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The European Summit for Clinical Nanomedicine and Targeted Medicine – The Translati on to Knowledge Based Medicine
Eighth Conference and Exhibiti on, June 28 – July 1, 2015
Co-funded by the Swiss Confederati on, Swiss Department of Economic Aff airs, Educati on and Research
In Collaborati on with:
EXHIBITORS PROFILES 2015& Amendments to Proceedings (late incoming Files)
Exibitors:
Conference Venue: Congress Center, Messeplatz 21, 4058 Basel, Switzerland, Phone + 41 58 206 28 28, [email protected] Organizers Offi ce: CLINAM-Foundati on, Alemannengasse 12, P.B. 4016 Basel Phone +41 61 695 93 95, [email protected]
European Society for Nanomedicine
ESNAM
The European Summit for Clinical Nanomedicine and Targeted Medicine – The Translati on to Knowledge Based Medicine
Eighth Conference and Exhibiti on, June 28 – July 1, 2015
Co-funded by the Swiss Confederati on, Swiss Department of Economic Aff airs, Educati on and Research
In Collaborati on with:
EXHIBITORS PROFILES 2015& Amendments to Proceedings (late incoming Files)
Exibitors:
Conference Venue: Congress Center, Messeplatz 21, 4058 Basel, Switzerland, Phone + 41 58 206 28 28, [email protected] Organizers Offi ce: CLINAM-Foundati on, Alemannengasse 12, P.B. 4016 Basel Phone +41 61 695 93 95, [email protected]
European Society for Nanomedicine
ESNAM
Contents
EXHIBITORS PROFILES 2015 AMPHORA _____________________________________________ 3Beckman Coulter ________________________________________ 4CytoViva _______________________________________________ 5De Gruyter _____________________________________________ 6EVA ___________________________________________________ 7i-net and EURESEARCH ____________________________________ 8InnoMedica _____________________________________________ 9Izon Science ___________________________________________ 10Lipoid ________________________________________________ 11Malvern Instruments ____________________________________ 12NanoAssemblr _________________________________________ 13Nanosurf ______________________________________________ 14NUOMEDIS ____________________________________________ 15Particle Metrix _________________________________________ 16Polymun Scientific ______________________________________ 17Schaefer-Tec ___________________________________________ 18SeroScience ___________________________________________ 19TECOmedical ___________________________________________ 20
AMENDMENTS TO PROCEEDINGS (late incoming Files) Session 17: Pushing the Limits in Novel Medicine – Gene Transfer,
Cells, Targeting, MaterialsDr. Matthias Reumann (CV in Main Proceedings) ____21
Session 23: Phe Regulation Environment in Nanomedicine and Targeted Medicine – We Must Come to TermsDr. med. Paul Orhii (for FDA Africa) ________________21 Prof. Dr. Guanjun Nie (replaces Prof. Dr. Yuliang Zhao) 21 Dr. Fatiha Sadallah _____________________________ 27
Session 27: Routes through the Body and the Cell: Pharmacokinetics and Intracellular Trafficking of NanocarrDr. Gesine Heuck (replaces Dr. Euan Ramsay) _______21
Session 30: Ethics: Value of Patient Involvement in the Personalized Treatment with Nanomedicine Dr. Jytte Lyngvig (New Co-Chair) _________________22Dr. Detlev Niese (CV in Main Proceedings) __________22
Session 32: Platform in Nanomedicine – The European Pathway of Nanomedicine Dr. David Bott ________________________________22Dr. Laurent Lévy ______________________________22Felix Michnacs ________________________________22Vivienne Williams, MSc. ________________________23
Poster Sessions:Dr. med. María Antonieta Annunziato _____________23Prof. Dr. med. Kenneth Ofokansi _________________25Julie Ruff, MSc. _______________________________27
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M IM
odulation nterference icroscopy
Features and advantages:
Modulation interference microscopy (MIM) technology is based on the
measurement of local topological phases of lightwave modulated by the object. MIM
device is a new versatile researching tool for 3D nanomeasuring. MIM consists of
navigation channel, and interference channel for phase images acquisitions.
Super high spatial resolution
- 10-100 nm - lateral
High operation speed up to 200 frames per seconds
No vacuum, no fluorescent markers
Nano-dynamics of sample structure
AMPHORABest in opticalmicroscopy
- 0.1 nm - vertical
MIM application - Biotechnology: in-vivo cell investigation, cell dynamics analysis (membrane and
intracellular processes);
- Pharmacology: real-time medicine screening;- Cell therapy: real-time diagnostics.
Material science:
Cancer cell morphologyLight microscopy
image
5 mm
Gradient MIMimage
3D MIM image
A new method for cancer diagnostics and anti-cancer medicine screening!
MIM image
100
200
0
5 mm5 mm
Discocyte Spherocyte
Stomacytes
Human RBC real-time analysis
Lymphocytes
intracellular organelles allocation
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Cell nano-dynamics - unique MIM feature
Wavelet portrait
Wavelet portrait
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BioMed: unlimited field of unique applications
Shvabe-Zurich GmbH, Talacker 42, CH-8001, Zurich, SwitzerlandTel./Fax: +41 43 321 63 54/55, E-mail: [email protected]
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PARTICLE CHARACTERIZATIONParticle Characterization uses the Coulter Principle (electrical sensing zonemethod), enhanced laser diffraction, polarization intensity differential scattering, photon correlation spectroscopy (PCS) and electrophoretic light scatte-ring, providing answers and solutions for those involved in the testing and measurement of the physical properties of particles. Besides offering a blend of innovative instruments, Beckman Coulter is dedicated to providing researchers, scientists and engineers in numerous industries with valuable information.
This powerful tool allows particle size, aspect ratio, and aggregation analysis of a wide variety of particles ranging in size from the molecular scale to a few microns in dia-meter. Regarded as a fundamental tool in the field of protein science, this robust andelegant system is finding new acceptance in the world of particle characterization.With multiple optical detection systems, extremely high sensitivity, and the ability to measure particles in native buffer conditions with unparalleled resolution, the analy-tical ultracentrifuge is quickly becoming a “go to” technique for materials scientists.
The DelsaMax Series represents the next generation of zeta potential and submicronparticle size instrumentation.With applications in biology, industrial materials, and nanotechnology, these instru-ments offer the most accurate, sensitive, and rapid answer to the toughest sizing and stability challenges.
The Multisizer 4e COULTER COUNTER is one of the most versatile and accurate particle sizing and counting analyzers, with an overall sizing range of 0.2 μm to 1,600 μm. Using the Coulter principle (electrical sensing zone method), the Multisizer 4e provides number, volume, mass and surface area size distributions in one measurement. A digi-tal pulse processor even allows real-time dynamic size measurements over the length of the analysis. Its high resolution and accuracy make the Multisizer 4e an ideal tool in R & D for both industrial and biological applications.
The LS 13 320 Series is one of the most versatile and sophisticated laser diffraction particle size analyzers available. Designed from conception to be fully compliant to ISO13320-1 (the ISO standard covering particle sizing by the laser diffraction method),the LS 13 320 Series combines up to four wavelengths of light, polarization intensity differential scattering (PIDS), and many powerful sample dispersion features to offer high resolution, reproducibility and accuracy in a size range from 0.017 μm to 2000 μm. Its FDA 21 CFR Part 11 compliance software and sample handling capability make the system easy to use and highly secure.
COMPANY PROFILE
Beckman Coulter GmbHEuropark Fichtenhain B 13, 47807 Krefeld, Telefon +49 2151 333-5, Fax +49 2151 333-639www.particle.com
Analytical Ultracentrifugation
DelsaMax SeriesNano Analysis
Multisizer 4eCOULTER COUNTER
LS 13 320 SeriesLaser Diffraction
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Label free bio-molecule, exosome and nanoparticle determination
The CytoViva Hyperspectral Microscope System allows researchers to spectrally confirm and spatially determine the location of drugs in cells without the use of a fluorophore.
Figure 1 Figure 2 Liposomal Drug spectra
In this experiment, a prostate cancer specific peptide is added to a doxorubicin loaded liposome. With the CytoViva Hyperspectral Microscope System, the researcher is able to create a reference spectral library unique to the liposomal drug. The reference spectral library can then be compared to an unknown sample. Figure 1 shows a tumor cell that has been incubated with the liposome construct. The red in Figure 2 confirms the presence and location of liposomal construct within the tumor cell.
CytoViva Hyperspectral Imaging System Patented Enhanced Darkfield Optical Microscope System with Hyperspectral Analysis
CytoViva is distributed in Europe by the Schaefer-Tec group. (www.schaefer-tec.com)
[email protected], Martin Bossard, CH-3422 Kirchberg www.cytoviva.com
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We are looking forward to giving you support! www.basel-inkubator.ch www.eva-basel.ch Hochbergerstrasse 60 c +41 61 633 30 10 +41 61 283 84 85 4057 Basel
THE ROAD TO SUCCESS
BASEL INKUBATOR is a joint initiative of the University of Basel, the University of Applied Sciences of Northwestern Switzer-land FHNW, ErfindungsVerwertung AG EVA and the canton Basel-Stadt. Spin out of the universities of the region with high-tech products in the area of natural sciences, medicine, information technology or engineering technology find affordable infrastructure and competent coaching to make their first steps in creating their start-up. As long as there is room available, BASEL INKBATOR is open for start-ups of other origin too.
EVA – the Basel start-up agency (ErfindungsVerwertung AG) is a limited company with Basler Kantonalbank BKB and Basellandschaftliche Kantonalbank BLKB as the major shareholders. It was founded in 1996 by these institutions and three innovative entrepreneurs in order to promote Life-Sciences start-up companies in Northwestern Switzerland. It offers coaching, access to a top level network, and seed financing to companies domiciled in the area. The current portfolio comprises 10 companies in drug development, diagnostics, and MedTech. Additional four companies qualified to be financed and will close their financing round soon. The portfolio of projects in an early stage consists of about 10 to 20 potential start-up companies.
The Basel life-sciences start-up agency
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i-net innovation networks The mission of i-net innovation networks switzerland is to
promote innovation in Northwestern Switzerland.
As a public private partnership between the cantons of Baselland,
Basel-Stadt, Jura and leading companies from the region, i-net supports companies in the technology fields
of ICT, Life Sciences, Medtech, Cleantech and Nanotechnology.
i-net offers companies and innovating entrepreneurs free advisory services and a wide range of
opportunities to network and foster knowledge and technology transfer. With about 60 events per year i-
net addresses a network of over 7000 people—from start-ups to global companies.
www.i-net.ch
Euresearch
Euresearch is the Swiss network mandated by the State Secretariat for Education, Research and Innovation
providing targeted information, hands-on advice and transnational partnering related to European research
and innovation programmes.
The network is composed of a Head Office in Bern as well as Regional Offices and Contact Points at the
universities, the Federal Institutes of Technology and the Universities of Applied Sciences.
www.euresearch.ch
WE INFORM
WE ADVISE
WE CONNECT
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InnoMedica Holding AG, Zug
InnoMedica Holding AG · Gesellschaftsstrasse 16 · CH - 3012 Bern www.innomedica.com
Summary Company Name: InnoMedica Holding AG Address: Gesellschaftsstrasse 16, 3012 Bern, Switzerland Phone: +41 (0)31 311 04 27 Email: [email protected] Website: www.innomedica.com
Ownership: Privately held company Type of shares: Bearer shares Shares outstanding: 1.121 million, CHF 1.00 per share Listing: SIX Swiss Exchange ISIN: CH0011082366 Trading: electronically, OTC Previous capital increases: Spring 2013: 54,100 shares at CHF 11.50 Spring 2014: 45,900 shares at CHF 14.50 (30% oversubscribed) Spring 2015: 21,000 shares at CHF 57.50
Company InnoMedica is a Swiss biotech startup company based in Bern (management, administration), Marly (production), Zug (headquarters) and Ibaraki (Japan; YAMAZAKI-DDS Co., Ltd.). In January 2013, InnoMedica initiated the project Targeted Liposomal Doxorubicin (TLD-1, Talidox) and started operating as an independent pharmaceutical company. Originally established in 2000, InnoMedica was a private equity company focused on investments in the fields of biochemistry and medicine. The vast experience in the Life Science sector combined with broad expertise in capital markets are an optimal foundation for the successful development of the product pipeline.
Product Pipeline Technology and Product: With Talidox (Targeted liposomal Doxorubicin) InnoMedica introduces an innovative platform technology based on an active targeting mechanism for the tissue specific delivery of a widely used anticancer drug (Doxorubicin). The liposome-based drug delivery system comprises the encapsulation of the active cytostatic agent Doxorubicin into an unilamellar liposomal particle which is actively directed to the sites of cancer. Talidox’ concept of active site specific targeting of Doxorubicin after intravenous administration is based on the coating of the liposomal particle with a natural glycan ligand able to recognize specific receptors that are overexpressed both in the cancer and cancer related inflammation.
The pivotal innovation of Talidox’ drug delivery relies on the nanotherapeutic refinement of current state of the art chemotherapy, intending to promote enhanced local distribution in the tumor tissue as well as to reduce the dose needed to achieve enhanced treatment efficacy. Cancer patients are expected to benefit from better chances of recovery along with reduction of adverse reactions leading to an increased quality of life during therapy.
The start of the phase I/II clinical study of Talidox is scheduled to take place in Q4 2015 in cooperation with the Swiss Group for Clinical Cancer Research.
The picture below graphically illustrates InnoMedica’s drug delivery system.
Research and development: As a subcontractor to pharmaceutical companies - we can encapsulate active pharmaceutical ingredients into liposomal particles and actively direct them to specific sites of diseases when inflammatory markers are present. Currently InnoMedica’s research activities are performed in collaboration with the John A. Burns School of Medicine (University of Hawaii), the Theodor Kocher Institute (University of Bern) and the Mario Negri Institute in Milan. Research activities are focused on the functionality and characterization of the new drug delivery system in general and Talidox in particular. InnoMedica’s technology serves as a development platform for the treatment of various kinds of cancer, even multi resistant tumors. Later, the product pipeline can be extended applying the same technology encapsulating other active agents to address inflammatory diseases or diseases with inflammation-specific symptoms like arteriosclerosis, multiple sclerosis etc.
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IZON SCIENCE LIMITED [email protected] www.izon.com
Izon Science provides instrumentation for accurate particle-by-particle measurement of concentration, size and charge of 40nm to 20 micron sized particles. The measurement principle used is Tunable Resistive Pulse Sensing (TRPS). Unlike light scattering methods, TRPS produces the necessary resolution, accurate and reproducible results for medical grade analysis. Measurement is in absolute (SI) units not arbitrary numbers. Reliable data of the highest quality from TRPS allows researchers to meet strict measurement and QA requirements of the medical world.
Particle by Particle measurement with TRPS: When a particle enters the pore it blocks a proportion of the ions flowing through the pore – this causes a pulse in the ionic current the magnitude and duration of the pulse is proportional to the particle size and velocity, respectively. The pulse of every particle passing through is directly compared with the pulse of a traceable calibrated standard. TRPS is recognized as the most accurate technology for the simultaneous characterisation of size, concentration and charge properties of nanoparticles by a wide range of organisations including academic, research institutions and scientific companies. Particle types measured with TRPS include: lipsomes, polymeric drug delivery PLGA lipid, micelles, red blood cells and blood platelets. TRPS enables accurate measurements and provides several benefits to users:
Calibrated method ensures validation of data and repeatability Long term stability of particle solution can be better understood with precise measurement of aggregation Accurate measurements of size and charge facilitate in distinguishing different particle solutions
The chart on the left displays measurement of a known trimodal mixture of standard particles by DLS, TRPS, PTA and DCS. Of the 4 techniques, only TRPS was able to resolve the 3 particulate systems in the mixture. In addition, only TRPS can directly measure particle concentration for each distribution. (Image reference: Journal of Colloid and Interface Science, Will Anderson, Darby Kozak, Victoria A. Coleman, Åsa K. Jämting, Matt Trau).
Find out more about the qNano Gold instrument upgrade based on TRPS technology for accurate size, concentration and surface charge measurement and analysis: www.izon.com
Figure 1: Size specific concentration with TRPS
Figure 2: TRPS size analysis for liposome synthesis
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GMP Phospholipids
Egg and Soybean Phospholipids
Hydrogenated Phospholipids
Monoacyl Phospholipids
Synthetic Phospholipids
PEGylated Phospholipids
Delivery Systems
Ready for Use Lipid Mixes
Purified Oils and Fatty Acids
Phospholipid Reference Standards
Your Partner from Research up to the Approved Drug
Founded in 1977, Lipoid has gained an outstanding reputation in the development and industrial
production of high quality lecithin and phospholipids for the pharmaceutical industry. Today, we are
the only company worldwide offering the whole range of natural and synthetic phospholipids in
industrial scale. Environmental protection and sustainability determines our strategy within all phases
of the value chain. This long-standing expertise, in combination with the exceptional quality of our
products, enables our customers to develop and market innovative products for the benefit of the
general public.
Contact Germany Headquarters and Manufacturing
Lipoid GmbH
Frigenstrasse 4
D-67065 Ludwigshafen
Phone + 49 (0) 621 538 190
Contact Worldwide
Lipoid AG
Sennweidstrasse 44
CH-6312 Steinhausen
Phone + 41 (0) 41 741 740 8
www.lipoid.com
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Biopharmaceutical Solutions - from Malvern Instruments
Malvern Instruments GmbH | Rigipsstr. 19 | 71083 Herrenberg | Tel +49 (0) 7032 97770 | Fax: +49 (0) 7032 77854 | Web http://www.malvern.com
Particle Characterization: NanoSight (NTA) Visualize and measure nanoparticle size / protein size and concentration; quantify early aggregation in bio formulations. High resolution distribution data:
Graph of a sample with peaks at 100 nm, 200 nm, 400 nm and 600nm Archimedes (RMM) uses the technique of resonant mass measurement to detect and accurately count particles in the size range 50nm - 5µm, and reliably measure their buoyant mass, dry mass and size. Particularly useful for the characterization of protein aggregates in formulation or buffer.
Morphologi G3-ID provides a unique capability, combining automated static imaging features of the Morphologi G3 with chemical identification of individual particles using Raman spectroscopy to enable the measurement of component specific particle size and particle shape distributions.
Mastersizer 3000 Smarter Laser Diffraction Particle Sizing. The Mastersizer 3000 is the latest generation of the world’s most popular particle sizing instrument.
NEW: Zetasizer Helix The system retains all of the functionality of the Zetasizer Nano ZSP and adds Raman spectroscopy to determine secondary and tertiary structure of proteins and protein-based biotherapeutics
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Microfluidics-based development and manufacture of liposomes and nanoparticles for drug delivery applications
Traditional methods for producing lipid nanoparticles (LNP) are inconsistent, difficult to scale, and labor-intensive. Here, we describe the NanoAssemblr™ platform: a scalable, microfluidics-based system for the development and manufacture of liposomes and nanoparticles for drug delivery applications. The NanoAssemblr™ uses automated instrumentation and custom engineered microfluidic chips to formulate nanoparticles and liposomes by nanoprecipitation using millisecond mixing of nanoliter reaction volumes.
This well-controlled process mediates bottom-up self-assembly of nanoparticles with reproducible sizes and low polydispersity. At the same time it is easily scaled by parallelizing microfluidic mixers, which maintains identical reaction conditions for batch sizes from milliliters to liters. Individual microfluidic mixers are capable of producing LNP at 1-24 mL/min. The NanoAssemblr™ Benchtop Instrument is capable of formulating 1-20 mL, which is ideal for low-cost formulation and process development. Implementing a continuous flow pumping system allows for siRNA-LNP batch sizes in the 25-500 mL range for pre-clinical studies. Incorporating multiple mixers into a single microfluidic chip increases the throughput while maintaining identical reaction conditions. This technique allows for massive parallelization to achieve production scales from milliliters to liters.
NanoAssemblr System with microfluidic chip
NanoAssemblr is distributed in Europe by the Schaefer-Tec group. (www.schaefer-tec.com)
[email protected], Martin Bossard, CH-3422 Kirchberg www.nanoassemblr.com
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Flex-ANA: Automated Nanomechanical Analysis
swiss qualitywww.nanosurf.com
Nanosurf®
Typical Setup. Digital cameras, a video and afm parking station, active vibration isolation, and an acoustic enclosure are all included with the system.
Real-time data acquisition and analysis.
User interface. Touchscreen spot selection.
Based on the popular Nanosurf FlexAFM, this fully automated system was developed specifically for the nanomechanical analysis of large, uneven, or rough surfaces, such as found in biomaterials and tissues. An integrated 100-µm Z-stage with position sensor allows highly accurate force measurements.
System features
� Real-time automated measurement, evaluation and analysis of data
� Large X-, Y-, and Z-range to meet varying sample dimensions
� A unique proprietary algorithm that conforms to sample surface undulations outside of the AFM’s Z-range during measurements
� Fully integrated, automated atomic force microscope with user-friendly touchscreen software interface
Applications
Automated material hardness/elasticity/adhesion measurements and force mapping of materials such as soft coatings, block-copolymers, tissue samples, cell matrix, tissue scaffolds, and biopsies for diagnostic research.
Automated stage specifications
Description Specification
Range (X / Y / Z / δz) 32 / 32 / 5 / 0.1mm
Positioning accuracy (X / Y / Z / δz) <1 / <1 / <1 / <0.001 µm
Sample Platform Size (X / Y) 35 / 35 mm
AFM specifications
Description Specification
Scan range (XY) 100 µm
Height range (Z)10 µm
(Additional 100 µm through δz option of the automated stage)
XY Linearity mean error < 0.1%
XY flatness at maximum range Typ. 5 nm
Z noise level (RMS dynamic mode in air): Typ. 30 pm in appropriate environment
Reference
Plodinec et al. 2012, Nature Nanotechnology 7, 757–765.
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In - Vitro Nanomechanical Cancer Diagnostics
Nano - fabricated 20nm fine tip of ARTIDIS® (Automated Reliable Tissue Diagnostics) probing a neoplastic lesion.
Detecting (breast) cancer’s fingerprints
Nuomedis is dedicated to uncover the mechanical profile of (breast) cancer at a nano-meter scale. For this reason ARTIDIS® has been developed. It uses a 20nm –fine tip to indent at several thousand locations across a biopsy and harvest its nanomechanical profile, meaning what are the specific mechanical properties of the tissue on a nano-meter scale. This gives an understanding of how stiff or sticky the tissue is and makes it possible to directly differentiate healthy, benign and malignant tissue. As seen in the figure below specific stiffness distributions are obtained when measuring on different tissue samples for different disease conditions. In parallel, distinctive nanomechanical stiffness profile across the tumor provide a prognostic indicator of tumor progression and aggressiveness.
By adding this new dimension to (breast) cancer diagnostics and prognostics nuomedis can achieve a higher quality of life for patients by preventing over – or under treatment.
Normal tissue Benign tumor Invasive cancer
HealthyUnimodal distributionwith peak stiffness from 1.13 to 1.83kPa
BenignUnimodal distributionwith stiffness valuesfrom 1.91 to 3.68kPa
CancerMultimodal distribu-tion with an initial peak at 0.31-0.75kPa, second peak at 1.54 – 1.99 kPa, third peak up to 20kPa
ARTIDIS® is a tissue analysis protocol that complements standard histology and other methods by its ability to simultaneously di-agnose and prognose disease development and optimize treatment outcome while minimizing side effects. ARTIDIS® compares very favorably with gene expression profiling, yet it is faster (hours versus days to weeks) and cost-effective.
nuomedis® nuomedis.com
centimeter scale nanometer scale
Nuomedis Team
Nuomedis AG was founded in 2014 as a result of a research collaboration between Nanosurf AG and the inventor team at Biozen-trum University of Basel starting in 2011. The executive management brings together over 30 years of business experience in the field of nanotechnology and scientific experience from renowned institutions to perform at its best.
nuomedis®
M. Plodinec, 2012. The Nanomechanical Signature of Breast Cancer. Nature Nanotechnology 104(2)
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Particle Metrix GmbH
Am Latumer See 11-13 � 40668 Meerbusch / Germany � Phone: +49 (0)2150/705679-0
[email protected] � www.particle-metrix.de
Exploring Nanoparticles with Particle Metrix Analyzers
Particle Metrix GmbH is a German based company producing colloid analyzers for efficient nanoparticle characterization. Stabino®, NANO-flex® and ZetaView® deliver comprehensive and robust answers for naturally occurring as well as human-generated nanoparticles.
ZetaView® - NTA Nanoparticle Tracking Analyzer
ZetaView® individual particle tracking visualizleass siccal micro-electrophoresis and Brownian motion, either in scattering or fluorescent mode. Sub-volume scanning generates statistically robust results in concentration, size, stability and fluorescent selectivity. Sample cell handling is reduced to a few handholds.
180° Backscattering NANO-flex® - Nanoparticle Size Distributions
The Particle Metrix NANO-flex® sizing instrument integrates a flexible measuring probe with 8 mm ø. Thus, it can be used in many ways, in-situ online and in the lab. Minimum is 1 droplet.
Stabino® - System for Analysis of Charge Characteristics
Charge titrations on macromolecular solutions and particle dispersions are made in Minutes. The measured particle interface potential reacts on pH, conductivity and polyelectr olyte surrounding. Compared to optical methods, it is robust, fast and can be applied to undiluted samples.
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Liposomal Formulation of DrugsLiposomes protect, transport and release your drug at the right place and time. By this, a reduced dose achieves better efficacy and avoids side effects with a non-invasive application. A liposomal formulation can clearly improve the therapeutic index of your drug.
ServiceS
■ Formulation Development
■Analytical Method Development
■ Process Development
■ GMP Production
■ Filling
■ Clinical & Regulatory Support
cLinicaL & reguLatory Support
■ IMPD / IND, IRB Submission
■ Pre-/Clinical Development Concepts
■ Organisation of Clinical Studies
■ Legal Representative
■ Requests for Scientific Advice
polymun Scientific immunbiologische Forschung gmbH, CEO: Dr. Dietmar Katinger, MBA www.polymun.comDonaustr. 99, 3400 Klosterneuburg, Austria, T +43-2243-25060-300, F +43-2243-25060-399, [email protected]
Polymun offers the development of liposomal formulations for all kinds of pharmaceutically active ingredients such as oligo-nucleo tides, small molecules and proteins as well as vaccine antigens. A broad spectrum of analytical methods has been established for this purpose. Polymun produces GMP material including all necessary docu mentation for IMPD/IND.
We assist in planning and implementation of clinical trials. Finally, license agreements are offered for the respective substance on an exclusive basis. Contracts can be arranged step by step - proof of concept, in-depth analysis, GMP production, product license - or all in one.
Main cHaracteriSticS oF our tecHnoLogy
FuLL ScaLabiLity
The injection module is the heart of the liposome production. The process parameters determine the size of the liposomes regardless of the scale. Production of 250 liters of liposome preparation takes only 1.5 hour. Large scale also can be achieved by using several injection modules in parallel.
aSeptic proceSS
A closed system is used for production. All components can be added via sterile filtration. Subsequent concentration by crossflow filtration is possible as well.
HoMogeneouS, uniForM veSicLeS
All process parameters are controlled precisely. This results in a very narrow size distribution, necessary for reliable targeting and transport characteristics.
SingLe Step proceSS
Liposome size is adjusted by modulating the process parameters during vesicle formation. No additional downsizing is required.
exceLLent batcH to batcH conSiStency
High quality of raw materials and precisely controlled process parameters guarantee excellent reproducibility – essential for pharmaceutical products.
MiLD proceDure – StabiLity
The crossflow injection technique is a very mild procedure that allows the processing of sensitive drugs. Together with the high quality of raw materials and narrow size distribution, we achieve long term stability of liposomes even at room temperature.
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The Schaefer-Tec group is a European distributor of scientific instruments for Nano- and Bio- Technology
Please contact your nearest office in: Germany, Poland, Switzerland, France, Italy, Romania
We represent the following products in Europe:
The CytoViva Hyperspectral System allows researchers to spectrally confirm and spatially determine the location of drugs and nanoparticles in cells without the use of a fluorophore. (www.cytoviva.com)
The NanoAssemblrTM platform exploits microfluidics for the rapid and controlled manufacture of nanomedicines (e.g. liposome nanoparticle based drugs). (www.nanoassemblr.com)
TRPS (Tunable Resistive Pulse Sensing) measures the main Nano-Particle parameters with very high accuracy and repeatability. Particle Size, Particle Concentration, Particle Charge (www.izon.com)
[email protected], Martin Bossard, CH-3422 Kirchberg www.schaefer-tec.com
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is a small/micro biotech enterprise (SME), spin-off company of Semmelweis University Medical School in Budapest, Hungary, founded in 2006 by medical scientists. It provides research services and regulatory testing for pharmaceutical companies in regards to the safety of drugs in R&D. Specifically, SRS utilizes state-of-art in vitro technologies and large and small animal models for assessing the potential of drug candidates (most importantly intravenous drugs, biologicals, nanomedicines and contrast media) to cause hypersensitivity (allergic, pseudoallergic or infusion) reactions and other adverse immune effects, including antibody production (immunogenicity).
Contact: [email protected] [email protected] Address: 1089 Budapest Nagyvárad tér 4, Hungary Tel: 36-30-415-0007 36-20-825-9690 Fax: 36-1-210-0100
SeroScience Ltd. has special expertise in the prediction of complement activation-related pseudoallergy (CARPA) that represents a major barrier to the clinical use of many nanomedicines and biologicals.
Complement activation assays in vitro in human/animal sera/plasma/whole blood
ELISA for human C3a, C5a, C4d, Bb, SC5b-9
ELISA for all animal C3 (PAN-C3) SRBC (CH50) hemolytic assay for all
animals ELISAs for serum/plasma TXB2, PAF,
histamine, leukotrienes, triptase in man and animals
FACS analysis of basophil activation ELISAs for anti-drug antibody (ADA)
measurements
Analysis of test drug-induced hemodynamic, hematological, laboratory and skin changes in pigs/minipigs/dogs/rats/mice (CARPA assays)
www.seroscience.com
SPECIAL SECTION ON CARPA IN THE
CLINAM ISSUE OF THE EUROPEAN J. NANOMEDICINE
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Company Name TECOmedical AG Address Gewerbestrasse 10 Postal Code/City 4450 / Sissach / Switzerland Telephone +41 61 985 81 00 Email [email protected] Website www.tecomedical.com Founded in 1984, the Swiss‐based TECOmedical Group and the subsidiaries in Germany, France, Austria and Benelux provide assays and services for (pre)clinical studies, biosafety and toxicology studies, medical research and in vitro diagnostics. We offer an extensive portfolio of specialty assays, assay systems and services to Pharma and Biotech companies, CROs, medical and research centers. Specialty assays for (pre‐)clinical studies, medical research, diagnostics and therapy control. bone/calcium/cartilage metabolism diabetes/obesity/metabolic syndrome liver disease & apoptosis drug‐induced liver & kidney injury complement system cardiovascular disease oxidative stress growth metabolism. Specialty assays and test systems for biosafety of medical devices, transplants, implants, pharmaceuticals and blood products Haemocompatability related to activation of the complement (C) system – Anaphylatoxins Complement C activation related to pseudoallergy (CARPA) Complement activation in animals (in vitro & in vivo) Cytotoxicity Specialty assays for toxicology Detection of drug induced liver injury (DILI) Detection of drug induced kidney injury (DIKI) Vitellogenin assay for endocrine disruption potential of chemical substances according to OECD for laboratory and
environmental use. This is the first Vitellogenin fish assay allowing non‐destructive, non‐invasive sampling from epidermal mucosa.
Custom Assay Development & Services Custom ELISA Assay development and Services are offered to organizations like Biotech companies, CROs, Pharma and Research institutions, requiring specialty assays and studies based on customer specifications. Host Cell Protein testing for recombinant protein pharmaceuticals Immunogenicity assays to test for Anti Drug Antibodies (ADA) High sensitive ELISAs Food safety assays Veterinary assays Environmental assays Assay Services include measurement of study samples, validation of new and existing assays, test adaption, pilot to medium size manufacturing of ELISA kits and assay components.
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CHALLENGES OF CLINICAL RESEARCH IN NANOMEDICINEDR. MaTThIas REuMaNN, (CV in Main Proceedings), Systems Biology, IBM Research – Zurich, [email protected]
The impact of supercomputing has been demonstrated in material science, chemistry, physics, life sciences and applications in health-care are now also emerging. Especially with the advent of big data and the opportunities of data science in healthcare, there is a dire need for innovative supercomputing to turn the volumes of data with high variety that is being produced at high speeds into action-able information and knowledge. For the data revolution to have an impact in improving health, supercomputing and cognitive com-puting will be essential to collect and perceive the data, to extract, understand and translate the information content in context of the situation so that medical professionals can take the right decisions leading to better informed actions and improved outcomes. For example, Genome Wide Association Studies have produced volumes of genetic data of single nucleotide polymorphisms (SNPs) to identify markers that are associated with a phenotypic trait, i.e. a certain disease. The statistical univariate analysis of a single in-dependent marker is computational feasible. However, complex disease are caused by gene – gene interactions and a multivari-ate analysis is required to discover the SNP pair or triplet that is the underlying cause for the disease. The exhaustive analysis of all data would take prohibitively long (up to hundreds of years) even on specialized hardware like GPUs. The result is that researchers only consider a small fraction of data in their analysis. The informa-tion in the rest of data is buried and untouched and arguably dead. Supercomputing enables us to alleviate the computational barrier and two-way interaction analysis on a state of the art GWAS data set can be carried out within minutes today. Also, three-way analy-sis is now feasible and within reach of tractable computation time. While this shows how supercomputing can overcome computa-tional barriers in big data challenges in healthcare, the analysis yields big data in form of results in return. Even if only the top 10 or 100 hits are considered, the results need to be interpreted in the context of the specific microbiological and clinical domain. The clinician and researcher perform this cognitive task based on their knowledge and education. However, the corpus of knowledge giv-en by all publications exceeds the human capacity to be taken in fast and in tangible time. Again, relevant information that has been published can be lost in the decision process to cure a patient on a daily basis. Cognitive computing enables us to automatically put the results of the data analysis into the context of the knowledge domain given the published corpus of knowledge and hence revives all information to be taken into account to improve treatment out-comes.Hence, the combination of supercomputing technologies with cog-nitive computing enable us to have impact in the clinical decision process today and is an essential component of precision medicine in the future.
Paul OrhiiDr Paul Botwev Orhii was appointed the Director General of the National Agency for Food and Drug Administration and Control (NAFDAC) in 2009. Charged with the responsibility of regulat-ing and controlling the importation expor-tation, manufacture, advertisement, sale and use of regulated products in Nigeria;
he has put in place several regulatory reforms.Since assuming office, he has strengthened the Agency’s regulatory capacity and fostered unprecedented National/ Regional/ Interna-tional cooperation and collaboration. This includes but is not lim-ited to the support of local pharmaceutical manufacturing by the World Health Organization (WHO) Prequalification Programme in
Guangjun NieProf. Guangjun Nie received his PhD in Bio-physics at the Institute of Biophysics, Aca-demia Sinica. After that he 2007 graduated in Business Administration in Biotechnol-ogy Management and worked for 6 years as Postdoctoral Associate at the Jewish General Hospital, McGill University, Cana-da. Since 2008 he is Professor of Nanobiol-
ogy and Nanomedicine at the National Center for Nanoscience and Technology in Beijing. Gunagjun Nie received numerous honors, published in the last 12 years more than 40 Peer-reviewed publica-tions. Between 2011 -2014 he was one of the chosen as one of the 100 Top Talents by the Chinese Academy of Sciences.
Nigeria; a quality assurance initiative which has since produced the first four companies in West Africa to be certified by WHO to have attained best international standards in Pharmaceutical Manufac-turing. This stellar achievement is the foundation for procurement by the United Nations and other international agencies which our local manufacturers now enjoy.His novel use of Cutting Edge Technology has heralded the entry of the Mass Authentication Service (MAS) also known as ‘Scratch and text’ that enables consumers in Nigeria to detect counterfeit medicines using text messaging. Furthermore, his deployment of TRUSCAN, a handheld device which allows speedy detection of counterfeits makes NAFDAC the first regulatory authority globally to use both technologies.He gained international recognition for his fight against counter-feiting and was appointed the first chair of the WHO member state mechanism against Spurious/falsely-labelled /falsified/counterfeit (SFFC) medicines.A consummate professional, his training as a Medical Doctor, a Chrono-Neuropsychopharmacologist, a Biomedical Scientist and an Attorney has stood him in good stead in the discharge of his duties.Furthermore, he has keyed into global initiatives that enhance reg-ulation and entrenched the agency’s position as one of the top 20 medicines regulatory agencies in the world.He has received several prestigious awards both nationally and internationally. In recognition of his immense contributions to na-tional development, he was awarded the prestigious Nigerian Na-tional Honour of the Officer of the Niger (OON).
Gesine Heuck Ph.D., Pharm DGesine Heuck, Ph.D. is a field application scientist at Precision NanoSystems Inc. and the lead contact for academic and interna-tional clients working with the microfluidic NanoAssemblrTM Platform. She has over 8 years experience in the development and translation of nanomedicines. Gesine
completed her Degree in Pharmacy at the Universities of Kiel and Regensburg, Germany, and the University of Michigan, Ann Arbor, USA. She obtained her Ph.D. from the University of Geneva, Swit-zerland, where she worked on the nanoencapsulation of the com-mercial drug Hexvix® for photodynamic therapy and fluorescence photodetection, while collaborating closely with the Institute Pas-teur to investigate the heme pathway in gram-negative bacteria.Gesine worked as postdoctoral fellow at the Centre of Drug Re-search and Development (CDRD) in Vancouver, Canada, to develop early project formulations. She has a passion for grass-roots sci-ence and seeing the unfolding of nanomedicines into commerciali-zation.
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BENEFITS AND COMPLEXITIES OF PATIENT IN-vOLvEMENT IN THE DEvELOPMENT OF PERSONAL-IzED NANOMEDICINE TREATMENTSDR. DETlEf NIEsE, M.D., Priv.Doz., lic.pharmSince many years, patients and patient representatives have an increasingly important role to play in the discovery and development of medicines. This not the least reflected by the legal requirement in Europe to include patient representatives on the decision making bodies of regulatory authorities responsible for licensing of new medicines. More recently, the European pharmaceutical industry and the European Commission joined forces in commissioning the European Academy for Therapeutic Innovation (EUPATI), a project under the roof of the Innovative Medicines Initiative (IMI) aiming at educating patient representatives and the public at large with regard to the medicines development process.For the development of nano medicinal products the involvement of patients and the public as well may be even more important. The knowledge is scarce in the lay public of the true opportunities and risks of nano particle based medicines. Rather, many people may have heard about the potentially dangerous effects of exhaustions from cars, heatings and industrial facilities (“Feinstaub”). It is often highlighted that the danger caused by such small particles is primarily a consequence of their size rather their chemical structure. How can such particles cure diseases?The early involvement of patients and the active education of the public at large may indeed contribute to a much more open and fact based debate. At the same time, it may reduce the risk that this promising technology may suffer from the same negative public image as biotechnology, gene technology or synthetic biology did in the past.Well educated patients and representatives are willing and able to assess the risk-benefit of new health technologies. Fears within industry are as old as they are unjustified that such involvement may cause problems regarding protection of IP or may help the competition. Many companies involve very actively patients and patient organisations in the general medicines development process with mutual benefit. For nano medicines such involvement is even more critical.
David Bott After 26 years with BP, Courtaulds and ICI, spent in both their corporate centres and business units, David got involved with start-ups 10 years ago. He was diverted into spending 7 years setting up and direct-ing the Technology Strategy Board (now rebranded as Innovate UK). He is a Princi-pal Fellow at WMG, non-executive Chair-
man of Oxford Biomaterials, and a non-executive director of Ox-ford Advanced Surfaces, has been a member of Sheffield University Council and has engaged in a wide variety of activities involving materials, design, sustainability and innovation.
BuILDING SuPPORT FROM CONCEPT TO COMMERCIALISATION – THE uK STORyDaVID BoTTIn 2004, the UK Government set up a special unit within the DTI to support innovative companies. In 2007 they turned it into a quasi-independent agency called the Technology Strategy Board. It was staffed with people from business and promoted “challenge-led” programmes, working with industry to determine which areas would happen on their own and which needed support from gov-ernment. Over the last 8 years it has become the primary govern-ment vehicle to promote economic growth through innovation, and despite a relatively short lifetime is beginning to show evi-dence that it is succeeding in tis goals.
Laurent Levy CEO NanobiotixLaurent LEVY, Ph.D. is co-founder and CEO of Nanobiotix. Laurent holds a doctorate in physical chemistry, specialized in nano-materials, from the Pierre and Marie Curie University (Paris) and from the CEA (Com-missariat à l’Énergie Atomique et aux Éner-gies Alternatives) and a DEA (first doctoral
diploma) in physics of condensed matter from the UPVI-ESPCI (Par-is). He has extensive experience in sciences and techniques related to nanotechnologies, a field in which he worked for more than 10 years. His research at the frontier of biotechnology and nanotech-nologies has resulted in the development of a number of concrete applications such as NanoXray, which could open a new method for cancer treatment. For many years, Laurent was a consultant in the development of application of nanotechnologies with large com-panies such as Sanofi (pharma), Guerbet (medical imaging), Rhodia (chemistry), as well as for biotechnology start-ups. Laurent is the author of 35 international scientific publications and communica-tions, has applied for several patents and completed his training by a post-doctoral fellowship at the Institute for Lasers, Photonics and Biophotonics, SUNY (State University of New York), Buffalo, USA.He is since October 2012 the vice-chair of the ETP Nanomedicine (ETPN) and is involved with many international groups working in the field.
DELIvERING NANOMEDICINES TO PATIENTS: A PRACTICAL GuIDElauRENT lEVy PhD, Mike A.W. Eaton, PhD, Olivier M.A. Fontaine, MScThis is a perspective on the current state of development of nanomedicines in Europe. The view is expressed that a much higher translational success rate could be achieved, with rewards for all stakeholders, if researchers understood the industrial decision points required for new drugs. Getting a drug through the clinic will not help patients unless it is developable by industry. This article is written in the hope that it will help researchers and SMEs to decide where they are in the established process, whether they are making progress and to determine what to do next. It attempts to map the early stages from ideation to first (time) in man (FIM).
Felix Michnacs Felix Michnacs is Product Manager and Trusted Deputy QPPV at TETEC AG, Re-utlingen. He has a 12 year experience in conducting clinical trials in different posi-tions with pharmaceuticals and medical devices. The Highlight of his experience is the development of a clinical development department under the strategic sourc-
Jytte LyngvigSenior VP and Managing Director, DIA Eu-rope, Middle East & Africa Between 2000 – 2013, Jytte Lyngvig was the Executive Director of the Danish Medi-cines Agency and a member of the Euro-pean Medicines Agencies Management Board. She served for 5 years as a vice chair of this Board and for 6 years as the char of
the Management Group of the Heads of Medicines Agencies. She is educated as chemical engineer and has a Ph.D. in Mathemati-cal Statistics and Operations Research, plus a business certificate in French.
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CONDuCT OF CLINICAL TRIALS wITH ATMPS IN EuROPEfElIx MIChNaCs, TETEC AG, ReutlingenResults from clinical trials that comprise confirmatory data about the safety and efficacy concerning the use of a pharmaceutical product in humans are the bases of a central market authorization. The care-ful planning and conduct of these clinical trials follows guidelines and regulations, i.e. the specifics of Good Clinical Practice (ICH-GCP). For advanced therapy medicinal products (ATMPs), the same principles for the initiation and conduct of clinical trials as far as for the market authorization do apply as for regular medicinal products .Beside the specifics and differences of ATMPs during all stages of their development which separate them from „conventional“ medic-inal products, there are also regulatory obstacles that have impact on the planning and conduct of clinical trials which will sometimes lead to big challenges for the sponsor of a clinical trial. These specific features especially apply for biotechnologically modified products like human tissues and combined ATMPs. One reason for this fact is that the vast majority of biotechnically modified, autologous tissue products are developed under the regulatory framework of drug de-velopment since January 2013, and that current developmental pro-grams do not necessarily follow effective regulatory principles. Fur-thermore, the pre-clinical development of these medicinal products is very often done by universities and research institutions where the focus is on scientific research, and less on the specific requirements of a classic drug development.Manufacturers of these pharmaceuticals as well as sponsors of clini-cal trials have to face these multifaceted challenges in a way that clin-ical trials can be planned and initiated in a clinical surrounding. These trials need to be feasible in a way that all data necessary for market authorization can be generated. In this lecture, the speaker will bring in his experience from clinical trials in numerous European countries, to draw a distinct picture of these obstacles and challenges concern-ing the planning and conduct of clinical trials with focus on operative issues and the knowledge from daily routine.
Vivienne Williams Vivienne Williams is CEO and co-founder of Cellix, a company providing microflu-idic pumping solutions, biochips and au-tomated platforms for cell-based assays. Vivienne is experienced in the commer-cialization of analytical and life science tools; and integrating technologies from diverse, multi-disciplinary fields and trans-
forming these elements into robust, practical products is key to Cellix’s growth. Vivienne is responsible for the establishment and growth of Cellix’s network of distributors across the US, Europe and Asia and establishing Cellix’s OEM business model. Vivienne holds a M.Sc. in experimental physics from Trinity College Dublin, Ireland. She has a broad background in cutting edge laboratory automation tools, instrumentation and plastic injection moulding techniques with a specific focus in microfluidics, micro-electromechanical sys-tems (MEMS) and fluid dynamics. Several US and European Patents have been granted relating to Cellix’s technology of which Vivienne is co-inventor. As CEO, Vivienne was awarded the Trinity Innovation award in 2014 and shortlisted for the Microsoft WMB Women in Technology award in 2011.
María Antonieta AnnunziatoInternist-Specialist on Infectious diseasesFounding President of LATNAMCLIFounding President of Asovenac: http://www.asovenac.orgChief Physician/Internist-Infectious dis-ease BANDESIR: http://www.bandesir.org/ Clinical research Biocontrolled: http://www.
biocontrolled.comBackground Education• Surgeon, Medical Doctor. University of Carabobo. Valencia/Cara-
bobo Venezuela. “Dr. Enrique Tejera”. 1992.• Specialist in Internal Medicine University of Carabobo. Hospital
Universitario “Dr. Angel Larralde”. Valencia-Venezuela, 1994-1997.
• Infectious Disease Specialist (Infectious diseases). Central Univer-sity of Venezuela. University Hospital of Caracas, 1998-2000.
• Studies Classic Guitar.at Music Conservatory. Maracay/Aragua. Venezuela. 1983-1998.
Summary• Founder of the Venezuelan Association of Clinical Nanomedicine:
ASOVENAC.• Founder of the Latin American Association of Clinical Nanomedi-
cine.• Thesis: Asymptomatic bacteriury in institutionalized elderly pa-
tients. Ancianato San Martin Porres. Valencia; Venezuela. Title of Surgeon. Submitted/approved, Nov 1992.
• Thesis: Clinical Manifestations, fungal and immunohistochemical anorectal warts(verruca vulgaris) in patients with HIV. University Hospital “Dr.Angel Larralde”. University of Carabobo; Venezuela. Department of Internal Medicine. To obtain the title Specialist in Internal Medicine. Submitted/approved, Nov 1997.
• Thesis: Anorectal findings in patients infected with HIV. Univer-sity Hospital of Caracas. Central University of Venezuela. Special Clinical Research to obtain the title of Specialist in Infectious Dis-eases. Presented/approved Dec 11, 2000.
• Internships in Clinical Research Laboratory Medicine Department in sub departments Acid/Base, Electrolyte and Blood Biochem-istry micro-methods balance for and participation in the devel-opment of methods for determining RBC intracellular potassium, ionized calcium by flame photometry. Duration: 09/01/92 to 04/30/93. Reported to Dpt Chief Dr. Antonio Delgado.
• Development of Clinical Research on Infectious Diseases Unit. University Hospital “Dr. Angel. Larralde”. Valencia/Venezuela. Chief Dr. Zenaida Castillo. (1995-1997).
• Making Viral Herpes crops in the virology laboratory of the Na-tional Institute of Health. Reported to Lic Clovis Vázquez. Caracas. Venezuela. (1998-1999)
ing from resources and capacities from the “mother company” B|Braun Melsungen AG, BU Aesculap. Focus of his work are – Team acquisition and training of staff, – the Design and development of a clinical phase I-II trials as well as the design and development of clinical phase-III & IV trials. He has the authorship for many clinical documents for market approval submissions and is a well-known trainer and speaker for the industrial challenges and opportunities for translation of novel technologies in the regenerative medical sector.
LAB-ON-CHIP FOR IvD: FROM PRODuCT DEvELOPMENT TO MARKET ACCESS. VIVIENNE WIllIaMsCellix has been successful in commercializing nanotechnologies for the research community providing lab-on-a-chip solutions with precision microfluidic liquid handling for cell-based assays targeted at drug discovery and applied cell biology applications. As a result of this, we have furthered our understanding of requirements in bringing technology to end-users. Through interaction with our customers and key partners, we have recently worked on advancements in processes and manufacturing in the area of microfluidics and impedance based spectroscopy detection for cellular characterization. This has resulted in a new small, portable haematology analyzer for the clinical diagnostics market. This talk will present the product development of this device together with an analysis on market drivers and barriers and ultimately effective routes to commercialization.
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• Chief Physician: Infectious disease Internist-chair at BANDESIR Jan 2000-Present. http://www.bandesir.org/
• Internist and infectious Diseases Interconsultant. VidaMed Clinic.• Clinical Researcher at Biocontrolled: Review and discussion of pro-
tocols Phase I Clinical Studies, Monitoring of Clinical Trials Phase I, Design and execution of Phase III-IV Clinical studies. Currently Active .(July2008-Present). http://www.biocontrolled.com/
• Laboratorios LETI, S.A.V. Medical Advisor, Department of Records Brand (Regulatory Affairs). Research, review, reporting and justi-fication of drugs/product categories A, B and C. Review research projects. Proofreading of prospects on internal drug develop-ment. (July2001-July 2008).
• Courses dictated to Leti Laboratorios & Ferrer personnel (Spain-Venezuela) on training: Basic Molecular Genetics, antivirals, antiretrovirals and Basic Oncology. Currently active.
• COMPASS INTERNATIONAL(Brújula Internacional) MEDICAL ADVI-SOR. TV Program & Training School led by Ambassador J. C. Pine-da. (Feb 2006-Present). Regularly interviewed on Brújula Inter-nacional/Globovision (www.globovision.com) on medical matters and internist/infectious diseases/clinical nanomedicine issues.
• Awards and prizes: Scientist “Dr. Miguel Perez Carreno” Award from
Lectures• Skin and soft tissue infections. Department of Dermatology.
“Hospital Carlos Arvelo”. Caracas, Venezuela. June 13. 2000.• Outpatient Management of severe infections. College of Physi-
cians. Carabobo. XII Days of Infectious Carabobo. Valencia-Vene-zuela. June 13, 2003.
• Update on New Carbapenems. V Conference on Infectious Dis-eases of the University Hospital of Caracas. Venezuela, Jan 29, 2005.
• National Symposium Coordinator for Avian Influenza. Caracas-Venezuela Red Cross. March 11, 2006.
• Drug costs: Brands versus Generic. Northeastern Univ XII Con-ference on Infectious Diseases. Eastern University (Universidad Oriente) Rio Caribe, Sucre State, Venezuela 02/06/2006.
• Respiratory infections. VII Venezuelan Congress of Infectious Dis-eases “Dr. Belisario Gallegos “. Guyanese XIV Conference of In-fectious Diseases. Sponsored by the Venezuelan Society of Infec-tious Diseases. Puerto Ordaz/Bolivar State. Venezuela 25/10/06.
• Anorectal pathology in HIV-AIDS patients. VIII Venezuelan Con-gress of Infectious Diseases “Dr. Ivan Brito Sponsored by the Ven-ezuelan Society of Infectious Diseases. 12-15 Nov 2008. Valencia Edo. Carabobo, Venezuela.
• Predicting genetic breast cancer (microarrays of genes). VI Re-gional Conference of Mastology. San Cristobal-Venezuela, 24-25 April 2009.
• What is H1N1 flu? XII and XV National Conference on Infectious Diseases, Zulia. Maracaibo, Venezuela, October 21-23, 2009.
• Human papillomavirus (HPV) in patients with HIV / AIDS. XVI Conference of the Venezuelan Society of Infectious Diseases. Maturin-Venezuela; June 18-20, 2010.
• Brainstorming on Infectious Diseases. What is better? staphylo-coccal infections: beta-lactams versus other drugs. IX Venezuelan Congress of Infectious Diseases “Dr. Pedro Navarro “, Caracas, October 12-15, 2010.
• Nanomedicine: Medical and Clinical Applications. Co participant in the panel of experts at the seminar: New medical technolo-gies and advances in medicine. XXXV Scientific Conference of the National Institute of Hygiene “Rafael Rangel”, Caracas October 21-25 2013.
• Ebola. Audirorium Red Cross of Venezuela. Caracas. 04/03/2015
Publications• Extrapulmonary coccidioidomycosis. Case report and literature
review. Magazine: Antibiotics and Infection. Vol.8. No, from July to September 2000.
• Outpatient Parenteral Antibiotic Treatment in Severe infections. Antibiotics and infection magazine (2004).
• General information on Avian Influenza. http://www.globovision.com/news.php?nid=21545.
CHALLENGES OF CLINICAL RESEARCH IN NANO-MEDICINEMaRía aNToNIETa aNNuNzIaTo, MDInternist, Specialist on Infectious Diseases and Clinical ResearcherPresident/Founder of The Latino American Association of Clinical Nanomedicine (LATNAMCLI). [email protected]/Founder of The Venezuelan Association of Clinical Nanomedicine (ASOVENAC)
SuMMARyA Clinical Trial can be defined as a systematic study that thoroughly follows the guidelines of the scientific method in researching vol-untary human subjects (in the context of a team of multidiscipli-nary experts led by specialized physicians). Its goal is to evaluate the safety and efficacy of drugs, related products, devices, cellular implants, tissues or organs, bio-materials, techniques or different preventive procedures, diagnostics or therapeutics used. Clinical research, in terms of standards, is regulated by a concentrated number of resolutions and norms that respond to both the ethical concerns of the Nüremberg Code and the Helsinki Declaration as well as the “ethical-techno-scientific” Good Clinical Practice (GCP) Guides of the World Health Organization (WHO) and its updatings for Drugs Tests. Pharmacologic Clinical Research in Venezuela and Latin America: As of April 2014, there were in the order of 190 253 clinical studies known worldwide, of which 82% were executed in 3 continents\, namely: The United States (44,6%), followed by Eu-rope (27,87%) and East Asia (9,59%).12 According to geographical distribution of clinical studies, presently 24 Latin American and Car-ibbean countries performed clinical research with a total of 8 661 clinical studies. Nevertheless, only six (6) countries shared 89% of the total of these studies. Brazil is the regional leader (4 425), fol-lowed, in second place, by Mexico (2,348) and Argentina (1,911). At the third level, we find Chile (1,053), Colombia (834) and Peru (763). At the fourth level Guatemala (235), Panamá (204) and Venezuela (150). It is important to stress that R&D and published papers have been dramatically reduced in Venezuela during the last 12 years and thousands of researchers and professionals from all disciplines, including approximately 14 000 physicians, have left the country for better opportunities.Clinical Research in Nanomedicine in Venezuela and latin ameri-ca: To seek out clinical studies using nanodrugs in human beings, in Venezuela and Latin America, an electronic search was made to ac-cess systematic reviews, clinical trials, summaries of evidence, eval-uations of health technologies and guidelines for clinical trials. In-dependent data bases were used such as LILACS, IBECS, MEDLINE, SciELO and Cochrane Plus library (in Spanish), among others. Key
• Special Job: Seasonal flu vaccine H1N1 virus mutation prevents H1N1. http://analitica.com/actualidad/actualidad-nacional/traba-jo-especial-vacunarse-contra-la-influenza-estacional-previene-mutacion-del-virus-ah1n1/
• Guidelines for the Management of Central Nervous System Infec-tions (Adult). Expert consensus. Coordinator: Dr. Maria Antonieta Annunziato. Members: Dr. Elizabeth, Dr. Santiago Bacci, Dr. Mil-vida Castrillo, Dr. Carmela Curcio, Dr. Regina Lopez. Noviembre 2010. http://www.buenastareas.com/ensayos/Consenso-Sobre-Infecciones-Snc-Svi-2010/26560637.html
• Nanotechnology applied to medicine. Science and health. Volume 1 .Nº September 2, 2010.
• Herbal Medicine: empiric use of ancestral development and clini-cal research. Herbal Medicine magazine. Volume 1. No. 1. Page 9-11. Year 2012
• What is the Human Papilloma Virus (HPV) ?. Infecto News maga-zine. 2011. Link: http://www.svinfectologia.com/inmunizaciones/preguntasexperto.htm.
• Vitamin D: overall evaluation and possible clinical use in different types of cancer. In publication.
• Evaluation of the Efficacy and Safety of Sildenafil Citrate Presen-tation on Form 50-mg orodispersible tablets Placebo Controlled. In publication
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words were used such as: nanomedicine, clinical studies, nanod-rugs, nanodrugs and pharmacokynetics; nanodrugs, bioavailability y bioequivalence. No published articles were found in nanomedi-cine applied to human beings, phase I, II and III, in Latin American Journals (consulted last time on June 7th, 2015). This deficiency might be due to regulatory constraints, or considering the fact that some clinical studies on bioavailability and/or bioequivalence (phase I) are in an approval period by the corresponding Health Authorities and then can be published or they are published (or in that process) in Journals outside Latin America. Clinical Research in Nanomedicine in Latin America and Bioethical implications: Clinical research in Nanomedicine in Latin America is, relatively, in an embryonic phase. Regarding the bio-ethical implications of nano-bio-technology and nanomedicine arises the need of creat-ing Nano-Bio-Ethics committees that will contribute to establish norms/standards for the proper and fair use of this new technology that will allow the registration and Health Sector approval of these products in each country of Latin America.Clinical Research in nanomedicine in latin america and Regula-tory Agencies: Regarding the regulation of nanodrugs and/or na-no-medical devices in Venezuela and the rest of Latin America it is concluded that the regulation is incipient and weak and regulatory norms as such were not found. The lack of specific rulings obligates to create harmonized International Norms that must be legislated/followed up by the corresponding authorities and/or governments of each Latin American country. Even with the existing challenges nanomedicine and clinical nanomedicine is one of the areas that can mostly contribute to the sustainable progress of Latin America in the context of the health sector. Nanomedicine advances new methods for diagnostic and screening of sicknesses, better drugs, better systems for drug management and optimized instruments for the monitoring of some biological parameters.
Kenneth C. OfokanskiPosition: Professor/Head of DepartmentDepartment of Pharmaceutics, Faculty of Pharmaceutical Sciences, University of Nige-ria, Nsukka, Nigeria.Tel: +234-81-31245821; +234-80-59793297E-mail: [email protected]; [email protected] Brief Biography: Born on January 17, 1971,
Professor Ofokansi obtained his B.Pharm., M. Pharm., and Ph.D degrees from the University of Nigeria, Nsukka. He joined the ser-vices of the University of Nigeria in 2000 as Lecturer II and rose to the rank of a Professor October 1, 2011. Prof. Ofokansi has over 68 scholarly articles in both local and international journals to his credit in addition to a number of book chapters. He has also attend-ed a number of local and international conferences/workshops.areas of Research interest/summary of expertise: Formulation of polymer-based nano- and micro-particulate drug delivery sys-tems; novel controlled delivery of various pharmaceutical actives; targeted drug delivery and formulation and delivery of proteins and peptide-based drugs, transdermal drug delivery systems, solid dispersions and lipid-based colloidal delivery systems. I also have interest in social health/pharmacy research. Prof. Ofokansi has expertise in bioanalytical techniques, cell culture and handling of laboratory animals. He has designed and conducted research in the areas of novel drug delivery and analytical methods development, pharmacokinetics/pharmacodynamics, pharmaceutical applica-tions of ex vivo systems to study drug absorption from bioadhe-sive systems, polymer-based nanoparticles and microparticles. He has skills in biopharmaceutics and pharmaceutical microbiological techniques. Prof. Ofokansi has conducted experiments involving the use of Caco-2 cell to study intestinal drug absorption from na-noparticulate drug delivery systems. Membership of Professional Bodies: Prof. Ofokansi is a member of the following professional bodies/organizations: Pharmaceuti-cal Society of Nigeria (PSN), Nigerian Association of Pharmacists in
GELATIN-BASED NANOPARTICLES ENCAPSuLATING CyCLODEXTRIN-INSuLIN NON-COvALENT INCLuSION COMPLEX FOR ORAL DELIvERy OF HuMAN INSuLINKENNETh C. ofoKaNsI1*, Martha N. Ofokansi2, Gert Fricker3, Paul A. Akpa1 and Conrad Coester4
1Department of Pharmaceutics, University of Nigeria, Nsukka, 410001 Enugu State, Nigeria2Department of Pharmacology and Toxicology, University of Nigeria, Nsukka, 410001 Enugu State, Nigeria3Institute for Pharmacy and Molecular Biotechnology, Department of Pharmaceutical Technology and Biopharmaceutics, Ruprecht-Karls University, Im Neuenheimerfeld 366, 69120 Heidelberg, Germany4 Department of Pharmaceutical Technology and Biopharmaceutics, Ludwig-Maximillians University, Butenandstr. 5-13, Building B, 81377 Munich, Germany
ABSTRACTBiologically and conformationally stable insulin-loaded gelatin nanoparticles (NPs) and gelatin NPs encapsulating hydroxypropyl-β-cyclodextrin (HPβCD)-insulin inclusion complex were prepared and evaluated as a vehicle for the oral delivery of insulin in dia-betic rats. Results show that at 50 IU/kg dose, orally administered insulin-loaded and HPβCD-insulin-loaded NPs lowered blood glu-cose levels in diabetic rats by 37 and 45 % respectively, sustaining hypoglycemia for over 12 h. The pharmacological availability (PA) was calculated to be 6.1 and 7.2 % respectively for insulin-loaded and HPβCD-insulin-loaded NPs which was observed to be a signif-icant increase (P< 0.05) over 1.4 % evaluated for orally adminis-tered insulin solution alone. These preliminary findings show that gelatin-based nanosystems encapsulating HPβCD-insulin inclusion complex appear to be a promising system for oral delivery of hu-man insulin and was seen to have superior blood glucose lowering effects when compared with insulin-loaded gelatin NPs alone.IntroductionThe oral route remains the most convenient route of drug delivery owing, perhaps, to its numerous benefits including patient compli-ance and ease of administration. Insulin is the most effective drug in the treatment of advanced-stage diabetes. Despite significant advancement in the field of pharmaceutical research, development of a proper non-invasive insulin delivery system remains a major challenge [1]. Orally administered insulin undergoes a hepatic first pass metabolism, and will produce a similar effect as pancreas-se-creted insulin by inhibiting the hepatic gluconeogenesis and sup-pressing the hepatic glucose production. Oral delivery of peptides/proteins is restricted mainly due to their susceptibility to prote-olysis and inability to traverse across biological barriers. The ten-dency for insulin molecules to aggregate and form fibrils remains a fundamental obstacle in long-term therapeutic systems. Protein aggregation happens mainly by the interaction of hydrophobic resi-dues in the protein molecules and is often accompanied by drastic reduction of biological potency creating serious problems in for-mulating drug delivery systems. Cyclodextrin (CD) complexation
Academia (NAPA), West African Society of Pharmacology (WASP), Controlled Release Society (CRS), International Association for Pharmaceutical Technology (APV).Editorial Experience: Professor Ofokansi has served as a reviewer or is serving as reviewer to the following journals: International Journal of Pharmaceutics, American Association of Pharmaceutical Scien-tists, AAPS PharmSciTech Journal, African Journal of Pharmaceutical Research and Development, Nigeria, Editorial Secretary, African Jour-nal of Pharmaceutical Research and Development, Circulation Editor, Journal of Pharmaceutical & Allied Sciences, Nigeria, Scientific Re-search and Essays, European Journal of Pharmaceutics and Biophar-maceutics, Journal of Pharmaceutical and Allied Sciences, European Journal of Pharmaceutics and Biopharmaceutics, Drug Delivery, Drug Development and Industrial Pharmacy.
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represents a unique and effective strategy for improving protein therapy by stabilizing them against aggregation, thermal denatura-tion and degradation. Βeta-cyclodextrin (βCD) forms non-covalent inclusion complex with a wide variety of drugs/proteins and compl-exation often alters the physicochemical and biological properties of guest molecules [2]. Hydrophilic βCD inhibits the adsorption of insulin to hydrophobic surfaces and prevents self-aggregation of insulin at neutral pH. Proteins are mostly hydrophilic and too bulky to be wholly included into a βCD cavity. Hydrophobic side chains in the peptides penetrate into the βCD cavity leading to the forma-tion non-covalent inclusion complexes and cyclodextrins’ ability to sequester hydrophobic moieties helps in improving the stability of proteins. In the present study, an oral delivery system for human insulin based on gelatin NPs encapsulating HPβCD-insulin inclusion complex was developed and characterized and further evaluated in diabetic rat models.EXPERIMENTAL METHODSInsulin-loaded gelatin NPs and gelatin NPs encapsulating HPβCD-insulin inclusion complex were prepared by a one-step desolvation technique under very mild nanoprecipitation conditions (neutral pH of 7.0, ethanol:water admixture 70:30 as the desolvating agent and a temperature of 37 oC) and characterized with respect to par-ticle size, size distribution and zeta potential. Non-covalent inclu-sion complex formation between HPβCD and insulin was analyzed and confirmed by fluorescence spectroscopic studies. Rats were rendered diabetic by a single intraperitoneal injection of strepto-zotocin at 55 mg/kg body weight. After two weeks, rats with blood glucose levels above 400 mg/dL were randomly grouped (n = 9) and used for the experiments. The rats were starved 10 h before and 12 h during the experiment but water was provided ad libitum. Test samples were administered intragastrically by gavage and glycemia for each rat was measured in blood sampled from the tail vein prior to administration of insulin-loaded gelatin NPs, gelatin NPs encap-sulating HPβCD-insulin complex or insulin solution and at regular time intervals thereafter. Rats were divided into seven groups. NPs were administered at an insulin dose of 50 IU/kg for both insulin-loaded gelatin NPs and gelatin NPs encapsulating HPβCD-insulin complex. Control groups similarly received equivalent volumes of an insulin solution (50 IU/kg), an admixture of insulin solution (50 IU/kg) and unloaded NPs or a dispersion of unloaded NPs. Another control group received insulin solution (5.0 IU/kg) subcutaneously while the last control group received neither insulin solution nor the NPs. The purpose of this last control group was to monitor the reduction in glycemia that occurred naturally in diabetic rats when they remained fasted during the experiment. Blood glucose level was monitored throughout the experiment using a glucose meter and expressed as a percent of the baseline blood glucose level. The pharmacological availability (PA) of peroral insulin-loaded NPs and in solution was evaluated as the relative measure of the cumulative reduction in blood glucose levels compared to a 100 % availabil-ity of the control insulin solution administered subcutaneously at a dose of 5 IU/kg and results were adjudged significant at P ≤ 0.05.
RESuLTS AND DISCuSSIONGelatin nanoparticles produced by a one-step desolvation tech-nique had mean diameter in the range of 200 and 300 nm for both insulin-loaded and gelatin NPs encapsulating HPβCD-insulin inclu-sion complex NPs as shown by scanning electron microscopy (SEM) in Fig. 1. The SEM photomicrographs of the nanoparticles show the formation of monodisperse, smooth and spherical particles. Also contributing to the mild formulation conditions was the neu-trality of the pH of preparation since highly alkaline and/or acidic pH would lead to rapid degradation of insulin. Gentle nanopre-cipitation conditions are vital in ensuring the maintenance of the structural bioactivity of insulin due to its labile physicochemical properties. Results from fluorescence spectroscopy studies (data not shown) clearly suggest that addition of HPβCD to insulin en-hanced the fluorescence emission intensity of insulin, suggesting an interaction between these compounds. As the concentration of HPβCD was increased, fluorescence intensity of insulin solution was enhanced significantly. At 50 IU/kg dose, orally administered
insulin-loaded and HPβCD-insulin-loaded NPs lowered blood glu-cose levels in diabetic rats by 37 and 45 % respectively, sustaining hypoglycemia for over 12 h. The pharmacological availability (PA) was calculated to be 6.1 and 7.2 % respectively for insulin-loaded and HPβCD-insulin-loaded NPs which was observed to be a signifi-cant increase (P< 0.05) over 1.4 % evaluated for orally administered insulin solution alone (Fig. 2). Subcutaneously administered insulin sustained glycemia for only 3 h. Encapsulation of insulin into gela-tin NPs and inclusion of insulin into HPβCD was observed to be a key factor in the improved bioavailability over insulin solution. To investigate whether gelatin nanoparticles facilitated intestinal ab-sorption of free insulin, rats were treated orally with insulin solu-tion alone, and with unloaded nanoparticles suspended in insulin solution (50 IU/kg). A slight decrease in glycemia is discernible in Fig. 2 for the first 4 h after administration before returning to basal levels. It would appear that the presence of unloaded nanoparticles did enhance the hypoglycemic effect of oral insulin solution but not to a significant extent as to have produced an absorption-enhanc-ing effect. The slightly higher PA of the physical mixture of insulin and plain nanoparticles when compared with that of oral insulin solution may suggest that there was an association of insulin with the plain nanoparticles possibly through surface phenomena. The calculated PA of 1.4 % for oral insulin solution is also an indication that a small fraction of insulin could be absorbed through the intes-tinal wall to exert a hypoglycemic effect as has been observed by some investigators. The observed extended hypoglycemic effect of insulin-loaded nanoparticles in comparison to the marginal effect recorded in animals that received oral insulin solution is suggestive that gelatin nanoparticles were to a large extent able to protect the entrapped insulin from gastrointestinal degradation, leading ulti-mately to the uptake by the M-cells.
Fig. 1: SEM photomicrographs of the gelatin-nanoparticles. Gelatin NPs encapsulating HPβCD-insulin inclusion complex (A); Insulin-loaded gelatin NPs (B).
Fig. 3: Plasma glucose levels after formulations were administered to diabetic rats: 50 IU/kg insulin-loaded NPs (◆); 50 IU/kg insulin solution (▲); 50 IU/kg physical mixture of insulin solution and empty NPs (✻); empty NPs (■); 2.5 IU/kg subcutaneous insulin (X); received nothing (●); 50 IU/kg HPβCD-insulin-loaded NPs (+) (n = 6 for each studied group).
REFERENCES1. Cefalu, W.T., 2004. Concept strategies and feasibility of non-inva-sive insulin delivery. Diabetes Care 27, 230–246.2. Stella,V.J., Rajewski, R.A., 1997. Cyclodextrins: their future in drug formulation and delivery. Pharm. Res. 14, 556–567.
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IncreasIng the stabIlIty of PhotoacoustIc contrast enhancIng hollow gold nano-sPheres by MultIPodal lIgandsJulie Ruff1,2,Julia Steitz3, Stanley Fokong4, Fabian Kießling2,4 and Ulrich Simon1,2
1Institute of Inorganic Chemistry, RWTH Aachen University, Landoltweg 1, 52074 Aachen, Germany 2Integrated Interdisciplinary Institute of Technology for Medicine (I3TM), RWTH Aachen University, Germany3Institute of Laboratory Animal Science and Experimental Surgery, RWTH Aachen University, Aachen, Germany 4Department of Experimental Molecular Imaging, Medical Faculty, RWTH Aachen University, 52074 Aachen, GermanyPlasmonic gold nanoparticles (AuNP) haven been proven suited as contrast agents for photoacoustic (PA) imaging.[1] By means of quantitative analysis of the molar photoacoustic response we dem-onstrated recently that hollow gold nanospheres (HAuNS), exhibit-ing strong optical absorbance in the spectral window of biological tissues between 600 and 900 nm, provide a superior PA signal in-tensity (Figure 1a).[2] Their signal intensity can even be enhanced, when the HAuNS are molecularly interconnected to from net-works.[3] Furthermore, cytoxicity and biodistribution analyses re-vealed that with decreasing AuNP size the bioactivity increases[4], while with increasing particles size the retention time of the parti-cles in blood is significantly decreased.[5] This gives rise to evaluate HAuNS in the intermediate size range between a few and 50 nm as PA contrast agents, and we were already able to demonstrate the PA efficacy of 35nm HAuNS in a chicken breast phantom by means of a clinical scanner (Figure 1b). The particles tested, however, where not long-term stable under in vivo conditions, which is at-tributed to ligand replacement reactions by biomolecules, which have strong binding affinity to gold.In order to improve the chemical stability of the HAuNS under phys-iological conditions and to further enhance their biocompatibility, we synthesized PEG (polyethylene glycol) ligands bearing one, two and three thiols as anchor groups (PEG thiols), respectively. These ligands combine a high binding strength of the ligand to the gold surface with a high hydrophobic barrier and a high degree a hy-dration in the ligand periphery and they were applied to stabilize HAuNS with 35 nm diameter, having a shell thickness of 5.3 nm and an absorbance maximum at 852 nm. The stability of these PEGylated HAuNS was explored in three dif-ferent aspects: (1) stability towards competition reactions with the strong binding ligand dithiothreitol, (2) resistance towards oxida-
tive Au dissolution with potassium cyanide, and (3) colloidal sta-bility, tested by addition of salt. These studies revealed improved colloidal stability with increasing number of thiol anchor groups, while the cytotoxicity remained unaffected.
references[1] W. Lu, Q. Huang, G. Ku, X. Wen, M. Zhou, D. Guzatov, P. Brecht, R.
Su, A. Oraevsky, L.V. Wang, Biomaterials, 2010, 31, 2617–2626.[2] B.S. Gutrath, M.F. Beckmann, A. Buchkremer, T. Eckert, J. Timper,
A. Leifert, W. Richtering, G. Schmitz, U. Simon, Nanotechnology 2012, 23, 225707.
[3] A. Buchkremer, M.F. Beckmann, M. Linn, J. Ruff, R.R. Rosen-crantz, G. von Plessen, G. Schmitz, U. Simon, Mater. Res. Ex-press, 2014, 1, 045015.
[4] A. Leifert, Y. Pan, A. Kinkeldey, F. Schiefer, J. Setzler, O. Scheel, H. Lichtenbeld, G. Schmid, W. Wenzel, W. Jahnen-Dechent, U. Simon, PNAS, 2013, 110, 8004-8009.
[5] W. G. Kreyling, S. Hirn, W. Möller, C. Schleh, A. Wenk, G. I. Celik, J. Lipka, M. Schäffler, N. Haberl, B. D. Johnston, R. Sperling, G. Schmid, U. Simon, W.J. Parak, M. Semmler-Behnke, ACS Nano, 2014, 8, 222-233.
Julie Ruff Julie Ruff received her school education in the French-speaking part of Belgium and studied chemistry at the RWTH Aachen University, Germany. After receiving her Bachelor of Science in 2009, she focused her further studies on bioactive com-pounds and synthetic methods as well as materials and mesoscopic systems, es-
pecially on solid state materials, polymers and nanostructures in which she was graduated with a Master of Science in 2011. Subse-quently, she joined the group of Prof. Dr. U. Simon, Chair of Inorgan-ic chemistry and Electrochemistry as doctoral candidate and works as scientific employee at the Institute of Inorganic Chemistry. Her current research is devoted to the synthesis, characterization, and functionalization of hollow gold nanospheres and gold nanorods to be applied for diagnosis and therapy. Thereby she focusses on material improvements for photothermal therapy of neurodegen-erative diseases, such as Alzheimer’s disease, as well as for pho-toacoustic imaging. She is involved in interdisciplinary research projects with pre-clinical and clinical partners and has presented parts of her results at international conferences in Europe and USA. Fatiha Sadallah
Principal Scientific ManagerFatiha Sadallah is responsible for the IMI collaborative research in the field of On-cology, Stem cells, Education and Training. Between 2003 and 2009, Fatiha Sadallah held a scientific officer position at the DG-RTD, Directorate F, Biotechnology for Health Unit, her main responsibilities were
to contribute to the technical orientation and the development of the health work programme, in the area of regenerative medicine including: gene therapy, immunotherapy and stem cell therapy and to implement the EC research programmes in the field of biotech-nology for health.Between 2001 and 2003 Fatiha Sadallah held a management po-sition in a biotechnology compangny amaxa (Germany), providing scientific advice to major industrial and academic laboratories in a number of European countries to promote the use of the amaxa Nucleofector technology (non-viral gene transfer into primary cells); she has developed negotiating and advocacy skills in a chal-lenging start-up environment.Fatiha Sadallah held two different post doctoral positions at the WHO (World Health Organisation) Collaborating Centre for Vac-cinology and Neonatal Immunology, Centre Medical Universitaire de Genève, and at the Microbiology Department of Oregon Health Sciences University-USA, and has acquired extensive professional experience as a research scientist mainly in the field of molecular microbiology and immunology.Fatiha Sadallah holds a degree in Pharmacy and a PhD in Immunol-ogy from Geneva University of Medicine.
The European Summit for Clinical Nanomedicine and Targeted Medicine, CLINAM 8/15Basel, Switzerland, Sunday, June 28 – Wednesday, July 1, 2015
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