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Session 4: Enabling Technologies for Combination Product Design and Development

 

Moderator:

Prof. Frederic Hildebrand, Research Director, Biomaterial Research Group, Inserm Lille

 

H. Frederic HILDEBRAND was born in Berlin in 1943 and followed his education at the Bonn University up to the MSc in cell Biology. During his PhD (1972) and Habilitation to Research Directory (1978) at the he Lille-1 University of Science and Technology, he integrated INSERM where he promoted to Research Director in 1992 and became the Director of the Biomaterials Research Group (GRB), now included in the INSERM Research Unit U 1008 “Medicaments and Biomaterials for controlled release” His original main field is Cell Biology and Electron Microscopy. During his carrier he got the multi- and interdisciplinary competences in a first period in Human Toxicology, Cancer Research, Biochemistry. Since 1982, he enlarged his knowledge to the biological and clinical responses to implants and prostheses: orthopaedic surgery, stomatology, dentistry and vascular implants and prostheses. Since 1998, his main interests turned to the in vitro assessment of cytocompatibility of Biomaterials, the material / biosystem interaction and the functionalization, activation, and nanostructuration of material surfaces for medical devices.

In 1993, he co-created the Federation of Biomaterials and functionalised medical devices and became the chairman in 2001.

His activity lead to the co-operation with multiple laboratories and companies from France, Germany, Italy, Spain, UK, Belgium, China, Perou, and other countries. He was the scientific organiser of multiple national and international congresses (Council of Europe, European Science Foundation, E-MRS, EU, NATO, ICMAT, THERMIS,…), and his expertise is asked in national and international public and private scientific advisory committees and in the advisory boards of scientific journals.

His results lead to 5 patents with industrial transfer, more than 250 scientific publications, more than 560 communications and conferences, and near 100 invited lectures. With his contribution, the GRB got in 2009 the national award of innovation by Oseo.

 

 

 

 


 

 

Crispin Simon, CEO, Biocompatibles UK Ltd

 

Mr Crispin Simon is Chief Executive Officer of Biocompatibles International Plc. Crispin Simon joined the company in June 1998. After working at NM Rothschild and McKinsey & Company, he gained general management experience at senior executive level with Rexam plc (then Bowater) and then as President of the Endoscopy Division of Smith & Nephew plc, based in Boston, USA. Crispin Simon is a non-executive Director of Imperial Collage Healthcare NHS Trust and a Governor of Port Regis School.

 

 


 

 

Significance of multi-responsive microgels for biomedical applications

There are many responsive drug-delivery systems currently available, which are based on polymers, nanoparticles, microsphere and liposome. These systems have been developed to prolong the circulation time of drug molecules in the blood so that they can be delivered to the targeted site of action while protecting them from degradation in blood plasma. Applications of hydrogels as elements of control release systems have also been well described in the literature. A further focal area of responsive drug delivery is related to the development of nanogel, which provide high surface area and rapid response to external stimuli and can therefore solve problems of hydrogels’ slow response to stimuli. Furthermore, aqueous hydrogel suspensions have been one of the most studied colloidal systems as responsive nanogels since they can manifest dramatic changes in characteristics of the system such as shape, surface characteristics, solubility, and formation of an intricate molecular self-assembly or a sol-to-gel transition.

 

The major aims of our current study are to prepare, characterize and evaluate stimuli responsive silver loaded poly N-isopropyl acrylamide (pNIPAAm) nano-particulate carrier systems. These DDSs have been characterised using FTIR, DSC, AA, SEM and EDEX techniques. To confirm the biological activity of silver loaded gel anti bacterial assay will be carried out using various strains of gram negative and gram positive bacteria and for confirming the physiological activity of these gels, their drug release patterns will be studied at various physiological as well as pathological temperatures. This paper will present the results of the characterization of these nano-particulate DDSs as well as their drug release behaviour in response to environmental stimuli such as temperature.

 

Muhammad Zafar, Research Scholar, University of Bolton

 

Muhammad Zafar is a research scholar at the Institute for Materials Research and Innovation (IMRI), The University of Bolton, United Kingdom. He has received his MSc in ‘Botany’ and BSc in ‘Premedical Group’ from the University of Karachi, Pakistan. He is currently involved in synthesizing and characterizing the multi-responsive micro/nanogel materials for biomedical applications. He has presented several papers and posters in different conferences in United Kingdom, France and Pakistan. He has been as a medical representative for three years in pharmaceutical in Pakistan.

 

 


 

 

A bioabsorbable product, providing the controlled release of local anesthetics to minimize postoperative pain

Authors : E. Pélissier, C. Millot, C. Roques-Carmes, S. Piranda

 

This communication describes a new controlled-release substance, made of a blend of a bioabsorbable substrate and local anesthetics. The controlled-release of local anesthetics is obtained by progressive biodegradation of the substrate. The release rate can be modified depending on the compound composition and physical conditions of the making of. The amounts of local anesthetics released, are in accordance with the doses commonly used in humans by continuous wound infusion, as demonstrated by in vitro, as well as in vivo experiments on rats. The product can be either used on its own, under the form of an analgesic implant which can be placed in any type of surgical wound, or it can be applied on different sorts of medical implantable devices, to minimize postoperative pain.

 

Edouard Pélissier is a surgeon, fellow of the American College of Surgeons, Member of the National Academy of Surgery of France, Member of the New York Academy of Sciences.

 

Christine Millot is an engineer, specialized in characterization and micro-characterization of materials and biomaterials

 

Claude Roques-Carmes is Professor of physics of materials and biomaterials. He has created and managed the Laboratory of microanalysis of surfaces at ENSMM, from 1980 to 2006.

 

Serge Piranda is  an engineer, specialized in microtechniques. He has created in 1991 Statice sante certified ISO 13485.

 

Dr. Edouard Pelissier, Scientific Advisor, Statice Sante

 

 

 

 

 


 

 

 

Biomedical textiles in implantable medical devices

• The types of textile forming methods
• Mechanical and physical properties of textiles
• Medical devices leveraging biomedical textiles as an enabling technology
• Biomedical textile case studies
• The future of textiles in medical devices

 

This presentation will focus on the various methods to create biomedical textiles and the range of materials used to design in the unique physical and mechanical properties leveraged in medical devices. An overview highlights the wide range of textile structures including the order and orientation of polymeric and metallic filaments in a structure and how their distinct fabric geometries result in unique form and function capabilities to enable various design options. The versatility and variability of their properties and performance characteristics will also be discussed. Devices exist today that leverage biomedical textiles as a way of creating an effective repair of damaged or diseased tissue. Several examples will be cited. In addition, the presentation will address the potential for future medical devices that use a combination of resorbable and non-resorbable polymers, biologics and pharmaceuticals as a means of creating fibrous scaffolds and hybrid properties in a device.

 

Jeffrey M. Koslosky, Director of Technology & Product Development, Secant Medical LLC, USA

 

Jeffrey Koslosky joined parent organization, Prodesco, Inc., in June of 2000 as a Quality Engineer after originally working with the company for nine months as an intern.  Koslosky assumed the role of R&D Engineer in September 2002.  He also subsequently served as Senior R&D Engineer and R&D Manager.  Koslosky assumed the role of Director of Research and Development in November 2005 with responsibility for leading the technical aspect of corporate new business development activities.
Koslosky assumed the role of Director of Technology and Product Development following a corporate restructuring in September 2009.  In this role, he heads a team of engineers and technicians that works with the company’s clients to design and develop novel textile structures for their specific end applications.  His previous experience includes an engineering internship with Bally Ribbon Mills.  Koslosky holds a Bachelor of Science degree in Textile Engineering from Philadelphia University with a concentration in Biomaterials.

 

 

 


 

 

 

Bioceramics as Drug Carriers for Controlled-Release Technology

Current practice is nowhere near ideal: drug admission and effectiveness of drug in action are not well controlled.  New controlled release technology has been heavily investigated but the market predominantly consists of polymeric materials.  However, there are certain drawbacks of polymers, such as instability of physical structure and the fact that they are not controllable at nanometre scales. This presentation will cover how these issues can be addressed with alternative drug controlled release vehicles: bioceramics.  Superior characteristics of ceramics to polymers are biocompatibility, stability and, in particular, well controlled nano structure. Potential applications for targeting and long life drugs will also be discussed in the presentation.

 

Dr. Xiang Zhang, Principal Consultant, Medical Materials/Devices, CERAM

 

A materials scientist, Xiang undertook his PhD and postdoctoral research at Cranfield University where he studied micro-mechanics and micro-fracture mechanics of toughening plastics.
After spending a further four years on polymer research for industrial applications, Xiang was awarded an industrial fellowship at the University of Cambridge in 1995 to carry on research on nano and micro fracture mechanics of gamma-ray-irradiated polymers.
Xiang's industry experience was gained at Medisense, Abbott Laboratories, where, as Principal Scientist, his work covered almost all aspects of medical materials/devices from R&D and manufacturing support to failure analysis and QC. Prior to joining CERAM, Xiang worked as Director of Cambridge NanoTech, in the field of nano conductive materials and diagnostic medical devices. 
At CERAM, Xiang heads up the Medical Materials Division, leading innovative projects on bioceramics for orthopaedic applications and controlled release and transdermal drug delivery systems.

 

 

 


 

 

 

Peritoneal implants with controlled release of therapeutic molecules

Guillaume VERMET1,2, Nicolas BLANCHEMAIN3, Stéphanie DEGOUTIN1, Gilles SOLECKI2, Valery DALLE2, Bernard MARTEL1 & H. Frederic HILDEBRAND3.
1 - Université Lille Nord de France, USTL, UMR 8207 "Unité Matériaux et Transformations (UMET)" Equipe Ingénierie des Systèmes Polymères F-59655 VILLENEUVE D'ASCQ, France
2 - COUSIN BIOTECH, Allée des Roses, F-59117 WERVICQ-SUD, France
3 - Université Lille Nord de France, UDSL, INSERM U1008 "Médicaments et Biomatériaux à Libération Contrôlée", Faculté de Médecine, F-59045 LILLE, France
Hernia repair is the 2nd most practiced surgical intervention all medical disciplines confused.  The aim of the present project was the elaboration of visceral implants with a prolonged release of bioactive molecules.  The PET textile implants were functionalised with cyclodextrin (CD) acting as a host molecule, and a polycarboxylic acid used as crosslinking agent.  The mechanical and chemical properties of the textile were not altered.  The coating of PET fibres with the CD polymer was controlled by the settings of the duration and temperature applied in the thermofixation step and by the adjustment of the CD and cross-linking agent concentrations in the initial impregnating bath.
The therapeutical activation was realised by impregnation of the functionalised textile in solutions containing antibiotic or analgesic agents, which were adsorbed through inclusion complexation into the immobilized CDs cavities on the one hand, and through ionic bonding with the carboxylate residues issued from the cross-linking agent on the other hand.  The release assays and microbiological tests have shown a significantly sustained liberation of antibiotic agents and persistence of bacteriostatic/bactericidal effects on Escherichia coli (gram -) and Staphylococcus aureus (gram +).

 

Dr. Nicolas Blanchemain, Assistant professor, Biomaterial Research Unity, Inserm Lille

 

Nicolas BLANCHEMAIN was born in Lille in 1978.
After his Engineer Diploma of Polytech’Lille, he integrated the Biomaterials Research Group (GRB), now INSERM Research Unit U 1008 “Medicaments and Biomaterials for controlled release”, where hegot his Master (2002) and PhD (2005) of Macromolecular and Organic Chemistry, and later obtained the Habilitation to Research Directory (2008) at the Lille-1 University of Science and Technology. Since 2009, he is Assistant Professor at the Lille-2 University of Law and Health.
His original main field is Material Science - Polymers. During his PhD training he got a complementary education in Biocompatibility and Biochemistry, so that he covers today the multidisciplinary fields of competence in the functionalization, activation, and nanostructuration of material surfaces for medical devices, in drug delivery systems, and in biological and clinical responses to medical devices.
In his short carrier, his results lead to 4 patents with industrial transfer, 35 scientific publications and more than 100 communications, conferences and invited lectures. With his contribution, the GRB got in 2009 the national award of innovation by Oseo.

 

 

 

 


 

 

 

Cost-effective nano-coating protection of medical devices (protein resistance, anti-microbial)

Modern consumer and industrial products are manufactured from a wide range of materials that are selected for specific bulk properties, cost effectiveness and/or look and feel.  However, many of the manufacturing materials chosen in this way, for sectors such as life sciences/medical devices, electronics, lifestyle, energy and filtration, do not display the optimum surface properties.  This presents a vast opportunity for surface modifications to display desirable properties such as protein resistance, anti-microbial and, water and oil repellency. It is critical that these modifications do not alter the bulk properties of the product, in order to retain desirable physical attributes. Additionally, the modification should be ultra-thin and well adhered.
A novel, patented liquid-repellent technology, by P2i, can readily apply functional nano-coatings onto the surface of a wide variety of products made from a diverse range of materials.  The liquid repellent coating is 3x more repellent than PTFE.  It optimizes the surface properties to maximise liquid repellency and, protects items to liquid ingress and reduces the potential for cross-contamination.  Overall it protects products for extended use, adding considerable value to the product in question both as a suitable differentiator and/or a cost saver. 
The process uses a pulsed plasma deposition process at low pressures and, importantly, this allows coating of complete 3D products/end devices.  This technology is fully industrialised and delivers cost-effective processes with high reliability and repeatability, ease of use and low maintenance, and the ability to operate in a range of countries and environments.  Today it is used in a number of market sectors, including medical electronic devices.

 

Dr. Delwyn Evans, Principal Chemist, P2i

 

After over four years at P2i, he is currently their Principal Chemist.  This involves developing new and innovative solutions for surface modification from concept to commercialisation. 
Previously he’s worked on glucose biosensor products (Abbott Diagnostics), novel materials for the electronics industry (Cookson) and anti-biotic biosynthesis (University of Leeds/Glaxo).  He gained his qualifications in Chemistry at the University of York.

 

 

 

 

 

 

 

 

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