Graduate Certificate in Pharmaceutical Biotechnology

Department of Pharmaceutical Sciences, School of Pharmacy
University of Colorado Center for Pharmaceutical Biotechnology (a joint enterprise with the Department of Chemical Engineering at the University of Colorado at Boulder)

I. Statement of Purpose

The advent of biotechnology has forever altered the pharmaceutical industry, providing new classes of therapeutic agents that were almost inaccessible previously. Unfortunately, the products of recombinant DNA technology, recombinant proteins, DNA, RNA, and other complex biomolecules are relatively fragile, requiring special training to formulate, deliver, stabilize, and analyze them properly. Few programs exist where the emphasis within pharmaceutical sciences is on biotechnology products. In collaboration with the Department of Chemical Engineering in Boulder, we have developed an interdisciplinary training program in the area of pharmaceutical biotechnology, which is the only program of its kind in the country. It is administered through the University of Colorado Center for Pharmaceutical Biotechnology ("the Center"). The result has been rigorous training for the student and successful placement of our graduates in the pharmaceutical industry. However, there has not been a formal recognition of the training they have received, as they obtain a Ph.D. degree in Pharmaceutical Sciences. This certificate program will provide the appropriate recognition that these student deserve for engaging multidisciplinary thesis research projects, industrial internships, and joint courses (primarily with Chemical Engineering) in biochemistry, bioengineering, pharmacoeconomics, and pharmaceutical sciences.

It is important to note that this certificate cannot be obtained without successful completion of the Ph.D. degree program in Pharmaceutical Sciences. Therefore, it is not a stand-alone program. Note that the certificate cannot be awarded without certification from the Graduate School at the University of Colorado Denver that the student has met all of the requirements for the Ph.D. degree. The certificate simply affirms that they have done the additional work necessary to be recognized for officially completing the Certificate in Pharmaceutical Biotechnology.

II. Statement of Need

The University of Colorado has become a premier training site for scientists wishing to enter the drug development arms of pharmaceutical and biotechnology companies. As a result, the interest in students in the graduate programs in Pharmaceutical Sciences and Chemical Engineering has increased. The ability to distinguish these students from those that take the regular curriculum in these two programs will further our ability to attract more students of the highest caliber. As stated above, there is no program of this type in the country.

III. Statement of Resources

This Certificate Program includes faculty from two different graduate programs along with faculty from other schools, or even universities within Colorado. Each faculty has an appointment in a specific department, but agrees to participate in interdisciplinary training under the auspices of the Center. The graduate programs are supported by funds from the respective departments, schools, and campuses. Additional support is generated by Center faculty, mostly through federally- and industrially-sponsored research.

IV. Description of the Curriculum

Each student enrolled in the Certificate Program must satisfy the degree requirements of his or her own departmental program and of the Graduate School of that campus. In addition, the student must complete the following courses and requirements of the Certificate Program, as listed below:

Interdisciplinary Coursework

Core Science Courses:
PHSC 7651 (CHEN 5838) Pharmaceutical Biotechnology (3 credits)
PHSC 7354 Structural Analysis of Biomolecules I (2 credits)
PHSC 7653 Protein Formulation (2 credits)

Courses in Biotechnology:
PHSC 7649 (CHEN 5810) Introduction to Biotechnology (1 credit)
PHSC 7831 (CHEN 5818) Case Studies in Biotechnology (2 credits)

Courses on the Pharmaceutical Industry:
PHSC 7330 Issues in Drug Development (2 credits)
PHSC 7831 Case Studies in Biotechnology (2 credits)

All of the faculty involved in teaching these classes have graduate faculty appointments on their respective campuses.

Interdisciplinary Thesis Research

Students will perform thesis research under the direction of one of the faculty members listed below, all of whom have graduate faculty appointments on their respective campuses. Students will often have a number of participating faculty serve on their committee. Occasionally, an industrial scientist will also work with the student as a collaborator and/or committee member. In order to serve on the committee, this will require approval of a special graduate faculty appointment for that scientist. It is also expected that many of the students will conduct research projects that are supported to some degree by industry. The progress of the student will be monitored by both the thesis advisor and the Director of the Pharmaceutical Sciences program. The suitability of the thesis topic for the certificate must be approved by the Director of the Pharmaceutical Sciences program.

Ethics

Students must complete course work in research and biomedical ethics:
PHSC 7400 Ethical Issues in Toxicology and Pharmaceutical Sciences (1 credit)

The course will discuss informed consent, privacy issues, and will expose students to the process of human subject protocols as they go to an institutional review board. This will give students a valuable perspective and help students appreciate that they will be involved in a regulated industry that seeks to provide therapeutic agents to humans.

Industry Research Experience

It is required that students conduct a rotation (minimum 6 weeks) at a company performing scientific studies related to their thesis project. This requirement may be waived for students that have prior industrial experience. It is strongly encouraged that students identify an industrial scientist as a mentor during their graduate studies. In many cases, the industrial mentor would be given a special graduate faculty appointment and serve on the student's thesis committee.

Interdisciplinary Seminars, Symposia, Conferences

The graduate programs in Pharmaceutical Sciences and Chemical Engineering hold seminars weekly, and the speakers often present work of interest to someone working in pharmaceutical biotechnology. The student is required to attend at least six seminars outside of the Pharmaceutical Sciences in order to expand their insight into other scientific disciplines.

In addition, the Center hosts international meetings in Protein Stability (odd-numbered years) in Colorado. Students will be required to attend these conferences and present at least once at one of the meetings.

Completion of a Ph.D. Degree

In order for the certificate to be awarded, the student must also complete all of the requirements for the Ph.D. degree. The Certificate will be signed by the Certificate Program Director (who also serves as Director of the Ph.D. program in Pharmaceutical Sciences) and issued at graduation. The Certificate in Pharmaceutical Sciences requires that the student complete ALL of the requirements for the Ph.D. in Pharmaceutical Sciences as well as those outlined in this document.

V. Certificate Program Faculty

Pharmaceutical Sciences
Thomas Anchordoquy
John Carpenter
David Bain
Dan Gustafson
LaToya Jones
Karl Maluf
Kathleen Stringer

UCD
Frank Frerman
Robert Hodges

Chemical Engineering
Kristi Anseth
Ted Randolph
D. Khompala
D. Schwartz

CU-Boulder
Robert Sievers
Deborah Wuttke

The Pharmaceutical Sciences faculty listed are the graduate faculty who would be involved in directing the interdisciplinary thesis projects, often with the assistance of those faculty listed in other departments or universities. All participating faculty will have graduate faculty appointments on their respective campuses, and will obtain special graduate faculty appointments at the University of Colorado Denver. These faculty will teach the required courses and will direct and collaborate in the interdisciplinary research projects of the students. The list would be updated as additional faculty become involved.

VI. Admission Requirements

Students are recruited by normal processes to the Ph.D. program in Pharmaceutical Sciences, much like the students entering the Ph.D. program in Chemical Engineering. The special emphasis of the Pharmaceutical Sciences program on pharmaceutical biotechnology is highlighted on the web page for the program and in printed materials sent to prospective students. In the future, the specifics of the Certificate Program will be included in all electronic and printed materials associated with the Ph.D. program. Given the increasing involvement of faculty on the Health Sciences Center campus, we expect that the Certificate Program may be amended in the future to include other Ph.D. programs on campus.

Students must first be admitted in the graduate program and fulfill all of the criteria set by the program and the Graduate School. Based upon the last ten years since the Center has been in existence, most of the Pharmaceutical Sciences Students will opt to obtain the Certificate, meaning 2-4 per year will obtain the certificate, given current levels of enrollment.

Last updated: 11/14/08