Infectious Diseases Pharmacotherapy Fellowship
Preceptor
Michael J. Rybak, Pharm.D., M.P.H., Ph.D., FCCP, FIDP, FIDSA
General description of the program
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-three year program, the fellow is responsible for developing 3-6 research proposals for which the fellow will act as the lead 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.
Fellowship site
The fellowship site is located at the Eugene Applebaum College of Pharmacy and Health Sciences at Wayne State University and at the Detroit Medical Center. The Detroit Medical Center is made up of eight distinct hospitals. Six of the hospitals are located 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.
Fellowship tracks available
This 2-3 year fellowship program offers three tracks.
- Track 1 is a pharmacokinetic/pharmacodynamic program that offers PK/PD modeling, microbiological and instrument training, practical experience in clinical research.
- Track 2 is an ID health outcomes assessment program that applies clinical epidemiology and outcomes assessment training experiences in clinical research and antimicrobial stewardship.
- Track 3 combines the PK/PD laboratory experience with ID health outcomes. Candidates that choose this track will split their time between laboratory and ID health outcomes research.
Required coursework offered by the College of Pharmacy at Wayne State University*
Coursework is an important component of the fellowship training and consists of several important graduate courses spread out during the fellowship program. These courses are offered by the School of Medicine at Wayne State University and are at no cost to fellows enrolled in the fellowship training programs. Fellows with previous graduate degrees or coursework that cover these areas can opt-out of the required classes.
| Biomedical Statistics I | CME 6010 (3 credits) |
| Biomedical Statistics II | CME 6020 (3 credits) |
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| 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 and are offered free of charge with transferable graduate credits. Graduate Certificate Programs are available in Public Health/Epidemiology and Translational Research. In addition, fellows can elect to pursue the Master in Public Health degree during the fellowship program tuition free. * Applicants with prior equivalent graduate coursework may be excused from the above-required coursework. | |
Laboratory
The preceptor is the director of the Anti-Infective Research Laboratory. This 2000 square foot facility 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, two walk in incubator rooms, refrigerators and freezers including Cryo-freezers (-800C), microcentrifuge, refrigerated centrifuge, pH meters, micro balances, autoclave, Mili-Q water purification system, Gilford Spectrophotometer,Bio Rad iCycler iQ Multicolor Real time PCR Detection System, Bio Rad Model 3000Xi Electrophoresis Apparatus, Synoptics Limited ProtoCOL Colony Counter, Spiral Automated Diluters, Bioflux plate reader and florescence microscope, 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.).
Medical libraries
Wayne State University and the affiliated hospitals of the Detroit Medical Center have fully staffed medical libraries within walking distance from the fellowship site. 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.
Computer facilities
Each fellow has an Apple or comparable PC computer in the fellow-suite. Each computer is on line with the University's Internet connection and the hospital's computerized LAN system and is hard-wired or wireless connections. In addition, laptop (computer notebooks) are available for fellow 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, etc., Crystal Ball), Fortran coupler, Adapt5 PK software, graphic programs including Sigmaplot 11.0, and Power Point for Windows, Spread Sheet analysis programs (Excel), word processing (Microsoft Word), and statistical analysis programs (SPSS v26.0)
Personnel who assist in teaching the fellow laboratory-based or clinical research skills
Andrew Berti, Pharm.D. Ph.D., Assistant Professor of Pharmacy Practice. Dr. Berti's expertise is in microbiologic and genetic analysis of antibiotic resistance bacterial strains. Dr. Berti has expertise in both phenotypic and genotypic assessment of bacterial resistance as well as pharmacokinetic/pharmacodynamic model experience.
Razieh Kebriaei, Ph.D., Research Scientist, Department of Pharmacy Practice, Anti-Infective Research Laboratory. Dr. Kebriaei's expertise is in pharmacokinetic/pharmacodynamic modeling and prevention of antibiotic resistance.
Sara Alosaimy, Pharm.D., M.P.H., Research Scientist, Department of Pharmacy Practice, Anti-Infective Research Laboratory. Dr. Alosaimy's research expertise in in the area of epidemiologic and biostatistical evaluations of ID patient health outcomes including antimicrobial efficacy and safety.
Susan Davis, Pharm.D., Interim Associate Dean and Professor of Pharmacy Practice, Clinical Specialist, ID-Outcomes Henry Ford Hospital. Assists in training of fellows in patient outcome statistical analysis.
Hossein Salmnia, Ph.D., Director of Microbiology., Detroit Medical Center, Detroit Receiving Hospital. Dr. Salimnia is currently collaborating with us on some in-vitro susceptibility studies. He has provided support from his laboratory on several clinical and in-vitro projects.. Dr. Salimnia is available to myself and my fellows for consultation.
Paul Kilgore, M.D., M.P.H. Associate Professor of Pharmacy Practice. Paul is an experienced epidemiologist who specializes in Infectious Diseases. Paul joined us in September 2011.Paul was previously the Senior Scientist at the International Vaccine Institute in Seoul Korea. He was also an adjunct Professor for Graduate Studies at the School of Public Health at Seoul National University. Paul is interested in the outcome assessment of patients with infectious diseases in the community.
Fabrice Smieliauskas, Ph.D., Assistant Professor of Pharmacy Practice/Economics. Dr. Smieliauskas expertise is in economic and pharmacoeconomic assessments of health outcomes and the impact of medical technologies and procedures.
Other available liaisons: Steve Firestine, Ph.D., Professor and interim chair Pharmaceutical Sciences; expertise in anti-infective medicinal chemistry and Arun Iyer, Ph.D., Assistant Professor of Pharmaceutical Sciences; expertise in drug delivery enhancement.
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 and weekly 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
Fellows that choose the laboratory based program will gain hands-on experience in general laboratory skills, pharmacokinetic and pharmacodynamic modeling techniques, various microbiological skills including antimicrobial susceptibility testing and quantitative drug analysis. This training is provided on a one-to-one basis by the preceptor as well as other various support individuals including the second year fellow, our research assistants, other faculty members 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. 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: American Society of Microbiology (ASM Microbe), European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), ID-Week. 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: Antimicrobial Agents and Chemotherapy, Journal of Antimicrobial Chemotherapy, Clinical Infectious Diseases, Open Forum Infectious Diseases, Diagnostic Microbiology and Infectious Diseases, Journal of Infectious Diseases, Infectious Diseases and Therapy and Journal of Clinical Microbiology, Infection Control and Hospital Epidemiology.
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 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 and one on one for students electing to take the directed research course.
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, January 2005, October 2010).
Benefits
Fellows receive a competitive stipend plus full medical and dental coverage. Additional benefits include: paid expenses for selected professional meetings and symposiums, waived tuition for graduate studies including degree programs at Wayne State University.
