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JUUL

INTRODUCTION

In its continued commitment to smokers worldwide, JUUL Labs believes in supporting ethical independent research conducted by qualified third-party investigators. Independent research is key to best understanding the benefit/risk profile of our product, as well as addressing unmet needs. Independent research must set out to address meaningful scientific and/or clinical objectives supported by robust study designs where the privacy rights, safety and welfare of patients are paramount.   

Investigator Sponsored Research (ISR) is defined as: “Studies with scientific and medical merit developed and sponsored by an independent investigator or institution. An ISR may be a clinical or non-clinical study conducted without the participation of JUUL Labs, for which the ISR sponsor requests JUUL Labs to provide either funding, product or both.”  

JUUL Labs provides financial support and/or product for ISR pursuant to a written agreement, which requires that third-party sponsors comply with applicable local laws, rules, guidelines and regulations.  

Principles governing the evaluation of ISRs include:  

  • The validity of the scientific question being addressed, ensuring that ISR expands upon prior research

  • The ISR must be ethical, and safeguard subject privacy, safety and welfare, and be robust in design.   

  • A pledge by the investigator/sponsor to disseminate the findings in an appropriate, entirely transparent, and timely manner.  

ISR studies are conducted independent of JUUL Labs. The investigator or affiliated study sponsor will have responsibility for study conception, design, operational execution, data handling, data analysis, interpretation, reporting and publication, safety monitoring and ensuring compliance with all local laws and regulations. 

JUUL Labs commits to all worldwide ISR:   

  1.  Rigorous ethical and scientific standards when engaging and reviewing study proposals from third-party independent sponsors, including investigator qualification and institutional site credibility. In study sites where JUUL Labs is not satisfied that Good Clinical Practice (GCP) standards exist, we will not support ISR. However, JUUL Labs will consider, on a case-by-case basis, helping to develop local sponsor capabilities in GCP, if local policy and regulations permit.  

  2. Robust medical and scientific governance systems in place at all levels of the JUUL Labs organization (globally, regionally, locally) with no commercial funding or influence on any aspect of the ISR process. Under no circumstances will JUUL Labs permit the involvement of sales or marketing associates in any aspect of ISR design, review and approval, operational execution, funding or transfer of value to a sponsor/investigator undertaking an ISR.  

  3. The review/approval process focuses specific attention on ensuring that patient safety is of paramount importance to the proposed ISR.  

  4. Worldwide training at JUUL Labs on the policies and practices required for successful ISR support, including the rules of independence of the third-party investigators/sponsor and no undue influence from JUUL Labs, when engaging in all aspect of the ISR process (conception, design, operational execution, and data management, including data handling and interpretation).   

  5. Financial transparency on amount of monies and transfer of value provided to any investigator or institution worldwide undertaking an ISR as part of a contractual agreement with JUUL Labs.  

  6. Communication and enforcement with all third-party sponsors, their contractual commitment to publish their research findings in a timely manner, as well as the need to report safety information findings during the conduct of the ISR in accordance with JUUL Labs and local regulatory requirements and timings.  

Tracking and monitoring in an ongoing and transparent manner our ISR-contracted obligations and practices and sharing appropriate data with key stakeholders.

INVESTIGATOR SPONSORED RESEARCH

SELECTION AND QUALIFICATION OF INVESTIGATORS & SPONSORS OF ISR  

JUUL Labs will only accept ISR proposals from sponsors/investigators that are able to demonstrate high ethical and scientific standards as it relates to clinical research in human subjects as stipulated by the International Conference of Harmonization (ICH) Efficacy Guidelines E6 - GCP.   

Before the contracting of an ISR with a potential sponsor/principal investigator/sub-principal investigator or institution, JUUL Labs will require documentation that demonstrates the following:  

  • Recent evidence (within previous 3 years) of the potential investigator and site personnel being trained in GCP (e.g. a signed attestation by the potential investigator of having completed GCP training).  

  • Recent evidence (within previous 3 years) of the investigator’s experience in undertaking clinical research e.g., documentation from a Local Ethical Committee/Institutional Review Board confirming previous participation in clinical research, or documented proof of involvement in a previous clinical trial.  

  • Evidence of a current license to practice medicine and good medical standing (including no evidence of restrictions by a regulatory/government authority to undertake clinical research).  

  • Statement from the Institution regarding absence of sanctions or restrictions against the Institution by a regulatory authority related to clinical research.

  • JUUL Labs Medical Affairs staff will ensure the validity of all of the above requirements as well as those requirements stipulated in JUUL Labs Standard Operating Procedures used in the conduct of ISR.  

In countries/sites where JUUL Labs is not satisfied that GCP standards exist, JUUL Labs may work with an appropriate credible third party/stakeholder to help develop local sponsor capabilities in GCP and GLP, if local policy permits.  

SCIENTIFIC AND MEDICAL GOVERNANCE 

JUUL Labs Medical Affairs associates may be involved in non-promotional interactions with both investigators and healthcare professionals (HCPs). In certain instances, a HCP may also be an investigator. The purpose of these interactions is to exchange scientific and educational information with HCPs and/or investigators who are experts in research, patient care, or both. These scientific and educational interactions will not interfere with either the manner in which a research study may be conducted or influence the independent medical judgment regarding patient care. Medical Affairs associates will maintain a relationship and discussions with the investigator or investigator/HCP prior to, during, and post study.

JUUL Labs will consider supporting studies independently conceived, designed and planned by investigators or third-party sponsors. While JUUL Labs may communicate its general areas of research interest, individual ISR requests must be unsolicited. These unsolicited requests may be derived and submitted by an investigator independently following a scientific discussion or meeting with the investigator or institution. JUUL Labs medical colleagues may respond to investigator-expressed interests with a science-based discussion intended to:   

  1. Rationalize the scientific interest of JUUL Labs in specific investigator-expressed interests for which JUUL Labs has specific product (s) or development programs, and   

  2. Avoid unintended duplication in areas where there is known ongoing work with other collaborators.  

In addition, as part of the review and conduct of ISR:  

  • JUUL Labs must not direct the scope, objective, design, and operational conduct of any ISR. JUUL Labs may provide comments to ensure that the study is based on sound scientific reasoning and protects the safety of subjects in terms of dosing, schedule and potential interactions of approved or novel substances in combination studies.  

  • There will be no marketing or sales influence (actual or perceived) on the selection of an investigator, on the choice to support ISR, nor on any aspect of ISR design or execution.  

  • All ISR funding will be initiated and controlled via the Medical departments at JUUL Labs, with financial oversight. JUUL Labs support to the study is limited to coverage of financial expenses and/or with the supply of JUUL Labs products, without exceeding fair market value.  

  • Based on scientific merit and request by the ISR investigator, JUUL Labs may consider on a case-by-case basis additional support (e.g., laboratory analysis not available outside of JUUL Labs).   

  • The investigator and the institution where the investigator is conducting the study take full responsibility for the design, initiation, management, data analysis, safety monitoring and reporting of the study (including local regulatory obligations).  

The entire ISR process is regulated by JUUL Labs standard operating procedures that follow ethical research principles and can be summarized as follows:  

  • The ISR request is initiated by an investigator submitting a signed study concept sheet to the JUUL Labs medical or appropriate research department initiating a review process that documents and tracks all decisions taken. This will apply to all research relationships requiring written agreement, including the material transfer agreement. The type of agreement needed will be determined on a case by case basis.

  • Within this process, ISR proposals are appropriately evaluated by a formalized multidisciplinary team (which does not include Marketing and Sales personnel). The review and approval of an ISR is based on the following principles:  

    • Maintaining independence of the investigator and their study concept  

    • Good ethical and medical principles, which comply with the applicable regulatory requirements   

    • Sound scientific design and methodology  

    • Investigator’s qualifications and expertise  

    • Institution’s capability for conducting, monitoring, and hosting research

    • Ensuring that the ISR proposal is aligned with the JUUL Labs Medical strategic scope for the product   

  • The research proposal and provision of support between JUUL Labs and the institution and/or investigator must be appropriately documented in a contractual agreement that defines roles and responsibilities. The agreed financial support is linked with defined milestones such as patient recruitment and completion of the final study report and shall only be paid if these milestones are achieved.  

  • The progress and results of the ISR will be collected, analyzed, and adequately reported to JUUL Labs by the investigator, including, at a minimum, submission of periodic progress, final study report and safety information. 

TRAINING PRINCIPLES AND COMMITMENT 

JUUL Labs is committed to ensuring our ISR policies are followed throughout the organization. Accordingly, JUUL Labs is committed to communicating and enforcing the aforementioned principles and procedures for ISR to all relevant associates.  

JUUL Labs mandates training to sales and marketing associates to ensure that they understand that under no circumstances may they be involved in soliciting, planning, approving, or executing ISR. Furthermore, JUUL Labs medical, clinical and field associates will be trained on the appropriate steps to take if they receive an unsolicited request from an HCP to conduct ISR, or support the conduct of ISR.  

Furthermore, JUUL Labs will ensure that associates involved in the ISR processes across the globe (e.g., medical affairs associates, ISR cross-functional review team members) receive in-depth training on these policies and processes.   

All training will be documented and associates must certify that they have completed and understood the training. JUUL Labs will regularly review this training to assess and, if necessary, improve its effectiveness.  

PRINCIPLES OF FINANCIAL TRANSPARENCY 

JUUL Labs is committed to complete data and financial transparency. We believe that sharing information in all areas of clinical research, without compromising patient data or confidentiality, supports sustainable innovation and accountability. Therefore, when JUUL Labs provides direct or indirect financial support, including JUUL Labs products, to a third-party sponsor (e.g., investigators or research institutions) we believe that the scientific community and patients have a right to access information about the following: 

  • The type of ISRs we support (e.g., clinical and non-clinical, interventional and non-interventional, disease areas) and their geographical and site location.  

  • The institutions and investigators who we support through financial commitments to undertake ISRs.  

This means that at JUUL Labs we track all value transfers provided to an investigator or an institution and ensure that our interactions are properly documented in a written contract. We also encourage institutions and investigators that benefit from JUUL Labs research support to publicly share appropriate research results. All worldwide ISR agreements are filed in the centralized JUUL Labs Global ISR Repository.  

TRACKING AND MONITORING SYSTEMS  

Holding ourselves accountable to the highest ethical standards, we will monitor and audit JUUL Labs associate’s adherence to our policies, standards, and effectiveness of training on ISR as part of our global risk assurance program and compliance framework.   

JUUL Labs will monitor the investigator’s compliance and adherence to their contractual obligations related to disclosure of ISR findings, agreed upon milestones, and safety information reporting.  

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