TransCelerate Overview. Tozheg Roshankar

Transcription

1 TransCelerate Overview Tozheg Roshankar 11, Aug, 2016

2 TransCelerate is a not for profit entity created to drive collaboration Our vision To improve the health of people around the world by accelerating and simplifying the research and development of innovative new therapies. Founded in 2012 by 10 Members 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. Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 2

3 TransCelerate Today 18+ Organizations and 15 Active Initiatives Today Member Companies 5 Active Initiatives 17 Member Companies 12 Active Initiatives 1 Exploratory Initiative 18 Member Companies 15 Active Initiatives 2 Realized Initiatives 1 exploratory Initiative 10 Founding Members 5 Active Initiatives Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 3

4 TransCelerate s Organizational Structure High engagement from member talent is a key attribute in our success. External Counsel Accounting Firm Board of Directors CEO SVP, Global Operations Audit Firm Administrative Asst. Oversight Committee Portfolio Management Communication & Engagement Operations Quality Finance Active Portfolio Subcommittees Leadership Project Management Team Members Key: Member Company Talent Enabling Functions (Regulatory, Technology, Communications, etc.) Leadership Project Management Team Members Permanent Position Contracted Resources / Member Resources Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 4

5 TransCelerate Strategic Priorities TransCelerate assesses industry challenges and selects initiatives aligned with our five strategic priorities: Improve the Site Investigator Experience Facilitate Information Sharing Enable Harmonization of Clinical Trial Processes Enhance Sponsor Efficiencies Improve the Patient Experience Improve the Site Investigator Experience as they work with Sponsors to execute Clinical Trials. Facilitate the sharing of clinical trial related information as appropriate amongst industry stakeholders, focused on exchanges of information that would enable the industry to capture efficiencies. Enable the industry to move toward greater harmonization of clinical trial processes to facilitate the advancement of technologies and processes within the broader clinical ecosystem. Through collaboration, streamline redundant sponsor activities to reduce investigator and Patient burden, while refocusing resources to drive and deliver innovative drugs to patients faster and safely. Improve the Patient Experience by enabling earlier access to well run clinical studies. Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 5

6 TransCelerate s Portfolio of Initiatives TransCelerate s Portfolio of Initiatives focus on Quality, Patient Safety, and Accelerated Development Timelines. Active Design, Develop, & Deploy Phase Clinical Data Standards econsent Clinical Data Transparency elabels Clinical Research Awareness & Access esource Common Protocol Template Investigator Registry Comparator Network Patient Experience & Technology Placebo / Standard of Care Data Sharing Quality Management System Risk Based Monitoring Site Qualification and Training Shared Investigator Platform Realization Phase Realization Phase Clinical Clinical Trial Trial Diversification Diversification Pediatric Pediatric Trial Trial Efficiencies Efficiencies Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 6

7 Collaboration Key to Success

8 Engage with Key Stakeholders We also recognized the need to collaborate not only across participating Member Companies, but also regulatory authorities and industry groups. Investigator Sites Industry Initiatives Research and CRO Community Regulatory Authorities Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 8

9 TransCelerate s Relationship with SCRS The creation of Site Advocacy Groups with the Society for Clinical Research Sites provide a valuable feedback channel for interacting with Investigators and sites for select initiatives during solution development 30+ meetings with SAGs held to date Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 9

10 For a project such as Shared Investigator Platform We engaged the Site Community. Site Advocacy Groups Provided direct input to shape the platform s functionality, design and features. The Shared Investigator Platform Developed with sites, for sites. Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 10

11 TransCelerate : Accomplishments to Date TransCelerate has already delivered notable accomplishments to the industry Designed a Risk Based Monitoring Methodology and issued subsequent publications across the industry showing an improvement in quality metrics, and > 15,000+ Unique downloads of TransCelerate Papers Operationalized an effective Good Clinical Practice (GCP) certification program to eliminate investigator sites taking duplicative GCP training with >130,000 GCP training certificates issued by 9 Member Companies and150 external training providers have attested that the training courses offered meet mutual recognition of minimum criteria. Launched the Investigator Registry and Shared Investigator Platform that will greatly enhance communication between sponsors and sites. Operationalized a network of TransCelerate Member Companies to secure Comparator Drugs for studies, with 100+ Product Transactions and transaction spend exceeding $100M. Launched a Common Protocol Template containing common structure and model language to improve accuracy in data recordation and speed study start up. Created a platform to share Placebo data from Clinical Studies across participating companies. Published a Clinical QMS Conceptual Framework taking a proactive quality approach to all stages of clinical research. Published a model approach for Data De-identification and Anonymization of Individual Patient Data in Clinical Studies. Launched BioCelerate - A subsidiary of TransCelerate focused on preclinical collaboration. Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 11

12 Stay Informed and Engaged Send questions, comments at any time Newsletter & Monthly s Sign up on our website to hear from us! Industry articles and updates LinkedIn: TransCelerate BioPharma Inc. Industry articles and updates on our initiatives Copyright 2015 TransCelerate BioPharma Inc., All rights reserved. 12

13 THANK YOU QUESTIONS?