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Bioengineering, Biotechnology, and Imaging

Presentation at the November 19, 2007 NCDD Meeting

Chair: Barbara B. Bass, MD

Vice Chair: David A. Lieberman, MD

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Research Goal 1

Define optimal procedural approach for patients with digestive disorders amenable to either endoscopic, image-guided or minimal access surgery

• RCT

• Registry

• Defined outcomes: efficacy, morbidity and mortality, QOL, cost

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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.

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Research Goal 2

Develop innovative technology for the diagnosis and treatment of luminal disease.

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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.

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Research Goal 3

Use tissue engineering and regenerative medicine approaches to develop innovative treatments for digestive diseases.

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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.

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Research Goal 4

Expand the application and integration of imaging and procedural technologies to deliver targeted interventions with minimal tissue injury to patients with digestive disorders

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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.

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Research Goal 5

Develop high-fidelity interactive simulators of the digestive system.

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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

• Prediction of outcomes

• Develop high-fidelity simulators to allow multimodality procedural rehearsal

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Major Challenges/Steps To Achieve Goals

• Translational and clinical research

• Academia-industry collaboration

• Regenerative medicine

• Fostering research teams

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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 trainingpathways

   1. Surgery- gastroenterology

   2. Radiology— surgery— GI

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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

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Major Challenges/Steps To Achieve Goals

Regenerative Medicine

Challenge:

• The gastrointestinal tract is comprised of many complex structures

• The gastrointestinal 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

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Major Challenges/Steps To Achieve Goals

Fostering Research Teams

Challenge:

1. Biotechnology research requires collaboration between diverse disciplines

2. Biotechnology research requires very high 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