Peter Trask Email and Phone Number

• Consult on PCOR issues and reviewed and approve key PCOR deliverables• Contribute to the design, conduct, analysis & interpretation of PCOR research• Identify priorities within oncology, align with senior stakeholders to agree on what PCOR will commit to deliver, and resource team accordingly• Effectively communicate the value PCOR can bring to the TA• Be the key link with Regulators, Agencies, Key Opinion Leaders, Academics, Investigators and represent Roche externally on PCOR issues • Lead PCOR and cross-functional initiatives in addressing a variety of business needs• Provide input on forecasting for personnel & resources, recruitment• Accountable for staff development including performance reviews, input into individual development plans, training staff, & ensuring compliance of training

• Provide supervision to junior colleagues on development of PRO strategy• Create standardized processes for documenting PRO endpoints and strategy• Provide final functional review on study-related documents• Work with internal cross-functional teams to develop and implement outcome strategies that ensured relevant outcome endpoints and study design met the needs of global regulatory agencies and key stakeholders• Work with external key opinion leaders to obtain guidance on outcome implementation• Support the development and validation of instruments for outcomes as needed• Engage with the FDA and EU regulatory and HTA organizations around PRO endpoints• Manage internal and external supported activities to enhance PRO development

• Provide strategic insight into the proper implementation and execution of PROs and COAs across the Sanofi portfolio • Directly manage staff in Health Economics and Outcomes Research• Create training materials on PRO principles and appropriate administration of PROs in the clinical trials.• Represent payers-PRO needs to R&D early in Drug Development to support go/no-go decisions• Sanofi representative on external initiatives focused on PROs (e.g. Critical Path PRO Consortium), including those designed to shape the environment regarding policy, standards and use of PROs• Develop PRO questionnaires and endpoints for clinical development programs including those related to label claims; prepare relevant sections of documentation for regulatory agency meetings; participate in regulatory meetings; and provide robust evidence in support of submission activities related to PRO label claims

• Directly managed staff in Global Evidence and Value Development responsible for the Oncology portfolio and ensured the effective generation of HEOR strategic plans for each product within the portfolio• Created a patient-reported outcomes (PRO) Repository in Oncology to consolidate PROs and related information pertinent to a clinical trial to optimize efficiencies; established ePROs as the benchmark for assessing patient endpoints in Oncology trials• Developed strategies for assessing health economic and outcomes (including real-world evidence) for seven early (phase I/II) and two late (phase III) stage of development oncology programs • Responsible for the design, validation, implementation, monitoring, training, and analysis of PRO endpoints in phase II and III national and global clinical studies in solid and liquid tumors• Wrote abstracts and publications on the PRO outcomes from the clinical trials • Oversaw external vendors in the on time and budget completion of indirect treatment comparison studies and analyses of real-world treatment studies

Directly managed staff in Oncology Outcomes Research (OR) responsible for two late stage development compounds in NSCLC and NHLInformally mentored junior colleagues responsible for other compounds in the oncology portfolioDeveloped strategies for assessing health economic and patient-reported outcomes (PROs) for seven early (phase I/II) and two late (phase III) stage of development oncology programsResponsible for the design, validation, implementation, monitoring, training, and analysis of PRO endpoints in phase Ib, II, and III national and global clinical studies in solid and liquid tumorsWrote PRO sections of protocols, statistical analysis plans, clinical study reports, and summary of clinical efficacy from phase Ib though phase III clinical trialsWrote abstracts and publications on the PRO outcomes from the clinical trials Managed budgets approaching 1 million dollars and oversaw external vendors in the on time and budget completion of database and economic modeling studies, chart reviews, and AMCP and Global Value Dossiers. Collaborated with academic institutions to develop and validate patient-reported measures to assess symptom intensity and interference in various cancersCollaborated on the development of a set of standards for assessing issues (efficacy, safety, clinical and patient-reported endpoints) in Oncology trialsActively contributed to internal committees including tumor strategy teams, data standards committees, and protocol review committeesLed internal committees (PRO document standardization, Lung Cancer Tumor Team)Provided consultation to OR colleagues across therapeutic areas (pain/inflammation, dermatology, diabetes/obesity, depression)

Directly supported and implemented health economic and patient-reported outcome strategies for phase II-III Oncology development programsResponsible for the design, validation, implementation, monitoring, training, and analysis of HRQOL questionnaires for use in phase II-III national and global clinical studiesWrote HRQOL clinical study reports, protocols, abstracts and publications from phase II clinical trials. Provided mentoring to junior faculty in Oncology OR and consultation to OR colleagues across therapeutic areas (pain/inflammation, dermatology, diabetes/obesity, depression) Collaborated with academic institutions to develop and validate patient-reported measures to assess symptom intensity and interference in various cancers.Collaborated on the development of a set of standards for assessing issues (efficacy, safety, clinical and patient-reported endpoints) in Oncology trials.Led internal committees (educational task force, PRO document standardization, OR training for study managers)Represented Pfizer on Moffitt Quality of Care Initiative study meetings

Directly supported and implemented health economic and patient-reported outcome strategies for phase II-III Oncology development programsResponsible for the design, validation, implementation, monitoring, training, and analysis of HRQOL questionnaires for use in phase II-III national and global clinical studiesWrote HRQOL clinical study reports, protocols, abstracts and publications from phase II clinical trials. Collaborated with academic institutions to develop and validate a patient-reported measure to assess symptom intensity and interference in thyroid cancer.Validated a measure of patient satisfaction with cancer treatment.Collaborated on the development of a set of standards for assessing issues (efficacy, safety, clinical and patient-reported endpoints) in Oncology trials.Participated as a member of internal committees

Supported early development productsParticipated on study teams who were developing phase II clinical trialsParticipated as a member of internal committees