Tido von SchoenAngerer, MD

1

Research needs for treatment and for
point-of-care diagnostics of TBRio de Janeiro,
January 23, 2009
Tido von Schoen-Angerer, MD Executive
Director Campaign for Access to Essential
Medicines
2
TB and MSF

• 25,400 TB patients in 31 countries (83 projects)
  in 2007
• 574 MDR patients in 12 projects in 2007

3
Major gaps and research needs

• Urgent need to improve MDR treatment
• 500,000 new MDR-TB cases/ year, lt 30,000 notified
  in 2007, of notified 3681 started on treatment in
  GLC approved programmes Global TB Control 2009,
  WHO
• Recommendations for MDR-TB treatment mainly based
  on expert opinion and observational studies.
• Regimens vary substantially, from standardized
  4-5-drug regimens given for lt 18 months, to
  individualized 24-month regimens utilizing gt 5
  drugs.
• Treatment outcomes of patients with MDR-TB remain
  suboptimal
• Long duration and toxicity of drugs lead to
  relatively high default rates /- 15
• Treatment success slightly above 60 in
  GLC-approved sites.
• Drug RD goals
• Short term improve MDR treatment trial new
  drugs in MDR patients
• Long term develop new first regimen that is also
  active against MDR
• Need for a point-of-care test to better detect
  active TB
• Smear microscopy insensitive, requires at least 2
  sputum,is labour intensive, has a subjective
  readout and requires external QA.

4
- Research Excellence to Stop TB Resistance -
RESIST-TB

• Workshop on Clinical Trials for DR-TB, held in
  Cambridge, MA, USA (June, 2008) -
  http//www.ghdonline.org/drtb/
• Mission for RESIST-TB
• To promote and conduct clinical research to cure
  and prevent drug-resistant TB throughout the
  world
• Goals
• Develop trial(s) to shorten treatment for DR-TB,
  without reducing effectiveness
• Develop trial designs to isolate the activity of
  individual drugs in DR-TB regimens and to
  optimize their dosing and duration
• Develop trial(s) to reduce the incidence of TB
  among close contacts of patients with DR-TB

5
New Diagnostics Technologies for TB
Source Stop TB Partnership, Retooling Task
Force New Diagnostic Technologies for
Tuberculosis Control. 2008
6
Expert Meeting on Defining Test Specifications
for a TB point-of-care testParis, March 17 18,
2009

• Objective reach agreement on minimum
  specifications that meets medical needs
• Approx. 30 clinicians, laboratory experts and
  test developers
• Preceding  expert check  survey
• 30 participants from 17 different countries
  surveyed by phone TB practitioners involved at
  all levels of care, professionals in charge of TB
  programs at national level or working in a
  research institution

7
Towards TB POC test specifications

• Outcome of expert workshop hosted by MSF, TAG,
  PIH, Paris, March 17-18, 2009

8
Towards TB POC test specifications
9
Towards TB POC test specifications
10
Stimulating RD for a TB POC next steps

• Finalise and validate specifications through
  wider user survey
• Need for a clearing house with open access to
  information and regular, rigorous evaluation of
  progress of different areas (biomarkers,
  platforms etc)
• Adequacy of specimen banking system need to be
  assessed/improved.Need common specimen bank to
  assess markers
• Current candidate biomarkers need to be
  systematically evaluated
• Develop methodologies to evaluate, verify and
  validate POC test (to be done by NDWG blueprint?)
• Need for more actors to become involved
• Need for more funding and new funding mechanisms,
  incl. a prize fund for a TB point-of-care test

11
Stimulating innovation and access ia

• WHO Commission on Intellectual Property,
  Innovation and Public Health, 2006 There is no
  evidence that the implementation of the TRIPS
  agreement in developing countries will
  significantly boost RD in pharmaceuticals on
  Type II and particularly Type III diseases.
  Insufficient market incentives are the decisive
  factor.
• WHA resolution 60.30 (2007) Calls on WHO to
  encourage the development of proposals for
  health-needs driven research and development
  also addressing the linkage between the cost of
  research and development and the price of
  medicines, vaccines, diagnostic kits and other
  health-care products...

12
Intergovernmental Working Group on Public Health,
Innovation IP 2006 - 2008

• Ensure intellectual property barriers do not
  prevent access
• WHO to explore innovative ways for stimulating
  RD, such as Prize fund, and that do not cause
  high prices ?e.g. Bolivia Barbados proposals
• Look into patent pools to promote both innovation
  and access to patented technologies ? UNITAID
  medicines patent pool
• Promote public access to the result of government
  funded research and the creation of open
  databases and compound libraries to facilitate
  innovation
• Explore utility of an essential health and
  biomedical RD treaty as a mechanism for
  sustainable financing of essential RD
• Expert working group on innovative sources of
  financing for RD established, examining
  proposals in 2009