PART I
THE MEDICAL DERMATOLOGY FEBRUARY 5-7, 2021 Summit
CONFERENCE GUIDE
DELIVERING THE PREMIER EVENT IN MEDICAL DERMATOLOGY STRAIGHT TO YOU
WELCOME tter
Dear Participants,
Le
Welcome to the first half of the 19th Annual South Beach Symposium— SBS Part I: The Medical Dermatology Summit. In so many ways, this year’s conference is our most transformative and unparalleled yet. To begin, this marks the first year that SBS will be delivered by LiVDerm, a leading medical education hub dedicated to revolutionizing dermatology education. Additionally, for the first time ever, the Annual South Beach Symposium will be delivered in two distinct parts: SBS Part I: The Medical Dermatology Summit (delivered 100% online) and SBS Part II: The Aesthetic Dermatology Summit (delivered in-person). These new changes have allowed us to dive deeper than ever before into the topics that most interest our broad community of practitioners. Subsequently, you’ll notice that this event will provide an expansive view on all the latest updates, trends, and strategies available in medical dermatology. With frontline expertise from renowned clinical authorities, participants will examine a wide array of topics including the impact of COVID-19 on the dermatology industry, skin of color, cutaneous oncology, hair restoration, and much more. The field of medical dermatology is continuously adapting and clinicians seeking to deliver top-tier, effective care must always stand ready to integrate the latest knowledge into practice. Of course, with the added challenges and complexities of providing care during a global pandemic, the events of the past year have only increased the pace of change and advancement. With a steadfast commitment to provide the most cutting-edge, clinically relevant, and practically actionable knowledge in dermatology, this event meets the current moment many clinicians find themselves in with real solutions. As we enter a new season, we welcome you and our entire community of clinicians to adapt and grow with us as we navigate the many new challenges and exciting opportunities our industry faces ahead, with the continued skillful leadership that South Beach Symposium has long been known for. On behalf of the entire LiVDerm Team, thank you for your time and dedication to advancing dermatological wellness. In Good Health, The LiVDerm Team
TABLE OF
Contents
Welcome Letter
2-3
Schedule-at-a-Glance - SBS
4–8
Expert Speaker Line-Up - SBS
10 – 12
CE Symposia Listing
13 - 14
Sponsors 15 Accreditation
16 - 25
Association & Media Partners
27
Professional Poster Sessions
28
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SCHEDULE AT A GLANCE FRIDAY February 5, 2021 1:45 PM - 1:45 AM
Opening Remarks Mark Nestor, MD, PhD
1:45 PM - 2:00 PM
Medical Dermatology in the Age of COVID19 Leon Kircik, MD
2:00 PM - 2:15 PM
Telehealth vs. Patient Visits Mark Kaufmann, MD vs. Linda Stein Gold, MD
2:15 PM - 2:30 PM
New Coding for 2021 Mark Kaufmann, MD
2:30 PM - 2:45 PM
Breaking News in Skin Cancer Darrell Rigel, MD
2:45 PM - 3:00 PM
Treating Inflammatory Diseases Amy McMichael, MD
3:00 PM - 3:15 PM
Panel Discussion | Q&A All Faculty
3:15 PM - 3:30 PM
Exhibit Break
Hair Restoration for the Dermatologist Session Director: Glynis R. Ablon, MD, FAAD
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3:30 PM - 3:45 PM
Keys to Patient Satisfaction + Compassion, Compliance & Results Glynis R. Ablon, MD, FAAD
3:45 PM - 4:00 PM
Etiology and Pathophysiology of Hair Loss Antonella Tosti, MD
4:00 PM - 4:15 PM
Hair Restoration & Diverse Patient Populations - Pearls and Pitfalls Valerie Callender, MD
4:15 PM - 4:30 PM
The Female Patient: Hair Loss Risk Assessment + Testing Glynis R. Ablon, MD, FAAD
4:30 PM - 4:45 PM
The Male Patient with Androgenetic Alopecia Marc Avram, MD
4:45 PM - 5:00 PM
Pros and Cons of Oral Therapy for Androgenetic Alopecia Marc Avram, MD
5:00 PM - 5:15 PM
Effect on Hormones and Hair Loss Diane Berson, MD
5:15 PM - 5:30 PM
Panel Discussion / Q&A All Faculty
SCHEDULE AT A GLANCE SATURDAY February 6, 2021 Medical Derm Therapeutic Toolkit Session Director: Leon Kircik, MD 8:00 AM - 8:10 AM
Treatments for Wounds Robert Kirsner, MD
8:10 AM - 8:20 AM
Off Label Rxing Linda Stein Gold, MD
8:20 AM - 8:30 AM
Melasma - Step by Step Seemal Desai, MD
8:30 AM - 8:45 AM
Panel Discussion | Q&A All Faculty
Acne & Rosacea Bootcamp Session Director: James Q. Del Rosso, DO 8:45 AM - 9:00 AM
Top Acne Treatments 2021 James Q. Del Rosso, DO
9:00 AM - 9:15 AM
Let the Oral Therapy Debate Begin Diane Berson, MD
9:15 AM - 9:30 AM
Rosacea: What is New Linda Stein Gold, MD
9:30 AM - 9:45 AM
Let the Oral Therapy Debate Begin Diane Berson, MD
9:45 AM - 10:00 AM Exhibit Break Diversity in Derm Treatments: Skin of Color Symposium, in partnership with the Skin of Color Society Session Director: Amy McMichael, MD Supported by educational grants from Galderma and Incyte. 10:00 AM - 10:15 AM Clinical and Aesthetic Approaches to Melasma Amy McMichael, MD 10:15 AM - 10:30 AM How to Approach Post-Inflammatory Hyperpigmentation Valerie Callender, MD 10:30 AM - 10:45 AM Aesthetic Procedure Safety and Nuances Seemal Desai, MD 10:45 AM - 11:00 AM Panel Discussion | Q&A All Faculty
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SCHEDULE AT A GLANCE SATURDAY February 6, 2021 The Logic in Biologics Session Director: Leon Kircik, MD 11:00 AM - 11:20 AM Biologics and Psoriasis Mark Lebwohl, MD 11:20 AM - 11:30 AM Biologics and Hidradenitis Suppurativa Alice Gottlieb, MD 11:30 AM - 11:40 AM New Dermatologic Uses for Biologics David Cohen, MD 11:40 AM - 11:50 AM Panel Discussion | Q&A All Faculty 11:50 AM - 12:00 PM Exhibit Break CE Symposium: Clinical Update: Novel Agents for the Long-Term Management of Moderate-to-Severe Atopic Dermatitis Session Director: Linda Stein-Gold, MD, PhD Faculty: Andrew Alexis, MD and Peter Lio, MD Supported by educational grants from Incyte Corporation and Pfizer 12:00 PM - 12:15 PM Introduction, Pre-Survey, AD Overview Linda Stein Gold, MD, Peter Lio, MD 12:15 PM - 12:45 PM New and Emerging Therapies for AD Linda Stein Gold, MD, Peter Lio, MD, Andrew Alexis, MD 12:45 PM - 12:55 PM Expert Perspectives and Panel Discussion: Interpreting New Advances in Moderate-to- Severe AD Linda Stein Gold, MD, Peter Lio, MD, Andrew Alexis, MD 12:55 PM - 1:00 PM
Conclusions and Audience Q&A Linda Stein Gold, MD, Peter Lio, MD, Andrew Alexis, MD
I’ve Been Waiting for This My Whole Derm Life Session Director: Brian Berman, MD, PhD
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1:00 PM - 1:10 PM
Innovations in Actinic Keratoses and NMSC therapy Brian Berman, MD, PhD
1:10 PM - 1:20 PM
What is New in Excessive Sweating Dee Anna Glaser, MD
1:20 PM - 1:30 PM
Treatment for Scars Jill Waibel, MD
1:30 PM - 1:45 PM
The Latest in Photodynamic Therapy Neal Bhatia, MD
1:45 PM - 2:00 PM
Panel Discussion | Q&A All Faculty
2:00 PM - 2:15 PM
Active Stretch Session with NASM-Certified Fitness Instructor Aria Aloi
SCHEDULE AT A GLANCE SATURDAY February 6, 2021 Medical Derm Breakthroughs Session Director: Leon Kircik, MD 2:15 PM - 2:25 PM
Pharmaceutical Breakthroughs and Clinical Trials Update Leon Kircik, MD, FAAD
2:25 PM - 2:35 PM
Therapeutic Breakthrough of the New JAK Inhibitors for Alopecia Antonella Tosti, MD
2:35 PM - 2:45 PM New Approval for Pemphigus Vulgaris TBA 2:45 PM - 2:55 PM
RNAi Formulation for Non-Melanoma Skin Cancer Mark Nestor, MD, PhD
2:55 PM - 3:05 PM
Last Minute Innovations Leon Kircik, MD
3:05 PM - 3:20 PM
Panel Discussion | Q&A All Faculty
3:20 PM - 3:30 PM
Exhibit Break
Radiation Therapies: Let’s Talk Future Session Director: Brad Glick, DO 3:30 PM - 3:40 PM
Understanding the Differences in Radiation Therapies Mark Nestor, MD, PhD
3:40 PM - 3:50 PM
Treating the Lower Extremities William Roth, MD
3:50 PM - 4:00 PM
Superficial Radiation Therapy for Keloids Brian Berman, MD, PhD
4:00 PM - 4:10 PM
A Comprehensive Approach to Grenz Ray Therapy Brad Glick, DO
4:10 PM - 4:25 PM
Panel Discussion | Q&A All Faculty
4:25 PM - 4:45 PM
Exhibit Break
CE Symposium: Time to Think About Both Skin and Joint Disease: Optimizing the Diagnosis and Management of Psoriatic Arthritis Through Multidisciplinary, PatientCentered Care Session Director: Alice Gottlieb, MD Faculty: Joseph F. Merola, MD, MMSc; Alexis Ogdie, MD, MSCE Supported by educational grants from Janssen Pharmaceuticals 4:45 PM - 5:05 PM
Introduction, Pre-Test, Screening and diagnosing PsA
5:05 PM - 5:30 PM
Treatment of PsA
5:30 PM - 5:50 PM
Bringing it all Together: Developing a Patient-Centered Approach to Treatment – The Patient Perspective and Expert Panel Discussion
5:50 PM - 6:00 PM
Conclusions, Post-Test, Audience Q & A
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SCHEDULE AT A GLANCE SUNDAY February 7, 2021 7:00 AM - 8:00 AM
Breakfast Symposium Gene Expression Profiling in the Management of Cutaneous Squamous Cell Carcinoma Sherrif F. Ibrahim, MD, PhD
8:00 AM - 9:00 AM PME Symposium: Identifying Appropriate Patients With Advanced CSCC Who May Bene¬t From Systemic Therapy Armand Cognetta, MD 9:00 AM - 9:15 AM
Exhibit Break
Cutaneous Oncology Symposium Session Director: Mark Nestor, MD, PhD 9:15 AM - 9:25 AM
Innovations in Diagnosis: Precancer to Skin Cancer, Pathology and CPC Cases Clay Cockerell, MD
9:25 AM - 9:35 AM
Cutaneous Oncology Screening and Dermoscopy David Goldberg, MD
9:35 AM - 9:45 AM
Epidemiology and Clinical Presentation of Melanoma David Goldberg, MD
9:45 AM - 9:55 AM
Genetic Approaches to the Prognosis of Melanoma Darrell Rigel, MD
9:55 AM - 10:05 AM Treatment Approaches & Consensus Guidelines for Melanoma & Non-Melanoma Skin Cancer Jose Lutzky, MD 10:05 AM - 10:20 AM Exhibit Break 10:20 AM - 11:05 AM PME Symposium: Perspectives in the Management of Stage IA/IB MF-CTCL: Current Concepts in Clinical Practice Lindsay Ackerman, MD, FAAD 11:05 AM - 11:20 AM Exhibit Break 11:20 AM - 11:30 AM Epidemiology and Clinical Presentation of BCC and SCC David Goldberg, MD 11:30 AM - 11:40 AM Clinical Update: CSCC Treatment Emily Ruiz, MD 11:40 AM - 11:50 AM Radiation Therapies Mark Nestor, MD 11:50 AM - 12:00 PM Surgical Innovations Susan Weinkle, MD 12:00 PM - 12:30 PM Panel Discussion | Q&A All Faculty
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EXPERT SPEAKER LINE-UP CHAIR
Mark S. Nestor, MD, PhD Director, Center for Cosmetic Enhancement Director, Center for Clinical and Cosmetic Research Voluntary Professor Department of Dermatology and Cutaneous Surgery Department of Surgery, Division of Plastic and Reconstructive Surgery University of Miami Miller School of Medicine President, American Cutaneous Oncology Society Chair, 2021 South Beach Symposium Aventura, FL
SENIOR PLANNING COMMITTEE Z. Paul Lorenc, MD, FACS
David J. Goldberg, MD, JD
Lorenc Private Practice Aesthetics New York, NY
Medical Director, Skin Laser & Surgery Specialists of NY and NJ Hackensack, NJ
Leon Kircik, MD
Michael H. Gold, MD, FAAD
Medical Director Physicians Skin Care, PLLC Skin Sciences, PLLC DermResearch, PLLC Louisville, KY
Medical Director of Gold Skin Care Center, Advanced Aesthetics Medical Spa The Laser & Rejuvenation Center, and Tennessee Clinical Research Center Nashville, TN
FACULTY
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Glynis R. Ablon, MD, FAAD
Andrew F. Alexis, MD, MPH
Marc R. Avram, MD
Ablon Skin Institute and Research Center Manhattan Beach, CA
Chair of the Department of Dermatology at Mount Sinai Morningside and Mount Sinai West Professor of Dermatology at the Icahn School of Medicine at Mount Sinai New York, NY
Clinical Professor of Dermatology at the New York Presbyterian Hospital Weill Medical College at Cornell Medical Center New York, NY
Brian Berman, MD, PhD
Diane S. Berson, MD
Neal Bhatia, MD
Professor Emeritus, University of Miami Miller School of Medicine Miami Beach, FL
Associate Professor Weill Cornell Medicine New York City, NY
Director of Clinical Dermatology Therapeutics Clinical Research San Diego, CA
Valerie Callender, M
Clay Cockerell, MD
David E. Cohen, MD, MPH
Medical Director Callender Dermatology & Cosmetic Center Glenn Dale, MD
Clinical Professor, Dermatology and Pathology, UT Southwestern Dallas, TX
Charles C. and Dorothea E. Harris Professor and Vice Chairman for Clinical Affairs Director of Allergic, Occupational, and Environmental Dermatology New York University School of Medicine New York New York, NY
James Q. Del Rosso, DO
Seemal R. Desai, MD, FAAD
Dee Anna Glaser, MD
Dermatologist / Research Director Thomas Dermatology / JDR Dermatology Research Las Vegas, NV
Clinical Assistant Professor of Dermatology, The University of Texas Southwestern Medical Center Founder & Medical Director, Innovative Dermatology Plano, TX
Professor and Interim Chair of the Department of Dermatology at Saint Louis University School of Medicine, with a Secondary Appointment as Professor of Internal Medicine and Otolaryngology St. Louis, MO
Brad P. Glick, DO, MPH, FAAD
David Goldberg, MD, JD
Linda Stein-Gold, MD
Dermatologist Glick Skin Institute- SCA Dermatology Margate, FL
Medical Director, Skin Laser & Surgery Specialists of NY and NJ Hackensack, NJ
Director of Clinical Research Henry Ford Health System Bloomfield Hills, MI
Alice B Gottlieb, MD PhD
Leon Kircik MD
Mark Kaufmann, MD
Clinical Professor and Medical Director Dept.of Dermatology Icahn School of Medicine at Mt. Sinai New York, NY
Medical Director Physicians Skin Care, PLLC Skin Sciences, PLLC DermResearch, PLLC Louisville, KY
Chief Medical Officer Advanced Dermatology and Cosmetic Surgery Bal Harbour, FL
Robert S. Kirsner, MD, PhD
Mark Lebwohl, MD
Peter A. Lio, MD
Chairman and Harvey Blank Professor, University of Miami Miami, FL
Professor and Dean for Clinical Therapeutics Icahn School of Medicine at Mount Sinai New York, NY
Clinical Assistant Professor of Dermatology and Pediatrics Northwestern University Feinberg School of Medicine Chicago, IL
Jose Lutzky, MD
Andrea Maderal, MD
Amy McMichael, MD
Director, Cutaneous Oncology Services Director, Clinical Trials Coordinating Unit Professor, Department of Medicine, University of Miami Miami, FL
Assistant Professor University of Miami Miller School of Medicine Miami, FL
Chair of the Dermatology Department, Wake Forest Baptist Health Winston Salem, NC
Joseph F. Merola, MD
Mark S. Nestor, MD, PhD
Alexis Ogdie, MD
Associate Professor, Harvard Medical School Brigham and Women’s Hospital Boston, MA
Director, Center for Cosmetic Enhancement Director, Center for Clinical and Cosmetic Research Voluntary Professor Department of Dermatology and Cutaneous Surgery Department of Surgery, Division of Plastic and Reconstructive Surgery University of Miami Miller School of Medicine President, American Cutaneous Oncology Society Chair, 2021 South Beach Symposium Aventura, FL
Associate Professor of Medicine at the Hospital of the University of Pennsylvania Associate Professor of Epidemiology in Biostatistics and Epidemiology Philadelphia, PA
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Darrell Rigel, MD MS (MBA)
William Roth, MD, PA
Emily S. Ruiz, MD., MPH
Clinical Professor of Dermatology New York University School of Medicine New York, NY
Voluntary Clinical Professor of Dermatology U. Miami Department of Dermatology Boynton Beach, FL
Assistant professor in Dermatology Harvard Medical School Brigham and Women’s Hospital Boston, MA
Antonella Tosti, MD
Jill Waibel, MD
Susan H. Weinkle, MD
Fredric Brandt Endowed Professor of Dermatology Dr. Phillip Frost Department of Dermatology and Cutaneous Surgery University of Miami Miller School of Medicine Miami, FL
Miami Dermatology and Laser Institute Subsection Chief of Dermatology at Baptist Hospital and the Medical Director of Miami Cancer Institute’s Multidisciplinary Skin Cancer Clinic Clinical Voluntary Assistant Professor at the University of Miami. Miami, FL
Mohs Surgeon/ Cosmetic Dermatologist Susan H. Weinkle, MD Bradenton, Florida
ONDEMAND Markus Boos, MD PhD
David E. Cohen, MD, MPH
Brian Ginsberg, MD
Assistant Professor of Pediatrics University of Washington School of Medicine Seattle, WA
Charles C. and Dorothea E. Harris Professor and Vice Chairman for Clinical Affairs Director of Allergic, Occupational, and Environmental Dermatology New York University School of Medicine New York New York, NY
Dermatologist Chelsea Skin & Laser Assistant Clinical Professor in Dermatology at Mount Sinai Hospital New York, NY
Andrew Heyman, MD
Rajani Katta, MD
Jonette Keri, MD PhD
Medical Director of Integrative Medicine George Washington University Aldie, VA
Founder Katta Dermatology Bellaire, TX
Associate Professor University of Miami, Philip Frost Department of Dermatology and Cutaneous Surgery; Dermatology Service Chief, Miami VA Hospital Miami, FL
Peter A. Lio, MD
Mark S. Nestor, MD, PhD
Theodore Rosen. MD
Clinical Assistant Professor of Dermatology and Pediatrics Northwestern University Feinberg School of Medicine Chicago, IL
Director, Center for Cosmetic Enhancement Director, Center for Clinical and Cosmetic Research Voluntary Professor Department of Dermatology and Cutaneous Surgery Department of Surgery, Division of Plastic and Reconstructive Surgery University of Miami Miller School of Medicine President, American Cutaneous Oncology Society Chair, 2021 South Beach Symposium Aventura, FL
Professor and Vice-Chair, Department of Dermatology Baylor College of Medicine Houston, TX
Anthony M. Rossi, MD Assistant Attending, Assistant Professor of Dermatology Memorial Sloan Kettering Cancer Center / Weill Cornell Medical College New York, NY
Gil Yosipovitch, MD Professor University of Miami Miami, FL
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Sahar Swidan, PharmD, BCPS, ABAAHP, FAARFM, FACA Director of Professional Programming A4M/MMI Ann Arbor, MI
CE SYMPOSIAListing
Saturday, February 6, 2021 12:00 PM – 1:00 PM Eastern Time
Clinical Update: Novel Agents for the Long-Term Management of Moderate-to-Severe Atopic Dermatitis Chair: Linda Stein-Gold, MD Faculty: Peter A Lio, MD; Alexis F. Andrews, MD, MPH This activity is jointly provided by AKH, Inc. Advancing Knowledge in Healthcare and Tarsus Cardio Inc. dba LiVDERM.
EDUCATIONAL GRANT SUPPORT
Multisupported by educational grants from Pfizer Inc. and Incyte Corp.
TARGET AUDIENCE
This activity is designed for US-based physicians, nurses and professional staff members of medical practices specializing in dermatology as well as allergists, primary care physicians, nurses, nurse practitioners, physician assistants, and pharmacists.
FACULTY
PROGRAM OVERVIEW
The increasing incidence of Atopic dermatitis (AD) and poor recognition of the disease in some patient groups is a public health concern. AD symptoms and its daily management cause significant effects on quality of life for both patients and caregivers. AD is associated with an increase in other atopic manifestations as well as with serious comorbidities that can greatly affect overall patient health and wellbeing (Silverberg 2015; Simpson 2012; Yu 2016; Zheng 2011). Timely and adequate treatment of AD is essential for helping to promote better long-term outcomes and quality of life and may help prevent the development of other atopic conditions (Leung 2014). However, the treatment of AD is a clinical challenge. Patients continue to report treatment dissatisfaction, recurrent flares, and impaired quality of life (Silverberg 2018; Wei 2019). Targeted immunomodulatory agents, based on recent advances in the understanding of AD pathophysiology, represent additional options for long-term control, with one agent that is FDA approved and several others in advanced clinical development (Kalamaha 2019). Thus, additional education about current and emerging long-term strategies to AD management is crucial for their interpretation and application to clinical practice.
ndrew F. Alexis, MD, MPH A Chair of the Department of Dermatology at Mount Sinai Morningside and Mount Sinai West Professor of Dermatology at the Icahn School of Medicine at Mount Sinai New York, NY Peter A. Lio, MD Clinical Assistant Professor of Dermatology and Pediatrics Northwestern University Feinberg School of Medicine Chicago, IL Linda Stein-Gold, MD (Symposium Chair) Director of Clinical Research Henry Ford Health System Bloomfield Hills, MI
ACCREDITATION
Accreditation may be found on page 20
LEARNING OBJECTIVES
• Interpret the efficacy and safety of current non-pharmacological and pharmacological treatments for AD and their limitations in long-term disease management. • Summarize the mechanisms of action and evidence with new and emerging targeted immunomodulatory agents for long-term AD management. • Develop individualized treatment plans for patients with moderate-to-severe AD that go beyond just treating flares and symptoms in order to optimize long-term control and overall quality of life. www.livderm.org 13
CE SYMPOSIA Listing
Saturday, February 6, 2021 4:45 PM – 6:00 PM Eastern Time
Time to Think About Both Skin and Joint Disease: Optimizing the Diagnosis and Management of Psoriatic Arthritis Chair: Alice B Gottlieb, MD PhD Faculty: Joseph F. Merola, MD, MMSc; Alexis Ogdie, MD This activity is jointly provided by AKH, Inc. Advancing Knowledge in Healthcare and Tarsus Cardio Inc. dba LiVDERM.
EDUCATIONAL GRANT SUPPORT
Supported by an educational grant from Janssen Pharmaceuticals
TARGET AUDIENCE
This activity is designed for US-based physicians, nurses and professional staff members of medical practices specializing in dermatology, plastic surgery, cosmetic surgery, rheumatology and other dermatologic medical procedures.
FACULTY
PROGRAM OVERVIEW
Psoriasis is a chronic and inflammatory skin disease with potential systemic implications that affects 7.5 million people in the United States (Bhushan 2016; Soleymani 2018) that can lead to several comorbidities, including psoriatic arthritis, obesity, metabolic syndrome, and cardiovascular disease (Soleymani 2018). Early diagnosis and treatment are crucial in managing PsA, and clinicians need to understand the impact of both skin and joint aspects of psoriasis and PsA in order to minimize impact on patients’ quality of life (QOL). Current methods to assess disease severity may not be practical to use in routine care, contributing to the undertreatment or incorrect treatment of PsA (Elmets 2019). Due to ongoing suboptimal management of PsA, there is a need to educate clinicians that treat patients with PsA on the diagnosis and current treatment approach, particularly in light of new guidelines for psoriasis (Elmets 2019) and PsA (Singh 2019).
LEARNING OBJECTIVES
• Identify key clinical features of PsA to improve timely screening, diagnosis, or referral. • Utilize practical strategies to evaluate PsA severity that incorporate both joint and skin manifestation in order to guide treatment. • Develop individualized treatment strategies for patients with PsA based on the efficacy and safety of current and emerging pharmacotherapies, evidence-based guidelines, and patient specific needs and preferences.
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Alice B Gottlieb, MD PhD Clinical Professor and Medical Director Dept.of Dermatology Icahn School of Medicine at Mt. Sinai New York, NY Joseph F. Merola, MD, MMSc Associate Professor, Harvard Medical School Brigham and Women’s Hospital Boston, MA
Alexis Ogdie, MD Associate Professor of Medicine at the Hospital of the University of Pennsylvania Associate Professor of Epidemiology in Biostatistics and Epidemiology Philadelphia, PA
ACCREDITATION
Accreditation may be found on page 22
19th Annual South Beach Symposium presented by LiVDerm February 5-7, 2021 Online
ACTIVITY OVERVIEW At The Medical Dermatology Summit, led by renowned clinical authorities, attendees will gain actionable knowledge on the most relevant topics in medical dermatology including the impact of COVID-19 on the dermatology industry, cutaneous oncology, hair restoration, and much more all from the safety of their home. The summit will deliver an interactive educational experience that optimizes all the advantages of virtual education with live-streamed sessions, on-demand content, faculty Q&A, live engagement, and networking with key industry opinion leaders. TARGET AUDIENCE This symposium is designed for an audience of physicians, nurses and professional staff members of medical practices specializing in dermatology, pediatric dermatology, plastic surgery, cosmetic surgery and other dermatologic medical procedures. LEARNING OBJECTIVES Upon completion of the educational activity, participants should be able to: • Summarize new and emerging therapies for the treatment of acne. • Evaluate the efficacy and safety of acne treatments, including the need to appropriately modify therapy and practice antibiotic stewardship. • Describe recent advances in the treatment of actinic keratosis that have high levels of patient satisfaction, decreased treatment duration, and fewer side-effects. • List the pathogenic mechanisms of atopic dermatitis. • Review individualized treatment plans for patients with moderate-to-severe atopic dermatitis based on current guideline recommendations, the safety and efficacy of new and emerging treatment options, comorbidities, and patients’ quality of life. • List current and emerging treatment options for alopecia areata. • Review and compare efficacy and safety of biologic agents, devices, and techniques currently available in hair restoration for androgenic alopecia. • Define the efficacy and safety of emerging treatment options for hidradenitis suppurativa. • Review the new and emerging treatment options for hyperhidrosis. • Summarize new and emerging therapies for the treatment of psoriasis. • Review the significance of addressing comorbidities as important components of psoriasis therapy. • Review the clinical presentation of rosacea in order to ensure timely diagnosis. • Summarize traditional, new and emerging therapies for the treatment of rosacea. • Define the efficacy and safety of the current and new treatment options for seborrheic keratosis. • Interpret latest clinical evidence for emerging treatments of keloids. CRITERIA FOR SUCCESS Statements of credit will be awarded based on the participant’s attendance and submission of the activity evaluation form. A statement of credit will be available upon completion of an online evaluation/claimed credit form at www.southbeachsymposium.org. You must participate in the entire activity to receive credit. If you have questions about this CE activity, please contact AKH Inc. at tbrignoni@akhcme.com. Credit provided by AKH Inc., Advancing Knowledge in Healthcare In support of improving patient care, this activity has been planned and implemented by AKH Inc., Advancing Knowledge in Healthcare and Tarsus Cardio dba LiVDerm. AKH Inc., Advancing Knowledge in Healthcare is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team. This activity was planned by and for the healthcare team, and learners will receive 16.5 Interprofessional Continuing Education (IPCE) credit for learning and change. Physician AKH Inc., Advancing Knowledge in Healthcare designates this live activity for a maximum of 16.5 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Nurse 16.5 ANCC contact hours Physician Assistant AKH Inc., Advancing Knowledge in Healthcare has been authorized by the American Academy of PAs (AAPA) to award AAPA Category 1 CME credit for activities planned in accordance with AAPA CME Criteria. This activity is designated for 16.5 AAPA Category 1 CME credits. PAs should only claim credit commensurate with the extent of their participation. COMMERCIAL SUPPORT This activity is supported by educational grants from Janssen Biotech, Inc., administered by Janssen Scientific Affairs, LLC, Pfizer Inc., Sirnaomics, Inc.
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DISCLOSURE It is the policy of AKH Inc. to ensure independence, balance, objectivity, scientific rigor, and integrity in all of its continuing education activities. The author must disclose to the participants any significant relationships with ineligible companies whose products or devices may be mentioned in the activity or with the commercial supporter of this continuing education activity. Identified conflicts of interest are mitigated by AKH prior to accreditation of the activity. AKH planners and reviewers have no relevant financial relationships to disclose. DISCLOSURES NAME
RELATIONSHIP
COMPANY
Glynis Ablon, MD, FAAD
N/A
Nothing to disclose
Marc Avram, MD
N/A
Nothing to disclose
Brian Berman, MD, PhD
Biofrontera, Ferndale Laboratories, Inc., Galderma Laboratories, L.P., GlaxoSmithKline, LEO Pharma - Advisory Board, Medimetriks Pharmaceuticals Inc., Miragen - Consultant Honoraria, Encore - Consultant, Siranomics - Consultant, Pierre-Fabre - Consultant, Pfizer - Consultant, Lemonex - Consultant, Novan Consultant Honoraria, Novartis Pharmaceuticals Corp. - Advisory Board & Speaker Honoraria, Sonoma (Oculus Innovative Sciences, Inc.) - Consultant Stock Options, Sensus - Speaker Consultant Honoraria Investigator, Smith & Nephew - Advisory Board Honoraria, TopMD - Advisory Board, Ortho Dermatologics/Valeant - Advisory Board, Cutanea - Advisory Board, Birch BioMed - Advisory Board, Encore Dermatology - Consultant, Aclaris - Consultant, Aiviva - Consultant, Clark Pharmaceutical, Tigercat Pharma, Inc, Menlo Therapeutics - Consultant, BMS - Consultant, Pulse - Consultant, Almirall - Consultant, Mediwound - Consultant
Diane Berson, MD
Consultant
Aclaris, Allergan, Almirall, Cassiopea, CLN, Crown, Evolus, Ferndale, L'Oreal, Ortho Derm, Procter and Gamble, Regimen Pro, Revance, Sonoma
Neal Bhatia, MD
Consultant
Almirall, Biofrontera, Ortho, Sun Pharma
Markus Boos, MD PhD
N/A
Nothing to disclose
Valerie Callender, MD
Consultant
Aerolase
Speakers Bureau
Ortho Dermatologics
Clay Cockerell, MD
Consultant
Almirall
David Cohen, MD, MPH
Board of Directors
Kadmon, Timber, Evommune, Dermira
Consultant
Asana, Dermavant, Celgene, Cutanea, Ferndale Laboratories, Ferrer, FSJ, Leo, Medimetriks, UCB
FIDE. (FIDE receives industry sponsorship from AbbVie, Almirall, Amgen, Bausch and Lomb, Bristol-Myers Squibb, Celgene Dermavant, Dermira, Janssen, Kyowa Hakko Kirin, LEO, Lilly, Novartis, Ortho Dermatologics, Pfizer, Sanofi Genzyme, Sun Pharma, UCB, Valeant) James Del Rosso, DO
Consultant
Almirall, Bausch (Ortho), BioPharmX, Cassiopea, Inc., EPI Health, Galderma, LeoPharma, Mayne Pharma, Novan, SolGel, Sonoma, Sun Pharma, Vyne Therapeutics Inc
Contracted Research
Almirall, Bausch (Ortho), BioPharmx, Galderma, LeoPharma, Mayne Pharma, Novan, SolGel, Sun Pharma, Vyne Therapeutics Inc
Speakers Bureau
Almirall, Bausch (Ortho), EPI Health, Galderma, LeoPharma, Mayne Pharma, Sun Pharma, Vyne Therapeutics Inc
Advisory Board
Dermavan Sciences, Foundation for Research & Education of Dermatology
Consultant
Galderma Laboratories, Cassiopea SpA, Ortho Dermatologics, SkinCeuticals LLC, Dermira, Almirall, Scientis Sente Labs, Foamix, Pfizer Inc., Verrica Pharmaceuticals, Inc, Ferndale, Avita, Gore Range Capital, Incyte Corporation, Bristol Myers Squibb, UCB
Contracted Research
Abbvie, Atacama, Incyte Corporation, Dermavant Sciences, Novan, AOBiome, LLC, Brickell Biotec
Speakers Bureau
Almirall, Ortho Dermatologics
Stock
Gore Range Capital
Brian Ginsberg, MD
N/A
Nothing to disclose
Michael Gold, MD
Consultant
Aerolase, Alastin, Allergan, Alma Lasers, Almirall, BioFrontera, Clarify MD, Croma, DefenAge, Dermira, EndyMed, Essence Novel, Galderma, Hugel, IntraDerm, Invasix / InMode, Johnson & Johnson, Joylux, Lumenis, Merz, MTF, NanoPass, Neauvia, Novartis, Pierre Fabre / Glytone, Revision, Sensus, SentĂŠ, Skinbetter Science, Sofregen, Stratpharma, Suneva, Candela, Viviscal, Zimmer
Seemal Desai, MD
www.livderm.org 17
David Goldberg, MD
N/A
Nothing to disclose
Dee Anna Glaser, MD
Consultant
Brickell, Candesant, Dermira, Revance, Recross
Contracted Research
Allergan, Atacama, Brickell, Dermira, Galderma
Speakers Bureau
Allergan, Dermira, Galderma
Brad Glick, DO, MPH, FAAD
N/A
Nothing to disclose
Alice Gottlieb, MD, PhD
Consultant
Janssen , Novartis , UCB
Contracted Research
Janssen , Novartis and UCB (paid to MT Sinai School of Medicine)
Stock Options
XBiotech
Andrew Heyman, MD
N/A
Nothing to disclose
Rajani Katta, MD
Royalty
Author of a book for the general public on diet and dermatology
Mark Kaufmann, MD
Stock Options
Modernizing Medicine, Klara
Jonette Keri, MD, PhD
Speakers Bureau
Foamix Pharmcueticals
Leon Kircik, MD
Advisory Board
Aclaris, Allergan, Inc., Almirall, Anacor Pharmaceuticals, Biogen-Idec, Cassiopea, Inc., Colbar, Celgene, Cipher, Connetics Corporation, EOS, Exeltis, Ferndale, Laboratories, Inc., Foamix, Genentech, Inc., Intendis, Innocutis, Isdin, Johnson & Johnson, Nano Bio, OrthoNeutogena, Promius, Quinnova, SkinMedica, Inc., Stiefel Laboratories, Inc., Sun Pharma, Valeant Pharmaceuticals Intl, Warner-Chilcott
Consultant
Allergan, Inc., Almirall, Amgen, Inc., Anacor Pharmaceuticals, Cassiopea, Inc., Colbar, Cipher, CollaGenex, Connetics Corporation, Exeltis, Foamix, Genentech, Inc., Intendis, Isdin, Johnson & Johnson, Laboratory Skin Care Inc, LEO, Medical International Technologies, Merck, Merz, Novartis AG, OrthoNeutrogena, Promius, PuraCap, SkinMedica, Inc., Stiefel Laboratories, Inc., Sun Pharma, Taro, UCB, Valeant Pharmaceuticals, ZAGE
Contracted Research
Acambis, Allergan, Inc., Amgen, Inc., Anacor Pharmaceuticals, Astellas Pharma US, Inc., Asubio, Berlex Laboratories (Bayer HealthCare Pharmaceuticals),Biolife, Biopelle, Boehringer-Ingleheim, Breckinridge Pharma, Celgene, Centocor, Inc. Cellceutix, Coherus, CollaGenex, Combinatrix, Connetics Corporation, Coria, Dermavant, Dermira, Dow Pharmaceutical Sciences, Inc., DUSA, Eli Lilly, Exeltis, Ferndale Laboratories, Inc., Foamix, Genentech, Inc., GlaxoSmithKline, PLC, Healthpoint, LTD, Idera, Intendis, Johnson & Johnson, LEO, L’Oreal, 3M, Maruho, Medicis Pharmaceutical Corp., Merck, Nano Bio, Novartis AG, Noven Pharmaceuticals, Nucryst Pharmaceuticals Corp, Obagi, Onset, OrthoNeutrogena, Promius, QLT, Inc. Quinnova, Quatrix, , PharmaDerm, Pfizer, SkinMedica, Inc., Stiefal Laboratories, Inc., Sun Pharma, TolerRX, UCB, Valeant Pharmaceuticals Intl, Warner-Chilcott, XenoPort
Speakers Bureau
Abbott Laboratories, Allergan, Inc., Amgen, Inc., Assos Pharma, Astellas Pharma US, Inc., Cipher, CollaGenex, Connectics Corporation, Dermik Laboratories, Embil Pharmaceuticals, Exeltis, Foamix, Genentech, Inc., Innocutix, Innoval, Johnson & Johnson, LEO, L’Oreal, 3M, Onset, OrthoNeutrogena, PediaPharma, PharmaDerm, Serono (Merck Serono International SA),SkinMedica, Inc., Stiefel Laboratories, Inc., Sun Pharma, Taro, Triax, UCB, Valeant Pharmaceuticals, Intl, Warner-Chilcott,
Stock
Johnson & Johnson
Robert Kirsner, MD, PhD
N/A
Nothing to disclose
Mark Lebwohl, MD
Consultant
Aditum Bio, Allergan, Almirall, Arcutis, Inc., Avotres Therapeutics, BirchBioMed Inc., BMD skincare, Boehringer-Ingelheim, Bristol-Myers Squibb, Cara Therapeutics, Castle Biosciences, Corrona, Dermavant Sciences, Evelo, Evommune, Facilitate International Dermatologic Education, Foundation for Research and Education in Dermatology, Inozyme Pharma, Kyowa Kirin, LEO Pharma, Meiji Seika Pharma, Menlo, Mitsubishi, Neuroderm, Pfizer, Promius/Dr. Reddy's Laboratories, Serono, Theravance, and Verrica
Contracted Research
Abbvie, Amgen, Arcutis, Boehringer Ingelheim, Dermavant, Eli Lilly, Evommune, Incyte, Janssen Research & Development, LLC, Leo Pharmaceutucals, Ortho Dermatologics, Pfizer, and UCB, Inc
Consultant
UCB, Dermavant, Regeneron/Sanofi Genzyme, Dermira, Pfizer, LEO Pharmaceuticals, AbbVie, Kiniksa, Eli Lilly, Micreos, L'Oreal, Pierre-Fabre, Johnson & Johnson, Level Ex, Unilever, Menlo Therapeutics, Theraplex, IntraDerm, Exeltis, AOBiome, Realm Therapeutics, Altus Labs, Galderma, Verrica, Arbonne, Amyris, Bodewell, Burt's Bees, Kimberly-Clark
Contracted Research
National Eczema Association, AOBiome, Regeneron/Sanofi Genzyme, and AbbVie
Royalties
Theraplex: Theraplex AIM OTC moisturizer
Speakers Bureau
Regeneron/Sanofi Genzyme, Pfizer, Eli Lilly, Galderma, L'Oreal
Stock Options
Micreos Altus Labs
Peter Lio, MD
18 www.livderm.org
Z. Paul Lorenc, MD, FACS
N/A
Nothing to disclose
Jose Lutzky, MD
N/A
Nothing to disclose
Andrea Maderal, MD
N/A
Nothing to disclose
Amy McMichael, MD
Consultant
Allergan, Almirall, Bioniz, Cassiopea, Covance, eResearch Technology, Inc., Galderma, Incyte, Johnson & Johnson, Keranetics, Lilly, Merck & Co., Inc., Pfizer Proctor & Gamble, Revian, Samumed
Contracted Research
Allergan, Cassiopea, Concert Pharmaceuticals, Incyte, Pfizer Proctor & Gamble, Samumed
Royalties
Informa Healthcare, UpToDate
Mark Nestor, MD, PhD
N/A
Nothing to disclose
Darrell Rigel, MD
Consultant
Beiersdorf, Inc., Advisory Board Honoraria, Derm Tech International Advisory Board Honoraria, Castle Biosciences Advisory Board Honoraria, Ferndale Laboratories, Inc. Consultant Honoraria, Derm Tech International Consultant Honoraria, SciBASE Consultant Honoraria
Contracted Research
Castle Biosciences Investigator
Grants/Research
Stock Foamix
Theodore Rosen, MD
N/A
Nothing to disclose
Anthony Rossi, MD
Equipment Donated
Caliber ID
William Roth, MD
Consultant/advisory board
Sensus Healthcare (no compensation)
Contracted Research
Sensus Healthcare
Consultant
Genentech, Regeneron/Sanofi
Contracted Research
Merck, Regeneron
Consultant
Galderma, Sun, Pfizer, Amgen, Sanofi, Regeneron, Vyne Therapeutics Inc, Almirall, BMS, UCB, Sol Gel, Ortho Derm
Contracted Research
Galderma, Sun, Pfizer, Amgen, Sanofi, Regeneron, Vyne Therapeutics Inc, Almirall, UCB, Sol Gel, Ortho Derm, Novartis, AbbVie
Speakers Bureau
Galderma, Sun, Pfizer, Amgen, Sanofi, Regeneron, Vyne Therapeutics Inc, Ortho Derm
Employer
Pharmacy Solutions (President & CEO)
Emily Ruiz, MD MPH Linda Stein Gold, MD
Sahar Swidan, PharmD
Speakers Bureau
Amgen, Biohaven
Antonella Tosti, MD
Consultant
Almirall, Bristol Myers Squibb, DS Laboratories, Leo Pharmaceuticals, Lilly, Monat Global, P&G, Thirty Madison
Jill Waibel, MD
N/A
Nothing to disclose
Susan Weinkle, MD
Consultant
Allergan, Ethicon, Galderma, Merz Aesthetics, Proctor and Gamble, Teoxane, Evolus, Sinclair, Revance, Almirall
Contracted Research
Allergan, Derm Avance, Galderma, Teoxane, Evolus, Sinclair, Revance
Speakers Bureau
Allergan, Ethicon, Galderma, Merz Aesthetics
Stock Options
Derm Avance
Gil Yosipovitch, MD
N/A
Nothing to disclose
Dorothy Caputo, MA, BSN, RN - CE Director of Accreditations
N/A
Nothing to disclose
LiVDerm Planners and Reviewers
N/A
Nothing to disclose
AKH Planners and Reviewers
N/A
Nothing to disclose
All of the relevant financial relationships listed for these individuals have been mitigated.
DISCLAIMER This course is designed solely to provide the healthcare professional with information to assist in his/her practice and professional development and is not to be considered a diagnostic tool to replace professional advice or treatment. The course serves as a general guide to the healthcare professional, and therefore, cannot be considered as giving legal, nursing, medical, or other professional advice in specific cases. AKH Inc. specifically disclaim responsibility for any adverse consequences resulting directly or indirectly from information in the course, for undetected error, or through participant’s misunderstanding of the content. DISCLOSURE OF UNLABELED USE AND INVESTIGATIONAL PRODUCT This educational activity may include discussion of uses of agents that are investigational and/or unapproved by the FDA. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings. www.livderm.org 19
Clinical Update: Novel Agents for the Long-Term Management of Moderate-to-Severe Atopic Dermatitis February 6, 2021 Online
ACTIVITY OVERVIEW The increasing incidence of Atopic dermatitis (AD) and poor recognition of the disease in some patient groups is a public health concern. AD symptoms and its daily management cause significant effects on quality of life for both patients and caregivers. AD is associated with an increase in other atopic manifestations as well as with serious comorbidities that can greatly affect overall patient health and wellbeing (Silverberg 2015; Simpson 2012; Yu 2016; Zheng 2011). Timely and adequate treatment of AD is essential for helping to promote better long-term outcomes and quality of life and may help prevent the development of other atopic conditions (Leung 2014). However, the treatment of AD is a clinical challenge. Patients continue to report treatment dissatisfaction, recurrent flares, and impaired quality of life (Silverberg 2018; Wei 2019). Targeted immunomodulatory agents, based on recent advances in the understanding of AD pathophysiology, represent additional options for longterm control, with one agent that is FDA approved and several others in advanced clinical development (Kalamaha 2019). Thus, additional education about current and emerging long-term strategies to AD management is crucial for their interpretation and application to clinical practice. TARGET AUDIENCE This symposium is designed for an audience of physicians, nurses and professional staff members of medical practices specializing in dermatology as well as allergists, primary care physician, nurses, nurse practitioners, physician assistants and pharmacists. LEARNING OBJECTIVES Upon completion of the educational activity, participants should be able to: • Interpret the efficacy and safety of current non-pharmacological and pharmacological treatments for AD and their limitations in long-term disease management. • Summarize the mechanisms of action and evidence with new and emerging targeted immunomodulatory agents for long-term AD management • Develop individualized treatment plans for patients with moderate-to-severe AD that go beyond just treating flares and symptoms in order to optimize long-term control and overall quality of life CRITERIA FOR SUCCESS Statements of credit will be awarded based on the participant’s attendance and submission of the activity evaluation form. A statement of credit will be available upon completion of an online evaluation/claimed credit form at www.southbeachsymposium.org. You must participate in the entire activity to receive credit. If you have questions about this CE activity, please contact AKH Inc. at tbrignoni@akhcme.com.
Credit provided by AKH Inc., Advancing Knowledge in Healthcare
In support of improving patient care, this activity has been planned and implemented by AKH Inc., Advancing Knowledge in Healthcare and Tarsus Cardio dba LiVDerm. AKH Inc., Advancing Knowledge in Healthcare is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team. This activity was planned by and for the healthcare team, and learners will receive 1 Interprofessional Continuing Education (IPCE) credit for learning and change. Physician AKH Inc., Advancing Knowledge in Healthcare designates this live activity for a maximum of 1 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Nurse 1 ANCC contact hours Physician Assistant AKH Inc., Advancing Knowledge in Healthcare has been authorized by the American Academy of PAs (AAPA) to award AAPA Category 1 CME credit for activities planned in accordance with AAPA CME Criteria. This activity is designated for 1 AAPA Category 1 CME credits. PAs should only claim credit commensurate with the extent of their participation. Commercial Support This activity is supported by educational grants from Incyte Corporation, Pfizer Inc. DISCLOSURE It is the policy of AKH Inc. to ensure independence, balance, objectivity, scientific rigor, and integrity in all of its continuing education activities. The author must disclose to the participants any significant relationships with ineligible companies whose products or devices may be mentioned in the activity or with the commercial supporter of this continuing education activity. Identified conflicts of interest are mitigated by AKH prior to accreditation of the activity. AKH planners and reviewers have no relevant financial relationships to disclose.
20 www.livderm.org
DISCLOSURE It is the policy of AKH Inc. to ensure independence, balance, objectivity, scientific rigor, and integrity in all of its continuing education activities. The author must disclose to the participants any significant relationships with ineligible companies whose products or devices may be mentioned in the activity or with the commercial supporter of this continuing education activity. Identified conflicts of interest are mitigated by AKH prior to accreditation of the activity. AKH planners and reviewers have no relevant
DISCLOSURES NAME
RELATIONSHIP
COMPANY
Andrew Alexis, MD
Consultant
Leo, Novartis, Menlo, Galderma, Pfizer, Sanofi-Regeneron, Dermavant, Unilever, Beiersdorf, Valeant, L’Oreal, BMS, Menlo, Scientis, Bausch health , UCB, Foamix , Cassiopea, Arcutis, Janssen, Allergan, Almirall, Abbvie, Sol-Gel (Self); Pfizer, Sanofi-Regeneron (Spouse/partner)
Contracted Research
Leo, Novartis, Almirall, Bristol-Myers-Squibb, Celgene, Menlo, Galderma, Valeant (Bausch Health), Cara, Arcutis
Peter Lio, MD
Consultant
UCB, Dermavant, Regeneron/Sanofi Genzyme, Dermira, Pfizer, LEO Pharmaceuticals, AbbVie, Kiniksa, Eli Lilly, Micreos, L'Oreal, Pierre-Fabre, Johnson & Johnson, Level Ex, Unilever, Menlo Therapeutics, Theraplex, IntraDerm, Exeltis, AOBiome, Realm Therapeutics, Altus Labs, Galderma, Verrica, Arbonne, Amyris, Bodewell, Burt's Bees, Kimberly-Clark
Contracted Research
National Eczema Association, AOBiome, Regeneron/Sanofi Genzyme, and AbbVie
Royalties
Theraplex: Theraplex AIM OTC moisturizer
Speakers Bureau
Regeneron/Sanofi Genzyme, Pfizer, Eli Lilly, Galderma, L'Oreal
Stock Options
Micreos Altus Labs
Consultant
Galderma, Sun, Pfizer, Amgen, Sanofi, Regeneron, Vyne Therapeutics Inc, Almirall, BMS, UCB, Sol Gel, Ortho Derm
Contracted Research
Galderma, Sun, Pfizer, Amgen, Sanofi, Regeneron, Vyne Therapeutics Inc, Almirall, UCB, Sol Gel, Ortho Derm, Novartis, AbbVie
Speakers Bureau
Galderma, Sun, Pfizer, Amgen, Sanofi, Regeneron, Vyne Therapeutics Inc, Ortho Derm
Dorothy Caputo, MA, BSN, RN - CE Director of Accreditations
N/A
Nothing to disclose
LiVDerm Planners and Reviewers
N/A
Nothing to disclose
AKH Planners and Reviewers
N/A
Nothing to disclose
Linda Stein Gold, MD
All of the relevant financial relationships listed for these individuals have been mitigated.
DISCLAIMER This course is designed solely to provide the healthcare professional with information to assist in his/her practice and professional development and is not to be considered a diagnostic tool to replace professional advice or treatment. The course serves as a general guide to the healthcare professional, and therefore, cannot be considered as giving legal, nursing, medical, or other professional advice in specific cases. AKH Inc. specifically disclaim responsibility for any adverse consequences resulting directly or indirectly from information in the course, for undetected error, or through participant’s misunderstanding of the content. DISCLOSURE OF UNLABELED USE AND INVESTIGATIONAL PRODUCT This educational activity may include discussion of uses of agents that are investigational and/or unapproved by the FDA. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.
www.livderm.org 21
Time to Think About Both Skin and Joint Disease: Optimizing the Diagnosis and Management of Psoriatic Arthritis Through Multidisciplinary, Patient-Centered Care February 6, 2021 Online
ACTIVITY OVERVIEW Psoriasis is a chronic and inflammatory skin disease with potential systemic implications that affects 7.5 million people in the United States (Bhushan 2016; Soleymani 2018) that can lead to several comorbidities, including psoriatic arthritis, obesity, metabolic syndrome, and cardiovascular disease (Soleymani 2018). Early diagnosis and treatment are crucial in managing PsA, and clinicians need to understand the impact of both skin and joint aspects of psoriasis and PsA in order to minimize impact on patients’ quality of life (QOL). Current methods to assess disease severity may not be practical to use in routine care, contributing to the undertreatment or incorrect treatment of PsA (Elmets 2019). Due to ongoing suboptimal management of PsA, there is a need to educate clinicians that treat patients with PsA on the diagnosis and current treatment approach, particularly in light of new guidelines for psoriasis (Elmets 2019) and PsA (Singh 2019). TARGET AUDIENCE This symposium is designed for an audience of physicians, nurses and professional staff members of medical practices specializing in dermatology, plastic surgery, cosmetic surgery, rheumatology and other dermatologic medical procedures. LEARNING OBJECTIVES Upon completion of the educational activity, participants should be able to: • Identify key clinical features of PsA in order to improve timely screening, diagnosis, or referral • Utilize practical strategies to evaluate PsA severity that incorporate both joint and skin manifestation in order to guide treatment • Develop individualized treatment strategies for patients with PsA based on the efficacy and safety of current and emerging pharmacotherapies, evidence-based guidelines, and patient specific needs and preferences CRITERIA FOR SUCCESS Statements of credit will be awarded based on the participant’s attendance and submission of the activity evaluation form. A statement of credit will be available upon completion of an online evaluation/claimed credit form at www.southbeachsymposium.org. You must participate in the entire activity to receive credit. If you have questions about this CE activity, please contact AKH Inc. at tbrignoni@akhcme.com. Credit provided by AKH Inc., Advancing Knowledge in Healthcare In support of improving patient care, this activity has been planned and implemented by AKH Inc., Advancing Knowledge in Healthcare and Tarsus Cardio dba LiVDerm. AKH Inc., Advancing Knowledge in Healthcare is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team. This activity was planned by and for the healthcare team, and learners will receive 1.25 Interprofessional Continuing Education (IPCE) credit for learning and change. Physician AKH Inc., Advancing Knowledge in Healthcare designates this live activity for a maximum of 1.25 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Nurse 1.25 ANCC contact hours Physician Assistant AKH Inc., Advancing Knowledge in Healthcare has been authorized by the American Academy of PAs (AAPA) to award AAPA Category 1 CME credit for activities planned in accordance with AAPA CME Criteria. This activity is designated for 1.25 AAPA Category 1 CME credits. PAs should only claim credit commensurate with the extent of their participation. COMMERCIAL SUPPORT This activity is supported by educational grants from Janssen Biotech, Inc., administered by Janssen Scientific Affairs, LLC.
22 www.livderm.org
DISCLOSURE It is the policy of AKH Inc. to ensure independence, balance, objectivity, scientific rigor, and integrity in all of its continuing education activities. The author must disclose to the participants any significant relationships with ineligible companies whose products or devices may be mentioned in the activity or with the commercial supporter of this continuing education activity. Identified conflicts of interest are mitigated by AKH prior to accreditation of the activity. AKH planners and reviewers have no relevant financial relationships to disclose. Disclosures NAME
RELATIONSHIP
COMPANY
Alice Gottlieb, MD, PhD
Consultant
Janssen , Novartis , UCB
Contracted Research
Janssen , Novartis and UCB (paid to MT Sinai School of Medicine)
Stock Options
XBiotech
Joseph Merola, MD, MMSc
Consultant
Abbvie, Amgen, Bayer, Eli Lilly, Novartis, Janssen, UCB, Celgene, Sanofi-Regeneron, Biogen, Pfizer, and BMS
Alexis Ogdie-Beatty, MD
Consulting/Advisory Boards
Abbvie, Amgen, BMS, Celgene, Corrona, Gilead, Janssen, Lilly, Novartis, Pfizer, UCB
Grants
Pfizer to Penn, Novartis to Penn, Amgen to Forward/NDB
Royalties
Novartis to my husband
Other Funding
NIAMS, Rheumatology Research Foundation, National Psoriasis Foundation, University of Pennsylvania
Dorothy Caputo, MA, BSN, RN - CE Director of Accreditations
N/A
Nothing to disclose
LiVDerm Planners and Reviewers
N/A
Nothing to disclose
AKH Planners and Reviewers
N/A
Nothing to disclose
All of the relevant financial relationships listed for these individuals have been mitigated.
DISCLAIMER This course is designed solely to provide the healthcare professional with information to assist in his/her practice and professional development and is not to be considered a diagnostic tool to replace professional advice or treatment. The course serves as a general guide to the healthcare professional, and therefore, cannot be considered as giving legal, nursing, medical, or other professional advice in specific cases. AKH Inc. specifically disclaim responsibility for any adverse consequences resulting directly or indirectly from information in the course, for undetected error, or through participant’s misunderstanding of the content. DISCLOSURE OF UNLABELED USE AND INVESTIGATIONAL PRODUCT This educational activity may include discussion of uses of agents that are investigational and/or unapproved by the FDA. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.
www.livderm.org 23
Diversity in Derm Treatments: Skin of Color February 6, 2021 Online
ACTIVITY OVERVIEW There are gaps in dermatologic care today concerning patients with skin of color (SOC) that need to be addressed through education and putting new knowledge into practice. Patients with SOC can be disproportionately affected by dermatologic conditions such as melasma, acne, rosacea, and hyperpigmentation. Even children with SOC can be more susceptible or have a greater disease burden, especially with conditions such as acne, vitiligo, atopic dermatitis, keloids, pityriasis alba, and traction alopecia. It is important that clinicians are not only aware of these disparities across multiple disease states, but that they are aware of changes to practice that need to be made. The Skin of Color Symposia is designed to address these gaps in dermatologic care for SOC patients by reviewing skin conditions prevalent in SOC patients or those which disproportionately burden SOC patients. Participants will gain education needed to better treat these conditions and modify current practices to accommodate the needs of patients with darker pigmented skin. TARGET AUDIENCE This symposium is designed for an audience of physicians, nurses and professional staff members of medical practices specializing in dermatology, plastic surgery, cosmetic surgery and other dermatologic medical procedures. LEARNING OBJECTIVES Upon completion of the educational activity, participants should be able to: • Identify the challenges in treating SOC patients for melasma and the considerations that must be made in designing a treatment plan • Review the clinical and aesthetic treatments available for melasma patients • List current and emerging vitiligo treatments for pediatric patients. • Describe the impact of vitiligo in patients with darker pigmented skin and implications for managing vitiligo in this setting. • Classify current and emerging treatments for acne patients, including recommendations for treating the pediatric patient population. • Summarize the challenges associated with different acne and rosacea treatment options for patients with skin of color • Prioritize how to diagnose acne and rosacea in patients with skin of color. • Articulate current and emerging AD treatments for pediatric patients. • Recognize the ways in which pediatric AD patients with SOC are affected in terms of managing their condition. • Distinguish the prevalence of keloids in the SOC population • Recall conventional treatment options for pediatric keloid patients CRITERIA FOR SUCCESS Statements of credit will be awarded based on the participant’s attendance and submission of the activity evaluation form. A statement of credit will be available upon completion of an online evaluation/claimed credit form at www.southbeachsymposium.org. You must participate in the entire activity to receive credit. If you have questions about this CE activity, please contact AKH Inc. at tbrignoni@akhcme.com.
Credit provided by AKH Inc., Advancing Knowledge in Healthcare
In support of improving patient care, this activity has been planned and implemented by AKH Inc., Advancing Knowledge in Healthcare and Tarsus Cardio dba LiVDerm. AKH Inc., Advancing Knowledge in Healthcare is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team. This activity was planned by and for the healthcare team, and learners will receive 1 Interprofessional Continuing Education (IPCE) credit for learning and change. Physician AKH Inc., Advancing Knowledge in Healthcare designates this live activity for a maximum of 1 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Nurse 1 ANCC contact hours Physician Assistant AKH Inc., Advancing Knowledge in Healthcare has been authorized by the American Academy of PAs (AAPA) to award AAPA Category 1 CME credit for activities planned in accordance with AAPA CME Criteria. This activity is designated for 1 AAPA Category 1 CME credits. PAs should only claim credit commensurate with the extent of their participation.
24 www.livderm.org
COMMERCIAL SUPPORT This activity is supported by educational grants from Galderma Laboratories, L.P., Incyte Corporation. DISCLOSURE It is the policy of AKH Inc. to ensure independence, balance, objectivity, scientific rigor, and integrity in all of its continuing education activities. The author must disclose to the participants any significant relationships with ineligible companies whose products or devices may be mentioned in the activity or with the commercial supporter of this continuing education activity. Identified conflicts of interest are mitigated by AKH prior to accreditation of the activity. AKH planners and reviewers have no relevant financial relationships to disclose. Disclosures NAME
RELATIONSHIP
COMPANY
Valleri Callender, MD
Consultant
Janssen , Novartis , UCB
Speakers Bureau
Aerolase
Advisory Board
Dermavan Sciences, Foundation for Research & Education of Dermatology
Consultant
Galderma Laboratories, Cassiopea SpA, Ortho Dermatologics, SkinCeuticals LLC, Dermira, Almirall, Scientis Sente Labs, Foamix, Pfizer Inc., Verrica Pharmaceuticals, Inc, Ferndale, Avita, Gore Range Capital, Incyte Corporation, Bristol Myers Squibb, UCB
Contracted Research
Abbvie, Atacama, Incyte Corporation, Dermavant Sciences, Novan, AOBiome, LLC, Brickell Biotec
Speakers Bureau
Almirall, Ortho Dermatologics
Stock
Gore Range Capital
Consultant
Allergan, Almirall, Bioniz, Cassiopea, Covance, eResearch Technology, Inc., Galderma, Incyte, Johnson & Johnson, Keranetics, Lilly, Merck & Co., Inc., Pfizer Proctor & Gamble, Revian, Samumed
Contracted Research
Allergan, Cassiopea, Concert Pharmaceuticals, Incyte, Pfizer Proctor & Gamble, Samumed
Royalties
Informa Healthcare, UpToDate
Dorothy Caputo, MA, BSN, RN - CE Director of Accreditations
N/A
Nothing to disclose
LiVDerm Planners and Reviewers
N/A
Nothing to disclose
AKH Planners and Reviewers
N/A
Nothing to disclose
Seemal Desai, MD
Amy McMichael, MD
All of the relevant financial relationships listed for these individuals have been mitigated. DISCLAIMER This course is designed solely to provide the healthcare professional with information to assist in his/her practice and professional development and is not to be considered a diagnostic tool to replace professional advice or treatment. The course serves as a general guide to the healthcare professional, and therefore, cannot be considered as giving legal, nursing, medical, or other professional advice in specific cases. AKH Inc. specifically disclaim responsibility for any adverse consequences resulting directly or indirectly from information in the course, for undetected error, or through participant’s misunderstanding of the content. DISCLOSURE OF UNLABELED USE AND INVESTIGATIONAL PRODUCT This educational activity may include discussion of uses of agents that are investigational and/or unapproved by the FDA. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.
www.livderm.org 25
Non Educational Content
26 www.livderm.org
The 2021 South Beach Symposium gratefully acknowledges the following:
ASSOCIATION
www.skinofcolorsociety.org
MEDIA
The South Beach Symposium (SBS) gratefully acknowledges the independent grant support received from:
SBS Part I General Support
SBS Part I Satellite Symposia
• Janssen • Pfizer • Sirnaomics
• Galderma • Incyte • Janssen • Pfizer www.livderm.org 27
PROFESSIONAL Poster Sessions 1. Andreas Sygros Hospital
11. Dr. Kircik
19. Peter MacCallum Cancer Centre
Primary analysis of Phase 2 results for cemiplimab in patients (pts) with locally advanced basal cell carcinoma (laBCC) who progress on or are intolerant to hedgehog inhibitors (HHIs) Alexander J. Stratigos,1 Aleksandar Sekulic,2 Ketty Peris,3 Oliver Bechter,4 Martin Kaatz,5 Karl D. Lewis,6 Nicole Basset-Seguin,7 Anne Lynn S. Chang,8 StĂŠphane Dalle,9 Almudena Fernandez Orland,10 Lisa Licitra,11 Caroline Robert,12 Claas Ulrich,13 Axel Hauschild,14 Michael R. Migden,15 Reinhard Dummer,16 Siyu Li,17 Timothy Bowler,17 Matthew G. Fury17
Oral Sarecycline For Treatment Of Papulopustular Rosacea: Results Of A Pilot Sudy Evaluation Of Effectiveness And Safety James Q. Del Rosso, DOa; Leon H. Kircik, MDb; Cheryl Effron, MDc; Zoe D. Draelos, MDd
Phase 2 study of cemiplimab in patients (pts) with advanced cutaneous squamous cell carcinoma (CSCC): longer follow-up Danny Rischin,1 Nikhil I. Khushalani,2 Chrysalyne D. Schmults,3 Alexander Guminski,4 Anne Lynn S. Chang,5 Karl D. Lewis,6 Annette M. Lim,1 Leonel Hernandez-Aya,7 Brett G.M. Hughes,8 Dirk Schadendorf,9 Axel Hauschild,10 Elizabeth Stankevich,11 Jocelyn Booth,11 Siyu Li,11 Zhen Chen,11 Emmanuel Okoye,12 Israel Lowy,11 Matthew G. Fury,11 Michael R. Migden13
4. Castle Biosciences Development, Validation, and Clinical Utility of the 35-Gene Expression Profile Test for Use as an Adjunctive Melanoma Diagnostic Tool Matthew S. Goldberg, M.D.1,2, Aaron S. Farberg, M.D.3, Kelli L. Ahmed, Ph.D.1, Christine N. Bailey, M.P.H.1, Jeffrey Wilkinson, Ph.D.1, Brooke H. Russell, Ph.D.1, Kelly Douglas1, Clare Johnson, R.N.1, Olga Zolochevska Ph.D.1, Kyle R. Covington, Ph.D.1, Robert W. Cook, Ph.D.1
12. Dr. May E. Venturanza Efficacy and Safety of Ruxolitinib Cream for the Treatment of Atopic Dermatitis: Pooled Analysis of Two Phase 3, Randomized, Double-Blind Studies Kim Papp, MD, PhD,1 Jacek C. Szepietowski, MD, PhD,2 Leon Kircik, MD,3 Darryl Toth, MD,4 Michael E. Kuligowski, MD, PhD, MBA,5 May E. Venturanza, MD,5 Kang Sun, PhD,5 Eric L. Simpson, MD, MCR6
13. Dr. Phillip Frost Dept of Dermatology & Cutaneous Surgery Loose Anagen and Short Anagen Syndrome Registry: Establishment and Future Prospects aEran C. Gwillim, MD, aMichael J.
5. Castle Biosciences
14. LEO Pharma
31-Gene expression profiling improves risk stratification in patients with T1 cutaneous melanoma Ann Quick, Brian Martin, Christine Bailey, Kyle Covington, Robert Cook
Efficacy and safety of tralokinumab in a United States subpopulation of patients with moderate-to-severe atopic dermatitis: a subanalysis of ECZTRA 3, a phase 3, randomized, double-blind, placebo-controlled study B.E. Elewski,1 M.J. Zirwas,2 K. Veverka,3 J. Zoidis,3 A. Kurbasic,4 J.I. Silverberg5
6. Castle Biosciences Clinical utility of the 40-gene expression profile (40GEP) for improved patient management decisions and disease related outcomes when combined with current clinicopathological risk factors for cutaneous squamous cell carcinoma (cSCC): Case Series J Au, MD1; SJ Kurley, PhD2; A Fitzgerald, PhD2; A-K Somani, MD, PhD1 1Indiana University School of Medicine; 2Castle Biosciences, Inc.
15. LEO Pharma
7. Castle Biosciences
18. Miami Cancer Institute
The Clinical and Financial Impact of the 31-Gene Expression Profile Testing on Sentinel Lymph Node Biopsy Patient Selection in Patients with T1b Cutaneous Melanomas Justin W. Marson, MD1, Ann Quick PhD2, Brian Martin PhD2, Graham H. Litchman, DO, MS3, Darrell S. Rigel, MD, MS4
Demographics, prior therapies, and reasons for cemiplimab treatment: prospective CemiplimAb-rwlc Survivorship and Epidemiology (C.A.S.E.) study in patients with advanced cutaneous squamous cell carcinoma (CSCC) Guilherme Rabinowits,1 Jade Homsi,2 Mina Nikanjam,3 Rhonda Gentry,4 John Strasswimmer,5 Suraj Venna,6 Michael R. Migden,7 Sunandana Chandra,8 Emily Ruiz,9 Haixin R. Zhang,10 Jennifer McGinniss,10 Alex Seluzhytsky,11 Jigar Desai10
9. Cerave Racial/ethnic variations in skin barrier: Implications for skin care recommendations in skin of color. Andrew F. Alexis1*, Heather Woolery-Lloyd2*, Anneke Andriessen3, Seemal R. Desai4, George Han5, Maritza Perez6, Wendy Roberts7, Susan Taylor8
28 www.livderm.org
Efficacy and safety of tralokinumab in a United States subpopulation of patients with moderate-to-severe atopic dermatitis: a subanalysis of ECZTRA 1 and 2, two phase 3, randomized, double-blinded, placebo-controlled trials A. Blauvelt,1 N.J. Korman,2 N. Bhatia,3 K. Veverka,4 J. Zoidis,4 A. Kuznetsova,5 E.L. Simpson6
20. Regeneron Patterns of hedgehog inhibitor (HHI) treatment interruptions and reinitiations among patients with basal cell carcinoma (BCC) in real-world clinical practice Jessica J. Jalbert1, Chieh-I Chen1, Ning Wu1, Matthew G. Fury1, Emily Ruiz2, Wenzhen Ge1
21. Skinbetter Science LLC Efficacy and Tolerability of a Double-Conjugated Retinoid/AHA Cream Containing Salicylic Acid in Subjects with Mild to Moderate Blemish-Prone Skin Deanne M. Robinson, MD, FAAD1; Daniel P. Friedmann, MD, FAAD2; Jennifer Gordon, MD2; Mitchell Wortzman, PhD3; Diane Nelson, RN, MPH3
22. Univeristy of Colorado Hospital Interim analysis of Phase 2 results for cemiplimab in patients (pts) with metastatic basal cell carcinoma (mBCC) who progressed on or are intolerant to hedgehog inhibitors (HHIs) Karl D. Lewis,1 Ketty Peris,2 Aleksandar Sekulic,3 Alexander J. Stratigos,4 Lara Dunn,5 Zeynep Eroglu,6 Anne Lynn S. Chang,7 Michael R. Migden,8 Siyu Li,9 Kosalai Mohan,9 Ebony Coates,9 Emmanuel Okoye,9 Jean-François Baurain,10 Oliver Bechter,11 Axel Hauschild,12 Marcus O. Butler,13 Leonel Hernandez-Aya,14 Lisa Licitra,15 Rogerio I. Neves,16 Emily S. Ruiz,17 Frank Seebach,9 Israel Lowy,9 Timothy Bowler,9 Matthew G. Fury9
23. Univeristy of Texas Cemiplimab improves health-related quality of life (HRQoL) and reduces pain in patients with advanced cutaneous squamous cell carcinoma (CSCC): results from a post hoc exploratory analysis of a Phase 2 clinical trial Michael R. Migden,1 Danny Rischin,2 Medha Sasane,3 Vera Mastey,4 Anna Pavlick,5 Chrysalyne D. Schmults,6 Zhen Chen,4 Alexander Guminski,7 Axel Hauschild,8 Denise Bury,9 Stacie Hudgens,10 Anne Lynn S. Chang,11 Guilherme Rabinowits,12 Sherrif Ibrahim,13 Matthew G. Fury,4 Israel Lowy,4 Siyu Li,4 Chieh-I Chen4
Providing personalized, clinically actionable, tumor-specific genomic information to enable more accurate treatment plan decisions
Accurately identify the risk of recurrence or metastasis Accurately identifies risk of recurrence or metastasis in Stage I-III cutaneous melanoma patients Informs two key clinical management decisions:
Sentinel Lymph Node Biopsy (SLNB patient selection Intesity of follow up, surveillance imaging and referral to surgical or medical oncology Classifies test results as Class 1A, Class 1B/2A, Class 2B Studied in over 5,700 patients Over 58,000 tests ordered to date Supported by evidence from over 25 peer-reviewed publications including 2 meta-analyses Achieves level 1A evidence classification 230+ clinical US sites in collaboration with Castle Biosciences
More accurately identify the risk of metastasis Accurately identifies risk of metastasis in SCC patients with one or more risk factors Classifies patients as low risk (Class 1), moderate (Class 2A) or high (Class 2B) biological risk of metastasis Results can inform management decisions within established guidelines for SCC patients Provides unique, complimentary information for SCC management Supported by four peer-reviewed publications
Testing Instructions Ordering DecisionDx tests are simple, with minimal burden to physician office staff. To submit an order, download the requisition form from the website visit CastleTestInfo.com or fax the following items to Castle Biosciences at 866-712-5207:
1. Requisition Form
(complete with physician signature)
2. Letter of Medical Necessity
(template available) complete with treating physician signature
Improving diagnostic resolution for the benefit of patient care A highly accurate and objective test for difficult-todiagnose melanocytic lesions Designed to provide a result of either benign or malignant in >96% of lesions receiving a test result Classifies test results as Benign, Intermediate-Risk or Malignant Added diagnostic clarity provides confidence to dermatopathologists while helping dermatologists deliver more informed patient management plans
Contact us at
CastleTestInfo.com
3. Pathology Report
(from the primary biopsy specimen)
4. Copy of patient’s insurance Information On average, results are available within 5 days from the time a sample is received in the Castle Biosciences laboratory. Results will be sent via fax and available to view online through our secure online portal. Delivery via US mail is available upon request.
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BirchBioMed Inc. Announces Positive Topline Data from Phase 2 Study of FS2 for Treatment of Keloid Scars Topical FS2 shows statistically significant improvement versus the market leader
VANCOUVER, BC – BirchBioMed Inc., a clinical-stage immunology company focused on the prevention and reduction of immunological fibrotic conditions and defects in the immune system, has announced statistically significant, positive results of a double-blind study into the safety and efficacy of topical FS2 in the treatment of keloid scars. FS2, the active ingredient in BirchBioMed’s FS2 cream, has been shown to inhibit the formation of collagen, which is the major component of scars. “The study definitively shows that FS2 has significant efficacy on mature keloid scars as compared not only to the vehicle control but to an active scar treatment (Mederma),” said Dr. Mark Nestor, M.D., Ph.D., the study’s principal investigator and director of the Center for Clinical and Cosmetic Research in Aventura, Florida. “Showing significant benefit on mature keloid scars points to significant efficacy for the treatment of hypertrophic scars as well as cosmetic benefit to all post-surgical scars.” The prospective randomized double-blind trial compared the safety and efficacy of topical FS2 versus the market leading scar cream (Mederma) and a vehicle (placebo cream) in the treatment of mature keloids in 75 subjects. Trial participants were evaluated using both the Vancouver Scar Scale (VSS) and the Patient and Observer Scar Assessment Scale (POSAS). The percentage change in VSS scores for FS2 showed a statistically significant improvement when compared to Mederma (p<0.001) and versus vehicle (p<0.05) at the conclusion of the 180-day trial. Secondary data analysis using POSAS showed dramatic patient satisfaction with FS2 patients scoring a 51% improvement with FS2 versus Mederma’s 28% (p<0.05) and vehicle 20% (p<0.01). Neither Mederma nor vehicle showed statistically significant improvement according to the subjects’ evaluations. “Subjects using FS2 graded the improvement in their scar greater than Mederma and vehicle at every time point culminating in highly significant differences at 180 days,” said Dr. Nestor. “This signifies that it wasn’t only the appearance of the keloid scar that changed over time with FS2 but more fundamentally the way the subject globally felt about the improvement. Furthermore, there were no safety concerns noted and no significant local skin reactions observed.” As BirchBioMed’s lead antifibrotic platform therapy, FS2 acts at the molecular level by reducing production of two primary extracellular scar-forming proteins (collagen and fibronectin) and by increasing the production of key scar-degrading enzymes (MMP-1 and MMP-3) to stop the formation of scars and promote the breakdown of existing scars. “We are delighted with the results of FS2 in providing a safe and effective treatment for disfiguring scars that often profoundly affect a patient’s quality of life,” said Mark S. Miller, chief executive officer of BirchBioMed. “Scarring poses a chronic and growing therapeutic challenge for millions of patients each year. The global cost of treating scars is expected to reach $41.8 billion in 2022, compared with $21.4 billion just three years ago. Moreover, the U.S. National Institutes of Health estimates that 11 million Americans suffer from keloid scars, making it all the more critical that we develop cost-effective and successful treatments.”
About BirchBioMed BirchBioMed Inc. is a clinical-stage immunology company focused on the prevention and reduction of immunological fibrotic conditions and reversing defects in the immune system. As a University of British Columbia (UBC) spinoff, BirchBioMed holds the exclusive, worldwide pharmaceutical license from UBC for two breakthrough medical technologies in the treatment of scarring and certain autoimmune diseases. For further information, contact: Susan Elliott Chief Marketing Officer BirchBioMed Inc. Phone: (905) 833-0826 susan.elliott@birchbiomed.com birchbiomed.com
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