Nanomedicine: Nanomedicine: current view, present and future main - PowerPoint PPT Presentation

Med.UL Med.UL i Med.UL i Med.UL Research Institute for Medicines and Pharmaceutical Sciences Research Institute for Medicines and Pharmaceutical Sciences – Research Institute for Medicines and Pharmaceutical Sciences – Research Institute for Medicines and Pharmaceutical Sciences i i Nanomedicine: Nanomedicine: current view, present and future main regulatory current view, present and future main regulatory challenges challenges EMEA, AdHoc Informal Group, April 29th (2009) EMEA, AdHoc Informal Group, April 29th (2009) Rogé ério Gaspar rio Gaspar Rog Med.UL – Med.UL – i Med.UL i Med.UL rgaspar@ff.ul.pt / / http://www.imed.ul.pt http://www.imed.ul.pt rgaspar@ff.ul.pt i i Nanomedicine & Drug Delivery Systems Group [ i Med.UL (Research Institute for Medicines and Pharmaceutical Sciences)] http://www.imed.ul.pt/Research/Nanomedicine%20and%20Drug%20Delivery%20Systems.htm

Med.UL i Med.UL Current positions Current positions Research Institute for Medicines and Pharmaceutical Sciences – Research Institute for Medicines and Pharmaceutical Sciences i Academic Academic • Full Professor, Faculty of Pharmacy University of Lisbon (FFUL, • Full Professor, Faculty of Pharmacy University of Lisbon (FFUL, Portugal) Portugal) • • Coordination of Pharmaceutical Technology sector (FFUL) Coordination of Pharmaceutical Technology sector (FFUL) • Coordinator of Nanomedicine & Drug Delivery Systems research • Coordinator of Nanomedicine & Drug Delivery Systems research group at the Research Institute for Medicines and Pharmaceutical group at the Research Institute for Medicines and Pharmaceutical Sciences (iMed.UL) Sciences (iMed.UL) • Member of the General Council at the University of Lisbon (Portugal) gal) • Member of the General Council at the University of Lisbon (Portu • Member of the Medicines Evaluation Committee at INFARMED • Member of the Medicines Evaluation Committee at INFARMED (Portugal) (Portugal) Med.UL – i Med.UL • • Member of the coordination of MSc Member of the coordination of MSc s s in in • • Regulatory Affairs, Regulatory Affairs, i • • Pharmaceutical Engineering, Pharmaceutical Engineering, • • Advanced Pharmacotechnics Advanced Pharmacotechnics • • Doctoral Programme in Bionanotechnology Doctoral Programme in Bionanotechnology

Med.UL i Med.UL Main dates Main dates Research Institute for Medicines and Pharmaceutical Sciences – Research Institute for Medicines and Pharmaceutical Sciences i • 1984- -2006: University of Coimbra 2006: University of Coimbra • 1984 • 1995- -2002: INFARMED & EMEA (expert, CPMP & QWP member, 2002: INFARMED & EMEA (expert, CPMP & QWP member, • 1995 management board, GMP inspectors group & MRA- -Japan); Japan); management board, GMP inspectors group & MRA Pharmaceutical Committee and Standing Committee (European Pharmaceutical Committee and Standing Committee (European Comission); Medicines working group (European Council / EU) Comission); Medicines working group (European Council / EU) • 2002- -2008: Consultant to Pharmaceutical Industry 2008: Consultant to Pharmaceutical Industry • 2002 • 2005- -2006: Consultant for training to ASEAN regulatory authorities 2006: Consultant for training to ASEAN regulatory authorities • 2005 • Since 2006: University of Lisbon • Since 2006: University of Lisbon Med.UL – • Since 2008: associated to Pharmacies Association (Portugal) as a • Since 2008: associated to Pharmacies Association (Portugal) as a i Med.UL consultant in issues not related to medicinal products consultant in issues not related to medicinal products • Since 2008: back to Medicines Evaluation Committee at INFARMED • Since 2008: back to Medicines Evaluation Committee at INFARMED i

Med.UL i Med.UL Drug Carriers Unit / Center of Neurosciences and Cell Drug Carriers Unit / Center of Neurosciences and Cell Biology Biology Research Institute for Medicines and Pharmaceutical Sciences – Research Institute for Medicines and Pharmaceutical Sciences @ University of Coimbra (1993- -2000) 2000) @ University of Coimbra (1993 i • A few examples of previous research • A few examples of previous research – Leishmania therapy with polymeric nanoparticles therapy with polymeric nanoparticles – Leishmania • Gaspar et al, Pharmaceutical Research 9 (6): 782-787 (1992) – – Polymeric nanoparticles steric stabilisation Polymeric nanoparticles steric stabilisation: physico : physico- -chemical mechanisms chemical mechanisms • Lourenço et al, International Journal of Pharmaceutics 138: 1-12 (1996) – Nanoparticles for protein delivery Nanoparticles for protein delivery – • Martins et al, International Journal of Pharmaceutics 142: 75-84 (1996) Macrophage interactions with polymeric nanoparticles (ROI and NO production) with polymeric nanoparticles (ROI and NO production) – – Macrophage interactions • Cruz et al, Pharmaceutical Research 14 (1): 73-79 (1997) – – Nanocapsules and nanoparticles in mechanisms in ocular delivery Nanocapsules and nanoparticles in mechanisms in ocular delivery Alfar et al, ” , II Spanish-Portuguese Congress on Controlled Release, SPLC-CRS, 2-5 th February 1997 • – Polymeric nanoparticles with new contrast agents for MRI new contrast agents for MRI – Polymeric nanoparticles with • Gameiro , MSc thesis 2004 Lipoplexes and pH sensitive liposomes for gene and antisense oligonucleotide gene and antisense oligonucleotide – – Lipoplexes and pH sensitive liposomes for delivery delivery Med.UL – i Med.UL • Simões et al, Gene Therapy , 6, 1798-1807 (1999) – – Lentiviral vectors for Huntington Lentiviral vectors for Huntington’ ’s disease s disease • Gene Therapy NFP37 Annual Meeting, Friburg, Switzerland, 6-7 October 2000 i – – Cancer therapy using paclitaxel biodegradable nanoparticles Cancer therapy using paclitaxel biodegradable nanoparticles • Fonseca et al, Journal of Controlled Release 83, 273-286 (2002) – Cancer therapy using sterically stabilised targeted liposomes Cancer therapy using sterically stabilised targeted liposomes – • Moreira et al, Pharmaceutical Research 19, 265-269 (2002)

i Med.UL i Med.UL i Med.UL i Med.UL – – Research Institute for Medicines and Pharmaceutical Sciences Research Institute for Medicines and Pharmaceutical Sciences carriers Nanopharmaceuticals: overall view of particulate

i Med.UL i Med.UL i Med.UL i Med.UL – – Research Institute for Medicines and Pharmaceutical Sciences Research Institute for Medicines and Pharmaceutical Sciences Nanomedicine & Nanomedicine & DDS DDS Lisbon approach to 3Ds: Lisbon approach to 3Ds: iMed.UL iMed.UL

Med.UL i Med.UL NANOMEDICINE & Drug Delivery Systems NANOMEDICINE & Drug Delivery Systems Coordination Rogério Research Institute for Medicines and Pharmaceutical Sciences – Research Institute for Medicines and Pharmaceutical Sciences Gaspar National & International i Colaborations Projects 1 2 3 4 Oncology & Infectious Dermal Pulmonary Infectious Dermal Pulmonary Inflamation Diseases Research Delivery and Diseases Research Delivery and L L iposomes Liposomes Liposomes macromolecular macromolecular iposomes Nanoparticles Nanoparticles Nanoparticles Nanoparticles complexation complexation Vaccines Vaccines Polymeric Ther. Polymeric Ther. Therapeutic activity (a m a s tig o te s /5 0 0 n u c le i) x liv e r w e ig th x 2 x 1 0 5 300 of Trifluralin Liposom es 250 200 150 100 50 Med.UL – 0 i Med.UL Negative Positive Liposomal 1 2 3 Control Control (Sb) TFL Team i

Med.UL i Med.UL Nanomedicine & Drug Delivery Nanomedicine & Drug Delivery Systems Systems Research Institute for Medicines and Pharmaceutical Sciences – Research Institute for Medicines and Pharmaceutical Sciences Internal Network Internal Network i NeuronGlia MolCellBio MetGen NeuronGlia MolCellBio MetGen Animal models siRNA nanosystems Protein formulations and stabilisat Animal models siRNA nanosystems Protein formulations and stabilisat Nano- -formulations formulations Transport proteins and models Nano Transport proteins and models Nano&DDS Nano&DDS Animal models Animal models Antibiotics in bone cement PK/Animal models PK/Animal models Antibiotics in bone cement Animal models Animal models Med.UL – Toxicity i Med.UL AHA/Chitosan Bacterial Activity Toxicity AHA/Chitosan Bacterial Activity Chemical- -based DDS based DDS Chemical MedChem PharmacolSci MedChem PharmacolSci i ChemBioTox ChemBioTox