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Investigator Initiated Research and Grants

Accord BioPharma may provide monetary, in-kind, or other support for scientific research in response to unsolicited requests from independent researchers. This enables Accord BioPharma to contribute to the scientific understanding and body of knowledge about Accord BioPharma products and disease areas in order to enhance the practice of medicine and ultimately improve patient care.

All types of research programs will be considered for funding through Accord BioPharma’s Investigator-Initiated Research (IIR) and Grants Policy. IIRs are clinical studies that are initiated, developed, and conducted by a qualified researcher external to Accord who assumes all legal and regulatory responsibility for the research. Potential IIR programs may be funded following a rigorous review process.

Investigator Responsibilities & Expectations

Applicants awarded funding by Accord’s research grants program fulfill the role of the study sponsor and investigator. Accord fulfills the role of primary funding source. Funded sponsor-investigators are responsible for the design, management and conduct of the study, as well as maintaining compliance with all applicable laws and regulations. Accord and the sponsor-investigators will generate study-specific, progress-based milestones to align expectations and ensure timely execution of the study.

Instructions for Grant Submission

Researchers interested in applying for competitive research funding through Accord’s IIR Review Committee (IRC) should familiarize themselves with investigator expectations, Accord’s funding priorities, and the research grant review process.

The full list of responsibilities of the requestor or investigator is available by emailing IRC@accord-healthcare.com.

Competitive Review Process

The Accord IRC carefully evaluates applications based on the following criteria:
  • Investigator independence in proposal design and submission
  • Scientific merit
  • Adherence to ethical guidelines and patient risk assessment
  • Consistency with Accord’s scientific objectives
  • Investigator expertise and qualifications
  • Consistent with established funding priorities and fair market value
  • Availability of funding, support study drug availability
  • Use of proposed funding
  • Investigator compliance history

IIR and Unrestricted Medical Educational Grants Review Process

  • The investigator submits an abbreviated Letter of Intent (LOI) or medical educational grant form on the website with all required information and supporting documentation.
  • Study ID is assigned internally by Accord. An internal review is initiated.
  • The requester of a medical education grant will be notified if approved or not. If seeking IIR approval, investigator will be notified of additional interest and requested to submit a full application.
  • If seeking IIR approval, Investigator shall submit a full protocol, itemized budget, and timelines for IRC review.
  • If the IRC and Accord Compliance fully accept the submission, contracting will take place amongst both parties.

Start Your Application

You will be required to submit the following documentation for evaluation. Below are templates to help facilitate the review of your application.

The Accord IRC reviews applications each quarter of the calendar year. Below outlines the deadline for submission for review for the next following quarter.
LOI or Grant Submission Deadline Review Period Acknowledgement Date IIR Submission Deadline IIR Acknowledgement Date
November 1, 2023 November 30, 2023 December 15, 2023 January 15, 2024 May 15, 2024
LOI or Grant Submission Deadline: November
1, 2023
Review Period: November
30, 2023
Acknowledgement Date: December
15, 2023
IIR Submission Deadline: January
15, 2024
IIR Acknowledgement Date: May
15, 2024
You will be promptly notified of Accord’s IRC funding decision via email. If you have any questions regarding the process or would like to speak to the investigator-sponsored studies program team regarding your new or existing application, please contact us at IRC@accord-healthcare.com.
Apply for grant

IMPORTANT SAFETY INFORMATION

Do not use CAMCEVI® in patients with hypersensitivity to GnRH, GnRH agonist analogs, or any of the components of CAMCEVI as anaphylactic reactions to these drugs have been reported in the medical literature.

CAMCEVI, like other GnRH agonists, causes a transient increase in serum levels of testosterone during the first week of treatment which can cause transient worsening of symptoms. As with other GnRH agonists, cases of ureteral obstruction and spinal cord compression, have been observed, which may contribute to paralysis with or without fatal complications.

Patients with metastatic vertebral lesions and/or with urinary tract obstruction should be closely observed during the first few weeks of therapy.

Hyperglycemia and an increased risk of developing diabetes have been reported in men receiving GnRH agonists. Blood glucose levels should be monitored and managed according to current clinical practice.

Increased risk of myocardial infarction, sudden cardiac death, and stroke has been reported in association with the use of GnRH agonists. The risk appears low based on the reported odds ratios, and should be evaluated carefully along with cardiovascular risk factors when determining a treatment for patients with prostate cancer. Patients should be monitored for cardiovascular disease and be managed according to current clinical practice.

Androgen deprivation therapy may prolong the QT/QTc interval. Consider periodic monitoring of electrocardiograms and electrolytes.

Convulsions have been reported in patients receiving GnRH agonists, like CAMCEVI. Patients experiencing convulsions should be managed according to the current clinical practice.

Monitor serum levels of testosterone following injection of CAMCEVI.

Based on findings in animal studies and mechanism of action, CAMCEVI may cause fetal harm when administered to pregnant women.

The most common (≥10%) adverse reactions during a median follow-up of 336 days were hot flush, hypertension, injection site reactions, upper respiratory tract infections, musculoskeletal pain, fatigue, and pain in extremity.

INDICATION

CAMCEVI is indicated for the treatment of adult patients with advanced prostate cancer.

Click here for full Prescribing Information.

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