case study nanotechnology - australian pesticides and ... · concluding thoughts • regulations...
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Case study nanotechnology
Phil Reeves | 5 November 2014 APVMA Advisory Board Futures Forum 2014
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Outline of case study
Part 1: Regulating new technologies
• the importance of effectively regulating advanced
technologies
• new technologies in veterinary medicine
Part 2: Individualized and targeted drug therapy
• what is the challenge?
• does nanotechnology offer a solution?
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Technology-driven advances
continued advances in computer technology
microfluidics
nanotechnology
high-throughput screening
increased control and targeting of drug delivery
increased knowledge of pharmacogenomics
Future drug developments in veterinary medicine
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The importance of effectively
regulating advanced technologies
Is the regulatory framework developed for mid- and
late-20th century drugs and technology appropriate for
effectively regulating 21st century products?
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The most important single advance in
veterinary pharmacology/therapeutics
over the next 35 years
‘Improving the method by which regulatory agencies approve veterinary medications for animals, so that sponsors will be encouraged to bring more compounds forward to meet the needs of animals and the veterinarians who treat them’ Professor Mark Papich
‘Pharmacodynamics ……… provided that (a) companies consider research and innovation as their pivotal role; and (b) regulatory authorities do not apply the brake of precautionary principle but rather seek to understand and facilitate innovations.’ Professor Pierre Louis Toutain
Source: Lees P et al (2013) J Vet Pharmacol Ther 36:105-115
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The most important single advance in
veterinary pharmacology/therapeutics
over the next 35 years
‘Advances in nanotechnologies with novel and beneficial applications in veterinary medicine’ Phil Reeves
‘Individualized and targeted drug therapy across all species, using miniature sensing and delivery devices, some with embedded PK-PD algorithms or using nanodelivery platforms that provide local feedback on delivery mechanisms’ Professor Jim Riviere
Source: Lees P et al (2013) J Vet Pharmacol Ther 36:105-115
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Part 2: Individualized and targeted
drug therapy
• what is the challenge?
• does nanotechnology offer a solution?
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Meeting public health expectations in
the 21st century
There is a need to develop new antimicrobial drugs having
minimal impact on gut flora and on environmental bacterial
ecosystems.
This need might be met either by developing:
• new antimicrobial drugs; or
• new formulations of existing drugs to guarantee an
appropriate pharmacokinetic (PK) profile and/or
pharmacodynamic (PD) selectivity for target pathogens
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Appropriate pharmacokinetic profile
Salicylate half-life values:
Goat 0.8 hours
Horse 1 hour
Pig 5.9 hours
Dog 8.6 hours
Cat 37.6 hours
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Appropriate pharmacodynamic
selectivity for target pathogens Time-dependent effects
• time that plasma concentration > MIC for most of the dosing interval
Concentration-dependent effects
• do not need to maintain plasma concentration > MIC
Time
Pla
sma
Co
nc.
MIC
Time
Pla
sma
Co
nc.
MIC
Time
Pla
sma
Co
nc.
MIC Key: MIC = minimum inhibitory concentration
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Pre-2014 two of the nanomaterials
used in drug delivery
Liposome Dendrimer
Images copyright Russell Kightley
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2014 Report of a novel nanomaterial
Panel A: Amphiphilic Janos dendrimer depicted in 2-D
Panel B: Amphiphilic Janos dendrimer depicted in 3-D
Key: Hydrophilic and hydrophobic components are shown in blue and green, respectively.
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Microfluidic device
• coupled to microcomputers containing pharmacokinetic (PK) algorithms to optimise dosage regimens, thereby facilitating individualization of therapeutics
Image copyright Russell Kightley
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Lotus effect
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Release of drug by photo-triggering
Image copyright Russell Kightley
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Concluding thoughts
• regulations developed for mid- and late-20th century
drugs and technology need updating and harmonising to
effectively regulate 21st century products
• regulatory boundaries applicable to various combination
products need to be clarified e.g. drug and delivery
devices, implanted physiological feedback systems and
nanoparticle drug carriers
• scientists with new perspectives and expertise need to
be appointed while others with experience to integrate
new technologies into the regulatory assessment
systems should be retained
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Thank you for your attention!