Embed Size (px)
Citation preview
Public-Private Partnerships for Novel TB Therapies – CPTR
Can Better Collaboration Among Regulators Facilitate Access?
Pre-ICDRA, Singapore, 2010
Vincent Ahonkhai, MD
2
Outline
The problem
New paradigm
New partnerships
What can regulators contribute?
Summary & what you yourself can do
3
TB is still a major disease
• 9.4 million new cases
• 11.1 million total cases
• 1.3 million deaths among HIV negative patients
• 0.5 million deaths among HIV positive patients
• 0.5 million Multi Drug Resistant TB patients
Slide adapted from: Jeremiah Chakaya’s presentation at TB Open Forum 4 meetings in Addis Ababa, 18-19 August 2010
4
Global disease
Slide adapted from Haileyesus Getahun’s presentation at TB Open Forum 4 meetings in Addis Ababa, 18-19 August 2010
WesternPacific
SoutheastAsia
Africa
Europe
EMRAmericas
55% of cases in Asia
34%
5
No new drugs since the 1970s
Slide adapted from: Barbara Laughon’s presentation at TB Open Forum 4 meetings in Addis Ababa, 18-19 August 2010
1940 1950 1960 1970 1980 1990 2000 2010
1943Streptomycin
(S)
1948PAS
1952Isoniazid (H)
1954Pyrazinamide (Z)
1955Cycloserine
1957Kanamycin
1960Ethionamide
1961Ethambutol (E)
1963Capreomycin
1963Rifampicin (R)
6
Current TB regimens
Slide adapted from: Ngozi Erondu’s presentation at TB Open Forum 4 meetings in Addis Ababa, 18-19 August 2010
Patient Population• Drug-Susceptible DS-TB
• Drug-Resistant M(X)DR-TB
• TB/HIV Co-Infection
• Latent TB Infection
Need shorter, simpler, more affordable therapies against both DS and DR-TB
Current Therapy• 4 drugs; ≥ 6 month therapy
(2RHZE + 4RH)
• Few drugs (including injectables); ≥ 18 months; toxicities
• Drug-drug interactions (DDI) with ARVs
• 6-9 months H
* Rifampin (R), Isoniazid (H), Pyrazinamide (Z), Ethambutol (E)
7
The problem
New paradigm
New partnerships
What can regulators contribute?
Summary & what you yourself can do
8
What is the Critical Path to TB drug Regimens (CPTR)?
Slide adapted from: Jan Gheuens’ presentation at TB Open Forum 4 meetings in Addis Ababa, 18-19 August 2010
Main goal of CPTR: to accelerate the development of new, safe, highly effective and shorterduration TB regimens through early drug combination testing prior to individual drug approval.
9
Need novel regulatory science
Need to develop new “regulatory science” to facilitate TB drugdevelopment
1. Biomarkers – early bactericidal activity
2. Identify animal models
3. New clinical trial designs – factorial trials
4. Different pathways for drug-sensitive vs. drug-resistant disease
Slide adapted from: Jan Gheuens’ presentation at TB Open Forum 4 meetings in Addis Ababa, 18-19 August 2010
10
The problem
New paradigm
New partnerships
What can regulators contribute?
Summary & what you yourself can do
11
CPTR initiative
Slide adapted from: Jan Gheuens’ presentation at TB Open Forum 4 meetings in Addis Ababa, 18-19 August 2010
CPTR InitiativeBMGF, in association with the TB Alliance and C-Path, will work to
accelerate the development of new TB drug regimens
- Data Standards/Integration- New clinical trial designs- Qualified Biomarkers- Disease Progression Models
CPTR RegulatoryScience Consortium
1CPTR Drug
Development Coalition
2CPTR Infrastructureand implementation
3
- Drug combination testing anddevelopment
- Clinical trial capacity- Regulatory harmonization- Funding
C-PATH partners- TB Alliance- Pharma companies- Regulators- Academia/research- Patient representatives
TB Alliance partners- Pharma companies
BMGF partners- TB Alliance- Pharma companies- NIH, CDC- Regulators- Other funders- Patient representatives- RUF
Focus
12
TB partnerships are extensive
Slide adapted from: Jan Gheuens’ and Barbara Laughon’s presentations at TB Open Forum 4 meetings in Addis Ababa, 18-19 August 2010
13
The problem
New paradigm
New partnerships
What can regulators contribute?
Summary & what you yourself can do
14
Launch of the CPTR initiative
Slide adapted from: Jan Gheuens’ presentation at TB Open Forum 4 meetings in Addis Ababa, 18-19 August 2010
15
Regulators’ view from disease-endemic regions
Should regulators and developers not work together earlier during the development phases?
Should multi-center clinical trials not routinely include sites in countries with a heavy burden of disease?
Should we not lobby for better attention to pediatric & geriatric medicines?
How do we foster transparency & funding for R&D of TB medicines – a shift from traditional methods?
Slide adapted from: Mandisa Hela’s presentation at TB Open Forum 4 meetings in Addis Ababa, 18-19 August 2010
16
The problem
New paradigm
New partnerships
What can regulators contribute?
Summary & what you yourself can do
17
Summary: CPTR partnership
Who?
What?
How?
18
What you yourself can do
Identify who can join CPTR from:
1. Your NRA2. Your Regional Harmonization group – ICH, EMA,
ASEAN, PANDRA, GCC, AMRH, etc.
How can you facilitate clinical trials in high-burdenTB regions:
Contact [email protected] and [email protected]
19
Thank you
![TB was first identified in 460 BCE by Hippocrates and ... · CPTR (critical path to TB [drug] regimens) 20112011 BCG vaccine introduced 1921 FDA approves Bedaquiline, the first new](https://img.pdfslide.net/doc/110x75/5eda591eb3745412b571312b/tb-was-first-identified-in-460-bce-by-hippocrates-and-cptr-critical-path-to.jpg)
