505(b)(2) Formulation Considerations for New Topical Drug Products

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Discover how 505(b)(2) topical drug products extend market exclusivity!

Section 505(b)(2) provides a faster and more cost-effective pathway for approval of a new drug product. The pathway may apply to an already-approved drug for which a new therapeutic opportunity is identified, such as use in a new indication, a new route of administration such as topical or transdermal, a new dosage form or a new formulation. Unlike a generic product approval, an NDA via the 505(b)(2) pathway can provide several years of market exclusivity.

Stream this on-demand webinar “505(b)(2) Formulation Considerations for New Topical Drug Products” presented by Tioga Research's CEO, John M. Newsam, and Sinclair Research's Director of Toxicology and Dermatology, Dr. Jeffrey Klein, PhD, DABT, this live webinar will cover strategy, innovation, research and preclinical development program considerations for progressing 505(b)(2) topical drug programs to the clinic.

In our webinar, Sinclair Research and Tioga Research will help you learn: 

  • 505(b)(2) regulatory strategy considerations for topical drug products
  • Topical formulation considerations for optimize drug delivery
  • Preclinical testing requirements for 505(b)(2) topical drug products
  • Tips for selecting effective CRO partners to support your 505(b)(2) program

About the Presenters:

John_NewsamDr. John M. Newsam is CEO of Tioga Research, a research and early development CRO focused on formulation innovation of skin-applied products and skin permeation screening services based in San Diego, CA. In addition to leading Tioga’s innovative services, Dr. Newsam has decades of experience as a materials chemist and early phase biotech consultant and has authored over 170 scientific publications on topics such as high throughput experimentation, skin-applied formulations, zeolites and crystallography and materials simulation.

jeff_kleinDr. Jeffrey A. Klein, PhD, DABT, is a diplomate of the American Board of Toxicology and past president of the Society of Toxicology's Dermal Toxicology Specialty Section. Dr. Klein is responsible for Sinclair Research's scientific direction in toxicology and dermatology services and operational processes, bringing decades of experience as both a study director and program manager at CROs and as a Sponsor leading dermal toxicology programs for both pharmaceutical and biotech companies. In addition to his expertise in dermal toxicology, he has a strong background in molecular biology, neuroscience and genetics.

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