|Volume 20, Number 3||1995|
My observations are based on working experiences in industrial research of animal health drugs and agricultural chemicals in a "high research profile" company, in a drug company with a "moderate research profile" and a rather lengthy experience in academic research not only concerning animal health problems but also comparative biomedical research of infectious and non-infectious entities.
What would a successful academic/industrial partnership accomplish? A successful partnership should produce benefits for all partners. To accomplish this, a clear definition of each partner's responsibility is needed. It is these benefits and responsibilities that require a detailed discussion.
As a preamble to a discussion of benefits and the responsibilities, let us consider the purpose of veterinary research on the basis of the past 30 or 40 years. Ideally, the purpose of veterinary research is to improve the well-being of animals in all aspects, and, more recently, to strengthen the people/animal bond, hopefully for the benefit of both! Pragmatically, however, a large portion of veterinary research has been expended to produce food and fiber more efficiently and at reduced cost. A major portion of veterinary research at academic institutions has consisted of biomedical research utilizing the use of animals to study models of human diseases, infectious and non-infectious. During the 60s and 70s, 75% of the total research support received by colleges of veterinary medicine was provided by the federal government via NIH, NSF, USDA, etc., for the purpose of conducting comparative biomedical research. With this support came the advent and sanctification of "indirect costs" with its good and bad features. Thus, the largest portion of research conducted by colleges was for biomedical purposes concerning human diseases. While it is true that animal well-being gets some "spin-off" from this thrust, the question remains: If research for animal well-being isn't done at Colleges of Veterinary Medicine where will it be done? With regard to food animals it wasn't until the late 1970s that the federal government via the USDA made a significant effort to provide resources to fund research for animals diseases.
It is axiomatic that the source of funding drives the direction of research. It is obvious in recent times that federal funding sources are undergoing periods of containment and reduction. Thus, it is indeed timely and appropriate to consider various kinds of research partnerships if veterinary medicine is to be a vital research force in those diseases of domestic animals that have an impact on the availability of food and fiber, the public's health, and domestic animals used for human bonding.
Currently, the largest area of ongoing research involves food and fiber production utilizing chemicals and biologic agents for disease control, hormonal manipulations, and the development of new diagnostic aids.
Corporate research needs products that are effective, safe, and profitable. There is absolutely nothing wrong with making profit. I am convinced that a veterinary scientist in the corporate world can make contributions to advance veterinary research that are as significant as those made in the academic world. The goals and objectives for corporate research are clear, specific, and it is easy to measure success and progress. On the other hand, academic research has goals that are a bit more complex. Most academic researchers have responsibilities in both research and teaching and some also have service responsibilities. When comparing corporate goals to academic goals, industry goals are profit based via products or services that are effective and safe. The successful achievement of corporate objectives are easily measured by the degree of profitability; in shortãproducts, services, and profit. Usually the more profit the more research, and the converse is also true.
Academic goals are perceived, real or imagined, to be more difficult as evidenced by the annual bloodletting ritual called faculty evaluations. Seriously, the more responsibilities the more difficult it becomes to measure contributions and to assign them to the proper category and priority. Obviously these differences require patience and understanding when attempting to set goals in a research partnership.
Another difference for the scientists is the matter of selecting new research leads. The industrial scientist frequently get new product leads by a stepdaughter relationship with pharmaceutical research for human medications. And in some academic institutions the research thrust may have a stepdaughter relationship with the teaching program which may provide some leads especially at the graduate level but the matter of priority frequently creates a time hiatus in research program. This is a difference that must be addressed when establishing time frames.
Research achievements in the corporate world are easily measured and are clearly visible because the goals are specific targets with established time frames. Academic research goals are usually more complex and may change within a short period of time and may change with a new administration. However, an academic researcher with the desire of having a strong research program will overcome academic compartmentalization and other hurdles to establish a viable and productive program.
People-The First Factor of Success or Failure
I believe there are at least three important factors that will determine the success or failure of a research partnership. They are people, resources and time. The most important factor is people. There must be a primary area of mutual research interest. If academic and corporate researchers have an interest, for example in bovine respiratory disease, can goals and objectives be established that are in harmony and within an acceptable time frame? The identification of mutual goals may be difficult. For example, an immunologist may not be interested in the clinical investigation of a new drug to control shipping fever unless there are indications that the drug may involve immunologic changes. In many cases each member of the partnership is challenged to think of goals and objectives in different and nontraditional ways. The goals must be beneficial to each partner.
Although testimony and opinions may be helpful for a new product, the collection of good defensible data is essential. The industrial partner needs data to establish efficacy and safety of a candidate drug or agent. In such a venture the academic partner needs good data for peer recognition which will augment his or her research program with more support for research and graduate students and hopefully help make a positive contribution to veterinary research. In summary the partners need to 1) establish mutually beneficial goals and objectives; 2) construct a reasonable time frame; and 3) set in place a communication system and schedule to record the progress of the partnership research. These are all items that can be put in place by people working together with similar commitments and motivation. Some of these items are normal procedures in the corporate world but not in the academic world.
Resources-The Second Factor of Success or Failure
In addition to the need for scientists, a research partnership also requires resources and time. It has been my experience in industry that major resources are provided after a management decision has been made to follow a new lead and form a complete research program. Dollars and facilities are committed and often funds are made available for extra mural research and services. Extra mural support is commonly used to support clinical trials, to perform research not available in the corporate laboratories, to establish liaison with needed expertise, and some corporations also help support training and scholarship in needed research fields.
Financial support in the academic world from federal and state governments has been limited in recent times. Legislators are reluctant to support research probably because their lack of understanding of what research can do and its benefits. This lack of understanding may be due to the academics failure to recognize the need for an educational program directed to citizens and legislators so there is a better understanding of research benefits. Certainly bureaucratic waste at state and federal levels coupled with tax increases makes the case for research support difficult. So what is the point?
The point is this. There is not a better time than now to establish good working partnerships with industry and academia. Today there is more time spent in nonproductive activities dealing with questionable government requirements of semiquasi scientific merit than ten years ago. Yet, it continues to expand. Industry has suffered the brunt of the "bottleneck" at great expense of money and time. Certainly there hasn't been a shortage of lawyers in regulatory agencies. More and more agency decisions are made on the basis of legal merit rather than on scientific merit.
I propose there should be a third partner-not so much as a direct partner but as an educational member for enlightenment. That is the government agency responsible for approving the product. Academia, rightly or wrongly, is perceived to be at the cutting edge of research when it comes to new knowledge. Development of new veterinary research thrusts with a partnership of industry, academia, and government may augment all aspects and facilitate understanding and subsequent approval of new agents. It may even help make more judgments on the basis of science.
Not too long ago the US lead the world in new drug development, drug availability, advances, and safety. Unfortunately we have been passed by other countries with different systems of regulation and a more favorable environment for enterprise. At times it seems that regulation of new research products has been caught in an amorphous glob that could be called the "Dark Ages of Technology," i.e., statistical technology, analytical technology, and legal and political technology. In the past academic researchers have been asked by government or industry to support their case after a regulatory decision or policy has been made. This is the wrong time and the issue is usually in a confrontational mode. Positions have been taken and reputations are threatened. I believe it would be better if there was a continuous educational involvement by all three partners so the length of time for understanding potential areas of conflict would be reduced.
So, the time is right for good working partnerships that should be cost effective and hopefully expeditious to a better understanding of what is effective and safe.
Time-The Third Factor of Success or Failure
The last factor is time, probably our most expensive factor; time is critical in the industrial world. The urgency in the corporate world is influenced by patent life, possible patent infringement, competition with similar products or analogues, and usually products representing good potential markets require timeline that should be met to minimize financial outlay. Scientists working in industry are used to time-frames of days, months, or 1-2 years. Time constraints in academia are different. Obtaining tenure takes 6 or more years,. Some grants may be funded for 3 or more years. Academic research has not usually been noted for fast turn-around time. In summary, what is the message?
1. The time is right.
2. Understanding of each partners' needs is essential.
3. What can you contribute and when?
4. There is a need for new thinking regarding the mode for doing research.