Two-day Tissue Adhesives / Soft Tissue Workshop / Symposium, September 26-27, 2011

The Food and Drug Administration (FDA) is announcing a Workshop to facilitate medical device innovation with the focus on tissue adhesive materials. In the last 20 years there has been an explosion in the number of biomaterials being used as adhesives. There is incredible variation in the indications, adhesion mechanisms and formulation of these adhesives. To date, such adhesives have only been approved for use on the skin and some other limited anatomic sites but are being proposed for use as an adhesive in many internal anatomic locations. Since the FDA first approved a single synthetic cyanoacrylate tissue adhesive for topical wound closure, in 1998, an extended family of chemical tissue adhesives has emerged. This new family is comprised of fibrin-based adhesives, synthetic and protein polymers, and cements –- all of which extend application beyond wound closure to indications such as hemostasis and bone bonding. Many of these emerging tissue adhesives could modify difficult surgical procedures by stabilizing tissue surfaces through hemostasis, sealing of wounds, and fixation of tissue in areas inaccessible to staples, clips, and suture placement.

The purpose of the workshop/symposium is to u nderstand these adhesives in terms of mechanism; toxicity and potential indications will guide innovation and help guide appropriate regulatory pathways to develop new tissue adhesive biomaterials that can be used clinically for external and/or internal applications. Discussions regarding the use of presently used and experimental tissue adhesive in animal studies and in recently reported clinical studies will provide insights into the design of future biodegradable or bioabsorbable tissue adhesives that may have potential to be used in humans for clinical applications. It is important to ensure existing products are used properly and new tissue adhesive biomaterials are developed properly for new intended uses and that new products can be efficiently developed more likely to result in safe products that benefit patients and consumers when implemented for clinical use.

---

This Two-day Tissue Adhesives/Soft Tissue Workshop/Symposium will be held on September 26 and September 27, 2011 beginning 8:00 a.m. at the FDA White Oak Campus, Building 2, A-2031, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993.

The meeting will be available via webcast.

DAY ONE

Time	Topic	Speaker(s)
8:30 a.m-8:40 a.m.	Welcome and Introductory Remarks	William Maisel, M.D.,MPH Deputy Director for Science, FDA/CDRH
8:40 a.m-8:55 a.m.	Keynote Address: FDA’s Role in Medical Device Innovation with the Focus on Tissue Adhesive Materials	Christy L. Foreman, M.S. Director, Office of Device Evaluation (ODE)/CDRH
8:55 a.m-9:05 a.m.	Introduction to Workshop/Symposium and Introduction of Clinical/Scientific Expert Speakers	Moderators: George Mattamal, PhD General Surgery Device Branch, DSORD/ODE James Quinn, MD MS Professor of Surgery Stanford University David Krause, PhD Chief, Plastic and Reconstructive Device Branch, DSORD/ODE
9 :05 - 9:35 a.m.	Clinical Overview, Historical Perspective and Future Direction of Tissue Adhesives, Sealants and Glues”	James Quinn, MD MS Professor of Surgery Research Director for Emergency Medicine Stanford University Palo Alto, California
9 :35 a.m-10:05 a.m.	Introduction to Adhesion Principles - Implications for Biomaterials -	Kashmiri Lal Mittal, PhD Editor-in- Chief. Journal of Adhesion Science and Technology
10:05 a.m-10:30 a.m.	Coffee/Break
10:30 a.m-11:00 a.m.	Cyanoacrylate Tissue Adhesives for Wound Closure in the Emergency Department	Judd E. Hollander, MD Professor of Surgery, Clinical Research Director Department of Emergency Medicine, University of Pennsylvania, PA
11:00 a.m-11: 30 a.m.	Use of Adhesive in Facial Plastic Surgery	Dean M. Toriumi, MD Professor of Surgery Division of Facial Plastic and Reconstructive Surgery, Department of Otolaryngology - Head & Neck Surgery University of Illinois at Chicago
11:30 a.m-12:00 p.m.	Use of Topical Skin Adhesives for Non incisional Wounds: Preclinical and Clinical Experience	Adam J. Singer, MD Professor of Surgery Vice Chairman for research, Department of Emergency Medicine Stony Brook University and Medical Center, NY
12:00 p.m. -1:00 p.m.	Lunch
1:00 p.m. - 3:00 p.m.	Industry Abstracts for Topical Uses (15 minutes each)
3:00 p.m. - 3:30 p.m.	Coffee/Break
3:30 p.m. - 4:30 p.m.	Panel Discussion 1 Topical Use of Adhesives - Where we have been where we are going Focus on guidance documents and Reclassification of tissue adhesive products Pre-clinical/ Clinical approach to new polymers and products Kits containing cleared/approved tissue adhesive products	Moderators: James Quinn MD MS, Stanford University David Krause, PhD Chief, Plastic and Reconstructive Device Branch, DSORD/ODE And † Panelists: George Mattamal, PhD, DSORD/ODE Anthony Watson, BS, MS, MBA, Director, DAGID/ODE Erin Keith, M.S, Deputy Director for Science and Policy, DSORD/ODE Charles Durfor, PhD, DSORD/ODE Roxolana Horbowyj, MD, MS, DSORD/ODE Peter Hudson, PhD, DSORD/ODE Joseph Nielsen, PhD, DSORD/ODE Stephen Curtis, DVM, DSORD/ODE Janette Alexander, MD,DSORD/ODE Kelley Burridge, PhD, DSORD/ODE, † Presenters will be on the panel
4:30 p.m-4:40 p.m.	Wrap-Up and Adjourn	Peter Rumm, MD, MPH, Deputy Director of Clinical, DSORD/ODE

DAY TWO

Time	Topic	Speaker(s)
8:30 a.m-8:40 a.m.	FDA Welcome and Opening Remarks	Markham C. Luke MD, PhD, Deputy Director of Clinical, ODE/FDA
8:40 a.m.- 9:10 a.m.	FDA Regulatory History of Tissue Adhesives, Sealants and Glues	David Krause, PhD Chief, Plastic and Reconstructive Device Branch, DSORD/ODE
9:10 am-9:40 a.m.	Sealants Regulated by the Center for Biologics Evaluation and Research (CBER)	Nisha Jain, M.D. Chief, Clinical Review Branch, Division of Hematology, OBRR/CBER
9:40 am-10:10 p.m.	The Use of Hemostats, Sealants, and Adhesives in Vascular Surgery	William D. Spotnitz, MD, MBA, FACS Professor of Surgery, Director of Surgical Therapeutic Advancement Center , University of Virginia Health System & Sandra G. Burks, RN, BSN, CCRC Associate Director of the Surgical Therapeutic Advancement Center Department of Surgery University of Virginia Health System
10:10-10:30 am.	Coffee/Break
10:30 a.m. 11:00 am.	Protein Polymers and Their Various Clinical Uses	K. Umit Yuksel, PhD Senior Director, Medical Adhesives, Sealants & Hemostats, CryoLife, Inc.
11:00 a.m.- 11:30 a.m	Adhesives Used as Liquid Embolic Agents	Charles W. Kerber, MD Clinical Professor Department of Radiology University of California San Diego, CA
11:30 a.m.- 12:00 pm	The Use of Hemostats, Sealants, and Adhesives in Lung Surgery	William D. Spotnitz, MD, MBA, FACS Professor of Surgery, Director of Surgical Therapeutic Advancement Center , University of Virginia Health System & Sandra G. Burks, RN, BSN, CCRC Associate Director of the Surgical Therapeutic Advancement Center Department of Surgery University of Virginia Health System
12:00 - 1:00 p.m.	Lunch
1:00p.m.- 2:30 p.m.	Industry Abstracts (15 minutes)
2:30 p.m. - 3:00 p.m.	Coffee Break
3:00 p.m-4:00 p.m.	Panel Discussion 2 Pre-clinical/Clinical approach to Implantable Adhesives Developing Guidance documents for Implantable Adhesives Manufacturing Controls	Moderators: James Quinn MD MS, Stanford University David Krause, PhD Chief, Plastic and Reconstructive Device Branch, DSORD/ODE And †Panelists: George Mattamal, PhD, DSORD/ODE Peter Rumm, MD, MPH, Deputy Director of Clinical, DSORD/ODE Jennifer Goode, BS DCD/ODE Peter Hudson, PhD, DSORD/ODE Stephen Curtis, DVM, DSORD/ODE Roxolana Horbowyj, MD, MS, DSORD/ODE Charles Durfor, PhD, DSORD/ODE Joseph Nielsen, PhD, DSORD/ODE Kelley Burridge, PhD,DSORD/ODE Janette Alexander, MD,DSORD/ODE † Presenters will be on the panel
4:00 p.m- 4:15 p.m.	Wrap-Up & Symposium/ Workshop Closing remarks	Mark Melkerson, M.S Director, DSORD/ODE & George Mattamal, PhD James Quinn, MD MS David Krause, PhD
4:30 p.m. -	Adjourn

If you wish to attend this Workshop, you must register by close of business on September 21, 2011.

There is no fee to register for the Workshop and registration will be on a first-come, first-served basis. Early registration is recommended because seating is limited.

If you need special accommodations due to a disability, or additional information regarding registration, please contact Alexander Cox, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 66, Silver Spring, MD 20993, 301-796-9696, Alexander.cox@fda.hhs.gov .

George Mattamal, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 66, Silver Spring, MD 20993, 301-796-6396, george.mattamal@fda.hhs.gov .