Introduction to TransCelerate December 2017

TransCelerate is a Not for Profit Entity Created to Drive Collaboration Founded in 2012 by 10 Members Our vision To improve the health of people around the world by accelerating and simplifying the research and development of innovative new therapies.   Our mission To collaborate across the global research and development community to identify, prioritize, design and facilitate implementation of solutions designed to drive the efficient, effective and high quality delivery of new medicines. Legally approved 8-Apr-2017

TransCelerate Founded Currently, 19 of the World’s Most Successful Biopharmaceutical Companies Comprise TransCelerate Membership 2017 2016 2014 TransCelerate Founded 19 Member Companies Launch of 2 Pharmacovigilance Initiatives Evolving Clinical Portfolio 12 Initiatives Delivering Solutions 7 Initiatives Focused on Facilitating Adoption Delivering an R&D Data Sharing Platform 25+ Solutions delivered to industry TransCelerate launched a subsidiary to focus on preclinical Currently 6 members Conducted Board Strategy Refresh 17 Member Companies 12 Active Initiatives 1 Exploratory Initiative 2012 10 Founding Members 5 Active Initiatives Growth of Global Impact: Country Network of 22 Countries Engagement with 14+ Global Regulatory Authorities

Engage with Key Stakeholders Patient Advocacy Groups Industry Initiatives Investigator Sites Regulatory Authorities Research and CRO Community Legally approved 8-Apr-2017 TransCelerate is well aware that it is part of a very wide healthcare eco-system. It is one thing to develop and design solutions that will benefit the pharma companies, it is another thing to get them adopted more broadly by the industry as a whole. Therefore it is critical for TransCelerate to engage with, and secure feedback from a variety of partners in the industry and regulatory bodies. Some examples: TransCelerate has engaged with BIO - BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations to ensure they understand what TransCelerate is trying to accomplish and are aware of TransCelerate’s proposed solutions for the industry. Secondly, as many of TransCelerate’s solutions are intended to improve efficiency at the study-level, ensuring that Investigator Sites and Clinical Research Organizations are aware of TransCelerate is important. To that end TransCelerate has an agreement with the Society for Clinical Research Sites (SCRS) www.myscrs.org  to establish dedicated Site Advocacy Groups, specifically to participate on TransCelerate workstream.  SCRS is a fast growing global organization created by the investigator community to advocate for the investigator community. SCRS provides TransCelerate direct access to investigative sites in the US, Europe, Latin America and soon China.   Through this newly formalized partnership, TransCelerate's working teams will have direct access to these top sites and investigators to gather timely input/feedback on various workstreams outputs. TransCelerate also engages with CROs through their trade organizations, ACRO and JCROA in Japan. Finally, TransCelerate recognizes the importance of open lines of communication & dialogue with regulatory bodies / health authorities around the world to ensure their input and guidance is obtained on proposed solutions and that their feedback is taken into account prior to any releases of deliverables. Efforts are ongoing to obtain this important input. We continue to reach out to key industry stakeholders for engagement opportunities at both a leadership and initiative level. IRBs and ERBs Coming 2016

How Does TransCelerate Work? Support & Resources (subject matter experts, time, overhead) WORKSTREAM Define problem scope Share best practices Discuss challenges Co-create solutions Member Companies Legally approved 8-Apr-2017 Industry Solutions

Info Sharing Harmonization TransCelerate Currently has 12 Active Initiatives Patient Experience & Information Sharing are focal areas of 2017 Focused on innovative solution delivery that is aligned to our future state with disciplined delivery in areas that are fit for TransCelerate Active Portfolio Patients Info Sharing Harmonization Sponsors Clinical Research Awareness Clinical Research Access & Info Exchange eLabels Patient Experience Patient Technology Common Protocol Template Data Standards Placebo / Standard of Care eSource Quality Management System Sites

TransCelerate and CPT Workstream Membership 19 member companies in TransCelerate 17 member companies have participated in the Common Protocol Template workstream Legally approved 8-Apr-2017 TransCelerate has 18 member companies with most member companies represented on the Common Protocol Template workstream.  This collective effort for the creation of the CPT has leveraged the talent and experience across the pharma industry.

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