1. Bioengineering, Biotechnology, and Imaging November 19, 2007 NCDD Meeting Chair: Barbara B. Bass, MD Vice Chair: David A. Lieberman, MD

2. Research Advances 1.Image enhanced endoscopy 1.High magnification, confocal, autoflourescence 2.Advances in endoscopic technologies 1.Stents and deployment devices 2.Operating endoscopes 1.Instrumentation 3.Ablation technologies and injection devices 3.Endoscopic ultrasound 1.Imaging 2.FNA 3.Staging

3. Research Advances 4. Access to the small bowel lumen Videocapsule endoscopy Double balloon enteroscopy 5. New technologies to detect colorectal neoplasm 1.CT colonography 2.Fecal DNA analysis 3.VCE

4. Research Advances 6.Improvements in body imaging 1.CT 2.MRI 3.Combined modality imaging and molecular imaging 4.FDG-PET 5.PET-CT 6.Image guided procedures and planning 7. Introduction of simulators in procedural training 1.GI simulators 2.Surgical training simulators

5. Research Advances 8.Advances in laparoscopic surgery 1.Improved tools and experience of surgical workforce 2.Expansion of minimal access techniques and devices to most abdominal surgical procedures 9.Preliminary success in regenerative medicine-tissue engineering applications in the digestive organs

6. Research Goal 1 Define optimal procedural approach for patients with digestive disorders amenable to either endoscopic, image- guided or minimal access surgery RCT Resgistry Defined outcomes: efficacy, morbidity and mortality, QOL, cost

7. Research Goal 1 Objectives Evaluate efficacy and outcome measures, including quality of life, for innovative surgical technologies. Perform a cost analysis of new surgical methods compared to traditional procedures. Conduct rigorous studies of physiologic and immunologic response to minimal access surgery to determine if biologic advantage exists for these procedures.

8. Research Goal 2 Develop innovative technology for the diagnosis and treatment of luminal disease.

9. Research Goal 2 Objectives Develop and validate a method to perform “molecular” biopsy of luminal abnormalities in real time. Develop improved endoscopic instrumentation for therapeutic endoscopy. Develop improved virtual endoscopy technology to access the luminal space of the GI tract. Define mechanisms of scar tissue formation in the gastrointestinal tract.

10. Use tissue engineering and regenerative medicine approaches to develop innovative treatments for digestive diseases. Research Goal 3

11. Research Goal 3 Objectives Identify and isolate local stem cell populations in the GI tract for tissue engineering applications. Develop scaffolds, both naturally occurring and synthetic, to support growth and differentiation of cell populations indigenous to the gastrointestinal tract. Develop tissue engineering and regenerative medicine methods for esophageal and small bowel disorders.

12. Expand the application and integration of imaging and proceudral technologies to deliver targeted interventions with minimal tissue injury to patients with digestive disorders Research Goal 4

13. Research Goal 4 Objectives Develop new PET tracers for clinical use including markers of proliferation, tumor specific antigens, markers of apoptosis, and inflammation. Develop intraoperative high-energy gamma and beta detectors to enhance intraoperative localization. Develop energy delivery and real time tracking devices to optimize local image guided interventions Develop navigation and control devices to allow single port laparoscopic procedures, intraluminal procedures, and natural orifice surgeries.

14. Research Goal 5 Develop high fidelity interactive simulators of the digestive system

15. Research Goal 5 Objectives Define the optimal use of simulation in training the procedural workforce –Metrics, transference, competency assessment, acquisition of new technologies Define the value of simulation in developing new procedures –Procedural design –Predicition of outcomes Develop high fidelity simulators to allow multimodality procedural rehearsal

16. Major Challenges/Steps To Achieve Goals Translational and Clinical Research Challenge: Advances require interaction of disciplines not traditionally aligned in academic environments: clinicians, engineers, computer scientists, imaging, molecular pharmacy Steps: 1.State of the art workshops 2.Consortia of integrated research programs 3.Funding requirements 4.Dual training programs: bioengineering – surgery 5.Development of non-traditional disciplines and training pathways 1.Surgery- gastroenterology 2.Radiology – surgery – GI

17. Major Challenges/Steps To Achieve Goals Academia-Industry Collaboration Challenge: Financial interests preclude open collaboration between industry and investigators. IP interests hamper productive collaboration with small cap partners. COI concerns limit PI interaction with major industry partners Steps: 1.Educate investigator workforce re IP management 2.Develop more effective policies to allow industry collaboration and manage COI

18. Major Challenges/Steps To Achieve Goals Regenerative Medicine Challenge: The gastrointestinal tract is comprised of many complex structures The gastroinestinal tract has been viewed as too complex an organ to make progress in RM Steps: Symposium on regenerative medicine research in the digestive system with input of other system leaders Consortium of investigators Partnership with organ failure and repair clinicians with RM/TE investigators

19. Major Challenges/Steps To Achieve Goals Fostering Research Teams Challenge: 1.Biotechnology research requires collaboration between diverse disciplines 2.Biotechnology research requires very gigh cost tools and technologies Steps: 1.Develop network of high density research centers in areas of emphasis: imaging, robotics, devices, 2.Develop infrastructure for AV integration to link research facilities - share images, robotics, simulation 3.Target resources to interdisciplinary research teams