Introduction to TransCelerate Date updated November 2018

A Not-for-Profit Entity Created to Foster Collaboration TransCelerate: A Not-for-Profit Entity Created to Foster Collaboration Our Shared Vision: To improve the health of people around the world by accelerating and simplifying the research and development of innovative new therapies. from TransCelerate Overview, 08 June 2018

Current state of organization Today 2012 2016 19 MEMBER COMPANIES 25+ including 4 pharmacovigilance initiatives INITIATIVES TransCelerate Founded BioCelerate Founded 10 MEMBER COMPANIES Novartis most recent member focus on preclinical research 22 Country Network Span 13 Global Regulatory Authorities engaged 5 INITIAL INITIATIVES From CPT 101 Webinar, 27Sep2018 BREADTH & DEPTH Over 30 solutions being delivered across 25+ initiatives, across 3 strategic priorities CULTURE OF COLLABORATION With an effective and proven governance structure have increased the ease and desire to collaborate FACILITATING FUTURE PLATFORM TRIALS 12+ initiatives deliver solutions that facilitate future platform trials platform to enable data sharing

The Reach of our Global Membership is Expanding Membership is available to biopharmaceutical research and development organizations that engage in innovative discovery, development and manufacturing of new medicines*. There are over 1,000 people from Member Companies that design and develop TransCelerate solutions. from TransCelerate Overview, 08 June 2018 * to be eligible for membership, companies must meet specified eligibility criteria.

RESEARCH AND CRO COMMUNITY* PATIENT ADVOCACY GROUPS* External Collaboration will continue to play a critical role in achieving our future state As a single stakeholder organization, we understand the value of robust collaboration with key stakeholders* across the R&D ecosystem which provide unique and important insights and perspectives. INVESTIGATOR SITES* RESEARCH AND CRO COMMUNITY* PATIENT ADVOCACY GROUPS* New slide for replacement- from TransCelerate Overview, 08 June 2018 (Speaker Notes Legally approved 8-Apr-2017 for prior version of this slide) 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. OTHER ASSOCIATIONS* HEALTH AUTHORITIES* * Representative organizations, not exhaustive

TransCelerate’s Initiatives deliver practical solutions to overcome inefficiencies in research & development IMPROVE THE PATIENT AND SITE EXPERIENCE HARMONIZE PROCESS AND SHARE INFORMATION Clinical Research Access and Information Exchange Clinical Research Awareness eConsent eLabels Patient Experience Patient Technology Site Qualification and Training Shared Investigator Platform OUR MISSION: Collaborate across the global biopharmaceutical R&D community to identify, prioritize, design and facilitate implementation of solutions designed to drive the efficient, effective and high- quality delivery of new medicines Clinical Data Standards Common Protocol Template Common Statistical Analysis Plan Template* Comparator Network DataCelerateTM eSource Digital Data Flow* Investigator Registry Placebo Standard of Care Toxicology Data Sharing Site/Investigator Experience from TransCelerate Overview, 08 June 2018 ENHANCE SPONSOR EFFICIENCIES & DRUG SAFETY Advancing Safety Analytics* Clinical Data Transparency Data Monitoring Committee* Intelligent Automation Opportunities in Pharmacovigilance* Interpretation of Pharmacovigilance Regulations Protocol Deviations* Quality Management System Risk-Based Monitoring Value of Safety Information Data Sources * New Initiative launched in 2018

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