Implementing Basket/Bucket and Umbrella Designs: What You Need to Know for Global Oncology Trials

Clinical Trials, Drug Discovery and Development, Life Sciences, Pharmaceutical,
  • Monday, May 08, 2017 | (External Link to Recording)
  • 60 min

Recent successes in the treatment of cancer have led to more complex trials such as master protocols using basket (or bucket) and umbrella designs. These combination designs, with or without cancer immunotherapy treatments, require careful deliberations to optimize dosages and include multiple tumor types in expansion cohorts. Making informed decisions in study design for your basket/bucket or umbrella trials requires relevant and timely evidence-based data.

This webinar will focus on some of the challenges faced in executing a complex global oncology trial. You will learn operational strategies to:

  • Make judicious selection of sites that have a proven track record for recruiting to oncology trials including multiple tumor types
  • Adapt your trial execution plan in response to emerging data from the development program, competitor data or health authority feedback
  • Plan ahead for regulatory approvals (and reimbursement) for successive indications and lines of treatment

We’ll also discuss the challenges around tumor tissue collection for archival, screening, sampling along with methods to support biomarker assays and optimize biomarker data availability.

Please join our experts with diverse backgrounds and perspectives. You’ll get up to speed on the rapidly evolving competitive clinical trial landscape in oncology and gain new insights on how to optimize your basket/bucket and umbrella designs.

Speakers

Amy Franke, Senior Director, Strategy and Planning, Covance

Amy Franke has been engaged in numerous early and late phase immuno-oncology programs, including umbrella and basket trials, across a diverse set of immune checkpoint inhibitors through to multiple vaccine products. She offers 20 years of experience in clinical research, including the past 15 years exclusively in management of oncology clinical trials within CROs, biotechnology and pharmaceutical companies. She has a bachelor’s degree in cellular and molecular biology and a master’s degree in bioethics.

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Bridget (Fitzsimmons) Weeks, Director, Project Management (Oncology), Covance

Bridget Weeks offers extensive oncology experience including immuno-oncology program leadership. She had more than 12 years of experience in clinical research and 16 years of global project management of Phase I-IV studies. Her focus is on Phase I-II oncology trials in both solid tumor and hematological cancer multi-study programs. Bridget has a bachelor’s degree in biology.

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Montessa Lizaso, RN, Senior Data Analyst, Strategy and Planning (Oncology), Covance

Montessa Lizaso is responsible for collecting various sources of scientific, marketing, community and clinical trials intelligence to enable program teams to precisely forecast and course-correct plans during study implementation. Ms. Lizaso brings the multidisciplinary skill and clinical insight of a registered nurse and research nurse to support Phase I, first-in-human trials with novel compounds from such sponsors as Novartis, Roche, and Merck, in an array of solid tumor types and immunotherapy treatments in oncology. Montessa Lizaso has a bachelor’s degree in nursing.

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Who Should Attend?

Executives, scientists and managers from pharma and biotech working in oncology drug development:

  • Strategic drug development
  • Clinical operations
  • Outsourcing and procurement
  • Clinical trial planning and optimization

Xtalks Partner

Covance

Covance is one of the world’s largest and most comprehensive drug development services companies, with annual revenues greater than $2 billion and more than 12,000 employees in more than 60 countries.

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