Status of Implementation and Maintenance/Governance Plans December 2017

Status of Implementation Over 4,300 Downloads of the CPT from TransCelerate website through November 2017! Member companies, other sponsors, academic institutions, major cancer centers health authorities. Across all major global regions. 15 Member Companies are implementing CPT. Implementation Status Reported via Public Survey: Study Phases using CPT I, II, III, IV Geographies where CPT is used N America, S America, UK, Europe, Japan, China, Asia Pacific, Africa/Middle East Therapeutic Areas where CPT is used Cardiovascular, Dermatology, Gastroenterology, Immunology, Infectious Diseases, Metabolic Disorders, Neuroscience, Oncology, Ophthalmology, Respiratory, Urology, Vaccines, Women’s Health, Devices Health Authority comments on CPT text/format 95% no comment; 5% comment(n=1); 0% rejected/mandatory revisions due to CPT text/format IRB/ERC comments on CPT text/format 100% no comment; 0% comment; Legally approved 8-Apr-2017

CPT Maintenance/Governance Plans Governance Model being refined Posted Template & Implementation Toolkit Ongoing Maintenance & Governance of Template Collect and report metrics and feedback Updates to the templates and libraries Update of the template and libraries as needed based on stakeholder feedback, regulatory guidance etc. Additional TA libraries Metrics to monitor extent of adoption, regulator feedback Metrics to assess efficiencies gained Feedback collected via the TransCelerate website Legally approved 8-Apr-2017

Testimonials and Value Stories See the additional Toolkit Resource “CPT Testimonials and Value Stories” for recent feedback from the CPT Community, including: Benefits realized by companies who have already adopted CPT Reactions to the template from internal teams (Sponsor) and external users Tips for organizations considering adopting CPT An example of a Sponsor CPT journey

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