Transcript Challenges in Clinical Application for Nanotechnology

Challenges in Clinical
Applications for Nanotechnology
• N. Tony Eissa, MD
• Table 3
Identifying Clinical Targets
• Short-term Goal:
• Take existing mature conventional approach
(either diagnostic or therapeutic) and
enhance their efficacy using nano
technology.
Identifying Clinical Targets
• Diagnosis:
• Early Detection of Cancer: Use
nanoparticles with multiple probes to detect
pre-defined changes in specific protein
levels in pre-cancerous cells.
• Imaging for micrometastasis
• Staging of Cancer
Identifying Clinical Targets
• Therapy:
• Drug Delivery: Use nanoparticles targeted
to specific cancer cell surface receptors to
guide delivery
• Form translational alliance between current
biotechnology and nanomedicine
Identifying Clinical Targets
• Some clinical areas amenable to wide use of
nanomedicine include Cancer, Diabetes,
Thrombosis, Vascular diseases, etc.
• It is important to emphasize to keep openmind approach for potential clinical
applications.
Key Barriers
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Toxicity:
short term - no toxicity in animals
long term- not known
Toxicity for both the host and the
environment should be addressed
Key Barriers
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Conjugation Chemistry Challenges:
Making nanoparticles that are application-specific
Putting the “drug” on the particle
Maintaining drug activity on the particle
Making the drug come off the particle once
application is done
Key Barriers
• Delivery:
• Ensuring Delivery to target organ/cell
• Allow systemic administration but deliver to
localized distant sites.
Key Barriers
• “Language” Barriers: between various team
involved in nano medicine such as:
• Chemists
• Physicists
• Engineers
• Mathematicians
• Molecular cell biologists
• Clinical Physicians
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GMP Challenges
No standards for:
Purity and homogeneity of nanoparticles
Manufacturing Methods
Testing and Validation
Action Items
• Encourage nano applications to already mature
area of research
• Use nano technology to enhance existing
diagnostic or therapeutic applications, e.g.,
imaging, drug delivery
• Use established cellular recognition systems for
delivery testing
Action Items
• Establish NIH programs and review groups that
are “nano-friendly”
• Fund more toxicological studies for nano
applications
• Increase funding for conjugation chemistry for
nano particles
Action Items
• Establish training programs in nano medicine with
a focus on interdisciplinary approach
• Undergraduate
• T32 graduate and post-graduate
• K12 program for nano medicine scholars
• K08, K23 physician scientist programs in nano
medicine
Action Items
• GMP
• NIH and FDA need to discuss with the scientific
community standards for GMP and made this
information available to investigators rather than
leaving the burden of proof to individual
investigators