Challenges in Clinical Applications for Nanotechnology

1
Challenges in Clinical Applications for
Nanotechnology

• N. Tony Eissa, MD
• Table 3

2
Identifying Clinical Targets

• Short-term Goal
• Take existing mature conventional approach
  (either diagnostic or therapeutic) and enhance
  their efficacy using nano technology.

3
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

4
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

5
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 open-mind
  approach for potential clinical applications.

6
Key Barriers

• Toxicity
• short term - no toxicity in animals
• long term- not known
• Toxicity for both the host and the environment
  should be addressed

7
Key Barriers

• 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

8
Key Barriers

• Delivery
• Ensuring Delivery to target organ/cell
• Allow systemic administration but deliver to
  localized distant sites.

9
Key Barriers

• Language Barriers between various team
  involved in nano medicine such as
• Chemists
• Physicists
• Engineers
• Mathematicians
• Molecular cell biologists
• Clinical Physicians

10
Key Barriers

• GMP Challenges
• No standards for
• Purity and homogeneity of nanoparticles
• Manufacturing Methods
• Testing and Validation

11
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

12
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

13
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

14
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