The need for interdisciplinary collaboration is arising as a result of accelerating advances in basic science, including massive research and development funding by both government and industry, which has spurred the so-called “nanotechnology revolution” and developments at the intersection of the life and physical sciences, increasing emphasis by federal research funding agencies on interdisciplinary and inter-institutional research and by market influences. A number of barriers presently limit the interaction between academics and industry, including the typically very time-consuming and slow pace of technology transfer, which is compounded in the case of interdisciplinary and inter-institutional licensing, as well as the natural, and understandable, antipathies that exist between academia and industry as a result of their differing missions and approaches to scientific discovery. Moreover, if mechanisms are not in place at the outset of an inter-university collaboration, then the transition of inventions to clinical applications can be fraught with additional complexities and barriers. Policies suggested by the National Nanotechnology Initiative offer a number of ideas for overcoming barriers to multidisciplinary and inter-institutional research and illustrate some of the ways in which academia can structure partnerships with industry that will not only provide needed funding for multidisciplinary and inter-institutional biomedical research in an era of diminishing federal resources, but may permit academia, on the one hand, and industry, on the other, to benefit from the strengths provided by the other without compromising either academia's or industry's basic missions.
The NIH Roadmap for Medical Research notes: “… as science has advanced over the past decade and the molecular secrets of life have become more accessible, two fundamental themes are apparent: the study of human biology and behavior is a wonderfully dynamic process, and the traditional divisions within health research may in some instances impede the pace of scientific discovery.” Available at http://nihroadmap.nih.gov/interdisciplinary.
Other examples of nanotechnology companies that, according to their websites, are developing products in the life sciences industry include: Insert Therapeutics, Inc. (focuses on designing and developing patented cyclodextrin-containing polymer delivery systems that combine with small-molecule drugs and nucleic acids to significantly improve drug solubility, stability, circulation, and targeting for enhanced safety and efficacy); Calando, Inc. (develops nanostructures for delivery and therapeutic use of RNA interference); Nanotechnica, Inc. (pursuing in the near term the development of several early-stage nanotechnologies such as scanning probes and integrated microfluidic systems for separation and detection of molecules); Potentia Pharmaceuticals, Inc. (an early stage biotechnology company focused on developing novel therapeutics, primarily in the area of macular degeneration); Surface Logix Inc. (leverages its expertise in biophysical chemistry to create new small molecule drugs that are optimized to meet the challenges of human physiology, including multiple internal programs focused primarily on cardiovascular disease, oncology, and metabolic disorders); Nanosys (has a technology platform incorporating high performance inorganic nanostructures, with over 400 patent and patent applications, currently being applied to address opportunities in the energy, defense, electronics, computing, and life science industries); Nanosphere (commercializing certain nanoparticle probes, bio-barcode technology, and automated instruments that enable ultrasensitive detection of multiple proteins and nucleic acids simultaneously, direct genomic detection without amplification or enzymes, and 5–6 orders of magnitude more sensitive detection than ELISA-based methods for proteins); Ohmx Corporation (a protein biosensor company focused on the development of portable electrical detection devices for use in diagnostics, drug development, and industrial applications such as biodefense, food, water, animal, and environmental testing); Acumen Pharmaceutics, Inc. (a preclinical drug company focused on developing therapeutics and diagnostics for Alzheimer's disease and other memory-related disorders). See also Baluch A, supra note 2.
For example, Accelerate Brain Cancer Cure, Inc. (ABC2), a nonprofit organization founded in 2001 by Daniel H. Case III, a leading investment banker who had been diagnosed with and subsequently died from brain cancer. “ABC2 funds outstanding and novel translational science…. Central to our approach is a fast-track award process geared to provoke new ideas from scientists working in diverse areas of research. We give funding preference to applications focused on programs that will benefit patients with advanced brain cancer in the near term, although we also support projects with other relevant research guidelines.” See http://www.abc2.org.
7.
According to a widely cited Tufts University study from 2001, the average cost to develop a new drug is $802 million to $1 billion. Frantz A. “Biotech Battle,” Lowell Sun (July 16, 2004). However, this estimate is not universally accepted. “The study included a ‘highly selected' sample of the most expensive new drugs. The average cost of drugs in this sample came to $403 million.” See, e.g., AngellM. “The Truth about the Drug Companies,” Chicago Sun-Times (August 22, 2004). References available through LexisNexis news database.
8.
BaluchA, supra note 2, at 3–7.
9.
KrimskyS. Science in the Private Interest: Has the Lure of Profits Corrupted Biomedical Research?Lanham: Rowman Littlefield Publisher, 2003; Krimsky S. “Reforming Research Ethics in an Age of Multivested Science,” in Buying in or Selling Out, ed. Stein D. New Brunswick, NJ: Rutgers University Press, 2004; Horton R. “The Dawn of McScience,” New York Review of Books, March 11, 2004; Raube W. “The Emerging Partnerships Among the National Institutes of Health, Academic Health Centers and Industry,” Preparing for Science in the 21st Century, eds. Harrison D, Osterweis M, and Rubin E. Association of Academic Health Centers, 1991; Krimsky S. “The Profit of Scientific Discovery and its Normative Implications,” Chicago-Kent Law Review, 75: 15–39, 1999; Editorial, “He Who Pays the Piper Calls the Tune,” J R Coll Physicians Edinb, 33: 229-234, 2003.
10.
37 CFR 1.45(c) (2005).
11.
35U.S.C. § 116(2005).
12.
37 CFR 1.56 (2005). See Baluch A, supra note 2, at 22.
13.
The Manual of Patent Examining Procedures provides that “[a]ll parties having any portion of the ownership in [a] patent property must act together as a composite entity in patent matters before the [Patent and Trademark] Office.” The Manual of Patent Examining Procedures, 8th ed., rev. 3: 300–2 and 300–3, August 2005, quoted in Baluch A, supra note 2, at 23.
AndrewS. Baluch describes the new paradigm in university technology transfer that the NSECs embody as an “evolutionary model” of tech transfer, as opposed to the more radical or “revolutionary” model typified by Albany Nanotech, the largest and best-funded nanotechnology research center in the United States, which is located in a new College of Nanoscale Science & Engineering at the State University of New York (SUNY) at Albany. Due in part to the fact that Albany Nanotech receives the majority of its funding from private companies and the State of New York rather than the federal government (including $493 million from IBM, Tokyo Electron Ltd., and International SeMaTech, matched by $310 million from New York), Albany Nanotech has a unique technology transfer process that is a byproduct of its public/private origins and its purpose “to provide a virtual ‘one-stop-shop’ for its business partners,” which includes the following: “pre-competitive” collaboration among partners with common R&D interests at the early research or proof-of-concept research stage; a manufacturing capability, including a 200-mm wafer processing, characterization, and prototype fabrication facility and a network of over 100 corporate partners that comprise “the complete spectrum or ‘food chain’ of companies supporting the development of advanced devices, components, and systems”; and the provision of industry-compliant clean rooms and fabrication facilities for product testing. See Baluch A, supra note 2, at 13–21.
18.
Id. at 14.
19.
See BaluchA, supra note 2, at 13–18.
20.
See discussion of ethical and other issues raised by the overdependence of academia on industry support and the public policies that contribute to such dependence, discussed in the references at note 9, supra.
