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Quarter 4

Pulse on Progress

Table of Contents

Introduction

TransCelerate aspires for a future state where research and development is faster, more efficient and harnesses all the available information. We envision this happening in three ways:
  1. Full participation across all stakeholders – clinical trial sponsors, sites, investigators, health authorities, patients, and their healthcare providers
  2. Information is fully used to improve the overall quality, design, and development process. We protect patients through shared, proactive safety science
  3. Improving the execution of research and development through greater harmonization with the potential to conduct collaborative trials

Newest Resources and Company Milestones

  • After a successful career in drug development spanning more than 30 years, TransCelerate’s founding Chief Executive Officer Dalvir Gill announced his retirement, effective December 31, 2022. After an extensive search, the Board of Directors unanimously selected current Chief Operating Officer Janice Chang as TransCelerate’s new CEO, effective January 1, 2023.
  • In celebration of TransCelerate’s 10-year anniversary, hundreds of leaders from Member Companies around the world convened in Philadelphia for a special event to share in its success. Familiar faces of leadership filled the room, many of whom contributed to the foundational efforts within TransCelerate’s first five initiatives and have created a lasting impact that is still seen today. Leaders of TransCelerate and its Board of Directors shared their personal sentiments on the organization’s importance and impact of its solutions in the “Leadership Lens” video series.
    • Former TransCelerate CEO Dalvir Gill explained how the importance of the early, foundational work directly correlates to the transformational work that TransCelerate is taking on today.
    • Rod MacKenzie (formerly Chief Development Officer & Executive Vice President of Pfizer) shared his thoughts on the importance of the TransCelerate collaboration and the direct impact of TransCelerate to accelerate and simplify the processes related to development of the COVID-19 vaccine.Head, Global Development Kate Owen (Janssen Research & Development) shared her insights on the current challenges patients face and how TransCelerate’s Patients initiatives have influenced patient experience within clinical trials.
    • Head, Global Development Operations Badhri Srinivasan (Novartis) reflected on the Information Sharing initiatives and data sharing’s impact on the R&D ecosystem.
    • Peter Ronco (former Head, Global Development for Janssen R&D) shared his perspective on TransCelerate’s Process Harmonization Initiatives and how these solutions are enabling the industry to design better studies and automate the use and reuse of information to reduce the burden on healthcare systems and patients.
  • TransCelerate unveiled its strategic rebrand to better encompass the value and innovation that it brings to the biopharma ecosystem. The branding reflects the essence of how it brings together essential stakeholders—sponsors and the patient/ advocacy community; global Health Authorities; industry consortia; clinical investigator sites and academic research; CROs, technology and data providers—to “Accelerate Answers” to R&D’s most pressing drug development needs and get medicines to patients faster. The culmination of this effort was the launch of a new “About TransCelerate” video.

Pulse On Progress Updates

Information Sharing & Harmonization
Objectives

Enable the industry to move toward greater harmonization of process and facilitate the sharing of information amongst industry stakeholders to enable the industry to capture, optimize and experience efficiencies.

  • In the Fall of 2020, the Clinical Content & Reuse Initiative released “CSR Considerations for Studies Disrupted by the COVID-19 Pandemic.” Since that time, both ACRO and TransCelerate Member Companies have faced unprecedented interruptions to clinical trials caused by an increasingly diverse set of circumstances. ACRO and TransCelerate have taken the lessons learned from the past three years and published proposals to address these challenges in a new deliverable “Points to consider when developing a Clinical Study Report (CSR) for a clinical trial that has been disrupted due to unforeseen circumstances.”Additionally, the CC&R Solutions website has been updated the Implementation Toolkit to streamline resources and eliminate redundancy with an eye toward ease of maintenance and use. You can find more information in a Content Addendum document on the CC&R Solutions page.
  • Efforts are underway by the CC&R Initiative’s template content and technical experts to review and provide comments during the current public consultation period for the International Council for Harmonisation‘s (ICH) M11 Clinical electronic Structured Harmonised Protocol (CeSHarP) draft Guideline, Template, and Technical Specification, which have recently reached Step 2 of the ICH process. CC&R will continue to keep abreast of ICH M11 developments as the Expert Working Group continues through the ICH stepwise procedure.
  • The Privacy Methodology for Data Sharing Initiative released Clinical Data Sharing: A Proposed Methodology to Enable Data Privacy while Improving Data Utility to improve the quality and utility of the clinical trial data exchanged within TransCelerate’s Clinical Data Sharing via DataCelerate® while protecting patient privacy.This methodology builds upon existing industry solutions and reflects emergent thinking from TransCelerate Member Companies into recommendations and considerations for 14 key data variable types with examples and logic for how a transformation could appear before and after. This methodology aims to greatly improve transparency and reduce the variability in the data protection methods applied by companies to safeguard personal data in ways that will facilitate secondary reuse of data.

    With this launch, TransCelerate kicks off a public review period now through March of 2023, inviting the broader clinical R&D community to provide comments on the guidance and Data Transparency Checklist in the methodology.

  • Due to the emerging complexity of utilizing Real World Evidence (RWE) for regulatory decision-making, TransCelerate’s Real World Data Initiative developed the following resources:

    Through this exercise, the TransCelerate team identified the value of early internal sponsor cross-functional collaboration due to the unique scenarios that involve Real World Evidence. The purpose of the Preparing to Engage with Health Authorities on Real World Evidence document is to describe potential ways of engaging with Health Authorities (HAs), to discuss RWE proposals, and to better define some of the drivers of transparent RWE for regulatory decision-making that will promote sponsors’ understanding of HAs perspectives on RWE. The aim is to aid sponsor companies in the planning of a drug product development that intends to utilize RWE to answer research and/or regulatory questions. The document also provides recommendations to inform the development of study designs that will yield interpretable evidence that is fit for regulatory decision-making. These points are further explored through case studies based on sponsor company experiences that illustrate HA interactions and include the regulatory feedback and decisions obtained. The document primarily focuses on US and EU perspectives but many of these concepts can be applied globally.

  • The Real World Data Audit Readiness team is seeking public comment on its draft “RWD Audit Readiness Considerations” Public review is open until February 10, 2023.The RWD Audit Readiness Initiative drafted a functional list of key considerations of RWD quality that can assist researchers interested in using RWD for regulatory submissions. The overall goal of this list of considerations, when used in conjunction with published guidance documents from regulatory agencies and other groups of experts, is to help provide insights into what factors and circumstances may affect a Health Authority’s willingness to accept and use RWD as a basis for regulatory decision-making in the drug approval process.
Improve the Patient & Site Experience
Objectives

Improve the patient and site experience by decreasing burden, enabling a better-informed patient and improving clinical research awareness, participation & engagement.

  • The Diversity of Participants in Clinical Trials team published two solutions that further support their focus on developing solutions to equip sponsors and ecosystem stakeholders with the tools and resources needed to improve outcomes for diversifying participants in clinical trials. The Diversity Community-Based Site Engagement and Capacity Building solution provides an aggregated collection of insights and perspectives from the attending organizations of a June 2022 Roundtable Event, regarding considerations that sponsors, sites, and others have taken to enhance engagement and capacity building for community-based sites.The Sponsor Toolkit Site Engagement and Capacity Building Considerations for Diversity, Equity and Inclusion of Participants in Clinical Trials (DEICT) solution comprises a set of mitigation considerations designed to support efforts to sustainably partner with sites to enable the enrollment and retention of underrepresented patient populations in clinical trials. These mitigation considerations consist of perspectives from a series of stakeholder discussions and a Diversity Roundtable event and suggest considerations across different maturity levels.
  • The Patient Experience team published a Study Participant Feedback Questionnaire (SPFQ) Question Bank Addendum to provide new and replacement questions to be utilized in conjunction with SPFQ Version 1.0. The Question Bank Addendum was validated with a patient advisory board for additional input to ensure the questions resonated from a patient perspective.

    The SPFQ, developed with and for patients, is a set of three brief validated patient questionnaires designed to capture patients’ experiences at the beginning, during, and end of each clinical study, independent of disease and treatment. The newly developed Question Bank Addendum includes new questions focused on the following key themes:

    • The participant’s motivation to participate.
    • The participant’s perception of how appreciated they felt throughout the clinical study.
    • Decentralized clinical trial activities, amongst others.

    The Patient Experience team also launched version 2.0 of the Study Participant Feedback Questionnaire (SPFQ) Socialization Presentation and the SPFQ Implementation User Guide along with a new adoption resource, the Patient Protocol Engagement Toolkit (P-PET) Quick Start Video. The SPFQ Socialization Presentation, initially launched in 2019, is intended to support the SPFQ Implementation Team in facilitating the internal socialization of the SPFQ with leadership and colleagues. This document was modified to incorporate key learnings and implementation experiences from TransCelerate Member Companies to further demonstrate the value and benefits of this solution.

    The SPFQ Implementation User Guide is intended to support each sponsor company’s implementation of the SPFQ. This document was modified to provide additional considerations for resourcing and budgeting, getting study teams started, and data management and analysis. Considerations for key performance indicators (KPIs) have also been incorporated. The P-PET Toolkit Quick Start Video, which includes Japanese subtitles, was developed to help bolster the adoption of the P-PET Toolkit and guide users through key considerations for utilizing the P-PET throughout the patient engagement journey.

Enhance Sponsor Efficiencies
Objectives

Facilitate the advancement of innovative healthcare and clinical research through improved technologies, advanced data collection systems and simplified processes.

  • In early 2022, the Interpretation of Clinical Guidances and Regulations (IGR) Initiative was formed to tackle the new revisions of ICH E8 (2022) and E6 (2023). The team first narrowed down key topics in ICH E8 (R1) that they felt needed further consideration and resources. The team then validated these needs through a survey of TransCelerate Member Companies which was used to inform the development of five new solutions. These new resources include:
    • What You Need to Know About ICH E8 – Infographic: An easily sharable and digestible document for introducing and interpreting key components of ICH E8 such as Critical to Quality Factors, Open Dialogue, Critical Thinking, and Fit for Purpose.
    • Stakeholder Engagement for Clinical Development: A tool to help study sponsors manage quality by facilitating implementation of ICH E8’s principles regarding stakeholder engagement throughout the lifecycle of clinical development.
    • Culture & Engagement Resource Pack: A compilation of links to resources intended to provide informational and educational materials for the clinical development ecosystem to support the understanding, implementation, and operationalization of these newly introduced concepts in ICH E8 (R1).
    • Resources for the Application of Critical to Quality Factors: Considerations and information to help with the interpretation and application of Critical to Quality Factors throughout clinical studies. This suite of solutions intends to give an overview of ICH E8 (R1), and help sponsors and clinical quality professionals interpret key ICH E8 (R1) concepts such as Critical to Quality factors, engaging internal and external stakeholders, and developing a culture of critical thinking and open dialogue.

    In 2023, the team intends to publish case studies and a white paper on ICH E8 (R1) and then focus efforts on the expected new revision of ICH E6 (R3) and develop companion materials to aid in the interpretation of ICH E6 (R3).

Enhance Drug Safety
Objectives

Facilitate solutions that address a common set of challenges in drug safety surveillance such as engaging the public, collaborating with regulators, incorporating data and analytics, developing model approaches, and assessing the impact of efforts.

  • The Pharmacovigilance Agreements Optimization (PVAO) team recently launched their Pharmacovigilance Agreements Glossary (Version 2.0). This Glossary, which pulls definitions from regulatory sources, can help stakeholders operate more efficiently through all phases across the PVA lifecycle by facilitating more consistent use of key terminology and definitions. The Glossary is intended to provide users with a list of definitions and synonyms often incorporated into PVAs. In our effort to further support PV professionals, the initiative has added several more definitions:
    • Safety Corrective Action
    • Incident
    • Serious Adverse Event (SAE)
    • Serious Incident
    • Serious Injury
    • Serious Public Health Threat
    • Use Error

    Version 2.0 also offers added hyperlinks, cross-referenced related items, and an optimized alphabetical table. To help alleviate potentially harmful ambiguity, regulatory sources were utilized for the creation of definitions in the Glossary.

  • The Intelligent Automation Opportunities in Pharmacovigilance (IAO) team updated the Interactive ICSR and Automation Technologies Tool (IATT) and accompanying Technology Matrix. This further supports the initiative’s focus on identifying how intelligent automation technologies can be used to better support the execution of Pharmacovigilance activities/processes. The Interactive ICSR and Automation Technologies Tool (IATT) was revised and redesigned to provide 2020-2021 technology survey benchmarking data and insights from the team’s published peer reviewed paper, “Industry Perspective on Artificial Intelligence/Machine Learning in Pharmacovigilance,” which was published in Drug Safety. The data and insights address the industry usage of technologies aimed at automating the ICSR process and are intended to facilitate an understanding of automation opportunities across this process. The Technology Matrix was updated to provide technology survey benchmarking data for the 2020- 202 period regarding the types of technologies available in pharmacovigilance with an aggregated view of the level of implementation of each technology within each Individual Case Safety Report (ICSR) process step, comparing the aggregated implementation levels across time periods.

Check Out Our Blog

And if you haven’t already, check out our recent blog posts and media placements to learn about what we’ve been up to this past quarter:

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Keep Up with Us!

Mark Your Calendars

TransCelerate leaders and Member Companies are invited to participate and present at many biopharmaceutical research industry conferences and meetings across the globe to provide a perspective on industry challenges and clinical trial issues. Take a peek at a few places we will be presenting in the coming months. For detailed information on speaker presentations, visit the events page on the TransCelerate website.

February 2-8

DIA Global Pharmacovigilance & Risk Management Strategies Conference

North Bethesda, MD

February 2-9

SCOPE Summit

Orlando, FL

March 19-20

Society of Toxicology Annual Toxicology Expo

Nashville, TN

March 22-24

DIA Europe

Basel, Switzerland