Expanded Access

Fore Biotherapeutics Investigational Medicines Expanded Access (Compassionate Use) Policy

Fore Biotherapeutics is an oncology-focused biotechnology company dedicated to developing innovative treatments that provide a better outcome for cancer patients. Our goal is to efficiently bring safe and effective medicines to all appropriate patients by conducting rigorous clinical trials and obtaining marketing approval by regulatory authorities. Drugs which are being studied in clinical trials and not yet been approved as safe and effective by regulatory agencies such as the FDA are called investigational drugs.  Prior to such approval, participation in a clinical trial is the best way for patients to gain access to our investigational drugs. Information on clinical trials can be found here. However, we understand that some patients may not be able to participate in a clinical trial and may wish to seek access to investigational drugs before they are approved.

Expanded access, also called “compassionate use” or “named patient access” at Fore Biotherapeutics is the use of an investigational drug outside the clinical trial setting. It is intended to provide a treatment option for patients with a serious or life-threatening condition who are not eligible for or able to participate in a clinical trial and where there may be no other treatment options available.

When requested by a treating physician for a patient, Fore Biotherapeutics may provide access to the investigational product for individual patient use outside of the clinical trial setting when appropriate, and under requesting physician supervision. Due to variations in regulatory requirements in different territories concerning the provision of investigational products for expanded access, regional policies and local regulations will be considered prior to granting each request.

Fore Biotherapeutic will consider access for requests that meet the below criteria.

General Criteria for Granting Expanded Access

Fore uses the following criteria for considering requests to provide expanded access to individual patients:

  • The patient has a serious or immediately life-threatening illness
  • A strong biological rationale and there is preliminary clinical evidence supporting that the potential benefits to the patient outweigh the potential risks of treatment
  • The patient is not eligible or able to participate in a clinical trial or similar sponsored access program
  • There are no other suitable treatment options in the patient’s locale.
  • Providing the investigational drug will not interfere with clinical trials that could support the investigational drug’s development or regulatory approval for the treatment indication
  • There is adequate supply of the investigational product and providing access to the investigational drug will not impact supply need for clinical trials. An infrastructure for drug supply is in place for a given country.

Request Procedure

Requests for access to investigational drugs under development and prior to approval under this policy must be made by Treating Physicians. Treating Physicians should contact Fore by email at oib.e1719067709rof@s1719067709secca1719067709dedna1719067709pxe1719067709 or via the form below.  All such requests must be made in accordance with local laws and regulations. Treating Physicians must also obtain local regulatory approval for the proposed use, where necessary.

Upon submission of the request, a Fore medical professional will evaluate the request based on the scientific evidence available at the time of the request and the general criteria previously listed, in addition to other factors.

For an expanded access request to be considered, the patient’s treating physician must include the following information in the request:

  • Date of request
  • Requesting physician’s name, contact information, address (including country), professional designation, and qualifications
  • Medical rationale for request including an explanation for why alternative therapy cannot be used, why the patient does not qualify for a clinical trial, and why use of the requested investigational product is in the patient’s best interest
  • The physician’s intended treatment plan, including therapeutic indication and expected duration of treatment
  • Patient’s tumor type, Tumor Grade, Tumor Genetic Profile including co-occuring mutations.
  • Prior anticancer treatments, including surgeries, radiation(s), lines of systemic therapies, including the dates, best overall response, and reason for discontinuation therapies
  • Patient’s comorbidities, laboratory abnormalities, and concomitant medicines, including the dose

A response to the request for expanded access is typically received by the requesting physician within 20 days with either:

  • Approved
  • Request for additional information
  • Denied (with a rationale for non-approval)

As authorized by the 21st Century Cures Act, Fore Biotherapeutics may revise this expanded access policy at any time. Additionally, the posting of this policy by Fore Biotherapeutics shall not serve as a guarantee of access to any specific investigational drug by any individual patient.

Expanded Access to Fore Biotherapeutics Investigational Medicinal Products

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Please answer each question and acknowledge the certification below. As the patient’s treating physician, please submit this form along with patient’s relevant medical history, physical examinations, prior therapies and labs. Please ensure that the patient’s personal information is redacted.

Please read the criteria below. Do you attest that this patient and investigational medicine being requested meet these criteria to the best of your knowledge?

  • The patient suffers from a life threatening or serious disease or condition where there is an unmet medical need that cannot be met by existing products.
  • The patient is ineligible or unable to participate in any ongoing clinical study of the investigational product.
  • The potential benefits of the drug are expected to outweigh the risks to the patient.
  • The use of the investigational product in an expanded access protocol is compliant with local rules and regulations.

Please read the statements below and confirm eligibility.

  • I certify that I am the patient’s treating physician.
  • I certify the information provided in this application is complete and accurate to the best of my knowledge, and that once the investigational product requested under the Fore Biotherapeutic Expanded Access Policy is approved for release to this patient, I will be responsible for supervising the patient’s treatment. I understand and certify that all units of any investigational product shipped to me pursuant to this application will be provided to the above-named patient only, for his or her treatment, and will not be sold or otherwise distributed and that no patient or third party (including, but not limited to, Medicare (in the US) and any other governmental programs) shall be charged for such product. Additionally, no units of this investigational product will be submitted to Medicare/Medicaid in the US, or to any public or private third-party for reimbursement, or returned for credit. I understand eligibility is subject to Fore Biotherapeutic Expanded Access approval and the patient’s continued eligibility and compliance with all requirements, as set by Fore Biotherapeutics.
  • I certify that I will comply with all applicable regulatory requirements, including, but not limited to, obtaining informed consent as necessary from the patient/patient’s legal guardian, maintaining records and data as applicable, and carrying out the protocol for treatment use under appropriate regulatory and ethical standards, including regulatory agency and/or Institutional Review Board (IRB)/Institutional Ethics Committee (IEC) review as applicable and reporting of serious adverse events.

For treating physicians and patients in the European Union (EU), please be informed about the introduction of the new European regulation about personal data. This is known as the General Data Protection Regulation (GDPR). Fore Biotherapeutics is required to provide you with the following information under this new regulation:

Under the General Data Protection Regulation (GDPR) and specifically in relation to your personal information, we would like to provide you the following additional information:

The processing of your personal information is carried out under the responsibility of the data protection officer and data controller at Fore Biotherapeutics.

If you have any questions or concerns about your personal data protection rights or a complaint about the use of your personal information direct your questions to the Data Protection Officer, when necessary:

Fore Biotherapeutics
3675 Market Street
Suite 200

Philadelphia, PA 19104
Phone: +1 267-641-7575
Web Address: www.fore.bio
Email Address: oib.e1719067709rof@n1719067709oitce1719067709torp.1719067709atad1719067709