A biotech service provider and innovative R&D company from Debrecen (Hungary) Gábor Zahuczky, PhD

Transcription

1 A biotech service provider and innovative R&D company from Debrecen (Hungary) Gábor Zahuczky, PhD

2 Outline of the presentation 1) Introduction to the genomics era 2) About UD-GenoMed in general 3) Our services and projects 4) An example from our IP portfolio

3 3x 10 9 ATTGCTTGGCCAATT ATTGCTTTGCCAATT 0.1% difference! SNP

4 February 2001: Completion of the Draft Human Genome June, 2004 January, 2005 Public HGP Celera Genomics

5 The future of genomics rests on the foundation of the Human Genome Project Source: Francis S. Collins et al. Nature 422, (14 Apr 2003)

6 President Obama's State of the Union address, given on Feb. 12, 2013 Every dollar we invested to map the human genome returned $140 to our economy. Every dollar.

7 Functional impacts generated by the sequencing of the human genome 7

8 Biomedical Applications of Genomics and Human Genome Sequencing Diagnosis of single gene, Mendelian diseases and Disorders Knowledge of predisposition towards specific diseases Genomics driven drug discovery, known as rational drug development Therapeutic products custom prescribed based on patient genomics, to maximize effect and reduce or eliminate side effects Repurposing or revitalization of some drugs shelved in development because of impact on a genomic few Identification of means to combat infectious organisms Gene therapies for inherited genetic diseases and disorders 8

9 Personalized Medicine: The Right Drug

10 at the Right Dose for the Right Patient

11 at the Right Time.

12 Vehicles: biomarkers Biomarkers are objective measures on normal or pathogenic processes or pharmacologic responses to a therapeutic or other health care intervention

13 Types of biomarkers No consensus terminology and classification for biomarkers (ie: genomicglossaries.com)

14 Biomarkers in drug development Source: Borsook et al. Discovery Medicine, 2011

15 Facts on companion diagnostics 1% of marketed drugs have companion Dx 10% of marketed drugs recommend genetic testing for optimal treatment 30% of all treatments in late clinical development rely on biomarker data 50% of all treatments in early clinical development rely on biomarker data 60% of all treatments in preclinical development rely on biomarker data 50% of all clinical trials collect DNA from patients to aid in biomarker development

16 In a nutshell UD-GenoMed Medical Genomic Technologies R&D Services Ltd. Innovative R&D spin-off company and service laboratory Independent legal entity with University of Debrecen share and with SME status Located in Nagyerdei Krt. 98. Theoretical Building Rents infrastructure from Clinical Genomic Center Interface for Clinical Genomic Center 16

17 Rationale of UDG foundation Concept: Commercializing services of Clinical Genomic Center Initializing functional genomic studies and clinical collaborations Develop pharma collaborations focusing on biomarker discovery By means of grants it begins to develop own IPs based on its own research activity 17

18 Milestones of UDG history 2008 SCHIZO08 project, services starting 2009 new projects - EPIGEN, new services (Affymetrix workstation) 2010 capital raising by individuals, EU grants, R&D projects with pharma partners 2010 Cell and protein engineering unit 2011 Illumina NGS installation 2012 IP patenting (3 pc) 2013 Business portfolio diversification 18

19 Our value chain of a clinical genomic study 19

20 Functional analysis services Functional analyses Real-time PCR applications customized Agilent Bioanalyser (QC) and Affymetrix Microarray services Sanger sequencing and fragment analysis Next generation seq. with illumina HiScan SQ Epigenetics and epigenomic analysis 20

21 For more information about our ongoing projects: Projects I. II. III. Ongoing project name SCHIZO-08 Biomarker discovery Dx dev. Immunprecipitation control dev. Ig v region sequencing Protein and cell engineering Tear Depletion Kit Development TRANSCOM, TRANSPATH TARGETAMD Project leader(s) László Nagy Bea Scholtz László Nagy Gábor Zahuczky Bálint László Bálint Gábor Zahuczky Zsolt Keresztessy Tőzsér Csutak Zahuczky László Fésüs Petrovski Gorán 21

22 Pharma-Biotech partnership model Stabile pharma partnership Patents, publicationts Predictable resource needs Diagnostic valorization of research projects Diagnostic utilization of platform technologies Separation of R&D and Dx activities CDx support for therapies (added value projects) Central Labor service Access to R&D grants targeting SMEs Extension to new therapeutic fields Dx development and approval Base for application of Dx systems Patents, publicationts Partnerships with KOLs Biotech SME interests 22 Pharma company interest

23 I. Biomarker discovery companion diagnostics development Prediction of Infliximab responsiveness from peripherial blood with gene expression analysis in rheumatoid arthritis and Crohn s disease 23

24 Fundamental problem #1 Approximately 30% of rheumatoid arthritis patients fail to respond to biologic therapy. Genes and Immunity Van Baarsen et al., 2010.,

25 Fundamental problem #2 Efficacy may decline following cycling to a second TNF inhibitor. Rubbert-Roth et al., 2009, Arthritis Research & Therapy

26 Canonical variance analysis (CVA) linear discriminant analysis (LDA)

27 Generated gene lists 27

28 F value of generated lists 28

29 Thank you for your kind attention! UD-GenoMed Medical Genomic Technologies Ltd. 98. Nagyerdei krt. Debrecen, Hungary H 4032 Phone/Fax: +36 (52) info@ud-genomed.hu 29