Pre-Congress Bone-tec 2013 Clinical Translational Workshop

Transcription

1 Pre-Congress Bone-tec 2013 Clinical Translational Workshop Sat, Dec 14, , Tan Tock Seng Hospital, Main Building, Level 3, Seminar Rm 1 & 2, 11 Jalan Tan Tock Seng, Singapore Clinical translational research has become an important field. The success for commercialization depends on many factors and this topic has been highlighted to be one key focus. This workshop which is the pre-congress workshop of Bone-tec 2013 will have 5 keynote presentations and for the first time, a hands on practical workshop on using bioresorbable for cranioplasty led by key surgeons. The main objective is to bring together clinicians, engineers, scientists, health care personnel, regulatory officers and research grant administrators from around the region to share the latest cutting edge work on translational research and the use of animal models to test the efficacy of medical devices and products. The forum is new in Singapore and will allow participants to address some challenging issues faced by researchers working on pre-clinical animal models. Of importance is the need for regulatory compliance and for GLP labs. It is hoped that all participants will ask questions after each presentation and also make a point to socialize in the coffee breaks and lunch. We trust this is just but the beginning of a new development in bringing people of like mind to discuss issues in clinical translational research in Singapore. Program : Registration : Opening address (Prof. Teoh) : Prof. Teoh Swee-Hin, From Biomaterial R&D to Regulatory Affairs to Commercialization : Prof Dr. Jan-Thorsten Schantz, Craniofacial Regenerative Medicine An Overview : Tea-break : Dr. Timothy Shim, Reconstruction of the Orbital Floor : Dr. Cheong Ee Cherk, The Principles of Upper and Midface Facial Fracture Fixation : Mr. Lim Jing, Innovative Biomaterial Development for the Oral and Maxillofacial Field : Panel Discussion : Lunch : Practical workshop (Limited to only first 18 registered participants) 1650: Closing

2 From Biomaterial R&D to Regulatory Affairs to Commercialization Prof Swee-Hin Teoh School of Chemical and Biomedical Engineering Nanyang Technological University The aim of tissue engineering (TE) is to restore tissue and organ functions to normality with minimal host rejection. This arose from the need to develop an alternative method of treating patients suffering from tissue loss or organ failure. TE has been heralded as the new wave to revolutionise the healthcarebiotechnology industry. It is a multidisciplinary field and involves the integration of engineering principles, basic life science, and molecular cell biology. TE involves the scaffold which acts as a temporary extra cellular matrix for the cells to adhere, differentiate and grow. Despite the many promises since two decades ago, there have been very few success stories and numerous problems from lack of vascularisation, tissue resorption, loss of cell functions to unwelcome long term side effects and premature collapse of the scaffold. In bone tissue engineering especially large bone defects we have yet to come up with a pefect solution. Issues we currently faced include: 1) angiogenesis; 2) mechanoinduction; 3) resorption; and 4) remodelling. We need to develop strategies for bone regeneration to bone remodelling by looking at 1) biodegradable scaffolds that can trap large quantity of cells, degrade slowly and at the same time allow mechano-induction for tissue remodelling, 2) stem cells and/or growth factor source and 3) bioreactor technology to assist the speed of cell proliferation and waste product removal. The present talk will bring some examples of animal and clinical success stories based on 3D scaffold technology based on polycaprolactone (PCL) and it s composite with stem cells and the use of a unique bi-axial bioreactor to induce surface stresses, uniform cell population and a variety of motion to allow nutrients/waste to flow easily in a large defect model. Early FDA and CE mark have helped the products to be used in human. Successful clinical case studies have been demonstrated for large cranial reconstruction and dental applications. We have shown for the first time that customised scaffolds produced in a clean room according to ISO13485 for bone TE is now commercially feasible and cost effective for the patient. The development of the new platform technology demonstrated the very much needed strategy of partnership between engineers and clinicians in order to bring fruition of early clinical relevance to research. Prof SH Teoh received his B Eng (1st Hons) and PhD from Materials Engineering Department, Monash University, Australia in 1978 and 1982 respectively. He is presently Professor of Bioengineering and Acting Chair, School of Chemical and Biomedical Engineering, Director Renaissance Engineering Program, Nanyang Technological University and a Fellow of the Academy of Engineers Singapore. He founded the Univ spin-off company- Osteopore International. It is here that he guided the company to obtain FDA approval and CE mark for bone scaffolds in the craniofacial indications. The scaffolds have now been implanted successfully in more than 1500 patients. He is one of a few experts who teach regulatory affairs in medical devices, and cgmp manufacturing. He has a passion for teaching biomaterials engineering and design. In 2003 and 2004 he was accorded the University Excellent Teacher Award. Prof Teoh s main field of research is in Biomaterials and Tissue Engineering. He also contributes significantly to professional bodies and has supervised more than 60 graduate students, filed 6 patents, given 45 keynote/invited lectures and published more than 300 technical papers. He is presently the Chairman, Singapore Academy, Asia Regulatory Professional Association (ARPA). He sits in as board of editors Tissue Engineering, Journal of Tissue Engineering and Regenerative Medicine, Journal of Mechanical Behaviour of Biomedical Materials,

3 Journal of Oral & Maxillofacial Research and Proceedings of the Institution of Mechanical Engineers Part H: Journal of Engineering in Medicine. Craniofacial Regenerative Medicine: An overview Dr. Jan-Thorsten Schantz Technische Universitat Munchen Craniofacial reconstruction of cases with complex anatomy challenges surgeons. The recently emerging field of tissue engineering and regenerative medicine has resulted in a variety of novel therapeutic concepts particularly in the craniofacial area. However, researchers still face significant problems when translating scientific concepts from the bench to the bedside. Reconstruction procedures depend on sustainability, aesthetic outcome, and functionality. Tissue engineering approaches yield powerful tools for long-term satisfying results enabling customized reconstruction and supporting natural healing processes. In conclusion, further advances of tissue-engineered reconstruction need multidisciplinary research to create complex tissue structures and make satisfactory outcomes clinically achievable for most patients. Dr. Schantz is a board certified plastic and reconstructive surgeon. He received his MD from the University of Freiburg Germany and his PhD from the National University of Singapore. He was trained in plastic surgery in Freiburg, Singapore and Munich and did an aesthetic fellowship at the Bodenseeklinik under Prof. Mang. Dr. Schantz is currently Assistant Professor for Plastic Surgery at the Department for Plastic and Hand Surgery at the Klinikum rechts der Isar der Technischen Universität München. Within the department Dr. Schantz is also a Director of Plastic Surgery Translational Research. For his research in the field of bone regeneration he received multiple international awards. In 2008 Dr. Schantz was part of the surgical team who performed the world s first double arm transplant. Dr. Schantz is editor of the book series Manuals in Biomedical Research and co-founder of the Singapore based biotech company Osteopore International. In 2013 Dr. Schantz was appointed a visiting Associate Professor at the Division of Bioengineering, Nanyang Technological University, Singapore.

4 The Principles of Upper and Midface Facial Fracture Fixation & Dr. Cheong Ee Cherk Section of Plastic, Reconstructive and Aesthetic Surgery Tan Tock Seng Hospital Dr. Cheong (M.B.B.S(Spore), M.R.C.S.(Ed), M.Med(Surg), FAMS(Plastic Surgery)) is currently the Chief, Section of Plastic, Reconstructive and Aesthetic Surgery as well as Programme Director, Plastic Surgery Residency Programme at Tan Tock Seng Hospital. His area of subspecialty is in craniofacial trauma reconstruction and completed his craniofacial surgery fellowship at the Chang Gung Memorial Hospital in Taiwan under the 2008 Singapore Ministry of Health and National Healthcare Group fellowship. He is also a faculty member AO Foundation Craniomaxillofacial Section. His lectures will cover the principles of upper and midface facial fracture fixation as well as the various surgical approaches. & Reconstruction of the Orbital Floor Dr. Timothy Shim Section of Plastic, Reconstructive and Aesthetic Surgery Tan Tock Seng Hospital Dr. Shim (M.B.B.S(Spore), M.R.C.S.(Ed), M.Med(Surg), FAMS(Plastic Surgery)) is currently a Consultant in the Section of Plastic, Reconstructive and Aesthetic Surgery, Tan Tock Seng Hospital. His area of subspecialty is in reconstructive microsurgery and completed his microsurgery fellowship at the University of Tokyo Hospital under the Singapore Ministry of Health Overseas Training Scholarship. However, he still maintains an interest and continues to perform surgery for facial trauma. His lecture will cover the utilization of resorbable and titanium implants for orbital wall reconstruction.

5 Innovative Biomaterial Development for the Oral and Maxillofacial Field Lim Jing School of Chemical and Biomedical Engineering, Division of Bioengineering Nanyang Technological University In the area of bone tissue engineering (BTE), various clinically relevant scaffolds for oral and maxillofacial reconstructions have been developed and commercialized over the years, but limited success has been achieved when incorporating relevant compositions of physiological bone. Physiological bone is made up of 70% organic phase (collagen, growth factors) and 30% of inorganic phase (minerals, trace elements). Within the inorganic phase, 70wt% is constituted by calcium phosphates (CaP). Importantly, bone is a vascularized tissue, with extensive vasculature providing a constant nutrient source to maintain bone homeostasis. We have recently reviewed some of the clinical challenges faced in scaffolds for translational BTE, and identified key issues such as vascularization, osseointegration, infection, degradation, and strength (VOIDS). We present our insights on current trends for scaffold technology, and future directions for next-generation clinical scaffolds. In this regard, we have developed a low-temperature, solvent-free approach of fabricating bioactive polycaprolactone (PCL) scaffolds and films for guided bone regeneration, as foundation work for the development of next-generation clinical scaffolds. Due to the multi-component, composite nature of bone, it is conceivable for a tissue engineered solution to be a composite system. To this end, much effort has focused on incorporating CaP within biocompatible polymer matrices. However, CaP loading capacity has been limited by deterioration in rheological properties with increasing amounts of CaP, which affects subsequent manufacturing processes. The current limit in CaP incorporation remains at 25wt%. Other methods of incorporating CaP are based on solvents, which hampers clinical relevance. The avoidance of high-temperature processing realizes the potential of incorporating biologically-relevant molecules, and the improvement in rheological properties following low-temperature processing allows for the incorporation of physiological amounts of tricalcium phosphate (TCP), which has been widely shown to be a potent regulator of mesenchymal stem cell (MSC) differentiation. Our preliminary results suggest the advantages in low-temperature composite processing, and lay the foundation for the further development of clinically-relevant, next generation BTE scaffold technology. Lim Jing received his B. Eng (Hons) and M. Eng from the Department of Mechanical Engineering, National University of Singapore, in 2011 and 2012 respectively. He is currently a PhD scholar under the School of Chemical and Biomedical Engineering, Division of Bioengineering, Nanyang Technological University, Singapore. He is also serving as the co-chair for the Asia Regulatory Professional Association (ARPA) alumni, responsible for communicating with other regulatory professionals within the region and assisting in promoting regulatory affairs in the school.