<< Previous Section | < Previous Page | Next Page > | Next Section >> Case: Regulatory Controls and Career Success Dr. Atkins is finally beginning to enjoy the success of her hard work on angiogenesis factors in cancer biology. Her work on HTGF (hypoxic tumor growth factor) led directly to her discovery of the HTGF receptor for which the active site was easily identified. She had gone early to the Office of Intellectual property, which got patent protection for HTGF and its receptor as well as the use of its active site. It was suggested that Dr Atkins form a company and license back the rights to develop her discoveries but she decided that she was enjoying her life, did not want further complications and could help a commercial firm develop the therapeutic agent. A major cancer-oriented biotechnology company Betagen, licensed Dr. Atkins' technology for a considerable sum. Although the company preferred to pay in cash, both the university and Dr. Atkins wanted and received a significant amount of equity, predicting that development of HTGF antagonists will be very profitable. Betagen then asked Dr. Atkins to be a major consultant to them. Her knowledge was worth $50,000 a year for monthly one day visits. They could pay her in cash or stock. It was up to her. After two years of hard work, with Atkins' insights, the appropriate antagonist was synthesized and tested extensively in animals. Phase 1 and 2 trials in HTGF-over expressing lung carcinoma, one of the leading target cancers were completed. Dr. Atkins is an oncologist specializing in lung cancer. She belongs to the departmental practice plan. She was approached by the contract clinical trials organization handling the HTGF antagonist to be the local PI for the definitive Phase 3 trial. She agreed to participate because she really wanted her patients to experience the benefits of her basic research. She wanted to be a truly translational investigator, so it was arranged. She presented the research protocol to the IRB and Conflict of Interest Review Committee (CIRC) for approval. The CIRC is concerned about her multiple roles - inventor, consultant, and PI and feels that there needs to be some accommodation made if the University is to accept the contract. She seeks a solution that will give her patients access to the trial. The Contract and Grant Officer signs the contract for the University. Dr. Atkins and all her co-investigators also sign the contract indicating that they have read the agreement and will adhere to the terms including the confidentiality statement. After the appropriate accommodation was made and the conflicts of interest noted in the informed consent document, the study was approved and began. About 3 months into the 2 year accrual period, Dr Atkins saw a journal advertisement from Betagen offering basic research support for investigators studying cancer growth inhibition. She applied and was awarded $100,000 annually for 3 years. Again, because of University rules Dr. Atkins had to provide the CIRC with information about her relationship to Betagen. She didn't understand why, since this basic science grant had nothing to do with the clinical trial and so she told her grant administrator to complete a negative disclosure form that she signed and submitted to the Contract and Grant Office with other grant paperwork. Dr. Atkins was pleased to be called by a large investment group about a year into the study to consult with them about newer treatments for cancer. They would pay $2500 per hour for her time on conference calls. She considered this a perquisite of her success and participates about every 3 months. Meanwhile, Betagen, anticipating the impending success of the trial, asks Dr. Atkins to join their Speakers Bureau to give oncologists a chance to hear her views on cancer therapy. She thought that this would give her greater exposure and prestige so she went to the speakers indoctrination meeting and was put on their list. She received numerous requests to give talks. She has begun to realize that all these activities are beginning to cut into her family life and her basic research but she loves the recognition and respect. Questions: Dr. Atkins has entered the golden period of her career. Has her success created issues in relation to University rules and regulations? What issues have arisen in terms of her core career as a result of her success? What are her reporting responsibilities to the CIRC? What are her reporting requirements to her department? Do any of her activities put her career at risk? << Previous Section | < Previous Page | Next Page > | Next Section >> Chapter 5 Quick Links Monitor Research Cases Bibliography Chapter 5 Download (PDF)