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REQUIRED COURSES

The trainees in the Biotechnology Training Program must complete the required and elective courses in the Biotechnology Training Program. These core courses include Molecular Cell Biology (PHCH 725), Advanced Pharmaceutical Biotechnology (PHCH 870), Issues in Scientific Integrity (PHCH 801), and Road Map to the Discovery, Development and Regulatory Approval of New Drugs (PHCH 512).

Pharmaceutical Chemistry 725 (PHCH 725): Molecular Cell Biology. This course provides students with the foundation of cellular and molecular biology in working with biotechnology-related products. This course is designed to provide an overview of cellular components, architecture, and the signaling pathways involved in cell communication and to foster an understanding of the mechanisms underlying health and disease. Students should develop an understanding of the relationships between molecular characteristics of biological components, cellular organization, and biological function of normal, stressed, and diseased eukaryotic cells, as well as obtain detailed knowledge of the major experimental strategies for investigating the molecular basis of these relationships. The expectation is that students will think critically about the lecture material and research papers and be able to expand on the fundamental principles discussed in order to translate this knowledge into advancing their research. The material in the course is organized by topic and presented using an integrated approach. The intent is to make the class more interactive as the semester progresses, which requires that everyone be well prepared to participate. Instructor: Professor J.S. Laurence (Pharmaceutical Chemistry).

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Pharmaceutical Chemistry 870 (PHCH 870): Advanced Pharmaceutical Biotechnology. The objective of this course is to introduce the students to the discovery, development, and production of pharmaceutical macromolecules and vaccines. In the discovery section, the role of structure in governing activity, specificity, and stability, particularly for pharmaceutically important proteins and vaccines, is covered. Physical and spectroscopic methods for the analysis of macromolecular structure are described. Degradation processes, both chemical and physical, that are peculiar to proteins and other macromolecules will be presented, as well as strategies designed to prevent them. Introduction to recombinant DNA technology, large-scale production, and purification and isolation procedures used for recombinant proteins in the pharmaceutical industry will be covered in the development and production sections. Several new topics, including oligonucleotides and combinatorial chemistry, as well vaccine design and development, have been added due to the recent increased attention to these topics. Scientific challenges in addressing regulatory guidelines (filing of NDAs and INDs) will also be discussed.  Instructors: Professors T.J. Siahaan (Pharmaceutical Chemistry), C.R. Middaugh (Pharmaceutical Chemistry), D. Volkin (Pharmaceutical Chemistry), Stevin Gehrke (Chemical and Petroleum Engineering) and invited speakers.

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Pharmaceutical Chemistry 801 (PHCH 801): Issues in Scientific Integrity. Lectures and discussion on ethical issues in the conduct of a scientific career, with emphasis on practical topics of special importance in molecular-level research in the chemical, biological, and pharmaceutical sciences are presented. Topics will include the nature of ethics, the scientist in the laboratory, and the scientist as author, grantee, reviewer, employer/employee, teacher/student, and citizen. Discussions will focus on case histories. Topics concerning ethics are also covered in a separate seminar using film and literature. Instructors: Professor W.D. Picking (Pharmaceutical Chemistry) and invited speakers.

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Pharmaceutical Chemistry (PHCH 512): Road Map to the Discovery, Development and Regulatory Approval of New Drugs. This course covers the steps involved in drug discovery, development and regulatory approval of small molecule drugs, large molecule (protein) drugs, and vaccines. The students will be exposed to challenges in preclinical and early clinical development as well as late stage clinical development of biotechnology-derived drug candidates and vaccines. The regulatory approval process of small and large molecules will be discussed. Instructors: Professor D. Volkin (Pharmaceutical Chemistry) and invited speakers.

ELECTIVE COURSE REQUIREMENTS FOR AREAS OF SPECIALIZATION

Trainees are required to select an area of specialization (e.g., formulation, vaccine development, delivery, analysis, protein structure, or bioinformatics) and satisfy the elective course re­quirements listed below. The elective courses in each area of specialization provide the trainees with exposure to the practical problems associated with formulation, delivery, analysis, vaccine development, and structural and bioinformatics characteristics of biotechnology-derived drug and vaccine candidates. Such information will be particularly helpful to trainees from departments other than pharmaceutical chemistry.

FORMULATION

Trainees selecting the traditional formulation and vaccine formulation areas of specialization are required to successfully complete Pharmaceutical Equilibria (Pharmaceutical Chemistry 862, PHCH 862) and Mechanisms of Drug Deterioration and Stabilization (Pharmaceutical Chemistry 972, PHCH 972).

Pharmaceutical Chemistry 862 (PHCH 862): Pharmaceutical Equilibria. The objective of this course is to discuss topics on equilibria in aqueous and non-aqueous systems with emphasis on solutions of interest to pharmaceutical and biotechnology scientists, including (a) association-dissociation equilibria, (b) complexation, (c) protein binding calculation of species concentrations, and (d) estimation of solubility and ionization constants. Methods for the determination of chemical potential in solution are presented. Physical properties of ideal and nonideal solutions are discussed, including methods for determining and predicting solubility and ionization phenomena. The thermodynamics of ligand-binding interactions and macromolecular conformational equilibria are developed, with special attention to small-molecule protein binding equilibria. Instructors: Professors C. Schöneich (Pharmaceutical Chemistry), C.R., Middaugh (Pharmaceutical Chemistry), and L. Forrest (Pharmaceutical Chemistry).

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Pharmaceutical Chemistry 972 (PHCH 972): Mechanisms of Drug Deterioration and Stabilization. The objective of the course is to prepare students to recognize drug molecules, based on their chemical structures that are likely to present stability problems under a variety of conditions. The course provides students with the principles necessary to conduct stability evaluations of drugs and the associated quantitative interpretation of data from a thorough study. It is not our objective to cover every drug or class of decomposition, but to choose examples of compounds and formulations that may be susceptible to chemical decomposition. Particular emphasis is placed on how these degradation processes can be prevented or reduced to allow the formulation of these drugs for therapeutic use. Instructors: V. Stella (Pharmaceutical Chemistry), C. Schöneich (Pharmaceutical Chemistry), and J. Stobaugh (Pharmaceutical Chemistry).

DELIVERY

Trainees selecting the delivery area of specialization are required to successfully complete Drug Delivery (Pharmaceutical Chemistry 715, PHCH 715) and Advanced Topics in Pharmacokinetics (Pharmaceutical Chemistry 976, PHCH 976).

Pharmaceutical Chemistry 715 (PHCH 715 or CPE 715): Drug Delivery. The objective of this course is to provide students with a breadth of knowledge of the current trends in drug delivery systems utilizing conventional routes of administration. Factors that influence the delivery of drugs, such as drug physicochemical properties, excipients, mechanisms of drug release, and methods of evaluation, will be discussed. The performance of calculations related to the physical and chemical properties of drugs and common dosage forms (solubility, stability, release, dissolution, diffusion, partitioning, dose, absorption, and disposition) will also be taught. Finally, the presence of biological barriers and the mechanisms of sub-cellular trafficking of drugs will be described. The performance of calculations based on a fundamental understanding of mass transport concepts governing the disposition of a drug during administration and upon contact with biological barriers will be covered. Instructor: Professor C. Berkland (Chemical & Petroleum Engineering and Pharmaceutical Chemistry).

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Pharmaceutical Chemistry 976 (PHCH 976): Pharmacokinetics. This course provides trainees with exposure to the quantitative treatment of the processes involved in drug absorption, distribution, metabolism, and excretion in living systems. Topics covered in this course include classical pharmacokinetics, non-linear pharmacokinetics, advanced concepts in pharmacokinetic modeling, biological barriers to efficient drug delivery, and pharmacokinetics in dosage form development. The students will be able to appreciate and use quantitative information to increase the effectiveness of drugs in individualization of dosing. The areas of biopharmaceutics, pharmacokinetics, and clinical pharmacokinetics will be presented. Instructors: J. Stobaugh (Pharmaceutical Chemistry) and J. Krise (Pharmaceutical Chemistry).

ANALYSIS

Trainees selecting the analytical area of specialization are required to successfully complete Pharmaceutical Analysis (Pharmaceutical Chemistry 864, PHCH 864), and Mass Spectrometry (Chemistry 826, CHEM 826).

Pharmaceutical Chemistry 864 (PHCH 864): Pharmaceutical Analysis. The course focuses on the principles of liquid phase separations accomplished by pressure-driven chromatography, a limited discussion of gas chromatography, electrically driven separations emphasizing capillary electrophoresis, mass spectrometry and sample preparation techniques useful for biological samples. Further aspects include assay validation and statistics, principles of the detectors used in LC and CE, immunoassays technologies and an introduction to DNA sequencing. Instructors: J. Stobaugh (Pharmaceutical Chemistry), S. Lunte (Chemistry and Pharmaceutical Chemistry), M. Wang (Pharmaceutical Chemistry), and L. Van Haandel (Pharmaceutical Chemistry).

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Chemistry 826 (CHEM 826): Mass Spectrometry. This course is focused on introducing students to mass spectrometry methods. The various ionization techniques and mass analyzers will be discussed, and many examples of different mass spectrometric applications will be introduced. Instructor: H. Desaire (Chemistry).

STRUCTURE

Trainees selecting the structure area of specialization are required to successfully complete Modern Biochemical and Biophysical methods (Biology 918, BIOL 918) and Spectrochemical Methods of Analysis (Chemistry 908, CHEM 908).

Biology 918 (BIOL 918): Modern Biochemical and Biophysical methods. This course emphasizes the use of techniques for solving problems of structure and function of biological macromolecules. Students complete several modules that consist of lectures relating to theory and practical aspects of each methodological approach and applying these techniques to solving a specific problem. Instructors: K. Kuczera (Chemistry and Molecular Biosciences).

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Chemistry 908 (CHEM 908): Spectrochemical Methods of Analysis.  This course is aimed at discussing general concepts of encoding chemical information such as electromagnetic radiation; major instrumental systems for decoding, interpretation, and presentation of the radiation signals; atomic emission, absorption, and fluorescence; ultraviolet, visible, infrared, and microwave absorption; molecular luminescence; scattering methods; mass spectrometry; magnetic resonance; and automated spectrometric systems. Instructor: C. Johnson (Chemistry).

BIOINFORMATICS

Trainees selecting the bioinformatics area of specialization are required to successfully complete Bioinformatics I/II (Bioinformatics 701/702, BINF 701/702).

Bioinformatics 701/702 (BINF 701/702): Bioinformatics I/II.  BINF 701/702 is the bioinformatics core course developed at the KU Center for Bioinformatics. The course is designed to introduce the most important and basic concepts, methods, and tools used in Bioinformatics. Topics include (but are not limited to) bioinformatics databases, sequence and structure alignment, protein structure prediction, protein folding, protein-protein interaction, Monte Carlo simulation, and molecular dynamics. Emphasis will be on the understanding and utilization of these concepts and algorithms. The objective is to help the students to rapidly reach the frontier of bioinformatics and be able to use the bioinformatics tools to solve problems in their own research. Instructors: I. Vakser (Bioinformatics), W. Im (Bioinformatics), and J. Karanicolas (Bioinformatics).


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