ATI Early-Phase Clinical Trial Career Development Program

The Advanced Therapeutics Initiative (ATI) early-phase clinical trial career development program is a multidisciplinary workforce-development program designed to cultivate the next generation of leaders in advanced therapeutics, translational science, and early-phase pediatric clinical research.

The program provides physicians and physician-scientists with structured mentorship, experiential learning opportunities, and practical exposure to the development and execution of early-phase and first-in-child clinical studies. Through close engagement with ATI leadership, experienced investigators, regulatory experts, and operational teams, fellows will gain the skills necessary to lead innovative therapeutic development programs and conduct complex early-phase clinical trials.

Program Goals

The ATI early-phase clinical trial career development program aims to:

  • Develop a pipeline of investigators capable of leading early-phase and first-in-child clinical studies
  • Increase institutional expertise in investigator-sponsored INDs, cell and gene therapy development, and novel therapeutic platforms
  • Accelerate translation of promising discoveries into clinical studies
  • Strengthen Lurie Children's position as a national leader in pediatric advanced therapeutics
  • Foster cross-disciplinary collaboration among investigators, operational teams, and innovation partners

Program Tracks

Track 1: Investigator-Initiated Trials and IND Development

For investigators seeking to design and conduct investigator-initiated studies.

Goal: Investigators advance a therapeutic concept toward regulatory submission.

Track 2: Cell and Gene Therapy Development

For investigators interested in cellular and genetic therapeutics.

Goal: Fellows gain hands-on exposure to protocol development, trial operations, manufacturing considerations, regulatory strategy, and long-term follow-up requirements.

Track 3: Aspiring Early-Phase Clinical Trialists

For early-career investigators interested in becoming leaders in Phase I and Phase II clinical research.

Goal: Fellows participate in the design and execution of ongoing ATI-supported studies while developing expertise in protocol development, safety oversight, and trial leadership.

Program Components

  • Individualized mentor pairing
  • Experiential learning through active trial participation
  • Regulatory and IND education
  • ATI operational and infrastructure exposure
  • Networking with ATI leadership and institutional partners
  • Capstone project

Eligibility

  • Junior faculty
  • Senior fellows transitioning to faculty positions
  • Early-career investigators with demonstrated interest in translational science or clinical research