CDER recently issued an updated draft guidance for Analgesic Indications. In this webinar, Brett Gordon and Ben Vaughn provide a high-level review of the agency’s guidance, offer strategies for analgesic product development and share experiences with PROs and paper vs. tablet collection. Ben Vaughn, Senior Statistical Scientist at Rho, has twelve years of experience in clinical research. He has participated in nearly 20 regulatory submissions, coproduced the ISE for two opioid products; and provided statistical consultation, display generation and submission work for four separate products for OA knee pain. Last spring he attended an FDA advisory committee to represent the sponsor for an opioid product. He has authored responses to various FDA queries regarding NDAs, PMAs, IDEs, and SPAs. Additionally, he has represented sponsors in FDA teleconferences and face-to-face meetings for both OA knee pain products and opioid products. His analytic experience includes cross-over studies, survival analysis, non-parametrics, and extensive work with linear and non-linear repeated measure models. Brett Gordon, Project Director at Rho, has more than fifteen years of overall clinical development experience, including eleven years in project management, encompassing trials of varying sizes and complexity, both domestically and internationally. He has extensive knowledge of clinical development including initial development plan formulation, protocol writing, trial implementation, monitoring and delivery, clinical study report writing, and regulatory submission to support of marketing applications. Brett has worked across numerous therapeutic areas and in particular possesses in-depth CNS experience, including four years at an orthobiologics company supporting clinical development activities for ultrasound bone healing and two hyaluronate products for osteoarthritis.

• published: 09 Oct 2014
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