Dr. Soli Makohliso, CEO · 30/05/2012 · One step cell lysis & RNA purification . Elute pure RNA...

Dr. Soli Makohliso, CEO

Fit for Health & Health NCP-Net Health Partnering Event 30 May 2012

Brussels

Ayanda Biosystems SA, PSE-C Parc Scientifique, EPFL, CH-1015 Lausanne, Switzerland

Cancer diagnostic & therapeutics solutions 2

Presentation Outline

• About Ayanda Biosystems

• Our experience with FP6 & FP7 Participation

• Concluding Perspectives


Company Profile

• Based at the Science Park of the Swiss Federal Institute of Technology (EPFL) in Lausanne.

• The goal of Ayanda is to become a leading development company of innovative tools for medical diagnostics and drug discovery applications.

• Ayanda acts as a bridge between IP/Technologies developed Swiss and European research centres of excellence, and the requirements of the market.

• Ayanda then brings together the necessary expertise and resources on a project by project basis to develop products with significant market potential.


MEA Technology

• MEA Biochips are essentially “smart Petri-dishes” that comprise an array of numerous extra-cellular metallic microelectrodes (60 to 256 currently) embedded on a glass substrate.

• They are used to monitor and stimulate extracellular electrical activity of cells/tissue.

• MEA Biochips are available with planar and 3D/tip-shaped electrode geometries. Currently, about 20 different electrode layouts available and can also be customized according to need.

• The 3D/tip-shaped electrodes is uniquely offered by Qwane, and is optimally suited for acute brain slice tissue recordings & stimulation.

• MEA Biochips are used in conjunction with an integrated electrical signal amplification and data acquisition system.


MEA Biochips

Planar electrode Tip-shaped 3D electrode


• Based on the proprietary nanotechnology from the Institute of Chemical Sciences & Engineering, EPFL.

SLIC™ Technology

• The SLIC nanobiosystem consists of a Synthetic Ligand-gated Ion Channel (SLIC) that is incorporated in a lipid-based matrix.

• The SLIC comprises a capture molecule that can recognise and bind a selected bio-molecule (e.g. antibody) with very high specificity.

• The recognition and binding events are monitored and detected via an ultra-sensitive electrical scheme (impedance spectroscopy), capable of detecting the binding of a few molecules.

[S. Terretaz et al. Angew Chem Int Ed 40 (2001) 1740-3]


Summary of Projects

1. SLIC - Biosensors in Molecular Diagnostics: Nanotechnology for the Analysis of species specific Microbial Transcripts (FP6 STREP: 2005 - 2007).

2. BeNatural - Bio-Engineered Nanomaterials for Research and Applications

(FP6 STREP: 2006 - 2009).

3. DETECTHIV - Sensitive nanoparticle assay for the detection of HIV

(FP6 STREP: 2007-2010)

4. PharMEA - Multi-Electrode Array (MEA) technology platform for industrial pharmacology and toxicology drug screening (FP7 R&D for SMEs: 2009 - 2011).

5. NeuroAct - Marie Curie Industry-Academia Partnerships and Pathways (FP7 Oct 2012 - 2015).


Grant Preparation Process

• For SMEs, important to define objective for FP participation - New products & IP, strengthening existing products, financial support, expertise etc.

=> For Ayanda - Valorisation of our SLIC IP, Expertise, Financial resources.

• We aimed for a relatively small consortium - STREP with 5 partners.

• When building a consortium, identify at least one or two potential partners with whom to form the nucleus of the consortium, of which one must be a full EU member - e.g. EPFL (CH), IMTEK (DE) for SLIC consortium.


• Based on the proprietary nanotechnology from the Institute of Chemical Sciences & Eng (LCPPM), EPFL.

• Envisaged Diagnostic Application Concept:

Lab-on-a-chip platform:

• Blood sample => Sample preparation => Detection and analysis and biochemistry with SLIC technology

SLIC™ Technology - Envisaged Dx Platform

• The SLIC bio-system consists of a synthetic ligand-gated ion channel (SLIC) that is incorporated in a lipid-based matrix.

• The SLIC comprises a capture molecule that can recognise and bind a selected bio-molecule (e.g. antibody) with very high specificity, even in full blood matrix.

• The recognition and binding events are monitored and detected via an ultra-sensitive electrical scheme (impedance spectroscopy), capable of detecting the binding of a few molecules.

[S. Terretaz et al. Angew Chem Int Ed 40 (2001) 1740-3]


Preparing the Proposal

• When calls came out in June 2002 we identified the call that had the best match to our objectives: • Research topic addressed: LSH-2003-1.2.5-4 New bioassays & biosensors using post-genomic

approaches for detection of harmful microbes. Budget: Eur 2 million.

• SLIC-Biosensors in Molecular Diagnostics: Nanotechnology for the Analysis of species

specific Microbial Transcripts • Acronym: SLIC

• Proposal Abstract (Abridged version):

• Molecular diagnostics of microbial pathogens is an integral part of modern medicine. Current widely used tools such as PCR are relatively expensive and unaffordable to many developing countries that need them most. The STREP consortium plans to develop a cost-effective platform for the identification of bacterial species based on the SLIC-Nanobiosystem. Using tmRNA transcripts of the bacterial ssrA gene, we will be able to detect, quantify and identify bacterial species in a single homogenous assay format. These transcripts occur in high abundance and contain a core sequence that is species specific, a feature which will be exploited to identify infectious disease pathogens.


The SLIC Consortium

Project No.: LSHB-CT-2005-513771STREP / Thematic Priority 1: Life Sciences, Genomics and Biotechnology for Health - Budget: EUR 2 million.

• Ayanda Biosystems S.A., Lausanne, Switzerland

Dr. Solomzi Makohliso, Coordinator • Laboratory of Physical Chemistry of Polymers & Membranes, EPFL, Switzerland

Prof. Horst Vogel, team leader

• IMTEK Albert Ludwigs Universitat Freiburg, Freiburg, Germany

Prof. Dr. G.A. Urban, team leader,

• DNA Diagnostics Laboratory, The National Diagnostics Centre, Galway, Ireland

Dr. Majella Maher, team leader,

• Estonian Biocentre, Laboratory of Gene Technology, Tartu, Estonia

Prof. Ants Kurg, team leader

• Eurelations AG, Zurich, Switzerland

Dr. Andrea Degen, Consortium Management


Electrophoresis electrodes

Lysis electrode

Bubble-expulsion structures

Phaseguides

SLIC Results - Cell Lysis & RNA Purification Lab-on-Chip


Harvest Cells

Introduce reagents into NucliPrep™ plate

One step cell lysis & RNA purification

Elute pure RNA for detection (e.g. RT-PCR)

NucliPrep™ HTS

step 1

step 2

step 3

< 1 min

≈ 8 min

< 1 min

On-Chip RNA Purification


BeNatural STREP

• MEA Biochip product achieved good global visibility, but a niche market.

• Here our objective was to strengthen existing product (MEA Biochips), and also innovate new MEA-based product lines addressing much larger markets.

• Strategy - Join a Network of Excellence (NoE) for nanobiotechnologies:

=> Nano-2-Life (www.nano2life.org).

http://www.nano2life.org/


BeNatural - Project Conception

• In Feb 04, I participated in a 2-day N2L workshop aimed at identifying potential project topics along with associated partners.

• Our objective was to identify opportunities for using our MEAs for biosensor applications.

=> Nanotube-based biosensors using electrochemical detection.

• Finalised consortium partners in Sep. 04, followed by 2 day workshop in Jan 05 to define WorkPackages.

• Grant finally submitted in Sep. 05 (score 28.1), and project start date Sep. 06.


BeNatural - Poject Summary

• Responded to call in NMP research area: “Using Nature as a model for New Nanotechnology-based processes.”

• Project Title: Bio-Engineered Nanomaterials for Research and Applications.

• The project aims to apply fundamental knowledge from structure and assembly of biological nanofibres and nanotubes towards innovative ways of designing and assembling man-made nanodevices. The main objectives of BeNatural were:

1. To develop novel self-assembling nanowires and nanotubes from building blocks inspired by natural folding and assembly.

2. To use these nanowires and nanotubes as templates for the growth of inorganic and bio/nanomaterials.

3. To develop techniques for manipulating, assembling and positioning these materials in a controlled manner, with a view to integrating them in future generations of nanoscale devices.

4. To use the self-assembling nanostructures in biosensing and tissue engineering applications (Ayanda’s main involvement).


BeNatural Consortium

• Department of Materials Science & Technology, University of Crete, Greece. Prof. Anna Mitraki, Coordinator - Design protein-based nanowires and nanotubes. • Department of Molecular Biology & Biotechnology, Tel-Aviv University, Israel. Prof. Ehud Gazit and Prof. Ari Barzilai peptide nanotubes - and tissue engineering.

• Department of Micro & Nanotechnology, Danish Technical University, Denmark. Prof. Winnie Svenden - Nanointegration and assembly.

• Laboratory of Biophysics & Surface Analysis, University of Nottingham, UK. Prof. Saul Tendler - Nanoscale characterization.

• Universidad de Santiago de Compostela, Spain. Dr. Mark van Raaij - Production of designed proteins.

• Institute Laue Langevin, Grenoble, France. Dr. Trevor Forsyth - Characterization of self-assembled nanotubes.

• Department of Biotechnology & Analytical Chemistry, Lund University, Sweden. Prof. Elisabeth Csoeregi - Consortium management and Biosensors.

• Ayanda Biosystems S.A., Lausanne, Switzerland. Dr. Solomzi Makohliso - Biosensor development and commercial exploitation.


PharMEA Key Objectives


The PharMEA Platform: Multi-Electrode Array technology platform for industrial pharmacology and toxicology drug screening (Budget: EUR 1.4M; 2009-2011)

Partners involved:

Partner Role in project 1. Ayanda Biosystems SA, Switzerland (coordinator) MEA biochips 2. Capsant Neurotechnologies Ltd., UK OTC bio-assays 3. Biologic SA, France Hardware

4. CEA-LETI MINATEC, France Hardware 5. Ecole d'ingénieurs de Genève, Switzerland OTC biochips 6. HEIG-VD, Switzerland Bio-informatics 7. Sanger Institute, Cambridge, UK Bio-assays

New features:

•Massive parallelization

•Real-time data analysis

•OTC platform

FP7 Project PharMEA


PharMEA Results

• Highest throughput MEA instrument prototype developed (512 - 1024 channels): – Multiwell format MEA Biochips. – Signal parameters extraction and data analysis tools (in real-time).

• Biological assays & protocols established for commonly used synaptic physiology

studies

• Strong intellectual property base – patent, know-how and proprietary software.

=> A spin-out Company was created to focus of these tools (www.qwane.com).

20


Summary

• SLIC - Technical challenges were encountered. However, a novel innovation was conceived: RNA Chip => Success overall.

• BeNatural - Technical objectives were attained. However, significant IP issues due to some “issues” with one partner. Ayanda never succeeded to gain promised IPR.

• DETECTHIV - Too many technical challenges and project objectives could not be achieved.

• PharMEA - Project objectives achieved, but some disagreement between one industry/RTD partnership and other SME closing down, leaving only Ayanda at the end. However, good success overall for Ayanda => Qwane Biosciences.


Perspectives - The Pros

• For SMEs: Good alternative source of funding, especially in recent

market environment - Cash in the Company without conceding equity.

• Good option to valorise our IP => Outsource Product Development. • Extends your R&D network & competences. • Opportunities to diversify product portfolio


Perspectives - The Cons

• Grant writing can be very time-consuming if you are project leader. • Negotiation process (FP6) very slow, tedious and difficult to understand

what’s needed, especially for first timers. Improvements in FP7. • If you are coordinator, the periodic reporting process can also be quite

cumbersome. • For SME’s must be careful for potential conflict of interests with other SME’s

in the consortium. • In general smaller consortium (e.g. STREP in FP6) is better than a large one

(e.g. Intergrated Project in FP6).


IPR & Commercialization Rights

• SME’s must make sure they are clear who will commercialise what

(and how they can make money) if project successful, and that they’re comfortable with the arrangement.

• Consortium Agreement must be drafted and contain all these elements, including the IP/commercial expectations of all the participating institutions. Any party bringing background IP must define terms of use of the IP with the agreement.

• Whenever possible, the workpackages should be designed and allocated such that it is clear who produces what, and who would own future IP from what deliverable etc.


Conclusions

• For SMEs, very important to define participation objectives beforehand.

• In Case 1: Objective was to valorise new IP (SLIC).

• In Case 2: Objective was to add innovative features to our product in the market in order to grow our market opportunities.

• In both cases, we also received much-needed cash resources.

• Our overall mission is to master the translation into innovative products of cutting-edge research results from EU centres of excellence.

• However, due to high risk profile it’s currently very difficult to find investor funding for this (critical) phase of product innovation chain:

=> Hence the immense value of public funding availability.

Dr. Soli Makohliso, CEO · 30/05/2012 · One step cell lysis & RNA purification . Elute pure RNA...

Documents

Transcript of Dr. Soli Makohliso, CEO · 30/05/2012 · One step cell lysis & RNA purification . Elute pure RNA...