Pharm.D. Pathways to Biomedical Research

Special Conference on Pharmacy Research

National Institutes of Health
Bethesda, Maryland
December 13-14, 2006

Introduction and Conference Objectives

The pharmacy community contributes to biomedicine at multiple levels including education, scholarly activity, and service through patient care. Pharmacists have a broad base of knowledge in pharmacology, including pharmacokinetics, pharmacodynamics, pharmacogenetics, pharmacotherapy, and pharmacoeconomics, as well as a strong understanding of human metabolism, transport, and elimination. Because of significant interest in translational/clinical research questions related to drug development and therapeutics, the field of pharmacy is in a unique position to conduct research toward achieving the goal of individualized prescription drug therapy. With the ability to envision translational endpoints, Pharm.D.s are a valuable component of the current biomedical research enterprise. However, there is a relative scarcity of Pharm.D. investigators that receive competitive funding. Schools of pharmacy now receive less than 1 percent, collectively, of the National Institutes of Health (NIH) budget.

Currently, 99 schools of pharmacy produce approximately 11,000 Pharm.D. graduates each year, and thus there is considerable merit in finding ways to increase the pool of biomedical researchers within this population. This conference aims to move the community to action in addressing this issue by fostering discussion of:

  • current pathways to independent scientist taken by Pharm.D.s and the factors in their success;
  • opportunities for pharmacy researchers;
  • education, training opportunities, and mentorship;
  • NIH training and research programs for which Pharm.D.s are eligible to apply;
  • potential new programs that may enhance the quality and number of independent Pharm.D. researchers; and
  • obstacles, reasons, and means for improvement.

Day 1

Role Models for Pharmaceutical Science Research

Scientific presentations given by:

  • Kathleen Giacomini, Ph.D., University of California, San Francisco School of Pharmacy
  • W. Douglas Figg, Pharm.D., MBA, .National Cancer Institute, NIH
  • Kim L.R. Brouwer, Pharm.D., Ph.D., University of North Carolina at Chapel Hill School of Pharmacy
  • Barry L. Carter, Pharm.D., University of Iowa College of Pharmacy
  • William E. Evans, Pharm.D., St. Jude Children's Research Hospital
  • Courtney V. Fletcher, Pharm.D., University of Colorado Health Sciences Center
  • Julie A. Johnson, Pharm.D., University of Florida College of Pharmacy
  • John G. Kuhn, Pharm.D., University of Texas Health Science Center at San Antonio
  • Howard L. McLeod, Pharm.D., University of North Carolina at Chapel Hill School of Pharmacy
  • Mary V. Relling, Pharm.D., St. Jude Children's Research Hospital
  • Timothy S. Tracy, Ph.D., University of Minnesota College of Pharmacy
  • Andy H. Strayer, Pharm.D., Pharmaceutical Product Development, Inc.

Pharmaceutical scientists can offer unique perspectives to clinical and translational research, such as introducing and integrating pharmacogenomic approaches and methods to clinical trials in various disease areas. In addition, Pharm.D. researchers can play an important bridging role between clinical investigators who may not otherwise find each other. Broad training in physiology and drug metabolism enables Pharm.D. scientists to pursue research interests in a range of therapeutic areas, including but not limited to oncology, cardiology, HIV/AIDS, liver disease, and health services research. NIH-funded pharmaceutical scientists that are currently conducting studies in these areas provided brief accounts of their research, described their own career paths, and offered suggestions on strengthening the Pharm.D researcher pipeline.

Despite a wide range of individual career trajectories, these successful pharmaceutical researchers all viewed certain characteristics of their training as pivotal to their becoming productive, independent scientists. These include i) high-quality mentoring, ii) grant-writing education and experience, iii) exposure to rigorous research, and iv) clinical acumen acquired through practice experience. The day's presentations converged around common themes, presented here in context of the talks and related discussion.

Leading pharmaceutical scientists have followed diverse paths to yield successful research careers.

Historically, most of the trailblazers in pharmacy research discovered their interest and compatibility with scientific investigation relatively late in the game. Most reported that they turned to research after realizing that clinical practice alone was not sufficient to hold their interest. Many also were dissatisfied with the lack of a literature basis for pharmacy practice. Once these investigators chose to pursue a research career, a common thread to their eventual success was the significant value of mentoring (occasionally from outside the profession). Whether on-site or from a distance, mentoring is an essential component of the professional development of junior investigators. Through continual nurturing from experienced investigators, junior scientists acquire the necessary professional skills for succeeding in research, such as grant-writing and manuscript preparation. Mentoring Pharm.D. students should also include a focus on raising awareness about clinical and translational research opportunities.

Many current pharmaceutical scientists also cite the importance of institutional support in boosting the chances for an inexperienced scientist to successfully transition to independent investigator. Since schools of pharmacy do not uniformly provide significant start-up packages to new investigators, other sources of funding (such as professional societies) represent an important alternative resource to becoming competitive for NIH funding.

Pharm.D. students have a wide range of research exposure and career interests in academia and industry.

Due to the heterogeneity of pre-pharmacy school educational experiences, research training needs are also quite variable. Some students pursue Ph.D. training after earning their Pharm.D. degree, whereas others obtain research experience through some type of post-doctoral fellowship after receiving a Pharm.D. degree. There is some debate about the value of each type of training approach, but general consensus exists that when it comes to training, one size does not fit all. Speakers agreed that a solid basic science education and meaningful clinical experience were both important ingredients of a successful pharmacy researcher.

It is acceptable for schools of pharmacy to differ in their relative concentrations of practice and research. However, research-intensive schools of pharmacy should consider developing research tracks for their pharmacy curricula; a critical mass of faculty is necessary for this approach to be effective in producing competent Pharm.D. researchers.

For those students who maintain a research focus, individual preference as well as research interest and application will influence whether that graduate seeks employment in academia, industry, or other venues such as the government. One reality is money: many recent graduates who have accumulated debt throughout their schooling find a high-paying position in industry difficult to turn down. It is also important to recognize that some Pharm.D. graduates may be drawn to industry irrespective of financial concerns, since Pharm.D.s have the opportunity to play key leadership roles in contract research organizations (CROs), pharmaceutical firms, and biotechnology companies earlier in their careers.

To increase the pool of pharmacy-trained clinical and translational scientists, the pharmacy community must work proactively to recruit students and overcome barriers.

Seasoned pharmaceutical science investigators feel that this community should be producing a body of research, but that many Pharm.D. students get little to no exposure to research during their training. Schools of pharmacy do not necessarily attract "research types," and a lack of role models contributes to this cyclic problem. There was general agreement that early recruitment of students to research is critical to increasing the investigator pool, and that recruitment strategies should be aggressively pursued. Once a student selects this path, it is important that the research experience be authentic such that he or she can develop a good understanding of the research process, including the ability to derive good scientific questions. While various approaches could provide this type of research exposure to interested students, it may be useful to emulate successful endeavors such as the Howard Hughes Medical Institute NIH Research Scholars program for medical and dental students. Summer research experiences are another possibility.

Many successful pharmaceutical scientists point to the importance of team science in conducting clinical and translational research. Despite the enthusiasm for bolstering numbers of research-oriented Pharm.D.s, there is some concern that rigorous research training may lead to a regression of clinical interest and/or acumen. Most within the field agree that to avert this potential problem, continued clinical experience, at some level, is necessary during Pharm.D. training so that these researchers continue to focus on clinical questions in their own research careers. One inescapable reality is that most clinical research studies take a long time, and this can be at odds with the promotion/tenure clock.

Food and Drug Administration (FDA) Perspectives

(Robert Powell, Pharm.D., Center for Drug Evaluation and Research, FDA)

The recent emergence of new technologies has enabled novel approaches for conducting human studies research, including model-based drug development. Many Pharm.D.s in industry and government are using these approaches, which may help prompt a paradigm shift in biomedicine from clinical- to molecular-based disease diagnosis and predisposition. Key drivers in this process include modeling and simulation; rapid compound selection in humans; biomarkers; innovative approaches to clinical trial design and registration (including provisional approval); and integrated safety assessment and risk management. Modern drug development is adopting an adaptive model with several go/no go decision nodes. The potential benefits of using modeling and simulation approaches include earlier detection of drug response; identification of patients with high recurrence risk; more accurate assessment of the impact of risk-benefit relationships; and reduction in trial failure rate.

Schools of pharmacy could take several steps to prepare Pharm.D. students for these new types of approaches. These include aligning school research programs with particular therapeutic strengths, recruiting and nurturing students with excellent quantitative skills, enhancing integration of the investigation of diseases and drugs, and creating meaningful partnerships with additional disciplines and academic departments.

There are no legal restrictions that prohibit scientists with a Pharm.D. degree to be a principle investigator on drug trials that FDA reviews. The only requirements are that principal investigators are qualified and that there is adequate medical participation regarding patient efficacy and safety in the design and conduct of the trial. Section 312.53 of the 5/1/2003 Code of Federal Regulations (21CFR312), Chapter 1 FDA, Part 312, Investigational New Drugs Selecting Investigators and Monitors, states the following:

  • Sponsors are responsible for selecting qualified investigators.
  • Selecting investigators. A sponsor shall select only investigators qualified by training and experience as appropriate experts to investigate the drug.
  • Curriculum vitae. A curriculum vitae or other statement of qualifications of the investigator showing the education, training, andexperience that qualifies the investigator as an expert in the clinical investigation of the drug for the use under investigation.
NIH Funding and Opportunities

(Kenneth W. Miller, Ph.D., American Association of Colleges of Pharmacy; Richard T. Okita, Ph.D., National Institute of General Medical Sciences (NIGMS), NIH; Timothy S. Tracy, Ph.D., University of Minnesota College of Pharmacy; Anne Zajicek, M.D., Pharm.D., National Institute of Child Health and Human Development, NIH; Peter C. Preusch, Ph.D., NIGMS, NIH)

An increase in the number of pharmaceutical scientists is important not only for the future success of pharmacy education, but also for improvement of the public's health through clinical and translational research endeavors. Currently, a very small proportion of the NIH extramural budget funds faculty research at a small number of pharmacy schools throughout the country. One reason for this is that historically, research funds for pharmaceutics were obtained from industry and other sources. Another factor is that clinical research in pharmacy has not received significant NIH funding support, in part because few pharmacy faculty apply for NIH awards. While it is true that the current budget climate is very limited, it is important for the pharmacy community to communicate with NIH about the need to support clinical pharmaceutics studies. One possibility is to submit suggestions to staff within the newly created Office of Portfolio Analysis and Strategic Initiatives (OPASI) in the NIH Office of the Director. Although there is a need for schools of pharmacy to continue to seek NIH research funds, institutional commitment to investigator research is a critical component. Adequate infrastructure and a vibrant research culture are both necessary for biomedical research to thrive.

Available NIH mechanisms that can be utilized for training Pharm.D.s include training grants and mentored research (K) awards. It is important to recognize that Institutes and Centers across NIH have varying eligibility requirements for NIH training awards. Detailed descriptions of these programs and their eligibility requirements are posted and continually updated on the NIH Web site. A listing of relevant mechanisms appears below.

Training Grants
  • F31 (Ruth Kirschstein NRSAs (predoctoral fellowships-available to Pharm.D. students and fellows)
  • F32 (Ruth Kirschstein NRSAs (postdoctoral fellowships--available to Pharm.D. students and fellows)
  • T32 (Ruth Kirschstein Institutional NRSAs (predoctoral and postdoctoral fellowships-available to pharmacy programs)
  • T35 (short-term institutional research training grants-available to pharmacy programs)
Mentored research awards
  • K99/R00 (NIH Pathway to Independence Award--available to recent Pharm.D. graduates)
  • K01 (Mentored Research Scientist Development Award-available to Pharm.D.s)
  • K02 (Independent Scientist Award--available to Pharm.D.s with other research support)
  • K08 (Mentored Clinical Scientist Development Award-available to Pharm.D.s)
  • K23 (Mentored Patient-Oriented Clinical Scientist Development Award-available to Pharm.D.s)
  • K24 (Mid-career investigator award in patient-oriented research--available to associate professor or equivalent level)
  • Roadmap K12 (Mentored Clinical Scientist Development Program Award-available to institutions)
  • K30 (Clinical Research Curriculum Award-available to institutions)
  • K07 (Academic Career Award-available to individuals to enhance educational or research capacity at their grantee institution)

Recently instituted NIH programs, including the Clinical and Translational Science Awards (CTSAs) and the Multiple Investigator initiative, will also offer opportunities to provide NIH research funding for pharmacy researchers. In addition, NIH loan repayment programs can play an important role in attracting health professionals to biomedical research.

Day 2

Perspectives on Pharm.D. Training
Developing academic partnerships and Pharm.D. curricula that train the next generation of pharmacy academicians and pharmaceutical scientists in government and industry

(Palmer Taylor, Ph.D., University of San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences)

The all-Pharm.D. approach that has now been fully instituted has been a positive step in pharmacy training, and it has expanded career opportunities for pharmacists. However, those Pharm.D. graduates interested in pursuing a research career must obtain training in the form of a Ph.D. or a postdoctoral fellowship, in addition to pharmacy residency training. The length of time required for this career progression may have untoward effects on age to scientific independence, tenure and/or promotion, and family concerns such as child-rearing. Exacerbating this issue is that fact that many pharmacy students are "late bloomers," educationally; these students often have completed one or more undergraduate degrees and may also have spent time in the work world. Nonetheless, rigorous training that is integrally linked to the research and resource base is critical for establishing a successful career in academic or industry research. The University of California, San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences has devised an emphasis-area (tracking) approach to provide more focused education, research, clinical and pharmaceutical development opportunities for students and faculty. The emphasis areas include Pharmaceutical Sciences, Pharmaceutical Technology and Management, and Clinical Pharmacy Practice.

Meeting the need for well-educated clinical scientists

(Marilyn K. Speedie, Ph.D., University of Minnesota College of Pharmacy)

It is true that currently, relatively few Pharm.D. students wish to become researchers, and thus schools of pharmacy must keep a focus on training a substantial cadre of pharmacists to provide direct patient care at the generalist level and to help lead changes in practice. This is important because the continuing, nationwide pharmacist shortage poses a significant problem for filling current faculty vacancies at schools of pharmacy. Making matters worse, the number of elderly Americans is expected to double by 2030. The number of prescriptions per patient is markedly higher in this population, leading to future increases in already excessive workloads for practicing pharmacists. However, there are some pharmacy students that desire to pursue research careers, and faculty and administrative staff should actively target, nurture, and educate this niche population to prepare them for research opportunities in academia and industry. Several steps can be taken to expand the pharmacy research enterprise. These include clarifying pharmacist roles, achieving a commonality of excellence, establishing mentoring programs, establishing financial models, addressing time-in-school concerns and other lifestyle issues, and enhancing clinical research by reducing barriers across schools.

Pathway approach to pharmacy education in the development of pharmacist scientists

(Mary Anne Koda-Kimble, Pharm.D., University of California, San Francisco School of Pharmacy)

Compared to years past, in recent times pharmacy school applicants are generally an older, more diverse group of students. This, combined with an increasing number of opportunities and roles for pharmacy graduates, has prompted the University of California, San Francisco School of Pharmacy to develop and implement a "pathway" educational approach in which students commit to a particular training route in the second year of their pharmacy education. This strategy aims to be nimble while maintaining a commitment to adhering to board-certification standards. All students pursue a core program, and then branch off to one of three pathways: Pharmaceutical Care, Pharmaceutical Policy and Management, or Pharmaceutical Science. The Pharmaceutical Science pathway enables students to develop skills required for clinical and basic science research. Students pursuing this avenue achieve competencies in bioanalysis; drug discovery and delivery; drug development; research design, presentation, administration, and dissemination; biostatistics; pharmacogenomics; and research skills. To date, the relatively new Pharmaceutical Sciences pathway has attracted few students, but those students have rated the program highly and are pursuing the next steps toward achieving success in their research careers. On the other hand, some students reported being hesitant to pursue research because of a lack of role models.

T32 training programs in clinical pharmacology: Lessons for developing training programs in clinical pharmacy

(Kathleen Giacomini, Ph.D., University of California, San Francisco School of Pharmacy)

To make the pharmacy community more generally aware of NIH research opportunities, a web site highlighting applicable resources and awards could be developed and publicized widely. NIGMS, who together with the National Cancer Institute provides the majority of NIH funding for pharmacy research, currently supports four postdoctoral training programs. One of these is the Clinical Pharmacology institutional training program. Currently, this program targets M.D.s, as reflected by recruitment language and program leadership. The program's goal is to provide intensive experience in research for physicians in the early postdoctoral years; it can also be combined with other subspecialty fellowships. One way to expand opportunities for Pharm.D. training would be to expand this award to provide eligibility for Pharm.D.s in addition to M.D.s.; i.e., to create a "Clinical Pharmacology and Clinical Pharmacy Training Program." Successful implementation of this program would depend on review panels having sufficient representation from faculty at schools of pharmacy.

Promoting research skills in Pharm.D. students: The Michigan Experience

(Frank Ascione, Pharm.D., MPH, Ph.D., University of Michigan College of Pharmacy)

For many years, the University of Michigan College of Pharmacy has required research experience within their curriculum. Currently, components of this program include the following: i) student-initiated advisor selection; ii) preparation of a research proposal; iii) implementation of the research plan; and iv) completion of the research project. Objectives of this program include introducing students to the research method; providing opportunities to participate in research; enhancing problem-solving and writing skills; and fostering faculty-student interactions. Several elements have been instrumental in making this program viable. These include maintaining an active research faculty (especially in clinical research), adhering to a recognizable focus in the curriculum, and providing strong administrative support to manage the program. A recent survey revealed that students widely endorsed the program's research component, citing its positive effects on career development and marketability. Over time, research projects have trended toward having a more clinical, less basic focus.

Report from the American Association of Colleges of Pharmacy (AACP) task force on Pharm.D. research training

(Robert A. Blouin, Pharm.D., University of North Carolina, Chapel Hill School of Pharmacy)

The AACP Clinical Scientist Task Force was established and charged with assessing the state of Pharm.D. research training. Specifically, the task force aimed to:

  • define the various career opportunities for clinical scientists;
  • define the competencies and outcomes required for each type of position;
  • explore the demand for such individuals;
  • examine the state of clinical scientist preparation;
  • make recommendations for unifying the way clinical scientists are trained for various positions;
  • discuss the collaborations needed to expand the graduation of clinical scientists; and
  • explore how to obtain further funding to allow graduate program expansion.

Preliminary findings that have emerged from the working discussions of this group include the recommendation that research-intensive university schools of pharmacy must accept as a necessary component of their research and graduate education mission the responsibility to develop an interdisciplinary graduate education program for the purpose of educating clinical scientists in experimental pharmacotherapy at the Ph.D. level.

The working model this group has derived for achieving the goal of increasing the number of pharmacy-trained clinical scientists includes developing and implementing an "Experimental Pharmacotherapeutics" Ph.D. program consisting of core courses and experiential requirements (but not requiring residency, fellowship training, or licensure in all cases). Several recommended elements will increase the chances for making this an effective training vehicle. These include a multidisciplinary advisory committee with co-mentors and a thesis project that investigates a hypothesis-driven clinical problem with patient interventions and a clinical trial. Substantial institutional commitment and infrastructure, including a critical mass of NIH-funded clinical investigators will likely be important for making this approach work. In the same vein, the pharmacy academic community must be prepared to actively recruit students for this type of program.

New Standards for Pharmacy School Accreditation

(Peter H. Vlasses, Pharm.D., Accreditation Council for Pharmacy Education(ACPE))

Three decades after the 1975 report "The Millis Study Commission on Pharmacy: A Road Map to a Profession's Future," the pharmacy community faces new challenges. The transition to new Doctor of Pharmacy standards and difficulties related to resource requirements (especially experiential education), coupled with a pharmacist workforce shortage, have significantly strained pharmacy faculty that are already in dwindling numbers. Challenging economic times have made it difficult for both public and private programs to maintain and enhance their quality. As a result, the further evolution of Pharm.D.s as clinical scientists has waned. The ACPE continues to revisit curriculum standards and has recently completed a new set of standards (Standards 2007) that focus on aspects related to scholarship and research. Two main objectives were to simplify and clarify expectation and intent of the standards and to provide additional guidance and direction where needed and requested.

Standards 2007 aims to align with existing policy, competencies, and other environmental factors. Professional competencies and outcome expectations have been defined and include providing patient care; managing/using health care system resources; and promoting health improvement in cooperation with patients, communities, and at-risk populations. Standards 2007 also provides guidance on the science foundation in the basic biomedical sciences, pharmaceutical sciences, social/behavioral/administrative pharmacy sciences, and clinical sciences.

The ACPE will continue to improve the standardization and consistency of its accreditation procedures (for both the professional degree and continuing education provider accreditation programs) through the increased use of standards-related process and outcome measures. A task force on professional doctorates is currently working to identify the core characteristics of a professional doctorate degree.

Educating Clinical Scientists: The NIH Roadmap CTSA Initiative

(Lawrence J. Hak, Pharm.D., University of Tennessee Health Science Center)

NIH recently introduced the CTSA program in an effort to transform clinical research by lowering barriers between disciplines and encouraging creative, innovative approaches to solving complex medical problems. To date, 12 full CTSA programs and 52 planning grants have received NIH support. CTSA programs are expected to be highly "interprofessional," with participation from multiple schools within an institution (including schools of pharmacy) and partnerships with independent and other research institutions. One key component of CTSAs is an advanced degree program with a clinical research curriculum, mentoring, and career development resources. Other features include support for all levels of clinical and translational research that integrates basic, translational, and clinical investigators, and research support services. The University of Tennessee Health Sciences Center CTSA planning grant outlines a putative Clinical and Translational Science Institute (CTSI) that will contain an advanced degree (M.S. and Ph.D.) program in clinical investigation, with concentrations in clinical research, community-based research, and epidemiology. Markers of success of the CTSI, if funded, will include improving patient care through research-based strategies and promotion of faculty based on the values of team science.

Breakout Group Topics and Discussion

Meeting attendees were distributed into seven breakout groups that discussed focused topics of interest, and each group reported a summary of their discussion to all meeting participants.

Group 1 Topics and Discussion

What is the role of the pharmacy community in the NIH CTSAs?

There is enthusiastic support for the CTSA program within the pharmacy academic community, and most see this program as an opportunity, not a risk. Strategic, advanced planning will ensure that ongoing academic programs and specialty areas can continue alongside and/or mesh with newly developed CTSA programs and curricula. In addition, there is general consensus that clinical research with a specific pharmacotherapy component can be effectively designed into a CTSA proposal, given careful planning. Most important is that faculty at schools of pharmacy be fully integrated with CTSA activities and leadership beginning with the application-writing phase and continuing throughout the development and implementation of CTSA programs. Care should be taken to diversify pharmacy participation within an institution's CTSA applications to avoid being "sliced out" if created as an overly modular, "line-item" component. However, for efficiency, the components of different extramural training applications contributed by pharmacy schools should be developed in a modular fashion so that these components can be clearly delineated and readily accessible for multiple funding mechanisms. It will be important that pharmacists' participation in team science activities, such as the CTSAs, is rewarded with academic credit toward tenure and promotion.

Should K awards be used post-hire?

Many see K awards as being underutilized within the Pharm.D. community. The new Pathways to Independence K99/R00 award, in particular, provides a terrific opportunity for post-Pharm.D. research training, although it should be noted that these awards are highly competitive. In general, K awards can serve as a launching mechanism to enhance the number of pharmacy faculty members to compete for R01 (or equivalent) funding. F32 awards should also be considered as a preparatory step before a junior investigator considers applying for a K award, since early successful grant-writing experience often fosters subsequent academic success. One downside to K awards is that the substantial component of protected research time (75 to 80 percent) may lead to a peer perception that the tenure-eligible candidate has not devoted adequate time to teaching or service, and this may be viewed unfavorably by tenure committees. While this should not be considered a frank disadvantage, and young faculty should not be discouraged from applying for K awards, it is an important issue that departments must consider and adeptly manage.

How can the number of NIH awards to Pharm.D.s be increased?

Although NIH grants are very competitive, especially in the current budget climate, there are many mechanisms (e.g., K awards and training grants) that should be considered more often, in addition to funding from other sources (e.g., other agencies such as the Agency for Healthcare Research and Quality, foundations, and professional societies). A central problem is that many pharmacy faculty members do not even apply for NIH funding, although there is some concern that NIH accounting of this number may be inaccurate due to the inability to report "Pharm.D." as a degree on NIH grant applications. Pharmacy researchers should take responsibility for reporting post-award information to AACP, to enhance the quality (and hopefully quantity) of NIH-funded pharmacy initiatives, particularly of collaborative efforts not included in NIH grant data.

The pharmacy community should be proactive by encouraging strong mentorship of research trainees (within or outside their respective departments and schools) and also by communicating ideas to NIH. Two possibilities include i) changing eligibility text on program application forms to add "pharmacy" and "Pharm.D," and ii) promoting the development of a trans-NIH T32 postdoctoral training program for pharmaceutical scientists. It is important that the pharmacy research community consider NIH components beyond NIGMS, which has traditionally funded the bulk of pharmacy research, and that deans of research-intensive schools of pharmacy begin a dialogue with OPASI leadership. An AACP-sponsored, pharmacy-specific web site could help trainees and young faculty successfully navigate and develop strategies for finding NIH funding opportunities early in their careers.

Group 2 Topics and Discussion

Should schools of pharmacy reserve slots for students interested in research?

Most schools of pharmacy report having a limited, but real, number of incoming students interested in research. Integrating pharmacy practice faculty early in a student's curriculum may highlight the impact of pharmacy practice research on human health. If schools decide to establish formal research slots for such students, the criteria should be very clearly delineated. Honors programs could be developed to attract and house a pool of students interested in a research career. A few schools have begun pilot programs to track students, and the faculty and administration at these institutions should communicate successes and failures to the rest of the community. It is extremely important to continue to support and nurture research-oriented students. This may be achieved in a variety of ways, such as socialization (e.g. pizza lunches, career conversations with faculty), ongoing lab experience, summer research, and clerkships. Summer and other research experiences can be shared via a web site or online clearinghouse/listserv established for this purpose.

What are the advantages of a summer research experience or a "breakout" year, such as the Howard Hughes Medical Institute NIH Research Scholars program?

Although it is unlikely that attempts to expand the criteria of the Howard Hughes Medical Institute NIH Research Scholars program to include Pharm.D. students would be successful, the community should seriously consider the possibility of creating a similar program for Pharm.D.s. There may be other available sources of funds (e.g., the Foundation for the National Institutes of Health, the Bill and Melinda Gates Foundation) that could be used to establish a one-year pullout program for Pharm.D. students.

Group 3 Topics and Discussion

What is the role of a residency in training clinical scientists and what distinguishes a fellowship from an advanced residency?

Some Pharm.D. graduates do see research as a viable career option. However, in part due to a relatively small number of role models who work successfully in this capacity, there is a very small pool of potential research trainees. Compounding this situation is that faculty at pharmacy schools have not traditionally applied for NIH funding, diminishing the chances for developing and funding rigorous training programs.

The pharmacy community has seen a historical blurring of the terms residency and fellowship. Over time, the biggest change has been the divergence of fellowships toward either a research or a clinical focus-not both. Currently, there is little consistency in fellowship accreditation, and many faculty run these programs irrespective of these criteria, aiming instead to tailor programs to institutional strengths. While most agree that accreditation standards are impractical for defining fellowship criteria, more accurate descriptions of programs may contribute to attracting students with particular research interests (e.g., clinical vs. translational vs. basic).

Does a postdoctoral fellowship always constitute a research experience?

A perhaps underappreciated reality is that postdoctoral research training follows two distinct paths: i) scientists who want to become clinical investigators and ii) clinicians who want to become scientific investigators. Required training for each path is quite different.

Regarding the first path, the group agreed that an organized, structured route is required to train Pharm.D.s to become clinical investigators that can successfully compete for NIH funding. For this avenue, the group endorsed the Experimental Pharmacotherapeutics graduate program proposed by the AACP Clinical Scientist Task Force. Depending on the student and his or her background, a residency may or may not be required as a component of this training. Faculty must work to identify potential students who would be likely to succeed in pursuing this career path, and a critical mass of funded clinical investigators would be necessary for the program to thrive. Another option is a clinical research master's degree that is given with a health professional doctoral degree in a combined program. Some of these approaches have been proposed, or are currently under way, at CTSAs.

The second pathway, for training more experienced clinicians to become scientific investigators, may be better suited to a master's-level program (e.g., a K30 clinical research curriculum award). Clarifying the best avenues for pursuing this path may be a good focus for the AACP Clinical Scientist Task Force.

Group 4 Topics and Discussion

Can collaboration between universities and with industry be improved?

Consensus within the field says that collaboration is still very difficult, not just between universities, but also between departments within an individual college of pharmacy. Part of the problem is that courses are run by departments, and turf battles persist. The possibility of sharing courses between institutions may be complicated by intellectual property- and tuition-related issues, as well as by a perceived "weakness" of importing curriculum. Alternatives include week-long workshops with visiting professors or adjunct faculty from within the university or industry. While lack of expertise in a fundamental area may be viewed by funding agencies as a weakness, lack of expertise in emerging, "hot" areas is likely to be a different matter.

Many view the new CTSA program as an excellent vehicle for expanding collaboration within academia and with industry; however, it is important to recognize potential barriers associated with intellectual property when students work within industry for extended periods or on industry-sponsored projects. An additional venue for students to work together with industry include biotechnology training grants, which by most accounts have been extremely successful for all parties involved.

What infrastructure is needed for addressing research-related issues such as facilities, mentoring, and resources?

One of the most important issues is establishing a supportive environment for obtaining research funding. Developing a cadre of research faculty that can successfully compete for NIH research funding depends on dedicating resources to infrastructure development. Grants administration duties exact a significant burden, especially on new faculty. Thus, it may be wise for schools of pharmacy to invest in hiring staff with expertise in the business side of research funding that can lend support, resources, and guidance for grant-writing and grant submission responsibilities.

What school-based and outside sources can be used to develop clinical scientists?

While K awards have many advantages, one downside is that young investigators who receive these awards may be disadvantaged with regard to the tenure clock. Some schools have addressed this problem by devising creative ways to delay the clock while junior scientists complete research training.

Group 5 Topics and Discussion

What will be the economic and societal impacts of developing a research workforce within the academic pharmacy community?

Economic factors have a strong impact on career choice and academic center vitality. Because institutions differ and have varied partners, it is likely that cost models will need to be developed and explored on an individual basis. Cost-sharing options should be considered, and issues of credit need to be addressed. Collectively, these issues are likely to cause growing pains within a college or an institution. Another serious consideration is time. Implementing new programs, building infrastructure and expertise, and establishing collaborations are time-intensive processes that must be factored in at the outset of any planning activities.

What are the best ways to meet the needs of both academia and industry?

There is room for much more "cross-pollination" between academia and industry. As a relatively applied research profession, pharmacy can gain from industry experience and co-mentoring. Students should be exposed to the broad array of career options in research, both in academia and industry.

Where can students find pharmaceutical faculty mentors and collaborators?

High-quality mentoring is a key ingredient for developing a successful research career. Students and faculty should be open-minded about seeking multiple mentors, both from diverse pharmacy school departments as well as from industry and other institutions. Checklists that outline good mentor characteristics may help students identify appropriate contacts.

What are the expectations and/or concerns of pharmacy practice faculty?

Because of the different goals and needs of the pharmacy practice community, it may be a good idea for these faculty members to convene a summit-type meeting similar to this conference, to discuss and consider the evolving nature of the pharmacy profession and training environment. It is critically important that research- and practice-oriented faculty continue to work together and partner in the education of students. Creating division among different pharmacy "factions" would likely have untoward consequences on students and on the future of the profession.

Group 6 Topics and Discussion

Should basic science boards be required to assure rigor in scientific coursework?

While there is strong consensus on the importance of basic science knowledge for every Pharm.D. student, there is less enthusiasm for instituting basic science board examinations. More rigorous assessment of faculty credentials through ACPE accreditation may be one strategy to standardize science instruction across schools. There is some question about the precise meaning of "scholarly activity" that is cited in the ACPE accreditation standards. For example, the mission of some schools of pharmacy centers on teaching and service, not research. Again, care should be taken to avoid creating different "camps" within schools that may erode collegiality and have negative effects on the education of students.

What is the best way to structure a Pharm.D./Ph.D. pathway?

Because of the distinct strengths of and variable resources available to individual institutions, a one-size-fits-all approach is unlikely to work. Diversity in the marketplace is also good for students, who will select an educational institution that best fits their needs and career goals. In some cases, a combined Pharm.D./master's degree may be sufficient for some areas of investigation, such as health services research.

What roles should investigators play?

There is a pressing need for pharmacists across the board: in academia, industry, and patient care. Pharmacy investigators can play leadership roles in research, especially given the shortage of clinical investigators and the need to break translational research barriers. Integrating pharmacy researchers within the CTSA network, as it grows, will offer new opportunities in this realm.

Group 7 Topics and Discussion

What are effective ways to nurture and mentor junior investigators?

There is general agreement that junior investigators have variable needs and skill sets, and that a multiplicity of strategies is best. Multidisciplinary research approaches can be especially effective, and some amount of clinical practice time is needed. Finding excellent mentors is among the most important criteria in independent investigator success. Establishing a mentorship team is a useful approach, and the mentors need not be located in the same department or institution. Learning the craft of writing a good grant application can be enhanced through peer evaluation and internal "review" processes. Many junior faculty are not aware of the several different funding opportunities (e.g., K awards) available to them, and thus enhanced communication about potential funding mechanisms would be especially useful.

Another key aspect to helping junior scientists become competitive researchers is providing protected time and liberal start-up packages that enable them to conduct experiments. One unintended effect of providing protected time, however, is that it may interfere with acquiring tenure. Some institutions have come up with workaround approaches, such as issuing two offer letters: one for a non-tenure track faculty phase, and one for a tenure-track faculty phase. Another strategy is to place new hires that lack postdoctoral training into a clinical series that can be followed by a tenure-track position.

Is it preferable to grow a clinical scientist program using school-based or outside grant support?

There is general consensus that institutions should consider several funding sources for building viable training programs, including increased enrollment/tuition dollars and training grant support. Although such grants are highly competitive, schools of pharmacy should continue to seek these funds. The CTSA program and the spirit it has generated may stimulate investment from within and outside institutions. Schools of pharmacy should also invest financial resources in recruiting pharmacy and other clinical doctoral graduates into new clinical scientist degree programs through summer research programs and campus visits for those students demonstrating interest. Rather than dollars, industry may be willing to provide resources such as equipment or even training sites.