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Biologics in Dermatology:

Considerations for Patients and Clinical Trials


Date: Wednesday, October 4, 2017

Time: 11am EDT / 4pm BST (UK) / 5pm CEST (EU-Central)

Duration: 60 minutes

Featured Speakers:

Traditional dermatologic treatment methods, including topicals, phototherapies and traditional drugs, do not always fully meet the needs of patients with the most severe disease presentation. For these patients, biologics present alternative treatment options and hope for new avenues to recovery. This webinar explores the evolution of biologics within the dermatology landscape, with an emphasis on clinical trial considerations for sponsors developing biologic agents.

Learning Objectives:

  • Understand the genesis of the use of biologics for dermatological conditions
  • Explore the classes of dermatology biologics
  • Review the benefits of biologics vs. other dermatology therapies, including safety, patient compliance, and quality of life
  • Understand the clinical trial considerations for biologics including inclusion/exclusion criteria, site selection and enrollment, and safety management

Keywords: Clinical Trials, Biologics, Dermatology


    Darcee Duke Strube, Senior Vice President, Dermatology Division, Novella Clinical

    Ms. Strube is responsible for developing and implementing strategic direction and provides executive oversight for all dermatology projects at specialty CRO Novella Clinical. Ms. Strube has more than 35 years of experience in clinical operations and business development positions in sponsor, CRO and site organizations. Prior to joining Novella in 2016, she held key roles in the Clinical Trials Division of TKL Research.

    Ms. Strube has extensive therapeutic expertise including acne, actinic keratosis, onychomycosis, psoriasis, rosacea and wound healing. She earned a Bachelor of Science in Biology from Fairleigh Dickinson University in New Jersey.

    Dr. James J. Milbauer MD, Dermatologist, Medical Monitor, Advisor

    James J. Milbauer, MD, is a board-certified dermatologist in private practice in Parsippany, New Jersey specializing in Dermatology and Dermatologic Surgery in adults and children. A seasoned researcher, Dr. Milbauer has served as a medical monitor and as a principal investigator for dozens of dermatology clinical trials over the past 15 years.

    A contributor to the Journal of the American Academy of Dermatology and The American Journal of Clinical Dermatology, Dr. Milbauer earned his medical degree from Albert Einstein College of Medicine of Yeshiva University and has been in practice for more than 20 years.


    Clinical study professionals responsible for dermatology drug development and clinical research in North America and Europe.

    VPs/Directors of:

    • Clinical Operations
    • Outsourcing
    • Procurement
    • Project Management
    • Study Management
    • Regulatory Affairs

    Novella Clinical, a Quintiles company, is a full-service specialty dermatology CRO led by a team of specialists with 20+ years of experience and global in-house expertise spanning dermatology products and aesthetics. Our specialists focus on the unique requirements of your program including regulatory, study design and patient recruitment needs. With strong clinical expertise and industry-leading technologies, Novella brings your dermatology product to market quickly and efficiently. For more information, visit novellaclinical.com/dermatology.

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