In designing the fellowship program at Wayne State University, particular attention was paid to ensure that those skills most important to a practicing clinical scientist would be developed. The fellowship program integrates classroom training, practical clinical experience, hands-on laboratory instruction and research design. Research participation is the major emphasis of the fellow's activities. Over the course of the two year program, the fellow is responsible for developing 2-3 research proposals for which the fellow will act as the primary investigator. The fellow also actively collaborates (co-investigator) with the preceptor, other fellows and investigators outside the department in the design and implementation of several (3-4) research proposals both laboratory and clinically based. In developing the protocol, the fellow is responsible for hypothesis formation, as well as the development and writing of appropriate methodology and statistical analysis required testing the given hypothesis. Each fellow is responsible for the development or direction of at least one clinical protocol (patient or healthy volunteers) requiring human investigation approval. Responsibilities include preparing the HIC application and human consent form as well as maintaining the appropriate study record keeping and HIC communication files.
The fellow is responsible for the writing and submission of their research results for national and/or international presentations in the form of platform and/or poster presentations. Fellows are also responsible for writing and submitting the results of their research to an appropriate peer-reviewed journal for publication.
The fellowship site is located in the Detroit Medical Center. There are 5 other associated hospitals in a four city block area in downtown Detroit. All hospitals are major teaching facilities for the health sciences at Wayne State University. Detroit Receiving Hospital specializes in trauma and critical care. Medical specialties include internal medicine, critical care, cardiology, and surgery, including a regional burn center and spinal cord injury unit. There is a formal Infectious Diseases consult service for which the preceptor has an established Pharm.D. clerkship program and an infectious diseases residency program. The hospital is also affiliated with a large outpatient clinic known as the University Health Center that is physically joined to Detroit Receiving Hospital. We have and are currently conducting and collaborating on both inpatient and outpatient antibiotic studies. Patient beds are available by arrangement with the hospital administration for healthy volunteer studies. We have also conducted in-house healthy volunteer antibiotic pharmacokinetic, drug interaction and toxicity studies. In addition, the preceptor and fellows have access to patients at all affiliated Wayne State University teaching hospitals.
Required Coursework Offered by the College of Pharmacy at Wayne State University:
Biomedical Statistics I
CME 6010 (3 credits)
Biomedical Statistics II
CME 6020 (3 credits)
Introduction to Clinical Research Design
PPR-7600 (4 credits)
In addition, graduate level courses are offered at the university in immunology, molecular biology, epidemiology and other related fields. These courses are accessible as needed for the fellow. Each fellow also takes a course in radiation materials and safety and is certified to handle radioactive materials often used in our drug assay procedures.
The preceptor is the director of the Anti-Infective Research Laboratory. This 3000 square foot laboratory is located in the new Eugene Applebaum College of Pharmacy and Health Sciences. The laboratory facility includes a media preparation and storage room, and a fully equipped microbiological laboratory. Equipment housed in the laboratory includes: 3 Precision microbiological incubators, refrigerators and freezers including a Cryo-freezer (-800C), microcentrifuge, refrigerated centrifuge, pH meters, micro balances, autoclave, Mili-Q water purification system, Gilford Spectrophotometer, Bio Rad Model 3000Xi Electrophoresis Apparatus, Synoptics Limited ProtoCOL Colony Counter, Abbott FPIA TDx Analyzer, Spiral Automated Diluter, Computer integrated laser bacterial colony counter, Waters HPLC (including UV and fluorescence detector, automated sampler, WISPR), Pharmacodynamic model equipment (peristaltic pumps, glass infection models, magnetic heat/stir plates etc.).
Wayne State University and the affiliated hospitals of the Detroit Medical Center have five fully staffed medical libraries within walking distance from the fellowship site. The Detroit Receiving Hospital Medical Library has very extensive medical resources including major biomedical journals, reference periodicals, textbooks and computer Medline capabilities. This library is located within 500 feet of the preceptor's laboratory. Wayne State University's Shiffmann Medical Library is the largest medical library in the state, servicing the entire Southeastern Michigan area. This facility is located adjacent to Detroit Receiving Hospital. In addition, the department of pharmacy's drug information facility has a large collection of biomedical journals and textbooks and routinely performs computer Medline searches.
Each fellow has an IBM compatible computer (6 pentium-based computers) in fellow-suite. Each computer is on line with the hospital's computerized LAN system and is hard-wiredconnected to the university's internet facility. In addition, each fellow has a laptop (computer notebook) available for their use. Software available to the fellow from their personal computer or from the local area network within the department of pharmacy includes: pharmacokinetic modeling programs (PC-Nonlin, PK Analyst, LAGRAN etc.), graphic programs including Sigmaplot 9.0 and Power Point0, Spread Sheet analysis programs (Excel), word processing (Microsoft Word), and statistical analysis programs (SPSS 13.0).
Grantsmanship, Identifying Appropriate Funding Agencies and Submission of Grant Proposals:
The fellow learns grantsmanship primarily through grant writing workshops sponsored by Wayne State University, by example from the preceptor, successful faculty members of the College of Pharmacy and School of Medicine, and from investigators within the Division of Infectious Diseases. The fellow participates in each grant submission, including the preparation of grant applications, protocol development, funding source identification, and budget development, including university or institution overhead requirements.
Fellows gain experience in identifying appropriate grant funding agencies from grant writing workshops and discussions with the preceptor during daily research meetings, by example (preceptor, other faculty members) and by circulation of Wayne State University postings of potential grant funding agencies. Funding agencies are discussed as part of each fellow's protocol development.
Laboratory and Technical Skills:
The fellow gains hands-on experience in general laboratory skills, various microbiological techniques, and quantitative drug analysis. This training is personally provided by the preceptor on a one-to-one basis as well as from other various support individuals including the second year fellow, our research technician, and personnel within the Division of Infectious Diseases at Wayne State University. Fellows receive experience with computer spread sheet analysis programs, graphic computer programs and statistical analysis software. Formal classes in computer spread sheet analysis, word processing, graphic programs. The fellow learns statistical approaches to analyzing data by attending formal graduate coursework (see previous course listings), by example from the preceptor, from consultation with collaborators such as biomedical statisticians, and by utilizing Wayne State University statistical laboratory and consultant staff.
Antimicrobial Clinical Trials:
Fellows gain experience from ongoing phase II, III, and IV antimicrobial clinical trials that we participate in at the Detroit Medical Center. The fellows are involved with patient enrollment, including obtaining consent, completing study case reports, and meeting with pharmaceutical study monitors, co-investigators, and research nurse practitioners. The fellows will also gain experience in directing the clinical research of pharmacy residents and staff and will be responsible for the preparation and execution of a clinical protocol.
Preparation and Submission of Abstracts, Manuscripts and Formal Presentations:
The fellow is responsible, as previously stated, for writing the results of their studies, and submitting and presenting the results in the form of abstracts and platform presentations at national and international peer-reviewed scientific meetings. The fellow is also responsible for writing and submitting the research in the form of a manuscript to a suitable peer-reviewed journal. The fellow learns this process from the preceptor and by example from and consultation with the collaborating research investigators.
Examples of meetings at which the fellows from this program have presented research results include: Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), American College of Clinical Pharmacy's Annual and Winter Research Meetings, and the American Society for Microbiology, and the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) Making A Difference In Infectious Diseases Pharmacotherapy (MAD-ID) European Congress of Clinical Microbiology and Infectious Diseases (ECCMID). In addition, the fellows present their research at the annual Wayne State University and University of Illinois Fellowship Forum. Examples of journals in which fellows have published include: Pharmacotherapy, Annals of Pharmacotherapy, Clinical Pharmacy, Antimicrobial Agents and Chemotherapy, Journal of Antimicrobial Chemotherapy, and Journal of Infectious Diseases.
Teaching and Academic Training:
Fellows receive an instructor appointment to the College of Pharmacy at Wayne State University. Under the preceptor's direction, the fellows will learn all aspects of didactic and clerkship student instruction. Fellows will receive guidance for development of lecture outlines, handout material, audiovisual preparation and exam writing skills. Fellows will provide 1-2 lectures for Pharm.D. students enrolled in the Infectious Diseases Therapeutic Module and 1-2 lectures in the undergraduate Infectious Diseases Therapeutic Module PHA-4210. In addition, the fellows will be responsible for assisting with the precepting of Pharm.D. students on site for the Infectious Diseases Clerkship Course PPR-7130
Length of Fellowship Program:
The fellowship training program is 2-3 years in length. This program meets all requirements set forth by the American College of Clinical Pharmacy (ACCP). It is one of the first fellowship sites to receive formal ACCP approval (November, 1992).
Fellows receive a competitive stipend plus full medical and dental coverage. Additional benefits include: paid membership in ASM, journal and book stipends, and paid expenses for professional meetings and symposiums.