Access to Investigational Therapies
We are committed to helping patients who have not had success with existing, available therapies and may benefit from our investigational therapies currently in development. The Corbus Pharmaceuticals Holdings, Inc. Policy for Access to Investigational Agents describes the principles and procedures that we will follow when considering a request. Please see below for further details.
I. Corbus Pharmaceuticals Holdings, Inc. Policy for Evaluating Access to Investigational Agents Outside of Clinical Trials
Corbus Pharmaceuticals Holdings, Inc., or Corbus, currently is testing in clinical trials investigational drugs that have not yet been approved by the US Food and Drug Administration (FDA) or other regulatory bodies for commercial sale. We have conducted and are conducting research on our investigational product pipeline so that we can better understand how these investigational therapies work and their safety and efficacy.
Patients with serious diseases or conditions often exhaust standard treatment options and seek out investigational therapies being tested in clinical trials. Sometimes these investigational therapies may be available to them as part of a clinical trial. People who take part in clinical trials help society by contributing to medical research, the development of new therapies, and the advancement of patient care. Other times, patients may not be able to participate in a clinical trial. When patients are not able to participate in a clinical trial, treating physicians can request drug companies like Corbus to make these investigational therapies available to their patients outside of clinical trials.
Corbus is committed to helping patients who have failed available therapies and may benefit from treatment access to the investigational therapies that we are developing in a manner that is both scientifically and ethically responsible. This Policy for Access to Investigational Agents describes the principles, criteria and government regulations that we will follow when considering a request from physicians for patients outside of our clinical trials. This document covers requests from a treating physician for investigational therapy for an individual patient, not requests for investigator-initiated trials.
- The investigational therapy must be in active clinical development. Corbus must be actively studying the investigational therapy in human subjects. In this way, Corbus is able to comply with local regulations regarding manufacturing, preclinical safety and reporting obligations. Restricting access to investigational therapies with active clinical programs also ensures that there are Corbus personnel who are trained and responsible for the safe release of the investigational therapy.
- The patient must be first considered for ongoing clinical trials of the investigational therapy. Treating physicians interested in treating their patient with Corbus investigational therapies in active clinical development must first try to enroll their patients in a clinical trial studying the investigational therapy. Clinical trials incorporate regular safety monitoring, and create a venue for investigator training on the potential risks of the investigational therapy. In addition, Corbus has a scientific and ethical obligation to complete clinical trials that could support FDA approval of the medicine. Clinical trials have the ability to establish clinical benefit for the investigational therapy, and thus transform an investigational therapy into an approved drug capable of offering benefit to a wider population.
- The patient must have a serious disease or condition. Serious is defined in this document as a disease or condition associated with morbidity that has a substantial impact on day-to-day functioning. Short-lived and self-limiting morbidity is not sufficient. Factors such as the likelihood that the disease is life-threatening or, if left untreated, will progress to a more serious condition should be considered.
- There must be a positive benefit-risk ratio for the patient. The potential benefits to the patient seeking access to the investigational therapy must always outweigh the collective potential risks to the patient of offering the investigational therapy. In establishing the benefit-risk ratio, Corbus will consider the outcome of the disease itself.
- The physician who requests access must be, in the opinion of Corbus, an expert qualified in the treatment of the patient's disease or condition. Such physician must agree to directly supervise treatment, be willing to obtain an IND from FDA, otherwise comply with relevant US federal and state regulations, and agree to follow Corbus policies applicable to expanded use in general and any conditions or restrictions set by Corbus for the particular drug and patient.
- The physician requesting access must provide:
- An explanation of the serious nature of the illness
- A scientifically justified rationale for the theoretical benefit that the investigational therapy could provide
- A statement that approved therapies typically used to treat the disease have been exhausted and the patient is no longer responsive to, or able to tolerate, these therapies
- A statement that there are no other viable therapy options, including participation in ongoing relevant clinical trials
- There must be sufficient clinical data to identify an appropriate dose (amount and frequency of the investigational therapy given) and appropriate formulation.
- After meeting the needs of clinical trials and other existing patients on therapy, Corbus must have, and believe it will continue to have throughout the likely duration of treatment, a sufficient supply of the investigational therapy to reasonably accommodate the likely duration of treatment. Corbus does not guarantee availability of the investigational therapy throughout the course of treatment once started, although Corbus will make reasonable efforts to maintain a supply of investigational therapy to the patient.
II. Procedure for Requesting Expanded Access and Response Times
- Treating physicians interested in treating a patient with a Corbus investigational drug that is in active clinical development must fill out the following request form and acknowledgement.
- When the form has been satisfactorily completed and submitted to Corbus, we will usually acknowledge receipt via email within 5 days of submission of the request.
- Making a request does not guarantee the granting of access to an investigational drug. Corbus will review the request and usually make a decision to grant or deny it or ask for more information within 20 business days.
III. Contact for Further Information and Link to ClinicalTrials.Gov
Persons with questions about Corbus' policy and procedures for expanded access or about expanded access to Corbus investigational drugs may send an email to the following address: firstname.lastname@example.org.
Further information about Corbus' expanded access program is available on the NIH's ClinicalTrials.gov website: ClinicalTrials.gov.