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Universities and Academic Medical Centers

Universities and academic medical centers have multiple areas in which they interact with the drug safety world:

• Discovery and licensing
  
• Specialized clinical research units (CRUs) that run studies
  
• Other clinical divisions that run studies
  
• Training medical students, pharmacists, nurses, epidemiologists, and other healthcare professionals
  
• Ethics Committees/Investigational Review Boards (IRBs)
  
• Data safety monitoring committees and adjudication committees
  
• Consultation to the industry
  
• Reporting ADRs that occur in the hospital

The Bayh-Dole Act, or Patent and Trademark Law Amendments Act, was passed in 1980 (35USC200-212 and 37CFR401). See Web Resource 39-1. Among other provisions, it gave universities the right to hold patents for discoveries from research that they performed that also had federal funding. Government agencies had been hesitant about letting universities and small businesses obtain or license government-held or government-sponsored patents. This act encouraged universities and small businesses to move discoveries into the marketplace. Examples now abound:

• New York University: Professor Jan Vilcek and colleagues at the New York University School of Medicine developed the drug infliximab (Remicade), from which many millions of dollars in royalties were made. Professor Vilcek donated $105 million to the medical school (New York Times, August 12, 2005).
  
• Emory: Emory University receives significant sums of money from the sales of emtricitabine (Emtriva) (Source: Emory University; Web Resource 39-2).
  
• University of California: “A Drug’s Royalties May Ease Hunger” (New York Times, March 7, 2004).
  
• Northwestern University: “Royalty Pharma Buys Portion of NWU’s Royalty Interest in Lyrica for $700M” (Web Resource 39-3).

In the American setting, the development of university-held patents has, of course, produced lawsuits over royalties.

• In 1999, Glaxo Wellcome agreed to pay the University of Minnesota royalties on the company’s worldwide sales of Ziagen, an antiviral AIDS drug, to settle a lawsuit brought by the university over royalties for patents held by a College of Pharmacy professor and subsequently licensed to Glaxo (Source: University of Minnesota; Web Resource 39-4).
  
• Princeton “University and the drug manufacturing company Eli Lilly filed a lawsuit last week against Barr Laboratories, alleging that Barr was infringing on a University patent covering the active chemical in the cancer drug Alimta. The suit aims to prevent Barr from manufacturing a generic version of the drug that brought in more than $1 billion in revenue for Lilly last year” (The Daily Princetonian, May 11, 2009, Web Resource 39-5).

If universities and medical centers conduct clinical studies, they also have the usual obligations of the investigator to report certain safety information to health authorities, ethics committees, and IRBs, as well as to contractual partners.

Many universities have established clinical research units, including the University of Chicago, University of Buffalo, University of Medicine and Dentistry of New Jersey-New Brunswick, Duke University, University of Miami, University of Pennsylvania, University of Arizona, and University of Kentucky. In addition, there are units in the United Kingdom, Belgium, Canada, Germany, and other countries. Duke University, in fact, runs a clinical research organization, which they note is the largest academic clinical research organization (CRO) in the world, with more than 3500 studies in over 60 countries.

These units may perform both inpatient and outpatient studies in phases I, II, III, and IV. When functioning as sponsors, the CRU takes on all sponsor responsibilities as outlined in the laws and regulations (and local institutional policies) for the study as if it were a pharmaceutical company or a large consortium running trials (e.g., cancer trials, National Institutes of Health). When it functions as a study site for a pharmaceutical company, its safety functions revolve primarily around sending AEs (particularly serious ones) to the sponsor and notifying the IRB of serious cases. Thus, such units may take on some or all of the safety functions in the trial.

Frequently, individual investigators within universities or medical centers contract with pharma companies, CROs, consortia, the National Institutes of Health, and others to run studies or participate in multicenter clinical trials. These trials are run separately from the CRU (if such a unit exists in the institution). In such a case, the investigator is responsible for complying with all safety obligations under the regulations and local university policies. Many universities now set up offices within the administration that handle such “extramural” research activities. They offer assistance to the investigators and ensure that the university collects the appropriate fees for use of their facilities. Doing clinical trials may serve as a significant source of revenue for academic centers. Some pharma companies encourage their medical staff to remain in contact with medical centers, and physicians in companies often hold academic appointments in academia. Some controversy has arisen where academic physicians and researchers form for-profit companies that aim to discover, market, or do further research on drugs. Universities in the United States and elsewhere are now attempting to create clear “firewalls” between companies and academia even to the point of forbidding company detailers (reps) from coming on site. Some academic centers do not allow their staff to use pens with drug or company logos.

Some countries have much tighter ties between academia and government. The French health authority (AFSSAPS; Web Resource 39-6, in French) has a network of 31 academic medical centers that collect ADRs and train physicians and other health professionals on drug safety matters. They also provide consultative work for the agency upon request.

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