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Importance of Ethics, Bio-security and Good Practices for Better Scientific Collaboration [Hechmi Louzir, Institut Pasteur de Tunis, Tunisia]
 

Importance of Ethics, Bio-security and Good Practices for Better Scientific Collaboration [Hechmi Louzir, Institut Pasteur de Tunis, Tunisia]

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Workshop on Higher Education and Professional Responsibility in CBRN Applied Sciences and Technology across the Sub-Mediterranean Region ...

Workshop on Higher Education and Professional Responsibility in CBRN Applied Sciences and Technology across the Sub-Mediterranean Region
3-4 April 2012. Palazzo Zorzi, Venice
Session 3. Inspiring Initiatives and Scientific Cooperation

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    Importance of Ethics, Bio-security and Good Practices for Better Scientific Collaboration [Hechmi Louzir, Institut Pasteur de Tunis, Tunisia] Importance of Ethics, Bio-security and Good Practices for Better Scientific Collaboration [Hechmi Louzir, Institut Pasteur de Tunis, Tunisia] Presentation Transcript

    • Importance of ethics, bio-security and good practices for better scientific collaborationHechmi Louzir, Institut Pasteur de Tunis13, Place Pasteur, 1002, Tunis-Belvédère, Tunisiahttp://www.pasteur.tn
    • Introduction• Interconnection and interdependence affect many global challenges like health, food resources, energy,• Scientific cooperation is essential to address and reduce the burden of the global challenges.• Collaboration between scientists contributes to build capacity and help address the problems we face.• Multidisciplinary is now essential for large projects.
    • Introduction (II)• The world is facing changes that science continues to explore the challenges.• This creates a situation of public concerns on the ethical aspects and the risk associated with this research.• The present and future generations of scientists are facing the enormous challenge of developing socially relevant research that could be translated into practice.
    • www.pasteur.tn Institut Pasteur de Tunis Over a century at the service of Public Health • Biomedical Analysis and Public Health Activities • Manufacturing of therapeutic sera and vaccines • Research & development • Training
    • Research & development Field of activities Infectious diseases +++ (national health priorities)Leishmaniasis, hydatidosis, tuberculosis, viralhepatitis, rabies, papillomavirus, enteroviruses, avianvirus, other veterinary microbial diseases, etc. Scorpion and snake envenoming Congenital immune deficiencies Genetic susceptibility to metabolic and infectiousdiseases, cancer R&D biotechnology and bioprocesses
    • Research & development Financial support•National support through the eligibility of the groupsto be Research Laboratories (9) supported by theTunisian Ministry of Higher Education and ScientificResearch•International financial supports from EuropeanCommission-PCRD; World Health Organization/TDR;National Institutes of Health; Walter Reed ArmyInstitute of Research; International Agency of AtomicEnergy; The Wellcome Trust; Agence Nationale deRecherche; OTAN; The network of Pasteur Institutes-RIIP; NEPAD; TWAS; notably).
    • International Partners of Institut Pasteur de Tunis 15 funding agencies 66 ongoing research projects More than 75 partners institutions in 28 countries CSE-Juin 2011
    • 140 Scientific publications of IPT 130 122120 111 Publications international journals 102100 94 87 Publications nationals80 73 TOTAL 65 5860 49 40 41 3840 35 36 33 27 2720 9 8 9 8 7 6 7 2 0 0 2003 2004 2005 2006 2007 2008 2009 2010 2011
    • Patents Chimeric polypeptide useful as a medicament comprises a selectin C-type lectin domain joined through a linker to an integrin von Willebrand A domain having a metal ion-dependent adhesion site (FR2909672, 2008-06-13) FATHALLAH MOHAMED DAHMANI; JARBOUI MOHAMED ALI; DELLAGI MOHAMED KOUSSAY METHOD FOR PREPARING RECOMBINANT MYCOBACTERIAL POLYPEPTIDES IN YEAST AND THEIR USE IN DIAGNOSIS OF MYCOBACTERIAL RELATED DISEASES (WO2008010096, 2008-01-24 ). FATHALLAH MOHAMED DAHMANI (TN); BARBOUCHE MOHAMED RIDHA (TN); HO JOHN L (US); BENABDESSELEM CHAOUKI (TN); DELLAGI KOUSSAY (TN); LARGUECHE BEYA (TN) RECOMBINANT PICHIA PASTORIS STRAINS AND PROCESS FOR THE PRODUCTION OF RECOMBINANT HUMAN INTERFERON ALPHA (WO2007099462, 2007-09-07) FATHALLAH MOHAMED DAHMANI (TN); KALLEL HELA (TN); DELLAGI KOUSSAY (TN); REBHI IMEN (TN); AYED ATEF (TN) MAUROCALCINE, ANALOGUES THEREOF AND THEIR THERAPEUTICAL USES (DE60126067D, 2007-03-08) KHARRAT RIAD (TN); MABROUK KAMEL (FR); EL-AYEB MOHAMMED (TN); ROCHAT HERVE (FR); SABATIER JEAN-MARC (FR) GENE ASSOCIATED WITH LEISHMANIA PARASITE VIRULENCE (YU99603, 2006-05-25) BEN ACHOUR YOSSER (TN); CHENIK MEHDI (TN); LOUZIR HECHMI (TN); DELLAGI KOUSSAY (TN) POLYPEPTIDES OF LEISHMANIA MAJOR AND POLYNUCLEOTIDES ENCODING SAME AND VACCINAL, THERAPEUTICAL AND DIAGNOSTIC APPLICATIONS THEREOF (WO2006108720, 2006-10-19) CHENIK MEHDI (TN); LAKHAL SAMI (TN); LOUZIR HECHMI (TN); DELLAGI KOUSSAY (TN) COMPOSITION COMPRISING THE N-TERMINAL REGION OF LEISHMANIA HISTONE H2B, USE THEREOF FOR INDUCING AN IMMUNE RESPONSE (WO2006097642, 2006-09-21) CHENIK MEHDI (TN); LOUZIR HECHMI (TN); DELLAGI KOUSSAY (TN) LEISHMANIA ANTIGENS SUITABLE FOR A DIAGNOSTIC KIT OF LEISHMANIA (WO2006079565, 2006-08-03) DELLAGI KOUSSAY (TN); KAMOUN- ESSGHAIER SAYDA (TN); GUIZANI IKRAM (TN) USE OF ZKW PEPTIDE FOR PREPARING AN INHIBITOR DRUG AGAINST PLATELET AGGREGATION (WO2005014021, 2005-02-17) MARRAKCHI NAZIHA (TN); MABROUK KAMEL (FR); SABATIER JEAN-MARC (FR); EL AYEB MOHAMED (TN); ROCHAT HERVE (FR) Amino-butyrate derivatives of venoms (GB2335923, 1999-10-06) SABATIER JEAN-MARC (FR); EL-AYEB MODHAMMED (TN); VAN RIETSCHOTEN JURPHAAS (FR); ROCHAT HERVE (FR) LEBETIN PEPTIDES AS PLATELET AGGREGATION INHIBITORS (WO9829436, 1998-07-09) ROCHAT HERVE (FR); MABROUK KAMEL (FR); EL-AYEB MOHAMMED (TN) VACCINE COMPOSITION COMPRISING RECOMBINANT BCG EXPRESSING GP63 FUSION PROTEIN (WO9610081, 1996-04-04) GICQUEL BRIGITTE (FR); ABDELHAK SONIA (FR); DELLAGI KOUSSAY (TN); LOUZIR HECHMI (TN)
    • Funding agencies (alphabetic order) Nature of the grantANR (Paris, France) R&DBIO-RAD (Paris, France) Patent strengtheningEuropean Commission (Brussels, Belgium) R&DFondation Mérieux (Lyon, France) Euro-Mediterranean Public Health Information SystemFort Dodge Animal Health Vaccine development and validationInternational Atomic Energy Agency(Vienna, Austria) R&D capacity building and trainingInstitut Pasteur International Network(Paris, France) R&D and Public Health Activities (control)Joint WHO/EMRO-COMSTECH(Islamabad, Pakistan) R&DNational Institutes of Health (Maryland, USA) R&D, clinical researchNorth Atlantic Treaty Organization(Brussel, Belgium) R&DThe New Partnership for Africa’s Development(Johannesburg, South Africa) R&DWalter Reed Army Institute Of Research(Washington, USA) Clinical trials (phase II and phase III)Welcome Trust (London, UK) R&D, trainingWHO/EMRO (Cairo, Egypt) R&D for controlWorld Health Organization TDR(Geneva, Switzerland) R&D, capacity building, training
    • The Institut PasteurInternational Network
    • Institut Pasteur de Tunis ANDI Centre of Excellence for Bio-molecules Discovery African Network for Drugs and Diagnostics Innovation (ANDI), United Nations Economic Commission for Africa(UNECA), Menelik II Avenue, PO Box 3001, Addis Ababa, Ethiopia. Tel: +251 11 544 362; E-mail: info@andi-africa.org
    • Norms &Regulations• Ethical aspects (based on the different recommendation issued by the international community)• The IPT has an Institutional Review Board (IRB) established since 1992, the first in Tunisia (before the National Committee of Medical Ethic).• The IRB meets to review proposals and relevant files and consent forms and, if needed, to provide corrective measures.• Clearance is only provided when the revised application meets ethics.• The transfer of biological material (between the IPT and other national or international research Centers) is governed specific procedure (MTA)
    • Norms &Regulations (II)• Compliance with good practice (clinical, laboratory, production):• Good Manufacturing Practice (GMP): IPT remains the only producer of vaccines and sera for human use in Tunisia. Our production is conducted according to current GMP and is focused on BCG and anti-sera (anti-rabies, anti-scorpion and anti- viper).• Now, efforts were developed to introduce Good Clinical Practice (GCP) in clinical trials.• Presently, the IPT is in the phase of introducing Good Laboratory Practice (GLP). Quality assurance is implemented at different levels with a specific committee (since 2008).• Aspects related to bio-safety and protocols for genetically modified organisms (GMO): role of our Hygiene and Security Committee.
    • Actions planned or ongoing in IPT• A monitoring committee of deontology (Comité de Veille Déontologique), created in 2012: A code of scientific deontology will be established, it will clearly state the rules of good conduct in research teams and investigation and seeks to respect people and their scientific work (conflict between researchers, students, fraud, plagiarism, etc.).• A committee for animal welfare: it will establish the rules and conditions for research using vertebrates animals.All these rules, standards and procedures are requiredfor good scientific collaboration. In some institutionsgaps exists, they constitute real barriers for success ingrant applications and scientific dissemination
    • Management of Intellectual Property Rights• Research is unethical if the results are not translated into practice for the benefit of patients and society.• It is the duty of the research team to make the necessary efforts to decision makers for translating the research results into practice.• At IPT, we have a small team in charge of all aspects related to IP, Technology Transfer, Valorization/Communication and promotion of Research projects: - Establish rules and procedures for declarations of invention, patenting. - Valorization of patents and other know-how to promote industrial applications, including public-private partnership. This is the best way for that research can lead to products that serve those in need.
    • Conclusion• For a good international collaboration a particular attention should be put regarding legal, ethical and procedural aspects, including IP.• It is the role of Scientists, Policy makers, Civil society, and Managers of research organizations.