Additional disclaimers: this page is in draft state, all information is FYI and not to be taken as an advise in any form.
The Single Patient IND process is not immediately obvious, as the application have to navigate the following non-obvious obstacles:
1) Physician: no set compensation/rule structure and deviates from day-to-day busy practices, discovery domain, ultimate responsibility. It is usually not the job of the physician to persuade a patient to go on the SPIND process.
2) Patient: potentially has to take the initiative in discovering possibilities that may or may not apply to the conditions.
3) Manufacturer: will not get compensated, providing pilot access and may carry additional risks to their commercial plans.
4) Regulatory body: shares responsibility with Physician and manufacturer.
IND Manufacturer: Review case and authorize IND usage, provide support for treatment plan.
Physicians: Obtaining Letter of Authorization from Manufacturer, devise medical plan to use IND, submit Form 3926 for review. Hours of works are required to obtain the Single Patient IND.
From Form 3926 Instructions, “You may choose to attach an
Investigator Brochure, scientific publication(s), or other supporting documents, if needed.”
Establishment the following: Safety, Potential Efficacy, Insufficiency / Unsatisfactory in current standards of care. Be flexible when the treatment plan can start — let’s plan on starting it at some point.
Patients: Very Informed and actively communication and collaboration with at least the Physician. May require proactive communications and collaborative information depends on efforts of engagement. May be possible to seek additional information from Manufacturer if necessary. Have realistic expectations, be prepared to some alternatives, be sincere, candid, demand and always stay well informed of all processes.
Regulatory bodies: reviews and make sure plans are in compliance with all set rules and regulations.