Considerations to Improve Patient Outcomes in Early Drug Development

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Premier Research | Regulatory Professionals, A Division of Premier Research

About this talk

Every drug development program must begin with an understanding of how the relevant key stakeholders factor into the development process. It’s not just a matter of courtesy; a comprehensive examination of the roles played by all participants has the potential to produce faster and more concrete results, leading to improved patient outcomes. Watch this webinar to learn about these and other vital product development considerations, such as: - Developing a framework for handling multiple endpoints for the drug’s go-to-market label - Determining the potential of adaptive design for optimizing the trial and evaluating the applicability of various adaptive design approaches - Key interactions and questions to ask when seeking regulatory input of pivotal study designs Presenters: Abie Ekangaki, Ph.D., Vice President, Statistical Consulting, Premier Research Rupa Doshi, Ph.D., Vice President, Oncology Strategy, Premier Research Naomi Kautz, Vice President, Regulatory Affairs, Regulatory Professionals, A Division of Premier Research

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Premier Research is a clinical research company, 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.