BIOMEDevice

Frank Richter, Head of Quality & Risk Management for Medical Devices, Sanofi-Aventis Deutschland GmbH

Mr. Frank Richter is Head of Quality and Risk Management in Global Medical Devices at sanofi-aventis. He holds a Qualified Engineer degree from the Technical University Munich. Starting at in 1995 at Hoffman-La Roche AG in Switzerland as a scientist in the R&D biotechnology department he moved to the position as GMP officer and assistant to the Head of Sterile and Dermal Manufacturing and Development. In 1998 he joined Novartis Pharma AG in Technical Research and Development as a Quality Compliance Manager and later as Head of Audits, Pre-approval Inspections and Training. In 2001 he joined Aventis as a global auditor reporting to the associate vice president, Global Quality Audit and moved in 2006 to the sanofi-aventis Medical Devices Manufacturing Site as Head of Risk Management for marketed devices and devices under development. Frank hosted successfully more than 25 national and international authority inspections for drug substances, drug products, biotech products and devices.

Prof. Dr. Markus Veit, CEO, i.DRAS GmbH

Prof. Veit is pharmacist. Since more than ten years he works in the field of regulatory affairs of medicinal products and medical devices. In recent years he has additionally focussed on regulatory affairs for drug device combination products and has successfully supervised the consultation procedures in different projects on drug device combination products. Prof. Veit is Scientific Director of the German Pharmaceutical Manufactures Research Association and Chair of the Scientific Expert Committee Herbal Medicinal Products, German Pharmaceutical Manufacturers Research Association. Additionally he is member in:

- German Pharmacopeia: Expert committee Pharmaceutical Chemistry
- German Pharmaceutical Manufacturers Association, Expert committee on analytics and hygiene
- German Pharmaceutical Manufacturers Association, Expert committee on validation
- Society of medicinal plant research, Expert committee on clinical studies

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.

- Molecular trends influencing the market for self-injection devices
- Diabetes trends as key driver
- Platform demands for multidose and monodose devices
- Market outlook and summary

Ian Thompson, Head of Business Development, Delivery Systems, Ypsomed AG

Ian Thompson has been with Ypsomed AG since 1995 working with pharma companies to develop and bring to market innovative self-injection systems.
He studied biochemistry and biotechnology and has worked mainly in the area selling and marketing technical products, and since 1990 in the field of medical devices.

Early transdermal products were focused on passive delivery of low dose, lipid soluble, small molecules. A commercially successful technology, even today, but limited to delivery of drugs with those certain characteristics. Further development of transdermal delivery technology includes chemical enhancement, microneedles and the addition of active systems such as iontophoresis. To date, bringing products to market that meet the challenges of transdermal delivery of biologics in a commercially viable way, has not been met. However, technology improvements including bypassing the stratum corneum via ablation are in development. Utilizing radio frequency, lasers and batteries, microchannels are created in the skin that allow for the delivery of larger water soluble compounds in varying doses. These latest generations of transdermal delivery technologies and related products are currently in clinical development. A leading technology, the Altea Therapeutics PassPort® Transdermal System is a transdermal technology that offers a safer, painless, and convenient way to deliver a wide range of currently injected biologics via the skin. The technology has the potential to increase drug effectiveness by enhancing drug safety and patient convenience as compared to injections. This presentation will provide the audience with a brief overview of passive and active transdermal technologies and a detailed view of the more recent advances in the transdermal delivery of biologics including how it works and compares.

Steven P. Damon, Senior Vice President, Business Development, Altea Therapeutics

Steven Damon is the Senior Vice President of Business Development for Altea Therapeutics in Atlanta, Georgia. At Altea, his leadership responsibilities include product licensing, strategic planning, product portfolio development and intellectual property management. Steve has over 25 years of experience with various business roles in the medical and pharmaceutical industries. His experience includes business development, commercial development and mergers and acquisitions. Prior to joining Altea Therapeutics, Steven Damon was at Durect Corporation, Cupertino, Ca, where, as Executive Director, he completed several product partnership agreements with major pharmaceutical companies, was responsible for the Alzet drug delivery pump animal research business, and was founder and President of a wholly owned subsidiary - Absorbable Polymers International. He was previously Executive Director at Kimberly-Clark Professional Healthcare, Roswell, Ga, with lead responsibilities for commercial development of the healthcare business in Europe and key responsibilities for a number of major acquisition deals.

This presentation will start with an introduction to the problems of drug delivery to the brain and the spinal cord as a cause of failure of CNS therapeutics. Drugs may be administered systemically with ligands that bind to receptors on CNS lesions. Some strategies to cross the blood brain barrier (BBB) will be described with an example of use of nanoparticles for targeted drug delivery to the brain across the BBB. Special preparation of drugs used for neurologic disorders can provide controlled and improved delivery to the site of action. Various devices including catheters and pumps are used to deliver the drugs directly to the brain substance or into the cerebrospinal fluid (CSF) in the ventricles of the brain. Intrathecal drug delivery involves introduction of the drugs directly into the CSF around the spinal cord. Besides drugs, strategies for delivery of biological therapies such as cell and gene therapies will also be described.

Prof. K.K. Jain M. D, CEO, Jain PharmaBiotech

Professor K. K. Jain is a physician trained in neurology/neurosurgery with specialist qualifications. He worked for 25 years in various academic positions, research and private practice worldwide mostly in Canada and the US. His research in the pre-biotechnology era was most on development of biomedical devices for surgery, mostly lasers and operating microscopes. He has been involved in pharmaceutical industry and biotechnology since 1989 and is currently CEO of Jain PharmaBiotech, Basel, Switzerland. He was elected a fellow of the Faculty of Pharmaceutical Medicine of the Royal Colleges of UK in 2000. He is the author of 425 publications including 17 books (2 as editor) and 49 special reports on biopharmaceutical topics including molecular diagnostics, biochips, gene therapy, cell therapy, RNA interference, neuroprotection and drug delivery. Prof. Jain has been interested in integrating various biotechnologies to develop personalized medicine since 1998 when he wrote the first monograph on this topic. He is the author of "Textbook of Personalized Medicine (Springer 2009) and "Handbook of Biomarkers" (Springer 2010), and Handbook of Neuroprotection (Springer 2011). In addition, he edited two books relevant to drug delivery: Drug Delivery Systems (Springer 2008) and Drug Delivery to the Central Nervous system (Springer 2010).

Combination of diagnostics and therapeutics is an important part of personalized medicine. Companion diagnostics help in the selection of effective and safe drugs best suited for an individual patient. Example of these will be given for cancer management. Biomarkers can be important common denominators of diagnostics and therapeutics. Nanobiotechnology plays an important role in this area and nanoparticles used for diagnosis can also be used as tools for delivery of therapeutics. Molecular diagnostics can be used for stratification of patients in clinical trials, which can guide in differentiating responders from non-responders to a therapy and selecting patients for treatment. Finally advantages and drawbacks of parallel development of diagnostics and therapeutics will be discussed along with regulatory issues.

Prof. K.K. Jain M. D, CEO, Jain PharmaBiotech

Professor K. K. Jain is a physician trained in neurology/neurosurgery with specialist qualifications. He worked for 25 years in various academic positions, research and private practice worldwide mostly in Canada and the US. His research in the pre-biotechnology era was most on development of biomedical devices for surgery, mostly lasers and operating microscopes. He has been involved in pharmaceutical industry and biotechnology since 1989 and is currently CEO of Jain PharmaBiotech, Basel, Switzerland. He was elected a fellow of the Faculty of Pharmaceutical Medicine of the Royal Colleges of UK in 2000. He is the author of 425 publications including 17 books (2 as editor) and 49 special reports on biopharmaceutical topics including molecular diagnostics, biochips, gene therapy, cell therapy, RNA interference, neuroprotection and drug delivery. Prof. Jain has been interested in integrating various biotechnologies to develop personalized medicine since 1998 when he wrote the first monograph on this topic. He is the author of "Textbook of Personalized Medicine (Springer 2009) and "Handbook of Biomarkers" (Springer 2010), and Handbook of Neuroprotection (Springer 2011). In addition, he edited two books relevant to drug delivery: Drug Delivery Systems (Springer 2008) and Drug Delivery to the Central Nervous system (Springer 2010).