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.
Register for 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
Speakers
Abie Ekangaki, Ph.D., Vice President, Statistical Consulting, Premier Research
Abie Ekangaki is responsible for bringing expertise in biostatistics to shape clinical trial design strategies and methodologies for regulatory submissions and otherwise and provides broad biostatistical consulting for both internal and external clients. He advises on efficient trial designs for clinical trial programs and applies his statistical expertise, drug development, and operational experience across different therapeutic areas.
With more than 25 years of experience as a biostatistician, Dr. Ekangaki has worked as a research scientist with the World Health Organization in Switzerland, as a statistics lecturer at Macquarie University in Australia, and has over 19 years in the pharmaceutical industry in both large pharma and CROs, where he has held several lead technical and senior leadership positions.
Message Presenter
Rupa Doshi, Executive Director, Program Strategy – Oncology, Premier Research
Rupa Doshi is an Executive Director, Oncology at Premier Research. With more than 23 years in the industry, Rupa is an experienced professional with demonstrated leadership skills in clinical operations, global project/program management, customer management and strategy development. Her experience spans the clinical development spectrum from pre-IND to NDA and she has also led global teams in the execution of full service complex clinical trials across all phases.
Rupa brings drug discovery and clinical development experience with biologics, small molecules as well as cell and gene therapy products over a range of indications. Her doctoral research focus was on breast cancer, her post-doctoral research was in site directed mutagenesis and she holds patents in the area of angiogenesis. Rupa has also supported three products resulting in agency approval.
Message Presenter
Naomi Kautz, Senior Director, Regulatory Affairs, RPI, A Division of Premier Research
Naomi brings 20 years of multidisciplinary experience in biotechnology/pharmaceutical industry in Regulatory Affairs, Research and Development, and Policy after receiving her academic training in biochemistry. Her tenure in Regulatory Affairs has spanned early stage through late stage development and NDAs. Since 2009, her area of focus in Regulatory Affairs has been in the development of cell and gene therapy. In 2018, Naomi joined Regulatory Professionals, a regulatory consultancy firm that provides regulatory expertise to small and mid-sized biotechnology and pharmaceutical companies for both biologics and small molecule drug development programs. RPI is a division of Premier Research.
Message PresenterWho Should Attend?
- Companies currently in or entering Phase 1 or Phase 2
- CEO/COO of biotechs
- Regulatory executives
What You Will Learn
In this webinar, participants will learn about:
- 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
Xtalks Partner
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. Visit premier-research.com.
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