Conflict of Interest Statement: MTS has received consulting fees from attorneys representing plaintiffs in cases involving exposure to benzene, glyphosate and other chemical agents. DWF has received consulting fees from attorneys in cases involving exposure to asbestos, PCBs, TCE and other chemical agents. SM and HL are employees of Amgen. MF was an employee of Amgen during the initial meetings and is currently an employee of Expansion Therapeutics. The other authors declare no competing interests. The views expressed in this publication are those of the authors and do not necessarily represent the decisions, policy or views of their respective institutions. Reference to commercial products or services does not constitute endorsement. Manuscript word count: excluding references, tables and figure 6,883.Figure and tables; Manuscript figures: 1; Manuscript tables: 2