Why Industry Collaborations Matter TransCelerate BioPharma, Inc.

Transcription

1 Why Industry Collaborations Matter TransCelerate BioPharma, Inc. Jackie Kent Eli Lilly & Co. Shared Investigator Platform Initiative Leader, TransCelerate BioPharma Inc. Introduced by: Carlo Maccarrone GlaxoSmithKline Australia Country Lead, TransCelerate BioPharma Inc. 1

2 Faculty Disclosure In compliance with ANCC Guidelines, I hereby declare: I do not have financial or other relationships with the manufacturer(s) of any commercial service(s) discussed in this educational activity. Jackie Kent Senior Director, Product Delivery Supply Planning and Systems 2

3 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. 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. Founded in 2012 by 10 Members

4 TransCelerate Today 18+ Organizations and 14 Active Initiatives Today Member Companies 5 Active Initiatives 17 Member Companies 12 Active Initiatives 1 Exploratory Initiative 18 Member Companies 14 Active Initiatives 2 Ideation Efforts 2 Realized Initiatives 1 exploratory Initiative 10 Founding Members 5 Active Initiatives

5 TransCelerate s Portfolio of Initiatives

6 Several Initiatives seek to alleviate burdens placed on Investigator Sites TransCelerate s Portfolio of Initiatives focus on Quality, Patient Safety, and Accelerated Development Timelines.

7 The Investigator Registry 7

8 Before the Investigator Registry Inefficient and burdensome: Sponsors invest resources, significant time and budget in identifying qualified investigators and setting up study sites. Our objective: To establish a investigator database across the Pharma industry. Providing a global collaborative system that would be beneficial for clinical trial efficiency and productivity.

9 The Investigator Registry

10 The Investigator Registry : Benefits to Sites 1. Improve the Site Investigator experience as they work with Sponsors to execute Clinical Trials 2. Reduce burden on sites to constantly update multiple records 3. One definitive source for Investigator information 10

11 The Shared Investigator Platform 11

12 The Shared Investigator Platform

13 Before the Shared Investigator Platform Inefficient and burdensome: Clinical trial sites must use many different websites, each requiring unique login credentials, to perform clinical trial responsibilities and communicate with their Sponsors. Site staff repeatedly prepare and provide the same information to each of their Sponsors. This is time consuming, cumbersome and often difficult. Our objective: Reduce the burden on investigative sites by providing them with a single point of access, harmonized content and services, and streamlined interaction with participating clinical trial Sponsors. Benefits: Ease of use, reduced burden on sites, and harmonized clinical trial content and services for investigative sites and sponsors.

14 How did we approach the project? We engaged the Site Community. Site Advocacy Groups Provided direct input to shape the platform s functionality, design, and features.

15 SIP Landing Page Single Sign On Profiles at User and Facility Levels Dedicated 24/7 Help Desk

16 The Shared Investigator Platform : Benefits Shared Investigator Platform Quality, streamline processes, regulatory compliance, capacity. Costs related to: Training Document exchange Support & maintain Help desk Startup time Investigators Productivity (via reduced redundant tasks & streamlined processes), access to information. Study startup time, redundant training. Streamlined electronic audit process, insight into trial, harmonized information model.

17 SIP Roadmap - Release 1 Single Sign On User Profile Facility Profile Training Feasibility Surveys Study Workspace Document Exchange Tasks, Alerts & Notifications Dashboards and Reporting Search capabilities Release 2 (Proposed functionality) Document Management (e.g., versioning, workflow, e-signatures, Integration to sponsor etmf Safety Letters Surveys -new types, analysis Enhanced functionality Expanded Reporting Release 3 (Future proposed features) PI/Sponsor Collaboration Online FAQ Discussion Boards Online Meeting Investigator Payments Non-drug supply ordering Drug supply ordering/iwrs The Shared Investigator Platform - developed with sites, for sites.

18 After Release 2* SIP Will Enable a Site User to: * Orange text denotes proposed R2 new features/functions

19 Integrated Tasks and Activities are One Example of how SIP Creates a Streamlined User Experience

20 SIP User Profile

21 SIP Facility Profile

22 Creating the CV in SIP

23 Abbreviated CV

24 Site Qualification & Training 24

25 Before Site Qualification & Training Inefficient and burdensome: Redundant training (e.g. Good Clinical Practice (GCP) & EDC training) and inconsistent processes to collect non-study specific information are pain points for investigators, sites, and biopharmaceutical companies. Our objective: Simplify and enhance the clinical trial site qualification and training process by creating efficiencies with a site-level focus. Benefits: Realization of improved quality of clinical site and improved study start-up times. Also, improved collaboration with sites.

26 Site Qualification and Training: Benefits to Sites 1. Reduced study start up times. 2. Reduced administrative burden as sites no longer have to repeat the same information in different formats. 3. Less redundancy in GCP & EDC System Training re-training, as participating Sponsors accept completion credit. 4. You have more time to focus on the protocol.

27 Site Qualification and Training Resources GCP Training Mutual Recognition: 12 Member Companies and 110+ external training providers have attested that their GCP training courses meet the mutually recognized minimum criteria 115,000+ GCP training completion certificates issued by 9 Member Companies Forms and Templates: Downloadable from TransCelerate Website Financial Disclosure Form (FiDS) Protocol Informed Consent Tracking Log Site Profile Form Curriculum Vitae Template Form FDA 1572 Guidance for Completion Site Signature & Delegation of Responsibilities Log Site Specific Informed Consent Tracking Log Informational Programs for Investigator Sites: 12 programs published and viewable on website *Note: Some TransCelerate Member Companies do not have ability to report on number of certificates issued which is why number only represents 9 members.

28 Site Qualification and Training Resources GCP Training Mutual Recognition: Forms & Templates: *Note: Some TransCelerate Member Companies do not have ability to report on number of certificates issued which is why number only represents 9 members.

29 Site Qualification and Training Resources GCP Training Mutual Recognition: *Note: Some TransCelerate Member Companies do not have ability to report on number of certificates issued which is why number only represents 9 members.

30 Site Qualification and Training Resources Informational Programs for Investigators: Basic, readily available information in the key concepts of Clinical Research. The program consists of 12 topics. Each topic s run time varies between 20 to 40 minutes. Does not replace GCP Training.

31 Common Protocol Template 31

32 Before The Common Protocol Template Inefficient and burdensome: Ever-longer and more complex protocols mean: Interpreting multiple sponsors formats and layouts Searching for key information Creating worksheets and flowcharts to make sense of the protocol Our objective: Create a model protocol with a streamlined heading structure, harmonized language that can be used across study types, and libraries of text for specific participant types and therapeutic areas (including objectives and endpoints)

33 The TransCelerate Common Protocol Template A streamlined, highly flexible protocol template Intended for use in any phase trial and in any disease area Developed and maintained by TransCelerate member company subject matter experts Available to download for any sponsor or organization Voluntary for any sponsor to adopt Sets the stage for future end-to-end automated data flow 33

34 The Model for the Common Protocol Template Libraries group and store content which is used to populate the template Model Endpoint Definitions developed for asthma and diabetes Libraries Healthy Volunteer Patient Asthma Diabetes Core Protocol Backbone Common Level 1 & 2 Headings Common text Used across all phases Focus on investigators Appendices Non-study specific info, items triggered by event Core is streamlined and focused on site needs Proposed Appendices to apply as applicable A sustainable Governance Model is currently in development Common Protocol Template and Guidance Governance Model Implementation materials in Toolkit 34

35 Common Protocol Template The Benefit to Sites 1. Improved site access to information with streamlined structure and increased consistency across protocols. 2. The Common Protocol Template will improve your access to information with protocols streamlined and organized with investigator focus. 3. Common Protocol Template will increase consistency between sponsor protocols which makes it easier to conduct studies. 4. The Common Protocol Template reduces the need for additional workflow documentation such as study manuals. 35

36 36 Questions?