(1) The lead institution of higher learning of a consortium shall submit to the department a proposal for purposes of conducting an ibogaine drug development clinical trial in accordance with this chapter.
(2) A proposal submitted under subsection (1) of this section must provide:(a) The identity of all consortium members;(b) A detailed description of the planned strategy for obtaining approval for the drug development clinical trial from the FDA;(c) A detailed drug development clinical trial design that includes:(i) A description of the composition of the consortium’s drug development clinical trial team and the expertise of the team members;(ii) A drug development clinical trial participant recruitment plan;(iii) Patient screening criteria and cardiac safety protocols;(iv) Administration protocols;(v) An aftercare and post-acute treatment support plan; and(vi) A data integrity plan;(d) A plan to coordinate with the lead consortium to seek a breakthrough therapy designation for ibogaine from the FDA under 21 USC Section 356;(e) A proposal to recognize this state’s commercial interest in all intellectual property that may be generated over the course of the drug development clinical trial, including:(i) The treatment that is the subject of the trial;(ii) Administration protocols;(iii) Treatment models or techniques; and(iv) Technology used in the trial;(f) A plan to establish a corporate presence in this state and to promote and maintain ibogaine-related biomedical research, development, treatment, manufacturing, and distribution in this state;(g) A plan to secure third-party payor approval for ibogaine treatment following approval by the FDA through:(i) Private insurers;(ii) Medicare;(iii) Medicaid; and(iv) The TRICARE program of the United States Department of Defense;(h) A plan to ensure ibogaine treatment access to uninsured individuals following approval by the FDA;(i) A plan to train and credential medical providers to administer ibogaine treatment according to developed clinical standards; and(j) Financial disclosures that verify the consortium’s capacity to fully match state funding with funds received from non-state sources.
(a) The identity of all consortium members;
(b) A detailed description of the planned strategy for obtaining approval for the drug development clinical trial from the FDA;
(c) A detailed drug development clinical trial design that includes:(i) A description of the composition of the consortium’s drug development clinical trial team and the expertise of the team members;(ii) A drug development clinical trial participant recruitment plan;(iii) Patient screening criteria and cardiac safety protocols;(iv) Administration protocols;(v) An aftercare and post-acute treatment support plan; and(vi) A data integrity plan;
(i) A description of the composition of the consortium’s drug development clinical trial team and the expertise of the team members;
(ii) A drug development clinical trial participant recruitment plan;
(iii) Patient screening criteria and cardiac safety protocols;
(iv) Administration protocols;
(v) An aftercare and post-acute treatment support plan; and
(vi) A data integrity plan;
(d) A plan to coordinate with the lead consortium to seek a breakthrough therapy designation for ibogaine from the FDA under 21 USC Section 356;
(e) A proposal to recognize this state’s commercial interest in all intellectual property that may be generated over the course of the drug development clinical trial, including:(i) The treatment that is the subject of the trial;(ii) Administration protocols;(iii) Treatment models or techniques; and(iv) Technology used in the trial;
(i) The treatment that is the subject of the trial;
(ii) Administration protocols;
(iii) Treatment models or techniques; and
(iv) Technology used in the trial;
(f) A plan to establish a corporate presence in this state and to promote and maintain ibogaine-related biomedical research, development, treatment, manufacturing, and distribution in this state;
(g) A plan to secure third-party payor approval for ibogaine treatment following approval by the FDA through:(i) Private insurers;(ii) Medicare;(iii) Medicaid; and(iv) The TRICARE program of the United States Department of Defense;
(i) Private insurers;
(ii) Medicare;
(iii) Medicaid; and
(iv) The TRICARE program of the United States Department of Defense;
(h) A plan to ensure ibogaine treatment access to uninsured individuals following approval by the FDA;
(i) A plan to train and credential medical providers to administer ibogaine treatment according to developed clinical standards; and
(j) Financial disclosures that verify the consortium’s capacity to fully match state funding with funds received from non-state sources.