1. How can we work together? Partnering with Industry: An Investigator’s Perspective Robert L. Coleman, MD M. D. Anderson Cancer Center

2. How can we work together? Industry Relations Spectrum: Preclinical to Phase IV The complexity of the relationship is proportional to the phase of development – Companies are organized under different management strategies to guide their pipeline (e.g. “discovery” team, late preclinical team, phase I team, “global” team) – Corporate oversight is proportional to budget Mostly collaborative but it’s important to understand the competing interests & perspectives

3. How can we work together? Working Well with Industry: Perspective

4. How can we work together? Investigator’s Goals: Perspective Oversee or participate with new therapy – Competitive advantage for site or practice Academic capital > financial (but not always) – Publications, portfolio, promotion, grants Support is linked to infrastructure costs Translational objectives: – May be “owned” by the PI’s – May be “shared” interest with Sponsor – May be “unique” to the Sponsor

5. How can we work together? Bench to Bedside to Bench…repeat Trials of this nature are good examples of close collaborations between industry and investigators – Examples: Home grown agents Novel therapeutics from start-ups or small research divisions in bigger companies Relatively low cost studies but relatively unlikely to result in registration paths (5% rule)

6. How can we work together? Competing Interests: Potential Obstacles Intellectual property Time-lines for accrual Budgets – The sense of “something for nothing…” – Drug-only trials Constrained or limited development – Combination trials with agents outside the Sponsor’s portfolio Options: CRADA or purchase – Industry may kill a potentially viable program Pemetrexed Abraxane Cast of Arrested Development

7. How can we work together? Competing Interests: Potential Obstacles Internal business discussions of development plans – Direction may be crafted by: Interpretation of preclinical or phase I “signals” Registration opportunities Advice from focus groups or external advisors – May be at odds with “optimal” or lengthier strategy Challenges: – Sponsor’s knowledge or understanding of the disease type/environment – Corporate way of doing things (always RP2D)

8. How can we work together? Challenges to Collaboration: Cooperative Groups Timelines to FPI, annual accrual, completion dates Prioritization of potentially competing agents – PARPi’s, mTOR’s, anti-angiogenics – Institutional policy against having more than 1 registration trial in the same class of agent Industry reluctance on registration paths (FDA or EMEA package) Reluctance of the cooperative groups to participate with industry if they feel the data is not or cannot be independently auditable Costs associated with translational objectives Important to have a “champion” who can tactfully navigate the bureaucracy

9. How can we work together? Challenges to Collaboration

10. How can we work together? Challenges to Collaboration COI: industry relationships are being increasingly scrutinized in clinical investigation – Many of the most experienced Investigators are necessarily “tapped” for advice in development Investigator (NCI) definition: – “’Investigator’ means the Principal Investigator AND any other person who is responsible for the design, conduct, or reporting of research funded by PHS, or proposed for such funding.” “…relating to financial interests, ‘Investigator’ includes the Investigator’s spouse and dependent children” Significant COI requires reassignment of the Investigator, consent disclosure, and transfer of patient care while on study

11. How can we work together? Building Industry Rapport Strong relationships can lead to important and expeditious milestones in clinical medicine Important to understand the issues upon which industry and the scientific community wrestle to optimize collaborative interaction Communication, confidence and transparency are key to this process

12. How can we work together? Thanks!