©
 Rogério
 Gaspar,
 2013
 
Nanomedicines
 within
 regulatory
 science:
 
 
The “nanotechnology revolu...
Rogério Gaspar
October 24th 2013
Reference
 posi:ons
 
• 
• 
• 
• 
• 
• 
• 
• 
• 
• 
• 
• 
• 
• 
• 
Vice-­‐Rector
...
EUFEPS
Regulatory Science Network
 
 
Launched
 at
 1st
 Mee:ng
 of
 the
 Steering
 CommiDee
 
Leid...
The
 global
 agenda
 for
 “medicines
 research”:
 
EUFEPS
 as
 an
 indispensable
 partner
Rogério Gas...
Rogério Gaspar
October 24th 2013
The
 global
 agenda
 for
 “medicines
 research”:
 
Regulatory
 Science
 ...
Rogério Gaspar
October 24th 2013
 
European
 Journal
 of
 Pharmaceu:cal
 Sciences
 47
 (2012):
 979-­‐98...
©
 Rogério
 Gaspar,
 2013
 
Personalized
 Medicine
 
 
&
 the
 integra:on
 of
 diagnos:cs
 and
...
Rogério Gaspar
October 24th 2013
Where
 does
 nanotechnology
 belong
 in
 the
 map
 of
 science?
 
Alan...
Liposomal
 
-­‐
 lipidic
 
±
 targeEng
 and
 
 
imaging
 agents
 
Technology
 Classes
 
Rogério Ga...
Liposomal
 
-­‐
 lipidic
 
±
 targeEng
 and
 
 
imaging
 agents
 
Technology
 Classes
 
Rogério Ga...
44 marketed Nano-delivery products
Product
 
Abraxane
 
Abelcet
 
Generic
 
Formulation
 
Indication
 
P...
18 marketed Pharmaceutical products
Product
 
Composition
 
Indication
 
Company
 
Rogério Gaspar
October 24th...
Rogério Gaspar
October 24th 2013
Diagnos:cs
 &
 Therapeu:cs
 
Faculdade
 de
 Farmácia
 da
 Universidade
...
15 marketed Imaging/diagnostic & biomaterial
Product
 
Lateral flow tests
 
 
Composition
 
Indication
 
In ...
Rogério Gaspar
October 24th 2013
>70 Nanomedical Products in Clinical trials
Cardiovascular
Diseases
 
Endocrinology
...
Nanopharmaceu:cals:
 
 
overall
 view
 of
 par:culate
 carriers
 transla:on
 
Faculdade
 de
 Farmácia...
Issues
• 
Rogério Gaspar
October 24th 2013
Materials Science
–  Challenges arising from new materials (inorganic nanopar...
Key factors for design
Rogério Gaspar
October 24th 2013
(in respect of specific medical use)
•  Materials Science and F...
Rogério Gaspar
October 24th 2013
(a)
 Amphiphlic
 fullerene
 monomer
 
 
 
 
 
 able
 to
 self
 a...
Rogério Gaspar
October 24th 2013
(a)
 liposome
 containing
 two
 
 
 
 
 
 
 drugs
 
 
(b)
 p...
Methodology
 Harmonisa:on
 
 
versus
 Technology
 Transfer
 
Marina
 A.
 Dobrovolskaia
 and
 ScoZ
 ...
Rogério Gaspar
October 24th 2013
Technology
 (science-­‐based)
 strategies
 
•  Con:nuous
 manufacturing
 
–  B...
Rogério Gaspar
October 24th 2013
Faculdade
 de
 Farmácia
 da
 Universidade
 de
 Lisboa
 
iMed.UL
 (Medici...
Rogério Gaspar
October 24th 2013
Hook,
 A.
 L.,
 Chang,
 C.
 Y.,
 Yang,
 J.,
 Scurr,
 D.
 J.,
 Lang...
Rogério Gaspar
October 24th 2013
Belliveau
 et
 al,
 Molecular
 Therapy–Nucleic
 Acids
 (2012)
 1,
 e37;	...
Rogério Gaspar
October 24th 2013
Faculdade
 de
 Farmácia
 da
 Universidade
 de
 Lisboa
 
iMed.UL
 (Medici...
Intracellular
 trafficking
 modula:on
 
 
for
 advanced
 drug
 delivery
 
Rogério Gaspar
October 24th 2013
...
Rogério Gaspar
October 24th 2013
Challenges
 from
 metas:sa:on
 and
 recurrence
 
Klopp
 AH,
 Lacerda
 L,...
Rogério Gaspar
October 24th 2013
Salva:,
 A.
 et
 al.
 Nature
 Nanotech.
 8,
 137–143
 (2013).
 
 
Ga...
Rogério Gaspar
October 24th 2013
(a)
 biological
 phenomena
 that
 can
 theore:cally
 influence
 nanomedicin...
General approaches to NanoDDS design
 
Rogério Gaspar
October 24th 2013
Petros
 and
 DeSimone,
 Strategies
 in...
Clinical
 Trials
 
 
Heidi
 Ledford,
 “4
 ways
 to
 fix
 the
 Clinical
 trial”,
 Nature,
 477
...
Rogério Gaspar
October 24th 2013
Quan:ta:ve
 Systems
 Pharmacology
 
Quan:ta:ve
 and
 Systems
 Pharmacology	...
Rogério Gaspar
October 24th 2013
Current and future regulatory challenges
•  combination therapy
–  The trend for reformu...
Rogério Gaspar
October 24th 2013
AAPS
 J,
 2013
 (In
 Press)
 
Faculdade
 de
 Farmácia
 da
 Universida...
Rogério Gaspar
October 24th 2013
Faculdade
 de
 Farmácia
 da
 Universidade
 de
 Lisboa
 
iMed.UL
 (Medici...
Rogério Gaspar
October 24th 2013
New
 areas
 for
 pharmaceu:cal/health
 R&D:
 
Advanced
 Therapies
 
Adapt...
Rogério Gaspar
October 24th 2013
Nanomedicine
 NOW
 ?
 
"Converging
 today’s
 Building
 Blocks
 to
 Ethic...
Pharmaceutical Sciences beyond 2020 –
The rise of a new era in healthcare
Faculdade
 de
 Farmácia
 da
 Universida...
 
Intracellular
 Trafficking
 Modula:on
 for
 
 
Advanced
 Drug
 Delivery
 
Bioorganic
 Chemistry|Pedro
...
of 40

Nano far 2013_10_24_rogerio_gaspar

Published on: Mar 3, 2016
Published in: Technology      Health & Medicine      
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Transcripts - Nano far 2013_10_24_rogerio_gaspar

  • 1. ©  Rogério  Gaspar,  2013   Nanomedicines  within  regulatory  science:     The “nanotechnology revolution” current  opportuni:es  within  R&D  and  future  developments  for  healthcare   Rogério  Sá  Gaspar   Faculdade  de  Farmácia  da  Universidade  de  Lisboa  &     iMed.UL  (Medicines  Research  Ins:tute,  hDp://www.imed.ul.pt  )   rgaspar@ff.ul.pt   24/10/13   Faculdade  de  Farmácia  da  Ua  Universidade  Lisboa   Faculdade  de  Farmácia  d niversidade  de  de  Lisboa   iMed.UL  (Medicines  Research  Ins:tute)   iMed.UL  (Medicines  Research  Ins:tute)   1
  • 2. Rogério Gaspar October 24th 2013 Reference  posi:ons   •  •  •  •  •  •  •  •  •  •  •  •  •  •  •  Vice-­‐Rector  R&D,  University  of  Lisboa  (ULisboa),  Portugal  (2013-­‐  )   General  Council  of  University  of  Lisbon  (UL,  Portugal),  2008-­‐2013   Vice-­‐Dean,  Research  &  Tech  Transfer/  InternaEonal  Affairs  (FFUL).  2012-­‐2013   Head  of  Department  PharmaceuEcal  Technology,  FFUL,  2007-­‐2013   Leader  research  group  “Nanomedicine  &  Drug  Delivery  Systems”  (iMed.UL),  2007-­‐2013   Group  Leader  InTraCell_ADD  (iMed.UL),  2013-­‐   SPCF,  Vice-­‐President  Portuguese  Society  for  PharmaceuEcal  Sciences  (2011-­‐)   FIP,  Vice-­‐chair  Regulatory  Science  Special  Interest  Group  (2011-­‐)   EUFEPS,  ExecuEve  CommiZee  (2009-­‐2013),  VP  for  Science  Policy  in  2011/2012   EUFEPS,  Chair  of  Regulatory  Science  Network  (2011-­‐)   External  Advisory  Board  of  EuroNanoMedNet  (ERA-­‐NET  in  Nanomedicine,  FP7,  EU)   Strategic  Advisory  Board  CIBER-­‐BBN  (Spain)   External  Advisory  Board  of  European  Doctoral  Program  in  Nanomedicine  (NANOFAR)   ScienEfic  Advisory  Board  of  TRANS-­‐INT  (Large  FP-­‐7  project)   ScienEfic  Advisory  Board  of  Z-­‐Cube  (Zambon  group,  Milano,  Italy)   •  Editorial  Board/Interna:onal  Advisory  Board:  Nanomedicine:  Nanotechnology,  Biology,  and  Medicine  (Elsevier),   InternaEonal  Journal  of  Nanomedicine  (Dove  Press),  Drug  Delivery  and  TranslaEonal  Research  (Springer)  (…)   Faculdade  de  Farmácia  da  Universidade  de  Lisboa   iMed.UL  (Medicines  Research  Ins:tute)
  • 3. EUFEPS Regulatory Science Network     Launched  at  1st  Mee:ng  of  the  Steering  CommiDee   Leiden  (Netherlands),  Saturday  (morning),  January  15th,  2011   Rogério  Gaspar  (chair)  (iMed.UL  &  University  of  Lisboa)   Hans  Linden    (Secretary)  (EUFEPS  Senate  &  EUFEPS  European  Projects)   Daan  Crommelin  (EUFEPS  Senate,  TI  Pharma  &  University  of  Utrecht)   Beatriz  Silva  Lima  (iMed.UL  &  University  of  Lisboa;  EMA-­‐CHMP/ch.SWP)   Bert  Leudens  (MEB,  Netherlands;  EMA-­‐CHMP;  Utrecht  University)   Malcolm  Rowland    (Manchester,  UK  /  EUFEPS  Senate)   Afla  Hincal  (EUFEPS  Senate;  HaceDepe  University,  Ankara)     and  also  invited  observers  from  other  EUFEPS  networks   Faculdade  de  Farmácia  da  Universidade  de  Lisboa   iMed.UL  (Medicines  Research  Ins:tute)
  • 4. The  global  agenda  for  “medicines  research”:   EUFEPS  as  an  indispensable  partner Rogério Gaspar October 24th 2013 Environment  &  Pharmaceu:cals   Biotechnology         QbD  &  PAT   Safety     Sciences     Quality   Safety     Sciences   Pharmaco-­‐ kine:cs   Bioavailability  &   Biopharmaceu:cs   PharmacoGene:cs  &   PharmacoGenomics   Faculdade  de  Farmácia  da  Universidade  de  Lisboa   iMed.UL  (Medicines  Research  Ins:tute)
  • 5. Rogério Gaspar October 24th 2013 The  global  agenda  for  “medicines  research”:   Regulatory  Science   Systems  Approaches:  5  S   Pharmacology   Toxicology   TherapeuEcs   Technologies   Complex   Faculdade  de  Farmácia  da  Universidade  de  Lisboa   iMed.UL  (Medicines  Research  Ins:tute)
  • 6. Rogério Gaspar October 24th 2013   European  Journal  of  Pharmaceu:cal  Sciences  47  (2012):  979-­‐987,  doi  10.1016/j.ejps.2012.09.020   Faculdade  de  Farmácia  da  Universidade  de  Lisboa   iMed.UL  (Medicines  Research  Ins:tute)
  • 7. ©  Rogério  Gaspar,  2013   Personalized  Medicine     &  the  integra:on  of  diagnos:cs  and  therapeu:cs   The  Path  to  Personalized  Medicine   Margaret  A.  Hamburg,  M.D.,  and  Francis  S.  Collins,  M.D.,  Ph.D.   The  New  England  Journal  of  Medicine  June  15,  2010.     The  success  of  personalized  medicine  depends  on  having  accurate  diagnos=c   tests  that  iden=fy  pa=ents  who  can  benefit  from  targeted  therapies.     Increasingly,  however,  the  use  of  therapeuDc  innovaDons  for  a  specific  paDent   is  conDngent  on  or  guided  by  the  results  from  a  diagnosDc  test  that  has  not   been  independently  reviewed  for  accuracy  and  reliability  by  the  FDA.       The  agency's  goal  is  an  efficient  review  process  that  produces  diagnos=c– therapeu=c  approaches  that  clinicians  can  rely  on  and  allows  companies  that   invest  in  establishing  the  validity  and  usefulness  of  tests  to  make  specific,  FDA-­‐ backed  claims  about  benefits.     New  England  Journal  of  Medicine.  The  Path  to  Personalized  Medicine.     hKp://content.nejm.org/cgi/content/full/NEJMp1006304     Faculdade  de  Farmácia  da  Universidade  armácia  da  Universidade  de  Lisboa   Faculdade  de  F de  Lisboa   24/10/13   iMed.UL  (Research  Ins:tute  for  MResearch  Ind  Pharmaceu:cal  Sciences)   iMed.UL  (Medicines   edicines  a ns:tute)   7   01/02/2013
  • 8. Rogério Gaspar October 24th 2013 Where  does  nanotechnology  belong  in  the  map  of  science?   Alan  L.  Porter  and  Jan  You=e,  Nature  Nanotechnology,  (September  2009):  534-­‐536   The  posi:on  of  nanoscience  and  nanotechnology  over  a  base  map  of  science.  Each  node  in  this  map15  is  one  of  the  175  subject  categories  in  the  SCI.  The  size  of  each  node  is  propor:onal  to   the  number  of  nanopapers  published  in  journals  in  each  subject  category  during  the  period  January–July  2008.  Loca:on  on  the  axes  in  this  Kamada–Kawai  algorithm  representa:on  has  no   Faculdade  de  Farmácia  da  Universidade  olouring  to  reflect   inherent  meaning:  the  connec:ng  arcs  and  proximity  reflect  similarity  based  on  cross-­‐cita:on  paDerns,  reinforced  by  cde  Lisboa   the  clustering  of  subject  categories  into   macrodisciplines   iMed.UL  (Medicines  Research  Ins:tute)
  • 9. Liposomal   -­‐  lipidic   ±  targeEng  and     imaging  agents   Technology  Classes   Rogério Gaspar in  clinical  trial  or  the  market   October 24th 2013 Polymer   Conjugates   1  drug   polymer-­‐drug     conjugates  ±     targe:ng/imaging     agents   PEG  (polymer)   -­‐protein     -­‐aptamer  conjugates   Protein/Ab   Conjugates   2  drugs   combinaEon    therapy   lipidic  drug  mixtures   Block     copolymer   micelles   5-­‐25   nm   60-­‐2 00   drug  maybe  entrapped     or  covalently  bound     ±  targe:ng  groups   <1,000   lipidic,  protein  or   polymeric,  inorganic   drug  non   covalently   or  covalent  bound   metallic:-­‐  gold,   silver,    iron  oxide   (polymer  coaEngs   used  to  stabilise)   Crosslinked     (Nano)  Gels   mulElayered   nanoparEcle   nanocapsule,   nanoshell   (NB  many     nanopar:cles     are  not  round)   Nano-­‐sized     drug  crystals   Bioac:ve     Synthe:c     Polymers/Vesicles   Faculdade  de  Farmácia  da  Universidade  de  Lisboa   iMed.UL  (Medicines  Research  Ins:tute)   ©Ruth  Duncan,  2010   ©R.Duncan  and  R.Gaspar,  2011
  • 10. Liposomal   -­‐  lipidic   ±  targeEng  and     imaging  agents   Technology  Classes   Rogério Gaspar in  clinical  trial  or  the  market   October 24th 2013 Polymer   Conjugates   1  drug   polymer-­‐drug     conjugates  ±     targe:ng/imaging     agents   PEG  (polymer)   -­‐protein     -­‐aptamer  conjugates   Protein/Ab   Conjugates   2  drugs   combinaEon    therapy   lipidic  drug  mixtures   Block     copolymer   micelles   5-­‐25   nm   60-­‐2 00   drug  maybe  entrapped     or  covalently  bound     ±  targe:ng  groups   <1,000   lipidic,  protein  or   polymeric,  inorganic   drug  non   covalently   or  covalent  bound   metallic:-­‐  gold,   silver,    iron  oxide   (polymer  coaEngs   used  to  stabilise)   Crosslinked     (Nano)  Gels   mulElayered   nanoparEcle   nanocapsule,   nanoshell   (NB  many     nanopar:cles     are  not  round)   Nano-­‐sized     drug  crystals   Bioac:ve     Synthe:c     Polymers/Vesicles   Faculdade  de  Farmácia  da  Universidade  de  Lisboa   iMed.UL  (Medicines  Research  Ins:tute)   ©Ruth  Duncan,  2010   ©R.Duncan  and  R.Gaspar,  2011
  • 11. 44 marketed Nano-delivery products Product   Abraxane   Abelcet   Generic   Formulation   Indication   Paclitaxel   Polymeric   nanoparticles   Cancer   chemotherapy   Amphotericin B   Liposomal   formulation   Fungal infections   Manufacturer   Celgene     Elan/Alkermes, Enzon,   Cephalon   Product   Generic   Formulation   Indication   Manufacturer   Solid/lipid   nanoparticles   Osteoarthritis   AlphaRx   Inflexal V   Subunit influenza   vaccine   Virosome   Influenza prophylaxis   Crucell   Paliperidone   Nanocrystal   Antipsychotic   Janssen   Indaflex   Indomethacin     Adagen   Adenosine   deaminase   PEGylation   Enzyme replacement   therapy   Enzon, Sigma-Tau     Invega   Sustenna   AmBisome   Amphotericin B   Liposomal   Formulation   Oral and perioral   infections   Astellas/Gilead   Sciences   Macugen   Pegaptanib   Pegylated anti-vegf   aptamer   OSI Pharmaceuticals/   Pfizer   Amphotec   Amphotericin B   Liposomal   Formulation   Oral and perioral   infections   Three Rivers   Pharmaceuticals/ALZA   Age-related   macular   degeneration   nanocrystal   formulation   Moderate to severe   pain   Cancer chemotherapy   Elan/Alkermes, Pfizer   Doxorubicin   citrate complex   Liposome encapsulated   Avinza   Morphine   sulphate   Myocet   Cephalon/Zeneus   Pharma/ Sopherion   Therapeutics   Glatiramer   acetate   Copolymer of lglutamic acid, lalanine, l-tyrosine and l-lysine)   Megace ES   Megestrol acetate   Nanocrystal formulation   Cancer therapy   Multiple sclerosis   Teva Pharmaceuticals   Elan/Alkermes+Par+BristolMyers Squibb   MuGard   Hydrogel mouth rinse   Nanogel   Head and neck cancers   Access Pharma   Chiesi Farmaceutici   SpA   Naprelan   Nanoxel   Neulasta   Naproxen   Paclitaxel   Filgrastim   Oncospar PEGLasparaginase   Nanocrystal formulation   Polymeric nanoparticles   Pegylation   Pegylation   Arthritis, gout   Cancer chemotherapy   Neutropenia   Elan/Alkermes   Dabur Pharma   Amgen   Enzon/Schering-   Plough   Pegasys   Peginterferon alfa   2a   Pegylation   Copaxone     Curosurf   Poractant alfa   Liposome   Neonatal respiratory   distress   DaunoXome   Daunorubicin   PEGylated liposome   Formulation   Cancer   chemotherapy   Gilead Sciences   DepoCyt   Cytarabine   Sustained-release   Liposomes   Cancer   chemotherapy   SkyePharma/Enzon   Depodur   Morphine   sulphate   Liposome   Pacira   Pharmaceuticals   Pacira   Pharmaceuticals   Diprivan   Propofol   Liposomes   Induction of   anesthesia   AstraZeneca   PegIntron   Peginterferon alfa   2b   Pegylation   Doxorubicin   PEGylated liposome   Formulation   Cancer   chemotherapy   ALZA/ OrthoBiotech/   Schering Plough   Rapamune   Sirolimus   Nanocrystal formulation   Renagel   Sevelamer hcl   Poly (allylamine) resin   Salinum   Potassium,   magnesium, chlorine   Somavert   Ritalin LA   Doxil/CaelyX   Oncospar     Cancers   Hepatitis B, hepatitis C   Roche/Nektar   Chronic hepatitis C   Schering-Plough   Immunosuppression   Hyperphosphatemia in hemodialysis   Wyeth Élan/Alkermes   Oral liquid   Xerostomia     Pegvisomant   Polymer protein conjugate   Acromegaly   Pfizer   Methylphenidate   Hcl   Pulsatile release   Nanocrystal formulation   ADHD   Elan/Novartis   Abbott   Abbott Élan/Alkermes   SkyePharma/ First Horizon   Pharmaceuticals/Sciele   Pharma       Elestrin   Elestrin Estradiol gel   Phosphate   nanoparticles   Menopausal   symptoms   BioSante   Elyzol   Metronidazole   Dental gel   Parodontitis Camurus   Camurus   Emend   Aprepitant   Nanocrystal   Formulation   Anti-emetic   Merck & Co+   Elan/Alkermes   Epaxal   Hepatitis A   vaccine   Virosome technology   Prevention of   Hepatitis A infection   Berna Biotech   Episil   Bioadhesive   barrier   Fluidcrystal   Oral pain   Sinclair/Teva   Survanta   Beractant   Liposome encapsulated   Estrasorb   Estradiol gel   Micellar   Nanoparticles   Menopausal   symptoms   Novavax/Espirit   Pharma   Neonatal respiratory distress   Tricor   Fenofibrate   Nanocrystal formulation   Lipid reduction   Focalin XR   Dexmethylphen   idate hcl   Nanocrystals   ADHD   Novartis   Élan/Alkermes   Triglide   Fenofibrate   Nanocrystal formulation   Lipid reduction   Fosrenol   Lanthanum   carbonate   Inorganic   Nanoparticles   End-stage renal   disease   Shire   Genexal PM   Paclitaxel   Polymeric micelles   Cancers   Samyang   Verelan/   Verelan   PM   Verapamil   Elan’s SODAS Hypertension   Multiparticulate technology     Genzyme   Elan/Alkermes Schwarz   Source  BCC  Research   Faculdade  de  Farmácia  da  Universidade  de  Lisboa   iMed.UL  (Medicines  Research  Ins:tute)   01/02/2013
  • 12. 18 marketed Pharmaceutical products Product   Composition   Indication   Company   Rogério Gaspar October 24th 2013 Annual   Sales   ($ Millions)   Abelcet   Amphotericin B/lipid   Fungal infections   Enzon   23   Ambisome   Liposomal   amphotericin B   Fungal infections   Gilead   350   Doxil, Caelyx   Liposomal   doxorubicin   Kaposi’s sarcoma   Ortho, Schering-Plough   360   Depocyt   Liposomal cytarabine   Cancer   Skyepharma   170   Visudyne   Liposomal verteporfin     Age-related macular degeneration   QLT, Novartis   150   Estrasorb   Estradiol in micelles   Menopause   Novavax   130   Adagen   PEG-adenosine   deaminase   Immunodeficiency   Enzon   33   Neulasta   Oncospar   Pegasys   PEG-GCSF   PEG-asparaginase   PEG- α -interferon 2a   Neutropenia   Leukemia   Hepatitis C   Amgen   Enzon   Nektar, Roche   PEG-Intron   PEG-α -interferon 2b   Hepatitis C   Enzon, Schering-Plough   975   Macugen   Pegylated anti-VEGF   aptamer   Age-related macular degeneration   OSI Pharmaceuticals, Pfizer   175   Somavert   Copaxone   PEG-HGH   Copolymer of amino-acids   Acromegaly   Multiple sclerosis   Nektar, Pfizer   TEVA   Renagel   Crosslinked   poly(allylamine) resin   Chronic kidney   Disease   Genzyme   575   Megace ES   Nanocrystalline   megestrol acetate   Eating disorders   Elan, Par   55   Rapamune   Nanocrystalline   sirolimus   Immunosuppression   Elan, Wyeth   340   Abraxane   Paclitaxel proteinbound   nanoparticles   Cancer   Abraxis, AstraZeneca   675   Faculdade  de  Farmácia  da  Universidade  de  Lisboa   iMed.UL  (Medicines  Research  Ins:tute)   500   65   1,650   325   3,250   01/02/2013
  • 13. Rogério Gaspar October 24th 2013 Diagnos:cs  &  Therapeu:cs   Faculdade  de  Farmácia  da  Universidade  de  Lisboa   iMed.UL  (Medicines  Research  Ins:tute)
  • 14. 15 marketed Imaging/diagnostic & biomaterial Product   Lateral flow tests     Composition   Indication   In vivo Imaging   Iron nanoparticles   Liver tumors   Iron nanoparticles   Liver tumors       Iron nanoparticles   Imaging abdominal     structures   In Vitro Diagnostics   Colloidal gold   Pregnancy, ovulation, HIV   etc   Clinical cell separation     Magnetic nanoparticles     Resovist   Feridex/Endorem     Gastromark/Lumirem     Ceram X duo   Filtek Supreme   Mondial     Premise     Tetric Evoceram   Ostim   Perossal   Vitoss   Acticoat   Pacemaker   Immunodiagnostics     Biomaterials   Nanoparticle composite   Dental filling material   Nanoparticle composite   Dental filling material   Nanoparticle-containing Dental restoration   dental prosthesis   Nanoparticle composite   Dental repair     Nanoparticle composite   Dental Repair   Nano-hydroxy apatite   Bone defects   Nano-hydroxy apatite   Bone defects   Nano-hydroxy apatite   Bone defects   Silver nanoparticles   Antimicrobial wound care   Active Implants   Fractal electrodes   Heart failure   Rogério Gaspar October 24th 2013 Company   Schering, Berlin   Advanced Magnetics,   Guerbet   Advanced Magnetics,   Guerbet   British Biocell,   Amersham/GE,   Nymox   Dynal/InVitrogen,   Miltenyl Biotec,   Immunicon   Dentspley   3M Espe   Heraeus Kulzer   Sybron Dental Specialities   Ivoclar Vivadent   Osartis   Aap implantate   Orthovita   Nucryst   Biotronik   Faculdade  de  Farmácia  da  Universidade  de  Lisboa   iMed.UL  (Medicines  Research  Ins:tute)   01/02/2013
  • 15. Rogério Gaspar October 24th 2013 >70 Nanomedical Products in Clinical trials Cardiovascular Diseases   Endocrinology   NCE Brilinta (ticagrelor); AstraZeneca; For the reduction of thrombotic events in patients with acute coronary syndrome, Approved July 2011 NCE Afinitor (everolimus); Novartis; For the treatment of advanced pancreatic neuroendocrine tumors, Approved May 2011   Immunology   Infectious Diseases   Hematology     Musculoskeletal   AB Actemra (tocilizumab); Genentech; For the treatment of systemic juvenile idiopathic arthritis, Approved April 2011 NCE Abstral (fentanyl sublingual tablets); ProStrakan; For the treatment of breakthrough cancer pain in opioid-tolerant patients, Approved January 2011 NCE Abstral (fentanyl sublingual tablets); ProStrakan; For the treatment of breakthrough cancer pain in opioid-tolerant patients, Approved January 2011 NCE Duexis (ibuprofen and famotidine); Horizon Pharma; For the relief of rheumatoid arthritis and osteoarthritis and prevention of gastric ulcers, Approved April 2011 NCEGralise (gabapentin); Abbott; For the treatment of postherpetic neuralgia, Approved February 2011 NANO Adcretris (brentuximab vedotin); Seattle Genetics; For the treatment of Hodgkin lymphoma and anaplastic large cell lymphoma, Approved August 2011 NCE Horizant (gabapentin enacarbil); GlaxoSmithKline; For the treatment of restless legs syndrome, Approved April 2011 NCE Afinitor (everolimus); Novartis; For the treatment of advanced pancreatic neuroendocrine tumors, Approved May 2011     NCE Ferriprox (deferiprone); Apotex; For the treatment of transfusional iron overload due to thalassemia, Approved October 2011 AB Benlysta (belimumab); Human Genome Sciences; For the treatment of systemic lupus erythematosus, Approved March 2011 NCE Xarelto (rivaroxaban); Bayer; For the prophylaxis of deep vein thrombosis during knee or hip replacement surgery, Approved July 2011 NCE Sutent (sunitinib malate); Pfizer ; For the treatment of pancreatic neuroendocrine tumors, Approved May 2011 AB Soliris (eculizumab); Alexion; For the treatment of atypical hemolytic uremic syndrome, Approved September 2011 NCE Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate); Gilead; For the treatment of HIV-1 in treatment-naive adults, Approved August of 2011             Nephrology   Urology     Dermatology   Plastic Surgery   peptide Firazyr (icatibant); Shire; For the treatment of acute attacks of hereditary angioedema, Approved August of 2011   NCE Tradjenta (linagliptin); Boehringer Ingelheim; For the treatment of type II diabetes, Approved May 2011   Gastroenterology   NCE Gralise (gabapentin); Abbott; For the treatment of postherpetic neuralgia, Approved February 2011 NCE Afinitor (everolimus); Novartis; For the treatment of advanced pancreatic neuroendocrine tumors, Approved May 2011 CELL laViv (azficel-T); Fibrocell Science; For the improvement of nasolabial fold wrinkles in adults, NCE Dificid (fidaxomicin); Optimer Pharmaceuticals; For the treatment of Approved June 2011 Clostridium difficile-associated diarrhea, Approved May 2011         NANO Sylatron (peginterferon alfa-2b); Merck; For the treatment of melanoma, Approved April NCE Duexis (ibuprofen and famotidine); Horizon Pharma; For the relief of rheumatoid arthritis and 2011 osteoarthritis and prevention of gastric ulcers, Approved April 2011         NCE Juvisync (sitagliptin and simvastatin); Merck; For the treatment of type II diabetes, Approved October 2011   Oncology   NCE Arcapta (indacaterol maleate inhalation powder); Novartis; For the treatment of airflow obstruction resulting from chronic obstructive pulmonary disease, Approved July 2011 NCE Edarbi (azilsartan medoxomil); Takeda; For the treatment of hypertension, Approved February 2011   Neurology   NANO Adcretris (brentuximab vedotin); Seattle Genetics; For the treatment of Hodgkin lymphoma and anaplastic large cell lymphoma, Approved August 2011 NCE Xarelto(rivaroxaban); Bayer; For the prophylaxis of deep vein thrombosis during knee or hip replacement surgery, Approved July 2011   Otolaryngology   NCE Vandetanib (vandetanib); Astra Zeneca; For the treatment of thyroid cancer, Approved April 2011   Pulmonary   Respiratory Diseases             NCE Daliresp (roflumilast); Forest Pharmaceuticals; For the treatment of chronic obstructive pulmonary disease, Approved February 2011 NBE Nulojix (belatacept); Bristol-Myers Squibb; For the prevention of organ rejection following kidney transplant, Approved June 2011 NCE Lazanda (fentanyl citrate) nasal spray; Archimedes; For the management of breakthrough cancer pain, Approved June 2011 NCE Lazanda (fentanyl citrate) nasal spray; Archimedes; For the management of breakthrough cancer pain, Approved June 2011 NCE Dificid (fidaxomicin); Optimer Pharmaceuticals; For the treatment of Clostridium difficile-associated diarrhea, Approved May 2011 AB Soliris (eculizumab); Alexion; For the treatment of atypical hemolytic uremic syndrome, Approved September 2011 NCE Onfi (clobazam); Lundbeck; For the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome, Approved October 2011 NCE Sutent (sunitinib malate); Pfizer; For the treatment of pancreatic neuroendocrine tumors, Approved May 2011 NCE Oxecta (oxycodone HCl); Pfizer; For the management of acute and chronic moderate to severe pain, Approved June 2011 NANO Sylatron (peginterferon alfa-2b); Merck; For the treatment of melanoma, Approved April 2011 NCE Potiga (ezogabine); Valeant Pharmaceuticals; For the treatment of partial- NCE Vandetanib (vandetanib); Astra Zeneca; For the treatment of thyroid cancer, Approved April onset seizures, Approved June 2011 2011         NCE Edurant (rilpivirine); Tibotec; For the treatment of HIV-1, Approved May 2011   Peptide Firazyr (icatibant); Shire; For the treatment of acute attacks of hereditary   angioedema, Approved August of 2011   Pharmacology   Toxicology           NCE Oxecta (oxycodone HCl); Pfizer; For the management of acute and chronic moderate to severe pain, Approved June 2011         NCE Arcapta (indacaterol maleate inhalation powder); Novartis; For the treatment of airflow obstruction resulting from chronic obstructive pulmonary disease, Approved July 2011 NCE Gralise (gabapentin); Abbott; For the treatment of postherpetic neuralgia, Approved NCE Viibryd (vilazodone hydrochloride); Clinical Data; For the treatment of major depressive NCE Xalkori (crizotinib); Pfizer; For the treatment of ALK+ non-small cell lung cancer, Approved February 2011 disorder, Approved January 2011 August of 2011 NCE Daliresp (roflumilast); Forest Pharmaceuticals; For the treatment of chronic obstructive pulmonary disease, Approved February 2011 NCE Incivek (telaprevir); Vertex; For the treatment of genotype 1 chronic hepatitis C, Approved May 2011 NCE Xalkori (crizotinib); Pfizer; For the treatment of ALK+ non-small cell lung cancer, Approved August of 2011 NBE Nulojix (belatacept); Bristol-Myers Squibb; For the prevention of organ rejection following kidney transplant, Approved June 2011     Rheumatology       antibody Yervoy (ipilimumab); Bristol-Myers Squibb; For the treatment of metastatic melanoma, Approved March 2011   NCE Zelboraf (vemurafenib); Roche; For the treatment of BRAF + melanoma, Approved August of 2011   17 NCE Incivek (telaprevir); Vertex; For the treatment of genotype 1 chronic hepatitis C, Approved May 2011       NCE Rectiv (nitroglycerin) ointment 0.4%; ProStrakan; For the treatment of chronic anal fissure, Approved June 2011     AB Actemra (tocilizumab); Genentech; For the treatment of systemic juvenile idiopathic arthritis, Approved April 2011   NCE Duexis (ibuprofen and famotidine); Horizon Pharma; For the relief of rheumatoid arthritis and osteoarthritis and prevention of gastric ulcers, Approved April 2011   Pediatrics   Neonatology       AB Yervoy (ipilimumab); Bristol-Myers Squibb; For the treatment of metastatic melanoma, Approved March 2011 AB Actemra (tocilizumab); Genentech; For the treatment of systemic juvenile idiopathic arthritis, Approved April 2011 NCE Zelboraf (vemurafenib); Roche; For the treatment of BRAF + melanoma, Approved August of 2011 NCE Daliresp (roflumilast); Forest Pharmaceuticals; For the treatment of chronic obstructive pulmonary disease, Approved February 2011 NCE Zytiga (abiraterone acetate); Centocor Ortho Biotech; For the treatment of prostate cancer, Approved May 2011       Obstetrics   Gynecology   NCE Makena (hydroxyprogesterone caproate injection); Hologic; For the prevention of risk of preterm birth, Approved February 2011   NCE Sutent (sunitinib malate); Pfizer; For the treatment of pancreatic neuroendocrine tumors, Approved May 2011   NCE Victrelis (boceprevir); Merck; For the treatment of chronic hepatitis C genotype 1, Approved May 2011   Pharmacology   Toxicology   NCE Oxecta (oxycodone HCl); Pfizer; For the management of acute and chronic moderate to severe pain, Approved June 2011   NCE Victrelis (boceprevir); Merck; For the treatment of chronic hepatitis C genotype 1, Approved May 2011             NCE Onfi (clobazam); Lundbeck; For the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome, Approved October 2011     http://www.centerwatch.com/drug-information/fda-approvals/drug-areas.aspx?mp=empty Faculdade  de  Farmácia  da  Universidade  de  Lisboa   iMed.UL  (Medicines  Research  Ins:tute)   01/02/2013
  • 16. Nanopharmaceu:cals:     overall  view  of  par:culate  carriers  transla:on   Faculdade  de  Farmácia  da  Universidade  de  Lisboa   iMed.UL  (Medicines  Research  Ins:tute)   Rogério Gaspar October 24th 2013 16
  • 17. Issues •  Rogério Gaspar October 24th 2013 Materials Science –  Challenges arising from new materials (inorganic nanoparticles, nonbiodegradable/ non-biocompatible materials, quantum dots, cationic particles and dendrimeric structures, carbon nanotubes) •  Formulation / Technologies –  Adapting existing technologies to new opportunities (e.g. Quality by Design, Process Analytical Technologies) •  Translational Research –  Adequacy of non-clinical methodology before first in man use (relevance of, appropriate toxicityfficcacy biomarkers and barriers related to disease phase and different routes of administration) •  Clinical development –  Comparability: non-inferiority versus superiority (risk-benefit management) •  Market Access –  Comparative pharmacoeconomic assessment Faculdade  de  Farmácia  da  Universidade  de  Lisboa   iMed.UL  (Medicines  Research  Ins:tute)   17
  • 18. Key factors for design Rogério Gaspar October 24th 2013 (in respect of specific medical use) •  Materials Science and Formulation (Technology) •  Understanding underlying basic molecular mechanisms •  Integrating anatomo-physiological issues with pathology or disease state and its progression •  Changes in biological interactions •  Impact in toxicity and efficacy •  Relevance of animal models (In vitro ??! In vivo !!?) •  Differences both in Pharmacokinetics and Pharmacodynamics •  Translational models adapted to specific questions with “nano” (PK/ PD versus specific organ toxicity and differential uptake of particles – translocation) •  Important issues in clinical development: How to move faster and safer? Comparability towards specific therapeutic indication? Faculdade  de  Farmácia  da  Universidade  de  Lisboa   iMed.UL  (Medicines  Research  Ins:tute)
  • 19. Rogério Gaspar October 24th 2013 (a)  Amphiphlic  fullerene  monomer            able  to  self  assemble     (d)  disc  shaped  silicon              microparEcles     (b)  Amphiphilic  carbon              nanotubes     (e)  quantum  dots     (c)  PEGylated  gold            TNF  alpha     (f)  polyglcerol  dendrimers               (h)  Nanoworm     (g)  PRINT  parEcles       (i)  polystyrene  parEcles   containing  Fe3O4  and  with   quantum  dots  on  the  surface       Duncan,  R.  and  Gaspar,  R.  (2011),  Nanomedicine(s)  under  the  microscope,  Molecular  Pharmaceu:cs,  8  (6),  2101–2141,  DOI:  10.1021/mp200394t     Faculdade  de  Farmácia  da  Universidade  de  Lisboa   iMed.UL  (Medicines  Research  Ins:tute)
  • 20. Rogério Gaspar October 24th 2013 (a)  liposome  containing  two              drugs     (b)  polymer  conjugate                containing  two  drugs   (d)  liposome  containing              gold  nanoparEcles     (c)  liposome  containing  a              polymer-­‐drug  conjugate     (e)  disc  shaped  silicon  parEcles            as  mulEstaged  delivery  systems     Duncan,  R.  and  Gaspar,  R.  (2011),  Nanomedicine(s)  under  the  microscope,  Molecular  Pharmaceu:cs,  8  (6),  2101–2141,  DOI:  10.1021/mp200394t     Faculdade  de  Farmácia  da  Universidade  de  Lisboa   iMed.UL  (Medicines  Research  Ins:tute)
  • 21. Methodology  Harmonisa:on     versus  Technology  Transfer   Marina  A.  Dobrovolskaia  and  ScoZ  E.  McNeil  –    Immunological  properEes  of  engineered  nanomaterials,     Nature  Nanotechnology,  2:  469-­‐478  (2007)   ScoZ  E.  McNeil  -­‐  NanoparEcle  therapeuEcs:  a  personal  perspecEve     WIREs  Nanomed  Nanobiotechnol  2009  1  264–271   Faculdade  de  Farmácia  da  Universidade  de  Lisboa   iMed.UL  (Medicines  Research  Ins:tute)   Rogério Gaspar October 24th 2013
  • 22. Rogério Gaspar October 24th 2013 Technology  (science-­‐based)  strategies   •  Con:nuous  manufacturing   –  Batch  vs  conEnuous   –  Quality  by  Design  (QbD)  &  Process  AnalyEcal  Technologies  (PAT)   –  Microfluidic  processes  for  purposely  engineered  manufacturing  of   nanosystems   •  PRINT  technologies   –  ModulaEon  of  shape  and  size   –  AutomaEon  /  roboEzaEon  of  manufacturing  processes   –  CustomizaEon  /  adequacy  of  manufacturing  to  specific  clinical  needs   •  Integra:on  of  ICT  with  pharmaceu:cals   –  Increased  complexity  in  order  to  find  adequate  medical  intervenEon   –  IntegraEon  of  pharmaceuEcals  with  other  health  technologies   –  NanotheranosEcs   Faculdade  de  Farmácia  da  Universidade  de  Lisboa   iMed.UL  (Medicines  Research  Ins:tute)
  • 23. Rogério Gaspar October 24th 2013 Faculdade  de  Farmácia  da  Universidade  de  Lisboa   iMed.UL  (Medicines  Research  Ins:tute)
  • 24. Rogério Gaspar October 24th 2013 Hook,  A.  L.,  Chang,  C.  Y.,  Yang,  J.,  Scurr,  D.  J.,  Langer,  R.,  Anderson,  D.  G.,  et  al.  Polymer   Microarrays  for  High  Throughput  Discovery  of  Biomaterials.  J.  Vis.  Exp.  (59),  e3636,  doi: 10.3791/3636  (2012).   Faculdade  de  Farmácia  da  Universidade  de  Lisboa   iMed.UL  (Medicines  Research  Ins:tute)
  • 25. Rogério Gaspar October 24th 2013 Belliveau  et  al,  Molecular  Therapy–Nucleic  Acids  (2012)  1,  e37;  doi:10.1038/mtna.2012.28   Leung  et  al,  Journal  of  Physical-­‐Chemistry,  J.  Phys.  Chem.  C  2012,  116,  18440−18450,  doi.org/10.1021/jp303267y     Faculdade  de  Farmácia  da  Universidade  de  Lisboa   iMed.UL  (Medicines  Research  Ins:tute)
  • 26. Rogério Gaspar October 24th 2013 Faculdade  de  Farmácia  da  Universidade  de  Lisboa   iMed.UL  (Medicines  Research  Ins:tute)
  • 27. Intracellular  trafficking  modula:on     for  advanced  drug  delivery   Rogério Gaspar October 24th 2013 Cellular  Uptake  and  Intracellular  Trafficking  of  AnEsense  and  siRNA  OligonucleoEdes   Rudolph  L.  Juliano,  Xin  Ming  and  Osamu  Nakagawa,  Bioconjugate  Chemistry,  2011,    dx.doi.org/10.1021/bc200377d   Endocytosis  and  Intracellular  Trafficking  as  Gateways  for  Nanomedicine  Delivery:  OpportuniEes  and  Challenges   Ruth  Duncan  and  Simon  C.  W.  Richardson,  Molecular  PharmaceuEcs  2012,  dx.doi.org/10.1021/mp300293n   Faculdade  de  Farmácia  da  Universidade  de  Lisboa   iMed.UL  (Medicines  Research  Ins:tute)
  • 28. Rogério Gaspar October 24th 2013 Challenges  from  metas:sa:on  and  recurrence   Klopp  AH,  Lacerda  L,  et  al.  (2010)     Mesenchymal  Stem  Cells  Promote  Mammosphere  FormaEon  and  Decrease  E-­‐Cadherin     in  Normal  and  Malignant  Breast  Cells.  PLoS  ONE  5(8):  e12180.  doi:10.1371/journal.pone.0012180   Murielle  Mimeault  and  Surinder  K.  Batra,     New  promising  drug  targets  in  cancer-­‐  and  metastasis-­‐iniEaEng  cells,     Drug  Discovery  Today,  15(9/1)  354-­‐364  (2010)     Faculdade  de  Farmácia  da  Universidade  de  Lisboa   iMed.UL  (Medicines  Research  Ins:tute)
  • 29. Rogério Gaspar October 24th 2013 Salva:,  A.  et  al.  Nature  Nanotech.  8,  137–143  (2013).     Gaspar  R,  Nanopar:cles:  Pushed  off  target  with  proteins.  Nat  Nanotechnol.  2013  Feb;8(2):79-­‐80.  doi:  10.1038/nnano.2013.11.   24/10/13   Faculdade  de  Farmácia  Assembly  London   de  Lisboa   ETPN  General  da  Universidade   iMed.UL  (Medicines  Research  Ins:tute)   29
  • 30. Rogério Gaspar October 24th 2013 (a)  biological  phenomena  that  can  theore:cally  influence  nanomedicine  fate   solution properties escape through pores, fenestrations, between cells across cells rate  of  flow   pressure     mmHg   unstirred layer diffusion   convecEon   biological barriers cells, membranes, gels, metabolic degradation, protein interaction endothelial cells penetraEon  through   extracellular   matrix  or  a   mucin  barrier   glycocalyx   cellular  uptake  and   membrane  interac:on   receptor  docking,  endocytosis,   exocytosis,  cytosolic  delivery     Duncan,  R.  and  Gaspar,  R.  (2011),  Nanomedicine(s)  under  the  microscope,  Molecular  Pharmaceu:cs,  8  (6),  2101–2141,  DOI:  10.1021/mp200394t     Faculdade  de  Farmácia  da  Universidade  de  Lisboa   iMed.UL  (Medicines  Research  Ins:tute)
  • 31. General approaches to NanoDDS design   Rogério Gaspar October 24th 2013 Petros  and  DeSimone,  Strategies  in  the  design  of  nanopar:cles  for  therapeu:c  applica:ons,    Nature  Reviews  in  Drug  Discovery  ,  9(8):  615-­‐627  (2010)     Alnylam,  media-­‐kit  at  hDp://www.alnylam.com/News-­‐and-­‐Events/Media-­‐Kit.php   Faculdade  de  Farmácia  da  Universidade  de  Lisboa   iMed.UL  (Medicines  Research  Ins:tute)
  • 32. Clinical  Trials     Heidi  Ledford,  “4  ways  to  fix  the  Clinical  trial”,  Nature,  477  (29  September  2011):  526-­‐528     Faculdade  de  Farmácia  da  Universidade  de  Lisboa   iMed.UL  (Medicines  Research  Ins:tute)   Rogério Gaspar October 24th 2013
  • 33. Rogério Gaspar October 24th 2013 Quan:ta:ve  Systems  Pharmacology   Quan:ta:ve  and  Systems  Pharmacology  in  the  Post-­‐genomic  Era:     New  Approaches  to  Discovering  Drugs  and  Understanding  Therapeu:c  Mechanisms  -­‐  An  NIH  White  Paper  by  the  QSP  Workshop  Group  –  October,  2011   Faculdade  de  Farmácia  da  Universidade  de  Lisboa   iMed.UL  (Medicines  Research  Ins:tute)
  • 34. Rogério Gaspar October 24th 2013 Current and future regulatory challenges •  combination therapy –  The trend for reformulation of old APIs, with advantages of combined administration on the same delivery system (issues on quality/stability, PK/PD, clinical, IP, market access) •  potential theranostic approaches –  Combined system that is able to localize to the target pathophysiology and deliver an appropriate therapeutic agent (both diagnostic and therapeutic functions) •  “follow-on” products –  A number of unresolved problems will arise if preventive action is not taken on matters related to old products, previously not classified as nanoparticles that are in fact colloidal nanoparticulate systems Faculdade  de  Farmácia  da  Universidade  de  Lisboa   iMed.UL  (Medicines  Research  Ins:tute)
  • 35. Rogério Gaspar October 24th 2013 AAPS  J,  2013  (In  Press)   Faculdade  de  Farmácia  da  Universidade  de  Lisboa   iMed.UL  (Medicines  Research  Ins:tute)
  • 36. Rogério Gaspar October 24th 2013 Faculdade  de  Farmácia  da  Universidade  de  Lisboa   iMed.UL  (Medicines  Research  Ins:tute)
  • 37. Rogério Gaspar October 24th 2013 New  areas  for  pharmaceu:cal/health  R&D:   Advanced  Therapies   Adapted  from  Patrick  Celis  (EMEA),  April  3rd,  2009   Faculdade  de  Farmácia  da  Universidade  de  Lisboa   iMed.UL  (Medicines  Research  Ins:tute)
  • 38. Rogério Gaspar October 24th 2013 Nanomedicine  NOW  ?   "Converging  today’s  Building  Blocks  to  Ethical  Medicine  -­‐  When   is  Nanomedicine  'NOW'?”   ...  the  answer  is  basically...         •  it  is  already  here  (for  the  last  30  years)  and     •  it  will  improve  clinical  management  performance   –  integra:ng  now  diagnos:cs  and  therapeu:cs  under  the  same   technology  plaxorms,     –  allowing  a  beZer  performance  by  the  healthcare  system   •  ...personalised  (subpopulaEon-­‐driven)  medicine  as  one  of  the  examples...   Faculdade  de  Farmácia  da  Universidade  de  Lisboa   iMed.UL  (Medicines  Research  Ins:tute)
  • 39. Pharmaceutical Sciences beyond 2020 – The rise of a new era in healthcare Faculdade  de  Farmácia  da  Universidade  de  Lisboa   iMed.UL  (Medicines  Research  Ins:tute)
  • 40.   Intracellular  Trafficking  Modula:on  for     Advanced  Drug  Delivery   Bioorganic  Chemistry|Pedro  Góis   Chemical  Biology  and  Toxicology|  Maria  H.  Ribeiro   HIV  Evolu:on,  Epidemiology  and  Preven:on|  Nuno  Taveira   Host-­‐Pathogen  Interac:ons  |  Elsa  Anes   Innova:ve  Plaxorms  for  Non-­‐parenteral  Delivery  Systems  |     Helena  Cabral  Marques   Intracellular  Trafficking  Modula:on  for  Advanced  Drug  Delivery|   Rogério  Gaspar   Medicinal  Chemistry  |  Rui  Moreira   Metabolism  and  Gene:cs  |  Isabel  Tavares  de  Almeida   Molecular  and  Cell  Biology  of  Eukaryo:c  Systems  |Cecília  Rodrigues   Molecular  Microbiology  and  Biotechnology  (M2B)  |  João  Gonçalves   Natural  Products  Chemistry  |  Maria  José  Umbelino  Ferreira   Nanostructured  Systems  for  Overcoming  Biological  Barriers  and   Immune  Response  Modula:on  |  António  José  Almeida   Neuron  Glia  Biology  in  Health  and  Disease  |  Dora  Brites   Pharmacoepidemiology  and  Social  Pharmacy  |  Afonso  Cavaco   Pharmacological  Sciences  |  Beatriz  Silva  Lima   Rogério Gaspar October 24th 2013 Rogério  Gaspar  (Group  Leader)     Bárbara  Mar:ns   Luisa  Corvo   Mafalda  Videira   Helena  Florindo   Liana  C.  Silva  (Ciência/FCT)   Ana  M.  Saraiva  (BPD/FCT)     Joana  Silva,  PhD  student  (BD/FCT)   Ana  Raquel  Varela,  PhD  Student  (BD/FCT)   Diana  Rafael,  PhD  student  (BD/FCT)     Eva  Zupancic,  PhD  student  (BD/FCT)   Ana  Cláudia  Carreira,  PhD  student  (BD/FCT)   Carina  Peres,  PhD  student  (BD/FCT)   João  Conniot,  PhD  student  (BD/FCT)   Nuno  Mar:nho,  PhD  student  (BD/FCT)   Vanessa  Gameiro  Sainz,  PhD  student  (BD/FCT)   Andreia  Giro  dos  Santos,  PhD  student,  Research  Fellow   Faculdade  de  Farmácia  da  Universidade  de  Lisboa   iMed.UL  (Medicines  Research  Ins:tute)

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