Thursday, November 17
8:30 am Pre-Conference Short Course Registration and Morning Coffee
Click here for short course details
12:00 pm Main Conference Registration
1:30 Chairperson’s Opening Remarks
Rosemarie Hunziker, Ph.D., Director, Tissue Engineering and Regenerative Medicine Program, National Institute of Biomedical Imaging and Bioengineering, NIH
1:40 Is 3D Always Necessary for Recapitulating Function for in vitro Tissue Engineered Systems?
James J. Hickman, Ph.D., Professor, Chemistry, Biomolecular Science and Electrical Engineering Director, Nanoscience Technology Center, Burnett School of Biomedical Sciences, University of Central Florida
For in vivo tissue engineering applications 3D is important, as one needs to capture as much capability for implants as possible and there are few functional 2D systems in the body. However, for in vitro systems it is more important to recapitulate the degree of function and 2D may be just fine for many applications. We will present our work with functional in vitro systems for cognitive function, motor control and myelination, as well as muscle, cardiac and lung function. We will also discuss the systems and functions found to require a 3D environment and those where a 2D system was all that was required to reproduce the function required for the application.
2:10 In Search of Biomarkers for Physiologically Relevant 3D Microtissue Formation in vitro – Who Needs Them?
William S. Kisaalita, Ph.D., Professor, Cellular Bioengineering Laboratory, Faculty of Engineering, University of Georgia
3D cell culture systems are gaining popularity over traditional 2D Petri dishes due to their superiority in emulating in vivo microenvironments. When applied in drug discovery, these systems are hypothesized to yield physiologically more relevant results, which should result in substantial development cost and time savings. Currently, a number of 3D culture systems are commercially available. In all these systems, the goal is to recapitulate an aspect of the in vivo microenvironment by mimicking in vivo cues (e.g., chemical, physical, and spatial). An emerging question is whether biomarkers for “three dimensionality” are needed, and if they are what the best bimolecular candidates are. Answers to these questions will be fully explored in this presentation.
2:40 Co-Presentation: The DARPA and NIH Microphysiological Systems Initiatives: Don’t Get Left Behind!
Rosemarie Hunziker, Ph.D., Director, Tissue Engineering and Regenerative Medicine Program, National Institute of Biomedical Imaging and Bioengineering, NIH
Anthony Bahinski, Ph.D., Advanced Technology Team, Wyss Institute for Biologically Inspired Engineering, Harvard University
3:25 Refreshment Break in the Exhibit Hall with Poster and Exhibit Viewing
4:00 Drug Discovery and Development in the 21st Century: What We Must Learn from the 20th Century?
Jack A. Reynolds, Ph.D., CEO, AnaBios Corporation
Our inability to understand the basic biology of an adverse event is a leading cause of pharmaceutical attrition and is a major impediment to efficient and successful drug development. Benefit and risk determinations (not safety and efficacy) are the major factors considered in regulatory decisions involving drug approval, labeling, risk evaluation and mitigation and even withdrawal from the marketplace. Pre-clinical safety testing currently relies heavily on the use of animal models, which have many limitations and have not changed significantly for decades. Perhaps most telling, the current models are not very helpful in advancing potential therapies for complex diseases or contributing to the benefit and risk dialogue, despite their continued widespread and mandated use. Innovation and the adoption of emerging methods or technologies are often missing in early drug development programs, especially in the preclinical area. In contrast, however, there have been modifications to the conduct of clinical trials as seen with screening INDs, micro-dosing protocols, adaptive clinical trials, translational medicine and risk management planning or risk mitigation strategies. Regulatory agencies have extended explicit overtures and shown a readiness to embrace change in the US and the Innovative Medicines Initiative in Europe. The current state of safety sciences and the related emerging technologies represent an unprecedented and timely opportunity to profoundly impact the science of drug development. By defining, characterizing, validating and integrating new methods and science into the development and decision making framework, this enterprise will improve public health decision making and enhance the efficiency of bringing new treatments to patients.
DRUG SAFETY EXECUTIVE COUNCIL (DSEC) PANEL
|
Sponsored by
 4:30 The Impact of 3D Tissue Models on Drug Development and Predictive Safety
Moderator: Ernest Bush, Ph.D., Vice President & Research Director, Cambridge Healthtech Associates
Panelists:
Adrian Roth, Ph.D., Head of Mechanistic Safety Europe, Non-Clinical Safety, Pharma Research, Hoffmann-La Roche AG
Jack A. Reynolds, Ph.D., CEO, AnaBios Corporation
Mei Zhang M.D., Ph.D., Senior Scientist, Lead Discovery Technologies, EMD Serono Research Institute, Inc.
Immanuel Freedman, Ph.D., Manager, Pharmacometrics, Biopharm Clinical Pharmacology and Biometrics, GlaxoSmithKline
Panelists will address the following issues:
- 3D tissue models come in a wide variety of cell types and systems. Which have you worked with or evaluated?
- What applications are you currently interested in evaluating with these new models for tissue systems?
- What are the specific advantages you hope to realize with these new model systems?
- How would you describe the general availability of these models on their cost effectiveness?
|
5:30 Welcome Reception in the Exhibit Hall with Poster Viewing
6:30 Close of Day
Day 1 | Day 2