Nouvelle réglementation sur les dispositifs de diagnostic in vitro (IVD) : êtes-vous prêts? Jeudi 13 octobre h30 19h00 BioArk, Monthey

Transcription

1 Nouvelle réglementation sur les dispositifs de diagnostic in vitro (IVD) : êtes-vous prêts? Jeudi 13 octobre h30 19h00 BioArk, Monthey

2 Nouvelle réglementation sur les dispositifs de diagnostic in vitro (IVD) : êtes-vous prêts? 16h30 17h00 17h30 18h15 18h45 Accueil Mise en contexte» Thierry Duvanel, Directeur de l unité Diagnostic, SBC» Kim Rochat, Senior Partner, Medidee La nouvelle réglementation et ses impacts» Michael Meier, Senior Partner, Medidee Retour d expériences d Augurix SA avec le Simtomax» Dr Silvia Anghel, Senior R&D Scientist, Augurix Apéritif et networking 2

3 Swiss Biotech Center (SBC) - Who we Are Location Based in Switzerland on BioArk campus, heart of Health Valley Mission We provide infrastructure and development expertise to bridge the gap between research and industrial production in two complimentary domains Biopharmaceuticals Point-of-care IVD Format Non-for-profit, self-sustained corporation 3

4 Laboratory Product 4

5 What we Do Many innovative products would never reach consumers without a bridge over the gap between research and industrial production. At SBC, this bridge is supported by three pillars : Two GMP/ISO-certified small-scale production facilities: our DxLab and BioLab Partnerships / Collaborations with industrial manufacturing providers and regulatory experts Facilitated access to public Swiss and EU financing 5

6 Swiss Biotech Center (SBC) What we do Financing Support Direct Assistance for Swiss/EU public funding Fondation pour l innovation en Valais The DxLab Design & Small-scale prod of lateral-flow assay Lateral-flow expertise Class D clean-room, 35m 2 Kinematic equipment ISO13485-QMS The BioLab USP/DSP for expression of recombinant proteins. Strong bioprocess expertise. Class C clean-room, 127m 2 Disposable bioreactors. cgmp certified. Industry Partnerships / Collaborations 6

7 With the DxLab With the BioLab Our Focus Academics Virtual Biotechs Small / Mid-size Biotechs Big pharma / biotech players Science-based Poor business orientation Poor industrial experience No labs, low Capex Project oriented Single asset Highly skilled (exexecutive from pharma) Partially integrated Core knowledge on internalized target Rely on CRO and CMO Reaching next clinical phase to valorize assets Fully integrated Capability to market drugs Large scale thinking Easy access to CRO and CMO Academics CROs Pharmas/biotechs Big Dx players Science-based Strong knowledge of targets Poor business orientation Poor industrial experience No Dx development capabilities Focused on execution of the trials Little Dx experience in manufacturing and regulatory Increasing focus on Dx Need to provide Dx as companion - stratification tools See Dx as a "different world" Very few oriented on POC only Fully integrated with development capabilities and experience Direct access to biomarkers 7

8 Biopharmaceutical The BioLab Manufacturing activities of biologics Recombinant proteins and monoclonal antibodies for therapeutic uses in human or in animals for clinical trials (Phases I-II) Cell-based therapeutics for clinical trials Activities in the field of Biologics that would require a specific environment cgmp certified upstream / downstream bioprocess 127 m 2 Class C clean room 2 disposable bioreactors Capacity up to 200l in batches

9 cgmp Manufacturing Platfrom Expansion USP DSP Final bulk IPC

10 Innovative fill & finish shop A flexible technology provided by the worldwide innovation leader in fill & finish lines. Positioned for clinical studies and small specialty batches.

11 Diagnostics The DxLab Full capacity to design, develop and manufacture lateral-flow assays Clinical human diagnostics Veterinary Environment Food Production capability in batches up to units (batch 0) Class D clean-room, hygrometry control Dedicated Kinematic lateral flow equipment ISO13485-compatible Quality Management System 11

12 Lateral Flow Technology Invented in the 1990s IP was owned by 2-3 major players expired Door open to new applications Pharma development Clinical testing Forensics Environment N 1 technology choice for Pointof-Care Testing (POCT) Visual or Scan reading Performance comparable to ELISA Short development cycle Low costs

13 DxLab - Our Offering Assay development Industrialization Conjugation on various label agents Gold colloids Nano Rods Cellulose Manufacturing procedures development Batch 0 Technical dossier Accelerators Off-the-shelf designs and products (1) EasyReader ou unique smartphone reader R&D Biotin-Avidin strips (1) Starting Q

14 Visual Reading of Lateral Flow Tests Common issues Test interpretation Is a faint line really a positive? Traceability Loose relationship between patient, sample and test results Immaterial results Visual reading = no test results report 14

15 Introducing EasyReader A smartphone to read and interpret your lateral flow test Optimal results interpretation with neuralnetwork based algorithm Test results storage Geo/Time tagging Integration with back-end server/database Guided Instructions for Use

16 Provided and maintained by SBC Built by SBC under responsibility of customer EasyReader - Architecture App-specific code User interface Geo/time tagging Local data management Connectivity Integration (social network ) EasyReader SDK Available Q1-17 Customizable 1-4 test lines Identifies the image capture area Reads a video stream of pictures Interprets results based on neuralnetwork algorithm Manages the lighting conditions ISO compliant Provides abstraction layer to ios and Android 16

17 Take Home Message SBC has the infrastructure and development expertise to bridge the gap between research and industrial production for Biopharmaceutical products and Point-of-care IVD 17

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