Meeting Proceedings of the “Phase I: Where Science Becomes Medicine” Conference, Manchester, UK

Donna M. Graham1,2,3, Louise Carter1,2,3, Matthew G. Krebs1,2,3, Duncan Jodrell4, Anne Armstrong2,3, Elaine Kilgour1,2,5, Tim Illidge1,2,3, Joseph Clarke,2 Rachel Chown2, Kaye Williams1,2, Caroline Dive1,2,5, Janelle Yorke1,2, Clare Dickinson2,3, Andrew Hughes1,2,5, Fiona Thistlethwaite1,2,3, Rob Bristow,1,2,3 Natalie Cook1,2,31Division of Cancer Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK, 2Manchester Cancer Research Centre, Manchester, UK, 3The Christie NHS Foundation Trust, Manchester, UK, 4Cancer Research UK Cambridge Institute (CRUK), University of Cambridge, Cambridge, UK, 5CRUK Manchester Institute, Manchester, UKPhase I clinical trials are the gateway to establishing new treatments for cancer patients by translating preclinical scientific advances to the clinic. The traditional Phase I design has involved small groups of patients, investigating toxicity and patient safety, and the pharmacodynamic and pharmacokinetic activities of novel treatments. Recent years have seen a rapid evolution in the scope and conduct of Phase I trials.The “Phase I: Where Science Becomes Medicine” conference, was held between the 14th and 16th of July 2019 in Manchester, UK with a dedicated focus on Phase I cancer trials and an overview of the dynamic landscape of the field. Global experts presented and discussed the key issues facing Phase I clinical triallists in a city with a long history of drug development and translational cancer research.Discussions were held across 10 sessions on a range of interlinked topics related to Phase I clinical trials. These included: novel drug targets and their impact on trial design, biomarkers and precision medicine, immunooncology, radiotherapy combinations, advanced therapies and trial methodology. The conference involved a mixture of plenary lectures, keynote speaker sessions, debates, poster presentations, a parallel nursing workshop, and exhibitions from various organizations.Over 220 delegates attended the conference with global representation. Delegates had diverse backgrounds spanning academia, industry and International professional healthcare bodies. Each session of the conference commenced with a video featuring patients’ and caregivers’ voices. These detailed first-hand accounts of how cancer and clinical trials affect participating patients and their families and provided a reminder of the importance of these trials and a focus for each session. In addition, 31 abstracts were accepted to be presented as posters and are included in the conference proceedings. Prizes were awarded to the top five posters (abstract numbers 7, 8, 18, 20 and 26).The meeting was opened by Professor Robert Bristow and Dr Natalie Cook who described the vision for the Phase I program in Manchester and the changes in cancer treatments over recent years. This included the increasing use of personalised therapies and genomic profiling, incorporation of novel combination therapies and the use of radiotherapy within a real-world evidence clinical database.Professor Lillian Siu, Chair of the Drug Development Program at Princess Margaret Cancer Centre in Toronto, delivered the first keynote of the conference, presenting “Phase I: Past and present”. She gave a fascinating overview of the evolution of Phase I clinical trials with novel designs, increasing patient numbers, incorporation of biomarkers and the emergence of immunotherapy as areas of change over recent years. Alongside these changes, Phase I trialists are also carrying the responsibilities of Phase II and III triallists due to the evolution of trial design. Despite this, the critical endpoints of safety and establishing recommended Phase II dose remain. Professor Siu highlighted a shift in trial design, where patients play an increasingly important role in both the development of and participation in Phase I trials.Dr Howard (Skip) Burris, Chief Medical Officer and Head of the Drug Development Programme of the Sarah Research Institute and 2019 of the of detailed the for Phase highlighted the of Phase I trials at the recent meeting and critical of biomarkers for drug and of patient also the role of real-world for patient and the to the Phase I to how for trials be to for a of the patient to of and to the drug and biomarkers were the focus of the where the cancer patient have genomic to each was by Dr who and Professor who the were delivered from Dr Donna and Dr Matthew and of of drug the emergence of as a and for patients, a to profiling, to clinical and The in of genomic to each session on novel targets and the impact on trial on the of Phase I trials. Professor the with an of how targets have the and conduct of clinical trials. 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