dif-Commercializing Research Discoveries 119how AMCs Can Commercialize technology in difficult Economic times It is important that, at a time when AMCs are financially stressed, they
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and Drug Discovery with the goal of linking the medical school with chemists from the pharmacy school to generate innovative drug research
Meanwhile, at Duke, Allen Roses, a former Duke professor, left GlaxoSmithKline after 10 years to head up Duke’s new drug discovery efforts Roses’ goal is to identify drug research opportunities that the pharmaceutical industry is not pursuing and then to bring them into what is currently a virtual company Once the new drugs are tested in animal models and humans, he hopes to sell them to pharmaceutical companies that will be able to bring the drugs to market Duke’s ability to develop potential compounds will be helped
by the award of one of the first clinical and translational science awards (CTSAs) from the National Institutes of Health—a grant focused on translating basic sci-ence findings into therapies that will improve health UPMC has taken a simi-lar approach by entering into an agreement to join Carnegie Mellon University
in developing innovative computer and software research and investment in a Carnegie Mellon spin-off that uses software to help organizations in procure-ment deals [32]
Using Academic Laboratories as Incubators
Another approach to commercializing discoveries has been to use academic oratories as incubator facilities to pursue industry-sponsored research Several universities have developed free-standing research institutes or foundations to separate research activities that are industry related These include the Draper and Lincoln Laboratories and the Whitehead Institute for Biomedical Research
lab-at the Massachusetts Institute of Technology, the Applied Physics Laborlab-atory lab-at the Johns Hopkins University, and the Wisconsin Alumni Research Foundation
of the University of Wisconsin-Madison These have proven successful largely due to a mission that is driven by a donor or sponsor (e.g., the need for the applied physics laboratory to carry out classified military research), a clear focus, and careful oversight and management by the associated university
However, using an academic laboratory within the confines of the university
to support industry-funded research raises significant concerns Great care must
be taken to ensure that there is no cross-talk between the trainees and nel in the laboratory on the university side and those on the corporate side This becomes a difficult situation when the proximity of the investigators and the common technology of the laboratory result in sharing of reagents, know-how,
person-or technology It is difficult to protect conflicts of interest, and it is equally ficult to adjudicate conflicts of commitment because of an inherent incentive for both faculty and staff to spend more time on for-profit activities than on fundamental research at a time when federal grant support is increasingly dif-ficult to obtain
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how AMCs Can Commercialize technology
in difficult Economic times
It is important that, at a time when AMCs are financially stressed, they seek new revenue sources; an important one is the commercialization of new technology that comes from the research labs of America’s medical schools The approaches outlined previously have led to successful financial ventures for a number of different AMCs As noted, however, each of these approaches has limitations and careful oversight is needed to ensure that conflicts of interest do not impede good judgment on the part of institutions and inventors and that decisions are always in the best interest of patients and subjects of clinical trials However, in the face of a global financial meltdown, when larger pharmaceutical companies are laying off staff and funding from private equity is decreasing, it is becoming increasingly difficult for AMCs to partner early-stage discoveries or spin off suc-cessful companies for the development of later stage products [33]
In addition, pre-money valuations by venture capital companies are at an time low Some AMCs will simply wait out the storm However, it may not be advantageous to wait out the current recession because the clock starts ticking once a patent is issued; therefore, long delays may waste substantial portions of the life of a patent, resulting in limited value once it is time to move toward commer-cialization Thus, AMCs must seek ways to commercialize their patents even at times of great financial stress in the U.S marketplace The suggestions in the fol-lowing sections, based on successful programs at a number of different academic institutions, may be helpful in times of crisis in the global financial markets
all-Intellectual Property Bundling
Intellectual property bundling is the aggregation of intellectual property from multiple institutions for the purpose of optimizing opportunities for licensing
to the pharmaceutical or device industry Although patents encourage cialization by giving the ownership rights to new discoveries to their inventors, the patent process often inhibits the exchange of information needed for the collaborative development of new technology Because so many processes in drug development require pieces of the new technology to come from the work
commer-of independent investigators, biotechnology companies must commer-often deal with multiple patent holders in order to develop a single product As a result, the
“downstream” researchers or biotechnology companies must negotiate licensing agreements with each of the different “upstream” patent holders in order to cre-ate a viable patent portfolio
Unfortunately, the costs of these numerous agreements often become hibitive and sometimes individual institutions are resistant, leading to what is
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commonly known as “patent thicket.” Pooling allows a group of patents from different institutions to be “bundled” together under the control of a single insti-tution, thereby creating a one-step process for potential licensees at a reason-able cost Technology bundling also allows institutions without the resources to pursue a large number of technology transfer agreements on their own to work collaboratively with other institutions to pursue joint efforts Collaboration is important; data show that fewer than half of the research universities actively seeking patents break even from technology transfer efforts and two-thirds of the revenue has gone to only 13 institutions [34] By defining preexisting guide-lines for patenting, a consortium of institutions can negotiate more effectively.The Larta Institute, a private firm specializing in technology transfer and the Ewing Marion Kaufman Foundation of Kansas City initiated the Technology Bundling Project [35] After reviewing more than 1,500 inventions from six institutions, the project group was able to identify 41 potential bundles made
up of 100 different technologies [35] A similar approach was taken by a group
of organizations in New Mexico, including the University of New Mexico, the National Center for Genome Resources, and other nonprofit institutions in the state, to create the Technology Research Collaborative [36] One of the fun-damental objectives of this group was to create institutional agreements that would support the ability of the organization to bundle patents and license them through a single entity [36]
However, it must be noted that these types of collaborative activities are not easy The various partners must negotiate the relative value of each contribu-tion, negotiate in advance how royalty revenues will be distributed, and identify the added value that comes from collaborating Furthermore, these agreements often require an outside arbiter to set values and to provide unbiased leadership [37] Nonetheless, in our current fiscal environment, such collaborative activities present an opportunity to overcome existing challenges
Development of Cross-Institutional
Collaborations in Technology Transfer
Technology transfer has become increasingly sophisticated and complex over the past decade, and AMCs undertaking efforts to commercialize their dis-coveries face some important challenges As in many businesses, the ability to obtain venture capital financing or to out-license new discoveries requires the talents of individuals who have at some time in their careers been part of the relatively small world of venture capital and/or the drug-development industry and have demonstrated success in their earlier endeavors Because many venture capitalists pay as much attention to the “jockey” as they do to the “horse” when
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they make their decisions about which new biotechnology companies they will finance, the experience level of the inventor or the individual chosen to run the new company is also of great importance Unfortunately, it is difficult to recruit individuals who have been successful in biotechnology venture capital
or in the development and leadership of biotechnology companies before they joined academia
Another challenge for AMCs developing technology transfer programs is the inherent cost of the patent process and the need to have attorneys familiar with the many different areas of biotechnology—from the synthesis of small molecules to the identification of the relevance of single nucleotide polymor-phisms in the human genome Patent attorneys with this type of expertise are neither inexpensive nor readily available, so technology transfer offices often receive advice from less experienced lawyers that leads them to patent a number
of products with little commercial value or to pass on patenting discoveries that might later be found to have enormous value Indeed, few inventors with whom
I have spoken thought that their technology transfer offices provided an optimal level of service
Technology transfer offices are undermanned and have excessive overhead This creates an optimal opportunity for a group of AMCs to partner in devel-oping a first-rate technology transfer program staffed with experts in the phar-maceutical and biotechnology business as well as patent attorneys Partnering would result in decreased overhead costs The increased number of patent filings would make it cost effective to hire first-rate patent attorneys on a full-time basis
or to outsource patent work to a single, high-quality attorney or firm and to explore the process of patent bundling when appropriate
Indeed, combining patent offices can be just one more part of the ration among various institutions that is now encouraged by the NIH and it has recently led to pooling of research efforts across all of Harvard’s hospitals and research institutions as well as the efforts of Boston University and Tufts University [38] At a time when venture capital funding is so difficult to obtain, collaborations among a large group of AMCs may also allow the various schools
collabo-to contribute collabo-to their own venture fund This would provide small start-up ages to new biotechnology companies and help them until improvements in the markets allow venture capital firms once again to invest actively in early-stage biotechnology at reasonable valuations
pack-Development of Nonprofit Biotechnology Companies
The Laboratory for Drug Discovery in Neurodegeneration (LDDN) looks like many other biotechnology start-ups Located in Cambridge, Massachusetts, with a mission of creating new drugs to treat human disease, the laboratory
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is quite unique because it is not a biotechnology company but rather a profit entity that sits under the Harvard Medical School umbrella [39] LDDN began in 2001 with part of a $37.5 million gift from an anonymous donor By focusing on drugs that are not blockbusters but rather treat specific diseases that affect a smaller number of patients, the center hopes to gain economic rewards Because LDDN has no shareholders, it does not have the usual pressures for rapid results and because it is a not-for-profit entity, it can seek collaborative help from the many parts of the Harvard Medical School research enterprise
not-for-A unique part of the program is that it funds sabbaticals for Harvard toral researchers This allows them to bring their target proteins or genes to the laboratory and work for a period of 12–18 months to develop small molecules that can alter the function of these proteins Thus, they are able to translate their basic research findings into therapeutic compounds The research is facilitated by the presence of a large library of compounds, robotic screening systems, and medicinal chemists
postdoc-However, like for-profit biotechnology laboratories, LDDN must raise money
to continue to support itself through grants and contracts Future funding will come from licensing deals and royalty streams In the meantime, its focus on a sin-gle disease raises enormous opportunities for fundraising from patients and family members The application of this type of not-for-profit biotech to other medical centers will require the same type of substantive donation or funding that was used to start LDDN However, this type of facility might be applicable to funding through a collaborative effort of a group of AMCs and their affiliated hospitals
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Trang 8III SphErE oF ACtIon:
EduCAtIon
Trang 9Chapter 7: Resolving the Physician Workforce Crisis
Chapter 8: The Changing Demographics of America’s AMCs
Chapter 9: Teaching Medical Professionalism in the AMC
EducationSphere III.
Trang 107 Chapter
resolving the physician Workforce Crisis
In the first place, the small town needs the best and not the worst doctor procurable For the country doctor has only himself to rely on: he cannot in every pinch hail specialist, expert, and nurse On his own skill, knowledge, resourcefulness, the welfare of his patient altogether depends The rural district is therefore entitled to the best trained physician that can be induced to go there
Abraham Flexner 1910 [1]
Introduction
In 1910, Flexner first noted concerns regarding the size of the physician force and the need to ensure that qualified physicians practiced in both small towns and large cities Today, the United States is facing a shortage of physi-cians that will imperil its ability to care for the ever increasing size of the U.S population—especially in rural and underserved urban areas [2,3] These short-ages come at a time when 20% of Americans live in regions that have already been designated as health professional shortage areas [4,5] Only recently has the general public begun to become aware of this brewing crisis For example, in
work-February 2008 USA Today described the plight of Nassawadox, Virginia, where
a shortage of surgeons had adversely affected care [4]
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This is not just a rural problem; over a dozen states have reported cian shortages or an expectation of physician shortages, a large number of specialties have pointed to shortages in their fields, and many practices in both rural and urban areas have reported an inability to fill vacant positions The workforce crisis has also had an enormous impact on the AMC, which must increase its ability to train students at the same time that the physician shortage compromises its ability to recruit and retain its own workforce An unprecedented number of academic positions are unfilled as academic medi-cal centers have an increasingly difficult time recruiting and retaining the high-quality physicians for which they have been renowned [6,7] This threat-ens the very foundation on which AMCs were built: providing excellence in patient care
physi-This chapter will describe the causes of the physician workforce crisis, describe how some AMCs are developing plans to enhance their ability to train physicians, discuss concerns regarding some of the new models being created for some medical schools, and present recommendations to create a national task force to address the physician workforce crisis
Causes of the physician Workforce Crisis
The history and causes of the workforce shortage have been detailed by Richard Cooper, a former medical school dean and leading authority on the topic [2,8,9]
In the 1970s, policy makers became concerned that the increased spending on healthcare was driven by physicians—a belief that led to the hypothesis that the economy would benefit if the total physician pool were to be decreased [8] The Graduate Medical Education National Advisory Committee advised Congress
in 1980 of a growing surplus of physicians and predicted a net excess of 70,000 physicians by 1990 and an excess of 140,000 by the year 2000 Governmental support for medical schools ceased and, as a result, so too did the expansion
of both allopathic and osteopathic medical schools [10] Thus, one important component of developing a physician workforce—undergraduate training—was crippled by decreased governmental support
The decrease in funding for undergraduate training had a profound effect Between 1980 and 2000 the number of students trained at allopathic medical schools did not change while the population of the United States increased sig-nificantly Thus, the number of physicians per capita graduating from American medical schools markedly decreased [8] The Council on Graduate Medical Education, a group that just a decade earlier had strongly supported the notion that there would be a physician surplus, reversed its earlier projections and noted that there would be physician shortages in the years ahead [3] Indeed,
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the Association of American Medical Colleges recommended that U.S medical schools increase their enrollments by 30% by the year 2015 [11]
By the fall of 2005, U.S allopathic medical schools had increased their ment levels by approximately 10% [12] By 2007, 115 of 126 allopathic medical schools had increased their first-year enrollment, which would be expected to increase growth to over 19,000 first-year students in 2012 [13] Unfortunately, these increases will be insufficient to meet all future needs of the U.S popula-tion, thus threatening the healthcare of the nation [14]
enroll-The ability to train more physicians has also been limited by federal tions on the number of postgraduate training slots In the late 1990s the American College of Physicians Health and Public Policy Committee and the Health and Public Policy Committee on Physician Workforce and Financing of Graduate Medical Education made a group of substantive recommendations regarding postgraduate medical education (internships, residencies, and fellowships) in the United States [15] Unfortunately, the only recommendation that received atten-tion from federal regulators was that the number of postgraduate year 1 (PGY-1) residency positions be decreased As a result, the Balanced Budget Act of 1997 froze federal funding for graduate medical education at its 1996 level According
restric-to Cooper, “this single action fully accounts for the leveling off of physician ply in 2005 and the projected decline thereafter” [8]
sup-With a cap on the number of postgraduate training positions, even if U.S allopathic and osteopathic medical schools were able to increase the number of medical students trained each year in the United States, the overall number of practicing physicians would not change substantially With an increase in the number of U.S graduates, programs that traditionally filled with international graduates would instead fill their programs with U.S graduates Thus, the total number of trainees would remain the same, but would be composed of a higher percentage of U.S graduates [16] Because of this, U.S teaching hospitals must increase their number of postgraduate training slots annually for a period of
10 years to reach a total of 35,000 trainees by 2020 in order even to begin to approach the future U.S workforce needs [8]
Not all experts agree that there is a shortage David Goodman has been a leading advocate of the view that current workforce planning has failed to out-line explicitly the expected patient or societal effects of training more physicians [17] Goodman suggests that U.S healthcare would be better served by investing
in coverage for uninsured children and reforming Medicare physician payments
to shore up the collapsing infrastructure of primary care medicine However, other studies have shown that simply increasing the supply of primary care phy-sicians will not result in better outcomes [18–20] Furthermore, the Institute of Medicine of the National Academies of Medicine, the most prestigious group of health science academicians in the United States, weighed in on the subject in
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April 2008 and clearly supported the contention of Cooper and others that the United States was clearly facing a healthcare workforce crisis [21]
Shortfall of Academic physicians
Just as there is a physician shortage in communities across the United States, there is also a critical demand for physician–scientists, physician–educators, and clinician–investigators (the academic workforce) in virtually all of our AMCs Furthermore, it is just as important to retain young investigators as
it is to retain established investigators A recent survey by the Association of American Medical Colleges reported that almost two out of every five faculty members leave academic medicine within a decade for more lucrative oppor-tunities in private practice or industry [22] After 10 years, only half of all academic faculty remained at their medical schools, while 38% had left aca-demic medicine Of even greater concern was the high attrition rate of young faculty: 43% Given the high cost of recruiting an individual faculty member and adverse affects of turnover on physician morale and satisfaction, the con-tinuing difficulties in recruiting and retaining young physicians to academic medical centers threaten their integrity and future
In 2001, CenterWatch, a group that oversees U.S clinical research prises, reported that by 2005 there would be a critical shortage of individu-als trained in clinical research [23] Consistent with this finding, only 8% of principal investigators conducting industry-sponsored clinical research at U.S academic medical centers are younger than 40 years of age [23] and fewer than 4% of competing research grants awarded by the NIH in 2001 went to inves-tigators who were 35 years of age or younger [24] This shortage has not gone unrecognized by policy analysts or by the clinical research industry In 1998, the NIH created a group of awards for new investigators (K23) or those who were at the midpoint of careers in patient-oriented research [25] In addition, a program (K30) was instituted to provide funds for clinical research training programs at
enter-55 institutions across the country [26]
The most valuable addition to the NIH grants portfolio in terms of ing the number of clinician investigators has been a clinical research loan repay-ment program that repays educational debts for individuals who spend the majority of their time in clinical research [27] However, the impact of this program is limited by the fact that it only applies to minority candidates, there are far more applicants than funding, and the repayments only cover a part of the 4-year medical school curriculum Corporate foundations have also invested
improv-in traimprov-inimprov-ing programs for climprov-inician–improv-investigators [28]