Partnering with Industry: An Investigator’s Perspective

1. Partnering with Industry:An Investigator’s Perspective Robert L. Coleman, MD M. D. Anderson Cancer Center

2. 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. Working Well with Industry: Perspective

4. 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. 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. Competing Interests: Potential Obstacles Cast of Arrested Development • 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

7. 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. 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. Challenges to Collaboration

10. 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. 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. Thanks!