| international clinical trials registry platform1 innovation of new antibiotics who technical...
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| International Clinical Trials Registry Platform1
Innovation of New Antibiotics
WHO Technical Briefing Seminar
Zafar Mirza
04 November 2014
WHO , Geneva
Public Health, Innovation and Intellectual Property / EMP
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Innovation of New Antibiotics
1. Do we need new antibiotics? Is there a problem?
2. Why it is a problem?
3. What is happening to overcome this problem?
4. What more needs to happen and why?
"If current trends continue unabated, the future is easy to predict. Some experts say we are moving back to the pre-antibiotic era. No. This will be a post-antibiotic era. In terms of new replacement antibiotics, the pipeline is virtually dry, especially for gram-negative bacteria. The cupboard is nearly bare."
"A post-antibiotic era means, in effect, an end to modern medicine as we know it. Things as common as strep throat or a child’s scratched knee could once again kill."
Keynote address at the conference on Combating antimicrobial resistance: time for action ,
Copenhagen, Denmark, 14 March 2012
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Trends in susceptibility to anti-microbials – gonococcal infection
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Discovery of new classes of antibacterial drugs (1930s to 2000s)
WHO, 2012. The evolving threat of antimicrobial resistance. Options for action.
Need for development of therapies that do not drive resistance!
In recent decades, only 2 new classes of antibiotics have come to market, and there is dearth of novel antibiotics in the pipeline.
2012• "A serious market failure"
• "the spread of resistance to antibiotics is detrimental to public health and necessitates further R&D which is insufficiently incentivised and scientifically challenging."
• "a particular cause for concern currently is the low level of investment in R&D on antibiotics.
| Health Systems and Innovation8
CEWG on R&D for Antibiotics
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Innovation of New Antibiotics
1. Do we need new antibiotics? Is there a problem?
2. Why it is a problem?
3. What is happening and where?
4. What more needs to happen and why?
Disincentives for investing in R&D for new antibiotics
1. Infectious diseases are less common in HICs
2. Most infections are acute conditions requiring short treatments
3. Prescription only products
4. "Preservation of new antibiotics" mean less use
5. Antibiotics quickly develop resistance
Bigger Problem
A recent study* found that of the 850 new medical products registered from 2000 to 2011: only 37 (4%) were indicated for neglected diseases; 148445 clinical trials registered in Dec 31, 2011, only 2016 (1%) were for neglected diseases.
* The drug and vaccine landscape for neglected diseases (2000–11): a systematic assessment. By Belen Pedrique, Nathalie Strub-Wourgaft, Claudette Some, Piero Olliaro, Patrice Trouiller, Nathan Ford, Bernard Pécoul, Jean-Hervé Bradol. The Lancet 2013
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Innovation of New Antibiotics
1. Do we need new antibiotics? Is there a problem?
2. Why it is a problem?
3. What is happening and where?
4. What more needs to happen and why?
• Biomedical Advanced Research and Development Authority (BARDA), part of the US DHHS: Broad Spectrum Antimicrobials (BSA) program e.g. porfolio partnership with GSK $ 200 million over 5 years.
• IMI’s PPP model is based on a 50:50 partnership between the EC and the European Federation of Pharmaceutical Industries and Associations – ND4BB, since 2012 projects amounting to 600 million Euros
• UK Longitude Prize 2014. 10 million pounds prize, the challenge set is to create a cost-effective, accurate, rapid and easy-to-use test for bacterial infections.
Some major initiatives to foster innovation of new antibiotics and diagnostics
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Innovation of New Antibiotics
1. Do we need new antibiotics? Is there a problem?
2. Why it is a problem?
3. What is happening and where?
4. What more needs to happen and why?
2001
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Current Situation
IMI IFPMA manufacturiers
Company A
Market
EU, US or other investors
$300M/project
Irrational use of antibiotics
Market fall off in few years w resistance
Antibiotic X
IPIP Licensed to Agrobusiness Subsidiary Y
Proposed Initiative: Innovation for AMR
Innovation Development Production (under contract)
Managed Market
Prizes
Initiative Consortium IP
IFPMA, Generic manufacturers
WHO IP
AcademicsBiotechs
BiotechsPharma
Pharma
Approx $2B
Antibiotic X, Y, Z…