1. What is the process to develop, evaluate and implement collaboration?

• Provide examples that illustrate when academic/industry interests favor a collaboration
• How does an academic PI attract sponsors after developing a CT product or device?
• How does Industry engage academic sites to participate when they develop a CT product or device?
• What meetings are available that foster collaborations between academic/industry — Phacilitate,
• Provide examples of successful collaborations.
• Provide examples of challenging collaborations.

2. Describe types of collaborations (R&D, Phase 1, II, III, etc)

• Academic PI develops protocol involving CT product or device, secures industry sponsor, PI holds IND and mainly deals with company. SOPs, training, etc developed in CT facility with PI experience
• Industry develops CT product or device — CT facility becomes part of multi-centered study with PI involvement
• Hospital-based CT facilities may be the central distributor of all CT products to patients (as opposed to pharmacy for drug distribution), academic PI involved, but company deals directly with CT facility regarding SOPs, storage, shipment.

3. Describe types of agreements/contracts

• Academic PI negotiates agreements/contracts with company via institution legal department, CT facility then invoices PI for services — agreement with PI
• CT facility negotiates agreements/contracts with company through institutional legal department
• Describe the some of the critical points to cover in these type agreements/contracts
• How to best assure that both sides are not hit by surprise and disappointment — planning for the best and worst outcomes?
• What priorities are set (by the CT facility) about scheduling for company A's protocol activities
• If the CT facility creates all the SOPs/BPRs for the industry-sponsored trial, who owns them? Does the company have the right to take them without financial compensation?
• What are the legal implications?
• Signing NDAs — who can actually do this in academic environment?
• IP matters — who and when must these submissions be made?
• What are the publication and authorship agreements?
• Conflict of interest — physicians consulting with the company?

4. Creating a budget

• Include start-up fees to recover time/materials for training and setting up
• Phasing the project into deliverables with payment
• Rate adjustments for industry vs. NIH-sponsored protocols
• Should the process start before finances are agreed to and provided?

5. Regulatory affairs

• Who writes the CMC?
• Do you have a pre-pre IND or pre IND meeting?
• Who should attend FDA meeting?
• Should consultants be brought in (tox, biodistribution, etc?)