Short Courses

Tuesday, June 9

Afternoon Courses | 2:00 – 5:00 pm

Allosteric Modulators of GPCRs, (PAMs NAMs)

The course will provide an overview on allosteric modulation of class A, B and C GPCRs: screening, molecular pharmacology, signal bias, medicinal chemistry and development challenges. For each of these areas, we will cover the theory and best practices while delving into case studies to highlight key challenges and caveats.

Instructors:

Corey Hopkins, Ph.D., Research Assistant Professor, Vanderbilt Center for Neuroscience Drug Discovery

Cody J. Wenthur, Pharm. D., Graduate Student, Department of Pharmacology, Vanderbilt University Medical Center

Imaging of Blood-Brain Barrier Function

Topics to be covered:

• Review of structure and function of the BBB and delivering therapeutic agents to specific regions of the brain
• In vitro imaging, both qualitative and quantitative, microscopy and other imaging techniques
• In vivo imaging in animals, both qualitative and quantitative using different imaging modalities, nuclear, ultrasound, MRI and optical
• In vivo imaging in humans, both qualitative and quantitative

Instructors:

King C. Li, M.D., FRCP(C), MBA, Senior Associate Dean for Clinical and Translational Research; Professor and Chair, Department of Radiology, Wake Forest School of Medicine

Lawrence Berliner, Ph.D., Professor of Chemistry and Biochemistry, University of Denver; Emeritus, Ohio State University

Drug Metabolism and Its Impact on Decisions in Drug Discovery & Development

This short course will focus on concepts important for those wanting to understand how drug metabolism is applied to drug discovery and development. Topics will include how drugs are metabolized, the enzymes involved and the growing importance of transporters in drug disposition and safety. Those scientists involved in medicinal chemistry, pharmacology and drug metabolism will benefit from this overview.

• Biotransformation and the role of metabolism in drug toxicity
• Strategies to identify drug metabolites
• Enzymes involved in the metabolism of drugs
• Metabolism-based drug-drug interactions
• Transporters relevant for drug uptake and efflux
• Experimental systems to investigate transporters

Instructors:

David Stresser, Ph.D., Program Manager, Corning Gentest Contract Research Services,

Mingxiang Liao, Ph.D., Senior Scientist I, Department of Drug Metabolism and Pharmacokinetics, Takeda Pharmaceutical Intl. Company

John Erve, Ph.D., DABT, Jerve Scientific Consulting, Inc.

Tuesday, June 9

Dinner Courses | 6:00 – 9:00 pm

Understanding and Dealing with Drug Disposition in CNS

Topics to be covered:

• Enabling faster compound selection in CNS drug discovery by Pharmacokinetics/pharmacodynamics (PK/PD) modeling and simulation.
• Disposition of Biologics: the absorption, distribution and clearance of bio-therapeutics
• Kinetic relationship between systemic circulation and CNS
• Understanding Factors that affect Brain ISF/CSF production and clearance and its implications
• Onset of CNS diseases
• Drug – drug interaction
• Dosing strategy for drugs that may have CNS implications

Instructors:

Qin Wang, Ph.D., Principal Scientist, Translational Sciences, Biogen Idec

Margareta Hammarlund-Udenaes, Ph.D., Professor, Translational PK/PD, Department of Pharmaceutical Biosciences, Uppsala University

Navigating the CiPA Landscape

This dinner course will provide an important update on the
CiPA (Comprehensive in vitro Proarrhythmia Assay) initiative. Present ICH S7A and S7B guidelines regulate non-clinical testing for cardiovascular safety. The ICH guidelines have focused on QT/QTc intervals and potential arrhythmia. Experience has shown, however, that cardiovascular assessment should include more than the hERG assay and evaluation of other ion channels should be considered for a more comprehensive cardiovascular evaluation. The session will introduce and review these ion channel assays, describe other in vitro assays (i.e., stem cells cardiomyocytes), and in vivo and secondary cardiovascular assays. The current pharmaceutical and regulatory thinking process of cardiovascular evaluation will be discussed, including a proposal of modification/elimination of ICH E14.

Instructors:

Arthur M. "Buzz" Brown, M.D., Ph.D., Managing Director, ChanTest, a Charles River Company

Bernard Fermini, Ph.D., Associate Research Fellow, Global Safety Pharmacology, Pfizer Global Research & Development

Gary Gintant, Ph.D., Research Fellow, Integrative Pharmacology, Abbvie

Jeremy N. Ruskin, M.D., Professor of Medicine, Harvard Medical School; Director, Cardiac Arrhythmia Service, Massachusetts General Hospital

Thursday, June 11

Dinner Courses | 7:00 – 10:00 pm

The course will provide an overview of the various 3D cell culture models available, their strengths and weaknesses, and where and how these models are being used, specifically for oncology research. The instructors will share their experiences on how they tested and evaluated various cell culture reagents and growth matrices, what worked and what didn’t and what you need to consider when setting up low and high throughput screening experiments using 3D cell cultures in your lab. The challenges working with 3D cell cultures, from experimental design to data analysis will be discussed.

Instructors:

Arvind Rao, Ph.D., Assistant Professor, Department of Bioinformatics and Computational Biology, The University of Texas MD Anderson Cancer Center

Geoffrey A. Bartholomeusz, Ph.D., Associate Professor and Director of the siRNA Core Facility, Department of Experimental Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center

Sophie Lelièvre, D.V.M., LLM, Ph.D., Professor, Department of Basic Medical Sciences; Associate Director, Collaborative Science, NCI-Designated Purdue Center for Cancer Research, Purdue University

3D Printing

The promise of 3D bioprinting to create human tissues layer by layer is immense. Creating viable 3D screening models can lead to more effective drug development and more accurate drug testing. However, organ and tissue structures vary in complexity, and printing with living cells is complicated.

Topics to be covered:

• 3D Printer Platforms: Inkjet vs. Pressurized Printing
• 3D Modeling (CAT Scans, Laser Scans and CAD)
• Scaffold Selection
• Cell Source Selection
• Bioinks
• Vascularization

This dinner course is designed for biological researchers who are interested in learning more about 3D bioprinting, applying it to building a living tissue or organ of their choice and understanding the potential role in pharmaceutical drug research.

Instructors:

Michael Drues, Ph.D., President, Vascular Sciences

Richard J. Gilbert, M.D., Research Professor, Department of Chemistry and Chemical Biology, Northeastern University

David Kolesky, Research Scientist, Jennifer Lewis Laboratory, School of Engineering and Applied Sciences and Wyss Institute for Biologically Inspired Engineering, Harvard University

PDX Models Update

Patient derived xenograft platforms for conducting personalized treatment testing have been established. Remarkably, PDX models have a ~90% correlation with corresponding patient clinical responses, and this supports advancing PDX for use in matched patient PDX-directed clinical trials. Additionally, PDX models are being used prospectively in high-throughput in vivo screens across multitudes of models per screen to guide multiple phases of therapeutic advancement for a wide range of therapeutic classes. Biomarker data is being collected and analyzed to ascertain signatures of molecular response to treatment for creating downstream predictive patient treatment algorithms for designing better perspective treatments. Furthermore, advanced PDX in humanized mice models are being developed for immune checkpoint inhibitor testing. A comprehensive current status of the PDX research field including model characterization, humanized PDX for immune therapy testing, and co-clinical PDX developments will be presented. 

Topics to be covered:

• DX technology: core principles and latest advances
• Major applications including novel ones such as, circulating tumor cell-derived PDX advancements
• PDX models to study the immune response of cancer patients to their tumors, and others
• Utilizing data to inform clinical decisions

Instructors:

Richard B. Bankert, V.M.D., Ph.D., Professor, Department of Microbiology and Immunology, State University of New York at Buffalo

Neal Goodwin, Ph.D., Vice President Corporate Research Development Champions Oncology, Inc.

* Separate registration required.