Mr. VOLKMER. Thank you very much, Mr. Reimers. Dr. Rathmann? STATEMENT OF DR. GEORGE RATHMANN, PRESIDENT AND CHIEF EXECUTIVE OFFICER, AMGEN CORP., THOUSAND OAKS, CA Dr. RATHMANN. Well, echoing some of the same comments, reflecting the ideas of the leading biotechnology companies in this country and many of the scientists and many of the people who have studied the field, there is no question that today the United States enjoys a very important lead in this field. That lead has been the result of the Recombinant Advisory Committee, the funding of research by the National Institutes of Health, very strong and effective collaboration between universities and industries, and the risk-capital system that has made the investments possible to further this research and development. I think it's safe to say that today most of these contributions that put the United States in the leadership position have been accomplished by small biotechnology companies, representing dedicated scientists and business people working effectively in that system of collaboration with universities and with risk capital provided, many times, by the public. I think there are certainly possibilities for improving the system, but we should look very carefully at any elements that would adversely affect the momentum that has been created in the last few years that has placed the United States in the position not only for the good of the United States but probably in the position to further this science at a pace that would effectively contribute to worldwide health. So I would be cautious about making major shifts in what's happening, because it's working very effectively, and we are very pleased to be a part of it. Thank you. [The prepared statement of Dr. Rathmann follows:] The Role of Patients, Researchers, Universities and Private Companies in the Development and Marketing of Human Biological Products Statements Submitted by George B. Rathmann in Conjunction with the Subcommittee on Investigations and Oversight Hearing, Rapid advancements in biotechnology which have been accompanied by rapid acceleration in the development and commercialization of advanced biotechnology have led to the perception that a major change may be occurring in the relationship among patients, researchers, universities and private companies. This statement is intended to provide information which may be helpful for the subcommittee to understand the extent of such changes and their impact. University/Industry Relations--Based on the relationships which Amgen has developed not only with professors at universities, but with investigators at institutions and government laboratories coupled with previous experience in major businesses in this country, it appears that the situation today is more of an evolution than a revolution of typical relationships in the past. In general, academic professionals are open, candid, cooperative and willing to meet and talk freely about their work. Concerning fresh discoveries or those results which indicate new avenues of research and fundamental new ideas, academic investigators, government investigators and scientists at public institutions are highly selective in their communications which seems to have been true for many years. Their willingness to disclose such information is directly related to the confidence which they have that the information will not lead directly to competitive activities which might preempt their ongoing research. These concerns have always been a basis for some delay in communication or formal publication until the scope of the contribution can be established and the obvious extensions of the discovery or observation can be completed by the investigator. More open disclosure undoubtedly occurs when there is a formal relationship between two laboratories or a consultant relationship or other affiliation with an industrial laboratory. Even in such situations complete, real time communication seldom occurs. Selective communication and selective or delayed transfer of materials is determined more by professional issues rather than economic issues. The practice of Amgen and the general practice of most biotechnology companies is to accept the academic system as it stands and to acknowledge the freedom of the investigator to publish or not to publish, to disclose or not to disclose, consistent with the policies of the institution and the practices of the individual investigator. Effective collaboration between an industrial laboratory and an academic laboratory requires significant two-way communication. This raises the risk that proprietary information of the industrial laboratory may be incorporated in formal or informal disclosure by the academic laboratory. For this reason, industry laboratories frequently prefer exclusive consulting relationships or other exclusive relationships usually embracing a limited area of the academician's interest. Such exclusive relationships are well known and may have increased in recent years, but are far from the predominant mode of interaction. The following paragraph summarizes some of the types of relationships which Amgen has developed, and in none of these has the academic investigator been inhibited from publishing his own work. Where collaboration has led to significant new results, an effective ongoing relationship can only be maintained if such information is published reasonably promptly with mutually agreed upon authorship. Most of the relationships with universities which Amgen has established follow a similar pattern to historic precedent. Amgen has an active seminar program and invites speakers to present their work for discussion with the scientists at the company. More that 50 such seminars are presented each year and an honorarium is offered to the presenter although not accepted in every case. Such seminars may lead to informal collaboration with no particular contractual relationship. In those cases where either party perceives an obvious commercial potential for the collaboration, it is customary to negotiate an understanding with the full participation of university officials involved in such arrangements. Generally, such relationships include potential patent rights or at least the opportunity to discuss such rights at a future date with the understanding that a fair negotiation will ensue. It is often desirable for the company to have a firm understanding of possible patent rights in return for a specific level of funding toward a defined objective. When such an arrangement is viewed as beneficial to the university, the appropriate negotiations are conducted with university officials who are influenced by the preference of the academic investigator, the economic value and the apparent commitment of the company and the demonstrated capabilities to pursue successful commercialization. As has been generally true in the past, then, companies have relationships with university investigators ranging from single or occasional visits, informal collaboration, formal collaboration with or without consulting arrangements, consulting arrangements with or without formal collaboration (exclusive or nonexclusive), and formal exclusive relationships with understood financial commitments and patent rights. A new dimension which has been far more extensive, in recent years than in the past, is the development of scientific advisory boards with certain defined obligations to the company and a variety of financial understandings. It is the general practice of biotechnology companies to develop such relationships |