Kimberly Lindstrom
Senior Vice President - Regulatory Science & Gcp Quality Day One Biopharmaceuticals, Inc.
Regulatory professional with 20+ years of experience in academia and industry. Comprehensive experience in Regulatory Science encompassing global strategy, agency interactions, labeling, and NDA filings. A proven record of achievement through effective leadership and support of development teams with adaptability to deliver on evolving strategies.
Seminars
Tuesday 17th February 2026
Reconsidering Approaches to Regulatory Interactions to Overcome Challenges in Dose Selection, Preclinical Data Package and Clinical Endpoint Selection
2:00 pm
- Join this workshop to enjoy candid and actionable discussions around effectively communicating with regulatory agencies
- Exploring the necessary scientific and clinical data required to successfully advocate for regulatory waivers or alternative review pathways, particularly for a disease with a high failure rate and limited treatment options
- Innovative strategies for presenting a robust scientific rationale and a compelling data package that can persuade agencies to be more flexible, and for establishing a collaborative dialogue from the pre-IND stage through clinical development
- Discussing the validation of non-traditional endpoints and building strong scientific cases to convive regulators to accept them for accelerates approval, particularly given the
- challenges with endpoints like PFS and OS
- Discussing the benefits of a balanced perspective, where regulatory professionals from both the pharmaceutical industry and agencies can share their insights to better align on expectations and overcome shared challenges
- Discussing what a more flexible, adaptive regulatory framework for GBM drug development could look like including streamlining trial designs, facilitation biomarker driven
- patient selection and creating a clearer path to approval that incentivizes innovation whilst maintain patient safety
