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BIOMEDICA LIFE SCIENCES SA

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Organizing and Managing a Radiopharmaceutical Production Unit A strategic alliance ... Infrastructure Implementation of Good Manufacturing Practice ... – PowerPoint PPT presentation

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Title: BIOMEDICA LIFE SCIENCES SA


1
BIOMEDICA LIFE SCIENCES SA
  • Expanding a commercial SME
  • specializing in radiopharmaceuticals and
  • high-tech medical imaging instrumentation
  • into a dynamic group of Biotechnology companies

2
BIOMEDICA LIFE SCIENCES SAEstablished in
1994Total number of employees 29 2003 revenue
from sales 4,016 mil EBT 0,9 mil
Main concept for the expansion
  • Coupling BIOMEDICAs management and marketing
    resources and expertise
  • with
  • excellence in biotechnological research
  • of Greek Research Institutes and University
    Laboratories

3
Strategy Main Points and Objectives
  • 1. Establishing the companys RD base through
    the collaboration with research groups in
    National Research Centres and Universities
  • 2. Organizing and managing a state-of-the-art
    Radiopharmaceuticals Production Unit (GMP) based
    on the infrastructure and know-how of NCSR
    Demokritos
  • 3. Designing, conducting and funding of
    multicenter clinical trials in Greece and abroad
  • 4. Expanding into Molecular Diagnostics
    Genetic Testing

4
Establishing the RD BaseCollaborating with the
Greek Research Community I. Direct funding of
novel research ideas in Radiopharmacy and
Radiodiagnostics
  • 1. Radiolabeled Biomolecules in Diagnosis and
    Therapy
  • Tc99m labelled bombesin, minigastrin and
    neurotensin analogues
  • Principal Investigators A. Varvarigou, NCSR
    Demokritos T. Maina, B. Nock, NCSR
    Demokritos
  • Greek patents granted European patents
    pending
  • Tc99m labelled YIGSR for radiodiagnosis
    immunotherapy
  • Principal InvestigatorG. Koliakos, University
    of Thessalonica
  • Greek patent granted European patent granted
  • 2. Peptide Design and Synthesis
  • Principal Investigator P. Cordopatis,
    University of Patras
  • Greek patents granted European patents
    pending

5
II. Participating as co-sponsor and/or end-user
in selected research programs funded by GSRT and
EU
  • EKBAN 2003-2006 ?e???t? ???µ?s?µata
    ??t?µ???? (??????) ?a? ?e???????e? ??a G???d?a??
    Te?ape?a ?a? S??e?? ?????? ?p?p?d?? ??f?as?
    Te?ape?t???? ???te???? se e?t?µ??? S?st?µata
    ?a?a?????, ???F? ??µ????t??, ??st?t??t?
    Pasteur, Biomedica, 582.000 (budget of project,
    Biomedica participation 245.000 )
  • ??O? 2003-2006 ???pt??? ?a? a???????s?
    ?ad??ep?s?µasµ???? ß??µ????? ??a d?????s? ?/?a?
    ?e?ape?a ?e?p?as??? d?af???? µ??f?? Biomedica,
    264.000 (granted by 50)
  • ????? ??????????S S????G?S??S

6
Biomedica Research Personnel
  • May 2004
  • BIOMEDICA Funded Research Programs
  • 7 full time positions 4 PhDs
  • Co-Sponsored Research Programs
  • 5 full time positions 4 PhDs

7
2. Organizing and Managing a
Radiopharmaceutical Production Unit
  • A strategic alliance between BIOMEDICA and the
    Institute of Radioisotopes Radiodiagnostic
    Products has been approved by the Board of
    Directors of NCSR Demokritos in May 2004

8
  • Joint Venture
  • Organization and Management of the Institutes
    unique Infrastructure
  • Implementation of Good Manufacturing Practice
    (GMP) Protocols

9
  • Production of selected highly demanded
    radiopharmaceuticals in Greece and abroad
  • Pilot production of novel products for clinical
    trials
  • Providing specialized GMP lyophilization services
    to third parties
  • Providing education and training

10
NCSR Demokritos Infrastructure
  • Class 100 lyophilization clean room
  • Radiochemical Radiobiological Quality Control
    Labs
  • Hot-Cells
  • A joint BIOMEDICA NCSR Demokritos team will
    carry out development, production and QC of
    radiopharmaceuticals

11
4. Expanding into Molecular Diagnostics
Genetic Testing
  • BioGenomica S.A.
  • Centre for Genetic Testing and Analyses
  • A spin-off Company of NCSR Demokritos
  • established in February 2004
  • The companys business plan has been successfully
    incorporated in the PRAXE Phase B Program of GSRT
    with a total budget of 2 mil .

12
BioGenomica SA Centre for Genetic
Testing and Analyses a spin-off company of NCSR
Demokritos
  • Genetic testing for predisposition to hereditary
    diseases
  • Cancer -Neurological and Psychiatric Disorders -
    Rare Diseases
  • DNA sequencing tailoring specific laboratory
    needs
  • Food industry Public health

13
  • Providing services to hospitals, clinics and
    diagnostic centres in Greece and abroad
  • Participation in international genetic testing
    networks
  • Providing services to the food and agricultural
    industry

14
  • June 2004
  • total number of employees 6 (3 PhDs)
  • State-of-the-art instrumentation
  • Automated DNA Sequencing, dHPLC, Real-time PCR
    and DNA microarray-based technologies
  • European Molecular Quality Network evaluation and
    accreditation

15
BioGenomica Research
  • Establishment of International Scientific
    Advisory Board
  • Design of clinical research protocols jointly
    with medical centers and collaborative groups and
    networks
  • Participation in large-scale genetic epidemiology
    studies
  • Incubation of basic science, biochemical and
    biophysical research projects jointly with
    Universities and Research Institutes

16
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