating metabolic pathways and studying the catalytic activity of enzymes and their role in the cell and in ecology. He joined PAT in 2013 as Global R&D Partnerships Manager as well as Pharmaceutical API Development Manager. During his missions, he succeeded at establishing public-private consortiums, and led the development of pharmaceutical drug candidates in neurology and anti-inflammation. He is since October 2018 CSO of Temisis.

Day One

Thursday 13th December 2018

2:35 pm | TEM1657 – A Novel Small Molecule Approach Targeting Psoriasis

Kendall Marcus
Director of the Division of Dermatology and Dental Products
FDA

Kendall Marcus is the Director of the Division of Dermatology and Dental Products at FDA and a board-certified specialist in Infectious Diseases. Dr. Marcus first joined the FDA as a Medical Officer in the Division of Antiviral Products (DAVP) in 2000. She served in DAVP as a Medical Team Leader from 2003-2009 and then as the Deputy Director of Safety from 2009-2014 before joining DDDP as Director in 2014. She received a B.S. from University of Maryland at College Park and an M.D. from the University of Maryland School of Medicine.

Day One

Thursday 13th December 2018

4:35 pm | Product Development in Dermatology

Lee Heeson
President - Worldwide Markets, Inflammation & Immunology
Celgene Corporation

Lee Heeson assumes the responsibility for the commercial operations for the Inflammation & Immunology franchise at Celgene, a global biopharmaceutical company focusing on the discovery, development and commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions. While Lee’s primary responsibility is to ensure the successful commercialization of Celgene’s therapies in the inflammation and immunology space, Lee is keen on working collaboratively with all stakeholders on innovative solutions to overcome the challenges of our health systems and ensure that every patient has access to the right therapy at the right time. Prior to his current role, Lee has held several leadership positions in various pharmaceutical companies, working across multiple therapeutic areas and geographies, including Europe, Latin America, the United States and Japan.

Day Two

Thursday 13th December 2018

1:30 pm | Panel Discussion: The Evolving Clinical, Regulatory & Commercial Paradigm in Dermatology

11:15 am | Begin with the End in Mind

Ofer Toledano
Vice President, R&D
Sol-Gel Technologies

Dr. Ofer Toledano has served as Sol-Gel’s vice president of research and development since 2004. Prior to joining Sol-Gel, Dr. Toledano served as manager of the formulation department at ADAMA Agricultural Solutions Ltd. (formerly known as Makhteshim Agan Industries Ltd.), an Israeli manufacturer and distributor of crop protection products from 1998 until 2004. Dr. Toledano holds a Ph.D. in chemistry from The Hebrew University of Jerusalem, Israel.

Day Two

Thursday 13th December 2018

9:00 am | New Topical Drugs Having a Novel Silica-Based Delivery System

Paul Lizzul
Chief Medical Officer
Sienna Biopharmaceuticals

Paul F. Lizzul, M.D., Ph.D., M.P.H., M.B.A. is Chief Medical Officer of Sienna Biopharmaceuticals. Sienna is clinical-stage biopharmaceutical company focused on bringing innovations in biotechnology to the discovery, development and commercialization of first-in-class, targeted, topical products in medical dermatology and aesthetics. Our objective is to progress a multi-asset pipeline of safe and effective topical therapies that enhance the health, appearance and quality of life of dermatology patients. Dr. Lizzul previously served as Senior Medical Director, Head of Safety, and program lead for setipiprant (PGD2 inhibitor for AGA) at Kythera until it was acquired by Allergan in 2015. Prior to joining Kythera, Dr. Lizzul served as an Assistant Professor of Dermatology and Associate Director of Clinical Research at the Tufts University School of Medicine where he conducted investigator-initiated and industry sponsored clinical trials in inflammatory skin diseases (psoriasis). Dr. Lizzul has authored articles in [academic] journals on topics including inflammation, psoriasis, aesthetics (Kybella) and health care reform. Dr. Lizzul is a diplomat of the American Board of Dermatology and a faculty member of the American Academy of Dermatology and previously served on the FDA’s Dermatology and Ophthalmic Drugs Advisory Committee. Dr. Lizzul is a volunteer member of the teaching faculty in the Department of Dermatology at University of California, Los Angeles School of Medicine. Dr. Lizzul completed his post-graduate medical internship at Greenwich Hospital, Yale University School of Medicine and his dermatology residency at the University of California Davis, where he was appointed chief resident. Dr. Lizzul earned his B.S. in Biology from Rensselaer Polytechnic Institute, and an M.D., Ph.D. in Molecular Genetics and Microbiology and M.P.H. in Epidemiology/Outcomes from the Rutgers/Robert Wood Johnson Medical School. Dr. Lizzul also earned an M.B.A. in Entrepreneurship from the Rutgers Business School.

Day One

Thursday 13th December 2018

6:20 pm | Chair’s Closing Remarks

3:35 pm | Bridging the Innovation Gap in the Treatment of Mild to Moderate Dermatological Diseases

8:45 am | Chair’s Opening Remarks

Day Two

Thursday 13th December 2018

2:45 pm | Chair’s Closing Remarks

8:50 am | Chair’s Opening Remarks

Rasmus Hogreffe
Head of Virtual Clinical Trials
LEO Innovation Lab

Rasmus Hogreffe joined the Leo Innovation Lab in January 2019 and is currently the Team Manager of the Virtual Clinical Trial project, with the main goal of improving treatment for patients, by making trials better and faster than ever before, using digital and remote innovations. He holds a Master in Medical Science (MSc. Medicine) from Aalborg University, Denmark and has, since 2010, been working in the healthcare industry in various positions within clinical research & development. Rasmus has extensive experience in the pharmaceuticals industry both within marketing, medical market access, HEOR, project management, sites-optimization, and study-start up. Rasmus has been involved in more than 40 clinical trials, giving him a broad knowledge regarding every aspect of clinical research.

Day One

Thursday 13th December 2018

5:50 pm | Digitisation of Dermatology - Is It Happening?

Robert Rissmann
Research Director Dermatology
Center for Human Drug Research

Dr. Robert Rissmann is a pharmacist (Berlin, Germany) and clinical pharmacologist (Leiden, NL). He obtained his PhD in skin pharmacology (2009) and has been working at the Centre for Human Drug Research, a full service CRO, in Leiden, NL since 2010. His main interest is on translational models in both immunology and dermatology for drug development in early phase clinical research. He is board member of the Dutch Society of Clinical Pharmacology and Biopharmacy. In 2015 he was appointed Associate Professor at Leiden University Medical Centre. He has published over 40 manuscripts in peer-reviewed journals and is currently heading the research group Skin Pharmacology at CHDR. Key collaborations entail academic partners via national and international projects as well as small biotech start- ups and big pharmaceutical companies for phase 1 and phase 2 trials.

Silvio Traversa
CSO
Sienna Biopharmaceuticals

Silvio was born in Ivrea (Italy) on November 25, 1969. He was granted a Degree in Chemistry in 1994, and a PhD in protein Chemistry in 1998. Silvio joined Serono (Drug Delivery Systems unit) in 1999, where he eventually became Head of the Protein Analysis and Peptide Synthesis Lab. In 2005, he joined Creabilis as Head of Discovery, and then Chief Scientific Officer. In 2010, Silvio attended the ‘Leadership and Strategy in Pharmaceuticals and Biotech’ at the Harvard Business School. Silvio is currently CSO at Sienna Biopharmaceuticals, which he joined in 2016 after the acquisition of Creabilis by Sienna on Dec 6, 2016.

Day One

Thursday 13th December 2018

9:00 am | Opening Keynote Panel Discussion: What’s Next in Dermatology Drug Development?

Day Two

Thursday 13th December 2018

9:30 am | The Topical-by-Design Technology - Defying Conventional Wisdom

Sonia Quaratino
CMO
Kymab

Dr. Sonia Quaratino joined Kymab in 2017 as Chief Medical Officer, responsible for the clinical strategy and execution of Kymab’s first-in-class and innovative programs in immunology and immuno-oncology through pre-clinical and early stage clinical trials. Dr. Quaratino brings to Kymab over 25 years of experience in industry and academic research with a broad experience as a clinical leader developing both cancer vaccines, small molecules and antibodies for solid and haematological malignancies. Before Kymab, Dr. Quaratino served as Global Clinical Program Leader at Novartis in Basel , developing early phase immuno-oncology programs including antibody therapeutics for solid tumours. Prior to that, she was Senior Medical Director in Oncology Early Clinical Development and Advisor in Immunology at Merck Serono in Darmstadt where she led Phase 1 and Phase 2 oncology and immuno-oncology clinical trials. Dr. Quaratino is also an accomplished scientist, having served as Professor in Immunology at the University of Southampton, her primary research focus was on the molecular and cellular mechanisms underlying the pathogenesis of chronic immune mediated diseases. Dr. Quaratino received her M.D. from the University of Palermo School of Medicine, completed her doctorate in haematology and oncology between the University of Palermo and Imperial College London and was awarded a PhD in Immunology at Imperial College.

Day One

Thursday 13th December 2018

12:15 pm | OX40L: A New Target in the Treatment of Dermatological Diseases?

9:00 am | Opening Keynote Panel Discussion: What’s Next in Dermatology Drug Development?

Volker Koscielny
Vice President, Global Medical Affairs, Inflammation & Immunology
Celgene Corporation

Volker Koscielny trained as a doctor at the Charite (Berlin) and practiced internal medicine in his native Germany. He holds a doctorate in Neuropathology and an MBA from the University of Durham (UK). Before joining Celgene as the head of Medical Affairs Europe, Middle East and Africa, Volker worked in several pharmaceutical companies in positions of increasing seniority in the UK, France and South Africa. His responsibilities in his current position include in particular post –marketing research and real world evidence generation.

Day Two

Thursday 13th December 2018

11:15 am | Begin with the End in Mind