Research Fellowships The Training Program Research Training Clinical Training Didactic Courses & Seminars

The Clinical Pharmacology Training Program is accepting applications.

The Division of Clinical Pharmacology and Experimental Therapeutics sponsors postdoctoral research fellowships. Fellowships are supported by the National Institute of General Medical Sciences (NIGMS) and the UCSF Schools of Pharmacy and Medicine. Fellowships are offered only to United States citizens or to individuals who are permanent residents. They are not available to support training for foreign nationals on non-immigrant visas.

The principal goal of these fellowships is to provide an intensive experience in scientific investigation for 1) board certified physicians (adult and pediatric) in their early postdoctoral years,; 2) PharmDs in their early postdoctoral years, preferably after their general residency training; and 3) PhDs with a clear interest in clinical pharmacology research.

The University of California, San Francisco, policy states in order to be considered a postdoctoral fellow, one must be a graduate of a medical, allopathic, osteopathic or pharmacy school within the last ten (10) years prior to beginning the fellowship. Applicants are encouraged to apply for a fellowship at least one year prior to the start of a fellowship period, which usually (although not necessarily) begins on July 1 of the academic year. The fellowship usually lasts two years, but may be extended a third year by mutual agreement between fellow and the faculty of the Division.

The UCSF Clinical Pharmacology Postdoctoral Training Program seeks candidates whose experience, teaching, research, or community service has prepared them to contribute to our commitment to diversity and excellence. UCSF is an Equal Opportunity/Affirmative Action Employer. The University undertakes affirmative action to assure equal employment opportunity for underutilized minorities and women, for persons with disabilities, and for covered veterans. All qualified applicants are encouraged to apply, including minorities and women.

The Clinical Pharmacology Fellowship Training Program at UCSF is rigorous, research-intensive and designed specifically to prepare fellows for positions as independent investigators and teachers in academia, industry and regulatory agencies. Since its inception in 1965, approximately 125 fellows have graduated from the program; most of these graduates are actively engaged in academic teaching and research.

We train our fellows using a variety of complimentary modalities, including:

• Mentored research
• More than 75% of the fellowship will be dedicated to conducting research projects (for details, see Research Training below)
• Fellows have a wide spectrum of research opportunities that are focused around a vigorous group of well-funded faculty.

Didactic coursework designed to provide basic skills in clinical trial design, pharmacokinetics and pharmacogenetics, and ethical issues in clinical research

• Weekly seminars/journal clubs focusing on the discipline of Clinical Pharmacology (for details, see Didactic Courses and Seminars below)
• Shadowing in decision-making committees (e.g., Pharmacy and Therapeutics Committee, Committee on Human Research)
• Clinical Consultation (for details, see Clinical Training below)
• Clinical Pharmacology and toxicology Consult service
• Poison Center

Areas of particular research strength at UCSF include:

• Pharmacogenetic influences on pharmacokinetics and inter-individual response to drug therapy
• Pediatric clinical pharmacology
• Geriatric clinical pharmacology
• Drug interactions based on human drug metabolism
• Many therapeutic areas: respiratory disease, organ transplantation, breast cancer, metabolic disorders, HIV, cardiovascular disease, addiction medicine and psychiatry to name a few.

Fellowship funding and visas:

Fellowship funding comes from an NIGMS T32 training grant.

For fellows supported by NIGMS funds:

Fellowships provided by the NIGMS are offered only to United States citizens or to individuals who are permanent residents. They are not available to support training for foreign nationals on non-immigrant visas.

Participation in the fellowship provided by NIGMS entails a payback agreement, in which fellows are required to devote an amount of time equal to the number of years of stipend support in subsequent academic pursuits. For further information about this provision, fellowship applicants are encouraged to ask questions of faculty members in the Division or to request information directly from NIGMS.

Physician postdoctoral fellows who have clinical activities at UCSF or its affiliated hospitals are required to receive salary at rates established annually by the University of California Office of the President (UCOP). UCOP salary rates are approximately $7,000 - $8,000 higher than the previously listed NIH stipend levels, so a source for additional funding will have to be arranged.

PharmDs will be appointed as postdoctoral fellows and be paid at the appropriate NIH stipend level, regardless of whether or not they have clinical activities.

NIGMS stipend salary levels are determined by the number of years of relevant postdoctoral training at the time of the appointment into the fellowship. The following table shows the stipend levels effective July 1, 2010.

For fellows supported by other (non-NIGMS) funds:

All foreign fellows who are accepted into the fellowship program (and who will be paid by UCSF or their home governments or institutions) must apply for J-1 exchange visitor status.

Foreign fellows who are physicians and have clinical responsibilities under supervision must apply for ECFMG sponsored J-1 exchange visitor status. To be eligible for ECFMG J-1 sponsorship for clinical training, one must meet ECFMG's requirements. For more information, visit ECFMG website at: http://www.ecfmg.org/evsp/j1fact.html

If fellows have obtained only a J1 visa (rather than the ECFMG J-1 visa), they may only observe patient care and may not provide patient care even with supervision.

Our fellows are expected to develop expertise in one or more of the following research areas:

1. Fundamental research on principles or mechanisms of drug action or toxicity.
2. Drug discovery and development (including post-marketing surveillance).
3. Pharmacogenomics.
4. Health Services Research (including studies of drug use and effects, pharmacoepidemiology, optimizing drug use).
5. In addition to specific research skills such as (a) design of clinical trials, (b) statistical analysis and research criticism skills, (c) scientific writing, including grant writing, and (d) familiarity with activities of institutional review boards for human research.

Our goal is to train health care and biopharmaceutical research scientists (M.D.s, Pharm.D.s and Ph.D.s) who have knowledge and expertise in drug action, in the rational and cost-effective use of drugs and the diagnosis and management of adverse effects of drug use. Our trainees are expected to develop research skills in some area of clinical pharmacology, with the intent both to acquire new knowledge and to have the experience required to evaluate and interpret pharmacologic research, which is necessary to make decisions about rational therapeutics. Many, but not all, trainees will become full time clinical research scientists in academic settings. Other trainees are likely to become involved in drug development in the pharmaceutical industry and others in drug regulation. Finally, we are training fellows to be teachers - of therapeutic principles, rational use of drugs for specific medical diseases, and evaluation and management of toxicologic problems. Most of our trainees will spend their careers associated with schools of medicine or pharmacy, where teaching and scholarly research are an essential activities. Specifically, we would like our fellows to become skilled in most or all the following activities.

Health Care Service Activities

1. Direct Patient Services
   1. Consultation on therapeutic problems, adverse drug reactions or lack of therapeutic response. This requires knowledge of pharmacologic action of drugs, principles of pharmacokinetics and pharmacodynamics, and knowledge of the influence of disease states on drug action.
   2. Evaluation and management of acute poisoning and other toxicologic emergencies and active involvement in poison control centers.
   3. Therapeutic drug monitoring.
2. Indirect Patient Services
   1. Hospital monitoring of drug use and effects, including adverse drug reaction monitoring.
   2. Participation in Pharmacy and Therapeutics Committees.
   3. Involvement in cost-effective management of medication use.
   4. Advice to colleagues concerning design and conduct of clinical research.
3. Society
   1. Participation in continuing medical education of physicians, continuing education of pharmacists and education of lay audiences about pharmacologic health issues.
   2. Knowledge about and participation in adverse drug reactions surveillance.
   3. Participation in governmental advisory committees related to therapeutic policies.

Teaching

Fellows are expected to develop a knowledge base and skills in teaching at several levels: (a) teaching of medical and pharmacy students, both pre-clinical and clinical; (b) teaching of housestaff, primarily bedside teaching; and (c) postgraduate teaching, including participation in continuing medical and pharmacy education courses.

Didactic Courses

In addition to the NIH sponsored didactic course, Principles of Clinical Pharmacology, trainees are encouraged to take other courses to develop specific expertise in biomathematics, computer science, pharmacokinetics, statistics, clinical trial design or other research-related skills, which are relevant to their particular research emphasis. These courses are offered by the School of Pharmacy, the Department of Medicine, the Cardiovascular Research Institute, and the Department of Epidemiology and Biostatistics.

1. School of Pharmacy Courses
   • Basic Principles of Pharmaceutical Sciences PSPG 245A (this course focuses on fundamental mechanisms of membrane transport, pharmacokinetics, modeling, and quantitation)

   • Basic Principles of Pharmaceutical Sciences PSPG 245B (this course focuses on mechanisms of pharmacology, toxicology, and drug metabolism barriers to drug delivery)

   • Basic Principles of Pharmaceutical Sciences PSPG 245C (an introduction into the genetic factors underlying the efficacy and toxicity of drugs. Topics to be covered include genomic methods in drug design, drug development and drug therapy)

   • PSPG 271: Advanced Pharmacokinetics in Clinical Drug Development (significant time will be devoted to theoretical aspects of the various topics, the focus will be on practical examples (real data) in how to design and interpret pharmacokinetic studies for use as a component of the regulatory drug approval process)

2. Department of Medicine & Cardiovascular Research Institute (CVRI) Courses
   • Statistics

   • Scientific Writing

   • Physiology 302 - The Art of Lecturing and Small Group Teaching

3. Department of Epidemiology and Biostatistics Courses
   • Training in Clinical Research (TICR) program: Summer Clinical Research Workshop
     Fellows will participate in a seven week program consisting of three courses (Designing Clinical Research, Responsible Conduct of Research, and Building a Career in Clinical Research) that provides instruction in the development of clinical research proposals that are scientifically sound, ethically appropriate, and provide entry to a career in academic medicine.

   • Advanced Training in Clinical Research (ATCR)
     A year long sequel to TICR Summer Program which provided further training to enable fellows to:
     • Plan, acquire funding for, and conduct clinical research
     • Analyze the data and interpret the results of their research
     • Present their research at scientific meetings and in the medical literature
     • Critique and interpret the research of others

Seminars

1. Clinical Pharmacology Didactic Seminar
   All first year fellows will participate in an intensive PK/PD workshop series (based upon the UCSF-sponsored course Pharmacokinetics for Pharmaceutical Scientists) from July - August consisting of weekly sessions to review PK and PD problem sets. The topics that are covered include: a general introduction to pharmacokinetics with an emphasis on clinical applications; clearance concepts; drug distribution concepts and IV bolus kinetics; constant rate input; absorption concepts and kinetics; renal and hepatic (metabolic) drug elimination.

   Additionally, one day per week from the beginning of September through the end of April, the didactic seminar follows the Principles of Clinical Pharmacology course outline, which is sponsored by the NIH Clinical Center. This weekly lecture series, consisting of 31 lectures in total, covers the fundamentals of clinical pharmacology as a translational scientific discipline focused on rational drug development and utilization in therapeutics and is divided into five broadly categorized "Training Modules" including: Pharmacokinetics, Drug Metabolism and Transport, Assessment of Drug Effects, Optimizing and Evaluating Patient Therapy, and Drug Discovery and Development. This lecture series will be given every other year.

   In addition, during the period from Fall through Spring, we hold a bi-monthly journal club in addition to the weekly lectures. The journal articles are selected to correspond with the topic discussed in the Principles of Clinical Pharmacology lecture for that week.

2. Journal Clubs
   Fellows participate in a bi-monthly journal club during which time the fellows present salient articles and are joined by a faculty discussant who has particular expertise in the research area covered in the journal articles. The journal club activity serves two main purposes. First, it provides a forum for group discussion of issues of common interest to all fellows. Fellows select one or two papers on a particular topic and a particular faculty person is invited to comment. Topics might include issues of drug development, clinical trial design or analysis, evaluating adverse drug reactions, urine drug screening, etc. Sessions are included on the ethics of biomedical research and human experimentation.

   The second purpose is to teach fellows how to critique and judge the validity of drug-related research. On alternate years the fellows review a self-study course, Studying a Study, Testing a Test. In this course the types of experimental design for various types of medical research and potential pitfalls, along with examples from well-known research studies are discussed.

   The journal clubs are attended by one or more faculty members who have particular interest and/or experience in the topic. Some of our faculty (in addition to Drs. Burchard and Benowitz) who do considerable fellows journal club teaching are Drs. Floren (clinical pharmacology and other topics in general clinical pharmacology), Dempsey (adverse drug reactions, pediatric clinical pharmacology), Haller (drug safety, alternative medications), Schwartz (cardiovascular and geriatric clinical pharmacology), Giacomini and Kroetz (drug metabolism and transport) and Spyker (drug development).

3. Clinical Pharmacology Research Seminar
   Fellows and faculty present their research at this seminar, which occurs every trimester. These seminars are intended to address research design, progress, problems encountered, and interpretation of results and plans for future research rather than accounts of finished work. The presentations are closely scrutinized and critiqued by other faculty and fellows. Through this seminar, research endeavors of fellows and faculty are critiqued at a time when input into the research can be most useful. This seminar teaches fellows how to design research and to critically review research data, gives the fellows exposure to various areas of pharmacologic research and methods used in such research, and gives them experience in presenting organized research seminars.

Optional Conferences

Of the large number of regular conferences and seminars presented at UCSF, these will be of particular interest to fellows:

1. UCSF Medical Grand Rounds 8:00-9:00am Thursdays Toland Hall
2. SFGH Medical Grand Rounds: 12:00-1:00pm Tuesdays Carr Auditorium