John Donaldson Email and Phone Number

• Leads companion diagnostic device validation studies and collaborates with pharma partners drug development program• Leads the external evaluations of internally developed devices • Joint Project Team member collaborating internally with cross functional team members and externally with CROs and pharma partners to ensure on time study completion • Authors and reviews study plans, protocols, and reports in support of PMA, De Novo, 510(k), Performance Evaluations, and Investigational Device Exemption submissions• Authors sections in regulatory submission packages for Health Authorities, Institutional Review Boards, and Ethics Committees • Responsible for the development and execution of device safety reporting to Health Authorities and ECs• Manages direct reports for specimen acquisition, biobanking, and clinical compliance

2016-2018• Leads companion diagnostic device validation studies and collaborates with pharma partners drug development program• Leads the external evaluations of internally developed devices • Joint Project Team member collaborating internally with cross functional team members and externally with CROs and pharma partners to ensure on time study completion • Authors and reviews study plans, protocols, and reports in support of De Novo, 510(k), Performance Evaluations, and Investigational Device Exemption submissions2013-2015• Project leader for the development of multiple IVDs in compliance with GMP and ISO quality regulationso Provided scientific/technical leadership to R&D scientists and associates on teamo Developed timelines and priorities for critical path items• Utilized customer requirements (design inputs) to develop product concepts and specifications (design outputs) that can be translated into actionable scientific activities.• Plan, execute, analyze, and present experiments on milestone tasks in support of strategic business needs to support 510(k), or other regulatory filing submissionso Assay protocol design and optimization; assay design verification, validation, and transfero Laboratory investigations, plans projects, and reviews and interprets scientific data and literature• Collaborate in a matrix environment with Regulatory, Marketing, Technical Services, Manufacturing, Quality, and Senior Leadership Team

Research and Development of diagnostic reagents under the Design Control process• Project leader for the development of multiple in vitro diagnostic reagents in a regulated environment• Conducts assay protocol design and optimization; assay design verification, validation, and transfer• Plans, executes, analyzes, and presents experiments on milestone tasks• Conducts laboratory investigations, plans projects, and reviews and interprets scientific literature• Provides performance data to support 510(k) and other regulatory filing submissions• Works in a matrix environment: regular interactions with Regulatory, Marketing, Technical Services, Manufacturing, and Senior Management• Corresponds with external customers, collaborators, and vendors• Performs activities in compliance with GMP and ISO quality regulations

Primary responsibility: Conduct pre-IND studies on TLK58747; work later published in Anticancer Research• Evaluated the cellular toxicity of lead Telik compounds for IND enabling studies• Examined signaling cascades impacted by Telik compounds using immunoblot analysis• Carried out cell proliferation assays using a BrdU incorporation ELISA• Performed apoptosis ELISA assays to evaluate caspase-3 activity in human cancer cell lines• Utilized flow cytometry to determine effect of Telik compounds on cell cycle progression

Studied Src kinase signaling under the guidance of Prof. G. Steven Martin