Open Forum 3
This two-day Open Forum was the third in a series of meetings aimed to raise and address key issues in TB drug development, with a special focus on regulatory affairs.
The Forum included sessions on the current global TB drug development portfolio, key issues in the critical path to TB drug registration, designing pivotal trials, conducting registration trials in high burden countries, challenges in TB drug development for resistant disease and developing regimens containing multiple novel agents.
These meetings are designed to bring together regulators, TB drug developers and other interested stakeholders, such as TB care providers, public health policy-makers, and community advocates from both major industrialized and high burden countries.
Click here to download the Final Meeting Agenda [.pdf - 134k]
This meeting was supported in part by unrestricted educational grants from AstraZeneca, Bayer, GlaxoSmithKline, Johnson & Johnson/Tibotec and sanofi-aventis.
view a webcast of the Open Forum 3 courtesy of Kaiser Family Foundation
Day One: 5 May 2008
- Status of the TB Drug Pipeline
- V. Balasubramanian, AstraZeneca
Discovery
.pdf - 2,200kb - Ann Ginsberg, TB Alliance
Clinical Development
.pdf - 436kb - Update on MDR/XDR TB
- Sarita Shah, Albert Einstein College of Medicine; Tugela Ferry Care and Research Collaboration (TF CaRes)
Epidemiology
.pdf - 4,600kb - Ernesto Jaramillo, World Health Organization
Current Standards of Care
.pdf - 228kb - Rachel Ross, Partners in Health
MDR TB: What is its impact on the community?
.pdf - 2,600kb - Issues in TB Drug Development for Sensitive Disease
-
Koen Andries, Tibotec
Preclinical Development
.pdf - 1,200kb - Christian Lienhardt, International Union Against Tuberculosis and Lung Disease
Clinical Development
.pdf - 440kb - Andrew Nunn, Medical Research Council, Clinical Trials Unit
Statistical Issues: Non-inferiority Design; Phase 3 Endpoints
.pdf - 192kb - Issues in TB Drug Development for Resistant Disease
- Charles Wells, Otsuka
"Strawman" Clinical Development Program
(presentation not available) - Mark Goldberger, Abbott Laboratories
Challenges for TB Drug Development
.pdf - 192kb - Regulatory Requirements for New TB Drugs in ASEAN Countries
- Abida Haq, National Pharmaceutical Control Bureau, Malaysia
Overview of the ASEAN Pharmaceutical Regulatory Harmonization Process: Activities of the Pharmaceutical Products Working Group of the ASEAN Consultative Committee on Standards and Quality
.pdf - 444kb - Tharnkamol Chanprapaph, Food and Drug Administration, Thailand
TB Drug Approval Guidelines in Thailand
.pdf - 212kb - Dinner Presentations
- Anand Grover, Lawyers Collective
Rights Based Approach in HIV/AIDS
.pdf - 56kb - Wim Vandevelde, European AIDS Treatment Group
Community as Allies in the Regulatory Process
.pdf - 544kb
Day Two: 6 May 2008
- Progress in the Development of EU Regulatory Guidance on the Clinical Development of New Agents for the Treatment of Tuberculosis
- Mair Powell, U.K. Medicines and Healthcare Products Regulatory Agency
.pdf - 1,800kb - Article 58: "A Route to Scientific Opinion"
- Eric Pelfrene, European Medicines Agency
.pdf - 2,500kb - The South African Medicines Control Council: Processes for Approval of New TB Drugs
- Rajen Misra, Department of Health
(presentation not available) - Advice to Sponsors: Meeting Regulatory Requirements for New TB Drug Approvals in China, India and Japan
- Huo Xiumin, China State Food and Drug Administration
.pdf - 388kb - Ashwini Kumar, Apothecaries Foundation, India
.pdf - 132kb - Junko Sato, Pharmaceuticals and Medical Devices Agency, Japan
.pdf - 1,100kb - Process for Incorporation of New TB Drugs into the WHO Essential List
- Nigor Mouzafarova, The World Health Organization
.pdf - 196kb - Challenges and Processes for Adoption of New TB Drugs
- Wang Ni, National Center for TB Control and Prevention, China
Processes Required to Change National TB Treatment Guidelines — China
.pdf - 264kb - KS Sachdeva, Central TB Division, Directorate General of Health
Services, India
Processes Required to Change National TB Treatment Guidelines — India
.pdf - 184kb - Tiar Salman, National TB Control Program, Indonesia
Processes Required to Change National TB Treatment Guidelines — Indonesia
.pdf - 1,300kb - Vu Xuan Phu, National TB Control Programme Manager, Viet Nam
Processes Required to Change National TB Treatment Guidelines — Viet Nam
.pdf - 1,300kb - Obatunde Oladapo, Positive Life Association of Nigeria
Role of Civil Society in Adoption of New Drugs through Retooling and Creating Consumer Demand
.pdf - 948kb - > click here to download all of the available presentations (.zip - 18,002kb)
Event Details
5-6 May 2008
InterContinental Hotel Nehru Place
New Delhi, India
Event Links
Final Meeting Agenda [.pdf - 134k]
Speaker and Moderator Bios [.pdf - 168k]
Sponsor Descriptions [.pdf - 100k]
Sponsors
