anfim - World Health Organization

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anfim - World Health Organization
ANFIM
Association of Needle Free
Injection Manufacturers
ANFIM MISSION
The Mission of ANFIM is to promote
and protect public health through the
advancement of needle-free injection
technology.
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ANFIM GOALS

Our Mission is achieved by the
accomplishment of the following Goals:
– Advocacy: Providing exposure, education, and
information to the healthcare, pharmaceutical, and
health insurance industries and to consumers.
– Image: Creating a positive, professional image
for the needle-free industry.
– Information: Providing members with access to
information regarding industry issues.
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ANFIM MEMBERS

Class 1: Manufacturer
– Antares Pharma (Mediject) - Bioject, Inc.
– Equidyne Systems, Inc.
- Keystone Industries

Class 2: Developer
– DCI, Inc.
– Team Consulting Ltd.

Class 3: Related Industry Members
– Eli Lilly & Company

- Felton International
- PowderJect Vaccines
- Novo Nordisk A/S
Class 4: Representatives from
– Centers for Disease Control (CDC)
– Program for Appropriate Technology in Health (PATH)
– US Food and Drug Administration (FDA)
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Needle Free Technology

What problems does it solve
–
–
–
–
–
–
–
Avoids needle stick hazard
No sharps disposal problems
Eliminates the concern for the re-use of needles
Injection pain is reduced in most cases
Speeds the injection cycle
Improved bio-availability of vaccines
Reduces the system cost of injection
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Needle Free History

In use since 1947
– Military
– International Public Health Campaigns

Widely used for mass immunizations and disease
eradication.
– Smallpox (1975)
– Polio (when injected)
– Measles (Brazil; 1990 to 1996)
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Needle Free Requirements for
the Developing World

Safety
– Pathogen Transfer Issues
– Disposal of Bio-Hazardous Material

Speed
– High Thru-put

Ease of Use
– Minimize training
– Reduce repetitive motion injuries for health care workers
– Simplify maintenance and spares logistics

Energy
– Should be capable of being self powered

Cost
– Must be comparable or less than traditional needle and
syringe on a per injection basis
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Review of the Industry

The following slides will provide a company by
company review of the state of the art.
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TEAM CONSULTING
www.team-consulting.com

TEAM is one of the leading product development
consultancies in the U.K., primarily serving the
medical device and healthcare markets.

Developing CHEMOMOTOR
– Motor Technology for Needle-free and Needled
Auto-injectors




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Low cost energy source
Tailored power profiles
Several thousand injections from a single filled device
Silent operation
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PowderJect
DNA Vaccines
Advantages:
 Direct Intracellular Delivery


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1,000-fold less DNA than Needle & Syringe delivery
– Lower Cost
– Safer
Elicits both Antibody and Cellular Responses
– Potential for both Px and Rx products
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PowderJect
Hepatitis B DNA Vaccination


PowderJect has
achieved both antibody
and cellular responses
PowderJect uses up to
2,500x lower dose
Company – Program
Humoral
Response
(antibodies)
Merck – Flu
(to 500 µg DNA)
Sporadic
after 3 doses
N/A
None Reported
Marginal
None
4/5 subjects were
positive for CTL
Wyeth – HSV & HIV
(to 300 µg DNA)
PMC – Malaria
(to 2,500 µg DNA)
PowderJect – HBV
(1-4 µg DNA)
Cellular Response
Protective level
8/8 evaluable
antibodies in all 12 subjects had cellular
subjects
responses
PowderJect is the world leader in DNA
vaccination
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Bioject
www.bioject.com

Biojector 2000
– Designed for the professional healthcare
market
 Immunization
programs
 Hospitals
 Clinics

Self Injectors
– Spring powered
– CO2 powered with electronics
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Why Consider the Bioject
Needle Free System ?

Proven Technology -- safer, faster, less invasive

Cost savings -- reduces expense of sharps waste disposal

Workforce Protection -- prevents dangerous and expensive
needle stick injuries; meets new OSHA safety requirements

Clinical efficacy -- improves vaccine efficacy, faster onset of
desired immune response

Operational Flexibility -- safely and quickly gives
immunizations, even in non- clinical locations

Patient Compliance -- patients prefer needlefree over the
needle and syringe
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from DCI, Inc.
LectraJet HS (high speed)
Jet Injection Kit (pat. pend.)
For Mass Immunization Campaigns
Funding provided by
Centers for Disease Control and Prevention
(SBIR Contract # 200-2000-10049)
Linda D’Antonio, DCI, Inc.
[email protected]
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LectraJet HS
Key Requirements

Eliminate the risk of cross-infection

High Speed – up to 600 shots per hour
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LectraJet HS

Single-use-auto-disable Ampules

DCI Ampule Management System
– Rapid retrieval and ejection of Ampules
– No contact with Ampule before or after shot
– On-site Ampule filling system

Electrical or Manual Power

Complete injection Kit
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Issues for Campaigns

Safety
– Eliminate risk of pathogen transfer


Re-use of needles
Nozzle contamination
– Eliminate sharps disposal

Speed
– Up to 600 injections per hour

Cost
– Comparable or less than the cost of needle and
syringe systems
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Thank You
ANFIM
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New York City School
Survey
1. How was this injection?
fdfdfas
Better than fdsfsaf
a needle
fdafdsfas
About the same
Rather haveggdfsf
a needle
No. of Responses
529
110
69
Percent
75%
15%
10%
2. Were you more comfortable knowing you were getting a needle-free injection?
fdfdfas
fdsfsaf
Yes
fdafdsfas
No
Don’t knowggdfsf
No. of Responses
526
67
115
Percent
74%
10%
16%
3. Next time, would you rather have a needle-free injection?
fdfdfas
Yes
fdsfsaf
fdafdsfas
No
ggdfsf
No preference
No. of Responses
602
33
73
Percent
85%
5%
10%
This survey represents 709 student patients who received their
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Hepatitis B immunization during the first round of injections.
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Oklahoma Preference Survey
Graph 2: Clients receiving multiple injection only.
Were you satisfied with your needle-free injection method?
No = 3%
Yes = 87%
Don't Know
= 10%
Results from those clients receiving multiple injections with the
Biojector were tabulated, showing an 87% satisfaction rating for the
needle-free system.
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