Fellowship

International Research Fellowship in Drug Development and Regulatory Science

Program Description

The Center for Drug Development Science (CDDS), in conjunction with the Department of Biopharmaceutical Sciences, School of Pharmacy offers a research training Fellowship for doctoral level scientists interested in pursuing careers in clinical development or regulation of drugs and biologicals. The goal of the program is to provide research experiences that enable the Fellow to gain expertise in drug development and regulatory sciences, and prepare the Fellow for a career as a drug development or regulatory scientist in an industrial, academic or regulatory setting. Fellows can partake of the Center's extensive resources with a focus in a specialized training track. The Center aims to support up to five new Fellows each year totaling ten or more fellows in two- or three-year programs.

Length of fellowship

Two to three years

Specialized areas of focus

• Drug Development Science
• • Pharmacokinetics
  • Physiologically based pharmacokinetics (PB-PK)
  • Pharmacokinetic / Pharmacodynamic (PK-PD) modeling
  • Application of pharmacometric principles in drug development
  • Clinical trial design and simulation
  • Biostatistical methodologies
• Drug Development Science Management
• • Project planning and management
  • Matrix management
  • Decision-making
  • Cross-functional team communications
  • Resource allocation
  • Time management
• Regulatory Science
• • Laws, regulations, guidelines, guidances, policies and procedures
  • Clinical development processes and phases
  • Phase IV commitments
  • Label driven drug development

Applicants

Qualifications: MD, PhD, PharmD, or equivalent, with a demonstrated interest in clinical investigation, drug development, drug regulation, or biopharmaceutical sciences.

Fellow's selection will be targeted towards biopharmaceutical and clinical scientists. Special consideration will be given to applicants from regulatory agencies; academic centers, and drug or biotechnology organizations in the US and elsewhere.

Download the application form (MS Word format).

Specialized training/course of study:

• Longitudinal drug development case studies involving collaborations and interactions with biopharmaceutical company scientists in the areas of clinical trial design, drug evaluation and regulatory science on real-time drug development programs.
• Problem solving case studies involving investigation of scientific and regulatory hurdles in drug development via co-consulting with CDDS faculty on real time drug development challenges.
• Courses, seminars and research conferences including clinical pharmacology conferences, FDA Advisory Committee meetings, and other local area conferences (e.g., NIH, USUHS, FDA).
• Retrospective analysis of the clinical development program for recently approved drugs and biologics.

Potential areas of study and research are identified in the table on the last page of this program description.

Didactic Opportunities

The following courses, workshops and seminars are available for Fellows to broaden their drug development and review experiences:

• General Principles of Pharmacology
• Pharmacokinetics
• Pharmacometrics
• Biostatistics
• Design and Conduct of Controlled Clinical Trials
• Modeling of Biological Systems
• Principles of Clinical Research (offered by the National Institutes of Health)
• Principles of Clinical Pharmacology (offered by the National Institutes of Health)
• FDA Advisory Committee meetings

Understanding of the clinical trial setting and observation of the research subject

The CDDS Research Fellows are encouraged to gain a high level of pharmacological and clinical knowledge in one or more therapeutic areas. This knowledge may be gained via the longitudinal drug development collaborations described or an internship at a drug or biotech company or at the FDA (typically undertaken in the 2nd year of the fellowship).

Supervision, Direction, and Evaluation

Supervision and direction are carefully tailored to the needs and goals of the individual Fellow and are key attributes of the Fellowship program. An initial inventory of incoming knowledge, skills, and experience (KSE) level in clinical pharmacology, drug development and regulatory environments will be undertaken upon entry into the Fellow's program.

(Download KSE Inventory Form, (Word format), or view KSE matrix)

After the initial KSE inventory is complete, a customized research and training program and plan will be developed for each Fellow in conjunction with the training faculty, and the CDDS Research Fellows Program Advisory Committee. A preceptor from the Core Faculty will be assigned to each Fellow. The Advisory Committee will meet once per year to review each Fellow's progress, to consider assignment of additional or new preceptors, and to recommend any necessary modifications to the research or training plan.

Research and Publications

Research (the derivation of new knowledge or scientific principles) is integral to the Fellowship Program. Each fellow is expected to undertake research as well as participate in the CDDS Technical Assistance Program (TAP) under the mentorship of the CDDS faculty. It is expected that one or more research projects will be undertaken by each Fellow in conjunction with the longitudinal and/or problem solving case studies. The research projects are expected to involve the full array of research procedures. It is expected that CDDS Research Fellows will publish the results of their research in peer-reviewed journals.

Program Faculty – UCSF

Howard Lee, MD, PhD
Adj. Assoc. Professor
Director, Center for Drug Development Science

Carl C. Peck, MD
Adjunct Professor
Director Emeritus

Nancy Sambol, PharmD
Assistant Professor

Adjunct Faculty - UCSF

Nicholas Holford, MBChB
University of Auckland, NZ
Adjunct Professor

Stephen Duffull
Chair of Clinical Pharmacy
School of Pharmacy
University of Otago
New Zealand
stephen.duffull@otago.ac.nz

Ellen Feigal, MD
Adjunct Professor

Charles Grudzinskas, PhD
Adjunct Professor

Jerry Collins, PhD
CDER/FDA
Adjunct Professor

Malcolm Rowland, PhD
Visiting Professor

David Feigal, MD
Adjunct Professor

Latest News

Improving Drug Development Using Patient Adherence Data in Clinical Trials, May 6-7, 2008.
Brochure (PDF)
Registration site

Advanced NONMEM workshop – March 17–19, 2008 at Mission Bay Conference Center, San Francisco, CA.
More information >

UCSF-CDDS to launch The American Course on Drug Development and Regulatory Science- September 2007
More information >

CDDS – Pharmacometric Services is available to drug researchers
More >

Howard Lee, MD, PhD, named Director of CDDS
More >

Lewis B. Sheiner Memorial. Symposium held at CDDS in December 2006
More >