Policy on Access to VelosBio Inc. Investigational Therapies
VelosBio Inc. (VelosBio) is committed to developing safe and effective therapies for patients with cancer. We believe that whenever possible, use of an investigational therapy for a patient as part of a clinical trial is preferable because clinical trials are designed to generate comprehensive safety and efficacy data that may lead to the approval of new medicines and, consequently, to wider availability for patients in need.
Under appropriate circumstances, such as when a patient may not qualify for a clinical trial, there are no clinical trials available, and/or a patient has exhausted all available treatments, VelosBio may consider providing its investigational products for treatment use outside of a clinical trial and prior to commercial availability. Such access may be described as “expanded access”, “compassionate use”, “early access”, or “emergency use” or using other terms.
VelosBio will review all requests for investigational drug access on a case-by-case basis, taking into consideration regulations and guidance issued by applicable health authorities. Among other criteria, VelosBio will consider whether:
- The patient has a serious, debilitating, or life-threatening medical condition for which no other medically appropriate treatment is available;
- The patient’s healthcare provider can provide an assessment of the benefits and risks of the proposed expanded access use that suggests that the potential benefits of access to the investigational therapy likely outweigh known potential risks in the context of the risks posed by the patient’s underlying medical conditions;
- The patient’s healthcare provider can provide relevant data (eg, medical records, etc) to support the assessment of benefits and risks, considering standards of patient confidentiality appropriate for the situation;
- The patient’s healthcare provider is currently licensed with the appropriate practitioner licensing board;
- The patient’s healthcare provider is willing and able to support any regulatory procedures required by the relevant regulatory authority;
- The patient’s healthcare provider is willing to enter into an expanded access agreement with VelosBio;
- The patient’s healthcare provider will obtain informed consent from the patient or his/her legal guardian(s) for use of the investigational therapy;
- The patient’s healthcare provider will supervise administration of the investigational therapy in accordance with any procedures specified by VelosBio (which in some countries may include a protocol for use of the investigational therapy);
- The patient’s healthcare provider is willing and able to report any side effects of the investigational therapy and any other results as requested by VelosBio to assess benefits and risks of the expanded access use;
- The patient does not qualify to participate in any ongoing clinical trial sponsored by VelosBio in an accessible geographical location;
- Sufficient data exist to support the proposed expanded access use and the assessment of the benefits and risks of the expanded access use;
- Access would not impede or compromise the ongoing clinical development program or regulatory approval of the investigational therapy; and
- There is adequate supply of the investigational therapy to support access and such supply will not negatively affect a clinical trial or anticipated product launch
Requests for access to a VelosBio investigational therapy must be made by the patient’s treating physician. Whenever possible, the patient, the patient’s parent/legal guardian, or patient caregiver should work through the treating physician rather than contacting VelosBio directly.
To initiate a request for access to a VelosBio investigational drug, the physician should email email@example.com. Such requests should aim to address Criteria 1-10 above. VelosBio will strive to respond to requests for access of an investigational product within five (5) business days of receiving a complete request that includes all necessary documentation.
VelosBio may revise this policy at any time consistent with the 21st Century Cures Act or changes in the clinical profile, clinical trials status, or regulatory status of the investigational drug. This Policy on access to VelosBio investigational therapies, the submission of a request for access to a VelosBio investigational drug, and VelosBio consideration of any such request does not constitute a promise or guarantee of access to a VelosBio investigational product.