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NIH Leadership Training in Pharmaceutical Biotechnology Program

The Center for Pharmaceutical Biotechnology at the University of Colorado has received a five-year, $1.4 million training grant from the National Institutes of Health, which will support graduate education and 12 new fellowships in this emerging, interdisciplinary field.

Established in 1997, the center is a joint enterprise between CU-Boulder and the Health Sciences Center - the first bridging the two campuses. Teaching and research within the center focuses on developing new ways to make drugs more stable, better methods of delivering drugs to patients and more detailed characterization of complex drug products.

Twelve faculty are currently involved in the center from the fields of chemical and biological engineering, chemistry, biochemistry, pharmaceutics, pharmaceutical biotechnology, molecular toxicology, and pediatrics.

Advantages to Participating in the Program

• Industrial Mentor program
• Fellowships
• Internships at state-of-the-art biotechnology companies
• Multidisciplinary approach with a real-world focus

Program Requirements

• Meet normal degree requirements in home department
• Course requirements: Intro to Modern Biotechnology, Case Studies in Biotechnology, Pharmaceutical Biotechnology
• Lab rotations: Three ten-week rotations (one of three must be done outside the student’s home department)
• Ethics training: CHEN 5838 Research Methods and Ethics, PHCL 7605 Research Ethics, or equivalent
• Seminars: trainees are expected to attend biotechnology seminars
• Industrial internship required, but waived for students with extensive industrial experience
• Students must attend three of the annual scientific conferences hosted by the Center for Pharmaceutical Biotechnology (usually held at Breckenridge, CO), as well as all 'supergroup' meetings/symposia held with colleagues in Boulder. Presentations are required for upper level students

Ethics Training
Ethics training is part of the curricular requirement for students in the Leadership in Pharmaceutical Biotechnology program. All students participating in the program are required to take either Research Ethics and Methods (CHEN 5838) or Ethics in Research (PHCL 7605). These courses are designed to introduce graduate students and postdoctoral fellows to issues in the ethics of research, publication, and reviewing of manuscripts and grants. Lectures and discussions of the history of scientific fraud, examples from recent cases, examples of ethical dilemmas and consequences of fraud are covered. Research Ethics and Methods has been team taught by training faculty (Randolph, Davis).

Two more required courses also feature ethics training. CHEN 5830 Introduction to Modern Biotechnology and CHEN 5831 Case Studies in Biotechnology (see below for more detail) are required of all students who participate in the program. Both of these courses are taught or team-taught by training faculty from the Department of Chemical and Biological Engineering (Randolph, Davis, Kompala). These courses reinforce concepts presented in the first two courses, and provide students with a grounding in the ethics of clinical trials and pharmaceutical development. In Case Studies in Biotechnology, we have successfully used the Integrity in Scientific Research video series prepared by the American Association for Advancement of Science as a springboard for deeper discussion on ethics within the bioscience laboratories. In addition, students are strongly encouraged to take an additional course on the ethics of human subject protocols. This course, Lectures in Ethics and Research of Human Subjects Reviews (PHSC 7339) builds on the broad-based ethics training that the students receive in the introductory courses. We believe that this level of training in ethical issues prepares our students well for subsequent employment in a highly regulated industry focused on the development of human therapeutics.

Laboratory Rotations
During the first year of study, each student is required to participate in three laboratory rotations. Each rotation is ten weeks in duration and involves approximately 15-20 hours per week, depending on the student’s course load. To encourage interdisciplinary interactions and to expose the students to the widest possible breadth of laboratory techniques, at least one and preferably two rotations are taken outside of the student’s home department. Students receive Independent Study or Research Methods credit for the rotations. These rotations serve a number of important functions. The students learn a variety of laboratory skills, and become familiar with the research being performed in the participating units. In addition, contacts are established that foster collaboration during the student’s later thesis research. In their laboratory rotations, first-year students are paired with advanced graduate students or post-doctoral researchers. This serves not only to guide the students as they learn new experimental techniques, but also to provide additional mentoring for students in their critical first year.

Laboratory rotation assignments are based largely on individual student choice. Before each rotation period, a list of available rotations is circulated to the students, who submit a rank-ordered list of their top three choices. Assignments are based on the submitted request and available laboratory spaces, with conflicts resolved by lottery. To help students make their choices, information is provided by a variety of means including individual advising sessions for each student participant, faculty research presentations in the Introduction to Modern Biotechnology course, graduate brochures, departmental retreats, and by speaking directly with the faculty, research associates and students working in the labs.

Industrial Internships
Students in the Leadership Training in Pharmaceutical Biotechnology program participate in our active industrial internship program. Typically, this internship takes place during the summer of the student’s first year, and lasts for 12 weeks. Such internships fill a valuable role in giving students a real taste of industrial research and helping them establish a network of contacts outside of the University. The students also learn new techniques on state-of-the-art equipment, and return to the University laboratories with fresh ideas and a better sense of where the challenges lie within their research area. Response from our industrial collaborators to this program has been overwhelmingly positive. This year, industrial projects were offered by a variety of companies including Zymogenetics, Merck, Alza, Amgen, Ribozyme Pharmaceuticals, Geneva Pharmaceuticals, Bayer, Monsanto, PowderJect, Inhale Therapeutics, NREL, Coors, and Sangamo; the total project offerings exceeded the number of participating students by approximately 2:1.

Interdisciplinary Thesis Work
Each student must complete and defend a doctoral thesis based on original research that meets the standards of the Graduate School and the faculty. Students in the training program may choose a research project and faculty advisors from any of the participating departments. Thesis projects within the Leadership in Pharmaceutical Biotechnology program are interdisciplinary. Each student’s thesis committee must have at least one member from the training faculty from outside the student’s home department. Our pilot tests of such interdisciplinary thesis projects have been very successful. Twenty-five current or recently graduated Ph.D. and Master’s students have chosen interdisciplinary research topics and co-advisors from the ranks of the training faculty; all of our graduating students are highly sought after by the pharmaceutical industry.

Participating Faculty

Thomas Anchordoquy, Assistant Professor

Kristi Anseth, Associate Professor of Chemical and Biological Engineering, University of Colorado, Boulder (ACS Unilever Award for Outstanding Polymer Graduate Research, Camille and Henry Dreyfus New Faculty Award, David and Lucile Packard Fellowship for Science and Engineering, College of Engineering John and Mercedes Peebles Teaching Innovation Award, University Women’s Club Margaret Willard Award, Department of Chemical and Biological Engineering Outstanding Graduate Teacher Award, NIH FIRST Award, 1998-NSF CAREER Award, ASEE Rocky Mountain Section Dow Outstanding New Faculty Award)

John Carpenter, Associate Professor of Pharmaceutical Sciences, University of Colorado Health Sciences Center, Denver (School of Pharmacy Excellence in Teaching Award, Eli Lilly New Investigator Award, Chancellor’s Award for Graduate Teaching, co-Director, Center for Pharmaceutical Biotechnology)

Carlos Catalano, Associate Professor of Pharmaceutical Sciences, University of Colorado Health Sciences Center, Denver (School of Pharmacy Excellence in Teaching Award)

Robert Davis, Professor of Chemical and Biological Engineering, University of Colorado, Boulder (National Science Foundation Presidential Young Investigator, Guggenheim fellowship, College of Engineering and Applied Science Outstanding Research Award, College of Engineering and Applied Science Outstanding Service Award, Patten Professorship, ASEE Rocky Mountain Outstanding Young Faculty Award)

Dhinakar Kompala, Associate Professor of Chemical and Biological Engineering, University of Colorado, Boulder (National Science Foundation Presidential Young Investigator Award)

Mark Manning, Associate Professor of Pharmaceutical Sciences, University of Colorado Health Sciences Center, Denver (co-Director, Center for Pharmaceutical Biotechnology, AAPS Research Achievement Award in Biotechnology)

Lawrence Ng, Assistant Professor of Pharmaceutical Sciences, University of Colorado Health Sciences Center, Denver (School of Pharmacy Excellence in Teaching Award)

Theodore W. Randolph, Professor of Chemical and Biological Engineering, University of Colorado, Boulder (National Science Foundation Presidential Young Investigator, Patten Associate Professorship, co-Director, Center for Pharmaceutical Biotechnology, University of Colorado Faculty Fellowship Award, Department of Chemical and Biological Engineering Research and Service Award, Department of Chemical and Biological Engineering Graduate Teaching Award)

Robert Sievers, Professor of Chemistry, University of Colorado, Boulder (Keene P. Dimick Award in Chromatography, Tswett Chromatography Medal, Distinguished Alumni Award, Univ. of Tulsa, Technical Achievement Award, Aerospace Research Laboratories Decoration for Exceptional Civilian Service, Dept. of Air Force)

Deborah Wuttke, Assistant Professor of Chemistry, University of Colorado, Boulder (National Science Foundation Postdoctoral Fellow, Scripps Research Institute)

Contacts:

Prof. John F. Carpenter
School of Pharmacy C238
Department of Pharmaceutical Sciences
4200 East Ninth Avenue
Denver, CO 80262
(303) 315-6075
John.Carpenter@UCHSC.edu

Prof. Ted W. Randolph
Department of Chemical and Biological Engineering
Engineering Center ECCH-111
Boulder, CO 80309
(303) 492-4776
Theodore.Randolph@Colorado.edu