1. Introduction to TransCelerate
December 2017

2. 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

3. 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

4. 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)  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

5. 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

6. 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

7. 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.

8. Thank you