University Medical Center Benefits

c Clinical research trials c Investigator initiated trials o Access to novel products c Data sharing from company

(lab, animal, & clinical) o Presentations o Publications c Education (products, research) c Funding - Risks: c Conflicts of interest c Ethics c Independence c Targeted research

Fig. 3.3. Company-University Relationships manuscript for major publications from a study, especially because data analysis is performed by the company for study regulatory reports and publications as well, but the investigators contribute principally to the construct of the publication and edit all content. Companies will require the opportunity to review and comment about any other publication generated by investigators who are faculty from study data.

The university receives a host of benefits in their research collaborations with the industry (Fig. 3.3). Access to novel products to improve disease mitigation is an obvious prominent benefit. Access to the pivotal clinical trials for novel products is a related benefit as a research opportunity, to their stature in the medical community, and for future publications. A university often will have access to company data beyond the study that they are participating in because most pivotal trials are multicenter, including laboratory data, animal studies, and data from other institutions also participating in the studies. Certainly, the research grant funding is a major benefit to university faculty, who are measured by their ability to bring in grants to their university for promotion in rank. One grant, for example, for a pivotal study in which their institution contributes only 50 patients can be as much as $250,000 to $750,000, with a generous overhead that goes to the general university and department coffers. The study also offers a publication opportunity with novel science or new products for patient care, yet another criterion for faculty advancement. Educational benefits are obtained even somewhat passively by working on and learning about novel products in a research setting. At a major study site, thought leaders at the university become product experts who will conduct CME programs for regional clinicians. The university thought leader will also benefit from consultantships to companies, serving on expert panels for R&D and also marketing, assisting in identifying best products opportunities and their profiles, providing or critiquing research ideas and designs, presenting to FDA and regulatory authorities, and even market research on the company products. The consultantships provide several benefits, such as fees and honoraria for the work and also prestige in the research community for this recognized expertise. Another research benefit for the university faculty is follow-up investigator-initiated research projects (after an NDA approval), which become more likely to be funded, based on their experience with the product and their existing relationship with the company. However, some risks must be dealt with by the university clinician, related to independence already mentioned above, access to clinical data, publication opportunity, presentation (of data) opportunity, and possibly patent opportunity. Conflict of interest, or ethical conduct, is such a major issue that some institutions limit such research collaborations with companies. Another question with drug company-sponsored research is that the research work is targeted by the company, related to a specific disease and product, and the company writes the draft of the protocol, which are significant limits to independence for faculty [28].

The reputation of a company is influenced by the R&D operations. The next figure (Fig. 3.4) summarizes the assessments (2003 and 2004) by Pharmaceutical Executive trade magazine of the reputation of 19 pharmaceutical companies [29, 30]. Interviews were conducted (about 400) with industry executives and industry analysts, who were asked to rank the companies from highest, no.1, to lowest, no.10, on nine (2004) and ten (2004) parameters, which are defined in the two publications, and an overall assessment. Reputation strength scores were calculated based on their model (proprietary to authors) and the company executives' assessments with the ten criteria listed in Figure 3.4, which are prioritized in the model. Each criterion is scored separately, the companies are rated on individual criteria, and a composite score is created. Six issues are the expected criteria for business effectiveness (ranking of importance noted in parentheses): workforce (2), financial

Criteria

1. Ethical B. Marketing

Behavior Effectiveness

2. Workforce 7. Community

Outreach

3. Financial Stability

4. Leaders

5. 3rd Party io. Charitable

3rd I Relations

8. Strategy

9. Global Capability

0. Charital Support

Methods:

- Strengths Scores (10 criteria)

- 19 companies assessed

- Interviews conducted by business school

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