External Research advances the scientific body of knowledge and contributes to the development of better medicines for patients.

Overview

This program is open to all researchers who are interested in conducting their own research. External investigators can collaborate with TESARO's R&D experts to develop preclinical programs or clinical trials. TESARO may provide compound and/or funding to support independent research activities.

TESARO's Areas of Research Interest

  • Research in oncology disease areas which provides additional scientific information or fills existing data gaps in TESARO's existing portfolio
  • Expansion in the understanding of expected risks and side effect management
  • Innovative combinations with strong scientific rationale
  • Identification of predictive biomarkers for patient selection or stratification
  • Patient Reported Outcomes Research

Researcher Requirements

  • You are qualified by training and experience to undertake the proposed research and have a current license, if necessary
  • The idea is yours and the research materials will be authored by you
  • You are not seeking funding for research that would otherwise be paid for by your institution
  • You have the ability to grant an option to license inventions arising from the research to TESARO

Researcher Responsibilities

  • Design and execution of the research with timely communication of results to TESARO
  • Compliance with all local laws and regulatory requirements
  • For clinical studies, public registration on a clinical trial website and reporting of serious adverse events
  • Analysis, reporting and publication of results

TESARO's Review Criteria

  • Designed to address a legitimate medical or scientific question related to the use of a TESARO product, product candidate or disease area of interest
  • Aligned with TESARO's medical and research strategy
  • Scientifically rigorous and capable of answering the trial or study hypothesis
  • Conducted by a qualified investigator at a facility with appropriate experience conducting research activities
  • Designed to meet ethical guidelines concerning human subjects in research

Timelines for Review

Preclinical submissions are reviewed on a rolling basis and can be sent in at any time. Clinical submissions are reviewed on a quarterly basis, as outlined in the table below.

Clinical Reviews Timeline

Investigator Concept Submissions

Rolling

Investigator LOI
Including Budget Estimate

December
15
March
15
June
15
September
15

TESARO Communication
of Decision

February May August November

Investigator Full
Protocol Submission

May
15
July
15
October
15
January
15

TESARO Protocol
Comments to Investigator

within 4 weeks of protocol submission

Revised Protocol
Submission by Investigator

within 3 weeks of receipt of comments