INVESTIGATOR-INITIATED TRIALS (IITs)

IITs are unsolicited clinical studies initiated and managed by nonpharmaceutical company researcher(s), including individual investigators, academic and community institutions, collaborative study groups, or cooperative groups. Dendreon’s IIT program aims to answer medical and scientific questions regarding sipuleucel-T, enhancing the understanding of its safe and appropriate application.

Investigators bear the legal and regulatory responsibilities of the trial sponsor for the conduct and management of the study, complying with applicable laws and regulations. Such obligations associated with the conduct of the study include, but are but not limited to, the following:

•

IRB submission
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Subject enrollment and retention
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Safety report
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Data generation: study reports or publications
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Obtaining and maintaining an Investigational New Drug (IND) application, if applicable

Scope of Support

Dendreon may support IITs with funding, materials, and/or information, as allowed under local laws and regulations, provided that they align with the company-defined areas of strategic interest.

Eligibility

The proposed concept / idea should aim to improve treatment of disease, understanding of therapies, patient outcomes, and the quality of healthcare.

Types of IITs eligible for support, include, but are not limited to, the following:

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Combinations with other investigational or approved therapies: checkpoint inhibitors, poly-[ADP-ribose] polymerase (PARP) inhibitors, radiopharmaceuticals, etc
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Sequencing with androgen receptor targeted agents (ARTAs)
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Exploring the subsets (eg, based on genetic makeup or biomarkers) of patients with metastatic castration-resistant prostate cancer (mCRPC) who may obtain enhanced clinical benefits

The following are out of scope:

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Nonclinical studies (preclinical, real-world studies, etc)
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Compassionate use

How to Apply

Investigators requesting IIT support should complete the form below and upload the following documentation for review and consideration:

1.
A letter of request, including deadline for financial support
2.
Detailed proposal with total budget requested. Please include the expected starting date, duration of the study, name of the institution, and description of the study design
3.
W-9 form
4.
An itemized budget, with listed cosponsors, if any
5.
CV of investigator(s)

First Name*

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Professional degree

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Please upload the following documents:

Accepted file formats: Excel, PDF, and Word. Files should not exceed 35MB.

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A letter of request, including deadline for financial support*
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Detailed proposal with total budget requested.*
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W-9 form*
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Itemized budget (with listed cosponsors, if any)*
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Investigator's CV
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APPLICATION SUBMITTED

Thank you for your investigator-initiated trial application. A member of the Medical Affairs team has been assigned this case. Our Program Review Committee will respond within 30 business days. For a more immediate response, please email medicalgrantrequests@dendreon.com.

COVID-19 Update

At Dendreon Pharmaceuticals LLC, the health and well-being of our employees, patients, and communities are of high importance.

Our priority remains serving the needs of our patients, healthcare professionals, and our community. During these unprecedented times, Dendreon manufacturing facilities remain open and operational. As an added precautionary measure, Dendreon has limited manufacturing facility access to essential personnel only. This preserves our ability to continue serving healthcare professionals and patients, while protecting the health of our employees.

We are currently unaware of any logistical issues related to the manufacture of PROVENGE^® (sipuleucel-T). For up‐to‐date information, please contact Dendreon On Call at (877) 336-3736 and select option #2.

Many of the apheresis collection centers, which are operated independently of Dendreon, are taking additional measures to maintain patient safety in response to COVID‐19, including travel‐related recommendations and pre‐screening calls to assess patients’ health. The reasons for these efforts are to minimize the number of patients unable to undergo leukapheresis and to keep every apheresis center as safe as possible for patients and staff. Please reach out to your apheresis collection center for additional information.

Dendreon will continue to monitor and assess the COVID-19 situation in the United States and will update this notice as necessary. For further information, please send your requests to MAC@dendreon.com

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REQUEST SUBMITTED

Thank you for your interest in the CME & Grant Requests program. A member of the Medical Affairs team has been assigned this case. Our Program Review Committee will respond within 30 business days. For a more immediate response, please email medicalgrantrequests@dendreon.com.

Welcome to Dendreon Medical Affairs.

The information available on this site is for healthcare professionals practicing within the United States in need of trusted clinical and scientific information on our product. Medical information available through this website is not medical advice, and patient care remains the ultimate responsibility of the licensed health care professional.

Dendreon does not recommend the use of its products in any manner inconsistent with the FDA-approved Prescribing Information. In the United States, please refer to the full Prescribing Information for approved indication and Important Safety Information.

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THANK YOU

Thank you for your request for medical information. A member of the Medical Affairs team has been assigned this case. Our response times are typically within 48 to 72 hours. However, timing may depend on the nature of the information requested and the need to obtain input from subject matter experts within the company.