Entries by David Stark
Maui Derm 2016 Highlights: Concerns for Using Biosimilars in Daily Practice
J. Wu, MD Are we following “first, do no harm”? Dr. Wu explained that non-medical switching of patients from originator products is already happening and it is affecting patients. Results from patients followed in Europe have indicated that patients with forced non-medical switches to biosimilars have more hospitalizations and emergency department and physician visits than […]
Maui Derm 2016 Highlights: Biosimilar Clinical Study Design, Extrapolation, and Interchangeability
B. Strober, MD, PhD Is it really the same? The designs of clinical trials for biosimilars are very different from those for originator agents: sample sizes are smaller and durations are shorter. All of these studies are aimed at demonstrating equivalence between the biosimilar and the originator. It is remarkable that approval for one indication may confer […]
Maui Derm 2016 Highlights: Pre-clinical Characterization of Biosimilars
A. Blauvelt, MD Before you consider a potentially less-expensive option, you need to understand exactly what you’re getting. A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an FDA-approved biological product, known as a reference product, and has no clinically meaningful differences in terms […]
Maui Derm 2016 Highlights: Pharmaceutical Counterfeits – Are They in Your Practice or in Patient Hands?
M. Gold, MD Dr. Michael Gold explained the grim reality – There continues to be a huge global marketplace for fake toxins, fillers, and similar aesthetic products promising efficacy at cheap prices. Fraught with innumerable safety risks, and derived from uncontrolled and dubious production methods, many of these fake products contain toxic or at best […]
Maui Derm 2016 Highlights: Leaders in Industry
G. Martin, MD P. Berns T. Curran J. Duffey Pharma Industry Leaders Defend Against Biosimilars: Industry leaders from AbbVie, Celgene and Anacor believe that they will able to defend current branded biologic products against biosimilars. AbbVie is expected to defend Humira against biosimilars in inflammatory diseases through 2022. These industry leaders explained that cutting costs […]
Maui Derm 2016 Highlights: Psoriasis
B. Strober, MD, PhD C. Leonardi, MD J. Gelfand, MD A. Blauvelt, MD A. Kavanaugh, MD L. Stein-Gold, MD Newer Biologic Therapies Show Promise for Psoriasis Relief: There has been increased focus on the IL-23/IL-17 in psoriasis and its treatment. IL-23 is upstream (targeted by tildrakizumab, guselkumab, and BI 655066), IL-17 is in the middle […]
Maui Derm 2016 Highlights: Pediatric Dermatology
S. Fallon-Friedlander, MD I. Frieden, MD L. Eichenfield, MD J. Treat, MD Our faculty presented some fantastic insights into pediatric dermatology including: Neonatal Herpes Simplex Virus – The Dark Side of the Force? Neonatal herpes simplex virus (HSV) infection is rare occurring in 1/2000 – 1/5000 live births. HSV encephalitis and disseminated HSV are most […]
Maui Derm 2016 Highlights: Dermoscopy Workshop
Ashfaq Marghoob, MD A two-step dermoscopy algorithm can be employed for the assessment of skin lesions: Step 1 is determination of whether a lesion is melanocytic or non-melanocytic and involves assessment of: Network Aggregated or peripheral rim of nodules Streaks Homogeneous blue pigment Parallel pattern on volar skin Pseudo-network system on the face If the […]
Maui Derm 2016 Highlights: Pigmented Lesions
Hensin Tsao, MD, PhD Ilona Frieden, MD Ashfaq Marghoob, MD Whitney High, MD, JD Keith Flaherty MD We should remember during examination and diagnosis that the number of nevi is a risk factor for melanoma. Especially when they vary in shape, size, and color. Literature supports the notion that the number of nevi (DN) can […]