New treatment options for moderate to severe dermatological diseases and areas of high unmet need are driving a revolution in clinical development of dermatology drugs. But questions remain: What indications should be pursued? How to design a study that targets the right endpoints? And how will environmental constraints affect the research?
This webinar will explore dermatology trials from the vantage point of study design, patient access, data quality, regulatory considerations, and more. Panelists will discuss what’s required to understand the disease burden, patients’ treatment goals, and critical elements in devising effective recruitment and retention strategies.
Panelists will discuss the importance of careful study design in creating a trial that meets regulatory and safety guidelines and selects endpoints that will demonstrate the value of the investigational drug while staying flexible throughout the trial. The webinar will also examine the evolving regulatory environment, emphasizing the importance of early communication with regulators — including what to ask and how.
Other topics will include:
- How an innovative clinical development plan can get you to market sooner, with a competitive edge
- Five operational considerations to keep top of mind
- What corners you absolutely cannot cut
- Best practices in the current clinical development landscape
Speakers
Jasmina Jankicevic, M.D., Vice President, Medical Affairs, Dermatology and Medical Aesthetics, Premier Research
Dr. Jasmina Jankicevic works with pharma, biotech, medical device and cosmetic companies to drive clinical development, medical affairs and successful commercialization of innovative dermatologic and medical aesthetics solutions.
As a clinician, researcher, teacher and industry leader, Dr. Jankicevic has dedicated 20 years to innovation and optimization of therapeutic paradigms for more than 30 skin disorders including psoriasis, acne, rosacea, atopic dermatitis, skin and nail infections, wounds, hair loss, pigmentary disorders, autoimmune bullous dermatoses, genodermatoses, connective tissue diseases, photodamage, actinic keratosis and skin cancers. Jasmina Jankicevic has successfully led clinical development programs and medical strategy in several companies including Premier Research, Allergan, Leo Pharma, and Murad. Dr. Jankicevic is a trained dermatologist, and scientist, certified clinical research professional, trained journalist, published author and sought-after speaker. She holds Medical Degree, Master of Medical Sciences Degree and Board-Certification in Dermatology and Venereology from University of Belgrade, Serbia.
Message Presenter
Kristi Miller, Ph.D., Head of Global Regulatory Affairs Strategy, RPI, A Division of Premier Research
Kristi Miller leads a diverse, cross-functional team of regulatory affairs professionals at RPI in developing and implementing global regulatory strategy in conjunction with clients across all stages of development and diverse therapeutic areas, including neurology, immunology, and oncology. Prior to joining RPI, Miller was the Director of Global Regulatory Affairsat Phamacyclics and previously spent 10 years at Genentech in the area of regulatory affairs, providing regulatory leadership and executed strategy for products across development (pre-IND through post-marketing), including indications in asthma and ophthalmology. Miller holds a B.S. degree in Genetic Engineering from Cedar Crest College and a Ph.D. in Tumor Cell Biology from Northwestern University.
Message Presenter
Lori Lombardo, Senior Director, Program Delivery, Premier Research
Lori Lombardo is currently a Senior Director, Program Delivery in the Dermatology Franchise. Lombardo is responsible for providing operational oversight of Dermatology studies within Premier Research and has over 24 years of industry experience in Pharmaceutical and Clinical Research Organizations. Lombardo has supported numerous therapeutic indications in Dermatology from Rare and Uncommon Dermatology studies to Dermatologic Device studies.
Message PresenterWho Should Attend?
Managers and above at biotech and specialty pharma companies with job functions including but not limited to:
- Clinical Operations
- Medical Affairs
- Project Management
- Regulatory Affairs
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Premier Research
Premier Research, a clinical research company, is dedicated to helping biotech, specialty pharma, and device innovators transform life-changing ideas and breakthrough science into new medical treatments.
As a global company, Premier specializes in the use of innovative technologies for smart study design and trial management to deliver clean, conclusive data to sponsors.
Whether it’s developing product lifecycle strategies, reducing clinical development cycle times, securing access to patients, navigating global regulations, maximizing the impact of limited rare disease data, or providing expertise in specific therapeutic areas, Premier is committed to helping its customers answer the unmet needs of patients across a broad range of medical conditions.
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